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Code · REGISTER · 2007-07-03 · Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services · Notices

Notices. Notice of intent

48,762 words·~222 min read·/register/2007/07/03/07-3218

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6210-01-S-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-232] Intent To Develop Two Interaction Profiles AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services. ACTION: Notice of intent. SUMMARY: This notice announces the intent of ATSDR to develop two interaction profiles. DATES: The development of the interaction profiles will start on or about July 15, 2007. ADDRESSES:
Previously completed interaction profiles are available on the ATSDR Web site, *http://www.atsdr.cdc.gov.* FOR FURTHER INFORMATION, CONTACT: Dr. Hana Pohl, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F-32, 1600 Clifton Road, Atlanta, Georgia 30333, telephone
(888)422-8737 SUPPLEMENTARY INFORMATION: Interaction profiles are developed by ATSDR for hazardous substances at National Priority List
(NPL)sites. Sections 104(i)(3) and
(5)of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended by the Superfund Amendments and Reauthorization Act of 1986 [42 U.S.C. Sections 9604(i)(3) and (5)], mandate that ATSDR shall assess whether adequate information on health effects is available for the priority hazardous substances. Where such information is not available or under development, ATSDR shall, in cooperation with the National Toxicology Program, initiate a program of research to determine these health effects. The Act further directs that, where feasible, ATSDR shall develop methods to determine the health effects of substances in combination with other substances with which they are commonly found. To carry out these legislative mandates, ATSDR has developed a program to evaluate the health effects of chemical mixtures. As part of this program, ATSDR developed a guidance manual that outlines the latest methods for assessing the health effects of chemical mixtures. In addition, ATSDR is developing a series of documents, called interaction profiles, for certain chemical mixtures of special concern to ATSDR. The purpose of an interaction profile is to evaluate data on the toxicology of the whole mixture (if available) and on the joint toxic action of the chemicals in the mixture in order to recommend approaches for the exposure-based assessment of the potential hazard to public health. The entire interaction profile development process is as follows: • ATSDR selects substances/chemicals for development of interaction profiles through inter/intra agency communications dialogue and literature reviews. • After the selection, a letter is sent to individuals and agencies on ATSDR's mailing list providing notice of ATSDR's intent to create an interaction profile. • A notice is posted in the **Federal Register** to inform the public of ATSDR's intent to develop a particular interaction profile. • The draft interaction profile undergoes both internal and external peer review. • A **Federal Register** notice announces the release of the official draft for public comment. • ATSDR posts a link to the draft interaction profile on its Web site, giving the public an opportunity to provide comments. • ATSDR reviews all public comments and revises the draft, as appropriate, before issuing the final version. The following documents will be developed starting on or about July 15, 2007. Document 1 Interaction profile for chlorinated dibenzo-p-dioxins, polybrominated diphenyl ethers, and phthalates. Document 2 Interaction profile for pyrethroid pesticides, organophosphate pesticides, and polychlorinated biphenyls. The notice of intent is open for comments during the June 15-July 15 period. Send all comments to Dr. Hana Pohl, ATSDR, Division of Toxicology and Environmental Medicine, Mailstop F-32, 1600 Clifton Road, Atlanta, GA 30333. Dated: June 25, 2007. Kenneth Rose, Acting Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E7-12833 Filed 7-2-07; 8:45 am] BILLING CODE 4163-70-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging Purpose of Notice: Availability of Funding Opportunity Announcement *Funding Opportunity Title/Program Name:* Advanced Performance Outcome Measurement Project (POMP). *Announcement Type:* Initial. *Funding Opportunity Number:* HHS-2006-AoA-PO-0716. *Statutory Authority:* The Older Americans Act, Public Law 109-365. *Catalog of Federal Domestic Assistance
(CFDA)Number:* 93.048, Title IV and Title II, Discretionary Projects. *Dates:* The deadline date for the submission of applications is August 15, 2007. I. Funding Opportunity Description This announcement seeks proposals for Advanced Performance Outcome Measurement Projects
(POMP)that will be funded with grant awards. Advanced POMP projects have been designed for the purpose of developing more robust performance outcome measures quantifying program impact in a manner that can be associated with cost. The purpose of this competition is to enhance or expand the existing POMP projects. Grant projects will receive technical support if requested. A detailed description of the funding opportunity may be found at *http://www.aoa.gov* and *http://www.gpra.net.* II. Award Information 1. Funding Instrument Type Grant. 2. Anticipated Total Priority Area Funding per Budget Period AoA intends to make available, under this program announcement, grant awards for up to nine projects for a two year period at a federal share of approximately $60,000-$70,000 per year for the first year and approximately $80,000-$100,000 for the second year contingent on the availability of funds. III. Eligibility Criteria and Other Requirements 1. Eligible Applicants Only state agencies on aging that received an Advanced Performance Outcome Measurement Project award in FY 2004 are eligible to apply. These states are Arizona, Florida, Georgia, Iowa, New York, North Carolina, Ohio, Rhode Island and South Carolina. 2. Cost Sharing or Matching Grantees are required to provide at least 25 percent of the total program costs from non-federal cash or in-kind resources in order to be considered for the award. 3. DUNS Number All grant applicants must obtain a D-U-N-S number from Dun and Bradstreet. It is a nine-digit identification number, which provides unique identifiers of single business entities. The D-U-N-S number is free and easy to obtain from *http://www.dnb.com/US/duns_update/.* 4. Intergovernmental Review Executive Order 12372, Intergovernmental Review of Federal Programs, is not applicable to these grant applications. IV. Application and Submission Information Application kits are available by writing to the U.S. Department of Health and Human Services, Administration on Aging, Office of Evaluation, Washington, DC 20201, by calling 202-357-0145, or online at *http://www.grants.gov* or *http://www.gpra.net.* Applications must be submitted electronically to *http://www.grants.gov.* In order to be able to submit the application, you must register in the Central Contractor Registry
(CCR)database. Information about CCR is available at *http://www.grants.gov/CCRRegister.* Instructions for the electronic submission of grant applications are available at *http://www.grants.gov.* To receive consideration, applications must be submitted electronically by midnight Eastern time by the deadline listed in the DATES section at the beginning of this Notice. V. Responsiveness Criteria Each application submitted will be screened to determine whether it was received by the closing date and time. Applications received by the closing date and time will be screened for completeness and conformity with the requirements outlined in Sections III and IV of this Notice and the Program Announcement. Only complete applications that meet these requirements will be reviewed and evaluated competitively. VI. Application Review Information Eligible applications in response to this announcement will be reviewed according to the following evaluation criteria: • Purpose and Need for Assistance—(20 points) • Approach, Workplan and Activities—(30 points) • Outcomes/Evaluation/Dissemination—(25 points) • Level of Effort—(25 points). VII. Agency Contacts Direct inquiries regarding programmatic issues to U.S. Department of Health and Human Services, Administration on Aging, Office of Evaluation, Washington, DC 20201, telephone:
(202)357-0145. Dated: June 28, 2007. Josefina G. Carbonell, Assistant Secretary for Aging. [FR Doc. E7-12858 Filed 7-2-07; 8:45 am] BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control—Special Emphasis Panel: Center To Protect Worker Rights, Program Announcement
(PA)07-318 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned committee: *Time and Date:* 1 p.m.-2 p.m., July 18, 2007 (Closed). *Place:* 626 Cochran Mill Road, Building 20, Room 313, Pittsburgh, PA 15236. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to PA 07-318, “Center to Protect Worker Rights.” *For Further Information Contact:* George Bockosh, M.S., Designated Federal Officer, 626 Cochran Mill Road, Pittsburgh, PA 15236, telephone 412.386.6465. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 27, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-12837 Filed 7-2-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Injury Prevention and Control Initial Review Group (NCIPC/IRG) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned committee: *Times and Date:* 2 p.m.-2:30 p.m., July 31, 2007 (Open). 2:30 p.m.-5 p.m., July 31, 2007 (Closed). *Place:* The conference call will originate at the Centers for Disease Control and Prevention, Yale Building, Koger Center, Atlanta, Georgia. *Status:* Portions of the meetings will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Section 10(d) of Public Law 92-463. *Purpose:* This group is charged with providing advice and guidance to the Secretary, Department of Health and Human Services, and the Director, CDC, concerning the scientific and technical merit of grant and cooperative agreement applications received from academic institutions and other public and private profit and nonprofit organizations, including State and local government agencies, to conduct specific injury research that focuses on prevention and control. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of individual research grant and cooperative agreement applications submitted in response to one Fiscal Year 2007 Request for Applications related to the following individual research announcement: RFA-CE-07-011, “Multi-Level Parent Training Effectiveness Trial—Phase II (U49).” Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Jane Suen, NCIPC/ERPO, CDC, 4770 Buford Highway, NE., M/S K02, Atlanta, Georgia 30341-3724, telephone 770/488-4281, or Tony Johnson, telephone 770/488-1556. The Director, Management Analysis and Services Office has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 27, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-12822 Filed 7-2-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on Public Advisory Panels or Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2008. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups. DATES: Because scheduled vacancies occur on various dates throughout each year, no cutoff date is established for the receipt of nominations. However, when possible, nominations should be received at least 6 months before the date of scheduled vacancies for each year, as indicated in this notice. ADDRESSES: Send all nominations and curricula vitae to the following contact persons listed in table 1 of this document: **Table 1.** Contact Person Committee/Panel Geretta P. Wood, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3993, or e-mail *Geretta.Wood@fda.hhs.gov* Certain Device Panels of the Medical Devices Advisory Committee Nancy M. Wynne, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: *Nancy.Wynne@fda.hhs.gov* National Mammography Quality Assurance Advisory Committee Collin L. Figueroa, Center for Devices and Radiological Health (HFZ-342), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, e-mail: *Collin.Figueroa@fda.hhs.gov* Device Good Manufacturing Practice Advisory Committee Richard V. Kaczmarek, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: *Richard.Kaczmarek@fda.hhs.gov* Technical Electronic Product Radiation Safety Standards Committee FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices and Radiological Health (HFZ-17), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8938, e-mail: *Kathleen.Walker@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Vacancies FDA is requesting nominations of voting members for vacancies listed as follows: **Table 2.** Committee/Panel Expertise Needed Current & Upcoming Vacancies Approximate Date Needed Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee—anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia 2 3 Immediately December 1, 2007 Circulatory System Devices Panel of the Medical Devices Advisory Committee—interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive heart failure 3 July 1, 2008 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee—doctors of medicine or philosophy with experience in clinical chemistry, clinical toxicology, clinical pathology, clinical laboratory medicine, endocrinology, and diabetes 2 March 1, 2008 Dental Products Panel of the Medical Devices Advisory Committee—dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials, periodontology, tissue engineering, and dental anatomy 2 3 Immediately November 1, 2007 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee—surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians 2 2 1 Immediately September 1, 2007 September 1, 2008 Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee—hematologists (benign and/or malignant hematology), hematopathologists (general and special hematology, coagulation and homeostasis, and hematological oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive and prognostic biomarkers 2 March 1, 2008 Immunology Devices Panel of the Medical Devices Advisory Committee—persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine 3 March 1, 2008 Microbiology Devices Panel of the Medical Devices Advisory Committee—infectious disease clinicians, e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in tropical medicine and emerging infectious diseases, mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists 4 Immediately Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee—experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. Individuals with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training. Individuals with experience in genetic counseling, medical ethics as well as ancillary fields of study will be considered 4 3 Immediately June 1, 2008 Neurological Devices Panel of the Medical Devices Advisory Committee—neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians 2 December 1, 2007 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee—experts in perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; biostatisticians and engineers with experience in obstetrics/gynecology devices; urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic (optical) spectroscopy; experts in midwifery; labor and delivery nursing 1 February 1, 2008 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee—orthopedic surgeons (joint, spine, trauma, and pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians 2 1 Immediately September 1, 2008 Radiological Devices Panel of the Medical Devices Advisory Committee—physicians with experience in general radiology, mammography, ultrasound, magnetic resonance, computed tomography, other radiological subspecialties and radiation oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging and image analysis 2 February 1, 2008 National Mammography Quality Assurance Advisory Committee—physician, practitioner, or other health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography 4 February 1, 2008 Device Good Manufacturing Practice Advisory Committee: Nine vacancies occurring immediately; three government representatives, two industry representatives, two public representatives and two health professionals 9 Immediately Technical Electronic Product Radiation Safety Standards Committee—15 vacancies occurring immediately, five government representatives, five industry representative and five general public representatives 15 Immediately II. Functions A. Medical Devices Advisory Committee The committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The panels engage in a number of activities to fulfill the functions of the Federal Food, Drug, and Cosmetic Act (the act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area performs the following duties:
(1)Advises the Commissioner of Food and Drugs (the Commissioner) regarding recommended classification or reclassification of devices into one of three regulatory categories,
(2)advises on any possible risks to health associated with the use of devices,
(3)advises on formulation of product development protocols,
(4)reviews premarket approval applications for medical devices,
(5)reviews guidelines and guidance documents,(6) recommends exemption of certain devices from the application of portions of the act,
(7)advises on the necessity to ban a device, and
(8)responds to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and agency guidance and policies. The panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or agency decisions or actions. B. National Mammography Quality Assurance Advisory Committee The functions of the committee are to advise FDA on the following topics:
(1)Developing appropriate quality standards and regulations for mammography facilities,
(2)developing appropriate standards and regulations for bodies accrediting mammography facilities under this program,
(3)developing regulations with respect to sanctions,
(4)developing procedures for monitoring compliance with standards,
(5)establishing a mechanism to investigate consumer complaints,
(6)reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities,
(7)determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas,
(8)determining whether there will exist a sufficient number of medical physicists after October 1, 1999, and
(9)determining the costs and benefits of compliance with these requirements. C. Device Good Manufacturing Practice Advisory Committee The functions of the committee are to review proposed regulations issuance regarding good manufacturing practices governing the methods used in, and the facilities and controls used for manufacture, packaging, storage, installation, and servicing of devices, and make recommendations regarding the feasibility and reasonableness of those proposed regulations. The committee also reviews and makes recommendations on proposed guidelines developed to assist the medical device industry in meeting the good manufacturing practice requirements, and provides advice with regard to any petition submitted by a manufacturer for an exemption or variance from good manufacturing practice regulations. Section 520 of the act (21 U.S.C. 360(j)), as amended, provides that the Device Good Manufacturing Practice Advisory Committee shall be composed of nine members as follows:
(1)Three of the members shall be appointed from persons who are officers or employees of any Federal, State, or local government;
(2)two shall be representatives of interests of the device manufacturing industry;
(3)two shall be representatives of the interests of physicians and other health professionals; and
(4)two shall be representatives of the interests of the general public. D. Technical Electronic Product Radiation Safety Standards Committee The function of the committee is to provide advice and consultation on the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation from such products. The committee may recommend electronic product radiation safety standards for consideration. Section 534(f) of the act (21 U.S.C. 360kk(f)), as amended by the Safe Medical Devices Act of 1990, provides that the Technical Electronic Product Radiation Safety Standards Committee include five members from governmental agencies, including State or Federal Governments, five members from the affected industries, and five members from the general public, of which at least one shall be a representative of organized labor. III. Qualifications A. Panels of the Medical Devices Advisory Committee Persons nominated for membership on the panels should have adequately diversified experience appropriate to the work of the panel in such fields as clinical and administrative medicine, engineering, biological and physical sciences, statistics, and other related professions. The nature of specialized training and experience necessary to qualify the nominee as an expert suitable for appointment may include experience in medical practice, teaching, and/or research relevant to the field of activity of the panel. The particular needs at this time for each panel are listed in section I of this document. The term of office is up to 4 years, depending on the appointment date. B. National Mammography Quality Assurance Advisory Committee Persons nominated for membership should be physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise include a significant focus on mammography and individuals identified with consumer interests. Prior experience on Federal public advisory committees in the same or similar subject areas will also be considered relevant professional expertise. The particular needs at this time for this committee are listed in section I of this document. The term of office is up to 4 years, depending on the appointment date. C. Device Good Manufacturing Practice Advisory Committee Persons nominated for membership as a health professional or officer or employee of any Federal, State, or local government should have knowledge of or expertise in any one or more of the following areas: Quality assurance concerning the design, manufacture, and use of medical devices. To be eligible for selection as a representative of the general public or industry, nominees should possess appropriate qualifications to understand and contribute to the committee's work. The particular needs at this time for this committee are listed in section I of this document. The term of office is up to 4 years, depending on the appointment date. D. Technical Electronic Product Radiation Safety Standards Committee Persons nominated should be technically qualified by training and experience in one or more fields of science or engineering applicable to electronic product radiation safety. The particular needs at this time for this committee are listed in section I of this document. The term of office is up to 4 years, depending on the appointment date. IV. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on one or more of the advisory panels or advisory committees. Self-nominations are also accepted. Nominations will include complete curriculum vitae of each nominee, current business address and telephone number. Nominations will specify the advisory panel(s) or advisory committee(s) for which the nominee is recommended. Nominations will include confirmation that the nominee is aware of the nomination, is willing to serve as a member of the advisory committee if selected, and appears to have no conflict of interest that would preclude membership. Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees. Dated: June 26, 2007. Randall W. Lutter Deputy Commissioner for Policy. [FR Doc. E7-12799 Filed 7-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998N-0359] (formerly 98N-0359) Program Priorities in the Center for Food Safety and Applied Nutrition; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration
(FDA)is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year
(FY)2008. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority-setting process. DATES: Submit written or electronic comments by September 4, 2007. ADDRESSES: Submit written comments concerning this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Tracy Summers, Center for Food Safety and Applied Nutrition (HFS-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20740, e-mail: *Tsummers@.fda.hhs.gov* , 301-827-1603. SUPPLEMENTARY INFORMATION: I. Background On June 5, 2007, CFSAN released a document entitled “FY 2007 Report to Stakeholders.” The document, a copy of which is available on CFSAN's Web page ( *http://www.cfsan.fda.gov/~dms/cfsan607.html* ), includes the Center's priority workplan for fiscal year 2007, i.e., October 1, 2006, through September 30, 2007. The FY 2007 workplan is based on input we received from our stakeholders (see 71 FR 37083; June 29, 2006), as well as input generated internally. Throughout the priority-setting process, we focused on one central question: “Where do we do the most good for consumers and the overall public health?” The FY 2007 workplan is structured like the FY 2006 plan. It contains only those activities previously listed as “A” list items. Our goal is to fully complete at least 90 percent of the activities listed under sections 1 through 4 of the FY 2007 workplan by the end of the FY, September 30, 2007. The FY 2006 workplan also includes a fifth section entitled, “Priority Ongoing Activities.” Many of these activities are core functions that we perform on a regular basis and are among our very highest priorities. II. 2008 CFSAN Program Priorities FDA is requesting comments on what program priorities CFSAN should consider establishing for FY 2008. The input will be used to develop CFSAN's FY 2008 workplan. The workplan will set forth the Center's program priorities for the period of October 1, 2007, through September 30, 2008. FDA intends to make the FY 2008 workplan available on its Web site. The format of the FY 2008 workplan will be similar to the FY 2007 workplan in that it will be divided into the following five sections:
(1)Food Defense
(2)Food Safety
(3)Nutrition and Labeling
(4)Dietary Supplements and Cosmetics
(5)Priority On-Going Activities While there will likely be continuity and follow-through on many activities between the 2007 and 2008 work plans, the final FY 2008 Congressional Appropriation will unquestionably affect what we will be able to commit to accomplish in FY 2008. Accordingly, FDA requests comments on broad program areas that should continue to be a priority as well as new program areas or activities that should be added as a high priority for FY 2008. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-12884 Filed 7-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Studies of Safety and Effectiveness of Orphan Products; Availability of Grants; Request for Applications: RFA-FD08-001; Research Project Grants (R01); Catalog of Federal Domestic Assistance Number: 93.103 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. I. Funding Opportunity Description The Food and Drug Administration
(FDA)is announcing changes to its Office of Orphan Products Development
(OPD)grant program for fiscal years
(FY)2009 and 2010. This announcement supersedes the previous announcement of this program, which was published in the **Federal Register** of December 19, 2005 (70 FR 75198). 1. Background OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information about OPD is available on FDA's Web site at *www.fda.gov/orphan* . 2. Program Research Goals The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will improve the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's “Background and Significance” section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 *et seq.* ), regulations issued under it, and applicable Department of Health and Human Services
(HHS)statutes and regulations. II. Award Information Except for applications for studies of medical foods that do not need premarket approval, FDA will only award grants to support premarket clinical studies to determine safety and effectiveness for approval under section 505 or 515 of the act (21 U.S.C. 355 or 360e) or safety, purity, and potency for licensing under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act (42 U.S.C. 241). FDA's research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103. 1. Award Instrument Support will be in the form of a research project
(R01)grant. All awards will be subject to all policies and requirements that govern the research grant programs of the PHS Act as incorporated in the HHS Grants Policy Statement, dated October 1, 2006, ( *http://www.hhs.gov/grantsnet/adminis/gpd/index.htm* ), including the provisions of 42 CFR part 52 and 45 CFR parts 74 and 92. The regulations issued under Executive Order 12372 do not apply to this program. The National Institutes of Health
(NIH)modular grant program does not apply to this FDA grant program. All grant awards are subject to applicable requirements for clinical investigations imposed by sections 505, 512, and 515 of the act (21 U.S.C. 360b), section 351 of the PHS Act, regulations issued under any of these sections, and other applicable HHS statutes and regulations regarding human subject protection. 2. Award Amount Of the estimated FY 2009 funding ($14.2 million), approximately $10 million will fund noncompeting continuation awards, and approximately $4.2 million will fund 10 to 12 new awards, subject to availability of funds. It is anticipated that funding for the number of noncompeting continuation awards and new awards in FY 2010 will be similar to FY 2009. Grants will be awarded up to $200,000 or up to $400,000 in total (direct plus indirect) costs per year for up to 4 years. Please note that the dollar limitation will apply to total costs, not direct costs, as in previous years. A fourth year of funding is available only for phase 2 or 3 clinical studies. Applications for the smaller grants ($200,000) may be for phase 1, 2, or 3 studies. Study proposals for the larger grants ($400,000) must be for studies continuing in phase 2 or 3 of investigation. Phase 1 studies include the initial introduction of an investigational new drug
(IND)or device into humans, are usually conducted in healthy volunteer subjects, and are designed to determine the metabolic and pharmacological actions of the product in humans, the side effects including those associated with increasing drug doses. In some Phase 1 studies that include subjects with the rare disorder, it may also be possible to gain early evidence on effectiveness. Phase 2 studies include early controlled clinical studies conducted to:
(1)Evaluate the effectiveness of the product for a particular indication in patients with the disease or condition and
(2)determine the common short-term side effects and risks associated with it. Phase 3 studies gather more information about effectiveness and safety that is necessary to evaluate the overall risk-benefit ratio of the product and to provide an acceptable basis for product labeling. Budgets for each year of requested support may not exceed the $200,000 or $400,000 total cost limit, whichever is applicable. 3. Length of Support The length of support will depend on the nature of the study. For those studies with an expected duration of more than 1 year, a second, third, or fourth year of noncompetitive continuation of support will depend on the following factors:
(1)Performance during the preceding year;
(2)compliance with regulatory requirements of IND/investigational device exemption (IDE); and
(3)availability of Federal funds. A fourth year of funding is available only for phase 2 or 3 clinical studies. 4. Funding Plan In addition to the requirement for an active IND/IDE discussed in section V.B.4 of this document, documentation of assurances with the Office of Human Research Protection
(OHRP)(see section IV.5.A of this document) must be on file with the FDA grants management office before an award is made. Any institution receiving Federal funds must have an institutional review board
(IRB)of record even if that institution is overseeing research conducted at other performance sites. To avoid funding studies that may not receive or may experience a delay in receiving IRB approval, documentation of IRB approval and Federal Wide Assurance (FWA or assurance) for the IRB of record for all performance sites must be on file with the FDA grants management office before an award to fund the study will be made. In addition, if a grant is awarded, grantees will be informed of any additional documentation that should be submitted to FDA's IRB. 5. Dun and Bradstreet Number
(DUNS)Beginning October 1, 2003, applicants are required to have a DUNS number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a 9-digit identification number that uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, call 1-866-705-5711. Be certain that you identify yourself as a Federal grant applicant when you contact Dun and Bradstreet. 6. Central Contractor Registration For the grants.gov electronic application process, applicants are required to register with the Central Contractor Registration
(CCR)database. This database is a governmentwide warehouse of commercial and financial information for all organizations conducting business with the Federal Government. Registration with CCR is a requirement and is consistent with the governmentwide management reform to create a citizen-centered Web presence and build electronic government (e-gov) infrastructures in and across agencies to establish a “single face to industry.” The preferred method for completing a registration is through the Internet at *http://www.ccr.gov* . 1 This Web site provides a CCR handbook with detailed information on data you will need prior to beginning the online registration, as well as steps to walk you through the registration process. You must have a DUNS number to begin your registration. Call Dunn & Bradstreet, Inc. at the telephone number listed in section II.5 of this document if you do not have a DUNS number. 1 (FDA has verified the non-FDA Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the **Federal Register** .) In order to access grants.gov, an applicant will be required to register with the Credential Provider. Information about this process is available at *http://www.grants.gov/applicants/iregister_credential_provider.jsp* . III. Eligibility Information 1. Eligible Applicants The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. An application that has received two prior disapprovals is not eligible to apply. 2. Cost Sharing or Matching This grant program does not require the applicant to match or share in the project costs if an award is made. IV. Application and Submission Information 1. Content and Form of Application Submission A. General Information FDA is accepting new applications for this program electronically via *www.grants.gov* . Applicants should apply electronically by visiting the Web site *www.grants.gov* and following instructions under “Apply for Grants.” The required application, SF424 R&R (Research & Related Portable Document Formats) can be completed and submitted online. We strongly encourage using the “Tips” posted on *www.grants.gov* under the announcement number when preparing your submission. If you experience technical difficulties with your online submission, you should contact either the grants.gov Customer Response Center *http://www.grants.gov/contactus/contactus.jsp* or Dianna Jessee, Grants Management Specialist (see Agency Contacts in section VII of this document). To comply with the President's Management Agenda, HHS is participating as a partner in the new governmentwide grants.gov application site. Users of grants.gov will be able to download a copy of the application package, complete it offline, and then upload and submit the application via the grants.gov Web site. When you enter the grants.gov Web site, you will find information about submitting an application electronically through the Web site. In addition, this process is similar to the R01 Grant Application process currently used at NIH. You can visit the following Web site for helpful background on preparing to apply, preparing an application, and submitting an application to grants.gov: *http://era.nih.gov/ElectronicReceipt/* . In order to apply electronically, the applicant must have a DUNS number and register in the CCR database as described in sections II.5 and II.6 of this document. In unusual circumstances, additional information may be considered, on a case-by-case basis, for inclusion in the ad hoc expert panel review; however, FDA cannot assure inclusion of any information after the receipt date other than evidence of final IRB approval, FWA or assurance, and certification of adequate supply of study product. If an application for the same study was submitted in response to a previous request for application
(RFA)but has not yet been funded, an application in response to this notice will be considered a request to withdraw the previous application. The applicant for a resubmitted application should address the issues presented in the summary statement from the previous review and include a copy of the summary statement itself as part of the resubmitted application. An application that has received two prior disapprovals is not eligible for resubmission. B. Format for Application In FY 2009 and 2010, all applications must be submitted electronically through grants.gov. The application must be on SF424 R&R (Research and Related Portable Document Format). The title of the proposed study must include the name of the product and the disease/disorder to be studied and the IND/IDE number. The narrative portion, excluding appendices, of the application may not exceed 100 pages in length and must be single-spaced in 12-point font. The appendices should also not exceed 100 pages in length (separate from the narrative portion of the application). 2. Submission Dates and Times For FY 2009, the application receipt date is February 6, 2008, and for FY 2010, the application receipt date is February 4, 2009. Please note that there is only one receipt date for FY 2009 and one receipt date for FY 2010. Applications must be received by the close of business on the established receipt date. Late applications may be accepted under extreme circumstances beyond the control of the applicant. Applications not received on time will not be considered for review and will generally be returned to the applicant. The protocol in the grant application should be submitted to the IND/IDE no later than January 7, 2008, for FY 2009 and no later than January 5, 2009, for FY 2010. 3. Intergovernmental Review This program is not subject to review under the terms of Executive Order 12372. 4. Funding Restrictions A. Protection of Human Research Subjects All institutions engaged in human subject research financially supported by HHS must file an assurance of protection for human subjects with the OHRP (45 CFR part 46). Applicants are advised to visit the OHRP Web site at *http://www.hhs.gov/ohrp* for guidance on human subject protection issues. The requirement to file an assurance applies to both “awardee” and collaborating “performance site” institutions. Awardee institutions are automatically considered to be “engaged” in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears the responsibility for protecting human subjects under the award. The awardee institution is also responsible for, among other things, ensuring that all collaborating performance site institutions engaged in the research hold an approved assurance prior to their initiation of the research. No awardee or performance site institution may spend funds on human subject research or enroll subjects without the approved and applicable assurance(s) on file with OHRP. An awardee institution must, therefore, have its own IRB of record and assurance. The IRB of record may be an IRB already being used by one of the “performance sites,” but it must specifically be registered as the IRB of record with OHRP. For further information, applicants should review the section on human subjects in the application instructions as posted on the grants.gov application Web site. The clinical protocol should comply with ICHE6 “Good Clinical Practice Consolidated Guidance” which sets an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and good clinical practice available on the Internet at *http://www.fda.gov/oc/gcp/* . B. Key Personnel and Human Subject Protection Education The awardee institution is responsible for ensuring that all key personnel receive appropriate training in their human subject protection responsibilities. Key personnel include all principal investigators, co-investigators, and performance site investigators responsible for the design and conduct of the study. HHS, FDA, and OPD do not prescribe or endorse any specific education programs. Many institutions have already developed educational programs on the protection of research subjects and have made participation in such programs a requirement for their investigators. Other sources of appropriate instruction might include the online tutorials offered by the Office of Human Subjects Research, NIH at *http://ohsr.od.nih.gov/* and by OHRP at *use http://www.hhs.gov/ohrp/education/* . Within 30 days of the award, the principal investigator should provide a letter to FDA's grants management office that includes the names of the key personnel, the title of the human subjects protection education program completed for each key personnel, and a one-sentence description of the program. This letter should be signed by the principal investigator and cosigned by an institution official and sent to the Grants Management Specialist whose name appears on the official Notice of Grant Award (NGA). 5. Other Submission Requirements Informed Consent Consent forms, assent forms, and any other information given to a subject are part of the grant application and must be provided, even if in a draft form. The applicant is referred to HHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details regarding the required elements of informed consent. V. Application Review Information 1. Criteria A. General Information FDA grants management and program staff will review all applications sent in response to this notice. To be responsive, an application must be submitted in accordance with the requirements of this notice. Applications found to be nonresponsive will be returned to the applicant without further consideration. Applicants are strongly encouraged to contact FDA to resolve any questions about criteria before submitting their application. Please direct all questions of a technical or scientific nature to the OPD program staff and all questions of an administrative or financial nature to the grants management staff (see Agency Contacts in section VII of this document). B. Program Review Criteria 1. Applications must propose clinical trials intended to provide safety and/or efficacy data. 2. There must be an explanation in the “Background and Significance” section of how the proposed study will either contribute to product approval or provide essential data needed for product development. 3. The “Background and Significance” section of the application must contain information documenting the prevalence, not incidence, of the population to be served by the product is fewer than 200,000 individuals in the United States. The applicant should include a detailed explanation supplemented by authoritative references in support of the prevalence figure. Diagnostic tests and vaccines will qualify only if the population of intended use is fewer than 200,000 individuals in the United States per year. 4. The study protocol proposed in the grant application must be under an active IND or IDE (not on clinical hold) to qualify the application for scientific and technical review. Additional IND/IDE information is described as follows: • The proposed clinical protocol should be submitted to the applicable FDA IND/IDE review division a minimum of 30 days before the grant application deadline. The number assigned to the IND/IDE that includes the proposed study should appear on the face page of the application with the title of the project. The date the subject protocol was submitted to FDA for the IND/IDE review should also be provided. Protocols that would otherwise be eligible for an exemption from the IND regulations must be conducted under an active IND to be eligible for funding under this FDA grant program. If the sponsor of the IND/IDE is other than the principal investigator listed on the application, a letter from the sponsor permitting access to the IND/IDE must be submitted in both the IND/IDE and in the grant application. The name(s) of the principal investigator(s) named in the application and in the study protocol must be submitted to the IND/IDE. Studies of already approved products, evaluating new orphan indications, are also subject to these IND/IDE requirements. • Only medical foods that do not need premarket approval and medical devices that are classified as nonsignificant risk
