Notices. Notice

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegations of Authority This notice amends Part K of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), as follows: Chapter KA, The Office of the Assistant Secretary (OAS), as previously amended at 69 FR 76949, December 23, 2004, (transferring the Freedom of Information Act

(FOIA)function from the Office of the Assistant Secretary, Office of the Executive Secretariat, to the Division of Public Information, Office of Public Affairs) and at 71 FR 71549, December 11, 2006 (this notice inadvertently published the transfer of the FOIA Officer and Office of Inspector General hotline functions from the Office of the Assistant Secretary to the Office of Public Affairs), and Chapter KN, Office of Public Affairs (OPA), as previously amended 69 FR 76949, December 23, 2004, and at 71 FR 71549, 71550, December 11, 2006. This notice announces the transfer of the FOIA functions from the Division of Public Information, Office of Public Affairs, and places them in the Office of the Assistant Secretary for Children and Families. Because of the error in 2006 we are republishing the affected organizational structures of the Office of the Assistant Secretary and the Office of Public Affairs in their entirety. The changes are as follows: I. Under Chapter KA, Office of the Assistant Secretary for Children and Families, delete in its entirety and replace with the following: *KA.00 Mission.* The Office of the Assistant Secretary for Children and Families

(OAS)provides executive direction, leadership, and guidance for all ACF programs. OAS provides national leadership to develop and coordinate public and private initiatives for carrying out programs that promote permanency placement planning, family stability, and self-sufficiency. OAS advises the Secretary on issues affecting America's children and families, including Native Americans, persons with developmental disabilities, refugees, and legalized aliens. OAS provides leadership on human service issues and conducts emergency preparedness and response operations during a nationally declared emergency. OAS handles Freedom of Information Act requests and inquiries and coordinates hotline calls received by the Office of Inspector General and the Government Accountability Office relating to ACF operations and personnel. *KA.10 Organization.* The Office of the Assistant Secretary for Children and Families is headed by the Assistant Secretary for Children and Families who reports directly to the Secretary and consists of: Office of the Assistant Secretary for Children and Families

(KA)President's Committee for People with Intellectual Disabilities Staff

(KAD)Executive Secretariat Office

(KAF)Office of Human Services Emergency Preparedness and Response

(KAG)*KA.20 Functions A. Office of the Assistant Secretary for Children and Families (KA):* The Office of the Assistant Secretary for Children and Families is responsible to the Secretary for carrying out ACF's mission and provides executive supervision of the major components of ACF. These responsibilities include providing executive leadership and direction to plan and coordinate ACF program activities to ensure their effectiveness, approving instructions, policies, publications, and grant awards issued by ACF, and representing ACF in relationships with governmental and non-governmental organizations. The Assistant Secretary for Children and Families also serves as the Director of the Office of Child Support Enforcement, and signs official child support enforcement documents as the Assistant Secretary for Children and Families. The Principal Deputy Assistant Secretary serves as an alter ego to the Assistant Secretary for Children and Families on program matters and acts in the absence of the Assistant Secretary for Children and Families. The Office coordinates hotline calls received by the Office of Inspector General and the Government Accountability Office relating to ACF operations and personnel and assists the ACF FOIA Officer in processing FOIA inquiries and requests relating to ACF programs and activities. *B. President's Committee for People With Intellectual Disabilities Staff (KAD):* The President's Committee for People with Intellectual Disabilities (PCPID) staff provides general staff support for a Presidential-level advisory body. It coordinates all meetings and Congressional hearing arrangements; provides such advice and assistance in the areas of intellectual disabilities as the President or the Secretary may request; prepares and issues an annual report to the President concerning intellectual disabilities and such additional reports or recommendations as the President may require or as PCPID may deem appropriate; and evaluates the national effort to prevent and ameliorate intellectual disabilities. It works with other Federal, State, local governments, and private-sector organizations to achieve Presidential goals vis-à-vis intellectual disabilities, and develops and disseminates information to increase public awareness of intellectual disabilities to reduce its incidence and to alleviate its effects. The staff supporting PCPID reports to the Deputy Assistant Secretary for Policy and External Affairs. *C. The Executive Secretariat Office (KAF):* The Executive Secretariat Office (ExecSec) ensures that issues requiring the attention of the Assistant Secretary, Deputy Assistant Secretaries and/or executive staff are addressed on a timely and coordinated basis and facilitates decisions on matters requiring immediate action, including White House, Congressional, and Secretarial assignments. ExecSec serves as the ACF liaison with the HHS Executive Secretariat. ExecSec receives, assesses, and controls incoming correspondence and assignments to the appropriate ACF component(s) for response and action and provides assistance and advice to ACF staff on the development of responses to correspondence. ExecSec provides assistance to ACF staff on the use of the controlled correspondence system. ExecSec coordinates and/or prepares Congressional correspondence; tracks development of periodic reports; and facilitates Departmental clearances. ExecSec is headed by a Director who reports to the Principal Deputy Assistant Secretary. *D. The Office of Human Services Emergency Preparedness and Response (KAG):* The Office of Human Services Emergency Preparedness and Response (OHSEPR) provides general staff support for the implementation and coordination of ACF program and human services emergency planning, preparedness, and response during nationally declared emergencies. OHSEPR oversees disaster assessment, response operations and asset-management protocols. OHSEPR coordinates with ACF Central and Regional Offices, ACF State- and local grantee-funded programs, ACF program partner organizations, and the Office of the Secretary, Office of the Assistant Secretary for Preparedness and Response (ASPR). OHSEPR coordinates, through ASPR, with the Department of Homeland Security Federal Emergency Management Agency on human services emergency planning as part of the National Emergency Plan. The staff supporting OHSEPR reports to the Director of OHSEPR who reports to the Principal Deputy Assistant Secretary. II. Under Chapter KN, Office of Public Affairs, Delete in Its Entirety and Replace With the Following: *KN.00 Mission.* The Office of Public Affairs

