Advisory Committees; Tentative Schedule of Meetings for 2007, 78443-78445 [E6-22389]

Download as PDF 78443 Federal Register / Vol. 71, No. 250 / Friday, December 29, 2006 / Notices Title of Information Collection: Medicaid Statistical Information System. Use: State data are reported by the Federally mandated electronic process, known as Medicaid Statistical Information System (MSIS). These data are the basis of actuarial forecasts for Medicaid service utilization and costs; of analysis and cost savings estimates required for legislative initiatives relating to Medicaid; and for responding to requests for information from CMS components, the Department, Congress and other customers. Form Number: CMS–R–284 (OMB#: 0938–0345). Frequency: Quarterly. Affected Public: State, Local or Tribal Government. Number of Respondents: 53. Total Annual Responses: 212. Total Annual Hours: 3,392. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email 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. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Katherine Astrich, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395–6974. 4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1220. Dated: December 21, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–22233 Filed 12–28–06; 8:45 am] The IOM, at the request of the Commissioner, undertook a study of the use of FDA’s advisory committees. In its final report in 1992, one of the IOM’s recommendations was for FDA to adopt a policy of publishing an advance yearly schedule of its upcoming public advisory committee meetings in the Federal Register; FDA has implemented this recommendation. The annual publication of tentatively scheduled advisory committee meetings will provide both advisory committee members and the public with the opportunity, in advance, to schedule attendance at FDA’s upcoming advisory committee meetings. Because the schedule is tentative amendments to this notice will not be published in the Federal Register. However, changes to the schedule will be posted on the FDA advisory committees’ Internet site located at https://www.fda.gov/oc/ advisory/default.htm. FDA will continue to publish a Federal Register notice 15 days in advance of each upcoming advisory committee meeting, to announce the meeting (21 CFR 14.20). The following list announces FDA’s tentatively scheduled advisory committee meetings for 2007. You may also obtain up-to-date information by calling the Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Tentative Schedule of Meetings for 2007 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2007. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA’s advisory committees. In its final report, one of the IOM’s recommendations was for the agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM’s recommendation. FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee Oversight and Management Staff (HF– SUPPLEMENTARY INFORMATION: TABLE 1. Committee Name Tentative Date(s) of Meeting(s) Advisory Committee 10–Digit Information Line Code OFFICE OF THE COMMISSIONER Pediatric Advisory Committee April day(s) to be announced. 8732310001 Science Board to the Food and Drug Administration June day(s) to be announced. 3014512603 Allergenic Products Advisory Committee April 18, October 19. 3014512388 Blood Products Advisory Committee April 26–27, August 16–17, December 13–14. 3014519516 Cellular Tissue and Gene Therapies Advisory Committee March 29–30, July 26–27, November 15–16. 3014512389 Transmissible Spongiform Encephalopathies Advisory Committee to be announced. 3014512392 Vaccines and Related Biological Advisory Committee February 27–28, May 16–17, September 19–20, November 14–15. 3014512391 March 29. 3014512529 pwalker on PROD1PC69 with NOTICES CENTER FOR BIOLOGICS EVALUATION AND RESEARCH CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic and Life Support Drugs Advisory Committee VerDate Aug<31>2005 18:15 Dec 28, 2006 Jkt 211001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1 78444 Federal Register / Vol. 71, No. 250 / Friday, December 29, 2006 / Notices TABLE 1.—Continued Committee Name Tentative Date(s) of Meeting(s) Advisory Committee 10–Digit Information Line Code Anti Infective Drugs Advisory Committee April 11–12. 3014512530 Antiviral Drugs Advisory Committee April, August day(s) to be announced. 3014512531 Arthritis Advisory Committee April 12. 3014512532 Cardiovascular and Renal Health Advisory Committee April 17–18, August 21–22, October 16–17, December 11–12. 3014512533 Dermatologic and Ophthalmic Drugs Advisory Committee To be announced. 3014512534 Drug Safety and Risk Management Advisory Committee To be announced. 3014512535 Endocrinologic and Metabolic Drugs Advisory Committee June 13–14, September 5–6, November 13–14. 3014512536 Gastrointestinal Drugs Advisory Committee To be announced. 3014512538 Nonprescription Drugs Advisory Committee March, April day (s) to be announced. 3014512541 Oncologic Drugs Advisory Committee March 28–29, June 1, September 11–12, December 4–5. 3014512542 Peripheral and Central Nervous System Drugs June 18–20, September 13–14. 3014512543 Pharmaceutical for Science, Advisory Committee for April, May day(s) to be announced. 3014512539 Psychopharmacologic Drugs Advisory Committee March, April, September, October day(s) to be announced. 3014512544 Pulmonary Allergy Drugs Advisory Committee May day(s) to be announced. 3014512545 Reproductive Health Drugs, Advisory Committee for January 23–24. 3014512537 Device Good Manufacturing Practice Advisory Committee July 18. 3014512398 Medical Devices Advisory Committee (Comprised of 18 Panels) Anesthesiology and Respiratory Therapy Devices Panel October 9–10. 