[Federal Register Volume 68, Number 20 (Thursday, January 30, 2003)]
[Notices]
[Pages 4788-4789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0018]


Draft Guidance for Industry on the Collection of Race and 
Ethnicity Data in Clinical Trials for FDA Regulated Products; 
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availability of a draft guidance for industry entitled ``Collection of 
Race and Ethnicity Data in Clinical Trials for FDA Regulated 
Products.'' This draft guidance recommends a standardized approach for 
collecting race and ethnicity information in clinical trials conducted 
in the United States and abroad for certain FDA regulated products. The 
standardized approach being recommended was developed by the Office of 
Management and Budget (OMB).

DATES:  Submit written or electronic comments on the draft guidance by 
March 31, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send two self-addressed adhesive labels to assist that 
office in processing your requests. Submit written comments on the 
draft guidance to the Dockets Management Branch (HFA-305), Food and 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 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Katherine Hollinger, Office of Health Science and Coordination (HF-
8), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5400; or
    Nancy Derr, Center For Drug Evaluation and Research (HFD-5), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
594-5400; or
    Ilan Irony, Center for Biologics Evaluation and Research (HFM-576), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 
301-827-5378; or
    IDE Staff, Center for Devices and Radiological Health (HFZ-403), 
9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Collection of Race and Ethnicity Data in Clinical Trials for 
FDA Regulated Products.'' FDA believes that the use of the OMB race and 
ethnicity categories will facilitate comparisons across clinical 
studies analyzed by FDA with data collected by other Federal agencies. 
Although FDA has long requested race and ethnicity data on subjects in 
certain clinical trials, the agency is now making recommendations on 
the categories to use when collecting and reporting the data.
    In the final rule entitled ``Investigational New Drug Applications 
and New Drug Applications'' (demographic rule) (63 FR 6854, February 
11, 1998), the agency recommended that sponsors ask subjects in certain 
clinical trials to identify their racial group and, if desired, to use 
the OMB categories when collecting race and ethnicity 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 announces the adoption of OMB Directive 15 
as part of its policy on collecting and reporting data on race and 
ethnicity. HHS recommended methods for the collection and inclusion of 
racial and ethnic categories in HHS-funded and HHS-sponsored data 
collection and reporting systems in all HHS programs, including both 
health and social services. This HHS policy states that the categories 
in OMB Directive 15 and its revisions be used when collecting and 
reporting data in HHS data systems or reporting HHS-funded statistics. 
The HHS policy was developed to: (1) Help monitor HHS programs, (2) 
determine that Federal funds are being used in a nondiscriminatory 
manner, and (3) promote the availability of standard racial and ethnic 
data across various agencies to facilitate HHS responses to major 
health and human services issues.
    Information on patient safety is reported by Federal agencies using 
the OMB recommendations. The application of OMB recommendations for the 
standardized collection and representation of race and ethnicity in 
clinical trial data is expected to enhance the comparability of data 
among clinical studies submitted to FDA and with reported health 
statistics. The recommendations made in this draft guidance are 
suggested for collecting race and ethnicity data in clinical trials 
developed to study pharmaceutical products and devices where necessary 
to determine safety and effectiveness. The agency recommends using more 
detailed race and ethnicity categories when appropriate to the study or 
locale, but recommends that the OMB categories be identified for all 
clinical trial participants when submitting data to the agency. In 
addition to asking for comments on this guidance generally, FDA 
specifically is asking for comments on the general applicability of 
this draft guidance to clinical trials of medical devices.
    This draft guidance does not discuss increasing the number of 
studies in

[[Page 4789]]

which subpopulations are exposed to a product. The draft guidance also 
does not discuss increasing the total number of participants or members 
of a subpopulation in clinical trials.
    This draft guidance contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520). The collection of information in sections 
III and IV of this draft guidance are approved under OMB control number 
0910-0014.
    This level 1 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 how to 
collect race and ethnicity data in certain clinical trials for FDA 
regulated products. 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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Two 
copies of any 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 
draft guidance and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 24, 2003.
Margaret M. Dotzel,
Assistant Commissioner fro Policy.
[FR Doc. 03-2162 Filed 1-29-03; 8:45 am]
BILLING CODE 4160-01-S