(OPA)develops, directs, and coordinates public affairs and communications services for ACF. OPA provides leadership, direction, and oversight in promoting ACF's public affairs policies, programs, and initiatives. OPA provides printing and distribution services for ACF. *KN.10 Organization.* The Office of Public Affairs is headed by a Director who reports to the Assistant Secretary for Children and Families. The Office is organized as follows: Office of the Director

(KNA)Division of Public Information

(KNB)Division of Publications Services

(KNC)*KN.20 Functions. A. Office of the Director (KNA):* The Office of the Director provides leadership and direction to OPA in administering OPA's responsibilities. The Office provides direction and leadership in the areas of public relations policy and communications services. The Office serves as an advisor to the Assistant Secretary for Children and Families in the areas of public affairs; provides advice on strategies and approaches to be used to improve public understanding of and access to ACF programs and policies; and coordinates and serves as ACF liaison with the Assistant Secretary for Public Affairs. The Office serves as Regional Liaison on public affairs issues. The Deputy Director assists the Director in carrying out the responsibilities of the Office. *B. Division of Public Information (KNB):* The Division of Public Information develops and implements public affairs strategies to achieve ACF program objectives in coordination with other ACF components. The Division coordinates news media relations strategy; responds to all media inquiries concerning ACF programs and related issues; develops fact sheets, news releases, feature articles for magazines and other publications on ACF programs and initiatives; and manages preparation and clearance of speeches and official statements on ACF programs. The Division coordinates regional public affairs policies and public affairs activities pertaining to ACF programs and initiatives. *C. Division of Publications Services (KNC):* The Division of Publications Services directs the audio-visual, publication and printing management services for ACF. The Division manages preparation and clearance of all ACF audio-visual products, publications, and graphic designs, including planning, budget oversight, and technical support. The Division provides centralized graphics design services to ACF. The Division reviews requests for proposals for contracts and grants that involve publications, audio-visual materials and/or public information and education activity. The Division also provides technical leadership and services in public information, printing, and mail distribution. The Division recommends approaches for meeting internal and external communications needs of ACF. The Division acts as focal point for clearance of all publications and audio-visual projects whether produced in-house or by contract or grant. Dated: May 30, 2007. Daniel C. Schneider, Acting Assistant Secretary for Children and Families. [FR Doc. E7-10777 Filed 6-4-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0202] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of December 20, 2006 (71 FR 76344), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0520. The approval expires on May 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: May 29, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10785 Filed 6-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is requesting nominations for members to serve on the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. Elsewhere in this issue of the **Federal Register** , FDA is publishing a document announcing the establishment of this committee. FDA has 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: Nominations received on or before July 20, 2007 will be given first consideration for membership on the Risk Communication Advisory Committee. Nominations received after July 20, 2007 will be considered for nomination to the Risk Communication Advisory Committee should nominees still be needed. ADDRESSES: All nominations for membership should be sent to the contact person listed in the FOR FURTHER INFORMATION CONTACT section of this document. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, the primary contact is Lee Zwanziger, Office of Planning, Office of the Commissioner (HFP-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2895, FAX: 301-827-5260, e-mail: *rcac@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on the Risk Communication Advisory Committee. I. Function of the Risk Communication Advisory Committee The committee advises the Commissioner of Food and Drugs on strategies and programs designed to communicate with the public about both the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. The committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products. II. Criteria for Voting Members A. Experts Persons nominated for membership must have scientific expertise or extensive experience in one or more of the following fields: Risk communication; risk perception; social marketing; communications; cognitive, social, health, behavioral, or other relevant specialties of psychology or sociology; decision analysis; qualitative or quantitative research methodology; health literacy; cultural competency; journalism; and/or biomedical ethics. B. Public Members Persons nominated for membership on the committee to provide a perspective from real-world experience on the communication needs of the various groups who use FDA-regulated products must have the following skills:

(1)Ability to communicate the interests and perspectives of consumers, patients, patient-caregivers, or health professionals;

(2)ability to discuss benefits and risks; and

(3)ability to understand the results of research studies. In addition, preference will be given to nominees who have one or more of the following qualifications:

(1)Ability to analyze technical data;

(2)understanding of research design;

(3)ability to disseminate information about the advisory committee experience to the community; and

(4)ties to a consumer, patient, and/or community-based organization. As a member of the Risk Communication Advisory Committee, these individuals will serve in their individual capacities. However, we expect that they can also serve as conduits between FDA and the general public. Nominated individuals may include patients and patients' family members, health professionals, communicators in health, medicine, and science, and persons affiliated with consumer, specific disease, or patient safety advocacy groups. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current resume or curriculum vitae of each nominee, including current business address, telephone number, and e-mail address if available. Nominations must also acknowledge that the nominee is aware of the nomination, is willing to serve as a member, and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning matters related to financial holdings, employment, and research grants and/or contracts. 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: May 28, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-10737 Filed 6-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee; Risk Communication Advisory Committee; Establishment AGENCY: Food and Drug Administration ACTION: Notice of establishment. Under the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Commissioner of Food and Drugs (the Commissioner), announces the establishment of the Risk Communication Advisory Committee. The Commissioner has determined that it is in the public interest to establish such a committee. The Risk Communication Advisory Committee shall provide advice to the Commissioner or designee on strategies and programs designed to communicate with the public about both the risks and benefits of Food and Drug Administration (FDA)-regulated products so as to facilitate optimal use of these products. The committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products. Duration of this committee is 2 years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest. The Risk Communication Advisory Committee will be composed of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Some members will be selected to provide experience-based insights on the communications needs of the various groups who use FDA-regulated products. The latter may include patients and patients' family members, health professional, communicators in health, medicine and science, persons affiliated with consumer, specific disease, or patient safety advocacy groups. Depending on the meeting topic(s), at least one nonvoting member identified with relevant industry interests may be invited from existing members of other FDA Advisory Committees. FOR FURTHER INFORMATION CONTACT: Lee Zwanziger, Office of Planning, Office of the Commissioner (HFP-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2895, FAX: 301-827-5260, or *rcac@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the **Federal Register** , FDA is publishing a request for nominations for advisory committee members and notice of a change to the advisory committee telephone information line adding the establishment of the Risk Communication Advisory Committee. FDA plans to publish in the near future a final rule adding the Risk Communication Advisory Committee to the list of FDA standing advisory committees in 21 CFR 14.100. Dated: May 28, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-10740 Filed 6-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2006E-0332 and 2006E-0333] Determination of Regulatory Review Period for Purposes of Patent Extension; NAMENDA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for NAMENDA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of two applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product. ADDRESSES: Submit written comments and petitions 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: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product, NAMENDA (memantine hydrochloride). NAMENDA is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Subsequent to this approval, the Patent and Trademark Office received two patent term restoration applications for NAMENDA (U.S. Patent Nos. 5,061,703 and 5,614,560) from Forest Laboratories, Inc., acting as agent for Merz Pharma GmbH & Co. KGaA, and the Patent and Trademark Office requested FDA's assistance in determining these patents' eligibilities for patent term restoration. In a letter dated January 26, 2007, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of NAMENDA represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for NAMENDA is 5,001 days. Of this time, 4,699 days occurred during the testing phase of the regulatory review period, while 302 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : February 7, 1990. The applicant claims October 9, 1997, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the original IND effective date was February 7, 1990, which was the date the original IND was removed from clinical hold. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : December 19, 2002. FDA has verified the applicant's claim that the new drug application

