Advisory Committees; Tentative Schedule of Meetings for 2006, 76058-76060 [E5-7645]

Download as PDF 76058 Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices implementation for a risk control plan is 90 days, which is the minimum recommended time to achieve long-term behavior change. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR REGULATORS1 No. of Recordkeepers Types of Records Voluntary Food Safety Management System Evaluation (includes validation, verification, and completion of verification inspection checklist) Annual Frequency of Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 1 50,000 16 800,000 50,000 Total Annual Burden for Regulators 1 There 800,000 are no capital costs or operating and maintenance costs associated with this collection of information. It is difficult to predict the number of State, local, and tribal regulatory jurisdictions that will use the Regulator’s Manual. But FDA anticipates that retail and foodservice establishments which voluntarily develop and implement a food safety management system based on the Operator’s Manual will request their regulatory authorities to conduct an evaluation of their system. The estimates in table 2 of this document for the annual burden to State, local, and tribal regulators that follow the recommendations in the Regulator’s Manual were calculated based on the usual time needed for one person to evaluate a voluntarily-implemented food safety management system and record the findings. The number of times an inspector may be asked by an operator to evaluate a voluntarilyimplemented system is not expected to exceed once per year. Dated: December 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5–7644 Filed 12–21–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Tentative Schedule of Meetings for 2006 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 2006. 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, Committee Name undertook a study of the use of the 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 schedule advisory committee meeting for 2006. 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). Tentative Date(s) of Meetings Advisory Committee 10-Digit Information Line Code OFFICE OF THE COMMISSIONER Pediatric Advisory Committee March, June, and November day(s) to be announced. 8732310001 Science Board to the Food and Drug Administration April and November day(s) to be announced. 3014512603 Allergenic Products Advisory Committee March 31, September 13. 3014512388 Blood Products Advisory Committee March 9–10, July 13–14, October 26–27. 3014519516 Cellular, Tissue and Gene Therapies Advisory Committee February 9–10, July 13–14, November 2–3. 3014512389 Transmissible Spongiform Encephalopathies Advisory Committee To be announced. 3014512392 cchase on PROD1PC60 with NOTICES CENTER FOR BIOLOGICS EVALUATION AND RESEARCH VerDate Aug<31>2005 18:18 Dec 21, 2005 Jkt 208001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\22DEN1.SGM 22DEN1 Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices Committee Name Tentative Date(s) of Meetings Vaccines and Related Biological Products Advisory Committee 76059 Advisory Committee 10-Digit Information Line Code February 17, May 17–18, September 20–21, November 15–16. 3014512391 Anesthetic and Life Support Drugs Advisory Committee To be announced. 3014512529 Anti-Infective Drugs Advisory Committee To be announced. 3014512530 Antiviral Drugs Advisory Committee To be announced. 3014512531 Arthritis Advisory Committee To be announced. 3014512532 Cardiovascular and Renal Drugs Advisory Committee April 25–26, July 25–26, November 1–2. 3014512533 Dermatologic and Ophthalmic Drugs Advisory Committee To be announced. 3014512534 Drug Safety and Risk Management Advisory Committee February 9–10, May 4–5. 3014512535 Endocrinologic and Metabolic Drugs Advisory Committee January 23, May 3–4, August 23–24, November 8–9. 3014512536 Gastrointestinal Drugs Advisory Committee September and November day(s) to be announced. 3014512538 Nonprescription Drugs Advisory Committee January 23–24. 3014512541 Oncologic Drugs Advisory Committee March 14 (Pediatric Subcommittee), March 15, June 2, September 12–13, December 6–7. 3014512542 Peripheral and Central Nervous System Drugs Advisory Committee March 7–8. 3014512543 Pharmaceutical Science, Advisory Committee for April 13–14 (Clinical Pharmacology Subcommittee), October 18–19 (Clinical Pharmacology Subcommittee), April, May, and October day(s) to be announced. 3014512539 Psychopharmacologic Drugs Advisory Committee To be announced. 3014512544 Pulmonary-Allergy Drugs Advisory Committee January 24. 3014512545 Reproductive Health Drugs, Advisory Committee for May and June day(s) to be announced. 3014512537 No tentative meeting scheduled. 3014512398 Anesthesiology and Respiratory Therapy Devices Panel April 7, October 6. 3014512624 Circulatory System Devices Panel February 16, April 21, June 16, August 18, October 20. 3014512625 Clinical Chemistry and Clinical Toxicology Devices Panel February 22–23, May 24–25, September 7–8, December 6–7. 