(NSR)are free from these IND/IDE requirements. Applicants studying an NSR device should provide a letter in the application from FDA's Center for Devices and Radiological Health indicating the device is an NSR device. 5. The requested budget must be within the limits, either $200,000 in total costs per year for up to 3 years for any phase study, or $400,000 in total costs per year for up to 4 years for phase 2 or 3 studies. Any application received that requests support over the maximum amount allowable for that particular study will be considered non-responsive. 6. In an appendix to the application, there must be evidence that the product to be studied is available to the applicant in the form and quantity needed for the clinical trial proposed. A current letter from the supplier as an appendix will be acceptable. If negotiations regarding the supply of the study product are underway but have not been finalized at the time of application, please provide a letter indicating such in the application. Verification of adequate supply of study product will be necessary before an award is made. 7. The protocol should be submitted in the application. The narrative portion of the application should be no more than 100 pages, single-spaced, with 1/2-inch margins, and in unreduced 12-point font. The appendices should also be no more than 100 pages (separate from the narrative portion of the application). C. Scientific/Technical Review Criteria The ad hoc expert panel will review the application based on the following scientific and technical merit criteria: 1. The soundness of the rationale for the proposed study; 2. The quality and appropriateness of the study design, including the design of the monitoring plans; 3. The statistical justification for the number of patients chosen for the study, based on the proposed outcome measures, and the appropriateness of the statistical procedures for analysis of the results; 4. The adequacy of the evidence that the proposed number of eligible subjects can be recruited in the requested timeframe; 5. The qualifications of the investigator and support staff, and the resources available to them; 6. The adequacy of the justification for the request for financial support; 7. The adequacy of plans for complying with regulations for protection of human subjects and monitoring; and 8. The ability of the applicant to complete the proposed study within its budget and within time limits stated in this RFA. 2. Review and Selection Process Responsive applications will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. Consultation with the proper FDA review division may also occur during this phase of the review to determine whether the proposed study will provide acceptable data that could contribute to product approval. Responsive applications will be subject to a second review by the National Cancer Institute, National Cancer Advisory Board
(NCAB)for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or his designee. A score will be assigned based on the scientific/technical review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the OPD grant program. VI. Award Administration Information 1. Award Notices A formal notification in the form of an NGA will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NGA will be generated via e-mail or hard copy from FDA to the authorized grantee business official. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent they are considered allowable pre-award costs. 2. Administrative Requirements All FDA grant awardees must adhere to the requirements stated in the RFA, the NGA, associated Terms and Conditions, as well as any relevant FDA or HHS statutory or regulatory requirements. 3. Reporting A. Reporting Requirements When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement, dated October 1, 2006, ( *http://www.hhs.gov/grantsnet/adminis/gpd/index.htm* ). Also, all new and continuing grants must comply with all regulatory requirements necessary to keep the status of their IND/IDE “active” and “in effect,” that is, not on “clinical hold.” Failure to meet regulatory requirements will be grounds for suspension or termination of the grant. B. Monitoring Activities The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer or specialist and the principal investigator. Information including, but not limited to, information regarding study progress, enrollment, problems, adverse events, changes in protocol, and study monitoring activities will be requested. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those which state that future funding of the study will depend on recommendations from the OPD project officer. The scope of the recommendations will confirm the following:
(1)There has been acceptable progress toward enrollment, based on specific circumstances of the study;
(2)there is an adequate supply of the product/device; and
(3)there is continued compliance with all applicable FDA and HHS regulatory requirements for the trial. The grantee must file a final program progress report, financial status report, and invention statement within 90 days after the end date of the project period as noted on the notice of grant award. VII. Agency Contacts FDA encourages your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: *Scientific/Research Contact* : Debra Y. Lewis, Director, Orphan Products Grants Program, Office of Orphan Products Development (HF-35), Food and Drug Administration 5600 Fishers Lane, rm. 6A-55, Rockville, MD 20857, 301-827-3666, e-mail: *debra.lewis@fda.hhs.gov.* *Administrative/Financial Management Contact* : Dianna L. Jessee, Grants Management Specialist, Division of Acquisition Support and Grants, Office of Acquisitions & Grant Services (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm. 2141, Rockville, MD 20857, 301-827-7177, e-mail: *dianna.jessee@fda.hhs.gov* . VIII. Other Information Required Federal Citations Clinical Trials Data Bank The Food and Drug Administration Modernization Act of 1997 established a requirement that certain information be entered into the Clinical Trials Data Bank
(CTDB)for federally and privately funded clinical effectiveness trials conducted under an IND for drugs (including trials for biological products) to treat serious or life-threatening diseases or conditions (42 U.S.C. 282(j)). Information on noneffectiveness trials, or for drugs to treat diseases or conditions not considered serious or life-threatening, may also be entered into this database but such information is not required. This CTDB provides patients, family members, healthcare providers, researchers, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Library of Medicine has developed this site in collaboration with NIH and FDA. The CTDB is available to the public through the Internet at *http://clinicaltrials.gov* . The CTDB contains the following information:
(1)Information about clinical trials, both federally and privately funded, of experimental treatments (drug and biological products) for patients with serious or life-threatening diseases or conditions;
(2)a description of the purpose of each experimental drug;
(3)the patient eligibility criteria;
(4)a description of the location of clinical trial sites; and
(5)a point of contact for those wanting to enroll in the trial. In 2007, the Best Pharmaceuticals for Children Act also required that the CTDB include a description of whether, and through what procedure, the manufacturer or sponsor of an IND will respond to a request for protocol exception, with appropriate safeguards, for single-patient and expanded access use of the investigational drug, particularly in children. The OPD program staff will provide more information to grantees about entering the required information in the CTDB after awards are made. Freedom of Information Act
(FOIA)Data included in the application may be considered trade secret or confidential commercial information within the meaning of the Freedom of Information Act (5 U.S.C. 552) and FDA's statute and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law. Use of Animals in Research Recipients of PHS support for activities involving live vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( *http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf* ) as mandated by the Health Research Extension Act of 1985 ( *http://grants.nih.gov/grants/olaw/references/hrea1985.htm* ), and the USDA Animal Welfare Regulations ( *http://www.nal.usda.gov/awic/legislat/usdaleg1.htm* ) as applicable. Inclusion of Women And Minorities in Clinical Research Applicants for PHS clinical research grants are encouraged to include minorities and women in study populations so research findings can be of benefit to all people at risk of the disease or condition under study. It is recommended that applicants place special emphasis on including minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy applies to research subjects of all ages. If women or minorities are excluded or poorly represented in clinical research, the applicant should provide a clear and compelling rationale that shows inclusion is inappropriate. Inclusion of Children as Participants in Clinical Research FDA regulations at 21 CFR part 50, subpart D contain additional requirements that must be met by IRBs reviewing clinical investigations regulated by FDA and involving children as subjects. FDA is part of HHS; accordingly, the research project grants under this program are supported by HHS, and HHS regulations at 45 CFR part 46, subpart D also apply to research involving children as subjects. Standards for Privacy of Individually Identifiable Health Information HHS issued final modification to the “Standards for Privacy of Individually Identifiable Health Information,” the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Web site *http://www.hhs.gov/ocr/* provides information on the Privacy Rule, including a complete regulation text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at *http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html* . Healthy People 2010 PHS is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010,” a PHS-led national activity for setting priority areas. This Funding Opportunity Announcement is related to one or more of the priority areas. Potential applicants may obtain a copy of “Healthy People 2010” at *http://www.health.gov/healthypeople* . Smoke-Free Workplace The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. Authority and Regulations This program is described in the CFDA at *http://www.cfda.gov/* and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of sections 301 and 405 of the PHS Act as amended (42 U.S.C. 241 and 284) and under federal regulations 42 CFR part 52 and 45 CFR parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement, dated October 1, 2006, ( *http://www.hhs.gov/grantsnet/adminis/gpd/index.htm* ). Dated: June 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-12881 Filed 7-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005P-0207] Medical Devices; Cardiovascular Devices; Denial of Request for Change in Classification of Impedance Plethysmograph AGENCY: Food and Drug Administration, HHS. ACTION: Notice; denial of petition. SUMMARY: The Food and Drug Administration
(FDA)is denying the petition submitted by Life Measurements Inc., to reclassify the SONAMET Body Composition Analyzers (BOD POD and PEA POD) from class II to class I. The agency is denying the petition because Life Measurements Inc., failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. This notice also summarizes the basis for the agency's decision. FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021. SUPPLEMENTARY INFORMATION: I. Classification and Reclassification of Devices Under the 1976 Amendments The Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 301 *et seq.* ), as amended by the 1976 amendments (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA)(Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices under the 1976 amendments were class I (general controls), class II (performance standards), and class III (premarket approval). Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the amendments), generally referred to as preamendments devices, are classified after FDA has:
(1)Received a recommendation from a device classification panel (an FDA advisory committee);
(2)published the panel's recommendation for comment, along with a proposed regulation classifying the device type; and
(3)published a final regulation classifying the device type. FDA has classified most preamendments devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless:
(1)The device type is reclassified into class I or II;
(2)FDA issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the act; or
(3)FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807, subpart E, of the regulations. A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a Premarket Application
(PMA)until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval. Reclassification of classified preamendments devices is governed by section 513(e) of the act. This section of the act provides that FDA may, by rulemaking, reclassify a device (in a proceeding that parallels the initial classification proceeding) based on “new information.” The reclassification can be initiated by FDA or by the petition of an interested person. The term “new information,” as used in sections 513(e) and 515(b)(2)(A)(iv) of the act, includes information developed as a result of a reevaluation of the data before the agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., *Holland Rantos* v. *United States Department of Health, Education, and Welfare* , 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); *Upjohn* v. *Finch* , 422 F.2d 944 (6th Cir. 1970); *Bell* v. *Goddard* , 366 F.2d 177 (7th Cir. 1966).) Reevaluation of the data previously before the agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see *Bell* v. *Goddard* , supra, 366 F.2d at 181; *Ethicon, Inc.* v. *FDA* , 762 F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in “medical science.” (See *Upjohn* v. *Finch* , supra, 422 F.2d at 951.) Regardless of whether data before the agency are past or new data, the “new information” upon which reclassification under section 513(e) of the act is based must consist of “valid scientific evidence,” as defined in section 513(a)(3) of the act and § 560.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., *General Medical Co.* v. *FDA* , 770 F.2d 214 (D.C. Cir. 1985); *Contact Lens Assoc.* v. *FDA* , 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985).) In addition, § 860.123(a)(6) (21 CFR 860.123(a)(6)) provides that a reclassification petition must include a “full statement of the reasons, together with supporting data satisfying the requirements of § 860.7, why the device should not be classified into its present classification and how the proposed classification will provide reasonable assurance of the safety and effectiveness of the device ” (§ 860.123(a)(6)). The “supporting data satisfying the requirements of § 860.7” referred to is “valid scientific evidence.” For the purpose of reclassification, the valid scientific evidence upon which the agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA. (See section 520(c) of the act (21 U.S.C. 360j(c).) II. Reclassification Under the SMDA The SMDA further amended the act to change the definition of a class II device. Under the SMDA, class II devices are those devices which cannot be classified into class I because general controls by themselves are not sufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act). Thus, the definition of a class II device was changed from “performance standards” to “special controls.” In order for a device to be reclassified from class II into class I, the agency must determine that special controls are not necessary to provide reasonable assurance of its safety and effectiveness. III. Background In the **Federal Register** of February 5, 1980 (45 FR 7930), FDA issued a final rule classifying the Impedance Plethysmograph into class II (§ 870.2770 (21 CFR 870.2770)). The preamble to the proposal to classify the device included the recommendation of the Cardiovascular Device Classification Panel (the Panel). The Panel's recommendation, among other things, identified the following risks to health associated with the use of the device:
(1)Cardiac arrhythmias or electrical shock—Excessive electrical leakage current can disturb the normal electrophysiology of the heart, leading to the onset of cardiac arrhythmias and
(2)Misdiagnosis—If the zero or calibration of the device is inaccurate or unstable, or if frequency response of the device is improper, the device can generate inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily. On May 25, 2005, FDA received a petition requesting that FDA reclassify SONAMET Body Composition Analyzers (BOD POD and PEA POD) from class II to class I (Ref. 1). Under § 860.120(b) (21 CFR 860.120(b)) the reclassification of any device within a generic type of devices causes the reclassification of all substantially equivalent devices within that generic type of device. The May 25, 2005, petition also requested that the SONAMET Body Composition Analyzers (BOD POD and PEA POD) be given their own product code because their devices are based on air displacement plethysmography technology, not impedance plethysmograph technology. IV. Device Description The SONAMET Body Composition Analyzers (BOD POD and PEA POD) are classified within the generic type of device impedance plethysmograph (§ 870.2770) and given the product code MNW. Both SONAMET Body Composition Analyzers were found substantially equivalent to class II devices under § 870.2770. V. FDA's Decision After reviewing the reclassification petition, FDA has found that the petition does not contain sufficient valid scientific evidence to support a determination that general controls would provide reasonable assurance of the devices' safety and effectiveness for their intended uses. Therefore, FDA is denying the reclassification request. FDA did determine that both SONAMET Body Composition Analyzers are substantially equivalent to other legally marketed body composition analyzers classified under § 870.2770, product code MNW, the product code for body composition analysis devices. However, due to variations in the technology of impedance plethysmographs and displacement plethysmographs, FDA has given displacement plethysmographs for body composition their own product code under § 870.2770. FDA is adding a new product code, OAC, to § 870.2770 and updating the product code for the SONAMET Body Composition Analyzers (BOD POD and PEA POD) under § 870.2770. This new product code will be used to classify any plethysmograph device using air displacement for body composition analysis that is determined to be substantially equivalent. VI. Reasons for the Denial FDA has determined that Life Measurement Inc., has not presented new scientific information sufficient to support the requested change in classification (class II to class I) of their devices. According to § 860.120(b), the reclassification of any device within a generic type of device causes the reclassification of all substantially equivalent devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all substantially equivalent devices within the same generic type. Life Measurement Inc., has
(1)not provided sufficient evidence to reclassify their own devices and has
(2)not provided the required elements of a reclassification petition to down-classify any or all other body composition analyzers of different technology under § 870.2770. The petitioner's accompanying data refers only to one of Life Measurement Inc.'s two devices proposed for reclassification, the BOD POD. No new information on the PEA POD was provided. The PEA POD, which is intended for use in newborns and infants, is the more critical of the two devices. While the patient population being tested with the BOD POD can terminate usage of the device during measurement, the patient population using the PEA POD (infants) is helpless to intervene in any aspect of the device operation if safety is suddenly compromised. All the evidence presented by the petitioner is anecdotal and not sufficient to support the conclusion that general controls would provide reasonable assurance of the safety and effectiveness of this type device, including the Life Measurement Inc., devices. No published studies have been provided specifically targeting safety regarding devices of this type, including the Life Measurement Inc., devices, to support the petition. Additionally, the petitioner has not provided any information about adverse events or time of use for either of these devices. However, Life Measurement Inc.'s differing technology for body composition is a legitimate basis for consideration of a new product code. FDA agrees that variations in the technology of impedance plethysmographs and air displacement plethysmographs for body composition analysis warrant FDA's assigning air displacement plethysmographs for body composition analysis (e.g., BOD POD) their own product code under § 870.2770. FDA has added a new product code, OAC, to § 870.2770 and includes the SONAMET Body Composition Analyzers (BOD POD and PEA POD) under it. FDA believes that the petition lacks sufficient valid scientific evidence to allow FDA to determine that general controls would provide reasonable assurance of the safety and effectiveness of the impedance plethysmograph for its intended use. Therefore, the impedance plethysmograph shall be retained in class II. VII. References The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Petition from Life Measurement Inc., for the reclassification of the SONAMET Body Composition Analyzers (BOD POD and PEA POD) devices, dated March 21, 2005. Dated: June 25, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-12883 Filed 7-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005P-0213] Neurological Devices; Denial of Request for Change in Classification of Cutaneous Electrode AGENCY: Food and Drug Administration, HHS. ACTION: Notice; denial of petition. SUMMARY: The Food and Drug Administration
(FDA)is denying the petition submitted by Scientific Laboratory Products LTD., to reclassify electroencephalogram
(EEG)electrodes from class II to class I. The agency is denying the petition because the Scientific Laboratory Products LTD., failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. This document also summarizes the basis for the agency's decision. FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021. SUPPLEMENTARY INFORMATION: I. Classification and Reclassification of Devices Under the Medical Device Amendments of 1976 (the 1976 Amendments) The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 *et seq* .), as amended by the 1976 amendments (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA)(Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices under the 1976 amendments were class I (general controls); class II (performance standards); and class III (premarket approval). Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the amendments), generally referred to as preamendments devices, are classified after FDA has done the following:
(1)Received a recommendation from a device classification panel (an FDA advisory committee);
(2)published the panel's recommendation for comment, along with a proposed regulation classifying the device type; and
(3)published a final regulation classifying the device type. FDA has classified most preamendments devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless:
(1)The device type is reclassified into class I or II;
(2)FDA issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the act; or
(3)FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations. A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application
(PMA)until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval. Reclassification of classified preamendments devices is governed by section 513(e) of the act (21 U.S.C. 360c(e)). This section of the act provides that FDA may, by rulemaking, reclassify a device (in a proceeding that parallels the initial classification proceeding) based on “new information.” The reclassification can be initiated by FDA or by the petition of an interested person. The term “new information,” as used in sections 513(e) and 515(b)(2)(A)(iv) of the act, includes information developed as a result of a reevaluation of the data before the agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., *Holland Rantos* v. *United States Department of Health, Education, and Welfare* , 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); *Upjohn* v. *Finch* , 422 F.2d 944 (6th Cir. 1970); *Bell* v. *Goddard* , 366 F.2d 177 (7th Cir. 1966).) Reevaluation of the data previously before the agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see *Bell* v. *Goddard* , supra, 366 F.2d at 181; *Ethicon, Inc.* v. *FDA* , 762 F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in “medical science.” (See *Upjohn* v. *Finch* , supra, 422 F.2d at 951.) Regardless of whether data before the agency are past or new data, the “new information” upon which reclassification under section 513(e) of the act is based must consist of “valid scientific evidence,” as defined in section 513(a)(3) of the act and § 860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., *General Medical Co.* v. *FDA* , 770 F.2d 214 (D.C. Cir. 1985); *Contact Lens Assoc.* v. *FDA* , 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)). In addition, § 860.123(a)(6) (21 CFR 860.123(a)(6)) provides that a reclassification petition must include a “full statement of the reasons, together with supporting data satisfying the requirements of § 860.7, why the device should not be classified into its present classification, and how the proposed classification will provide reasonable assurance of the safety and effectiveness of the device.” (§ 860.123(a)(6).) The “supporting data satisfying the requirements of § 860.7” referred to is “valid scientific evidence.” For the purpose of reclassification, the valid scientific evidence upon which the agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA. (See section 520(c) of the act (21 U.S.C. 360j(c).) II. Reclassification under SMDA SMDA further amended the act to change the definition of a class II device. Under SMDA, class II devices are those devices which cannot be classified into class I because general controls by themselves are not sufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act). Thus, the definition of a class II device was changed from “performance standards” to “special controls.” In order for a device to be reclassified from class II into class I, the agency must determine that special controls are not necessary to provide reasonable assurance of its safety and effectiveness. III. Background In the **Federal Register** of September 4, 1979 (44 FR 51732), FDA issued a final rule classifying the cutaneous electrode into class II (21 CFR 882.1320). The preamble to the proposal to classify the device included the recommendation of the Neurological Device Classification Panel (the Panel). The Panel's recommendation, among other things, identified the following risks to health associated with the use of the device:
(1)Burns, since poor design or incorrect application of the electrodes could result in skin burns when the device is used to apply stimulation and
(2)toxic reactions, since materials or substances in the electrodes that are in contact with the skin could produce adverse reactions. The panel recommended that cutaneous electrodes be classified as class II because the electrical properties of the device must be controlled to assure that, when physiological signals are recorded, they are adequately reproduced. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily. Additionally, the panel recommended Class II to assure that only materials with known and acceptable properties are used in electrodes. On May 31, 2005, FDA received a petition requesting that FDA reclassify electroencephalogram electrodes from class II to class I (Ref. 1). Under § 860.120(b) (21 CFR 860.120(b)), the reclassification of any device within a generic type of devices causes the reclassification of all substantially equivalent devices within that generic type of device. IV. Device Description The electroencephalogram electrode device is classified within the generic type of device cutaneous electrode (21 CFR 882.1320). FDA identifies cutaneous electrode as an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. V. FDA's Decision After reviewing the reclassification petition, FDA has found that the petition contains insufficient valid scientific evidence to allow FDA to determine that general controls would provide reasonable assurance of the device's safety and effectiveness for its intended use. FDA, therefore, is denying the petition. VI. Reasons for the Denial FDA has determined that Scientific Laboratory Products LTD., has not presented sufficient new scientific information to support the requested change in classification of this device. According to § 860.120(b), the reclassification of any device within a generic type of device causes the reclassification of all substantially equivalent devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all substantially equivalent devices within the same generic type. The petitioner has not provided any evidence to reclassify their own device or the generic cutaneous electrode device category. FDA believes that the petition lacks sufficient valid scientific evidence to allow the agency to determine that general controls would provide reasonable assurance of the safety and effectiveness of the cutaneous electrode for its intended use. Therefore, the cutaneous electrode shall be retained in class II. VII. References The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Petition from Scientific Laboratory Products LTD., for the reclassification of the electroencephalogram electrode device, dated May 16, 2005. Dated: June 25, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-12882 Filed 7-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0233] Draft Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft guidance for industry entitled “Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.” Since FDA began accepting new drug application
(NDA)and biologics license application
(BLA)submissions in the common technical document
(CTD)format, there has been much confusion regarding where within the CTD to include an integrated summary of effectiveness
(ISE)and integrated summary of safety (ISS), both of which are required components of an NDA submission and recommended components of a BLA submission. This guidance informs applicants on where to place the ISE and ISS in the CTD. This guidance addresses specific FDA requirements not discussed in the ICH guidance for industry M4E: The CTD—Efficacy. This guidance is intended to improve application quality and consistency. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by September 4, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The guidance may also be obtained from the Center for Biologics Evaluation and Research by mail by calling 1-800-835-4709 or 301-827-1800. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Howard Chazin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6470, Silver Spring, MD 20993-0002, 301-796-0700; or Leonard Wilson, Center for Biologics Evaluation and Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.” This guidance is intended for applicants submitting an NDA or BLA in the CTD or electronic common technical document
(eCTD)format. Since FDA adopted the CTD, a standard way to organize a marketing or licensing application, there has been much confusion regarding where to place an ISE and ISS within the CTD. The ISE and ISS are unique requirements of the United States and are not addressed fully by ICH M4E. The pertinent Federal regulations that require an ISE and an ISS for NDAs are §§ 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a), respectively (21 CFR 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a)). Although there are no corresponding regulations requiring an ISE or ISS for BLAs, applicants are encouraged to provide these analyses. A common problem with the way many of the CTD-formatted applications are submitted is that the applicants incorrectly assume that the clinical summaries in Module 2 satisfy the regulatory requirement for the ISE and ISS. This assumption can result in a determination by FDA that an application is incomplete. The ISE and ISS are detailed integrated analyses of all relevant data from the clinical study reports, not summaries, despite their names. FDA considers the ISE and ISS critical components of the clinical efficacy and safety portions of a marketing or licensing application. Therefore, the ISE and ISS are required in applications submitted to the FDA in accordance with the regulations (§§ 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a)). This guidance focuses on where to place ISE and ISS documents within the structure of the CTD or eCTD. When finalized, this guidance will update, in the guidance on the format and content of the clinical and statistical sections of an application, the part of sections II.G and H that relates to placement of the ISE and ISS. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the location for an ISE and ISS within the CTD. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/cder/guidance/index.htm* , *http://www.fda.gov/cber/guidelines.htm* , or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: June 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-12792 Filed 7-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0197] Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies.” This guidance document describes a means by which filtering facepiece respirators for use by the general public in public health medical emergencies may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule to classify the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). This guidance document is immediately in effect as a special control for the filtering facepiece respirator for use by the general public in public health medical emergencies, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance document are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sheila Murphey, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3700. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document will serve as a special control for the filtering facepiece respirator for use by the general public in public health medical emergencies. An additional special control is established in 21 CFR 880.6260. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the **Federal Register** announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to allow for public participation before issuing this guidance as a final guidance document. Thus, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA's GGPs regulation (§ 10.115). The guidance represents the agency's current thinking on special controls for the filtering facepiece respirator for use by the general public in public health medical emergencies. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1626 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations and in NIOSH regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB Control No. 0910-0120; the collections of information in 21 CFR part 801 have been approved under OMB Control No. 0910-0485; and the collections of information in 42 CFR part 84 (relating to NIOSH certification) have been approved under OMB Control No. 0920-0109. In addition, FDA concludes that the labeling statement in section 10.A of the guidance does not constitute a “collection of information” under the Paperwork Reduction Act of 1995. Rather, this labeling statement is “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)). V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 22, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-12790 Filed 7-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0234] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the draft guidance entitled “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.” This draft guidance document describes a means by which the tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the **Federal Register** , FDA is publishing a proposed rule to reclassify tissue adhesive for the topical approximation of skin from class III into class II (special controls). This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by September 4, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: George J. Mattamal, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3619. SUPPLEMENTARY INFORMATION: I. Background Tissue adhesive for the topical approximation of skin devices are intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches. This device is currently in class III and subject to premarket approval requirements (section 515 of the Federal Food, Drug, and Cosmetic Act (act); 21 U.S.C. 360e). On August 25, 2006, at a public meeting of FDA's General and Plastic Surgery Devices Panel (the Panel), the Panel unanimously recommended that the tissue adhesive for the topical approximation of skin device be reclassified from class III into class II and recommended that a guidance document, which the Panel thought should include several voluntary consensus standards, be the special control for the device. FDA considered the Panel's recommendations and, elsewhere in this issue of the **Federal Register** , is proposing to reclassify the tissue adhesive for the topical approximation of skin device into class II. If this reclassification rule is finalized, FDA intends that this guidance document will serve as the special control for this device. Following the effective date of any final reclassification rule based on this proposal, any firm submitting a premarket notification (510(k)) for a tissue adhesive for the topical approximation of skin device would need to address the issues covered in the special controls guidance document. However, the firm need only show that its device meets the recommendations of the guidance document or in some other way provides equivalent assurances of safety and effectiveness. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, if finalized, will represent the agency's current thinking on tissue adhesive for the topical approximation of skin devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number
(1630)to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, Subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 22, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-12795 Filed 7-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Citizenship and Immigration Services Agency Information Collection Activities: Form I-590, Extension of a Currently Approved Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Form I-590, Registration for Classification as Refugee; OMB Control Number 1615-0068. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until August 2, 2007. Written comments and suggestions regarding items contained in this notice, and especially with regard to the estimated public burden and associated response time should be directed to the Department of Homeland Security (DHS), USCIS, Chief, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, NW., 3rd floor, Suite 3008, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352, or via e-mail at *rfs.regs@dhs.gov* . When submitting comments by e-mail add the OMB Control Number 1615-0068 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agencies estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques and forms of information technology, e.g., permitting electronic submission of responses. *Overview of this information collection:*
(1)*Type of Information Collection:* Extension of a currently approved information collection.
