Advisory Committees; Tentative Schedule of Meetings for 2008, 2507-2509 [E8-567]

Download as PDF 2507 Federal Register / Vol. 73, No. 10 / Tuesday, January 15, 2008 / Notices Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a Federal Register notice announcing that date. Dated: January 7, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–571 Filed 1–14–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 2007N–0240] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers SUMMARY: In the Federal Register of October 11, 2007 (72 FR 57950), 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 0910–0233. The approval expires on January 31, 2011. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: January 9, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–573 Filed 1–14–08; 8:45 am] Food and Drug Administration AGENCY: Lane, Rockville, MD 20857, 301–827– 4816. BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Tentative Schedule of Meetings for 2008 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 2008. 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, Committee Name 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. 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 2008. 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). SUPPLEMENTARY INFORMATION: Tentative Date of Meeting(s) Advisory Committee 10-Digit Information Line Code OFFICE OF THE COMMISSIONER Pediatric Advisory Committee March and November days to be announced 8732310001 Risk Communication Advisory Committee February 28–29, May 15–16, August 21–22, November 17–18 8732112560 Science Board to FDA May and October days to be announced 3014512603 rwilkins on PROD1PC63 with NOTICES CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee April 29, October 17 3014512388 Blood Products Advisory Committee May 1–2, August 14–15, December 11–12 3014519516 Cellular, Tissue and Gene Therapies Advisory Committee April 10–11, November 13–14 3014512389 VerDate Aug<31>2005 17:48 Jan 14, 2008 Jkt 214001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\15JAN1.SGM 15JAN1 2508 Federal Register / Vol. 73, No. 10 / Tuesday, January 15, 2008 / Notices Committee Name Tentative Date of Meeting(s) Advisory Committee 10-Digit Information Line Code Transmissible Spongiform Encephalopathies Advisory Committee To be announced 3014512392 Vaccines and Related Biological Products Advisory Committee February 20–21, May 21–22, September 24–25, November 19–20 3014512391 Anesthetic and Life Support Drugs Advisory Committee March 11, May days to be announced 3014512529 Anti-Infective Drugs Advisory Committee February 27–28, April 1–3 3014512530 Antiviral Drugs Advisory Committee To be announced 3014512531 Arthritis Advisory Committee July, September, and November days to be announced 3014512532 Cardiovascular and Renal Drugs Advisory Committee June 24–25, August 19–20, December 9–10 3014512533 Dermatologic and Ophthalmic Drugs Advisory Committee April days to be announced 3014512534 Drug Safety and Risk Management Advisory Committee February 1, May days to be announced 3014512535 Endocrinologic and Metabolic Drugs Advisory Committee April 16–17, July 1–2, October 29–30, November 19–20 3014512536 Gastrointestinal Drugs Advisory Committee January 23, May days to be announced 3014512538 Nonprescription Drugs Advisory Committee To be announced 3014512541 Oncologic Drugs Advisory Committee March 13, April days to be announced, May 30, September 10–11, December 15–16 3014512542 Peripheral and Central Nervous System Drugs Advisory Committee May days to be announced 3014512543 Pharmaceutical Science and Clinical Pharmacology, Advisory Committee for March 18–19 3014512539 Psychopharmacologic Drugs Advisory Committee February 6 3014512544 Pulmonary-Allergy Drugs Advisory Committee February 20 3014512545 Reproductive Health Drugs, Advisory Committee for To be announced 3014512537 August 12, October 20–21 3014512398 CENTER FOR DRUG EVALUATION AND RESEARCH CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Device Good Manufacturing Practice Advisory Committee Medical Devices Advisory Committee (Comprised of 18 Panels) January 23, March 26, September 17 3014512624 Circulatory System Devices Panel August 26–27, November 14–15 3014512625 Clinical Chemistry and Clinical Toxicology