Science Board to the Food and Drug Administration; Request for Nominations SUBJECT>, 51830-51831 [E8-20574]

Download as PDF 51830 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–9314. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ‘‘Bioequivalence Recommendations for Specific Products,’’ that explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/CDER/GUIDANCE/ bioequivalence/default.htm. As described in that draft guidance, FDA adopted this process as a means to develop and disseminate productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Since that notice was published we have published a correction notice concerning Bioequivalence Recommendations for Specific Products on October 25, 2007 (72 FR 60683). This notice includes draft product-specific recommendations either newly posted or updated since the Federal Register notice dated October 25, 2007, through April 30, 2008. mstockstill on PROD1PC66 with NOTICES II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available The following draft BE productspecific recommendations have been newly posted since the FR notice dated October 25, 2007: (1) Abacavir Sulfate; Lamivudine (2) Alendronate Sodium (3) Alfuzosin HCl (4) Alprazolam (5) Amoxicillin; Clavulanate Potassium (multiple RLDs) (6) Amprenavir (7) Aripiprazole (8) Armodafinil (9) Atovaquone (10) Azithromycin (11) Balsalazide Disodium (12) Bupropion HCl (updated) (13) Carbamazepine (multiple dosage forms) (14) Cefdinir (15) Cefixime (16) Cetirizine HCl; Pseudoephedrine HCl (17) Ciprofloxacin; Ciprofloxacin HCl VerDate Aug<31>2005 18:40 Sep 04, 2008 Jkt 214001 (18) Ciprofloxacin HCl (19) Clarithromycin (20) Darunavir Ethanolate (21) Delavirdine Mesylate (22) Dexmethylphenidate (23) Diltiazem HCl (multiple dosage forms; multiple RLDs) (24) Divalproex Sodium (25) Doxycycline (multiple dosage forms) (26) Eprosartan Mesylate; Hydrochlorothiazide (27) Esterified Estrogens (28) Eszopiclone (29) Ethambutol HCl (30) Ethinyl Estradiol; Levonorgestrel (multiple RLDs) (31) Fenofibrate (32) Fluvastatin Sodium (multiple dosage forms) (33) Fosamprenavir Calcium (34) Glimepiride; Rosiglitazone Maleate (35) Lamivudine (36) Linezolid (37) Lisinopril (38) Lopinavir; Ritonavir (39) Memantine HCl (40) Mesalamine (41) Metoprolol Succinate (updated) (42) Minocycline HCl (43) Nelfinavir Mesylate (44) Nevirapine (45) Omeprazole; Sodium Bicarbonate; Magnesium Hydroxide (46) Oxymorphone HCl (multiple dosage forms) (47) Paliperidone (48) Paricalcitol (49) Phenytoin (50) Pimozide (51) Posaconazole (52) Quinine Sulfate (53) Saquinavir Mesylate (multiple dosage forms) (54) Solifenacin Succinate (55) Tenofovir Disoproxil Fumarate (56) Tinidazole (57) Tipranavir (58) Tolterodine Tartrate (59) Tramadol HCl (60) Trospium Chloride (61) Varenicline Tartrate (62) Zafirlukast (63) Zalcitabine (64) Zileuton (65) Zolmitriptan (66) Zonisamide III. Drug Products for Which Updated Draft Product-Specific BE Recommendations Are Available The following five product-specific recommendations previously made available on FDA’s Web site have been updated: 1. Risedronate Sodium 2. Fosinopril Sodium; Hydrochlorothiazide PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 3. Fluoxetine HCl; Olanzapine 4. Erlotinib HCl 5. Morphine Sulfate For a complete history of previous Federal Register notices pertaining to product-specific BE recommendations, please go to https://www.regulations.gov and enter FDA–2007–D–0369. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on any of the specific BE recommendations posted on FDA’s Web site. Two copies of mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance, notices, and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only at https://www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https:// www.regulations.gov. Dated: August 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–20580 Filed 9–4–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0450] Science Board to the Food and Drug Administration; Request for Nominations SUBJECT≤ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations to serve on the Science Board to the FDA (Science Board). E:\FR\FM\05SEN1.SGM 05SEN1 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices mstockstill on PROD1PC66 with NOTICES FDA has special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations qualified candidates from these groups. DATES: Nominations received on or before October 6, 2008 will be given first consideration for membership on the Science Board. Nominations received after October 6, 2008 will be considered for nomination to the Science Board should nominees still be needed. ADDRESSES: All nomination for membership should be sent electronically to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight & Management Staff, 5600 Fishers Lane (HF–4), rm. 15A–12, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, the primary contact is ˜ Carlos Pena, Office of Science and Health Coordination, Office of the Commissioner, Food and Drug Administration (HF–33), 5600 Fishers Lane, Rockville, MD 20857, 301–827– ˜ 6687, e-mail: carlos.Pena@fda.hhs.gov. Information about becoming a member on a FDA advisory committee can also be obtained by visiting FDA’s Web site by using the following link https:// www.fda.gov/oc/advisory/default.htm. SUPPLEMENTARY INFORMATION: FDA is requesting nominations to the Science Board. The Science Board will meet approximately four times a year. Meetings of the Science Board will be open to the public. All meetings will be announced in the Federal Register at least 15 days prior to each scheduled public meeting. I. General Function of the Committee The Science Board shall provide advice primarily to the Commissioner and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community. Additionally, the Science Board will provide advice to the Agency on keeping pace with technical and scientific evolutions in the fields of regulatory science; on formulating an appropriate research agenda; and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of Agency sponsored intramural and extramural scientific research programs. II. Criteria for Members Persons nominated for membership shall be knowledgeable in the fields of food safety, nutrition, chemistry, VerDate Aug<31>2005 18:40 Sep 04, 2008 Jkt 214001 pharmacology, toxicology, clinical research, or other scientific disciplines such as systems biology, wireless healthcare devices, nanotechnology, medical imaging, robotics, cell and tissue based products, regenerative medicine, and combination products. Members shall be chosen from academia and industry. The Science Board may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumeroriented organizations or other interested persons. The Science Board may also include technically qualified Federal members. III. Nomination Procedures Any interested person may nominate one or more qualified person for membership on the Science Board. Self nominations are also accepted. Nominations shall include the name of the committee, complete curriculum vitae of each nominee, and their current business address and telephone number and e-mail address if available. Each nomination shall state that the nominee is aware of the nomination, is willing to serve as a member, and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees. Dated: August 27, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–20574 Filed 9–4–08; 8:45 am] 51831 as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Complementary and Alternative Medicine, Special Emphasis Panel, Exploratory Grants for CAM Studies of Humans (R21). Date: October 20–21, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Jeanette M. Hosseini, PhD, Scientific Review Officer, Office of Scientific Review, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892, (301) 594–9096, jeanettehmail.nih.gov. Name of Committee: National Center for Complementary and Alternative Medicine, Special Emphasis Panel, Basic and Preclinical Research on CAM. Date: October 27–28, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriott Gaithersburg, 204 Boardwalk Place, Gaithersburg, MD 20878. Contact Person: Peter Kozel, PhD, Scientific Review Officer, NCCAM, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892–5475, 301–496–8004, kozelpmail.nih.gov. Dated: August 27, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–20626 Filed 9–4–08; 8:45 am] BILLING CODE 4140–01–M BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Emergency Management Agency National Institutes of Health Collection of Overpayments National Center for Complementary & Alternative Medicine; Notice of Closed Meetings AGENCY: Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., SUMMARY: This document provides notice that the Federal Emergency Management Agency (FEMA) has terminated the current procedures for the recoupment of overpayments of disaster assistance made pursuant to Section 408 of the Stafford Act, in connection with Hurricanes Katrina and Rita. Recoupment notices previously PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Federal Emergency Management Agency, DHS. ACTION: Notice. E:\FR\FM\05SEN1.SGM 05SEN1