3014512514 Dental Products Panel February 28, July 25, October 24. 3014512518 Ear, Nose, and Throat Devices Panel February 1–2, April 3–4, June 15–16, August 10– 11, October 11–12, December 4–5. 3014512522 Gastroenterology-Urology Devices Panel March 3, May 5, July 21, October 20. 3014512523 General and Plastic Surgery Devices Panel April 27–28, August 24–25, December 4–5. 3014512519 General Hospital and Personal Use Devices Panel February 9–10, June 12–13, September 28–29. 3014512520 Hematology and Pathology Devices Panel April 28, October 20. 3014512515 CENTER FOR DRUG EVALUATION AND RESEARCH CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Device Good Manufacturing Practice Advisory Committee cchase on PROD1PC60 with NOTICES Medical Devices Advisory Committee (Comprised of 18 Panels) VerDate Aug<31>2005 16:55 Dec 21, 2005 Jkt 208001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\22DEN1.SGM 22DEN1 76060 Federal Register / Vol. 70, No. 245 / Thursday, December 22, 2005 / Notices Committee Name Tentative Date(s) of Meetings Advisory Committee 10-Digit Information Line Code Immunology Devices Panel July 14, November 8. 3014512516 Medical Devices Dispute Resolution Panel Meeting scheduled as needed. 3014510232 Microbiology Devices Panel February 23–24, September 21–22, October 26– 27. 3014512517 Molecular and Clinical Genetics Panel April 13–14, October 5–6. 3014510231 Neurological Devices Panel March 2–4, August 3–4, June 5–6, August 28–29, November 13–14. 3014512513 Obstetrics-Gynecology Devices Panel March 27–28, June 5–6, August 28–29, November 13–14. 3014512524 Ophthalmic Devices Panel March 7–8, May 18, July 13–14, September 19– 20, November 2–3. 3014512396 Orthopaedic and Rehabilitation Devices Panel February 2–3, July 27–28, October 26–27, December 11–12. 3014512521 Radiological Devices Panel February 7, May 23, September 12, November 7. 3014512526 National Mammography Quality Assurance Advisory Committee August 28. 3014512397 Technical Electronic Product Radiation Safety Standards Committee October 4. 3014512399 March 1, May 3, July 12, September 13. 3014510564 March 15, October 16. 3014512548 Science Advisory Board to NCTR April day(s) to be announced. 3014512559 Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hands) February day(s) to be announced. 3014512560 CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Food Advisory Committee CENTER FOR VETERINARY MEDICINE Veterinary Medicine Advisory Committee NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR) Dated: December 14, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E5–7645 Filed 12–21–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004P–0329] Hand-Held, Doppler Ultrasound Prenatal Listening Devices AGENCY: Food and Drug Administration, cchase on PROD1PC60 with NOTICES HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public workshop to discuss scientific information bearing VerDate Aug<31>2005 16:55 Dec 21, 2005 Jkt 208001 on whether hand-held Doppler ultrasound prenatal listening devices should be made available for use overthe-counter (OTC). This 1-day workshop is intended to provide members of the academic, scientific, and clinical communities; industry; consumer, and patient advocacy groups; and others with a forum for presenting their perspectives about available scientific literature and clinical studies relating to hand-held Doppler ultrasound prenatal listening devices. Written comments submitted to the docket before the workshop and information gathered at the workshop will be used by FDA to further identify and evaluate the risks and benefits associated with possible OTC availability of hand-held prenatal Doppler ultrasound listening devices. Date and Time: The public workshop will be held on Wednesday, March 29, 2006, from 9 a.m. to 3:30 p.m. The deadline for registration is Friday, PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 March 10, 2006. Requests to make presentations at the public workshop and written or electronic comments will be accepted until Friday, March 10, 2006. Addresses: The public workshop will be held at the Hilton Washington DC North, 620 Perry Pkwy., Gaithersburg, MD, 20877. Additional information about and directions to the facility are available on the Internet at https:// www.hilton.com/en/hi/hotels/ index.jhtml?ctyhocn=GAIGHHF. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. E:\FR\FM\22DEN1.SGM 22DEN1

Agencies

[Federal Register Volume 70, Number 245 (Thursday, December 22, 2005)]
[Notices]
[Pages 76058-76060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7645]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committees; Tentative Schedule of Meetings for 2006

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 2006. 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 the 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 schedule advisory 
committee meeting for 2006. 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).