(NDA)(NDA 21-487) was initially submitted on December 19, 2002. 3. *The date the application was approved* : October 16, 2003. FDA has verified the applicant's claim that NDA 21-487 was approved on October 16, 2003. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,250 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by August 6, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 3, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 2, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-10730 Filed 6-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee Information Hotline AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that we have revised the Advisory Committee Information Hotline (the hotline). The hotline provides the public with access to the most current information available on FDA advisory committee meetings. This notice supersedes all previously published announcements of the hotline. FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Committee Management Officer (HF-4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1220. SUPPLEMENTARY INFORMATION: The hotline can be accessed by dialing 1-800-741-8138 or 301-443-0572. The advisory committee meeting information and information updates can also be accessed via FDA's advisory committee calendar at *http://www.fda.gov/oc/advisory/accalendar/2007/default.htm* . Each advisory committee is assigned a 10-digit number. This 10-digit number will appear in each individual notice of meeting. The public can obtain information about a particular advisory committee meeting by using the committee's 10-digit number. Information on the hotline is preliminary and may change before a meeting is actually held. The hotline will be updated when such changes are made. The following is a list of each advisory committee's 10-digit number to be used when accessing the hotline. Advisory Committee 10-Digit Access Number Office of the Commissioner Pediatric Advisory Committee 8732310001 Risk Communication Advisory Committee 8732112560 Science Board to the FDA 3014512603 Center for Biologics Evaluation and Research Allergenic Products Advisory Committee 3014512388 Blood Products Advisory Committee 3014519516 Cellular, Tissue & Gene Therapies Advisory Committee 3014512389 Transmissible Spongiform Encephalopathies Advisory Committee 3014512392 Vaccines and Related Biological Products Advisory Committee 3014512391 Center for Drug Evaluation and Research Anesthetic and Life Support Drugs Advisory Committee 3014512529 Anti-Infective Drugs Advisory Committee 3014512530 Antiviral Drugs Advisory Committee 3014512531 Arthritis Advisory Committee 3014512532 Cardiovascular and Renal Drugs Advisory Committee 3014512533 Dermatologic and Ophthalmic Drugs Advisory Committee 3014512534 Drug Safety and Risk Management Advisory Committee 3014512535 Endocrinologic and Metabolic Drugs Advisory Committee 3014512536 Gastrointestinal Drugs Advisory Committee 3014512538 Nonprescription Drugs Advisory Committee 3014512541 Oncologic Drugs Advisory Committee 3014512542 Peripheral and Central Nervous System Drugs Advisory Committee 3014512543 Pharmaceutical Science & Clinical Pharmacology, Advisory Committee for (formerly Advisory Committee for Pharmaceutical Science) 3014512539 Psychopharmacologic Drugs Advisory Committee 3014512544 Pulmonary-Allergy Drugs Advisory Committee 3014512545 Reproductive Health Drugs, Advisory Committee for 3014512537 Center for Food Safety and Applied Nutrition Food Advisory Committee 3014510564 Center for Devices and Radiological Health Device Good Manufacturing Practice Advisory Committee 3014512398 Medical Devices Advisory Committee (composed of 18 panels) Anesthesiology and Respiratory Therapy Devices Panel 3014512624 Circulatory System Devices Panel 3014512625 Clinical Chemistry and Clinical Toxicology Devices Panel 3014512514 Dental Products Panel 3014512518 Ear, Nose, and Throat Devices Panel 3014512522 Gastroenterology-Urology Devices Panel 3014512523 General and Plastic Surgery Devices Panel 3014512519 General Hospital and Personal Use Devices Panel 3014512520 Hematology and Pathology Devices Panel 3014512515 Immunology Devices Panel 3014512516 Medical Devices Dispute Resolution Panel 3014510232 Microbiology Devices Panel 3014512517 Molecular and Clinical Genetics Panel 3014510231 Neurological Devices Panel 3014512513 Obstetrics-Gynecology Devices 3014512524 Ophthalmic Devices Panel 3014512396 Orthopaedic and Rehabilitation Devices Panel 3014512521 Radiological Devices Panel 3014512526 National Mammography Quality Assurance Advisory Committee 3014512397 Technical Electronic Product Radiation Safety Standards Committee 3014512399 Center for Veterinary Medicine Veterinary Medicine Advisory Committee 3014512548 National Center for Toxicological Research

