Notices. Notice of quarterly meeting

6,498 words·~30 min read·/register/2007/10/19/07-5158·

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

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention The Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR): Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), CDC and NCEH/ATSDR announce the following committee meeting: *Times and Dates:* 8:30 a.m.-3:15 p.m., November 15, 2007. 8:30 a.m.-11:15 a.m., November 16, 2007. *Place:* CDC, 4770 Buford Highway, Chamblee, Georgia 30341. *Status:* Open to the public, limited only by the space available.

The meeting room accommodates approximately 75 people. *Purpose:* The Secretary, Department of Health and Human Services

(HHS)and by delegation, the Director, CDC, and Administrator, NCEH/ATSDR, are authorized under Section 301(42 U.S.C. 241) and Section 311 (42 U.S.C. 243) of the Public Health Service Act, as amended, to:

(1)Conduct, encourage, cooperate with, and assist other appropriate public authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and other impairments;

(2)assist states and their political subdivisions in the prevention of infectious diseases and other preventable conditions and in the promotion of health and well being; and

(3)train state and local personnel in health work. The BSC, NCEH/ATSDR provides advice and guidance to the Secretary, HHS; the Director, CDC, and Administrator, ATSDR; and the Director, NCEH/ATSDR, regarding program goals, objectives, strategies, and priorities in fulfillment of the agency's mission to protect and promote people's health. The board provides advice and guidance that will assist NCEH/ATSDR in ensuring scientific quality, timeliness, utility, and dissemination of results. The board also provides guidance to help NCEH/ATSDR work more efficiently and effectively with its various constituents and to fulfill its mission in protecting America's health. *Matters To Be Discussed:* An update on NCEH/ATSDR's Office of the Director, update on CDC Goals and Goal Action Plans, presentation on Formaldehyde and temporary housing units, presentation on NCEH and Top Off IV Exercise, update on ATSDR Response to BSC Program Peer Review: ATSDR Site-Specific Activities, presentation on Pandemic Flu and NCEH Laboratory Science, discussion on developing a national plan for chemical safety, and discussion on the BSC organizational and operational structure: subcommittees and/or workgroups. Agenda items are tentative and subject to change. The deadline for notification of attendance is November 5, 2007. *Contact Person for More Information:* Sandra Malcom, Committee Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E-28, Atlanta, Georgia 30303. Telephone

(770)488-4461, Fax

(404)498-0622, E-mail: *smalcom@cdc.gov.* 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 Substance and Disease Registry. Dated: October 11, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. E7-20629 Filed 10-18-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-102, 105 and CMS-10238] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Clinical Laboratory Improvement Amendment

(CLIA)Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001; *Use:* Information collected will be used by CMS in determining the amount of Federal Reimbursement for compliance surveys. Use of the information includes program evaluation, audit, budget formulation and budget approval; *Form Number:* CMS-102, 105 (OMB#: 0938-0599); *Frequency:* Reporting: Quarterly; *Affected Public:* State, Local or Tribal Governments; *Number of Respondents:* 50; *Total Annual Responses:* 550; *Total Annual Hours:* 4,500. 2. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Testing of Revised OASIS Instrument for Home Health Quality Measures & Data Analysis; *Use:* Medicare-certified home health agencies

