[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54946-54947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18595]


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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.

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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

[[Page 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