(NCTR)Science Advisory Board to NCTR 3014512559 The hotline will provide the most recent information available on upcoming advisory committee meetings, guidance for making an oral presentation during the open public hearing portion of a meeting, and procedures on obtaining copies of transcripts of advisory committee meetings. Because the hotline will communicate the most current information available about any particular advisory committee meeting, this system will provide interested parties with timely and equal access to such information. The hotline should also conserve agency resources by reducing the current volume of inquiries individual FDA offices and employees must handle concerning advisory committee schedules and procedures. 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: May 28, 2007. Randall W. Lutter, Associate Commissioner for Policy. [FR Doc. E7-10738 Filed 6-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0206] Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance document entitled “Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices.” The guidance sets forth the agency's recommendations for ensuring the safety of refrigerated carrot juice and other low-acid refrigerated juices. The guidance is in response to six recent cases of botulism poisoning linked to refrigerated carrot juice that occurred in the United States and Canada. DATES: This guidance is final June 5, 2007. Submit written or electronic comments on the guidance document at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Food Safety (HFS-317), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022, FAX: 301-436-2651. Send one self-addressed adhesive label to assist the office in processing your requests. Submit written comments on the 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022, or e-mail: *michael.kashtock@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance document entitled “Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices.” The purpose of the document is to provide guidance that will assist industry in processing and labeling refrigerated carrot juice and other refrigerated low-acid juices, which are subject to the pathogen reduction provisions of the Hazardous Analysis and Critical Control Point regulation for juice (21 CFR part 120) (the juice HACCP regulation), in a manner intended to provide for the safety of the juice when offered for sale by the processor and during handling by the consumer after purchase. This guidance is in response to six cases of botulism poisoning linked to refrigerated carrot juice that occurred in the United States and Canada in September and October 2006. *Clostridium botulinum* is a bacterium commonly found in soil. Botulism is a rare but serious paralytic illness caused by botulinum toxin, a nerve poison that under certain conditions is produced by *C. botulinum* . Botulism can be fatal and is considered a medical emergency. Foodborne botulism is not common in the United States. FDA is issuing this guidance as level 1 guidance consistent with FDA's good guidance practices regulation (§ 10.115 (21 CFR 10.115)). Consistent with FDA's good guidance practices regulation, the agency will accept comment, but is implementing the guidance document immediately in accordance with § 10.115(g)(2) because the agency has determined that prior public participation is not feasible or appropriate in light of the need to respond expeditiously to the recent cases of botulism linked to refrigerated carrot juice. This guidance represents the agency's current thinking on important practices for ensuring the safety of refrigerated carrot juice and other low-acid refrigerated juices subject to the juice HACCP regulation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT ). II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this guidance at any time. 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. The guidance and 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 guidance document at *http://www.cfsan.fda.gov/guidance.html* . Dated: May 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10792 Filed 6-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0213] Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Receipt Date; 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 “Providing Regulatory Submissions in Electronic Format—Receipt Date.” This draft guidance provides information on what FDA will consider to be the receipt date for certain submissions provided in electronic format to the Center for Drug Evaluation and Research

