**Guidance for Industry**

Collection of Race and Ethnicity Data in Clinical Trials

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Drug Evaluation and Research (CDER)**

**Center for Biologics Evaluation and Research (CBER)**

**Center for Devices and Radiologic Health (CDRH)**

**Office of the Commissioner (OC)**

**September 2005**

**Clinical Medical**

**Guidance for Industry**

Collection of Race and Ethnicity Data in Clinical Trials

*Additional copies are available from:*

*Office of Training and Communications*

*Division of Drug Information, HFD-240*

*Center for Drug Evaluation and Research (CDER)*

*Food and Drug Administration*

*5600 Fishers Lane, Rockville, MD 20857*

*Phone: 301-827-4573*

[*http://www.fda.gov/cder/guidance/index.htm*](http://www.fda.gov/cder/guidance/index.htm)

*or*

*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 20852-1488*

*Phone: 800-835-4709 or 301-827-1800*

*http://www.fda.gov/cber/guidelines.htm*

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Drug Evaluation and Research (CDER)**

**Center for Biologics Evaluation and Research (CBER)**

**Center for Devices and Radiologic Health (CDRH)**

**Office of the Commissioner (OC)**

**September 2005**

**Clinical Medical**

**TABLE OF CONTENTS**

# 

I. INTRODUCTION [1](#introduction)

II\. BACKGROUND [2](#background)

A. Relevance of Population Subgroup Studies
[3](#relevance-of-population-subgroup-studies)

B. FDA Decision to Recommend Use of the OMB Categories
[3](#fda-decision-to-recommend-use-of-the-omb-categories)

III\. collecTINg RACE AND ETHNICITY DATA IN CLINICAL TRIALS
[4](#collecting-race-and-ethnicity-data-in-clinical-trials)

IV\. Clinical Trials Conducted Outside of the United States
[5](#clinical-trials-conducted-outside-of-the-united-states)

V. PRESENTATION OF DEMOGRAPHIC TABULATIONS IN THE eCTD
[6](#presentation-of-demographic-tabulations-in-the-ectd)

APPENDIX 1 [8](#appendix-1)

History of federal efforts In DATA collection on Race and ethnicity and
other subpopulations
[8](#history-of-federal-efforts-in-data-collection-on-race-and-ethnicity-and-other-subpopulations)

Appendix 2 [12](#appendix-2)

Revised Directive 15 [12](#revised-directive-15)

REFERENCES [16](#references)

BIBLIOGRAPHY [17](#bibliography)

**Guidance for Industry**[^1]

**Collection of Race and Ethnicity Data in Clinical Trials**

This guidance represents the Food and Drug Administration\'s (FDA\'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.

# 

# INTRODUCTION 

This guidance recommends using 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. The recommended standardized approach was developed by the
Office of Management and Budget (OMB). The guidance lists the OMB
categories for race and ethnicity and describes FDA\'s reasons for
recommending the use of these categories. In addition, this guidance
recommends a format for race and ethnicity data within study data that
are submitted in standardized data sets such as the Study Data
Tabulation Model[^2] or in the electronic Common Technical Document
(eCTD).[^3]

This document is intended to provide guidance on meeting the
requirements set forth in the 1998 final rule on investigational new
drug (IND) applications and new drug applications (NDAs)[^4]
(Demographic Rule). The Demographic Rule requires IND holders to
tabulate in their annual report the number of subjects enrolled in
clinical studies of drugs and biologic products by age, race, and
gender, and sponsors of NDAs to include summaries of effectiveness and
safety data for important demographic subgroups, including racial
subgroups.[^5] This guidance is also intended to help applicants in
preparing biologics license applications (BLAs).

Although the regulations governing medical devices do not include
requirements for the collection of demographic data comparable to those
for INDs and NDAs, for those cases in which race and ethnicity data are
relevant to determining the safety and effectiveness of a device, FDA
encourages sponsors to collect the data in accordance with the OMB
recommendations and the information collection standards discussed in
this guidance document. Sponsors are also encouraged to discuss any race
or ethnicity issues with the appropriate review division in the Office
of Device Evaluation, Center for Devices and Radiological Health, when
developing their study protocols.

This guidance does not address the level of participation of racial and
ethnic groups in clinical trials. For questions related to the level of
participation or the size of a study sponsors should consult with the
review division prior to the start of a study.