(2)*Title of the Form/Collection:* Registration for Classification as Refugee.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-590. U.S. Citizenship and Immigration Services.
(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Primary:* Individuals or Households. This information collection provides a uniform method for applicants to apply for refugee status and contains the information needed in order to adjudicate such applications.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 140,000 responses at 35 minutes (.583) per response.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 81,620 annual burden hours. If you have additional comments, suggestions, or need a copy of the information collection instrument, please visit the USCIS Web site at: *http://www.regulations.gov/fdmspublic/component/main* . We may also be contacted at: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, NW., 3rd floor, Suite 3008, Washington, DC 20529, telephone number 202-272-8377. Dated: June 27, 2007. Richard A. Sloan, Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E7-12834 Filed 7-2-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR 5119-N-02] Notice of Proposed Extension of a Currently Approved Information Collection: Comment Request; Housing Discrimination Information Form HUD-903.1, HUD 903.1A, HUD-903-1B, HUD-903.1F, HUD-903.1KOR, HUD-903.1C, HUD-903.1CAM, HUD-903.1RUS AGENCY: Office of the Assistant Secretary for Fair Housing and Equal Opportunity, HUD. ACTION: Notice. SUMMARY: The proposed extension of the currently approved information collection requirement concerning Housing Discrimination Information Forms HUD 903.1, HUD 903.1A, HUD-903-1B, HUD-903.1F, HUD-903.1KOR, HUD-903.1C, HUD-903.1CAM, and HUD-903.1RUS will be submitted to the Office of Management and Budget
(OMB)for review, as required by the Paperwork Reduction Act. HUD will also solicit public comments on the subject proposal. DATES: *Comments Due Date:* September 4, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number, and should be sent to Juanina B. Harris, Administrative Support Specialist, U.S. Department of Housing and Urban Development, 451 7th Street, SW., Room 5124, Washington, DC 20410-2000; telephone:
(202)402-6979. FOR FURTHER INFORMATION CONTACT: Lynn Grosso, U.S. Department of Housing and Urban Development, 451 7th Street, SW., Room 5226, Washington, DC 20410-2000; telephone:
(202)402-5361 (this is not a toll-free number). Hearing or speech-impaired individuals may access this number via TTY/ASCII by calling the toll-free Federal Information Relay Service at
(800)877-8339. SUPPLEMENTARY INFORMATION: HUD is proposing this extension of a currently approved information collection to the OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed extension of the collection of information regarding alleged discriminatory housing practices under the Fair Housing Act
(Act)(42 U.S.C. 3601 *et seq.* ). The Act prohibits discrimination in the sale, rental, occupancy, advertising, and insuring of residential dwellings, and in residential real estate-related transactions, based on race, color, religion, sex, handicap (disability), familial status, or national origin. Any person who claims to have been injured by a discriminatory housing practice, or who believes that he or she will be injured by a discriminatory housing practice that is about to occur, may file a complaint with HUD not later than one year after the alleged discriminatory housing practice occurred or terminated. Form HUD-903.1 was developed in order to promote consistency in the documents that, by statute, must be provided to persons against whom complaints are filed, and for the convenience of the general public. Section 103.25 of HUD's Fair Housing Act regulation describes the information that must be included in each complaint filed with HUD. For purposes of meeting the Act's one-year time limitation for filing complaints with HUD, complaints need not be initially submitted on the Form that HUD provides. Housing Discrimination Information Form HUD-903.1 (English language), HUD-903.1A (Spanish language), HUD-903-1B (Chinese language), HUD-903.1F (Vietnamese language), HUD-903.1KOR (Korean language), HUD-903.1C (Arabic language), HUD-903.1CAM (Cambodian language), and HUD-903.1RUS (Russian language) may be submitted to HUD by mail, in person, by facsimile, or via the Internet to HUD's Office of Fair Housing and Equal Opportunity (FHEO). FHEO staff uses the information provided on the Form to verify HUD's authority to investigate the aggrieved person's allegations under the Act. Notice of Submission of Proposed Extension of Information Collection to OMB *Title of Proposal:* Housing Discrimination Information Form. *Office:* Fair Housing and Equal Opportunity, HUD. *OMB Control Number:* 2529-0011. *Description of the need for the information and proposed use:* HUD uses the Housing Discrimination Information Form HUD-903.1
(Form)to collect pertinent information from persons wishing to file housing discrimination complaints with HUD under the Fair Housing Act (Act). The Act makes it unlawful to discriminate in the sale, rental, occupancy, advertising, or insuring of residential dwellings; or to discriminate in residential real estate-related transactions, based on race, color, religion, sex, handicap (disability), familial status, or national origin. Any person who claims to have been injured by a discriminatory housing practice, or any person who believes that he or she will be injured by a discriminatory housing practice that is about to occur, may file a complaint with HUD not later than one year after the alleged discriminatory housing practice occurs or terminates. The Form promotes consistency in the collection of information necessary to contact persons who file housing discrimination complaints with HUD. It also aids in the collection of information necessary for initial assessments of HUD's authority to investigate alleged discriminatory housing practices under the Act. This information may subsequently be provided to persons against whom complaints are filed (“respondents”), as required under section 810(a)(1)(B)(ii) of the Act. *Agency form numbers, if applicable:* Form HUD-903.1 (English), Form HUD-903.1A (Spanish), Form HUD-903-1B (Chinese), Form HUD-903.1F (Vietnamese), Form HUD-903.1K (Korean), Form HUD-903.1AR (Arabic), Form HUD-903.1CAM (Cambodian), and Form HUD-903.1R (Russian). *Members of affected public:* Individuals or households; businesses or other for-profit, not-for-profit institutions; State, Local, or Tribal Governments. *Estimation of the total number of hours needed to prepare the information collection, including the number of respondents, frequency of response, and hours of responses:* During FY 2006, HUD staff received approximately 18,824 information submissions from persons wishing to file housing discrimination complaints with HUD. Telephone contacts accounted for 9,655 of this total. The remaining 9,169 complaint submissions were transmitted to HUD by mail, in-person, and via the Internet. HUD estimates that an aggrieved person requires approximately 45 minutes to complete the HUD 903.1 Form. The Form is completed once by each aggrieved person. Therefore, the total number of annual burden hours for this Form is 6,877 hours. 9,169 × 1 (frequency) × .45 minutes (.75 hrs.) = 6,877 (6,876.75) hours. *Annualized cost burden to complainants:* HUD does not provide postage-paid mailers for this information collection. Accordingly, persons who choose to submit this Form to HUD by mail must pay the prevailing cost of First Class Postage. As of the date of this Notice, the annualized cost burden per person, based on a one-time submission of this Form to HUD via First Class Postage, is Forty-One Cents ($0.41) per person. During FY 2006, FHEO staff received approximately 6,897 submissions of potential complaint information by mail. Based on this number, HUD estimates that the total annualized cost burden for aggrieved persons who submit this Form to HUD by mail is $2,815.47. Aggrieved persons also may submit the Form to HUD in person, by facsimile, or electronically via the Internet. *Status of the proposed information collection:* Renewal of a currently approved collection of pertinent information from persons wishing to file Fair Housing Act complaints with HUD. Authority: The Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35, as amended]. Dated: June 26, 2007. Lynn Grosso, Director, Office of Enforcement, FHEO. [FR Doc. E7-12892 Filed 7-2-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WY-060-1320-EL, WYW164812, WYW172388, WYW172685, WYW173408] Notice of Intent
(NOI)To Prepare an Environmental Impact Statement
(EIS)and Notice of Public Meeting on Four Federal Coal Lease Applications in the Decertified Powder River Federal Coal Production Region, WY AGENCY: Bureau of Land Management, Interior. ACTION: Notice of intent and notice of public meeting. SUMMARY: Pursuant to Section 102(2)(C) of the National Environmental Policy Act
(NEPA)of 1969, as amended, the Bureau of Land Management (BLM), Casper Field Office announces its intent to prepare one EIS on the potential impacts of leasing four tracts of Federal coal. The EIS will be called the Wright Area Coal EIS. Under the provisions of 43 Code of Federal Regulations
(CFR)3425.1, the BLM received the following applications to lease maintenance tracts (a maintenance tract is a parcel of land containing Federal coal reserves that can be leased to maintain production at an existing mine) in Campbell County, Wyoming: • Ark Land Company applied for a maintenance coal lease for approximately 4,590.19 acres (approximately 588.2 million tons of coal) in a maintenance tract of Federal coal adjacent to the Black Thunder Mine. The tract, which is referred to as the Hilight Field Tract, has been assigned case number WYW164812. • Ark Land Company applied for a maintenance coal lease for approximately 2,370.52 acres (approximately 428 million tons of coal) in a maintenance tract of Federal coal adjacent to the Black Thunder Mine. The tract, which is referred to as the West Hilight Field Tract, has been assigned case number WYW172388. • Jacobs Ranch Coal Company applied for a maintenance coal lease for approximately 5,944.37 acres (approximately 956 million tons of coal) in a maintenance tract of Federal coal adjacent to the Jacobs Ranch Mine. The tract, which is referred to as the West Jacobs Ranch Tract, has been assigned case number WYW172685. • BTU Western Resources, Inc. applied for a maintenance coal lease for approximately 5,116.65 acres (approximately 598 million tons of coal) in a maintenance tract of Federal coal adjacent to the North Antelope Rochelle Mine. The tract, which is referred to as the Porcupine Tract, has been assigned case number WYW173408. Consistent with Federal regulations under NEPA and the Mineral Leasing Act of 1920, as amended, the BLM must prepare an environmental analysis prior to holding a competitive Federal coal lease sale. The Powder River Regional Coal Team recommended that BLM process these four coal lease applications after they reviewed the Hilight Field, West Hilight Field, and West Jacobs Ranch Tracts at a public meeting held on April 19, 2006, in Casper, Wyoming, and the Porcupine Tract at a public meeting held on January 18, 2007, in Casper, Wyoming. DATES: This notice initiates the public scoping process. To provide the public with an opportunity to review the proposal and gain understanding of the coal leasing process, the BLM will host a meeting on July 24, 2007, at 7 p.m. at the Clarion Hotel and Convention Center, 2009 South Douglas Highway, in Gillette, Wyoming. At the meeting, the public is invited to submit comments and resource information, plus identify issues or concerns to be considered in the coal leasing process. The BLM can best use public input if comments and resource information are submitted by August 31, 2007. The BLM will announce future public meetings and other opportunities to submit comments on this project at least 15 days prior to the events. Announcements will be made through local news media and the Casper Field Office's Web site, which is: *http://www.wy.blm.gov/cfo/.* FOR FURTHER INFORMATION CONTACT: Sarah Bucklin or Mike Karbs, BLM Casper Field Office, 2987 Prospector Drive, Casper, Wyoming 82604. Ms. Bucklin or Mr. Karbs may also be reached at
(307)261-7600. ADDRESSES: Please submit written comments or concerns to the BLM Casper Field Office, Attn: Sarah Bucklin, 2987 Prospector Drive, Casper, Wyoming 82604. Written comments or resource information may also be hand-delivered to the BLM Casper Field Office or sent by facsimile to the attention of Sarah Bucklin at
(307)261-7587. Comments may be sent electronically to *casper_wymail@blm.gov* . Please include “Wright Area Coal EIS/Sarah Bucklin” in the subject line. Members of the public may examine documents pertinent to this proposal by visiting the Casper Field Office during its business hours (7:45 a.m. to 4:30 p.m.), Monday through Friday, except holidays. SUPPLEMENTARY INFORMATION: Ark Land Company submitted an application on October 7, 2005, to lease a maintenance tract of Federal coal adjacent to the company's Black Thunder Mine in Campbell County, Wyoming, which is operated by Thunder Basin Coal Company. The tract is known as the Hilight Field Tract. The Hilight Field Tract includes approximately 588.2 million tons of Federal coal reserves underlying the following lands in Campbell County, Wyoming: T. 44 N., R. 70 W., 6th PM, Wyoming Section 19: Lots 5 through 20; T. 43 N., R.71 W., 6th PM, Wyoming Section 23: Lots 1 through 16; Section 26: Lots 1 through 16; Section 35: Lots 1 through 16; T. 44 N., R. 71 W., 6th PM, Wyoming Section 23: Lots 1 through 16; Section 24: Lots 1 through 16; Section 26: Lots 1 through 16. Containing 4,590.19 acres, more or less. Ark Land Company proposes to mine the tract as a part of the Black Thunder Mine. At the 2006 mining rate of 92.2 million tons per year, the coal included in the Hilight Field Tract would extend the life of the Black Thunder Mine by as many as six years. Ark Land Company submitted an application on January 17, 2006, to lease a maintenance tract of Federal coal adjacent to the company's Black Thunder Mine in Campbell County, Wyoming, which is operated by Thunder Basin Coal Company. The tract is known as the West Hilight Field Tract. The West Hilight Field Tract includes approximately 428 million tons of Federal coal underlying the following lands in Campbell County, Wyoming: T. 43 N., R. 71 W., 6th PM, Wyoming Section 8: Lots 1, 2, 7 through 16; Section 9: Lots 1 through 16; Section 10: Lots 3 through 6, 11 through 14; Section 17: Lots 1 through 16; Section 20: Lots 1 through 4 Section 21: Lots 3, 4. Containing 2,370.52 acres, more or less. Thunder Basin Coal Company proposes to mine the tract as a part of the Black Thunder Mine. At the 2006 mining rate of 92.2 million tons per year, the coal included in the West Hilight Field Tract would extend the life of the Black Thunder Mine by as many as four years. Jacobs Ranch Coal Company submitted an application on March 24, 2006, to lease a maintenance tract of Federal coal adjacent to the company's Jacobs Ranch Mine in Campbell County, Wyoming. The tract is known as the West Jacobs Ranch Tract. The West Jacobs Ranch Tract includes approximately 956 million tons of Federal coal underlying the following lands in Campbell County, Wyoming: T. 43 N., R. 71 W., 6th PM, Wyoming Section 3: Lots 2, 5 through 19; Section 4: Lots 5 through 20; Section 5: Lots 5 through 20; T. 44 N., R. 71 W., 6th PM, Wyoming Section 22: Lots 9 through 16; Section 27: Lot 1 through 16; Section 28: Lots 1 through 3, 5 through 16; Section 29: Lots 5 through 15, SE 1/4 SE 1/4 ; Section 32: Lots 1 through 15, SW 1/4 SE 1/4 ; Section 33: Lots 1 through 15, NE 1/4 SE 1/4 ; Section 34: Lots 1 through 16. Containing 5,944.37 acres, more or less. Jacobs Ranch Coal Company proposes to mine the tract as a part of the Jacobs Ranch Mine. At the 2006 mining rate of 39.9 million tons per year, the coal included in the West Jacobs Ranch Tract would extend the life of the Jacobs Ranch Mine by as many as 23 years. BTU Western Resources, Inc. submitted an application on September 29, 2006, to lease a maintenance tract of Federal coal adjacent to the company's North Antelope Rochelle Mine in Campbell County, Wyoming, which is operated by Powder River Coal, LLC. The tract is known as the Porcupine Tract. The Porcupine Tract includes approximately 598 million tons of Federal coal underlying the following lands in Campbell County, Wyoming: T. 41 N., R. 70 W., 6th PM, Wyoming Section 7: Lots 17, 18; Section 18: Lots 6 through 11, 14 through 19; T. 42 N., R. 70 W., 6th PM, Wyoming Section 19: Lots 17 through 20; Section 20: Lots 13 through 16; Section 26: Lots 9 through 16; Section 27: Lots 9 through 16; Section 29: Lots 1 through 4; Section 30: Lots 5 through 8 T. 41 N., R. 71 W., 6th PM, Wyoming Section 12: Lots 13 through 16; Section 13: Lots 1 through 16; Section 14: Lots 1, 8, 9, 16; Section 23: Lots 1, 8(N 1/2 ); Section 24: Lots 2 through 4, 5(N 1/2 ), 6(N 1/2 ), 7(N 1/2 ); T. 42 N., R. 71 W., 6th PM, Wyoming Section 22: Lots 13 through 16; Section 23: Lots 13 through 16; Section 24: Lots 13 through 16; Section 25: Lots 1 through 4; Section 26: Lots 1 through 6, 11 through 14; Section 27: Lots 1 through 16; Section 35: Lots 3 through 6, 11 through 14. Containing 5,116.65 acres, more or less. BTU Western Resources, Inc. proposes to mine the tract as a part of the North Antelope Rochelle Mine. At the 2006 mining rate of 89.7 million tons per year, the coal included in the Porcupine Tract would extend the life of the North Antelope Rochelle by as many as six years. Lands in the Hilight Field, West Hilight Field, and Porcupine Tracts contain Federal surface administered by the Forest Service and private surface estate which overlies the Federal coal. Lands in the West Jacobs Ranch Tract contain private surface estate which overlies the Federal coal. The Black Thunder Mine, Jacobs Ranch Mine, and North Antelope Rochelle Mine are operating under approved mining permits from the Land Quality and Air Quality Divisions of the Wyoming Department of Environmental Quality. The USDA Forest Service and the Office of Surface Mining Reclamation and Enforcement
(OSM)will be cooperating agencies in the preparation of the EIS. Before the tracts can be leased, the Forest Service must consent to leasing the portions of the tracts that are part of the Thunder Basin National Grassland. If the four tracts are leased to the applicants, the new leases must be incorporated into the existing mining and reclamation plans for the adjacent mines. Before the Federal coal in each tract can be mined, the Secretary of the Interior must approve the revised Mineral Leasing Act
(MLA)mining plan for the mine in which each tract will be included. The OSM is the Federal agency that is responsible for recommending approval, approval with conditions, or disapproval of the revised MLA mining plan to the Office of the Secretary of the Interior. Other cooperating agencies may be identified during the scoping process. The BLM will provide interested parties the opportunity to submit comments or relevant information or both. This information will help the BLM identify issues to be considered in preparing the Wright Area Coal EIS. Issues that have been identified in analyzing the impacts of previous Federal coal leasing actions in the Wyoming Powder River Basin
(PRB)include the need for resolution of conflicts between existing and proposed oil and gas development and coal mining on the tracts proposed for coal leasing; potential impacts to big game herds and hunting; potential impacts to Greater sage-grouse; potential impacts to listed threatened and endangered species; potential health impacts related to blasting operations conducted by the mines to remove overburden and coal; the need to consider the cumulative impacts of coal leasing decisions combined with other existing and proposed development in the Wyoming PRB; and potential site-specific and cumulative impacts on air and water quality. Your response is important and will be considered in the EIS process. If you do respond, we will keep you informed of the availability of environmental documents that address impacts that might occur from this proposal. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Alan Rabinoff, Acting State Director. [FR Doc. E7-12889 Filed 7-2-07; 8:45 am] BILLING CODE 4310-22-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WO-260-09-1060-00-24 1A] Wild Horse and Burro Advisory Board; Meeting AGENCY: Bureau of Land Management, Interior. ACTION: Announcement of meeting. SUMMARY: The Bureau of Land Management
(BLM)announces that the Wild Horse and Burro Advisory Board will conduct a meeting on matters pertaining to management and protection of wild, free-roaming horses and burros on the Nation's public lands. DATES: The Advisory Board will meet Monday, July 30, 2007, from 8 a.m. to 5 p.m., local time. This will be a one day meeting. ADDRESSES: The Advisory Board will meet at The Grove Hotel, 245 South Capitol Blvd., Boise, Idaho, 83702. The Grove's phone number is 208-333-8000. Written comments pertaining to the Advisory Board meeting should be sent to: Bureau of Land Management, National Wild Horse and Burro Program, WO-260, Attention: Ramona DeLorme, 1340 Financial Boulevard, Reno, Nevada, 89502-7147. Submit written comments pertaining to the Advisory Board meeting no later than close of business, July 25, 2007. See the SUPPLEMENTARY INFORMATION section for electronic access and filing address. FOR FURTHER INFORMATION CONTACT: Ramona DeLorme, Wild Horse and Burro Administrative Assistant, at 775-861-6583. Individuals who use a telecommunications device for the deaf
(TDD)may reach Ms. DeLorme at any time by calling the Federal Information Relay Service at 1-800-877-8339. SUPPLEMENTARY INFORMATION: I. Public Meeting Under the authority of 43 CFR part 1784, the Wild Horse and Burro Advisory Board advises the Secretary of the Interior, the Director of the BLM, the Secretary of Agriculture, and the Chief of the Forest Service, on matters pertaining to management and protection of wild, free-roaming horses and burros on the Nation's public lands. The tentative agenda for the meeting is: Monday, July 30, 2007 (8 a.m.-5 p.m.) 8 a.m. Call to Order & Introductions. 8:15 a.m. Old Business: Approval of February 2006 Minutes. Update Pending Litigation. 8:45 a.m. Program Updates: Gathers. Adoptions. Facilities. Forest Service Update. Break (9:30 a.m.-9:45 a.m.) 9:45 a.m. Program Updates (continued): Program Accomplishments. BLM Response to Advisory Board Recommendations. Lunch (11:45 a.m.-1 p.m.) 1 p.m. New Business. Break (2:45 p.m.-3 p.m.) 3 p.m. Public Comments. 4 p.m. Board Recommendations. 4:45 p.m. Recap/Summary/Next Meeting/Date/Site. 5 p.m. Adjourn. The meeting site is accessible to individuals with disabilities. An individual with a disability needing an auxiliary aid or service to participate in the meeting, such as an interpreting service, assistive listening device, or materials in an alternate format, must notify the person listed under FOR FURTHER INFORMATION CONTACT two weeks before the scheduled meeting date. Although the BLM will attempt to meet a request received after that date, the requested auxiliary aid or service may not be available because of insufficient time to arrange it. The Federal Advisory Committee Management Regulations [41 CFR 101-6.1015(b),] require BLM to publish in the **Federal Register** notice of a meeting 15 days prior to the meeting date. II. Public Comment Procedures Members of the public may make oral statements to the Advisory Board on July 30, 2007, at the appropriate point in the agenda. This opportunity is anticipated to occur at 3 p.m., local time. Persons wishing to make statements should register with the BLM by noon on July 30, 2007, at the meeting location. Depending on the number of speakers, the Advisory Board may limit the length of presentations. At previous meetings, presentations have been limited to three minutes in length. Speakers should address the specific wild horse and burro-related topics listed on the agenda. Speakers must submit a written copy of their statement to the address listed in the ADDRESSES section or bring a written copy to the meeting. Participation in the Advisory Board meeting is not a prerequisite for submission of written comments. The BLM invites written comments from all interested parties. Your written comments should be specific and explain the reason for any recommendation. The BLM appreciates any and all comments, but those most useful and likely to influence decisions on management and protection of wild horses and burros are those that are either supported by quantitative information or studies or those that include citations to and analysis of applicable laws and regulations. Except for comments provided in electronic format, speakers should submit two copies of their written comments where feasible. The BLM will not necessarily consider comments received after the time indicated under the DATES section or at locations other than that listed in the ADDRESSES section. In the event there is a request under the Freedom of Information Act
(FOIA)for a copy of your comments, the BLM will make them available in their entirety, including your name and address. However, if you do not want the BLM to release your name and address in response to a FOIA request, you must state this prominently at the beginning of your comment. The BLM will honor your request to the extent allowed by law. The BLM will release all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, in their entirety, including names and addresses. Electronic Access and Filing Address Speakers may transmit comments electronically via the Internet to: *ramona_delorme@blm.gov* . Please include the identifier “WH&B” in the subject of your message and your name and address in the body of your message. Dated: June 27, 2007. Bud Cribley, Acting Assistant Director, Renewable Resources and Planning. [FR Doc. E7-12800 Filed 7-2-07; 8:45 am] BILLING CODE 4310-84-P INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701-TA-449 and 731-TA-1118-1121 (Preliminary)] Light-Walled Rectangular Pipe and Tube From China, Korea, Mexico, and Turkey AGENCY: United States International Trade Commission. ACTION: Institution and scheduling of a preliminary phase countervailing duty investigation and preliminary phase antidumping investigations. SUMMARY: The Commission hereby gives notice of the institution of investigation and commencement of preliminary phase countervailing duty investigation No. 701-TA-449 (Preliminary) under section 703(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports from China of light-walled rectangular pipe and tube, currently provided for in subheading 7306.61.50 of the Harmonized Tariff Schedule of the United States, 1 that are alleged to be subsidized by the Government of the People's Republic of China. The Commission also hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping investigations Nos. 731-TA-1118-1121 (Preliminary) under section 733(a) of the Tariff Act of 1930 (19 U.S.C. 1673b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports from China, Korea, Mexico, and Turkey of light-walled rectangular pipe and tube, currently provided for in subheading 7306.61.50 of the Harmonized Tariff Schedule of the United States, 1 that are alleged to be sold in the United States at less than fair value. Unless the Department of Commerce extends the time for initiation pursuant to section 702(c)(1)(B) of the Act (19 U.S.C. 1671a(c)(1)(B)), the Commission must reach preliminary determinations in antidumping and countervailing duty investigations in 45 days, or in this case by Monday, August 13, 2007. The Commission's views are due at Commerce within five business days thereafter, or by Monday, August 20, 2007. 1 Prior to February 3, 2007, the merchandise subject to these investigations was properly classified under subheading 7306.60.50 of the Harmonized Tariff Schedule of the United States. For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207). DATES: *Effective Date:* June 27, 2007. FOR FURTHER INFORMATION CONTACT: Russell Duncan ( *russell.duncan@usitc.gov* ), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server ( *http://www.usitc.gov* ). The public record for these investigations may be viewed on the Commission's electronic docket