(CDER)and the Center for Biologics Evaluation and Research (CBER). The receipt date of these submissions has a number of important regulatory implications. Under the draft guidance, FDA will not consider a submission to be received until it has passed a technical validation check to ensure that the submission can be opened, processed, and archived. 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 August 6, 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, or the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Submit written comments on the 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Gary Gensinger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1112, Silver Spring, MD 20993-0002, 301-796-0589; or Michael Fauntleroy, Center for Biologics Evaluation and Research (HFM-25), 11400 Rockville Pike,Rockville, MD 20852, 301-827-5132. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Receipt Date.” This draft guidance provides information on what FDA will consider to be the receipt date for submissions provided in electronic format to CDER and CBER. When FDA receives a submission, the receipt date is used to determine important regulatory milestones (e.g., 30-day safety review cycle for an investigational new drug application, review performance goal date for a new drug application or biologics license application). Occasionally, however, submissions in electronic format have technical deficiencies that prevent FDA from being able to open, process, and archive them. When this occurs, FDA's review cannot begin until these technical deficiencies are corrected. To encourage sponsors to ensure that electronic submissions are free of technical deficiencies that can delay FDA review of the submission, FDA is changing its policy on the receipt date for submissions provided in an electronic format. The guidance provides that FDA will not consider a submission to be received until it has passed a technical validation check to ensure that the submission can be opened, processed, and archived. 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 determining the receipt date for submissions in electronic format. 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 either *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: May 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10780 Filed 6-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Scholarships for Disadvantaged Students Program—(OMB No. 0915-0149)—Reinstatement The Scholarships for Disadvantaged Students

(SDS)Program has as its purpose the provision of funds to eligible schools to provide scholarships to full-time, financially needy students from disadvantaged backgrounds enrolled in health professions and nursing programs. To qualify for participation in the SDS program, a school must be carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including students who are members of racial and ethnic minority groups (section 737(d)(1)(B) of the Public Health Service Act). A school must meet the eligibility criteria to demonstrate that the program has achieved success based on the number and/or percentage of disadvantaged students who graduate from the school. In awarding SDS funds to eligible schools, funding priorities must be given to schools based on the proportion of graduating students going into primary care, the proportion of underrepresented minority students, and the proportion of graduates working in medically underserved communities (section 737(c) of the PHS Act). The estimated response burden is as follows: Form Number of respondents Responses per respondent Hours per response Total hour burden Application 500 1 20 10,000 Report 500 1 1 500 Total 500 10,500 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: May 24, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-10749 Filed 6-4-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS-2007-0027] Privacy Act; IDENT System of Records AGENCY: Privacy Office, Office of the Secretary, Department of Homeland Security. ACTION: Notice of updated Privacy Act system of records notice. SUMMARY: The Department of Homeland Security is republishing the Privacy Act system of records notice for the Automated Biometric Identification System in order

(1)to add a category of records that comprises unique personal identifiers that links individuals with their encounters, biometrics, records, and other data elements and

(DHS)is publishing a revision to an existing Privacy Act system of records known as Automated Biometric Identification System (IDENT). The notice for these systems of records was last published in the **Federal Register** on July 27, 2006 (71 FR 42651). DHS is republishing IDENT in order

(1)to add a category of records that comprises unique personal identifiers that links individuals with their encounters, biometrics, records, and other data elements and