FDA\'s guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency\'s current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word *should* in Agency guidances means that
something is suggested or recommended, but not required.

# BACKGROUND

FDA regulations require sponsors of NDAs to present a summary of safety
and effectiveness data by demographic subgroups (age, gender, race), as
well as an analysis of whether modifications of dose or dosage intervals
are needed for specific subgroups (21 CFR 314.50 (d)(5)(v) and
(vi)(a)).[^6] One consideration in such summaries is the identification
of a subject's race or ethnicity.

In 1997, OMB issued its revised recommendations for the collection and
use of race and ethnicity data by Federal agencies (Policy Directive
15).[^7] FDA is now recommending the use of the standardized OMB race
and ethnicity categories for data collection in clinical trials for two
reasons. First, the use of the recommended OMB categories will help
ensure consistency in demographic subset analyses in applications
submitted to FDA (21 CFR 314.50(d)(5)(v) and (vi)(a), 312.120,
314.106(b), and 601.2) and in data collected by other government
agencies. Second, consistency in these categories may make the
demographic subset analysis more useful in evaluating potential
differences in the safety and efficacy of pharmaceutical products among
population subgroups. To assess potential subgroup differences in a
meaningful way, it is important to use uniform, standard methods of
defining racial and ethnic subgroups.

## Relevance of Population Subgroup Studies

Differences in response to medical products have already been observed
in racially and ethnically distinct subgroups of the U.S.
population.[^8] These differences may be attributable to intrinsic
factors (e.g., genetics, metabolism, elimination), extrinsic factors
(e.g., diet, environmental exposure, sociocultural issues), or
interactions between these factors. For example, in the United States,
Whites[^9] are more likely than persons of Asian and African heritage to
have abnormally low levels of an important enzyme (CYP2D6) that
metabolizes drugs belonging to a variety of therapeutic areas, such as
antidepressants, antipsychotics, and beta blockers (Xie 2001). Other
studies have shown that Blacks respond poorly to several classes of
antihypertensive agents (beta blockers and angiotensin converting enzyme
(ACE) inhibitors) (Exner 2001 and Yancy 2001). Racial differences in
skin structure and physiology that can affect response to dermatologic
and topically applied products have been noted (Taylor 2002). Clinical
trials have demonstrated lower responses to interferon-alpha used in the
treatment of hepatitis C among Blacks when compared with other racial
subgroups (McHutchison 2000 and Reddy 1999).

## FDA Decision to Recommend Use of the OMB Categories

The OMB stated that its race and ethnicity categories were not
anthropologic or scientifically based designations, but instead were
categories that described the sociocultural construct of our society.
The Department of Health and Human Services (HHS) chose to adopt these
standardized categories for its agencies that report statistics because
the categories are relevant to assessing various health related data,
including public health surveillance and research. FDA believes that the
use of the current OMB categories and any future revisions will
facilitate comparisons across clinical studies analyzed by FDA and data
collected by other agencies. Collection of data using standard
categories can enhance patient safety by helping FDA evaluate potential
differences in drug response among subpopulations. Using standard
categories may also facilitate analyses seeking to identify differences
in response.

Although FDA has long requested race and ethnicity data on subjects in
certain clinical trials, the Agency has not previously made explicit
recommendations on the categories to use when collecting and reporting
the data. In 1998, the Agency issued the Demographic Rule, which
reflected growing recognition within the Agency and the health community
that (1) different subgroups of the population may respond differently
to specific drug products, and (2) although an effort should be made to
look for differences in effectiveness and adverse reactions among such
subgroups, that effort is not being made consistently.[^10] In the
Demographic Rule, FDA discussed the importance of collecting data in
clinical trials (and of presenting those data in applications to the
Agency) on population subgroups organized by gender, race, age, and
other relevant categories. The Agency recommended that sponsors ask
subjects in certain clinical trials to identify their racial group and,
if desired, that sponsors use OMB categories when collecting race and
ethnicity data.[^11]

During the past two decades, efforts have been under way in a number of
Federal organizations to collect race and ethnicity data in Federal
programs in a standardized way. (See Appendix 1 for a summary of those
efforts). In 1997, HHS issued a document entitled *Policy Statement on
Inclusion of Race and Ethnicity in DHHS Data Collection
Activities.*[^12] In this policy statement, HHS adopted the revised OMB
categories for including race and ethnicity in HHS funded and sponsored
data collection and reporting systems. The HHS policy states that the
categories described in revised OMB Directive 15 and its future
revisions should be used when collecting and reporting data in HHS data
systems or reporting HHS funded statistics.[^13]