3014512624 Circulatory System Devices Panel March 1–2, May 22–23, July 17–18, September 18–19, November 13–14. 3014512625 Clinical Chemistry and Clinical Toxicology Devices Panel June 12–13, September 13–14, December 4–5. 3014512514 Dental Products Panel February 14, June 6, August 29, November 7. 3014512518 Ear, Nose, and Throat Devices Panel April 24–25, June 14–15 August 14–15, October 18–19, December 11–12. 3014512522 Gastroenterology-Urology Devices Panel May 11, July 20, October 19. 3014512523 General and Plastic Surgery Devices Panel May 8–9, September 20–21, December 6–7. 3014512519 General Hospital and Personal Use Devices Panel April 3–4, September 26–27. 3014512520 Hematology and Pathology Devices Panel April 27, October 19. 3014512515 Immunology Devices Panel July 12, October 17. 3014512516 Medical Devices Dispute Resolution Panel Meeting Scheduled as Needed. 3014510232 Microbiology Devices Panel June 26–27, October 23–24. 3014512517 Molecular and Clinical Genetics Panel April 12, October 11. 3014510231 Neurological Devices Panel January 26, June 7–8, August 16–17, November 1–2. 3014512513 Obstetrics and Gynecology Devices Panel May 17–18, August 2–3, October 25–26, December 13–14. 3014512524 pwalker on PROD1PC69 with NOTICES CENTER FOR DEVICES AND RADIOLOGICAL HEALTH VerDate Aug<31>2005 18:15 Dec 28, 2006 Jkt 211001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1 Federal Register / Vol. 71, No. 250 / Friday, December 29, 2006 / Notices 78445 TABLE 1.—Continued Committee Name Tentative Date(s) of Meeting(s) Advisory Committee 10–Digit Information Line Code Ophthalmic Devices Panel May 24–25, July 12–13, October 2–3, November 29–30. 3014512396 Orthopaedic and Rehabilitation Devices Panel February 22–23, March 27–28, May 22–23, July 17–18 September 18–19. November 13–14 3014512521 Radiological Devices Panel May 15, August 21, November 13. 3014512526 National Mammography Quality Assurance Advisory Committee May 21–22. 3014512397 Technical Electronic Product Radiation Safety Standards Committee September 19. 3014512399 May 1–2, September 25–26. 3014510564 Veterinary Medicine Advisory Committee September 7. 3014512548 National Center for Toxicological Research (NCTR) September day(s) to be announced. 3014512559 CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Food Advisory Committee CENTER FOR VETERINARY MEDICINE Dated: December 22, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–22389 Filed 12–28–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Genetic Studies in a Cohort of U.S. Radiologic Technologists SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. pwalker on PROD1PC69 with NOTICES Proposed Collection Title: Genetic Studies in a Cohort of U.S. Radiologic Technologists (formerly known as ‘‘Generic Clearance to Collect Medical Outcome and Risk Factor Data from a Cohort of U.S. Radiologic Technologists’’). Type of Information Collection Request: Renewal with change of a previously approved collection (OMB No. 0925–0405, expiration 02/28/2007). VerDate Aug<31>2005 18:15 Dec 28, 2006 Jkt 211001 Need and Use of Information Collection: The primary aim of this collection is to substantially increase knowledge about the possible modifying role of genetic variation on the longterm health effects associated with protracted low-to moderate-dose radiation exposures. With this submission, the NIH, Office of Communications and Public Liaison, seeks to obtain OMB’s approval to collect biospecimens and risk factor data in this ongoing cohort study of U.S. radiologic technologists to assess genetic and molecular risk factors for cancer, and to evaluate possible modifying effects of genetic variation on radiation-cancer relationships. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 18,400 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. Overall study objectives are: (1) To quantify radiation dose-response for cancers of the breast, thyroid, and other radiogenic sites, and selected benign conditions related to cancer (e.g. thyroid nodules); (2) to assess cancer PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 risk associated with genotypic, phenotypic, or other biologically measurable factors (e.g. serum levels of C-reactive protein, insulin growth factors or binding proteins); and (3) to determine if genetic variation modifies the radiation-related cancer risk. A third follow-up of this cohort was completed during the past three years. During 2003–2005, the ‘‘Third Survey’’ questionnaire was mailed or administered by telephone to 101,694 living cohort members who had completed at least one prior survey; 73,838 technologists (73% response) completed the survey. The questionnaire elicited information on: Medical outcomes to assess radiationrelated risks; detailed employment data to refine the occupational radiation dose estimates; and behavioral and residential histories for estimating lifetime ultraviolet (UV) radiation exposure. Analyses of these data are currently underway and findings will address an important gap in the scientific understanding of radiation dose-rate effects, i.e., whether cumulative exposures of the same magnitude have the same health effects when received in a single or a few doses over a very short period of time (as in the atomic bomb or therapeutic exposures) or in many small doses over a protracted period of time (as in medical or nuclear occupational settings). There are few, if any, other study populations in which both quantified breast radiation doses and blood E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 71, Number 250 (Friday, December 29, 2006)]
[Notices]
[Pages 78443-78445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22389]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committees; Tentative Schedule of Meetings for 2007