(2)to add a new routine use consistent with Office of Management and Budget Memorandum M-07-16, Attachment 2 that permits DHS to be in the best position to respond in a timely and effective manner in the event of a data breach. This republished system of records notice will replace the previously published system of records notice for the Automated Biometric Identification System, **Federal Register** on July 27, 2006 (71 FR 42651). IDENT is the primary repository of biometric information held by DHS in connection with its several and varied missions and functions, including, but not limited to: The enforcement of civil and criminal laws (including the immigration and customs laws), including investigations, inquiries, and proceedings thereunder; and national security and intelligence activities. IDENT is a centralized and dynamic DHS-wide biometric database that also contains limited biographic and encounter history information needed to place the biometric information in proper context. The information is collected by, on behalf of, in support of, or in cooperation with DHS and its components and may contain personally identifiable information collected by other federal, state, local, tribal, foreign, and international agencies. As part of an effort to more accurately identify individuals and ensure that all encounters are appropriately linked, IDENT will generate, store, and retrieve data by unique numbers or sequence of numbers and characters. This SORN update adds a category of records to IDENT to include these unique numbers or sequence of numbers and characters, also known as enumerators that link individuals with their encounters, biometrics, records, and other data elements. Additionally, this SORN adds a new routine consistent with Office of Management and Budget Memorandum M-07-16, Attachment 2 that permits DHS to be in the best position to respond in a timely and effective manner in the event of a data breach. In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system change to the Office of Management and Budget and to Congress. DHS/US-VISIT-001 System name: DHS Automated Biometric Identification System (IDENT). System location: US-VISIT, Department of Homeland Security (DHS), Washington, DC 20528. Categories of individuals covered by the system: Categories of individuals covered by this notice consist of: A. Individuals whose biometrics are collected by, on behalf of, in support of, or in cooperation with DHS concerning operations that implement and/or enforce laws, regulations, treaties, or orders related to the mission of DHS. B. Individuals whose biometrics are collected by, on behalf of, in support of, or in cooperation with DHS as part of a background check or security screening in connection with their hiring, retention, performance of a job function, or the issuance of a license or credential. C. Individuals whose biometrics are collected by federal, state, local, tribal, foreign, or international agencies for national security, law enforcement, immigration, intelligence, or other DHS mission-related functions, and who are the subjects of wants, warrants, or lookouts or any other subject of interest. Categories of records in the system: IDENT contains biometric, biographic, unique machine-generated identifiers, and encounter-related data for operation/production, testing, and training environments. Biometric data includes, but is not limited to, fingerprints and photographs. Biographical data includes, but is not limited to, name, date of birth, nationality, and other personal descriptive data. The encounter data provides the context of the interaction with an individual including, but not limited to, location, document numbers, and reason fingerprinted. Unique machine-generated identifiers are identifiers that link individuals with their encounters, biometrics, records, and other data elements. Test data may be real or simulated biometric, biographic, encounter, or identifiers related data. Authority for maintenance of the system: 6 U.S.C. 202, 8 U.S.C. 1103, 1158, 1201, 1225, 1324, 1357, 1360, 1365a, 1365b, 1379, and 1732; 19 U.S.C. 1589a. Purpose(s): This system of records is established and maintained to provide a DHS-wide repository of biometrics captures in DHS or law enforcement encounters. This will enable DHS to carry out its DHS national security, law enforcement, immigration, intelligence, and other mission-related functions, and to provide associated testing, training, management reporting, planning and analysis, and other administrative uses, by allowing DHS to positively identify an individual whether the name information is the same or different based on biometrics. Routine uses of records maintained in the system, including categories of users and the purposes of such uses: In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3), as follows: A. To appropriate federal, state, local, tribal, foreign, or international agencies seeking information on the subjects of wants, warrants, or lookouts, or any other subject of interest, for purpose related to administering or enforcing the law, national security, immigration, or intelligence, where consistent with a DHS mission-related function as determined by DHS. B. To appropriate federal, state, local tribal, foreign, or international government agencies charged with national security, law enforcement, immigration, intelligence, or other DHS mission-related functions in connection with the hiring or retention by such an agency of an employee, the issuance of a security clearance, the reporting of an investigation of that employee (but only if the System of Records in which the investigatory files are maintained allows such disclosure), the letting of a contract, or the issuance of a license, grant, loan, or other benefit by the requesting agency. C. To an actual or potential party or to his or her attorney for the purpose of negotiation or discussion on such matters as settlement of the case or matter, or discovery proceedings. D. To a Congressional office from the record of an individual in response to an inquiry from that Congressional office made at the request of the individual to whom the record pertains. E. To the National Archives and Records Administration or other Federal government agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. Sections 2904 and 2906. F. To individual who are obligors or representatives of obligors of bonds posted. G. To contractors, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for the Federal Government, when necessary to accomplish a DHS mission function related to this system of records. Such recipients are required to comply with the Privacy Act, 5 U.S.C. 552a, as amended. H. To the Department of Justice

(DOJ)or other Federal agency for purposes of conducting litigation or proceedings before any court, adjudicative, or administrative body when

(1)DHS; or

(2)Any employee of DHS in his/her official capacity; or

(3)Any employee of DHS in his/her individual capacity, where DOJ or DHS has agreed to represent the employee; or