Agencies

[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51830-51831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0450]


Science Board to the Food and Drug Administration; Request for 
NominationsSUBJECT>

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is requesting nominations to 
serve on the Science Board to the FDA (Science Board).

[[Page 51831]]

    FDA has special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on 
advisory committees and, therefore, encourages nominations qualified 
candidates from these groups.

DATES: Nominations received on or before October 6, 2008 will be given 
first consideration for membership on the Science Board. Nominations 
received after October 6, 2008 will be considered for nomination to the 
Science Board should nominees still be needed.

ADDRESSES: All nomination for membership should be sent electronically 
to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight & 
Management Staff, 5600 Fishers Lane (HF-4), rm. 15A-12, Rockville, MD 
20857.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, the primary contact is Carlos Pe[ntilde]a, Office of 
Science and Health Coordination, Office of the Commissioner, Food and 
Drug Administration (HF-33), 5600 Fishers Lane, Rockville, MD 20857, 
301-827-6687, e-mail: carlos.Pe[ntilde]a@fda.hhs.gov. Information about 
becoming a member on a FDA advisory committee can also be obtained by 
visiting FDA's Web site by using the following link https://www.fda.gov/
oc/advisory/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations to the Science 
Board. The Science Board will meet approximately four times a year. 
Meetings of the Science Board will be open to the public. All meetings 
will be announced in the Federal Register at least 15 days prior to 
each scheduled public meeting.

I. General Function of the Committee

    The Science Board shall provide advice primarily to the 
Commissioner and other appropriate officials on specific complex and 
technical issues as well as emerging issues within the scientific 
community. Additionally, the Science Board will provide advice to the 
Agency on keeping pace with technical and scientific evolutions in the 
fields of regulatory science; on formulating an appropriate research 
agenda; and on upgrading its scientific and research facilities to keep 
pace with these changes. It will also provide the means for critical 
review of Agency sponsored intramural and extramural scientific 
research programs.

II. Criteria for Members

    Persons nominated for membership shall be knowledgeable in the 
fields of food safety, nutrition, chemistry, pharmacology, toxicology, 
clinical research, or other scientific disciplines such as systems 
biology, wireless healthcare devices, nanotechnology, medical imaging, 
robotics, cell and tissue based products, regenerative medicine, and 
combination products. Members shall be chosen from academia and 
industry. The Science Board may include one technically qualified 
member, selected by the Commissioner or designee, who is identified 
with consumer interests and is recommended by either a consortium of 
consumer-oriented organizations or other interested persons. The 
Science Board may also include technically qualified Federal members.

III. Nomination Procedures

    Any interested person may nominate one or more qualified person for 
membership on the Science Board. Self nominations are also accepted. 
Nominations shall include the name of the committee, complete 
curriculum vitae of each nominee, and their current business address 
and telephone number and e-mail address if available. Each nomination 
shall state that the nominee is aware of the nomination, is willing to 
serve as a member, and appears to have no conflict of interest that 
would preclude membership. FDA will ask the potential candidates to 
provide detailed information concerning such matters as financial 
holdings, employment, and research grants and/or contracts to permit 
evaluation of possible sources of conflict of interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.

    Dated: August 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-20574 Filed 9-4-08; 8:45 am]
BILLING CODE 4160-01-S
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