(EDIS)at *http://edis.usitc.gov.* SUPPLEMENTARY INFORMATION: *Background.* These investigations are being instituted in response to a petition filed on June 27, 2007, by the following firms: Allied Tube and Conduit, Harvey, IL; Atlas Tube, Plymouth, MI; California Steel and Tube, City of Industry, CA; Ex-L-Tube, Kansas City, MO; Hannibal Industries, Los Angeles, CA; Leavitt Tube Company LLC, Chicago, IL; Maruichi American Corporation, Sante Fe Springs, CA; Searing Industries, Rancho Cucamonga, CA; Southland Tube, Birmingham, AL; Vest Inc., Los Angeles, CA; Welded Tube, Concord, Ontario (Canada); and Western Tube and Conduit, Long Beach, CA. *Participation in the investigations and public service list.* Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in sections 201.11 and 207.10 of the Commission's rules, not later than seven days after publication of this notice in the **Federal Register** . Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to these investigations upon the expiration of the period for filing entries of appearance. *Limited disclosure of business proprietary information
(BPI)under an administrative protective order
(APO)and BPI service list.* Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in these investigations available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the **Federal Register** . A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO. *Conference.* The Commission's Director of Operations has scheduled a conference in connection with these investigations for 9:30 a.m. on Wednesday, July 18, 2007, at the U.S. International Trade Commission Building, 500 E Street SW., Washington, DC. Parties wishing to participate in the conference should contact Russell Duncan ( *russell.duncan@usitc.gov* ) not later than Monday, July 16, 2007, to arrange for their appearance. Parties in support of the imposition of countervailing and of antidumping duties in these investigations and parties in opposition to the imposition of such duties will each be collectively allocated one hour each within which to make an oral presentation at the conference. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the conference. *Written submissions.* As provided in sections 201.8 and 207.15 of the Commission's rules, any person may submit to the Commission on or before Monday, July 23, 2007, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties may file written testimony in connection with their presentation at the conference no later than three days before the conference. If briefs or written testimony contain BPI, they must conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's rules do not authorize filing of submissions with the Secretary by facsimile or electronic means, except to the extent permitted by section 201.8 of the Commission's rules, as amended, 67 FR 68036 (November 8, 2002). Even where electronic filing of a document is permitted, certain documents must also be filed in paper form, as specified in II
(C)of the Commission's Handbook on Electronic Filing Procedures, 67 FR 68168, 68173 (November 8, 2002). In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. Authority: These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules. Issued: June 28, 2007. By order of the Commission. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E7-12846 Filed 7-2-07; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II and prior to issuing a registration under 21 U.S.C. 952(a)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on March 29, 2007, Applied Science Labs, Division of Alltech Associates Inc., 2701 Carolean Industrial Drive, State College, Pennsylvania 16801, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as an importer of the basic classes of controlled substances listed in schedule I and II: Drug Schedule Heroin
(9200)I Cocaine
(9041)II Codeine
(9050)II Meperidine
(9230)II Methadone
(9250)II Morphine
(9300)II The company plans to import these controlled substances for the manufacture of reference standards. Any manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than August 2, 2007. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d),
(e)and (f). As noted in a previous notice published in the **Federal Register** on September 23, 1975, (40 FR 43745-46), all applicants for registration to import a basic class of any controlled substances in schedule I or II are and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C 958(a), 21 U.S.C 823(a), and 21 CFR 1301.34(b), (c), (d),
(e)and
(f)are satisfied. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12950 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 17, 2007, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made application by letter to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of Codeine (9050), a basic class of controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance as an intermediate to other opiates and supply as API to its customers. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than September 4, 2007. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12952 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 19, 2007, Dade Behring Inc., 100 GBC Drive, MS514, Post Office Box 6101, Attention: RA/QS, Newark, Delaware 19714-6101, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule I and II: Drug Schedule Tetrahydrocannabinols
(7370)I Benzoylecgonine
(9180)II Morphine
(9300)II The company plans to produce the listed controlled substances in bulk to be used in the manufacture of reagents and drug calibrator/controls for DEA exempt products. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than September 4, 2007. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12949 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated November 21, 2006 and published in the **Federal Register** on December 1, 2006, (71 FR 69590), Hospira, Inc., 1776 North Centennial Drive, McPherson, Kansas 67460-1247, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Remifentanil for use in dosage form manufacturing. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Hospira, Inc to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Hospira, Inc to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and section 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic class of controlled substance listed. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12953 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application This is notice that on February 12, 2007, Johnson Matthey Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, New Jersey 08066, made application by letter to the Drug Enforcement Administration
(DEA)to be registered as an importer of Coca Leaves (9040), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance to manufacture bulk Cocaine HCL for sale to finished dosage form manufacturers. As noted in a previous notice published in the **Federal Register** on September 23, 1975, (40 FR 43745), all applicants for registration to import a basic class of any controlled substances in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d),
(e)and
(f)are satisfied. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12941 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 13, 2007, Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742, made application by letter to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Cocaine
(9041)II Ecgonine
(9180)II The company plans on producing cocaine for sale to its customers, who are final dosage manufacturers. The ecgonine is formed during the manufacturing process for cocaine. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administrator, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537; or any being sent via express mail should be sent to Drug Enforcement Administration, Federal Register Representative (ODL); 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than September 4, 2007. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12947 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on February 2, 2007, Lipomed, Inc., One Broadway, Cambridge, Massachusetts 02142, made application by renewal to the Drug Enforcement Administration
(DEA)for registration as an importer of the basic classes of controlled substances listed in schedules II: Drug Schedule Cathinone
(1235)I Methcathinone
(1237)I N-Ethylamphetamine
(1475)I Methaqualone
(2565)I Gamma Hydroxybutyric Acid
(2010)I Lysergic acid diethylamide
(7315)I 2,5-Dimethoxy-4-(n)-propylthiophenethylamine
(7348)I Marihuana
(7360)I Tetrahydrocannabinols
(7370)I Mescaline
(7381)I 3,4,5-Trimethoxyamphetamine
(7390)I 4-Bromo-2,5-dimethoxyamphetamine
(7391)I 4-Bromo-2,5-dimethoxyphenethylamine
(7392)I 4-Methyl-2,5-dimethoxyamphetamine
(7395)I 2,5-Dimethoxyamphetamine
(7396)I 2,5-Dimethoxy-4-ethylamphetamine
(7399)I 3,4-Methylenedioxyamphetamine
(7400)I 3,4-Methylenedioxy-N-ethylamphetamine
(7404)I 3,4-Methylenedioxymethamphetamine
(7405)I 4-Methoxyamphetamine
(7411)I Dimethyltryptamine
(7435)I Psilocybin
(7437)I Psilocyn
(7438)I Acetyldihydrocodeine
(9051)I Dihydromorphine
(9145)I Heroin
(9200)I Normorphine
(9313)I Pholcodine
(9314)I Tilidine
(9750)I Amphetamine
(1100)II Methamphetamine
(1105)II Amobarbital
(2125)II Pentobarbital
(2270)II Secobarbital
(2315)II Phencyclidine
(7471)II Cocaine
(9041)II Codeine
(9050)II Dihydrocodeine
(9120)II Oxycodone
(9143)II Hydromorphone
(9150)II Benzoylecgonine
(9180)II Ethylmorphine
(9190)II Hydrocodone
(9193)II Levorphanol
(9220)II Meperidine
(9230)II Methadone
(9250)II Dextropropoxyphene, bulk (non-dosage forms)
(9273)II Morphine
(9300)II Thebaine
(9333)II Oxymorphone
(9652)II Alfentanil
(9737)II Fentanyl
(9801)II Sufentanil
(9740)II The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C 952 (a)(2)(B) may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537; or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than August 2, 2007. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d),
(e)and (f). As noted in a previous notice published in the **Federal Register** on September 23, 1975, (40 FR 43745), all applicants for registration to import a basic class of any controlled substances in schedule I or II are and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C 958(a); 21 U.S.C 823(a); and 21 CFR 1301.34(b), (c), (d),
(e)and
(f)are satisfied. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12954 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 15, 2007, Lonza Riverside, 900 River Road, Conshohocken, Pennsylvania 19428, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Gamma hydroxybutyric acid
(2010)I Amphetamine
(1100)II Methylphenidate
(1724)II The company plans to manufacture bulk products for finished dosage units and distribution to its customers. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than September 4, 2007. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12946 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 8, 2007, Penick Corporation, 33 Industrial Road, Pennsville, New Jersey 08070, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Cocaine
(9041)II Codeine
(9050)II Dihydrocodeine
(9120)II Oxycodone
(9143)II Hydromorphone
(9150)II Diphenoxylate
(9170)II Ecgonine
(9180)II Hydrocodone
(9193)II Morphine
(9300)II Thebaine
(9333)II Oxymorphone
(9652)II The company plans to manufacture the listed controlled substances as bulk controlled substance intermediates for distribution to its customers for further manufacture or to manufacture pharmaceutical dosage forms. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than September 4, 2007. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12945 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated March 19, 2007, and published in the **Federal Register** on March 27, 2007, (72 FR 14297), Roche Diagnostics Operations, Inc., Attn: Regulatory Compliance, 9115 Hague Road, Indianapolis, Indiana 46250, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule I and II: Drug Schedule Lysergic Acid Diethylamide
(7315)I Tetrahydrocannabinols
(7370)I Alphamethadol
(9605)I Phencyclidine
(7471)II Ecgonine
(9180)II Methadone
(9250)II Morphine
(9300)II The company plans to manufacture small quantities of the listed controlled substances for use in diagnostic products. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Roche Diagnostics Operations, Inc., to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Roche Diagnostics Operations, Inc., to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12951 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated March 19, 2007, and published in the **Federal Register** on March 27, 2007, (72 FR 14297), Stepan Company, Natural Products Dept., 100 W. Hunter Avenue, Maywood, New Jersey 07607, made application by renewal to the Drug Enforcement Administration
(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Cocaine
(9041)II Ecgonine
(9180)II The company plans to manufacture in bulk for distribution to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Stepan Company to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Stepan Company to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with State and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed. Dated: June 26, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7-12942 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Michael F. Myers, M.D.; Revocation of Registration On January 10, 2007, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Michael F. Myers, M.D. (Respondent) of Woodruff, South Carolina. The Order to Show Cause proposed the revocation of Respondent's DEA Certificate of Registration, BM5526009, as a practitioner, on the ground that Respondent's continued registration would be inconsistent with the public interest. Show Cause Order at 1 (citing 21 U.S.C. 824(a)(4)). The Immediate Suspension was imposed based on my preliminary finding that Respondent had “diverted large quantities of controlled substances,” and that there was a “substantial likelihood that [he] would continue to divert controlled substances to drug abusers.” *Id.* at 1-2. I therefore concluded that Respondent's “continued registration during the pendency of these proceedings would constitute an imminent danger to the public health and safety.” *Id.* The Show Cause Order alleged that Respondent “frequently grew marijuana in [his] residence,” that he “regularly purchased large quantities of marijuana,” that “he smoked marijuana throughout the day on a daily basis,” and that he “regularly distributed marijuana from [his] residence.” *Id.* at 2. The Show Cause Order further alleged that Respondent “regularly exchanged controlled substance prescriptions for marijuana and other prescription controlled substances.” *Id.* The Show Cause Order also alleged that Respondent “routinely sold controlled substance prescriptions and large quantities of marijuana to known drug peddlers.” *Id.* More specifically, the Show Cause Order alleged that Respondent had distributed marijuana on a continuing basis in quantities ranging from “small user amounts” to as much as five pounds. *Id.* The Show Cause Order also alleged that Respondent had prescribed Adderall, a schedule II controlled substance, and hydrocodone, a schedule III controlled substance, for a person without “performing any tests or formulat[ing] a diagnosis during the initial visit,” and he had “continued to authorize prescriptions for [these] controlled substances without an examination or further care.” *Id.* Relatedly, the Show Cause Order alleged that Respondent subsequently “received some of the hydrocodone from the prescriptions [he] wrote for this” person. *Id.* Next, the Show Cause Order alleged that Respondent had “prescribe[d] controlled substances to a person [he] knew was addicted to [them],” and that Respondent also “knew [that] this person was selling the filled prescriptions to support [his] addiction.” *Id.* The Show Cause Order further alleged that Respondent had engaged in a scheme to provide controlled prescription drugs to drug dealers. *Id.* According to the Show Cause Order, the dealers' runners would go to Respondent's residence to receive the prescriptions; after the prescriptions were filled, the dealer would provide Respondent with half of the drugs and sell the other half to drug abusers. *Id.* Finally, the Show Cause Order alleged that on May 10, 2006, law enforcement officers executed a search warrant at Respondent's home during which they found marijuana, pills which appeared to be prescription controlled substances, and assorted drug-related paraphernalia. *Id.* On January 12, 2007, DEA investigators personally served the Show Cause Order on Respondent. Since that time, neither Respondent, nor anyone purporting to represent him, has responded. Because
(1)more than thirty days have passed since service of the Show Cause Order, and
(2)no request for a hearing has been received, I conclude that Respondent has waived his right to a hearing. *See* 21 CFR 1301.43(d). I therefore enter this final order without a hearing based on relevant material contained in the investigative file and make the following findings. Findings Respondent is the holder of DEA Certificate of Registration, BM5526009, as a practitioner, which authorizes him to dispense controlled substances in schedules II through V. Respondent's registration was last renewed on February 15, 2006, and expires on January 31, 2009. In July 1996, Respondent was disciplined by the State Board of Medical Examiners of South Carolina, which found that he had written prescriptions for Lortab 7.5 (hydrocodone), and Didrex (benzphetamine), 1 using the names of other patients, which he then had filled and diverted to his personal use. Respondent admitted to the State's allegation. The Board fined him $7500, issued a reprimand, and imposed various conditions on his medical license including random drug testing. On October 17, 2000, however, the Board removed the conditions. 1 Both drugs are schedule III controlled substances. *See* 21 CFR 1308.13. According to the investigative file, the Board's conditions appeared to have had only a limited impact on Respondent. Beginning in the summer of 1999, while the Board's conditions were still in effect, Respondent purchased marijuana from a person who lived with him. During an interview, this person related that from 1999 until 2003, he had sold Respondent approximately 100 pounds of marijuana. The person further stated to investigators that he regularly traded marijuana for Lortab and Xanax prescriptions issued by Respondent. More specifically, Respondent would provide this person with prescriptions for 240 Lortab and 120 Xanax at the beginning of each month; Respondent would also write identical prescriptions in the name of the person's girlfriend at the end of each month. The person also told investigators that he could make more money selling the Lortab and Xanax than he could selling marijuana. Finally, the person related that Respondent gave him the combination to a safe that was located in Respondent's home and instructed him to place the marijuana in the safe. Investigators also interviewed a person who related that his father was the number one seller of OxyContin in the Williamston, South Carolina area. According to this person, his father was addicted to OxyContin, which Respondent had prescribed to him. This person stated that Respondent would write controlled substance prescriptions in other persons' names, and that his father would send a “runner” to Respondent's practice to pick up the prescriptions. The person further advised that after the prescriptions were filled, his father would give half of the drugs to the runner and swap the remaining half with Respondent for marijuana. The person also related that he had been present during a fall 2004 incident in which his father had gone to Respondent's home and obtained 2.5 pounds of marijuana. Moreover, during this incident, Respondent showed this person ten marijuana plants that he was growing in his basement. This person also told investigators of another fall 2004 incident in which he accompanied his father to Respondent's home as the latter retrieved one pound of marijuana from the mailbox. Finally, this person, who was being treated by Respondent for anxiety, related a late fall/early winter 2004 visit to Respondent's medical office. During the appointment, Respondent issued him prescriptions for both Xanax and Lortab. The person related to investigators that he was surprised to receive the Lortab prescription. Shortly after leaving Respondent's office, the person was contacted by his father who asked for half of the Lortab. The person further told investigators that he believed that Respondent had told his father about the issuance of the Lortab prescription. Subsequently, investigators interviewed the above person's brother, who corroborated his father's relationship with Respondent. Specifically, this person confirmed that for approximately five years, Respondent had provided his father with prescriptions for Lortab, Xanax, Roxicodone, Percocet and Oxycontin. The person stated that he had lived with his father from the year 2000 until 2003, during which time he observed his father sell large quantities of controlled substances to numerous individuals in the Williamston, South Carolina area. According to this person, his father would sell controlled substances to as many as twenty persons a day and made a significant amount of money doing so. The person further related that his father had both personally obtained controlled substance prescriptions from Respondent and also used a “runner” to obtain them. The person also stated that he was present on approximately five to seven occasions during which his father purchased marijuana from Respondent. The person also told investigators that while he was between the ages of fifteen to eighteen, he had purchased marijuana approximately twenty times from Respondent's son at his residence, and that on some occasions, he personally witnessed Respondent hand the marijuana to his son, who then delivered it to him. Investigators also interviewed a person who stated that he had sold marijuana for Respondent from the summer of 2004 through the summer of 2005. The person further related that from the time he first met Respondent in the year 2003 until the summer of 2005, he had observed approximately twenty-five to thirty pounds of marijuana at Respondent's home, scales used to weigh marijuana for resale, and a box of index cards which contained records of customers to whom Respondent had extended credit. The person also related that Respondent provided him with discounted marijuana as payment for his selling the drug on the latter's behalf, and that he had observed Respondent give another individual five to six pounds of the drug to sell. This person also told investigators that anytime he was in Respondent's presence, Respondent would be smoking marijuana. The person also stated that he was present numerous times when Respondent came home for lunch and that Respondent would smoke marijuana before returning to work. Investigators interviewed another person who related that between 1999 and the end of 2003, he had supplied Respondent with over one hundred pounds of marijuana. This person stated that during the last three to four months of 2003, he traveled to North Carolina every other week for the purpose of obtaining marijuana for Respondent. According to this person, prior to each trip, Respondent provided him with approximately $ 2000 to $ 3000 dollars, which was used to purchase three to four pounds of marijuana. Moreover, the person observed Respondent sell approximately twenty-five to thirty pounds of marijuana and that he was growing marijuana. The person also told investigators that from the end of 2002 through the end of 2003, Respondent issued him and another person, prescriptions for 240 Lortab and 120 Xanax in exchange for one pound of marijuana. The person stated that after filling the prescriptions, he would sell the Lortab and Xanax on the street. Finally, this person related an incident in which he and Respondent had smoked marijuana prior to the latter's performing surgery on his girlfriend. Investigators next interviewed the father of the two individuals whose statements are related above. This person stated that he had been abusing drugs most of his adult life, but it was not until Respondent gave him prescriptions for 150 Oxycontin (80 mg.) per month that he developed the worst addiction he had experienced in his life. According to this person, he became “hooked” on Oxycontin within six to eight months after Respondent first prescribed it for him, and began taking the drug intravenously. According to this person, Respondent also provided him with prescriptions for 240 Roxicodone tablets each month. The person also told investigators that he had had numerous conversations with Respondent regarding his addiction to Oxycontin, that he had told Respondent that he was shooting up the drug, and that he told Respondent that he was selling the drug to support his habit. Respondent, however, never suggested taking him off of Oxycontin, or that he enter a treatment program. The person further related that he and Respondent would supply each other with marijuana when the other's supply was low. The person stated that he had supplied Respondent with approximately 1/4 pound to one pound of marijuana and that Respondent had supplied him with three to four pounds. The person also told investigators that he had observed multiple pounds of marijuana while at Respondent's residence. On May 10, 2006, law enforcement authorities executed a search warrant at Respondent's residence. During the search, the authorities found marijuana roaches, marijuana seeds, two scales, and various paraphernalia including rolling papers, hemostats, pipes, and rollers. Thereafter, investigators interviewed an additional acquaintance of Respondent, who had met him through the latter's son. This person corroborated the information regarding Respondent's dealings in marijuana including the name of his primary supplier, his index card system for recording transactions, and his personal use. The person also stated that Respondent had given him marijuana to try on five to ten occasions, and that between 2003 and the end of 2004, he would obtain marijuana from a safe in Respondent's home approximately one to two times per week. The person further related that towards the end of 2004, he had told Respondent that he had knee pain and suspected that he suffered from Attention Deficit Disorder. Respondent told him to come to his office. While Respondent tested his reflexes during the visit, he conducted no further tests and gave no diagnosis. Nonetheless, Respondent prescribed Adderall, a schedule II controlled substance, and hydrocodone. Shortly after filling the initial prescription, the person visited Respondent's home and smoked marijuana. During this visit, Respondent asked the person to give him some of his hydrocodone. Moreover, upon filling a second prescription for hydrocodone, Respondent again asked the person to give him the tablets that he did not need. Respondent issued this person prescriptions for hydrocodone on a monthly basis between January 2005 and May 2006. The person admitted to investigators that he took very few hydrocodone tablets and regularly provided Respondent with sixty of them. The person further admitted to selling the majority of the remaining tablets to his mother. The person also stated that following Respondent's arrest, Respondent told him not to tell the authorities that he was giving hydrocodone to Respondent. On December 12, 2006, a federal grand jury indicted Respondent, charging him with conspiring to possess with the intent to distribute, and to distribute, marijuana, see 21 U.S.C. 846; and maintaining a residence for the purpose of distributing and using marijuana. *See id.* section 856(a)(1). The grand jury also indicted Respondent on twelve counts of knowingly and intentionally distributing Lortab (hydrocodone), and three counts of knowingly and intentionally distributing Xanax (alprazolam), outside of the usual course of medical practice and for other than a legitimate medical purpose, to an individual identified only as person A. *See id.* sections 841(a)(1), 841(b)(1)(D), & 841(b)(2). Finally, the grand jury indicted Respondent on thirteen additional counts of knowingly and intentionally distributing Lortab, outside of the usual course of medical practice and for other than a legitimate medical purpose, to an individual identified only as person B. *See* 21 U.S.C. 841(a)(1) & 841(b)(1)(D). Discussion Section 304(a) of the Controlled Substances Act provides that a registration to “dispense a controlled substance * * * may be suspended or revoked by the Attorney General upon a finding that the registrant * * * has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). In making the public interest determination, the Act requires the consideration of the following factors:
(1)The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2)The applicant's experience in dispensing * * * controlled substances.