Devices Panel April 9–10, August 13–14, December 4–5 3014512514 Dental Products Panel June 11, September 10, November 19 3014512518 Ear, Nose, and Throat Devices Panel April 16–17, June 25–26, August 28–29, October 28–29, December 10–11 3014512522 Gastroenterology-Urology Devices Panel October 17 3014512523 General and Plastic Surgery Devices Panel June 10–11, October 21–22 3014512519 General Hospital and Personal Use Devices Panel May 6–7, September 16–17 3014512520 Hematology and Pathology Devices Panel rwilkins on PROD1PC63 with NOTICES Anesthesiology and Respiratory Therapy Devices Panel April 25, October 17 3014512515 Immunology Devices Panel November 6–7 3014512516 Medical Devices Dispute Resolution Panel To be announced as needed 3014510232 Microbiology Devices Panel April 24–25, June 19–20, October 23–24 3014512517 VerDate Aug<31>2005 17:48 Jan 14, 2008 Jkt 214001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\15JAN1.SGM 15JAN1 2509 Federal Register / Vol. 73, No. 10 / Tuesday, January 15, 2008 / Notices Committee Name Tentative Date of Meeting(s) Advisory Committee 10-Digit Information Line Code Molecular and Clinical Genetics Panel May 6–7, November 11–12 3014510231 Neurological Devices Panel March 25–26, June 3–4, September 23–24, November 6– 7 3014512513 Obstetrics and Gynecology Devices Panel April 17–18, June 19–20, August 14–15, October 16–17, December 11–12 3014512524 Ophthalmic Devices Panel February 21–22, May 15–16, September 18–19, November 20–21 3014512396 Orthopedic and Rehabilitation Devices Panel April 21–22, June 16–17, August 18–19, October 20–21, December 8–9 3014512521 Radiological Devices Panel April 15–16, August 12, November 4 3014512526 National Mammography Quality Assurance Advisory Committee October 13–14 3014512397 Technical Electronic Product Radiation Safety Standards Committee October 8 3014512399 July 22, December 2 3014510564 March day to be announced 3014512548 August 12–13 3014512559 CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Food Advisory Committee CENTER FOR VETERINARY MEDICINE Veterinary Medicine Advisory Committee National Center for Toxicological Research (NCTR) Science Advisory Board to NCTR Dated: January 7, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–567 Filed 1–14–08; 8:45 am] Dated: January 7, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–490 Filed 1–14–08; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Fishers Lane, Rockville, MD 20857, 301–827–7001, FAX: 301–827–6776, email: Teresa.Watkins@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington DC area), code 3014512535. Please call the Information Line for up-to-date information on this meeting. Food and Drug Administration SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 2007, FDA announced that a meeting of the Drug Safety and Risk Management Advisory Committee would be held on February 1, 2008. On page 70336, in the second column, the first paragraph of the Agenda portion of document is amended to read as follows: Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22–054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Inc., used for the treatment of iron deficiency anemia in postpartum patients or iron deficiency anemia in patients with heavy uterine bleeding. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Health Resources and Services Administration BILLING CODE 4160–01–S Drug Safety and Risk Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of December 11, 2007 (72 FR 70336). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Teresa A. Watkins, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 VerDate Aug<31>2005 17:48 Jan 14, 2008 Jkt 214001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Notification of Exception to Competition Health Resources and Services Administration, HHS. AGENCY: Notification of Exception to Competition. ACTION: SUMMARY: The Health Resources and Services Administration (HRSA) is issuing a non-competitive program expansion supplement to the National Health Care for the Homeless Council (NHCHC) to provide expanded training and technical assistance to HRSAfunded grantees serving individuals who are homeless. Authority: This activity is under the authority of the Public Health Service Act, section 330(l). E:\FR\FM\15JAN1.SGM 15JAN1