(HHAs)must meet the Conditions of Participation

(COPs)as set forth at 42 CFR Part 484 and 488. Since 1999, the COPs have mandated that HHAs use the “Outcome and Assessment Information Set” (OASIS) data set when evaluating adult, non-maternity patients receiving skilled services. The OASIS is a patient-specific, comprehensive assessment that identifies each patient's need for home care and that meets the patient's medical, nursing, rehabilitative, social and discharge planning needs. Since OASIS data collection was mandated in 1999, CMS has been systematically collecting input on ways to improve the OASIS instrument and reduce the burden of the collection effort. In 2002, CMS introduced the “reduced-burden” OASIS that was a product of the Secretary's Regulatory Reform Advisory Committee to help guide HHS' broader efforts to streamline unnecessarily burdensome or inefficient regulations that interfere with the quality of health care. Since the 2002 revision, CMS has continued to solicit input on potential refinements and enhancements of the OASIS instrument from HHAs, industry associations, consumer representatives, researchers and other stakeholders. Abt Associates and their subcontractor UCHSC were awarded a contract by CMS in September 2006 to continue the process of refining the OASIS data set, as well as for the testing of the instrument and analysis of the impact of proposed changes. Under this contract, researchers from Abt Associates, University of Colorado Health Sciences Center (UCHSC), and Case Western Reserve University have assisted CMS in carrying out the revisions based on the input described in the previous section. Changes to the OASIS instrument include the following removal and revision of items: • Elimination of 7 original OASIS items not required for payment, quality or risk adjustment; • Replacement of 44 original OASIS items with items that are revised and/or simplified to respond to industry concerns by increasing clarity and user-friendliness, and/or reducing complexity and burden (e.g., removal of “prior status” assessment for all Activity of Daily Living

(ADL)and Instrumental Activity of Daily Living

(IADL)items). The revised OASIS also includes the addition of the following process items to support evidence-based practices: • A total of 7 process items to be collected only at Start of Care/Resumption of Care, 4 of which are to be asked seasonally (e.g.; flu vaccine); • A total of 10 process items to be collected only at Follow-up, Transfer or Discharge, either seasonally or on a small subpopulation; • A total of 13 process items to be collected at all OASIS time points, 6 of which are to be collected on a small subpopulation. We estimate the elimination, simplification and revision of existing OASIS items will have a burden impact equivalent to the complete elimination of 19 items. Since many of the process items will be collected only on small subpopulations or during specific months of the year, we estimate the impact of the addition of these items on burden to be equivalent to the addition of 20 items. Therefore, total impact of proposed OASIS revisions, including the elimination, revision and addition of items, changes the estimated burden of the OASIS very little while incorporating process measures needed to support evidence-based practices across the post-acute care spectrum. As a result of comments received during the 60-day comment period from the notice that published July 27, 2007 (72 FR 41328), we revised the information collection. The revisions include clarified language, corrected time point guidance, improved alignment with items in the CARE tool, improved skip patterns that allow clinicians to bypass questions not relevant to patients, and the addition of response options that allow clinicians to document patient improvement. It is the opinion of CMS that these revisions have resulted in an improved tool that addresses many of the concerns expressed by commenters, with no increase in burden. *Form Number:* CMS-10238 (OMB#: 0938-NEW); *Frequency:* Reporting: One-time; *Affected Public:* Private Sector—Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 11; *Total Annual Responses:* 11; *Total Annual Hours:* 173.58. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov,* or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on *November 19, 2007.* OMB Human Resources and Housing Branch, Attention: Katherine Astrich, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: October 11, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-20649 Filed 10-18-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families President's Committee for People With Intellectual Disabilities; Notice of Meeting AGENCY: President's Committee for People With Intellectual Disabilities (PCPID). ACTION: Notice of quarterly meeting. DATES: Thursday, November 15, 2007, from 2 p.m.-4 p.m. EST. The meeting will be conducted via conference call and will be open to the public using the dial-in information provided below. ADDRESSES: The conference call may be accessed on the date and time indicated by dialing 888-989-6481, passcode: PCPID. *Agenda:* PCPID will meet to formulate an action plan and timeline for completion of the 2008 Report to the President. FOR FURTHER INFORMATION CONTACT: Sally D. Atwater, Executive Director, President's Committee for People With Intellectual Disabilities, The Aerospace Center, Second Floor, West, 370 L'Enfant Promenade, SW., Washington, DC 20447. Telephone: 202-619-0634, fax: 202-205-9591. E-mail: *satwater@acf.hhs.gov.* SUPPLEMENTARY INFORMATION: PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and supports for persons with intellectual disabilities. PCPID, by Executive Order, is responsible for evaluating the adequacy of current practices in programs, services and supports for persons with intellectual disabilities, and for reviewing legislative proposals that impact the quality of life experienced by citizens with intellectual disabilities and their families. Dated: October 3, 2007. Sally D. Atwater, Executive Director, President's Committee for People With Intellectual Disabilities. [FR Doc. E7-20617 Filed 10-18-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0079] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables” 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 March 13, 2007 (72 FR 11364), 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 0910-0609. The approval expires on October 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: October 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-20632 Filed 10-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0182] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0459. Also include the FDA docket number found in brackets in the heading of this document. 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 compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank—(OMB Control Number 0910-0459)—Extension In the **Federal Register** of March 18, 2002 (67 FR 12022), FDA issued a guidance to industry on recommendations for investigational new drug application