------------------------------------------------------------------------
                                                     Advisory Committee
      Committee Name         Tentative Date(s) of   10-Digit Information
                                   Meetings               Line Code
------------------------------------------------------------------------
OFFICE OF THE COMMISSIONER
------------------------------------------------------------------------
Pediatric Advisory          March, June, and                  8732310001
 Committee                   November day(s) to be
                             announced.
------------------------------------------------------------------------
Science Board to the Food   April and November                3014512603
 and Drug Administration     day(s) to be
                             announced.
------------------------------------------------------------------------
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
------------------------------------------------------------------------
Allergenic Products         March 31, September               3014512388
 Advisory Committee          13.
------------------------------------------------------------------------
Blood Products Advisory     March 9-10, July 13-              3014519516
 Committee                   14, October 26-27.
------------------------------------------------------------------------
Cellular, Tissue and Gene   February 9-10, July 13-           3014512389
 Therapies Advisory          14, November 2-3.
 Committee
------------------------------------------------------------------------
Transmissible Spongiform    To be announced.                  3014512392
 Encephalopathies Advisory
 Committee
------------------------------------------------------------------------

[[Page 76059]]

 
Vaccines and Related        February 17, May 17-              3014512391
 Biological Products         18, September 20-21,
 Advisory Committee          November 15-16.
------------------------------------------------------------------------
CENTER FOR DRUG EVALUATION AND RESEARCH
------------------------------------------------------------------------
Anesthetic and Life         To be announced.                  3014512529
 Support Drugs Advisory
 Committee
------------------------------------------------------------------------
Anti-Infective Drugs        To be announced.                  3014512530
 Advisory Committee
------------------------------------------------------------------------
Antiviral Drugs Advisory    To be announced.                  3014512531
 Committee
------------------------------------------------------------------------
Arthritis Advisory          To be announced.                  3014512532
 Committee
------------------------------------------------------------------------
Cardiovascular and Renal    April 25-26, July 25-             3014512533
 Drugs Advisory Committee    26, November 1-2.
------------------------------------------------------------------------
Dermatologic and            To be announced.                  3014512534
 Ophthalmic Drugs Advisory
 Committee
------------------------------------------------------------------------
Drug Safety and Risk        February 9-10, May 4-             3014512535
 Management Advisory         5.
 Committee
------------------------------------------------------------------------
Endocrinologic and          January 23, May 3-4,              3014512536
 Metabolic Drugs Advisory    August 23-24,
 Committee                   November 8-9.
------------------------------------------------------------------------
Gastrointestinal Drugs      September and November            3014512538
 Advisory Committee          day(s) to be
                             announced.
------------------------------------------------------------------------
Nonprescription Drugs       January 23-24.                    3014512541
 Advisory Committee
------------------------------------------------------------------------
Oncologic Drugs Advisory    March 14 (Pediatric               3014512542
 Committee                   Subcommittee), March
                             15, June 2, September
                             12-13, December 6-7.
------------------------------------------------------------------------
Peripheral and Central      March 7-8.                        3014512543
 Nervous System Drugs
 Advisory Committee
------------------------------------------------------------------------
Pharmaceutical Science,     April 13-14 (Clinical             3014512539
 Advisory Committee for      Pharmacology
                             Subcommittee),
                             October 18-19
                             (Clinical
                             Pharmacology
                             Subcommittee),
                             April, May, and
                             October day(s) to be
                             announced.
------------------------------------------------------------------------
Psychopharmacologic Drugs   To be announced.                  3014512544
 Advisory Committee
------------------------------------------------------------------------
Pulmonary-Allergy Drugs     January 24.                       3014512545
 Advisory Committee
------------------------------------------------------------------------
Reproductive Health Drugs,  May and June day(s) to            3014512537
 Advisory Committee for      be announced.
------------------------------------------------------------------------
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
------------------------------------------------------------------------
Device Good Manufacturing   No tentative meeting              3014512398
 Practice Advisory           scheduled.
 Committee
------------------------------------------------------------------------
Medical Devices Advisory Committee (Comprised of 18 Panels)
------------------------------------------------------------------------
Anesthesiology and          April 7, October 6.               3014512624
 Respiratory Therapy
 Devices Panel
------------------------------------------------------------------------
Circulatory System Devices  February 16, April 21,            3014512625
 Panel                       June 16, August 18,
                             October 20.
------------------------------------------------------------------------
Clinical Chemistry and      February 22-23, May 24-           3014512514
 Clinical Toxicology         25, September 7-8,
 Devices Panel               December 6-7.
------------------------------------------------------------------------
Dental Products Panel       February 28, July 25,             3014512518
                             October 24.
------------------------------------------------------------------------
Ear, Nose, and Throat       February 1-2, April 3-            3014512522
 Devices Panel               4, June 15-16, August
                             10-11, October 11-12,
                             December 4-5.
------------------------------------------------------------------------
Gastroenterology-Urology    March 3, May 5, July              3014512523
 Devices Panel               21, October 20.
------------------------------------------------------------------------
General and Plastic         April 27-28, August 24-           3014512519
 Surgery Devices Panel       25, December 4-5.
------------------------------------------------------------------------
General Hospital and        February 9-10, June 12-           3014512520
 Personal Use Devices        13, September 28-29.
 Panel
------------------------------------------------------------------------
Hematology and Pathology    April 28, October 20.             3014512515
 Devices Panel
------------------------------------------------------------------------