(3)The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4)Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5)Such other conduct which may threaten the public health and safety. *Id.* “[T]hese factors are * * * considered in the disjunctive.” *Robert A. Leslie, M.D.* , 68 FR 15227, 15230 (2003). I “may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether a registration should be revoked.” *Id.* Moreover, case law establishes that I am “not required to make findings as to all of the factors.” *Hoxie* v. *DEA* , 419 F.3d 477, 482 (6th Cir. 2005); *see also Morall* v. *DEA* , 412 F.3d 165, 173-74 (D.C. Cir. 2005). Finally, section 304(d) provides that “[t]he Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety.” 21 U.S.C. 824(d). Here, analyzing the evidence under factors two and four establishes that Respondent has committed acts “inconsistent with the public interest,” and posed “an imminent danger to public health or safety,” which justified the immediate suspension of his registration. Relatedly, the record also demonstrates that Respondent's continued registration would be inconsistent with the public interest and that his registration should be revoked. Factors Two and Four—Respondent's Experience in Dispensing Controlled Substances and Record of Compliance with Applicable Laws The evidence in this case overwhelmingly establishes that Respondent has engaged in the criminal distribution of controlled substances in violation of 21 U.S.C. 841. More specifically, the evidence shows that Respondent was a marijuana dealer/distributor and had engaged in this criminal conduct for a period of at least five years. Moreover, the evidence establishes that Respondent engaged in the illegal manufacturing of marijuana. *Id.* Furthermore, Respondent used his DEA registration for criminal purposes. More specifically, the evidence shows that Respondent issued prescriptions for controlled substances which included OxyContin and Percocet (schedule II), Lortab (hydrocodone, schedule III), and Xanax (schedule IV), which he then traded for marijuana. Respondent also issued prescriptions without a legitimate medical purpose. *See* 21 CFR 1306.04(a) (“A prescription for a controlled substance * * * must be issued for a legitimate medical purpose by an individual acting in the usual course of his professional practice.”). Relatedly, Respondent issued prescriptions in the names of other “patients” so that he or his associates would then be able to acquire the drugs. Notably, Respondent had previously been sanctioned by the State Board for the same conduct. Finally, the record establishes that Respondent continued to prescribe Oxycontin to a “patient,” notwithstanding that the “patient” had told him:
(1)That he was addicted to the drug,
(2)that he was taking the drug intravenously, and
(3)that he was selling the drug to support his habit. It is indisputable that Respondent's criminal conduct created an “imminent danger to public health or safety,” 21 U.S.C. 824(d), and was “inconsistent with the public interest.” *Id.* 824(a)(4). I therefore hold that Respondent's continued registration would be “inconsistent with the public interest” and that his registration should be revoked. *Id.* Moreover, for the same reasons that led me to find that Respondent posed “an imminent danger to the public health or safety,” *id.* section 824(d), I conclude that the public interest requires that his registration be revoked effective immediately. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA Certificate of Registration, BM5526009, issued to Michael F. Myers, M.D., be, and it hereby is, revoked. I further order that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective immediately. Dated: June 22, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7-12771 Filed 7-2-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 07-7] Southwood Pharmaceuticals, Inc.; Revocation of Registration On November 30, 2006, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Southwood Pharmaceuticals, Inc. (Respondent), of Lake Forest, California. The Order immediately suspended Respondent's DEA Certificate of Registration, RS0204898, based on my preliminary finding that its continued registration “constitute[s] an imminent danger to the public health and safety because of the substantial likelihood that Southwood [would] continue to supply pharmacies that divert large quantities of controlled substances.” Show Cause Order at 3. The Order also sought the revocation of Respondent's registration on the ground that its continued registration is “inconsistent with the public interest.” Id. at 1 (citing 21 U.S.C. 823(d) & 824(a)(4)). The Show Cause Order alleged that between November 2005 and August 2006, Respondent's sales to pharmacies of hydrocodone products “increased from approximately 7,000 dosage units per month to approximately 3,000,000 dosage units per month,” and that the increase was “directly attributable to [its] supplying controlled substances to pharmacies that it knew or should have known were engaged in the widespread diversion of controlled substances.” Id. The Show Cause Order alleged that several of Respondent's customers were distributing “large amounts of hydrocodone based on orders placed by customers using various Internet Web sites.” Id. The Show Cause Order specifically alleged that “from December 12, 2005, to August 31, 2006, [Respondent] distributed approximately 8,671,000 dosage units of hydrocodone products to Medipharm-Rx, Inc.,” and did so “under circumstances that clearly indicated that Medipharm was engaged in the diversion of controlled substances.” Id. at 1-2. The Show Cause Order further alleged that these circumstances included that “ninety-nine percent of Medipharm's business [with Respondent] involved the sale of controlled substances,” that Medipharm was owned by an individual who also owned a Web site “that solicit[ed] orders for controlled substances” and used practitioners who issued prescriptions outside of “the usual course of professional practice,” and that “Medipharm's orders were of an unusual size, deviated substantially from a normal pattern, and were of an unusual frequency.” Id. at 2. Relatedly, the Show Cause Order alleged that Respondent had “also supplied controlled substances under similarly suspicious circumstances” to fourteen other pharmacies. Id. The Show Cause Order thus alleged that Respondent “repeatedly supplied excessive quantities of hydrocodone to pharmacies that it knew or should have known were diverting hydrocodone.” Id. Moreover, the Show Cause Order alleged that notwithstanding “the unusual size and frequency of the orders placed by Medipharm and others, as well as the fact that the orders substantially deviated from the normal pattern of orders received by” it, Respondent never reported any of the orders as suspicious. Id. at 2-3. Next, the Show Cause Order alleged that on July 17, 2006, the Office of Diversion Control's E-Commerce Section held a conference call with Respondent's representatives to discuss “the distribution of controlled substances to Internet pharmacies.” Id. at 3. During the call, DEA officials allegedly presented Respondent with “information on the characteristics of Internet pharmacies and the nature of their illegal activities.” Id. DEA officials also allegedly discussed with Respondent such subjects as DEA's 2001 Guidance Document on the use of the Internet to prescribe controlled substances, the requirement for a valid prescription under federal law and existing professional standards, DEA's regulation requiring the reporting of suspicious orders, and the “practices and ordering patterns of internet pharmacies.” Id. The Show Cause Order further alleged that notwithstanding this information, in August 2006, Respondent proceeded to distribute large quantities of hydrocodone to five different internet pharmacies. Id. The Show Cause Order thus alleged that Respondent “has failed to maintain effective controls against diversion and that [its] continued registration * * * would be inconsistent with the public interest.” Id. On December 6, 2006, the Show Cause Order was served on Respondent. ALJ Ex. 2. Thereafter, on December 29, 2006, Respondent, through its counsel, requested a hearing. ALJ Ex. 3. The matter was assigned to Administrative Law Judge
(ALJ)Gail Randall, who conducted a hearing in Arlington, Virginia, from February 5 through February 8, 2007. At the hearing, both parties called witnesses and introduced documentary evidence. Following the hearing, both parties submitted briefs containing proposed findings of fact, conclusions of law, and argument. On March 30, 2007, the ALJ issued her recommended decision (ALJ). In that decision, the ALJ concluded that DEA had proved that “Respondent's continued registration to handle hydrocodone products would be against the public interest.” ALJ at 61-62. The ALJ concluded, however, that Respondent “has kept an open dialogue with the DEA and has attempted to come into compliance with the DEA's regulations.” Id. at 62. While acknowledging “the egregious quantities of hydrocodone products the Respondent irresponsibly sold to registered [i]nternet pharmacies during 2005 and 2006,” the ALJ nonetheless “conclude[d] that revocation of * * * Respondent's entire DEA registration is too severe a remedy.” Id. Continuing, the ALJ explained that “the record contains no evidence of * * * Respondent's improper handling of any other controlled substances, especially in its sales of manufactured products to its practitioner customers.” Id. Noting that Respondent had hired an “experienced officer who will be making the final decisions concerning [its] compliance measures,” and that this would provide “an increased level of protection of the public interest,” the ALJ recommended that Respondent's authority to handle hydrocodone products be revoked but that it retain its authority to handle other controlled substances. Id. The ALJ further recommended that DEA monitor Respondent to ensure that it comply with both her proposed restrictions and Respondent's decision to cease distributing to Florida-based internet pharmacies. Id. Thereafter, the Government filed exceptions. In its exceptions, the Government contended that the record established that Respondent had also distributed excessive quantities of other controlled substances included phentermine and alprazolam. See Gov. Exceptions at 2-9. The Government also contended that the ALJ's reliance on Respondent's hiring of a new Chief Operating Officer
(COO)was misplaced because the company had, in fact, sold increasing amounts of controlled substances to “rogue [i]nternet pharmacies” for several months thereafter. Id. at 11. The Government further argued that under the “day to day leadership” of its new COO, Respondent had continued to constructively distribute controlled substances to its physician clients after its registration was suspended. Id. According to the Government, this conduct “refutes the ALJ's hypothesis that [the new COO] will effectively manage Respondent's compliance program.” Id. In response, Respondent argued that the Government had “largely buried its concerns” regarding the distribution of phentermine noting that the drug was not mentioned in the Show Cause Order, the lengthy stipulation of facts, or in the Government's opening statement. Respondent's Resp. at 2-3. Respondent further argued that it has stipulated that it will not “ship phentermine to any pharmacy, should its registration be restored.” Id. at 2. With respect to alprazolam, Respondent argued that “the government wholly buried its concern with this substance, making explicit reference to it only in its Exceptions.” Id. Finally, Respondent argued that the ALJ's findings regarding its new COO are based on credibility determinations and are entitled to deference. Id. at 4-6. Thereafter, on May 8, 2007, the ALJ forwarded the record to me for final agency action. Having reviewed the record as a whole, I hereby issue this decision and final order. I adopt the ALJ's findings of fact and conclusions of law except as expressly noted herein. However, for reasons explained below, I conclude that the ALJ's proposed remedy is insufficient to protect the public interest. While I am mindful of the corrective measures engaged in by Respondent, its sales of extraordinary quantities of controlled substances to entities which it had reason to know were diverting the drugs caused extraordinary harm to public health and safety. Therefore, Respondent's registration will be revoked and its pending renewal application will be denied. I make the following findings. Findings Respondent Southwood Pharmaceuticals, Inc., is the holder of DEA Certificate of Registration, RS0204898, which authorizes it to manufacture controlled substances in schedules 3, 3N, 4, and 5. GX 1. While the expiration date of its registration was February 28, 2007, see id., Respondent submitted a timely renewal application. See Resp. Ex. 110. Respondent's registration thus remains in effect (although in suspended status) pending the issuance of this order. 5 U.S.C. 558(c). Respondent's market niche was the repackaging of oral dose generic drug products into common prescription quantities which it then distributed. ALJ at 3. Until December 2005, Respondent's customer base was primarily comprised of dispensing physicians who specialized in treating injured workers, pain management and urgent care. Id. at 3-4. Respondent also distributed its products to group practices, specialty clinics and some traditional retail pharmacies. Id. Among the drugs distributed by Respondent were schedule III controlled substances containing hydrocodone. 1 See 21 CFR 1308.13(e). 1 By itself, hydrocodone is a schedule II controlled substance. 21 CFR 1308.12(b)(1). Respondent did not, however, distribute schedule II hydrocodone. Throughout this decision, the term hydrocodone refers to those schedule III controlled substances which contain hydrocodone. Respondent's Hydrocodone Sales According to data submitted by Respondent through DEA's ARCOS system, during the four-month period from August through November 2005, it sold 3,949,454 dosage units of hydrocodone products. ALJ at 4. Of this amount, Respondent's individual practitioner customers purchased 3,882,507 dosage units of the drug. Id. By contrast, Respondent sold approximately 29,940 dosage units of hydrocodone products to its retail pharmacy customers, for an average of 7,485 dosage units per month. Id. at 5. On December 7, 2005, Respondent entered a new line of business—supplying internet pharmacies—by selling hydrocodone to Medipharm-Rx, Inc. (Medipharm), a Florida-based internet pharmacy. 2 Id. Over the ensuing months, Respondent acquired numerous additional internet pharmacy customers to whom it repeatedly sold large quantities of hydrocodone. 2 For purposes of this decision, the term “internet pharmacy” refers to a pharmacy that fills a prescription that is issued by the physician without the physician having entered into a legitimate doctor-patient relationship under existing professional standards. Typically, a person seeking controlled substances goes to an internet site, fills out a questionnaire which requests basic medical information and payment/shipping information, and requests a specific drug; some Web sites may require that the patient submit a medical record, which is easily falsified. Thereafter, the customer's information is forwarded to a physician either contracted to or employed by the Web site, who reviews the information and issues a prescription, either with or without the benefit of a perfunctory telephone consultation, but always without having conducted a face-to-face review of the person's medical history and a physical exam. The prescription is then either forwarded to the pharmacy or downloaded electronically by the pharmacy; the pharmacy then fills the prescription and ships it to the customer. See GX 3. According to the stipulated facts, from December 2005 through October 2006, Respondent supplied Medipharm with an average of 1,011,882 dosage units of hydrocodone per month. ALJ at 5. Respondent also supplied Medipharm with approximately 538,290 dosage units of hydrocodone during the first half of November 2006, at which time Medipharm's registration was immediately suspended under 21 U.S.C. 824(d). Id. at 5-6. The following table reflects Respondent's monthly distributions of hydrocodone to Medipharm: Month Quantity December 2005 817,010 January 2006 939,340 February 2006 1,142,250 March 2006 1,071,450 April 2006 703,550 May 2006 808,500 June 2006 1,142,000 July 2006 800,340 August 2006 1,246,560 September 2006 1,450,380 October 2006 1,009,320 Id. at 5. According to a July 2006 report created by Respondent of its largest purchasers of controlled substances from December 2005 through June 2006, controlled substances constituted ninety-nine percent of its prescription drug sales to Medipharm. Resp. Ex. 47. On December 19, 2005, Respondent obtained another Florida-based internet pharmacy customer, Accumed Rx, Inc. (Accumed). ALJ at 7. Respondent supplied Accumed with approximately 5,884,212 dosage units of hydrocodone as tabulated below: Month Quantity December 2005 273,630 January 2006 203,070 February 2006 147,180 March 2006 83,500 April 2006 169,000 May 2006 519,380 June 2006 320,470 July 2006 442,000 August 2006 1,267,770 September 2006 503,020 October 2006 393,610 November 2006 1,561,582 Id. at 8. Between December 2005 and June 2006, controlled substances comprised ninety-nine percent of Respondent's prescription drug sales to Accumed. Resp. Ex. 47. On December 21, 2005, Respondent obtained another Florida-based internet pharmacy customer, Avee Pharmacy, Inc. (Avee). ALJ at 6. Respondent's sales of hydrocodone to Avee averaged 566,259 dosage units a month and are tabulated below: Month Quantity December 2005 346,140 January 2006 859,860 February 2006 0 March 2006 912,190 April 2006 76,190 May 2006 212,000 June 2006 442,800 July 2006 94,000 August 2006 506,430 September 2006 695,800 October 2006 537,900 November 2006 2,111,800 Id. Respondent also supplied Avee with 238,140 dosage units during the first five days of December 2006. Id. at 7. From December 2005 through June 2006, controlled substances constituted one hundred percent of Respondent's sales to Avee. Resp. Ex. 47. On November 17, 2006, Respondent notified Avee by letter that effective December 15, 2006, it would not supply the pharmacy, whose registration had been continued on a day-to-day basis past its expiration date and not renewed, unless it obtained a renewal of its registration. 3 Resp. Ex. 77. Between November 17 and December 5, 2006, however, Respondent supplied Avee with approximately 1,804,940 dosage units of hydrocodone. ALJ at 7. 3 Effective December 15, 2006, Respondent instituted a policy of not supplying registrants whose registration remained in effect on a day-to-day basis for more than two months past the expiration date. Resp. Ex. 77. Respondent's DEA registration was suspended before the policy became effective. On January 4, 2006, United Prescription Services, Inc. (United), another internet pharmacy, became a customer of Respondent. ALJ at 14. Respondent sold an average of 92,988 dosage units of hydrocodone per month to United as tabulated below: Month Quantity February 2006 341,160 March 2006 288,000 April 2006 18,000 May 2006 18,000 June 2006 37,200 July 2006 18,000 August 2006 18,000 September 2006 0 October 2006 12,000 November 2006 179,520 Id. From the date United became a customer through June 2006, controlled substances constituted one hundred percent of Respondent's prescription drug sales to it. Resp. Ex. 47. On November 17, 2006, Respondent notified United that it would stop supplying the pharmacy if it did not obtain a renewal of its registration. Id. at 14. From November 21, 2006, through December 5, 2006, however, Respondent distributed to United approximately 158,280 dosage units of hydrocodone. Id. On January 25, 2006, Respondent acquired two more internet pharmacy customers, RKR Holdings, d/b/a Medichem RX Pharmacy (Medichem), and Bi-Wise Drugs, Inc. (Bi-Wise). ALJ at 11, 13. Between January and November 2006, Respondent sold Medichem a monthly average of 216,638 dosage units of hydrocodone as tabulated below: Month Quantity January 2006 66,000 February 2006 264,000 March 2006 276,000 April 2006 168,000 May 2006 286,200 June 2006 264,000 July 2006 120,000 August 2006 216,000 September 2006 220,680 October 2006 262,140 November 2006 240,000 Id. at 11-12. From the date it became a customer through June 2006, controlled substances constituted one hundred percent of Respondent's prescription drug sales to Medichem. Resp. Ex. 47. From January 25 through October 2006, Respondent's hydrocodone sales to Bi-Wise averaged 117,150 dosage units per month. ALJ at 13. Moreover, from the date Bi-Wise became a customer through the end of June 2006, controlled substances constituted ninety-nine percent of Respondent's prescription drugs sales to it. Resp. Ex. 47. Respondent's hydrocodone sales to Bi-Wise are tabulated below: Month Quantity January 2006 70,800 February 2006 18,240 March 2006 152,750 April 2006 63,860 May 2006 112,300 June 2006 180,000 July 2006 131,750 August 2006 185,940 September 2006 111,180 October 2006 144,680 ALJ at 13. On February 16, 2006, Respondent acquired another internet pharmacy customer, Vin-Kash, Inc., d/b/a/ Medicom RX. Id. at 12. Through October 2006, Respondent supplied Medicom with an average of 190,281 dosage units of hydrocodone per month. Id. Respondent's sales are tabulated below: Month Quantity February 2006 14,000 March 2006 54,430 April 2006 157,850 May 2006 175,850 June 2006 231,100 July 2006 227,240 August 2006 117,650 September 2006 164,000 October 2006 375,690 November 2006 385,000 Id. Respondent also supplied Medicom with approximately 82,750 dosage units of hydrocodone during the first five days of December 2006. Id. at 13. Moreover, from the date it became a customer through June 2006, controlled substances comprised one hundred percent of Respondent's prescription drug sales to Medicom. Resp. Ex. 47. On February 20, 2006, Respondent obtained another internet pharmacy customer, Discount Mail Meds (Discount). ALJ at 8. From the inception of the relationship through November 2006, Respondent supplied Discount with an average of 330,324 dosage units of hydrocodone per month as tabulated below: Month Quantity February 2006 72,000 March 2006 269,500 April 2006 269,000 May 2006 364,500 June 2006 373,600 July 2006 317,780 August 2006 292,720 September 2006 340,100 October 2006 501,280 November 2006 502,760 Id. at 9. Respondent also supplied Discount with 43,200 dosage units of hydrocodone during the first five days of December 2006. Id. Moreover, from the date it became a customer through June 2006, controlled substances comprised one hundred percent of Respondent's prescription drug sales to Discount. Resp. Ex. 47. On February 22, 2006, Respondent commenced doing business with Universal Rx (Universal). ALJ at 9. From February through October 2006, Respondent supplied Universal with an average of 308,679 dosage units of hydrocodone per month as tabulated below: Month Quantity February 2006 60,000 March 2006 164,250 April 2206 291,000 May 2006 245,250 June 2006 384,700 July 2006 422,670 August 2006 394,070 September 2006 340,500 October 2006 453,690 November 2006 330,660 Id. at 9-10. From the date it became a customer through June 2006, controlled substances comprised one hundred percent of Respondent's prescription drug sales to Universal. Resp. Ex. 47. On November 17, 2006, Respondent notified Universal that, effective December 15, 2006, it would stop supplying the pharmacy unless it obtained a renewal of its registration. ALJ at 10. During the last two weeks of November 2006, Respondent shipped approximately 150,210 dosage units of hydrocodone to Universal. *Id* . On November 30, 2006, Respondent stopped shipments to Universal. *Id* On March 3, 2006, Respondent began doing business with Medcenter, Inc. (Medcenter), an entity owned by the same person who owned Medipharm. Id. at 10-11. From March through October 2006, Respondent supplied Medcenter with an average of 333,063 dosage units of hydrocodone per month as tabulated below: Month Quantity March 2006 340,500 April 2006 141,000 May 2006 153,000 June 2006 375,000 July 2006 102,000 August 2006 567,000 September 2006 378,000 October 2006 608,000 Id. Additionally, during the first two weeks of November, at which point Medcenter's DEA registration was suspended pursuant to 21 U.S.C. 824(d), Respondent distributed 313,680 dosages units of hydrocodone to it. *Id* . at 11. Moreover, from the date it became a customer through June 2006, controlled substances constituted one hundred percent of Respondent's prescription drug sales to Medcenter. Resp. Ex. 47. On March 9, 2006, Respondent commenced doing business with CRJ Pharmacy, Inc. (CRJ). ALJ at 15. From March through October 2006, Respondent sold CRJ an average of 79,803 units of hydrocodone per month as tabulated below: Month Quantity March 2006 63,360 April 2006 76,200 May 2006 25,320 June 2006 49,240 July 2006 52,200 August 2006 75,700 September 2006 96,000 October 2006 200,400 Id. From the date it became a customer through June 2006, controlled substances comprised ninety-eight percent of Respondent's prescription drug sales to CRJ. Resp. Ex. 47. In May 2006, Respondent acquired another two customers, Grand Pharmacy (Grand), and Akshar Chemists, Inc., d/b/a Medicine Shoppe (Medicine Shoppe). ALJ at 16-17. Respondent supplied Grand with an average of 144,102 dosage units of hydrocodone per month between May and November 2006 as tabulated below: Month Quantity May 2006 24,000 June 2006 228,720 July 2006 180,000 August 2006 180,000 September 2006 144,000 October 2006 144,000 November 2006 108,000 Id. at 17. During the same period, Respondent supplied the Medicine Shoppe with an average of 73,365 dosage units of hydrocodone per month as tabulated below: Month Quantity May 2006 62,100 June 2006 162,340 July 2006 164,875 August 2006 21,200 September 2006 12,000 October 2006 33,300 November 2006 57,740 Id. During the first five days of December 2006, Respondent also supplied the Medicine Shoppe with approximately 17,010 dosage units of hydrocodone. *Id* . In July 2006, Q-R-G, Inc., d/b/a Duane's Discount Group (Duane's), began purchasing hydrocodone from Respondent. *Id* . at 16. From July through November 2006, Respondent supplied Duane's with an average of 191,808 dosage units of hydrocodone per month as tabulated below: Month Quantity July 2006 188,400 August 2006 188,940 September 2006 145,500 October 2006 276,900 November 2006 159,300 Id. During the first five days of December 2006, Respondent supplied Duane's with an additional 74,850 dosage units of hydrocodone. 4 Id. 4 Respondent also sold 502,750 dosage units of hydrocodone to Woody Pharmacy Waterside, Inc., during April and May 2006, for an average of 251,375 units per month. ALJ at 15-16. Respondent also supplied Elite Pharmacy, Inc., with 140,000 dosage units of hydrocodone during the month of January 2006. Id. at 18. From the date it began supplying internet pharmacies in December 2005 through November 2006, Respondent sold a total of approximately 44,087,355 dosage units of hydrocodone to these entities. Gov. Ex. 43. at 1. 5 Respondent's monthly sales of hydrocodone to these entities grew from approximately 1.44 million dosage units in December 2005 to 5.78 million dosage units in November 2006. Id. at 2. By contrast, during the even longer time frame of August 2005 through November 2006, Respondent's sales of hydrocodone to its retail pharmacy customers never exceeded more than 16,040 dosage units in a month and typically never exceeded 10,000 dosage units in a month. Id. at 3. 5 This exhibit covers the period from August 2005 through November 2006. Gov. Ex. 43. As found above, Respondent did not begin distributing to internet pharmacies until December 2005. The Government also introduced into evidence a table showing the average purchase of hydrocodone products by retail pharmacies in the State of Florida and nationwide during the period October 1, 2005, through January 31, 2006. See Gov. Ex. 45, at 8. This evidence established that Florida retail pharmacies purchased an average of 23,850 dosage units of hydrocodone during the four month period; nationwide, retail pharmacies bought an average of 24,227 dosage units of the drug. Id. The record further establishes that many of Respondent's Florida-based pharmacy customers were, in fact, dispensing illegal prescriptions for controlled substances. More specifically, the record demonstrates that Avee (see GX 51), Medipharm (see GX 53 & 62), United (see GX 54), YPM Total Care Pharmacy (see GX 66), CRJ (GX 67), Bi-Wise (see Tr. 671-72); Universal (see id.), and Accumed (see id.), were dispensing large numbers of prescriptions which were not issued in the course of a legitimate doctor-patient relationship and thus violated Federal law. See 21 CFR 1306.04; see also Tr. 628-29, 639-45, 655-57, 660-67. Respondent's Due Diligence Efforts During the events at issue here, Mr. Robert Goodrich was Respondent's Director of Operations and Regulatory Affairs. Tr. 311. According to Mr. Goodrich, from “a regulatory perspective,” Respondent's due diligence in approving a new customer was limited to verifying that the customer had a State license and a DEA registration. Id. at 313-14. When asked by the Government whether Respondent had any processes in place prior to approving a new customer to purchase controlled substances, Mr. Goodrich testified that the primary process was to check the customer's DEA registration and that there was “no” secondary process. Id. at 318; see also ALJ at 34 (FOF 117). Based solely on its verifications of the entities' DEA registrations and state licenses, Respondent commenced to ship large quantities of controlled substances to the various internet pharmacies. In early February 2006, Mr. Goodrich traveled to the Tampa Bay, Florida area, to conduct on-site visits with Respondent's sales representative, Tom Mollick, at several of the internet pharmacy customers which Respondent had recently acquired including Medipharm, Accumed, Medichem, Bi-Wise, and Avee. Tr. 319. According to Mr. Goodrich, the pharmacies were selected because “it was apparent that they were a different type of a customer than what we'd been used to dealing with.” Id. At Medipharm, Mr. Goodrich found that it was filling 700 prescriptions a day and noted that it was a “Closed-Door (Mail Order) Pharmacy.” GX 16. In his report, Mr. Goodrich specifically noted that “[t]he mail order business has ties to internet pharmacy with a large amount of pain management and a growing percentage of traditional maintenance medications.” Id. At Accumed, Mr. Goodrich determined that it was filling 350 prescriptions a day and that it also was a “Closed-Door (Mail Order) Pharmacy.” GX 17. In his report, Mr. Goodrich observed that Accumed has “ties to the internet and * * * explained [its] requirement to check prescriber credentials.” Id. At Medichem, Mr. Goodrich found that it was both a “Retail & Closed-Door (Mail-Order) Pharmacy” with a volume of 100 prescriptions per day. GX 18. Mr. Goodrich noted that while “Medichem is primarily filling prescriptions on a local and state level * * * there was evidence of prescriptions being mailed out-of-state as well.” Id. Mr. Goodrich further observed that Medichem does “have some ties to the internet community and they appear to be in the process of determining their market niche.” Id. At Avee, Mr. Goodrich found that it was a “Closed-Door (Mail-Order) Pharmacy,” with a prescription volume of 500 per day. GX 20. Mr. Goodrich specifically noted that “Avee operates a closed pharmacy that provides mail order fulfillment of prescriptions from various sources, *including internet-connected medical providers who provide patient assessments and diagnosis through unconventional practice models. Many of these prescriptions are connected to pain management therapies involving the prescription of controlled substances* .” GX 20 (emphasis added). Mr. Goodrich's report further noted that DEA investigators had inspected Avee “earlier that day.” Id. Moreover, Avee's management discussed with him “the concerns that DEA had with establishing the validity of the doctor-patient relationship that formed the basis *of the digital diagnosis that resulted in a prescription for controlled substances being submitted to Avee for filling.