(IND)sponsors on submitting information about clinical trials for serious or life-threatening diseases to a Clinical Trials Data Bank developed by the National Library of Medicine (NLM), National Institutes of Health (NIH). This information is especially important for patients and their families seeking opportunities to participate in clinical trials of new drug treatments for serious or life-threatening diseases. The guidance describes three collections of information: Mandatory submissions, voluntary submissions, and certifications. *Mandatory Submissions* Section 113 of the Food and Drug Administration Modernization Act (FDAMA) of 1997 (the Modernization Act) (Public Law 105-115) requires that sponsors shall submit information to the Clinical Trials Data Bank when the clinical trial:

(1)Involves a treatment for a serious or life-threatening disease and

(2)is intended to assess the effectiveness of the treatment. The guidance discusses how sponsors can fulfill the requirements of section 113 of the Modernization Act. Specifically, sponsors should provide:

(1)Information about clinical trials, both federally and privately funded, of experimental treatments (drugs, including biological products) for patients with serious or life-threatening diseases;

(2)a description of the purpose of the experimental drug;

(3)patient eligibility criteria;

(4)the location of clinical trial sites; and

(5)a point of contact for patients wanting to enroll in the trial. Senate 1789, “Best Pharmaceuticals for Children Act” (Public Law 107-109) (BPCA), established a new requirement for the Clinical Trials Data Bank mandated by section 113 of FDAMA. Information submitted to the data bank must now include “a description of whether and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children.” The guidance was updated on January 27, 2004, to include a discussion of how sponsors can fulfill the BPCA requirements. As part of the resubmission process for OMB approval, this information collection request

(ICR)has been revised to include the burden associated with new requirements imposed by the Centers for Medicare and Medicaid Services (CMS). On September 19, 2000, the Health Care Financing Administration (now CMS) implemented a Clinical Trial Policy through the National Coverage Determination process. The Clinical Trial Policy was developed in response to a June 7, 2000, executive memorandum, issued by President Clinton, requiring Medicare to pay for routine patient costs in clinical trials. The original policy suggested that a registry be established into which studies meeting the criteria for coverage under the policy would be enrolled for administrative purposes. This registry was never established. On July 10, 2006, CMS opened a reconsideration of its national coverage determination on clinical trials. The purpose of the reconsideration is to further refine the policy to rename it the Clinical Research Policy