(4)The United States or any agency thereof is a party to the litigation or proceeding, or has an interest in such litigation or proceeding. I. To appropriate agencies, entities, and persons when

(1)it is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised;

(2)DHS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or ham to the security or integrity of this system or other systems or programs (whether maintained by DHS or another agency or entity) that rely upon the compromised information; and

(3)the disclosure is made to such agencies, entities, and persons when reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage: Information can be stored in case file folders, cabinets, safes, or a variety of electronic or computer databases and storage media. Retrievability: Records may be retrieved by biometrics or select personal identifiers, including but not limited to names, identification numbers, date of birth, nationality, document number, and address. Safeguards: The system is protected through multi-layer security mechanisms. The protective strategies are physical, technical, administrative, and environmental in nature, and provide access to control to sensitive data, physical access control to DHS facilities, confidentiality of communications, authentication of sending parties, and personnel screening to ensure that all personnel with access to data are screened through background investigations commensurate with the level of access required to perform their duties. Retention and disposal: The following proposal for retention and disposal is pending approval with National Archives and Records Administration (NARA): Records that are stored in an individual's file will be purged according to the retention and disposition guidelines that relate to the individual's file in DHS/US-VISIT-001, IDENT. Testing and training data will be purged when the data is no longer required (GRS 20). Electronic records for which the statute of limitations has expired for all criminal violations or that are older than 75 years will be purged. Fingerprint cards, created for the purpose of entering records in the database, will be destroyed after data entry. Work Measurement Reports and Statistical Reports will be maintained within the guidelines set forth in NCI-95-78-5/2 and NCI-85-78-1/2 respectively. System manager(s) and address: System Manager, IDENT Program Management Office, US-VISIT Program, U.S. Department of Homeland Security, Washington, DC 20528, USA. Notification procedure: To determine whether this system contains records relating to you, write to the US-VISIT Privacy Officer, US-VISIT Program, U.S. Department of Homeland Security, 245 Murray Lane, SW., Washington, DC 20528, USA. Record access procedures: The major part of this system is exempted from this requirement pursuant to 5 U.S.C. 552a(j)(2) and (k)(2). A determination as to the granting or denial of access shall be made at the time a request is received. Requests for access to records in this system must be in writing, and should be addressed to the US-VISIT Privacy Officer at the address in the Notification procedure section above. Such request may be submitted either by mail or in person. The envelope and letter shall be clearly marked “Privacy Officer—Access/Redress Request.” To identify a record, the record subject should provide his or her full name, date and place of birth; if appropriate, the date and place of entry into or departure from the United States; verification of identity by submitting a copy of fingerprints if appropriate (in accordance with 8 CFR 103.21(b) and/or pursuant to 28 U.S.C. 1746, make a dated statement under penalty of perjury as a substitute for notarization), and any other identifying information that may be of assistance in locating the record. The requestor shall also provide a return address for transmitting the records to be released. Contesting record procedures: The major part of this system is exempted from this requirement pursuant to U.S.C. 552a(j)(2) and (k)(2). A determination as to the granting or denial of a request shall be made at the time a request is received. An individual requesting amendment of records maintained in this system should direct his or her request to the System Manager noted above. The request should state clearly what information is being contested, the reasons for contesting it, and the proposed amendment to the information. Record source categories: Basic information contained in this system is supplied by individuals covered by this system, and from Federal, State, local, tribal, or foreign governments; private citizens; and public and private organizations. Exemptions claimed for the system: The Secretary of Homeland Security has exempted this system from 5 U.S.C. 552a(c)(3) and (4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(5) and (e)(8); (f)(2) through (5); and

(g)pursuant to 5 U.S.C. 552a(j)(2). In addition, the Secretary of Homeland Security has exempted portions of this system from 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), and (e)(4)(H) pursuant to 5 U.S.C. 552a(k)(2). These exemptions apply only to the extent that records in the system are subject to exemption pursuant to 5 U.S.C. 552a(j)(2) and (k)(2). Dated: May 25, 2007. Hugo Teufel III, Chief Privacy Officer. [FR Doc. 07-2781 Filed 5-31-07; 1:24 pm]

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