Agencies

[Federal Register Volume 73, Number 10 (Tuesday, January 15, 2008)]
[Notices]
[Pages 2507-2509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-567]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committees; Tentative Schedule of Meetings for 2008

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 2008. 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 2008. 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
                               Tentative Date of           10-Digit
      Committee Name              Meeting(s)           Information Line
                                                             Code
------------------------------------------------------------------------
OFFICE OF THE COMMISSIONER
------------------------------------------------------------------------
Pediatric Advisory         March and November days            8732310001
 Committee                  to be announced
------------------------------------------------------------------------
Risk Communication         February 28-29, May 15-            8732112560
 Advisory Committee         16, August 21-22,
                            November 17-18
------------------------------------------------------------------------
Science Board to FDA       May and October days to            3014512603
                            be announced
------------------------------------------------------------------------
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
------------------------------------------------------------------------
Allergenic Products        April 29, October 17               3014512388
 Advisory Committee
------------------------------------------------------------------------
Blood Products Advisory    May 1-2, August 14-15,             3014519516
 Committee                  December 11-12
------------------------------------------------------------------------
Cellular, Tissue and Gene  April 10-11, November 13-          3014512389
 Therapies Advisory         14
 Committee
------------------------------------------------------------------------

[[Page 2508]]

 
Transmissible Spongiform   To be announced                    3014512392
 Encephalopathies
 Advisory Committee
------------------------------------------------------------------------
Vaccines and Related       February 20-21, May 21-            3014512391
 Biological Products        22, September 24-25,
 Advisory Committee         November 19-20
------------------------------------------------------------------------
CENTER FOR DRUG EVALUATION AND RESEARCH
------------------------------------------------------------------------
Anesthetic and Life        March 11, May days to be           3014512529
 Support Drugs Advisory     announced
 Committee
------------------------------------------------------------------------
Anti-Infective Drugs       February 27-28, April 1-           3014512530
 Advisory Committee         3
------------------------------------------------------------------------
Antiviral Drugs Advisory   To be announced                    3014512531
 Committee
------------------------------------------------------------------------
Arthritis Advisory         July, September, and               3014512532
 Committee                  November days to be
                            announced
------------------------------------------------------------------------
Cardiovascular and Renal   June 24-25, August 19-             3014512533
 Drugs Advisory Committee   20, December 9-10
------------------------------------------------------------------------
Dermatologic and           April days to be                   3014512534
 Ophthalmic Drugs           announced
 Advisory Committee
------------------------------------------------------------------------
Drug Safety and Risk       February 1, May days to            3014512535
 Management Advisory        be announced
 Committee
------------------------------------------------------------------------
Endocrinologic and         April 16-17, July 1-2,             3014512536
 Metabolic Drugs Advisory   October 29-30, November
 Committee                  19-20
------------------------------------------------------------------------
Gastrointestinal Drugs     January 23, May days to            3014512538
 Advisory Committee         be announced
------------------------------------------------------------------------
Nonprescription Drugs      To be announced                    3014512541
 Advisory Committee
------------------------------------------------------------------------
Oncologic Drugs Advisory   March 13, April days to            3014512542
 Committee                  be announced, May 30,
                            September 10-11,
                            December 15-16
------------------------------------------------------------------------
Peripheral and Central     May days to be announced           3014512543
 Nervous System Drugs
 Advisory Committee
------------------------------------------------------------------------
Pharmaceutical Science     March 18-19                        3014512539
 and Clinical
 Pharmacology, Advisory
 Committee for
------------------------------------------------------------------------
Psychopharmacologic Drugs  February 6                         3014512544
 Advisory Committee
------------------------------------------------------------------------
Pulmonary-Allergy Drugs    February 20                        3014512545
 Advisory Committee
------------------------------------------------------------------------
Reproductive Health        To be announced                    3014512537
 Drugs, Advisory
 Committee for
------------------------------------------------------------------------
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
------------------------------------------------------------------------
Device Good Manufacturing  August 12, October 20-21           3014512398
 Practice Advisory
 Committee
------------------------------------------------------------------------
Medical Devices Advisory Committee (Comprised of 18 Panels)
------------------------------------------------------------------------
Anesthesiology and         January 23, March 26,              3014512624
 Respiratory Therapy        September 17
 Devices Panel
------------------------------------------------------------------------
Circulatory System         August 26-27, November             3014512625
 Devices Panel              14-15
------------------------------------------------------------------------
Clinical Chemistry and     April 9-10, August 13-             3014512514
 Clinical Toxicology        14, December 4-5
 Devices Panel
------------------------------------------------------------------------
Dental Products Panel      June 11, September 10,             3014512518
                            November 19
------------------------------------------------------------------------
Ear, Nose, and Throat      April 16-17, June 25-26,           3014512522
 Devices Panel              August 28-29, October
                            28-29, December 10-11
------------------------------------------------------------------------
Gastroenterology-Urology   October 17                         3014512523
 Devices Panel
------------------------------------------------------------------------
General and Plastic        June 10-11, October 21-            3014512519
 Surgery Devices Panel      22
------------------------------------------------------------------------
General Hospital and       May 6-7, September 16-17           3014512520
 Personal Use Devices
 Panel
------------------------------------------------------------------------
Hematology and Pathology   April 25, October 17               3014512515
 Devices Panel
------------------------------------------------------------------------
Immunology Devices Panel   November 6-7                       3014512516
------------------------------------------------------------------------
Medical Devices Dispute    To be announced as                 3014510232
 Resolution Panel           needed
------------------------------------------------------------------------
Microbiology Devices       April 24-25, June 19-20,           3014512517
 Panel                      October 23-24
------------------------------------------------------------------------

[[Page 2509]]

 
Molecular and Clinical     May 6-7, November 11-12            3014510231
 Genetics Panel
------------------------------------------------------------------------
Neurological Devices       March 25-26, June 3-4,             3014512513
 Panel                      September 23-24,
                            November 6-7
------------------------------------------------------------------------
Obstetrics and Gynecology  April 17-18, June 19-20,           3014512524
 Devices Panel              August 14-15, October
                            16-17, December 11-12
------------------------------------------------------------------------
Ophthalmic Devices Panel   February 21-22, May 15-            3014512396
                            16, September 18-19,
                            November 20-21
------------------------------------------------------------------------
Orthopedic and             April 21-22, June 16-17,           3014512521
 Rehabilitation Devices     August 18-19, October
 Panel                      20-21, December 8-9
------------------------------------------------------------------------
Radiological Devices       April 15-16, August 12,            3014512526
 Panel                      November 4
------------------------------------------------------------------------
National Mammography       October 13-14                      3014512397
 Quality Assurance
 Advisory Committee
------------------------------------------------------------------------
Technical Electronic       October 8                          3014512399
 Product Radiation Safety
 Standards Committee
------------------------------------------------------------------------
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
------------------------------------------------------------------------
Food Advisory Committee    July 22, December 2                3014510564
------------------------------------------------------------------------
CENTER FOR VETERINARY MEDICINE
------------------------------------------------------------------------
Veterinary Medicine        March day to be                    3014512548
 Advisory Committee         announced
------------------------------------------------------------------------
National Center for Toxicological Research (NCTR)
------------------------------------------------------------------------
Science Advisory Board to  August 12-13                       3014512559
 NCTR
------------------------------------------------------------------------


    Dated: January 7, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-567 Filed 1-14-08; 8:45 am]
BILLING CODE 4160-01-S
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