(CRP)to address several ambiguities, including the link between the CRP and the Coverage with Evidence Development concept, and the authority to allow the agency to pay for the costs of limited investigational items. One requirement to qualify for coverage of clinical costs under the proposed policy is that the study must be enrolled in the NLM Clinical Trials Data Bank. *Voluntary Submissions* Section 113 of the Modernization Act also specifies that sponsors may voluntarily submit information pertaining to results of clinical trials, including information on potential toxicities or adverse effects associated with the use or administration of the investigational treatment. Sponsors may also voluntarily submit studies that are not trials to test effectiveness, or not for serious or life-threatening diseases, to the Clinical Trials Data Bank. *Certifications* Section 113 of the Modernization Act specifies that the data bank will not include information relating to a trial if the sponsor certifies to the Secretary of Health and Human Services (the Secretary) that disclosure of the information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary makes a determination to the contrary. *Description of Respondents* : A sponsor of a drug or biologic product regulated by the agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act (42 U.S.C. 262) who submits a clinical trial to test effectiveness of a drug or biologic product for a serious or life-threatening disease. For the purposes of CMS, the respondents will be providers that are conducting or sponsoring clinical trials that are seeking to have the clinical costs of their studies reimbursed by Medicare. *Burden Estimate* : The information required under section 113(a) of the Modernization Act is currently submitted to FDA under 21 CFR part 312, and this collection of information is approved under OMB Control Number 0910-0014 until May 31, 2009, and, therefore, does not represent a new information collection requirement. Instead, preparation of submissions under section 113 of the Modernization Act involves extracting and reformatting information already submitted to FDA. Procedures (where and how) for the actual submission of this information to the Clinical Trials Data Bank are addressed in the guidance. The Center for Drug Evaluation and Research

(CDER)received 4,858 new protocols in 2005. CDER anticipates that protocol submission rates will remain at or near this level in the near future. Of these new protocols, an estimated two-thirds 1 are for serious or life-threatening diseases and would be subject to either voluntary or mandatory reporting requirements under section 113 of the Modernization Act. Two-thirds of 4,858 protocols per year is 3,239 new protocols per year. An estimated 50 percent 1 of the new protocols for serious or life-threatening diseases submitted to CDER are for clinical trials involving assessment for effectiveness, and are subject to the mandatory reporting requirements under section 113 of the Modernization Act. Fifty percent of 3,239 protocols per year is 1,620 new protocols per year subject to mandatory reporting. The remaining 3,238 new protocols per year are subject to voluntary reporting. 1 Estimate obtained from a review of 2,062 protocols submitted to CDER between January 1, 2002, and September 30, 2002. The Center for Biologics Evaluation and Research