* Id. (emphasis added). Mr. Goodrich further noted that the position of Avee's management “was that if the prescriber was not authorized to prescribe controlled substances, then the DEA should revoke the prescriber's DEA registration.” Id. According to Mr. Goodrich's report, DEA investigators had suggested to Avee's management that they meet with the physicians “from whom they receive the most prescriptions to better evaluate them.” Id. When asked by the Government what constitutes an “unconventional practice model?,” Mr. Goodrich testified that as he “understood it, that did not involve a patient going to the doctor's office necessarily and presenting themselves in person.” Tr. 347. Mr. Goodrich subsequently acknowledged that he knew as early as February 2006, that “[s]ome of the prescriptions [Avee] filled were not the result of physical contact between the doctor and the patient.” Id. at 348. Mr. Goodrich also testified that Avee had provided him with the names of two internet sites which were the source of some of the prescriptions it filled. Id. at 351-52. Notwithstanding the information he obtained during his visit with Avee, Mr. Goodrich made no follow-up inquiries with its management regarding whether they had determined if the physicians were writing legitimate prescriptions. Id. at 352-53. Indeed, Mr. Goodrich made no further inquiries of Avee regarding its business practices until the middle of August 2006, after a meeting with DEA. Id. at 353. When asked by the Government whether he was concerned by the fact that DEA had visited Avee, Mr. Goodrich acknowledged that he did not “know[] much about this telemedicine thing,” but “felt that if [Avee] weren't doing what they were supposed to do right, DEA wouldn't allow them to continue in business.” Id. at 354. Mr. Goodrich also testified that he was not troubled by Avee management's contention that “if the prescriber was not authorized to prescribe controlled substances, then the DEA should revoke the prescriber's DEA registration.” Id. Mr. Goodrich further acknowledged that at the time of his visit to Avee, he was not “versed” in the requirement that a prescription must be issued by a physician acting in the usual course of professional practice even though he asserted that he was then “aware that pharmacies had obligations to ensure that they had valid prescriptions.” Id. at 355. Mr. Goodrich admitted that he had not gone to DEA's website prior to Respondent's engaging in business with internet pharmacies to determine whether the Agency had posted any guidance on the subject. Id. at 358. Mr. Goodrich further testified that he “received most of” the information regarding the requirements for a valid prescription from DEA during a July 2006 meeting (which will be described more fully below). Id. at 357. Mr. Goodrich also attempted to visit Bi-Wise, but found that it was closed. Tr. 321; GX 19. According to his report, Bi-Wise was a retail and closed-door pharmacy with minimal prescription volume. GX 19. Mr. Goodrich further described it as a “[v]ery small retail unit located in strip mall” and that the “[c]ustomer is in [the] process of determining direction for [the] business.” Id. Mr. Goodrich testified that he did not attempt to go back to the pharmacy when it was open, Tr. 322, and never contacted anyone from Bi-Wise to further inquire into the nature of its business. Id. at 323. Furthermore, notwithstanding that Bi-Wise's purchases of hydrocodone from Respondent increased from 18,240 dosage units in February 2006 to 152,750 dosage units in March 2006, Mr. Goodrich never followed up with anyone at Bi-Wise to determine the reason for the increase. Id. at 325-26. This was so, Mr. Goodrich testified, because he did not “routinely look[] at” the data regarding the purchases of Respondent's customers. Id. at 326. As found above, during the ensuing months, Respondent took on additional internet pharmacies as customers and Respondent proceeded to sell extraordinary quantities of hydrocodone to them. Other than the five pharmacies visited on or about February 8, 2006, there is no evidence that Mr. Goodrich visited any of the other internet pharmacies which Respondent began supplying. Because of the large quantities of hydrocodone that Respondent was distributing to these entities, Respondent “was invited to the DEA Field Office in Riverside to be educated on the [Agency's] view of Internet pharmacies.” ALJ at 22 (FOF 72). On July 17, 2006, Michael Mapes, Chief of the Office of Diversion Control's E-Commerce Section, conducted a conference call with Mr. Goodrich and Ms. Grace Gonzales, Respondent's operations manager 6 to discuss various issues related to the dispensing of controlled substances by internet pharmacies. GX 49. Prior to the conference call, Mr. Goodrich was provided with a document entitled “Internet Diversion of Controlled Pharmaceuticals.” Tr. 411-12; GX 45. Included in the document was a table which showed the average sales by McKesson, another distributor, to seven internet pharmacies during the month of October 2005. See GX 45, at 7. Six of the seven pharmacies listed were Respondent's customers: Avee, Medipharm, Accumed, United, Universal, and Bi-Wise. Id. The table included a notation that the “Average Sales by McKesson to Each Targeted Pharmacy” was “311,057 dosage units.” Id. (emphasis added). It further indicated that McKesson's average sales of hydrocodone “to other customers” was “2,413 dosage units.” 7 Id. The document also included a page labeled “The Internet Pharmacies” which included photographs of both Avee and Medipharm. Id. at 9. 6 Additional DEA personnel were on the call including Group Supervisor
(GS)Lisa Young and Diversion Investigator
(DI)Cynthia Hooks of the DEA Riverside Office. GX 49. 7 The document also included the data (discussed earlier) regarding the average hydrocodone purchases over a four month period of pharmacies in Florida and nationwide, as well as the average purchases by the “Targeted Internet Pharmacies.” GX 45, at 8. At the time of the conference call, Mr. Goodrich was provided with an additional package of materials which included a powerpoint presentation, two Supreme Court decisions, 8 two agency final orders revoking the registrations of internet pharmacies for dispensing prescriptions that were not issued in the course of valid physician-patient relationships, 9 DEA's April 2001 Guidance Document on “Dispensing and Purchasing Controlled Substances over the Internet,” 10 and a copy of 21 CFR 1301.74, which sets forth the requirements pertaining to suspicious orders. See Gov. Ex. 61. The materials also contained a document from the National Association of Boards of Pharmacy entitled “Verified Internet Pharmacy Practice Sites (VIPPS ®) Most Frequently Asked Questions,” the American Medical Association's “Guidance for Physicians on Internet Prescribing,” the Federation of State Medical Boards' “Model Guidelines for the Appropriate Use of the Internet in Medical Practice,” and a list of suggested questions for determining the legitimacy of internet pharmacies. See id. Finally, DEA provided Mr. Goodrich with a copy of 21 U.S.C. 823. Id. 8 *Direct Sales Co., Inc.* v. *United States,* 319 U.S. 703 (1943); *United States* v. *Moore,* 423 U.S. 122 (1975). 9 EZRX, LLC, 69 FR 63178 (2004); *RX Network of South Florida* , *LLC,* 69 FR 62093 (2004). 10 Published at 66 FR 21181 (2001). During the conference call, Mr. Mapes specifically discussed the activities of Medipharm, Avee, Accumed, United, Bi-Wise and Universal in distributing controlled substances “through the internet” and reviewed the various slides from the Power Point presentation. Tr. at 30-31. Mr. Mapes also discussed various issues that Respondent should consider in assessing the legitimacy of its customers including the size and frequency of a pharmacy's orders, the range of products ordered by the pharmacy, the percent of controlled substances versus non-controlled drugs ordered, and the locations of/type of facility used by the pharmacies. Id. at 36-38. More specifically, Mr. Mapes advised that eighty percent of U.S. “pharmacies * * * are buying less than 5,000 dosages of hydrocodone in a month's time,” and that “in a typical retail pharmacy,” controlled substances might amount to between five and twenty percent of the pharmacy's purchases” with the other eighty to ninety percent of its purchases being non-controlled drugs. Id. at 37. Mr. Mapes also advised Respondent that as a distributor it was required to maintain effective controls against diversion. Id. at 39-40. Mr. Mapes later discussed with Mr. Goodrich and Ms. Gonzales the requirement under Federal Law that for a prescription to be valid, it must be issued in the usual course of medical practice, and “that an internet questionnaire alone is not sufficient to legally prescribe controlled substances.” Id. at 42-43; see also 21 CFR 1306.04(a). Mr. Mapes also discussed the factors that are necessary to establish a bonafide doctor-patient relationship. These include that a patient has a medical complaint, that a history be taken of the patient, that a physical exam be conducted, and that there be a nexus between the complaint, the history, the exam and the drug being prescribed. Id. at 42-43, 45-46; GX 61, at 13. Mr. Mapes also provided Mr. Goodrich and Ms. Gonzales with several examples of illegal internet pharmacies. Tr. at 48-49. In one of the examples, which involved a Florida pharmacy, the pharmacy's purchases of phentermine had doubled in a five month period from approximately 200,000 to 400,000 units and “one hundred percent of the drugs purchased by [the] pharmacy were controlled substances.” GX 61, at 10; Tr. 49. In another example, the pharmacy was located in an industrial warehouse and sold only hydrocodone and alprazolam (a schedule IV controlled substance), which it purchased in large quantities. Tr. 49; GX 61, at 11. In the final example, the pharmacy had advised the distributor that they were doing business over the Internet. Tr. 50. The pharmacy did not, however, have a VIPPS certification, made frequent large purchases of hydrocodone and various benzodiazepines, and ninety-nine percent of the drugs it ordered were controlled substances. Id.; GX 61, at 12. Mr. Mapes informed Mr. Goodrich and Ms. Gonzales that “a pattern of drugs being distributed to pharmacies [which] are diverting controlled substances demonstrates a lack of effective controls against diversion by the distributor” and could lead to the revocation of the distributor's registration. Tr. 51. Mr. Mapes further advised “that any distributor who was selling controlled substances that are being dispensed outside the course of professional practice must stop that distribution immediately.” Id. Mr. Mapes also discussed with Respondent's representatives whether it could ship an order which it had reported as suspicious. Id. at 57. Mr. Mapes advised that even if Respondent reported the order, the company still had to make the decision as to whether to ship the order. Id. at 57-58; GX 61, at 9. Moreover, Respondent's personnel asked DEA whether it should stop shipping controlled substances to the internet pharmacies. Tr. 79, 119-20, 342-43. DEA personnel told Mr. Goodrich and Ms. Gonzales that it cannot tell a distributor whether a particular order is legitimate or not, GX 61, at 9; and that whether to ship was “a business decision,” Tr. 79; but that Respondent “had an obligation to ensure that the products [it] distributed were used for legitimate medical purposes.” Id. 343. Following the meeting, Respondent continued to distribute large quantities of hydrocodone to numerous internet pharmacies including the six pharmacies that DEA officials specifically referred to as “targeted.” For instance, in August 2006, Respondent distributed “in excess of 1.2 million” dosage units of hydrocodone to Accumed. Id. at 341. Mr. Goodrich cited several reasons to justify Respondent's decision to continue shipping hydrocodone to Accumed. First, he stated that DEA “did not instruct us to cease shipments” and thus Respondent did not “have distinct direction.” Id. at 343-44. Second, Mr. Goodrich asserted that Respondent was conducting due diligence. Id. at 343. Third, Mr. Goodrich did not believe that Accumed was acting illegally. Id. at 345. In August 2006, Respondent also shipped large quantities of hydrocodone to the other internet pharmacies which DEA officials had referred to as “targeted.” It shipped 1,246,560 dosage units to Medipharm, 506,340 units to Avee, 185,940 units to Bi-Wise, and 399,070 units to Universal. Respondent also shipped large quantities to other entities which it had identified as internet pharmacies. See Resp. Ex. 52. Moreover, Respondent continued to make large shipments of hydrocodone to many of these pharmacies until either its registration was immediately suspended or the pharmacies' registrations were suspended. For example, it shipped Medipharm 1.45 million dosage units in September 2006 and just over 1 million dosage units in October 2006; it shipped Accumed 1.56 million dosage units in November 2006; it shipped Avee 2.11 million dosage units in November 2006; and it shipped Discount over 500,000 dosage units in both October and November 2006. Following the July 2006 conference call, Respondent did undertake additional measures to investigate the business activities of the pharmacies it had identified as filling prescriptions issued through the internet. On July 31, 2006, Mr. Goodrich wrote the Executive Director of the Florida State Board of Pharmacy identifying nineteen pharmacies located in the Tampa Bay area which, as a result of the DEA conference call and “additional research” conducted by Respondent, had led it to “question whether or not these pharmacies are operating legitimately.” Resp. Ex. 49, at 1-2. Respondent thus requested that the Florida Board “provide additional information to enable us to qualify the legitimacy of these customers.” Id. at 2. By letter dated August 14, 2006, the Executive Director of the Florida Board responded. Resp. Ex. 50. In the letter, the Executive Director wrote that “[t]he Board of Pharmacy can verify for you that these particular pharmacies do have active community pharmacy licenses in the state of Florida. Id. The Executive Director further advised that “only one of these licenses [sic] has been disciplined by the Florida Board,” that pharmacy being Avee, and enclosed a copy of the Board's final order pertaining to it. 11 Id. The letter, however, offered no specific information regarding the legitimacy of the various pharmacies' activities. See id. 11 According to the materials, Avee was sanctioned because it shipped hydrocodone to a person in Tennessee when it did not hold a Tennessee license authorizing it to dispense to residents of that State. See Resp. Ex. 50. Avee entered into a stipulation with the State under which it was fined $2,000 and required to pay $719.95 as costs. See id. Avee did, however, retain its Florida license. On August 15, 2006, Mr. Goodrich sent out a six-page questionnaire to seventeen of the pharmacies including all of the pharmacies which DEA had described as “targeted.” Resp. Ex. 51. The questionnaire noted that Respondent was conducting a “due diligence review of our business relationship” which had been prompted by four factors:
(1)An “[e]xtremely high percentage of controlled substance purchases vs. non controlled substance purchases,”
(2)“[e]xtremely high volume of controlled substance dosage units,”
(3)“[i]dentification of your operation as an internet pharmacy,” and
(4)“[i]dentification of your pharmacy filling prescriptions based on telemedicine.” Id. The questionnaire then stated that Respondent “has a responsibility to insure [sic] that all medications we distribute are used for legitimate medical purposes, much in the same way that your pharmacy has an obligation to ensure that every prescription you fill is a result of a valid medical examination by an authorized prescriber.” Id. The document asked a variety of questions. The first question asked the pharmacies to indicate the “overall percentage of controlled substances filled by [the] pharmacy,” and to list their other suppliers. Id. The second question was prefaced with the observation that “[t]he volume of controlled substances purchased by your pharmacy far exceeds the ‘average’ quantity of controlled substances purchased by pharmacies nationwide.” Id. at 2. The questionnaire then asked the pharmacy to “provide an explanation for the volume of your controlled substance purchases.” Id. The next set of questions began by noting that “[y]our pharmacy has been identified as an ‘internet pharmacy,' ” and that “both the FDA and DEA have raised concerns citing the potential for abuse.” Id. at 2. The questions then asked the pharmacy to provide the “percentage of prescriptions filled by your pharmacy [that] originate from the Internet,” to “list the website identifying your pharmacy,” to describe how “a patient provides prescriptions to your pharmacy,” and to indicate how patients pay for their prescriptions. Id. at 2-3. Later, the questionnaire observed that the “[u]se of the internet in a medical practice has raised many issues in regards to the issuance of a prescription, including, but not limited to, ensuring the validity of medical examinations, the establishment of a ‘bona fide’ doctor/patient relationship and the appropriateness of treatment where the physician is located in a different jurisdiction from the patient's residence.” Id. at 4. The questionnaire then asked a series of questions regarding how the pharmacies performed their “due diligence on prescriptions issued by doctors who use the internet in the course of their medical practice.” Id. These included asking the pharmacy to “list the web sites identifying the physicians who most commonly issue prescriptions filled by your pharmacy,” whether the pharmacy verified the physician's state license and DEA registrations, and whether the pharmacy verified that the physician was “also authorized to practice medicine in the state in which the patient is located.” Id. The questionnaire also asked whether the pharmacy had a protocol to ensure that “prescriptions issued through an internet-assisted encounter constitute[d] a valid medical exam.” Id. Next, the questionnaire observed that “a preponderance of prescription orders issued by a physician for the same products in the same prescription quantities” was indicative of “potential prescription abuse” and asked the pharmacy to attach its “policies and procedures that address prescription abuse.” Id. at 5. Finally, the questionnaire noted that “[m]any states have adopted laws and regulations pertaining to internet prescribing” that mandate “direct contact between the doctor and patient and the requisite physical exam(s).” Id. The questionnaire thus asked the pharmacy to “list those states [it had] identified that allow the filling of prescriptions issued without a face-to-face encounter between the physician and the patient.” Id. 12 12 In a letter dated August 15, 2006, Mr. Goodrich transmitted a copy of the questionnaire to the DEA Diversion Group Supervisor and advised that he had requested that the pharmacies respond “by the end of the month.” Resp. Ex. 52. Mr. Goodrich further wrote that “[i]f we do not receive a response, we will cease business with that particular company.” Id. Upon receiving the questionnaires, which Respondent sent by certified mail, the pharmacies responded in a variety of ways. Some, such as Bi-Wise, did not respond at all. See Resp. Ex. 58. Others, such as CRJ and YPM, failed to answer questions or indicated “N/A.” See Resp. Ex. 59 & 71. Others such as Accumed completed the questionnaire maintaining that they were not internet pharmacies, indicated “N/A” when asked to list the websites of the physicians who wrote the prescriptions they filled, and answered affirmatively that they had a protocol to ensure that the prescriptions were issued pursuant to a valid medical exam. Resp. Ex. 54. Likewise, Duane's stated that zero percent of the prescriptions it filled originated on the internet, that it had retained counsel to implement a strict compliance program to ensure that the prescriptions it filled were valid, and indicated “N/A” where asked to list the websites of the physicians who were commonly issuing the prescriptions that it filled. Res. Ex. 61. Some of the pharmacies provided information which Respondent deemed adequate but which clearly suggested that the prescriptions were illegal. For example, Respondent deemed Grand Pharmacy's response adequate. See ALJ at 24 (FOF 81). Yet in a letter, Grand's owner/president indicated that “[a]ll doctors Grand deal with require a current physical done in a physician's presence. All doctors Grand deal with have a physical *or extended phone dialogue* with the patient to establish the diagnosis and need for the medication.” Resp. Ex. 63, at 2 (emphasis added). It is noteworthy that Grand's response did not say that the physical was performed by the prescribing physician, what constituted a “current physical,” or that the doctors prescribing on the basis of a telephone call were the same doctors that had performed the physical exam. Notwithstanding the suspicious nature of the information, Mr. Goodrich deemed the answers satisfactory and did not inquire further, see Resp. Ex. 64; Respondent continued to ship large quantities of hydrocodone to Grand. The questionnaires completed by the Medicine Shoppe and Medicom, which apparently were owned by the same person, were of similar nature. For example, while the Medicine Shoppe's questionnaire indicated that it was “not an internet pharmacy,” and that only one to two percent of the prescriptions it filled originated on the internet, it also indicated the name of a website used by the “physicians who most commonly issue prescriptions filled by [the] pharmacy.” Resp. Ex. 65, at 2-4. Furthermore, in answer to the question of whether the pharmacy verified that the physicians were “authorized to practice medicine in the state [where] the patient is located,” the Medicine Shoppe stated: “No. The doctor[s] makes the consult from [the] state in which they are licensed.” Id. at 4. The Medicom questionnaire indicated that “[w]e are not [an] internet pharmacy; I receive Rx from doctors who have spoken [to] patients, discussed therapy, and also reviewed entire medical history.” Resp. Ex. 66, at 2. The questionnaire also indicated that it received prescriptions “via telemedicine,” and included the names of three websites used by physicians whose prescriptions the pharmacy was filling. Id. at 3-4. Furthermore, when asked whether the pharmacy verified that the physicians were “authorized to practice medicine in the state in which the patient is located,” Medicom likewise stated: “No. The doctor makes the consultation from the state they are licensed” in. 13 Id. at 4. 13 Both the Medicine Shoppe and Medicom included logs showing that the pharmacies had reviewed medical records pertaining to internet prescriptions and a form letter the pharmacy represented as sending to the physicians and which the physicians were supposedly required to sign and return to the pharmacies. See, e.g., Resp. Ex. 66. The record does not establish whether these two pharmacies actually sent the letter and whether the physicians signed it. Mr. Goodrich deemed both the Medicine Shoppe and Medicom's responses to be adequate. ALJ at 24-25 (FOFs 82 & 83). Notwithstanding the suspicious nature of their responses, Respondent continued to ship large quantities of hydrocodone to both pharmacies. The Medipharm and Universal questionnaires were prepared by the same attorney, who had previously served as an Assistant State Attorney. See Resp. Exs. 67 & 69. Both questionnaires indicated that the pharmacies were “not an ‘internet pharmacy,’ ” and that zero percent of the prescriptions originated on the internet. Resp. Exs. 67 at 2, 69 at 2. Both questionnaires indicated “N/A” where asked to “list the websites identifying the physicians who most commonly issue prescriptions filled by your pharmacy.” Resp. Exs. 67 at 4, 69 at 4. Moreover, both questionnaires indicated that the pharmacies had “retained counsel to prepare and implement a strict compliance program to ensure compliance with the applicable rules and regulations for prescription practice in each of the states in which [the pharmacy] is licensed and transacts business.” Id. The questionnaires also indicated that the pharmacies “routinely verif[ied]” that the doctors were “authorized to practice medicine in the state in which the patient is located.” Id. Finally, both pharmacies stated that they did “not fill prescriptions where the patient has not had a face-to-face encounter with a physician.” 14 Resp. Ex. 67, at 5; Resp. 69, at 5. 14 On November 2, 2006, the DEA Riverside Group Supervisor met with Mr. Goodrich at Respondent's facility to discuss Respondent's criteria and procedures for determining whether to ship to internet pharmacies. Tr. 102-03. During the meeting, Medipharm was specifically discussed. Id. at 104. According to the testimony of the Group Supervisor, Mr. Goodrich stated that “Medipharm * * * had a comprehensive compliance program, and * * * he ha[d] determined that they were innocent until proven guilty.” Id.; see also ALJ at 29 (FOF 98). United's questionnaire, which was submitted more than five weeks after Respondent's deadline, stated that it was “not an internet pharmacy” and that “[r]egulations regarding physicians requiring a face-to-face consultation is an issue of compliance for the physician and the relevant medical board.” Resp. Ex. 70. With respect to whether United verified that the physicians were authorized to practice medicine in the States where their patients were located, the pharmacy gave the non-responsive answer that “We are advised by the prescribing physician that they are authorized to practice medicine for their patients.” Id. Finally, in answering the question as to whether United had a protocol to ensure that the prescriptions were issued pursuant to a valid medical exam, the pharmacy stated: “United has a policy, through a signed affidavit, as well as providing us with recent medical history for the patient file, that the physician meets the standards noted. However, that being the case, we are not required [to determine] whether or not the physician has an internet or in-office encounter with his patient.” Id. United further stated that it was “not aware that it is a commonly accepted practice in the pharmacy industry, that the pharmacy verify the type of consultation a physician has with a patient.” Id. United also included a December 2005 report by Mudri Associates regarding the pharmacy's compliance with the CSA. 15 The report specifically noted that “[a] doctor expecting to have his prescriptions filled by [United] can anticipate having to complete an extensive background questionnaire. This background consists of samples of writing along with a signed acknowledgement pertaining to a notification of [United's] adherence to fulfilling their corresponding responsibilities with the physician.” Id. According to the report: 15 According to the stipulated facts, Mr. Mudri is a retired DEA Diversion Investigator. The physician is contacted and asked to acknowledge that there *[sic]* practice subscribes to sound medical judgment criteria, such as valid patient medical complaints, extensive physician interview and consultation, in-person patient examination, or supervision and/or direction of an examination by a consulting medical professional, documented in a patient file, along with the appropriateness of medications based upon this physician/patient relationship. Id. Respondent deemed United's response adequate. ALJ at 25 (FOF 84). Avee submitted its questionnaire nearly a month late. Resp. Ex. 55. Avee admitted that controlled substances comprised ninety percent of the prescriptions it filled and answered “N/A” to the question “What percentage of prescriptions filled by your pharmacy originate on the internet.” Id. at 1-2. Avee further maintained that it was not an internet pharmacy but rather a “mail order pharmacy,” and that it did not know what percentage of the physicians whose prescriptions it filled used the internet in the course of their medical practice. Id. at 3-4. Where asked to identify the websites of the physicians who were “most commonly issu[ing the] prescriptions filled by your pharmacy,” Avee wrote “N/A.” Id. at 4. Where asked if it verified that the prescribing physician was “authorized to practice medicine in the state in which the patient is located,” Avee wrote: “where the doctor is located.” Id. Upon reviewing Avee's questionnaire, Mr. Goodrich wrote back to it noting that he “was surprised that your responses to our questionnaire did not support the observations I made on site,” and added that he was “curious if your business model has changed in the past six months.” Resp. Ex. 56. Mr. Goodrich further noted that he was “unable to reconcile the information provided on our questionnaire with the information observed during a visit to [its] facility.” Id. Mr. Goodrich then indicated that he wished to visit Avee again and requested that it provide “a current overview of [its] internal due diligence protocols.” Id. In an undated letter, Avee outlined its compliance procedures and provided Mr. Goodrich with a copy of a letter regarding prescribing practices which it claimed it sent to the physicians whose prescriptions it filled. Resp. Ex. 57. Avee maintained that it required that this letter be signed annually by the physician and that it also conducted site visits at the physician's offices. Id. at 2. In its letter to the physicians, Avee listed the four elements of a legitimate doctor/patient relationship. Id. at 5. While the pharmacy accurately stated the four elements, the letter further added that “[t]o these, Avee would add an opportunity for the prescribing practitioner and patient, via some means, to confer.” Id. (emphasis added). Avee further maintained that “[i]t is not a requirement that the prescribing physician himself/herself took the history or performed the physical examination, as long as the prescribing practitioner *had full and meaningful access to the medical history and physical examination, and an opportunity to confer with the patient.* ” Id. (emphasis added). Avee's letter to its physicians clearly raised a substantial question as to the legality of the prescriptions it was filling and conflicted with information that DEA had previously provided Respondent regarding the requirements to establish a legitimate doctor-patient relationship. Indeed, it indicated that Avee's practices remained the same as Mr. Goodrich had observed during his February 2006 visit when he noted that the pharmacy filled “prescriptions from various sources, *including internet-connected medical providers who provide patient assessments and diagnosis through unconventional practice models.”* GX. 20 (emphasis added). Here again, Respondent continued to ship large quantities of controlled substances to Avee and did so up until December 6, 2006, when the immediate suspension order was served. As a result of the surveys, Respondent stopped shipping controlled substances to Bi-Wise, CRJ and YPM. ALJ at 25 (FOF 86). Even then, however, Respondent did not stop accepting orders from these entities until October 20, 2006, and did not stop shipping to them until October 27, 2006, nearly two months after the completed questionnaires were due. Id.; see also Gov. Ex. 36 (memorandum dated December 20, 2006, from Respondent's counsel to DEA attorney regarding discontinued pharmacy customers); Resp. Ex. 52 (questionnaire at p.6). Moreover, Respondent's own evidence indicates that it never sent a questionnaire to Discount Mail Meds (a/k/a Liddy's), see Resp. Ex. 52, at 2, and there is no completed questionnaire from it. See Resp. Exs. 51-72. Respondent, however, continued to sell large quantities of hydrocodone to Discount and sold it more than 500,000 dosage units a month in both October and November 2006. Finally, there is no evidence that Respondent ever received a completed questionnaire from Medcenter and Medichem. See Resp. Exs. 54-72; ALJ at 24-25 (Stipulated FOFs 77-86). Respondent nonetheless continued to supply Medcenter with large quantities until November 16, 2006, when the latter's registration was immediately suspended. It also continued to supply Medichem with large quantities of hydrocodone through November 2006. Respondent also adopted a policy under which it would, effective on December 15, 2006, cease distributing controlled substances to those pharmacies whose DEA registrations had not been automatically renewed but were continued on a day-to-day basis for a period of more than two months. Accordingly, on November 17, 2006, Mr. Goodrich wrote Avee, United, and Universal, notifying them of the policy and its effective date. See Resp. Exs. 77, 78, 79. Between the date of this letter and December 5, 2006 (the day before service of the Immediate Suspension), Respondent supplied Avee with more than 1.8 million dosage units of hydrocodone. ALJ at 7 (FOF 21). Moreover, between the date of its letter and November 30, 2006, Respondent supplied Universal with 150,210 dosage units. ALJ at 10 (FOF 31). Finally, from November 21, 2006 through December 5, 2006, Respondent supplied United with 158,280 dosage units of hydrocodone. ALJ at 14 (FOF 45). 16 16 The parties also stipulated that between January and May 2006, Respondent stopped accepting orders from seven other pharmacies based on “the cessation of their” registrations by DEA. ALJ at 25 (FOF 86). As a result of the surveys, in October 2006, Respondent updated its customer profile questionnaire for potential pharmacy customers. Id. at 26 (FOF 88). On this questionnaire, Respondent required potential customers to disclose information related to the prescriptions the pharmacy was dispensing including whether “they [were] the result of an internet- or telephone-based medical encounter.” Resp. Ex. 75. Respondent also required the pharmacy's responsible officer to attest to the validity of the information it provided. Id. Relatedly, in October 2006, Respondent revised its standard operating procedures