[[Page 76060]]

 
Immunology Devices Panel    July 14, November 8.              3014512516
------------------------------------------------------------------------
Medical Devices Dispute     Meeting scheduled as              3014510232
 Resolution Panel            needed.
------------------------------------------------------------------------
Microbiology Devices Panel  February 23-24,                   3014512517
                             September 21-22,
                             October 26-27.
------------------------------------------------------------------------
Molecular and Clinical      April 13-14, October 5-           3014510231
 Genetics Panel              6.
------------------------------------------------------------------------
Neurological Devices Panel  March 2-4, August 3-4,            3014512513
                             June 5-6, August 28-
                             29, November 13-14.
------------------------------------------------------------------------
Obstetrics-Gynecology       March 27-28, June 5-6,            3014512524
 Devices Panel               August 28-29,
                             November 13-14.
------------------------------------------------------------------------
Ophthalmic Devices Panel    March 7-8, May 18,                3014512396
                             July 13-14, September
                             19-20, November 2-3.
------------------------------------------------------------------------
Orthopaedic and             February 2-3, July 27-            3014512521
 Rehabilitation Devices      28, October 26-27,
 Panel                       December 11-12.
------------------------------------------------------------------------
Radiological Devices Panel  February 7, May 23,               3014512526
                             September 12,
                             November 7.
------------------------------------------------------------------------
National Mammography        August 28.                        3014512397
 Quality Assurance
 Advisory Committee
------------------------------------------------------------------------
Technical Electronic        October 4.                        3014512399
 Product Radiation Safety
 Standards Committee
------------------------------------------------------------------------
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
------------------------------------------------------------------------
Food Advisory Committee     March 1, May 3, July              3014510564
                             12, September 13.
------------------------------------------------------------------------
CENTER FOR VETERINARY MEDICINE
------------------------------------------------------------------------
Veterinary Medicine         March 15, October 16.             3014512548
 Advisory Committee
------------------------------------------------------------------------
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR)
------------------------------------------------------------------------
Science Advisory Board to   April day(s) to be                3014512559
 NCTR                        announced.
------------------------------------------------------------------------
Advisory Committee on       February day(s) to be             3014512560
 Special Studies Relating    announced.
 to the Possible Long-Term
 Health Effects of Phenoxy
 Herbicides and
 Contaminants (Ranch
 Hands)
------------------------------------------------------------------------


    Dated: December 14, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E5-7645 Filed 12-21-05; 8:45 am]
BILLING CODE 4160-01-S
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