60684 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 

site. The BE recommendations 

identified in this document were 

developed using the process described 

in that guidance. 

DATES: Submit written or electronic 

comments on the draft product-specific 

BE recommendations by January 23, 

2008. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the individual BE 

guidances to the Division of Drug 

Information (HFD–240), Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit written comments on the draft 

product-specific BE recommendations 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to either http:// 

www.fda.gov/dockets/ecomments or 

http://www.regulations.gov. See the 

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electronic access to the draft guidance 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, 7500 

Standish Pl., Rockville, MD 20855, 301–

827–0495. 

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availability of a draft guidance for 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described in that draft guidance, FDA 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. 

In that same issue of the Federal 

Register (72 FR 30386), FDA also 

announced that 200 product-specific BE 

recommendations were being made 

available on FDA’s Web site at http:// 

www.fda.gov/CDER/GUIDANCE/ 

bioequivalence/default.htm. However, a 

number of the recommendations listed 

in that notice were not posted on the 

Web site. In addition, some of the 

recommendations posted on the Web 

site were omitted from the Federal 

Register notice. Finally, four 

recommendations announced in the 

May 31, 2007, notice and posted on the 

Web site were incorrect and have now 

been corrected. This document clarifies 

the notice of May 31, 2007 (72 FR 

30386), as follows: 

A. Recommendations Listed in the May 

31, 2007, Federal Register Notice That 

Were Not Posted on the Web Site 

(1) Ganciclovir 

(2) Ibuprofen; Pseudoephedrine HCl 

(3) Felbamate (multiple dosage forms) 

(4) Leflunomide 

These drugs are now available on the 

Web site. 

B. Recommendations Posted on the Web 

Site That Were Not Listed in the May 31, 

2007, Federal Register Notice 

(1) Fosinopril Sodium 

(2) Hydrochlorothiazide and 

Irbesartan 

(3) Levonorgestrel 

(4) Lidocaine 

(5) Loratadine 

(6) Phenytoin Sodium (multiple 

RLDs) 

(7) Phenytoin 

(8) Terazosin HCl 

C. Recommendations Listed in the May 

31, 2007, Federal Register Notice and 

Posted on the Web Site That Were 

Incorrect 

(1) Mycophenolate mofetil tablet 

50723, corrected the analytes to measure 

(2) Mycophenolate mofetil capsule 

50722, corrected the analytes to measure 

(3) Erlotinib HCl tablet, deleted the 

IND requirement 

(4) Hydrochlorothiazide and losartan 

potassium tablets, added waiver 

strength 12.5 mg/100mg 

The recommendations listed in 

sections I.A, B, and C of this document 

are available for comment by (see 

DATES). 

II. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain these BE recommendations 

at either http://www.fda.gov/cder/ 

guidance/index.htm or http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: October 19, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–21062 Filed 10–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 Institute on 

Aging Special Emphasis Panel, Reverse Site 

Visit. 

Date: November 26–27, 2007. 

Time: 5 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Louise L. Hsu, PhD, Health 

Scientist Administrator, Scientific Review 

Office, National Institute on Aging, Gateway 

Building, 7201 Wisconsin Avenue/Suite 

2C212, Bethesda, MD 20892, (301) 496–7705, 

hsul@exmur.nia.nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, ‘‘Aging Brain 

Vasculature’’. 

Date: November 30, 2007. 

Time: 12 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

2C212, Bethesda, MD 20814, (Telephone 

Conference Call). 

Contact Person: William Cruce, PhD, 

Health Scientist Administrator, Scientific 

Review Office, National Institute on Aging, 

National Institutes of Health, Room 2C212, 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 60685 

7201 Wisconsin Avenue, Bethesda, MD 

20814, 301–402–7704, crucew@nia.nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, Comparative 

Longitudinal Studies. 

Date: December 6–7, 2007. 

Time: 6 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel, 8120 Wisconsin 

Ave., Bethesda, MD 20814. 

Contact Person: Wilbur C. Hadden, PhD, 

Health Scientist Administrator, National 

Institute on Aging, Gateway Building, Room 

2C212, 7201 Wisconsin Avenue, Bethesda, 

MD 20892, haddenw@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: October 19, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–5285 Filed 10–24–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; 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 

meeting. 

The meeting 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 Institute of 

Child Health and Human Development 

Special Emphasis Panel Training Program in 

Social Development. 

Date: November 13, 2007. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01E, 

Rockville, MD 20852. (Virtual Meeting) 

Contact Person: Carla T. Walls, PhD., 

Scientific Review Administrator, Division of 

Scientific Review National Institute of Child 

Health and Human Development, NIH, 6100 

Executive Blvd., Room 5B01, Bethesda, MD 

20892, (301) 435–6898, wallsc@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: October 19, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–5287 Filed 10–24–07; 8:45am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel NHP Models for HIV 

Therapeutics and Microbiocides. 

Date: November 16, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Holiday Inn Capitol, 550 C Street, 

SW., Saturn/Venus Room, Washington, DC 

20024. 

Contact Person: Lucy A. Ward, DVM, PhD., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID/DHHS, 

6700B Rockledge Drive, Bethesda, MD 

20892–7616, 301–496–2550, 

lward@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel Clinical Pharmacology 

Quality Assurance and Quality Control. 

Date: November 16, 2007. 

Time: 11 a.m. to 4 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

3147, Bethesda, MD 20817. (Telephone 

Conference Call) 

Contact Person: Mary J. Homer, PhD., 

Scientific Review Administrator, Scientific 

Review Program, National Institute of Allergy 

and Infectious Diseases, DEA/NIH/DHHS, 

6700–B Rockledge Drive MSC 7616 Room 

3147, Bethesda, MD 20892, 301–496–7042, 

mjhomer@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: October 19, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–5289 Filed 10–24–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel, Review of 

HIV/AIDS SBIR Applications. 

Date: November 13, 2007. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Mark P. Rubert, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, (301) 435–

1775, rubertm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Neural 

Control of Cardiovascular Function. 

Date: November 14, 2007. 

Time: 10 a.m. to 12 p.m. 

mstockstill on PROD1PC66 with NOTICES