(SOP)pertaining to the sale of controlled substances to pharmacy customers. ALJ 26 (FOF 88). The SOP adopted the requirement that Respondent's pharmacy customers certify whether they knowingly filled prescriptions that arose out of an internet or telephone-based medical encounter. Resp. Ex. 76. It also directed that “[i]f [a] pharmacy affirms that they fill prescriptions of this nature, they will be required to provide details of the compliance program they have adopted to ensure that these prescriptions are legal and valid.” Id. The SOP further noted that “[c]ustomers with significant purchases of controlled substances, significant activity in mail-order dispensing or with significant amounts of telemedicine dispensing will be subject to on-site assessments within four months after being accepted as a customer.” Id. at 2. Respondent's Failure to Report Suspicious Orders Under federal regulations, a registrant must “design and operate a system to disclose to the registrant suspicious orders of controlled substances”; suspicious orders must be reported to the local Field Division Office upon discovery by the registrant. 21 CFR 1301.74(b). Under the regulation, “[s]uspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” Id. 17 17 The parties also stipulated that every month since July 2002, Respondent had submitted ARCOS reports regarding its distributions of schedule III controlled substances including hydrocodone to the ARCOS Unit at DEA headquarters. ALJ at 18 (FOF 58) While the record establishes that Respondent had worked with a DEA DI to develop a system for detecting and reporting suspicious orders, ALJ at 20 (FOF 64), the system had been created when most of Respondent's customer base was comprised of physicians. Tr. 739. Moreover, no one from Respondent contacted the DI to discuss its decision to supply internet pharmacies and the criteria and procedures that should be used to determine whether the pharmacies' orders were suspicious. Id. at 741. Under Respondent's procedures, a monthly report was generated which identified those customers purchasing controlled substances and the percentage of controlled versus non-controlled drugs purchased by the customer. Resp. Ex. 109, ¶ 25.2. If a customer's monthly purchases of controlled substances deviated by “over 150%” from the customer's average monthly percentage of controlled substance purchases for the preceding six months, it was then subject to further review. Id. at ¶ 25.3. Under Respondent's system, “[i]f no customers [were] deemed suspicious,” it would send DEA “a report stating ‘no suspicious activity’ for the period.” Id. at ¶ 25.6. Moreover, twice a year, Respondent sent to DEA “a list of the largest purchasers of controlled substances.” Id. at ¶ 25.8. The customers on this list were not “reported as having suspicious purchases.” Id. According to Mr. Goodrich's testimony, Respondent did not have a procedure in place to monitor and detect excessive purchases on a monthly basis. Tr. 397-98. Respondent sent DEA e-mails reporting that it had “no suspicious activity to report” for the months of December 2005 (GX 9), January 2006 (GX 10), March 2006 (GX 11), and April 2006 (GX 12). In addition to the exhibits, testimony establishes that “Respondent did not report any suspicious orders through the month of December 2006,” ALJ at 36 (FOF 129, citing Tr. 95-96), even though the Florida internet pharmacies were purchasing quantities that greatly exceeded the average amount of hydrocodone (6,000 dosage units per month) purchased by a traditional brick-and-mortar retail pharmacy. GX 45, at 8; Tr. 608. Respondent, however, twice provided the DEA Riverside Field Office with a report listing its top purchasers of controlled substances. See Resp. Ex. 46, 47, & 48. The first of these, which Mr. Goodrich e-mailed to the DEA Riverside office on February 13, 2006, covered the period June through December 2005. See Resp. Ex. 46. The report included Avee, Medipharm and Accumed, indicated the date the pharmacies had become customers, 18 the number of bottles of controlled substances the pharmacies had ordered, and the percentage of prescription drugs ordered by the pharmacies that were controlled substances. See id. 18 According to the document, Medipharm had become a customer on December 7, 2005; Accumed and Avee became customers on December 19, 2005, and December 21, 2005, respectively. See Resp. Ex. 46. Mr. Goodrich provided the second report to DEA at the July 17, 2006 conference call. ALJ at 23 (FOF 72). This report covered the period December 2005 through June 2006, and included Medipharm, Accumed, Avee, United, Medichem, Bi-Wise, Medicom, Discount, Universal, Medcenter, CRJ, and Woody Pharmacy. See Resp. Ex. 47. The report likewise listed the date the pharmacies had become customers, the total amount of controlled substances ordered, and the percentage of prescription drugs ordered that were controlled substances. See id. Of the aforementioned pharmacies, the lowest percentage of controlled substances ordered was ninety-eight percent by CRJ. See id. Almost all of the above pharmacies had ordered only controlled substances. See id. Finally, the list did not include several of Respondent's recently acquired customers including Grand Pharmacy and the Medicine Shoppe. See id. At the hearing, Mr. Goodrich acknowledged that “an unusual quantity could be a determining factor” in deciding whether an order must be reported as suspicious. Tr. 490. Mr. Goodrich further admitted that some of the orders received by Respondent were of an unusual size. Id. Moreover, Mr. Goodrich further testified that following the July 17, 2006 conference call with DEA, Respondent did not report any of the orders placed by the Florida-based pharmacies to be suspicious because “[w]e considered [all of the pharmacies] suspicious at that point.” Tr. 424. On cross-examination, Mr. Robert Schwartz, who became Respondent's Chief Operating Officer on September 26, 2006, was asked a series of hypothetical questions based on the evidence in the case regarding the reporting of suspicious orders. Tr. 953-57. Mr. Schwartz testified that while he had previously worked in senior management positions at major pharmaceutical distributors such as H.D. Smith and Barnes Wholesale, he could not recall a pharmacy ordering 800,000 dosage units of hydrocodone in a month. Id. at 953. Mr. Schwartz also testified that an order for 2.1 million dosage units of the drug was “a lot of hydrocodone” and should be reported as suspicious because, based on his experience at Barnes, it was not consistent with what pharmacies ordered. Id. at 953-54. Similarly, Mr. Schwartz admitted that various changes in a pharmacy's ordering history (such as those which occurred here) would be suspicious and should be reported to DEA. Id. at 954-57. The ALJ further found that Mr. Schwartz “provided credible testimony concerning two possible justifications for the Respondent's sharp rise in the sale of hydrocodone products in August of 2006.” ALJ at 38 (FOF 135 (citing Tr. 930)). The first reason given was that there are “year-end inventory shortages” from the manufacturers and thus “wholesalers begin ‘to buy extra product from manufacturers in August, building up our inventories for the year-end,” and pharmacies “buy extra inventory at this time.” Id. The second reason was the State of Florida's implementation of its requirement, effective July 1, 2006, that “pedigree must be passed by each distributor who is not a manufacturer, before each distribution of a drug and provided to each person who receives the drug.” ALJ at 38-39 (FOF 137). Respondent met the pedigree requirements, and the developer of the software it used issued a press release announcing that Respondent was compliant with Florida law. See id.; Resp. Ex. 105. Respondent, however, introduced no evidence that it contacted any of its pharmacy customers that increased their purchases between July and August 2006 to determine if they had done so for either reason. Tr. 487. As Mr. Goodrich testified, he did not “know that the pedigree program had a direct impact on the hydrocodone that we distributed to our pharmacy customers.” Id. at 488. In fact, only seven of the pharmacies increased their purchases of hydrocodone from July to August 2006. During this period, four of the pharmacies actually decreased their hydrocodone purchases from Respondent and the remaining three purchased roughly the same amount. Relatedly, Mr. Goodrich admitted that Respondent did not even “develop a [suspicious orders] policy that specifically addressed the pharmacy customers until September of 2006.” ALJ at 34 (FOF 119). Furthermore, the orders of the Florida-based internet pharmacies were suspicious from the beginning because of their large size, their frequency, and the fact that controlled substances constituted the overwhelming percentage (and frequently 100 percent) of the products being purchased. See ALJ at 36-37 (FOF 130-132); see also Resp. Exs. 46 & 47. Even if Respondent had contacted the seven pharmacies and determined that they had increased their orders for either of the above reasons, their orders were still suspicious and subject to reporting. And as Mr. Goodrich testified, following the July 17, 2006 conference, he considered all of the Florida-based pharmacies to be suspicious. Tr. 424. Respondent's Corrective Actions and Post-Suspension Conduct The ALJ also made several findings regarding corrective actions instituted by Respondent. First, the ALJ found credible the testimony of Mr. Schwartz that on December 5, 2006, the day before the immediate suspension order was served on Respondent, he and its owner, Mr. John Sempre, had determined that it should stop supplying the Florida-based internet pharmacies. ALJ at 40 (citing Tr. 938-39). Mr. Schwartz also testified that if Respondent regained its registration, he and not Mr. Goodrich, would be responsible for reviewing suspicious order reports before they were submitted to DEA. Tr. 1027. Moreover, Mr. Schwartz was to “have ultimate authority” to accept or reject any new customer seeking to purchase controlled substances. ALJ at 41 (citing Tr. 1027). Finally, Respondent entered into an agreement with SynTegra, L.L.C., to review its procedures for monitoring and reporting suspicious orders to DEA. Resp. Ex. 102. After the immediate suspension of its registration, Respondent continued to receive orders for controlled substances which it forwarded on to Pharmapac, a competitor, for filling. Tr. 184-87, GX 63. Under the “Sold To” line on the Pharmapac invoices, typically the name of the individual practitioner who ordered the controlled substances was listed above Respondent's name and address. See GX 63, at 281-351. However, on the invoices “Ship To” line, the invoices contained the individual practitioner's name and address. See id. The invoices also included a label which stated: “Please send payment to: SOUTHWOOD PHARMACEUTICALS, INC., 60 Empire Drive, Lake Forest, CA 92630.” See id. On February 1, 2007, Respondent Mr. Schwartz wrote a letter to Respondent's customers indicating that it had “mistakenly placed a sticker on these invoices directing payment to Southwood Pharmaceuticals.” Resp. Ex. 107. The letter instructed Respondent's customers that the sticker be disregarded and that payment should be made directly to Pharmapac at its address. Id. The ALJ found that “Respondent processed an extensive number of orders for controlled substances in January of 2007,” and that “Respondent did receive payment from many of these customers consistent with the invoices dated during January of 2007.” ALJ at 44 (FOF 157) (citing GX 63). During the hearing, however, the parties stipulated that “[i]t was not [Respondent's] intent to retain any payment submitted to or through Southwood by [its] customers, in connection with orders forwarded to and filled by Pharmapac.” Tr. 1030. Moreover, the Government introduced no evidence establishing that Pharmapac is not registered with DEA to manufacture or distribute controlled substances. Discussion Section 304(a) of the Controlled Substances Act provides that “[a] registration * * * to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant * * * has committed such acts as would render [its] registration under section 823 * * * inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). As relevant here, Congress directed that the following factors be considered:
(1)Maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, or industrial channels;
(2)compliance with applicable State and local law;
(3)promotion of technical advances in the art of manufacturing these substances and the development of new substances;
(4)prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
(5)past experience in the manufacture, distribution, and dispensing of controlled substances, and the existence in the establishment of effective controls against diversion; and
(6)such other factors as may be relevant to and consistent with the public health and safety. 21 U.S.C. 823(d). These factors are considered in the disjunctive. I may rely on any one or a combination of factors and give each factor the weight I deem appropriate in determining whether to revoke a registration or to deny a pending application for renewal of a registration. See Green Acre Farms, Inc., 72 FR 24607, 24608 (2007); ALRA Laboratories, Inc., 59 FR 50620, 50621 (1994). Moreover, I am “not required to make findings as to all of the factors.” *Hoxie* v. *DEA* , 419 F.3d 477, 482 (6th Cir. 2005); *Morall* v. *DEA* , 412 F.3d 165, 173-74 (D.C. Cir. 2005). The Government bears the burden of proving that Respondent's continued registration would be inconsistent with the public interest. 21 CFR 1301.44(e). If, however, the Government establishes a prima facie case, the burden shifts to Respondent to show why its continued registration would not be inconsistent with the public interest. See Gregory D. Owens, 67 FR 50461, 50464 (2002). In this case, I conclude that factors one, five and six establish that Respondent's continued registration would “be inconsistent with the public interest.” 21 U.S.C. 823(d). Indeed, Respondent “concedes that the Government has established a prima facie case * * * that [its] continued registration may be inconsistent with the public interest.” Resp. Proposed Findings of Fact and Conclusions of Law (hereinafter, Resp. Br.) at 31. Respondent maintains, however, that the record “encompasses sufficient examples of mitigation and ongoing remediation by” it to compel the conclusion that revoking its registration “would be inconsistent with the public interest.” Id. For the reasons set forth below, I conclude otherwise and will order the revocation of Respondent's registration and the denial of its pending renewal application. Factors One and Five—Maintenance of Effective Controls Against the Diversion of Controlled Substances Into Other Than Legitimate Channels and Respondent's Past Experience in Distributing Controlled Substances Under DEA regulations, all “registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.” 21 CFR 1301.71(a). A registrant is further required to “design and operate a system to disclose to the registrant suspicious orders of controlled substances” and is required to “inform the [DEA] Field Division Office * * * in his area of suspicious orders when discovered by the registrant.” Id. 1301.74(b). As explained below, the record establishes that Respondent failed repeatedly to comply with both requirements. Respondent's Distributions of Hydrocodone and Due Diligence Efforts Beginning in December 2005, Respondent distributed massive quantities of hydrocodone, a highly abused drug and schedule III controlled substance, to entities which, notwithstanding their various assertions to Mr. Goodrich, were nothing more than drug pushers operating under the patina of legitimate authority. Respondent's due diligence measures “ which initially involved nothing more than verifying a pharmacy's DEA registration and state license—were wholly deficient. As the record demonstrates, Respondent sold Medipharm in excess of 1.75 million units of hydrocodone in the months of December 2005 and January 2006, before Mr. Goodrich even visited this entity to inquire into the nature of its business. Likewise, during the months of December 2005 and January 2006, Respondent sold more than 1.55 million dosages units of hydrocodone to Avee and 476,000 dosage units of the drug to Accumed before Mr. Goodrich even visited these entities. It also sold large quantities of hydrocodone to Medichem and Bi-Wise before Mr. Goodrich visited them. As Mr. Goodrich admitted, Respondent had “no” process in place to determine the nature of a potential customer's business before it sold to them. Moreover, during the February on-site visits with the above entities, Mr. Goodrich received substantial information which raised serious doubt as to the legality of their business practices. As the evidence demonstrates, Mr. Goodrich determined that Medipharm had a “mail order business [with] ties to internet pharmacy,” GX 16, that Accumed had “ties to the internet,” GX 17, and that Medichem was mailing prescriptions out-of-state and had “some ties to the internet community.” GX 18. At Avee, Mr. Goodrich found that it “provide[d] mail order fulfillment of prescriptions from various sources, *including internet-connected medical providers who provide patient assessments and diagnosis through unconventional practice models,”* with *“[m]any of these prescriptions* [being] *connected to pain management therapies involving the prescription of controlled substances.”* GX 20 (emphasis added). Avee's management also discussed with Mr. Goodrich a visit earlier that day by agency investigators and their concern as to “the validity of the doctor-patient relationship that formed the basis *of the digital diagnosis that resulted in a prescription for controlled substances being submitted to Avee for filling.”* Id. (emphasis added). Moreover, in his testimony, Mr. Goodrich admitted that he knew as early as his visit to Avee that “[s]ome of the prescriptions [it] filled were not the result of physical contact between the doctor and the patient,” Tr. 348, and that Avee had also provided him with the names of two websites that were the source of the prescriptions it filled. Id. at 351-52. The evidence further establishes that notwithstanding that he did not “know [ ] much about this telemedicine thing,” id. at 354, Mr. Goodrich did not order that Respondent's shipments to these pharmacies be stopped. Indeed, following the visits, Respondent shipped even larger monthly quantities of hydrocodone to some of the pharmacies. Furthermore, Mr. Goodrich testified that he did not assess whether Avee was operating illegally, claiming that he did not think he could “make that assessment.” Tr. 359. Indeed, Respondent remained disinterested in determining whether the Florida-based pharmacies were lawfully filling prescriptions until after the July 17, 2006, conference call with DEA officials. 19 19 It is true that Mr. Goodrich testified that he visited the DEA Diversion Control website in early 2006. However, he testified that he received most of the information about prescriptions during the July 2006 conference call. Tr. 357. Neither Mr. Goodrich nor any other witness for Respondent claimed to have reviewed the DEA April 2001 policy statement on prescribing controlled substances over the internet prior to it being provided to him by DEA officials. Moreover, Respondent makes no claim that following the February visits it consulted legal counsel to determine the legality of the prescribing practices of the Florida pharmacies. Notwithstanding that Mr. Goodrich had reason to know that the Florida-based internet pharmacies were not filling lawful prescriptions, Respondent proceeded to supply large quantities of hydrocodone to an additional eleven internet pharmacies (most of which were located in the Tampa Bay area) including United, Medicom, Discount, Universal, Medcenter, CRJ, Grand, Medicine Shoppe, Duane's, Woody, and Elite. Moreover, notwithstanding the large quantities that these pharmacies ordered, Mr. Goodrich apparently did not deem it necessary to conduct site visits to inquire into the nature of their businesses and whether they were filling lawful prescriptions. See, e.g., Resp. Br. at 34-35 (discussing “steps taken by Mr. Goodrich to ascertain that [Respondent's] pharmacy customers in Florida were not diverting controlled substances,” and noting only Goodrich's Feb. 8, 2006 site visits and the August 2006 pharmacy questionnaires). Moreover, Respondent continued to supply the pharmacies, notwithstanding that they were ordering hydrocodone in quantities that far exceeded what its traditional retail pharmacy customers ordered, that Respondent had information that controlled substances comprised between 98 and 100 percent of the prescription drugs being ordered by these entities, and that as Mr. Goodrich explained, these entities “were a different type of a customer than what we'd been used to dealing with.” Tr. 319. Respondent contends that it is “unfair” to compare what Mr. Goodrich learned during the site visits through his “lay inquiry” with what a DEA Diversion Investigator learned, “armed as she was by two decades of diversion investigation experience, search warrants, and a team of armed agents carrying intimidating badges.” Resp. Br. 35. The record demonstrates, however, that even without a warrant, a badge and a gun, Mr. Goodrich was able to obtain from Avee substantial information indicating that its practices were illegal and already subject to DEA's scrutiny. He was also able to obtain information from several other pharmacies which suggested that further inquiry was warranted as they were engaged in practices similar to those of Avee. Moreover, Respondent's argument ignores that it sold to numerous additional internet pharmacies without even conducting site visits. Furthermore, even after DEA presented information to it—on the proverbial silver platter—that Respondent's Florida-based internet pharmacy customers were likely engaged in illegal activity and even specifically mentioned that six of its customers were “targeted,” Respondent continued to distribute extraordinarily large quantities of hydrocodone to these pharmacies. To Medipharm, an entity described as a target of an investigation, in August 2006, Respondent distributed 1.25 million dosage units of hydrocodone. In September 2006, Respondent distributed to Medipharm 1.45 million dosage units of the drug, and in October 2006, more than 1 million dosage units. Furthermore, Respondent distributed an additional 538,000 dosage units to Medipharm during the first half of November 2006, at which time Medipharm's registration was suspended. To Accumed, another of the targeted pharmacies, in August 2006, Respondent sold approximately 1.268 million dosage units of hydrocodone. While in September and October 2006, Respondent's hydrocodone sales to Accumed declined to approximately 503,000 and 394,000 dosage units respectively, in November 2006, Respondent sold 1.56 million dosage units to it. As for Avee, which was also identified as a target, in August 2006, Respondent sold 506,430 dosage units of hydrocodone, an amount that was more than five times the previous month's sale. In September 2006, Respondent sold Avee approximately 696,000 dosage units; in October, it sold Avee 537,900 dosage units; and in November, it sold Avee 2.11 million dosage units. 20 20 Respondent also continued to ship large quantities of hydrocodone to Universal, another pharmacy which was identified as “targeted.” In August, it shipped 399,070 dosage units to Universal; in September, 340,500 dosage units; in October, 453,690 dosage units; and in November, 330,600 dosage units. It is true that following the July 17, 2006 conference call, Respondent attempted to perform additional due diligence. More specifically, Mr. Goodrich requested information from the Florida Board of Pharmacy as to whether the pharmacies were operating legitimately. The Florida Board, however, only provided information as to the licensure status of the pharmacies. Resp. Ex. 50. On August 15, 2006, Respondent also sent out a questionnaire to its internet pharmacy customers. It is true that Respondent did eventually cease shipping controlled substances to three of the pharmacies (Bi-Wise, CRJ and YPM) because these pharmacies either failed to respond (Bi-Wise) or gave inadequate responses on their questionnaires (CRJ and YPM). But even with respect to these pharmacies, Respondent did not cut off its shipments to them until late October 2006, nearly two months after its own deadline for completing the questionnaires, and sold them large quantities of hydrocodone notwithstanding that the pharmacies had failed to comply with Respondent's request for additional information. It is also true—as Respondent contends—that two of the pharmacies (Medipharm and Universal) submitted questionnaires which were “prepared by an apparently reputable attorney,” Resp. Br. 35, and which indicated that the pharmacies had “retained counsel to * * * implement a strict compliance program to ensure compliance with the applicable rules and regulations for prescription practice in each of the states in which” the pharmacies did business. Resp. Ex. 67, at 4; Resp. Ex. 69, at 4. These questionnaires further stated that the pharmacies “routinely verif[ied]” that the doctors were “authorized to practice medicine in the state in which the patient is located.” Resp. Ex. 67, at 4; Resp. Ex. 69, at 4. These two pharmacies further indicated, however, that they did “not fill prescriptions where the patient has not had a face-to-face encounter with a physician.” Resp. Ex. 67, at 5, Resp. Ex. 69, at 5 (emphasis added). Notably, the latter statement did not say that the patients had a face-to-face encounter with the prescribing physician. I need not decide whether it was reasonable for Respondent to continue shipping controlled substances to Medipharm and Universal in light of the ambiguous statements they provided and the massive quantities of controlled substances they were ordering. Even if it was, Respondent ignores the numerous instances in which it continued to ship to other pharmacies which had provided ample information casting serious doubt as to the validity of their activities. 21 21 Likewise, the answers submitted by Duane's appeared to be in order even if they were false. For example, Respondent continued shipping hydrocodone to Grand Pharmacy deeming its response to be adequate. Yet Grand stated that “[a]ll doctors Grand deal with have a physical *or extended phone dialogue with the patient to establish the diagnosis and need for the medication.* ” Resp. Ex. 63, at 2 (emphasis added). While this answer should have stood out like a swollen thumb, Mr. Goodrich deemed Grand's answers adequate and Respondent continued to ship large quantities of controlled substances to it. The Medicine Shoppe's questionnaire indicated the name of a website used by the “physicians who most commonly issue prescriptions filled by [the] pharmacy.” Resp. Ex. 65, at 4. Moreover, the pharmacy answered the question of whether it verified that the physicians were “authorized to practice medicine in the state where the patient is located,” stating: “No. The doctor makes the consult from the state in which they are licensed.” Id. at 4. Medicom—which apparently was owned by the same person who owned the Medicine Shoppe—stated that it was not an internet pharmacy. The pharmacy added, however, that it “receive[d] Rx from doctors who have spoken [to] patients, discussed therapy, and also reviewed entire medical history.” Resp. Ex. 66, at 2. Notably, Medicom did not maintain that the prescriptions were issued by the physicians pursuant to a face-to-face encounter with the patients. Moreover, the questionnaire indicated that the pharmacy received prescriptions “via telemedicine” and named three websites used by physicians whose prescriptions the pharmacy filled. Id., at 2 & 4. Finally, when asked whether it verified that the physicians were authorized to practice medicine in the states where the patients were located, Medicom answered: “No. The doctor makes the consultation from the state they are licensed” in. Id. at 4. Here again, Mr. Goodrich deemed both the Medicine Shoppe and Medicom's responses to be adequate despite the obvious indications that they were not filling lawful prescriptions and Respondent continued to ship hydrocodone to both pharmacies. Most significantly, in September 2006, it shipped 164,000 dosage units to Medicom; in October, it shipped 375,690 dosage units to Medicom; and in November, it shipped 385,000 dosage units to the pharmacy. Avee, another of the identified targets, sent its questionnaire in nearly a month late. On its questionnaire, Avee indicated that it was not an internet but rather a “mail order pharmacy.” Resp. Ex. 55, at 4. It also answered “N/A” to the questions which asked what percentage of the prescriptions it filled originated on the internet and to identify the websites used by the physicians who were commonly issuing the prescriptions it filled. Resp. Ex. 55, at 2 & 4. I acknowledge that Mr. Goodrich then undertook further inquiry to determine whether Avee had changed its business model and requested additional information regarding its due diligence protocols. Resp. Ex. 56. Avee wrote back including a copy of a letter it claimed to have sent to the physicians who issued the prescriptions it filled. Resp. Ex. 57. As found above, while that letter correctly stated the four elements of a legitimate doctor/patient relationship, it also stated that “[t]o these, Avee would add an opportunity for the prescribing practitioner and patient, *via some means, to confer.* ” Id. at 2 22 (emphasis added). Moreover, the letter maintained that “[i]t is not a requirement that the prescribing physician himself/herself took the history or performed the physical examination, as long as the prescribing practitioner had full and meaningful access to the medical history and physical examination, and *an opportunity to confer with the patient.* ” Id. (emphasis added). 22 This is page 5 of the exhibit. In short, Avee had not changed its practices from the time of the February 2006 on-site visit, when Mr. Goodrich noted that the pharmacy filled “prescriptions from various sources, *including internet-connected medical providers who provide patient assessments and diagnosis through unconventional practice models.”