Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 54947 

ID code sets and this will ensure that 

traceability is consistent.’’

3. Added text to address gaps in the 

characterization of race and ethnicity: 

‘‘Where gaps exist in the representation 

of race or ethnicity categories, sponsors 

are encouraged to discuss the race or 

ethnicity issue with the appropriate 

review division.’’

4. Added text to allow omission of 

characterization of Hispanic or Latino 

ethnicity for international clinical trials: 

‘‘the ethnicity question can be omitted 

for studies conducted abroad.’’

5. Changed the characterization of 

‘‘Black, of African heritage,’’ to ‘‘Black’’

for studies conducted abroad. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on collection of race 

and ethnicity data in clinical trials. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance at any time. 

Two copies of any 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 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 the documentat http:// 

www.fda.gov/cder/guidance/ 

index.htm,http://www.fda.gov/cber/ 

guidelines.htm orhttp://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: September 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18595 Filed 9–16–05; 8:45 am] 

BILLING CODE 4160–01–S 

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 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 

Allergy and Infectious Diseases Special 

Emphasis Panel Interferon-Alpha in Type 1 

Diabetes. 

Date: October 4, 2005. 

Time: 1 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

3256, Bethesda, MD 20817 (Telephone 

Conference Call). 

Contact Person: Mercy R. PrabhuDas, PhD., 

Scientific Review Administrator, Scientific 

Review Program, Division of Extramural 

Activities, National Institutes of Health/ 

NIAID, 6700B Rockledge Drive, MSC 7616, 

Bethesda, MD 20892–7616, 301–451–2615, 

mp457n@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel Center For AIDS Research: 

D–CFAR, CFAR. 

Date: October 6–7, 2005. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Barney Duane Price, PhD, 

Scientific Review Administrator, Scientific 

Review Program, DHHS/NIH/NIAID/DEA, 

Room 3265, 6700B Rockledge Drive, MSC 

7616, Bethesda, MD 20892–7616, 301–451–

2592, pricebd@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel STD Prevention Study. 

Date: October 11, 2005. 

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

Agenda: To provide concept review of 

proposed grant applications. 

Place: National Institutes of Health, 

Building 16, 16 Center Drive, Bethesda, MD 

20892. 

Contact Person: John A. Bogdan, PhD, 

Scientific Review Administrator, Scientific 

Review Program, Division of Extramural 

Activities, NIAID/NIH/DHHS, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–496–2550, 

jbogdan@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: September 12, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–18600 Filed 9–16–05; 8:45 am] 

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 

Meeting 

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: Allergy, Immunology, 

and Transplantation Research Committee 

Allergy, Immunology and Transplantation 

Research Committee 

Date: October 17, 2005. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Double Tree Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Quirijn Vos, PhD, 

Scientific Review Administrator, Scientific 

Review Program, Division of Extramural 

Activities, NIAID/NIH/DHHS, 6700B 

Rockledge Drive, MSC, 7616, Bethesda, MD 

20892–7616, (301) 451–2666, 

qvos@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)