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a 
tentative schedule of forthcoming meetings of its public advisory 
committees for 2007. During 1991, at the request of the Commissioner of 
Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) 
conducted a study of the use of FDA's advisory committees. In its final 
report, one of the IOM's recommendations was for the agency to publish 
an annual tentative schedule of its meetings in the Federal Register. 
This publication implements the IOM's recommendation.

FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee 
Oversight and Management Staff (HF-4), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-1220.

SUPPLEMENTARY INFORMATION: The IOM, at the request of the Commissioner, 
undertook a study of the use of FDA's advisory committees. In its final 
report in 1992, one of the IOM's recommendations was for FDA to adopt a 
policy of publishing an advance yearly schedule of its upcoming public 
advisory committee meetings in the Federal Register; FDA has 
implemented this recommendation. The annual publication of tentatively 
scheduled advisory committee meetings will provide both advisory 
committee members and the public with the opportunity, in advance, to 
schedule attendance at FDA's upcoming advisory committee meetings. 
Because the schedule is tentative amendments to this notice will not be 
published in the Federal Register. However, changes to the schedule 
will be posted on the FDA advisory committees' Internet site located at 
https://www.fda.gov/oc/advisory/default.htm. FDA will continue to 
publish a Federal Register notice 15 days in advance of each upcoming 
advisory committee meeting, to announce the meeting (21 CFR 14.20).
    The following list announces FDA's tentatively scheduled advisory 
committee meetings for 2007. You may also obtain up-to-date information 
by calling the Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC area).

                                Table 1.
------------------------------------------------------------------------
                                                     Advisory Committee
      Committee Name         Tentative Date(s) of   10-Digit Information
                                  Meeting(s)              Line Code
------------------------------------------------------------------------
OFFICE OF THE COMMISSIONER
------------------------------------------------------------------------
Pediatric Advisory          April day(s) to be                8732310001
 Committee                   announced.
------------------------------------------------------------------------
Science Board to the Food   June day(s) to be                 3014512603
 and Drug Administration     announced.
------------------------------------------------------------------------
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
------------------------------------------------------------------------
Allergenic Products         April 18, October 19.             3014512388
 Advisory Committee
------------------------------------------------------------------------
Blood Products Advisory     April 26-27, August 16-           3014519516
 Committee                   17, December 13-14.
------------------------------------------------------------------------
Cellular Tissue and Gene    March 29-30, July 26-             3014512389
 Therapies Advisory          27, November 15-16.
 Committee
------------------------------------------------------------------------
Transmissible Spongiform    Encephalopathies                  3014512392
                             Advisory Committee to
                             be announced.
------------------------------------------------------------------------
Vaccines and Related        February 27-28, May 16-           3014512391
 Biological Advisory         17, September 19-20,
 Committee                   November 14-15.
------------------------------------------------------------------------
CENTER FOR DRUG EVALUATION AND RESEARCH
------------------------------------------------------------------------
Anesthetic and Life         March 29.                         3014512529
 Support Drugs Advisory
 Committee
------------------------------------------------------------------------

[[Page 78444]]

