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electronic access to the draft guidance 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availability of a draft guidance for 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 

http://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described in that draft guidance, FDA 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. 

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 

(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 

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 http://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 

http://www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

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). 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 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 Pen ̃ 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.Pen ̃ 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 http:// 

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 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] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Closed 

Meetings 

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., 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Collection of Overpayments 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

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 

mstockstill on PROD1PC66 with NOTICES