(CBER)received 474 new protocols in 2005. CBER anticipates that protocol submission rates will remain at or near this level in the near future. An estimated two-thirds 1 of the new protocols submitted to CBER are for clinical trials involving a serious or life-threatening disease, and would be subject to either voluntary or mandatory reporting requirements under section 113 of the Modernization Act. Two-thirds of 474 new protocols per year is 316 new protocols per year. An estimated 50 percent 1 of the new protocols for serious or life-threatening diseases submitted to CBER are for clinical trials involving assessments for effectiveness. Fifty percent of 316 protocols per year is an estimated 158 new protocols per year subject to the mandatory reporting requirements under section 113 of the Modernization Act. The remaining 316 new protocols per year are subject to voluntary reporting. The estimated total number of new protocols for serious or life-threatening diseases subject to mandatory reporting requirements under section 113 of the Modernization Act is 1,620 for CDER plus 158 for CBER, or 1,778 new protocols per year. The remainder of protocols submitted to CDER or CBER will be subject to voluntary reporting, including clinical trials not involving a serious or life-threatening disease as well as trials in a serious or life-threatening disease but not involving assessment of effectiveness. Therefore, the total number of protocols (5,332) minus the protocols subject to mandatory reporting requirements (1,778) will be subject to voluntary reporting, or 3,554 protocols. Our total burden estimate includes multi-center studies and accounts for the quality control review of the data before it is submitted to the data bank. The number of IND amendments submitted in 2005 for protocol changes (e.g., changes in eligibility criteria) was 7,597 for CDER and 855 for CBER. The number of IND amendments submitted in 2005 for new investigators was 11,287 for CDER and 532 for CBER. The number of protocol changes and new investigators was apportioned proportionally between mandatory and voluntary submissions. We recognize that single submissions may include information about multiple sites. Generally, there is no submission to FDA when an individual study site is no longer recruiting study subjects. For this analysis, we assumed that the number of study sites closed each year is similar to the number of new investigator amendments received by FDA (11,287 CDER and 532 CBER). Generally, there is no submission to FDA when the study is closed to enrollment. We estimate the number of protocols closed to enrollment each year is similar to the number of new protocols submitted (4,858 CDER and 474 CBER). The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted under section 113(a) of the Modernization Act, including the time it takes to extract and reformat the information. FDA has been advised that some sponsors lack information system capabilities enabling efficient collection of company-wide information on clinical trials subject to reporting requirements under section 113(a) of the Modernization Act. The estimation of burden under section 113(a) reflects the relative inefficiency of this process for these firms. Based on its experience reviewing INDs, consideration of the information in the previous paragraphs, and further consultation with sponsors who submit protocol information to the Clinical Trials Data Bank, FDA estimated that approximately 4.6 hours on average would be needed per response. The estimate incorporates 2.6 hours for data extraction and 2.0 hours for reformatting based on data collected from organizations currently submitting protocols to the Clinical Trials Data Bank. We considered quality control issues when developing the current burden estimates of 2.6 hours for data extraction and the 2.0 hours estimated for reformatting. Additionally, the Internet-based data entry system developed by NIH incorporates features that further decrease the sponsor's time requirements for quality control procedures. The Clinical Trials Data Bank was set up to receive protocol information transmitted electronically by sponsors. Approximately 10 percent of sponsors electronically transmit information to the Clinical Trials Data Bank. If the sponsor chooses to manually enter the protocol information, the data entry system allows it to be entered in a uniform and efficient manner primarily through pulldown menus. As sponsors' familiarity with the data entry system increases, the hourly burden will continue to decrease. A sponsor of a study subject to the requirements of section 113 of the Modernization Act will have the option of submitting data under that section or certifying to the Secretary that disclosure of information for a specific protocol would substantially interfere with the timely enrollment of subjects in the clinical investigation. FDA has no means to accurately predict the proportion of protocols subject to the requirements of section 113 of the Modernization Act that will be subject to a certification submission. To date, no certifications have been received. It is anticipated that the burden associated with such certification will be comparable to that associated with submission of data regarding a protocol. Therefore, the overall burden is anticipated to be the same, regardless of whether the sponsor chooses data submission or certification for nonsubmission. Table 1 of this document reflects the estimate of this total burden. In the **Federal Register** of May 14, 2007 (72 FR 27140), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 New Protocols Recruitment Complete Protocol Changes New Investigators Sites Closed Total Responses Hours Per Response Total Hours CDER (mandatory) 1,620 1,620 2,507 3,725 13,197 4.6 60,706 CBER (mandatory) 158 158 282 176 950 4.6 4,370 CDER (voluntary) 3,238 3,238 5,090 7,562 26,690 4.6 122,774 CDER (voluntary) 316 316 573 356 1,917 4.6 8,818 Total 196,668 1 There are no capital costs or operating and maintenance costs associated with this collection of information. *CMS Burden Estimate:* The burden associated with CMS' requirements is the time and effort necessary for the provider to extract the data elements from the study protocol and reformatting and entering the information into the data bank. We estimate that approximately 745 clinical research studies will register on the NLM data bank. The number was derived from a search of the database on September 1, 2006, restricting the search by age (e.g., > 65 years of age); sponsor (e.g., NIH, industry, other federal agency, university/organization); Phase II, III, or IV; and by type of study (e.g., cancers and other neoplasms, diagnosis, and devices). The age, sponsor, and study phase was applied to each of the three separate searches by type of study. The following number of studies by study type, including trials no longer recruiting