54946 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 

clinical trial design and analysis plan 

meet defined objectives. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. 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. The Paperwork Reduction Act of 

1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collection of information in 

this guidance has been approved under 

OMB control number 0910–0001 

(expires May 31, 2008). 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The draft 

guidance and received comments may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. 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.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: September 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18512 Filed 9–16–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2002D–0018] (formerly 02D–

0018) 

Guidance for Industry on the 

Collection of Race and Ethnicity Data 

in Clinical Trials; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Collection of Race and 

Ethnicity Data in Clinical Trials.’’ This 

guidance provides recommendations on 

a standardized approach for collecting 

and reporting race and ethnicity 

information in clinical trials conducted 

in the United States and abroad for 

certain FDA regulated products. This 

document provides guidance on 

meeting the requirements in the 1998 

final rule on Investigational New Drug 

Applications and New Drug 

Applications (Demographic Rule) (63 FR 

6854, February 11, 1998). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, or the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835–

4709 or 301–827–1800. Submit written 

comments on the guidance to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Katherine Hollinger, Office of 

Women’s Health, Office of Science 

and Health Communication (HF–8), 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–0935, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

1401 Rockville Pike, Rockville, MD 

20852, 301–827–6210, or 

Investigational Device Exemption 

Staff (HFV–403), Center for Devices 

and Radiological Health, 9200 

Corporate Blvd., Rockville, MD 

20850, 301–594–1190. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Collection of Race and Ethnicity Data 

in Clinical Trials.’’ A draft of this 

guidance was issued on January 30, 

2003 (68 FR 4788). Based on comments 

received on the draft and the refinement 

of agency thinking on this topic, FDA 

has revised the draft guidance and is 

now issuing a guidance. This guidance 

is intended to assist sponsors in the 

collection of race and ethnicity 

information in clinical trials conducted 

in the United States and abroad for 

certain FDA regulated products using a 

standardized approach. The 

standardized approach was developed 

by the Office of Management and 

Budget (OMB). FDA believes that the 

use of the OMB approach will facilitate 

comparisons across clinical studies 

analyzed by FDA and data collected by 

other Federal agencies. Although FDA 

has long requested the racial and ethnic 

ancestral origins of subjects in certain 

clinical trials, the agency is now making 

recommendations on the methods and 

categories to use when collecting and 

reporting data. The Department of 

Health and Human Services (HHS) 

issued a 1999 report entitled 

‘‘Improving the Collection and Use of 

Racial and Ethnic Data in HHS,’’ in 

which HHS announced the adoption of 

OMB Directive 15 as part of its policy 

on collecting and reporting data on 

racial and ethnic ancestral origins. 

FDA received several comments in 

response to the January 2003 draft 

guidance and has made some clarifying 

changes in the final version of the 

guidance. Specifically, we have: 

1. Added reference to 21 CFR 

314.50(d)(5)(v) to include studies for 

efficacy. 

2. Clarified the traceability/mapping 

between more granular characterizations 

for racial and ethnic ancestral origins: 

‘‘When more detailed characterizations 

are desired, the use of Race and 

Ethnicity vocabulary tables located 

within Health Level Seven’s Reference 

Information Model Structural 

Vocabulary Tables is recommended. 

These tables provide the five and two 

OMB characterizations traceable to more 

detailed characterizations and concept 

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)