 
Anti Infective Drugs        April 11-12.                      3014512530
 Advisory Committee
------------------------------------------------------------------------
Antiviral Drugs Advisory    April, August day(s)              3014512531
 Committee                   to be announced.
------------------------------------------------------------------------
Arthritis Advisory          April 12.                         3014512532
 Committee
------------------------------------------------------------------------
Cardiovascular and Renal    April 17-18, August 21-           3014512533
 Health Advisory Committee   22, October 16-17,
                             December 11-12.
------------------------------------------------------------------------
Dermatologic and            To be announced.                  3014512534
 Ophthalmic Drugs Advisory
 Committee
------------------------------------------------------------------------
Drug Safety and Risk        To be announced.                  3014512535
 Management Advisory
 Committee
------------------------------------------------------------------------
Endocrinologic and          June 13-14, September             3014512536
 Metabolic Drugs Advisory    5-6, November 13-14.
 Committee
------------------------------------------------------------------------
Gastrointestinal Drugs      To be announced.                  3014512538
 Advisory Committee
------------------------------------------------------------------------
Nonprescription Drugs       March, April day (s)              3014512541
 Advisory Committee          to be announced.
------------------------------------------------------------------------
Oncologic Drugs Advisory    March 28-29, June 1,              3014512542
 Committee                   September 11-12,
                             December 4-5.
------------------------------------------------------------------------
Peripheral and Central      June 18-20, September             3014512543
 Nervous System Drugs        13-14.
------------------------------------------------------------------------
Pharmaceutical for          April, May day(s) to              3014512539
 Science, Advisory           be announced.
 Committee for
------------------------------------------------------------------------
Psychopharmacologic Drugs   March, April,                     3014512544
 Advisory Committee          September, October
                             day(s) to be
                             announced.
------------------------------------------------------------------------
Pulmonary Allergy Drugs     May day(s) to be                  3014512545
 Advisory Committee          announced.
------------------------------------------------------------------------
Reproductive Health Drugs,  January 23-24.                    3014512537
 Advisory Committee for
------------------------------------------------------------------------
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
------------------------------------------------------------------------
Device Good Manufacturing   July 18.                          3014512398
 Practice Advisory
 Committee
------------------------------------------------------------------------
Medical Devices Advisory    October 9-10.                     3014512624
 Committee (Comprised of
 18 Panels) Anesthesiology
 and Respiratory Therapy
 Devices Panel
------------------------------------------------------------------------
Circulatory System Devices  March 1-2, May 22-23,             3014512625
 Panel                       July 17-18, September
                             18-19, November 13-
                             14.
------------------------------------------------------------------------
Clinical Chemistry and      June 12-13, September             3014512514
 Clinical Toxicology         13-14, December 4-5.
 Devices Panel
------------------------------------------------------------------------
Dental Products Panel       February 14, June 6,              3014512518
                             August 29, November
                             7.
------------------------------------------------------------------------
Ear, Nose, and Throat       April 24-25, June 14-             3014512522
 Devices Panel               15 August 14-15,
                             October 18-19,
                             December 11-12.
------------------------------------------------------------------------
Gastroenterology-Urology    May 11, July 20,                  3014512523
 Devices Panel               October 19.
------------------------------------------------------------------------
General and Plastic         May 8-9, September 20-            3014512519
 Surgery Devices Panel       21, December 6-7.
------------------------------------------------------------------------
General Hospital and        April 3-4, September              3014512520
 Personal Use Devices        26-27.
 Panel
------------------------------------------------------------------------
Hematology and Pathology    April 27, October 19.             3014512515
 Devices Panel
------------------------------------------------------------------------
Immunology Devices Panel    July 12, October 17.              3014512516
------------------------------------------------------------------------
Medical Devices Dispute     Meeting Scheduled as              3014510232
 Resolution Panel            Needed.
------------------------------------------------------------------------
Microbiology Devices Panel  June 26-27, October 23-           3014512517
                             24.
------------------------------------------------------------------------
Molecular and Clinical      April 12, October 11.             3014510231
 Genetics Panel
------------------------------------------------------------------------
Neurological Devices Panel  January 26, June 7-8,             3014512513
                             August 16-17,
                             November 1-2.
------------------------------------------------------------------------
Obstetrics and Gynecology   May 17-18, August 2-3,            3014512524
 Devices Panel               October 25-26,
                             December 13-14.
------------------------------------------------------------------------

[[Page 78445]]

 
Ophthalmic Devices Panel    May 24-25, July 12-13,            3014512396
                             October 2-3, November
                             29-30.
------------------------------------------------------------------------
Orthopaedic and             February 22-23, March             3014512521
 Rehabilitation Devices      27-28, May 22-23,
 Panel                       July 17-18 September
                             18-19. November 13-14
------------------------------------------------------------------------
Radiological Devices Panel  May 15, August 21,                3014512526
                             November 13.
------------------------------------------------------------------------
National Mammography        May 21-22.                        3014512397
 Quality Assurance
 Advisory Committee
------------------------------------------------------------------------
Technical Electronic        September 19.                     3014512399
 Product Radiation Safety
 Standards Committee
------------------------------------------------------------------------
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
------------------------------------------------------------------------
Food Advisory Committee     May 1-2, September 25-            3014510564
                             26.
------------------------------------------------------------------------
CENTER FOR VETERINARY MEDICINE
------------------------------------------------------------------------
Veterinary Medicine         September 7.                      3014512548
 Advisory Committee
------------------------------------------------------------------------
National Center for         September day(s) to be            3014512559
 Toxicological Research      announced.
 (NCTR)
------------------------------------------------------------------------
------------------------------------------------------------------------


    Dated: December 22, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-22389 Filed 12-28-06; 8:45 am]
BILLING CODE 4160-01-S
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