was 562 for diagnosis, 164 for cancers and other neoplasms, and 19 for devices. In determining the total number of hours requested, the CMS estimate uses the same assumptions used by FDA to estimate its total number of burden hours. Therefore, the total annual burden associated with this requirement is 27,480 hours (5,974 responses x 4.6 hours per response). We believe the combined estimate of burden attributable to FDA and CMS requirements, 224,148 burden hours (196,668 burden hours + 27,480 burden hours) accurately reflects the total burden associated with this information collection request. We recognize that companies who are less familiar with the data entry system and the Clinical Trials Data Bank will require greater than 4.6 hours per response. However, as sponsor familiarity with the system increases, the hourly estimate will decrease. Dated: October 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-20662 Filed 10-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0327] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System; 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: Remote Medication Management System.” This guidance document describes a means by which remote medication management systems 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 remote medication management systems into class II (special controls). This guidance document is being immediately implemented as the special control for remote medication management systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). DATES: Submit written or electronic comments on the guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Class II Special Controls Guidance Document: Remote Medication Management System” 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 either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Richard Chapman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-2585. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule classifying remote medication management systems 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 the special control for remote medication management systems. 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 time frames 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 good guidance practices regulation (§ 10.115). The guidance represents the agency's current thinking on remote medication management systems. 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 To receive “Class II Special Controls Guidance Document: Remote Medication Management System,” 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 1621 to identify the guidance you are requesting. Persons interested in obtaining a copy of the guidance may do so by using the Internet. 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. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (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; 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 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: October 3, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-20635 Filed 10-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0365] Draft Guidance for Industry on the Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice; 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 “The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP).” The draft guidance is intended to aid drug manufacturers and ancillary testing laboratories in using mechanical calibration as an alternate approach to the use of calibrator tablets in calibrating an apparatus used for dissolution testing. The guidance provides references to information on critical tolerances that should be achieved with mechanical calibration. 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 January 17, 2008. 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. Submit electronic comments to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Albinus D'Sa, Center for Drug Evaluation and Research (HFD-320), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301-827-9044. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP).” FDA regulations require that laboratory apparatus be calibrated at suitable intervals in accordance with established written specifications (21 CFR 211.160(b)(4)). Historically, both chemical and mechanical means have been used in calibrating dissolution apparatuses. Since 1978, chemical calibration has been the predominant method of calibration, consistent with chapter 711 of the U. S. Pharmacopeia (USP), which describes the use of calibrator tablets. Chemical calibration of an apparatus is usually performed, in addition to mechanical calibration, every 6 months. Because the use of USP chemical calibration tablets can lead to variability in the dissolution measurement system, FDA is providing guidance on mechanical calibration as an alternate approach to calibrating dissolution equipment. As stated in the draft guidance, instead of using an external calibrator tablet, a firm can use an appropriately rigorous method of mechanical calibration as an alternative to ensure ongoing acceptability of the dissolution apparatus. 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 use of mechanical calibration of dissolution apparatus 1 and 2 as related to CGMP. 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* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: October 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-20664 Filed 10-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Public Health Service; Notice of Listing of Members of the Substance Abuse and Mental Health Services Administration's Senior Executive Service Performance Review Board

(PRB)The Substance Abuse and Mental Health Services Administration (SAMHSA) announces the persons who will serve on the Substance Abuse and Mental Health Services Administration's Performance Review Board. This action is being taken in accordance with Title 5, U.S.C., Section 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals, and requires that notice of the appointment of an individual to serve as a member by published in the **Federal Register** . The following persons will serve on the SAMHSA Performance Review Board, which is responsible for making recommendations on performance appraisal ratings, pay adjustments, and performance awards for SAMHSA's Senior Executive Service

(SES)members: Eric Broderick, D.D.S.—Chairperson. Westley Clark, M.D., J.D., M.P.H. Randy Grinnell. Anna Marsh, Ph.D. Dennis Romero, M.A. For further information about the SAMHSA Performance Review Board, contact the Division of Management Systems, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 3-1017, Rockville, Maryland 20857, telephone

(240)276-1124 (not a toll-free number). Dated: October 15, 2007. Terry L. Cline, Administrator, SAMHSA. [FR Doc. 07-5158 Filed 10-18-07; 8:45 am]

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