* GX 20 (emphasis added). Respondent nonetheless continued to ship large quantities of hydrocodone to Avee. Indeed, in September 2006, Respondent shipped 695,800 dosage units to Avee, in October, it shipped 537,900 dosage units to Avee, and in November, it shipped 2.11 million dosage units to the pharmacy. Accumed, another of the “targeted pharmacies,” represented in its questionnaire that it was “not an internet pharmacy,” and that zero percent of the prescriptions it filled originated on the internet. Resp. Ex. 54, at 2-3. It also indicated “N/A” where asked to list the websites used by the “physicians who most commonly issue prescriptions filled by your pharmacy.” Id. at 4. Notwithstanding the inconsistency between Accumed's answers and Mr. Goodrich's finding during the February site visit that the pharmacy had “ties to the internet,” GX 17, there is no evidence that Mr. Goodrich undertook any additional investigation to determine whether it was filling legitimate prescriptions. Here again, Respondent continued to sell extraordinary quantities of hydrocodone to the pharmacy. More specifically, in August 2006, Respondent sold Accumed 1.267 million dosage units; in September, it sold 503,020 dosage units; in October, it sold 393,610 dosage units; and in November, it sold more than 1.56 million dosage units. Finally, Respondent produced no evidence that it ever received responses from Medcenter, Discount Mail Meds (a/k/a Liddy's), and Medichem. See Resp. Exs. 54-72; ALJ at 24-25 (Stipulated FOF 77-86). Moreover, Respondent's evidence suggests that it did not even send a questionnaire to Discount Mail Meds. See Resp. Ex. 52, at 2. Respondent nonetheless continued to distribute large quantities of hydrocodone to Medcenter until November 16, 2006, when the pharmacy's registration was suspended. More specifically, Respondent sold Medcenter 378,000 dosage units in September, 608,000 dosage units in October, and approximately 314,000 dosage units in the first half of November. Respondent also distributed large quantities of hydrocodone to Discount and Medichem until the immediate suspension of its registration on December 6, 2006. Between August and November 2006, Respondent sold Medichem at least 216,000 dosage units each month. During the same period, the lowest amount Respondent sold to Discount was 292,720 dosage units in August. Moreover, in October and November, Respondent sold to Discount more than 500,000 dosage units each month. Accordingly, I conclude that even after being advised by agency officials that its internet pharmacy customers were likely engaged in illegal activity, Respondent failed miserably to conduct adequate due diligence. Notwithstanding the breadth of information provided during the conference call, Respondent did not stop selling to any of its internet pharmacy customers while it investigated the legitimacy of their businesses activities. Moreover, even when some of the pharmacies provided information indicating that the prescriptions they filled were likely illegal, Respondent continued to distribute large quantities of hydrocodone to them. Indeed, the only instances in which Respondent stopped supplying a pharmacy pursuant its “due diligence” program was when one pharmacy (Bi-Wise) entirely failed to submit the questionnaire and when two other pharmacies (CRJ and YPM) answered nearly every question with a dash or “N/A.” Furthermore, Respondent failed to even send a questionnaire to one of the pharmacies and continued to ship to two pharmacies which apparently never submitted a completed questionnaire. In short, the direct and foreseeable consequence of the manner in which Respondent conducted its due diligence program was the likely diversion of millions of dosage units of hydrocodone. Indeed, it is especially appalling that notwithstanding the information Respondent received from both this agency and the pharmacies, it did not immediately stop distributing hydrocodone to any of the pharmacies. Moreover, in several cases, Respondent actually distributed even larger quantities of the drug to them. As one of the DIs testified regarding Respondent's distribution of 2.1 million dosage units to Avee in November 2006, “[t]his is an obscene amount of drugs.” Tr. 617. The term “obscene” also fairly describes Respondent's experience in distributing hydrocodone to all of its internet pharmacy customers. 23 23 Respondent attempts to excuse its conduct on the ground that it repeatedly asked DEA officials whether it should stop selling to the pharmacies only to be told by DEA officials that they could not tell them whether or not to sell because that was a business decision. Resp. Br. 33. Several courts have held, however, that DEA has no authority under the CSA to tell a distributor whether to sell or not. *See PDK Labs Inc.,* v. *Ashcroft,* 338 F.Supp.2d 1, 14 (D.D.C. 2004). Respondent also faults the July 2006 presentation by agency personnel as “[s]easoned with antiquated case law and dense, professional material,” and asserts that it had “little pedagogic value.” Resp. Br. at 34. The Supreme Court's decision in *United States* v. *Moore,* 423 U.S. 122 (1975), however, remains good law. As for the purportedly “dense, professional materials,” these documents were typically no more than a handful of pages in length and surely capable of being understood by a person of reasonable intelligence. See GX 61. Indeed, based on the questionnaire Mr. Goodrich prepared, it seems clear that he understood the requirements for a valid prescription and legitimate doctor/patient relationship even if he chose to ignore the information provided by many of the pharmacies. See Resp. Ex. 52. I further note, however, that the Agency had no obligation to conduct the July 2006 briefing. In any event, in April 2001, the Agency published in the **Federal Register** a guidance document explaining the potential illegality under existing law of the activities engaged in by Respondent's internet pharmacy customers. *See Dispensing and Purchasing Controlled Substances over the Internet,* 66 FR 21181 (2001). Respondent's Failure to Report Suspicious Orders The record further demonstrates that Respondent repeatedly failed to report any of its sales to the Florida-based internet pharmacies as suspicious orders even though, as the ALJ concluded, the purchases by these customers “fell within the regulatory definition of suspicious orders.” ALJ at 49. From its first distribution of hydrocodone products in December 2005 through its last in December 2006, not once did Respondent report a suspicious order. Moreover, Respondent failed to report these distributions notwithstanding
(1)that the Florida-based pharmacies were ordering massive quantities of hydrocodone, quantities which greatly exceeded what Respondent sold to traditional retail pharmacies, and
(2)that controlled substances typically constituted all but a miniscule percentage of the prescriptions drugs being ordered by the Florida-based pharmacies. For example, between December 7 and December 31, 2005 (a three-and-a-half week period), Respondent distributed approximately 817,000 dosage units of hydrocodone to Medipharm. This amount was 109 times the amount of hydrocodone that Respondent typically sold in a month to its retail pharmacy customers. Moreover, controlled substances comprised 98 percent of Medipharm's purchases of prescriptions drugs from Respondent. Notwithstanding this information, Respondent did not deem Medipharm's purchases to be suspicious. It did not report any of Medipharm's subsequent purchases as suspicious even though the pharmacy never purchased less than 703,000 dosage units of hydrocodone in a month and purchased more than a million dosage units of this drug in six different months. Moreover, even though between December 2005 and June 2006, controlled substances constituted 99% of Medipharm's prescription drug purchases from it and was specifically identified as a targeted pharmacy, Respondent never reported the purchases as suspicious. As another example, between December 21st and 31st, 2005, Avee purchased approximately 346,000 dosage units of hydrocodone from Respondent. Just as in the case of Medipharm, this amount—which involved only ten days of purchases—greatly exceed Respondent's average monthly sale of hydrocodone to a traditional pharmacy. Moreover, while Avee was only a customer for ten days during the seven-month period of June through December 2005, Avee nonetheless made Respondent's list (ranking eighth) of its largest purchasers of controlled substances. See Resp. Ex. 46. Moreover, controlled substances constituted 100 percent of Avee's purchases of prescription drug products from Respondent. Id. Here again, Respondent did not report any of Avee's purchases as suspicious. It did not do so after Mr. Goodrich acquired information during the February site visit indicating that Avee was engaged in the filling of illegitimate prescriptions. Nor did it do so even after the July 2006 conference call when DEA officials informed Respondent that it was a targeted pharmacy. It did not do so even in November 2006, when it distributed more than 2.1 million dosage units of hydrocodone to Avee. Moreover, as it obtained additional Florida based customers, who proceeded to order excessive quantities of hydrocodone, Respondent never reported any of these pharmacies' orders as suspicious. To the contrary, on various occasions, it submitted e-mails to DEA field personnel affirmatively stating that it had reviewed its customer's purchases of controlled substances and had “no suspicious activity to report.” See GX 9 (Dec. 2005); GX 10 (Jan. 2006); GX 11 (Mar. 2006); GX 12 (April 2006). Respondent contends that “[t]he [G]overnment's focus on [its] failure to report orders as suspicious in early 2006 is a red herring.” Resp. Br. 34. Respondent argues that its failure to file suspicious order reports was not the result of any intent to mislead and points to the fact that in February 2006, it submitted a report that identified Medipharm, Avee and Accumed as among its largest purchasers of controlled substances. Id. Respondent also argues that by filing reports with DEA's ARCOS unit “it alerted the DEA to Southwood's commerce with internet pharmacies.” Id. Even if Mr. Goodrich had no intent to mislead by submitting these negative reports, Respondent still violated the regulation by failing to report suspicious orders. That some of the pharmacies were identified on the two reports Respondent submitted listing its largest purchasers of controlled substances (which Respondent submitted in February and July 2006), does not excuse its failure to comply with the regulation. Those reports did not comply with the regulation for several reasons. First, they were not timely submitted. See 21 CFR 1301.74(b) (requiring reporting of “suspicious orders when discovered by the registrant”). Indeed, many of the pharmacies had been purchasing extraordinary quantities of hydrocodone for months by the time Respondent submitted its July 2006 report. Second, the reports did not list several of the internet customers—even though they had purchased large quantities—either because they had only recently become customers (as in the case of Grand Pharmacy and the Medicine Shoppe), or because the pharmacy had only purchased hydrocodone from Respondent for a limited time (as in the case of Elite). Nor does Respondent's filing of ARCOS reports excuse its failure to report suspicious orders. The ARCOS reporting requirement and the suspicious orders reporting requirement serve two different purposes. While ARCOS provides the Agency with information regarding trends in the diversion of controlled substances, the reports need not be submitted until fifteen days after the end of the reporting period. In contrast, as explained above, a suspicious order must be reported “when discovered by the registrant.” 21 CFR 1301.74(b). The suspicious orders reporting requirement exists to provide investigators in the field with information regarding potential illegal activity in an expeditious manner. Respondent's compliance with the ARCOS reporting requirement is thus not a substitute for its failure to report suspicious orders. 24 24 Finally, Mr. Goodrich testified that the reason Respondent did not file the reports even after being told during the July 2006 conference call of the highly suspicious nature of the activities of the Florida-based pharmacies was that the pharmacies were already under investigation. Respondent's awareness of an ongoing investigation does not, however, excuse its failure to report its customers' continued suspicious orders. Indeed, such information might well enable the agency to complete its investigation. Accordingly, I further conclude that Respondent repeatedly violated federal regulations by failing to report suspicious orders. 21 CFR 1301.74(b). As explained above, the record also clearly establishes that Respondent's experience in distributing controlled substances is characterized by recurring distributions of extraordinary quantities of controlled substances to entities which then likely diverted the drugs by filling prescriptions which were unlawful. Moreover, Respondent's due diligence measures were wholly inadequate to protect against the diversion of the drugs. Respondent's failure to maintain effective controls against diversion and its experience in distributing controlled substances thus support the conclusion that its continued registration would be “inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Factor Six—Other Factors Relevant to and Consistent With Public Health and Safety Respondent “concedes that the Government has established a prima facie case * * * that [its] continued registration may be inconsistent with the public interest.” Resp. Br. 31. Respondent contends, however that there is sufficient evidence “of mitigation and ongoing remediation by [it] to compel a conclusion that to revoke its registration would be inconsistent with the public interest.” Id. (citations omitted). More specifically, Respondent argues that its “cooperation with and responsiveness to * * * DEA [should] also be considered in evaluating whether [its] continued registration is in keeping with the public interest.” Id. at 37. Respondent maintains that it has undertaken several remedial measures “to prevent the occurrence of further violations,” and that therefore, a sanction less than revocation is warranted. These measures include:
(1)The development of a new SOP “to more rapidly detect suspicious orders”;
(2)placing its new COO “in charge of DEA compliance”;
(3)retaining a consultant to audit its compliance efforts; and
(4)working with the consultant “to develop a means of interdicting suspicious orders of controlled substances before they are shipped.” Resp. Br. 36. The ALJ agreed with Respondent. According to the ALJ, “Respondent has worked with * * * DEA throughout its registration,” and had “worked closely with local DEA diversion investigators to establish systems to control against the diversion of controlled substances.” Id. at 54-55. The ALJ also noted that Respondent had “consistently submitted” ARCOS reports without any deficiencies noted. Id. at 54. Addressing the issue of its responsiveness to the Agency, the ALJ noted that Respondent attempted to obtain information from the Florida Board, that it sent questionnaires to the pharmacies and developed a new customer profile to evaluate new accounts, and that it adopted a policy under which it stopped filling orders placed by pharmacies whose registrations had been continued on a day-to-day basis but not renewed. Id. at 59-60. The ALJ also explained that “Respondent continues to demonstrate a willingness to bring its business practices into compliance with DEA regulations,” and noted that its new COO “has a firmer grasp [of] these regulatory requirements.” Id. at 61. Reasoning that Respondent had “kept an open dialogue with the DEA and has attempted to come into compliance with the DEA's regulations,” and had not previously been subject to enforcement action, the ALJ concluded that revocation of its “entire * * * registration is too severe a remedy” even though Respondent had “irresponsibly sold” what she described as “egregious quantities” of hydrocodone to the Florida internet pharmacies. Id. at 62. I disagree with both Respondent and the ALJ. As for Respondent's view, its “circumstances” do not “compare favorably with [those of] registrants” whose registrations have not been revoked, but rather, subjected to lesser sanctions. See Resp. Br. 36. As for the ALJ's view that Respondent had kept “an open dialogue,” the record amply establishes that Respondent is not a good listener. For support, Respondent cites my decision in Joy's Ideas, 70 FR 33195 (2005), where I noted that the registrant had taken “aggressive actions to improve her” accountability systems. Id. at 33198. Notwithstanding that the registrant “may have been an unknowing and unintentional contributor” to the methamphetamine problem, I still revoked her registration based on evidence that large amounts of the products she distributed were being diverted. Id. at 33198-99. The case thus does not support Respondent for two reasons:
(1)I revoked the registration in Joy's Ideas notwithstanding the mitigating evidence, and
(2)here, Respondent had reason to know that it was contributing to the diversion of hydrocodone through most, if not all, of the pharmacies it supplied. Respondent also cites Service Pharmacy, Inc., 61 FR 10791 (1996), which noted that a registrant's adherence to the terms of a consent order it had entered into with state authorities supported its being allowed to maintain its DEA registration. Respondent argues by analogy that its “cooperation with and responsiveness to * * * DEA [should] also be considered in evaluating whether [its] continued registration is [consistent] with the public interest.” Resp. Br. 37. I agree that Respondent's level of cooperation and responsiveness to DEA should be considered in determining the appropriate sanction. It is true that there is some evidence of Respondent's having been a cooperative registrant as to some issues involving its responsibilities under the CSA. In particular, Respondent worked with a diversion investigator to develop a suspicious orders reporting system (although it was developed for a different customer base). There was also no evidence of Respondent's non-compliance with the CSA prior to its decision to supply internet pharmacies. On the other hand, even were I to completely ignore Respondent's conduct during the period between December 2005, when it started supplying the pharmacies, and the July 2006 conference call, the record further demonstrates that it did not adequately respond to the information DEA provided it in July 2006. As explained above, Respondent did not cut off any of the pharmacies until more than three months after being informed of the potential illegality of the pharmacies' activities. Indeed, it did not even enforce the deadline it set in its questionnaire. Moreover, while some of the responses to the questionnaires were either false or were cleverly prepared by a wordsmith, in a number of other instances the responses contained information—which Respondent then ignored—that clearly suggested that the pharmacy was filling invalid prescriptions. Finally, Respondent continued to sell large quantities to many of the pharmacies—including those specifically identified as targeted—up until the suspension of either the pharmacy's registration or its own registration. Contrary to Respondent's view, the entire body of evidence regarding its cooperation and responsiveness does not support its continued registration. While finding that “Respondent continues to fail to adequately protect against diversion of hydrocodone products,” ALJ at 59, the ALJ nonetheless concluded that to revoke its entire registration would be “too severe a remedy,” presumably because there was “no evidence of [its] improper handling of any other controlled substances.” Id. at 62. The ALJ, however, offered no explanation as to why Respondent's procedures were nonetheless sufficient to entrust it with authority to distribute other controlled substances. To the extent the ALJ's recommendation was based on the lack of evidence showing that Respondent improperly handled other controlled substances, the ALJ erred. The Government is not required to prove that multiple categories of the drugs Respondent distributed were diverted in order to sustain the revocation of its entire registration. Rather, proof that a single category of a drug it distributed was diverted is enough to support the revocation of Respondent's entire registration. 25 25 As for the Government's exception, when a party intends to rely on evidence contained in a CD-ROM, it has the obligation to prepare a summary setting forth what the data contained therein show. That summary must be prepared and served on opposing counsel along with a copy of the CD-ROM in advance of the hearing. It is not the responsibility of the ALJ or this Office to plumb the depths of such an exhibit to determine what the data show. Moreover, such evidence should not be admitted into the record unless the proponent of the exhibit establishes an adequate foundation for its admission by identifying and authenticating the exhibit; this must be done even if opposing counsel do not object to its admission. The ALJ apparently was persuaded by the various measures undertaken by Respondent to bring itself into compliance. Among these was Respondent's hiring of its new COO. According to the ALJ, the new COO is “an experienced officer who will be making the final decisions concerning * * * Respondent's compliance measures,” and this hiring “operates as an increased level of protection of the public interest and [its] compliance with DEA regulations in its business practices.” ALJ at 62. The ALJ also noted that Respondent had voluntarily agreed “to cease selling controlled substances to Internet pharmacies.” Id. at 63. Relatedly, Respondent points to its retaining of a consultant to audit its DEA compliance efforts and to develop a means of interdicting suspicious orders before they are shipped. As for Respondent's hiring of its new COO, the record establishes that Mr. Schwartz commenced his duties on September 26, 2006. Mr. Schwartz was thus the COO for more than two months before the immediate suspension order was served. Yet during this period, Respondent continued to distribute extraordinary quantities of hydrocodone to numerous internet pharmacies. Moreover, with respect to some of the pharmacies, it actually distributed increasing quantities culminating with the 2.1 million dosage units it sold to Avee in November 2006. In his testimony, Mr. Schwartz claimed that he did not become aware of Respondent's sales to the internet pharmacies and DEA's interest in the matter until on or about November 2, 2006, when DEA investigators visited Respondent and again met with its employees including Mr. Goodrich. 26 Mr. Schwartz testified that it took “a couple of days” for him to be given the notebook which DEA investigators had provided to Respondent before the July conference call and review it, and that on December 5, 2007—approximately four weeks later—he and Mr. Sempre (Respondent's owner) came to the decision to cease doing business with the Florida pharmacies. 26 As Mr. Schwartz testified, “when a regulatory agency is on-site * * * everybody in the company knows about it. Word travels quickly.” Tr. 937. While the ALJ credited Mr. Schwartz's testimony, I decline to give any weight to Respondent's stroke-of-midnight decision in determining the appropriate sanction. See, e.g., *Vico Products Co., Inc.,* v. *NLRB,* 333 F.3d 198, 211 (D.C. Cir. 2003). As an initial matter, I note that it should not have taken five weeks for Mr. Schwartz to even become aware of Respondent's sales to the internet pharmacies. Moreover, given the information Mr. Schwartz claims to have reviewed and his extensive experience in the industry, it should not have taken another four weeks to decide to stop selling to these entities. Most importantly, the decision must be considered in light of the evidence that for nearly a year prior to it, Respondent distributed millions of dosage units of hydrocodone products to entities which were likely diverting the drugs. Moreover, Respondent continued to distribute hydrocodone to the pharmacies following at least two meetings in which DEA investigators discussed the questionable practices of these pharmacies. As the Seventh Circuit has noted, “[a]n agency rationally may conclude that past performance is the best predictor of future performance.” *ALRA Laboratories, Inc.,* v. *DEA,* 54 F.3d 450, 452 (7th Cir. 1995). In short, Respondent's decision is too little, too late, to persuade me that it can be entrusted with a registration. Nor does the other evidence Respondent presented regarding its remedial efforts persuade me that a sanction less than revocation is warranted. Respondent's distribution of 44 million dosage units of hydrocodone which were likely diverted caused extraordinary harm to the public health and safety. Moreover, the record establishes that Respondent had reason to know that the hydrocodone it distributed was likely being diverted. As the record demonstrates, for nearly a year, Respondent repeatedly supplied these drug pushers with large quantities of hydrocodone. Respondent commenced supplying the pharmacies showing little interest in determining whether they were engaged in lawful activity. Moreover, Respondent continued to supply the pharmacies even after being advised by this Agency of the likely illegality of their activities. Finally, while Respondent eventually undertook some inquiries, it then frequently ignored the information it obtained from the pharmacies themselves, which indicated that they were likely filling unlawful prescriptions, and continued to supply most of them. Given the scope of Respondent's conduct and the harm it caused, I decline to accept its assertions of reform. I therefore conclude that this factor also supports the conclusion that Respondent's continued registration “is inconsistent with the public interest.” 21 U.S.C. 823(d). Finally, for the same reasons which led me to order the immediate suspension of Respondent's registration, I further hold that this order shall be effective immediately. See 21 CFR 1316.67. My determination is based on the reasons set forth above, and those reasons are sufficient by themselves to support the revocation of Respondent's registration. There is, however, an additional consideration, which, while not necessary to decide this case, bears mentioning. Specifically, to allow Respondent to maintain its registration—even subject to the conditions as proposed by the ALJ and/or Respondent—would create a perverse incentive. A precedent which ignores how irresponsibly a registrant has acted and allows it to maintain its registration based on its claim of having reformed its business practices, could well prompt other registrants to ignore their obligations under the Act and sell massive quantities of controlled substances to diverters. I acknowledge that proceedings under sections 303 and 304 of the CSA are non-punitive. *See Samuel S. Jackson* 72 FR 23848, 23853 (2007); *Leo R. Miller,* 53 FR 21931, 21932 (1988). Relatedly, DEA precedent holds that a proceeding under these provisions ‘ “is a remedial measure, based upon the public interest and the necessity to protect the public from those individuals who have misused * * * their DEA Certificate of Registration, and who have not presented sufficient mitigating evidence to assure the Administrator that they can be [en]trusted with the responsibility carried by such a registration.’ ” *Jackson* , 72 FR at 23853 (quoting *Miller,* 53 FR at 21932). Neither *Jackson* nor any other agency decision holds, however, that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be revoked. Moreover, even when a proceeding serves a remedial purpose, an administrative agency can properly consider the need to deter others from engaging in similar acts. *Cf. Butz* v. *Glover Livestock Commission Co., Inc.,* 411 U.S. 182, 187 (1973). Consideration of the deterrent effect of a potential sanction is supported by the CSA's purpose of protecting the public interest, see 21 U.S.C. 801, and the broad grant of authority conveyed in the CSA's statutory text, which authorizes the revocation of a registration when a registrant has committed acts that render its “registration * * * inconsistent with the public interest,” id. 824(a)(4), and specifically directs the Attorney General to consider “such other factors as may be relevant to and consistent with the public health and safety.” Id. 823(d)(6). As noted by a recent study of the National Center on Addiction and Substance Abuse (CASA), “the abuse of controlled prescription drugs in America now eclipses abuse of all illicit drugs combined, except marijuana.” GX 3 (Declaration of Joseph T. Rannazzisi). According to the CASA study, “between 1992 and 2003, abuse of controlled prescription drugs grew at a rate twice that of marijuana abuse, five times greater than cocaine abuse, and 60 times greater than heroin abuse.” Id. Relatedly, CASA has found that the number of “controlled prescription drug-related visits to emergency rooms has increased three and a half times more than heroin-related visits and four times more than visits linked to cocaine abuse.” Id. Moreover, “between 1994 and 2002, emergency department reports of hydrocodone * * * overdoses increased by 170 percent.” Id. Equally alarming are the results of the National Institute of Drug Abuse
(NIDA)2004 survey of eighth, tenth and twelfth grade school children. According to the survey, “9.3 percent of twelfth graders reported using Vicodin, a brand name Schedule III controlled substance containing hydrocodone, without a prescription in the previous year.” Id. Illegitimate internet sites play an increasingly large and disturbing role in facilitating the growth of prescription drug abuse. Id. at 1-2.; *see also William R. Lockridge,* 71 FR 77791 (2006). Because these websites allow a person to obtain a controlled substance based on a prescription which is issued outside of a legitimate doctor/patient relationship and the safeguards that relationship provides, “[a]nyone—including children—can easily obtain highly addictive controlled substances online.” GX 3, at 2. As stated above, these websites and the pharmacies that fill the prescriptions issued by them, are nothing more than drug pushers operating under the patina of legitimate authority. Cutting off the supply sources of these pushers is of critical importance in protecting the American people from this extraordinary threat to public health and safety. In accomplishing this objective, this Agency cannot do it all itself. It must rely on registrants to fulfill their obligation under the Act to ensure that they do not supply controlled substances to entities which act as pushers. And to make clear, because of the threat to public safety posed by the diversion of controlled substances through the internet, the deterrent value of a sanction is an appropriate consideration in proceedings brought under sections 303 and 304 of the CSA. Order Pursuant to the authority vested in me by 21 U.S.C 823(d) & 824(a), as well as 28 CFR 0.100(b) & 0.104, I order that DEA Certificate of Registration, RS0204898, issued to Southwood Pharmaceuticals, Inc., be, and it hereby is, revoked. I further order that the pending application of Southwood Pharmaceuticals, Inc., for renewal of its registration be, and it hereby is, denied. Moreover, for the same reasons which led me to conclude that Respondent's continued registration constituted an imminent danger to public health and safety, this order is effective immediately. Dated: June 22, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. 07-3218 Filed 7-2-07; 8:45 am]
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  • Pub. L. 109-365
  • Pub. L. 92-463
  • 21 CFR 14
  • 42 CFR 52
  • 45 CFR 46
  • 45 CFR 46.116
  • 21 CFR 50
  • Pub. L. 103-227
  • Pub. L. 94-295
  • Pub. L. 101-629
  • Pub. L. 105-115
  • 21 CFR 807
  • 587 F.2d 1173
  • 422 F.2d 944
  • 366 F.2d 177
  • 762 F. Supp. 382
  • 770 F.2d 214
  • 766 F.2d 592
  • 474 U.S. 1062
  • 44 USC 3501-3520
  • 21 CFR 801
  • 42 CFR 84
  • 5 CFR 1320.3(c)(2)
  • 21 CFR 820
  • 21 CFR 812
  • 43 CFR 1784
  • 41 CFR 101
  • 19 CFR 201
  • 19 CFR 207
  • 419 F.3d 477
  • 412 F.3d 165
  • 319 U.S. 703
  • 423 U.S. 122
  • 338 F. Supp. 2d 1
  • 333 F.3d 198
  • 54 F.3d 450
  • 411 U.S. 182
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U.S.C.§ 331
U.S.C.§ 355
U.S.C.§ 262
U.S.C.§ 241
U.S.C.§ 360b
F. App'x587 F.2d 1173
F. App'x422 F.2d 944
F. App'x366 F.2d 177
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