The Agency recommends that sponsors use the categories outlined in this
guidance when collecting race and ethnicity data in clinical studies for
FDA-regulated products conducted in United States and abroad. More
detailed race and ethnicity data can be collected when appropriate to
the study or locale, but we recommend that these more detailed race and
ethnicity data be related to the identified OMB categories of all
clinical trial participants when submitting such data to the Agency.

# collecTINg RACE AND ETHNICITY DATA IN CLINICAL TRIALS 

# 

The recommendations in this section reflect the Agency\'s interest in
more consistent data collection. For studies conducted in the United
States, the Agency recommends that a two-question format be used, and
that trial participants self-report their racial and ethnic ancestral
origins. Based on the current OMB Directive, the Agency provides the
following recommendations for the collection of the data:

1.  We recommend using the two-question format for requesting race and
    ethnicity information, with the ethnicity question preceding the
    question about race.

2.  We recommend that study participants self-report race and ethnicity
    information whenever feasible, and that individuals be permitted to
    designate a multiracial identity. When the collection of
    self-reported designations is not feasible (e.g., because of the
    subject's inability to respond), we recommend that the information
    be requested from a first-degree relative or other knowledgeable
    source.

3.  For ethnicity, we recommend the following minimum choices be
    offered:

-   Hispanic or Latino

-   Not Hispanic or Latino

4.  When race and ethnicity information is collected separately, we
    recommend the following minimum choices be offered for race:[^14]

-   American Indian or Alaska Native

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-   Asian

-   Black or African American

-   Native Hawaiian or Other Pacific Islander

-   White

5.  In certain situations, as recommended in OMB Directive 15, more
    detailed race and ethnicity information may be desired (e.g.,
    *White* can reflect origins in Europe, the Middle East, or North
    Africa; *Asian* can reflect origins from areas ranging from India to
    Japan). If more detailed characterizations of race or ethnicity are
    collected to enhance data consistency, we recommend these
    characterizations be traceable to the five minimum designations for
    race and two designations for ethnicity (five and two) listed in
    numbers 3 and 4. When more detailed characterizations are desired,
    the use of Race and Ethnicity vocabulary tables located within
    Health Level Seven's[^15] Reference Information Model Structural
    Vocabulary Tables is recommended. These tables provide the OMB
    characterizations traceable to more detailed characterizations and
    concept ID code sets to help ensure that traceability is consistent.
    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.

# Clinical Trials Conducted Outside of the United States

To assist in assessing the relevance of foreign study population data to
U.S. populations, we recommend that sponsors use the OMB standardized
categories when collecting data from study participants in clinical
trials conducted outside of the United States. However, FDA recognizes
that the recommended categories for race and ethnicity were developed in
the United States and that these categories may not adequately describe
racial and ethnic groups in foreign countries. Therefore, for studies
conducted outside the United States, we recommend using more detailed
categories to provide sponsors the flexibility to adequately
characterize race and ethnicity. If sponsors choose to use more detailed
characterizations of race and ethnicity, it is important for analytical
purposes that the data can be traced back to the recommended categories
described below. When more detailed characterizations are desired, the
use of the Race and Ethnicity vocabulary tables located within Health
Level Seven's Reference Information Model Structural Vocabulary Tables
is recommended[^16]. These tables provide the five and two OMB
characterizations traceable to more detailed characterizations and
concept ID code sets and their use will help ensure that traceability is
consistent. Where gaps exist in the representation of race or ethnicity
categories, sponsors are encouraged to discuss the issue with the
appropriate review division.

1.  For ethnicity, we recommend the following categories or the use of
    categories that are mappable to the two categories listed below:

-   Hispanic or Latino

-   Not Hispanic or Latino

2.  When race is collected separately in clinical studies conducted in
    foreign countries, we recommend that the categories be modified to
    reflect the following, as appropriate:

-   American Indian or Alaska Native

-   Asian

-   Black

-   Native Hawaiian or Other Pacific Islander

-   White

    Note that the ethnic and racial categories for studies inside and
    outside the United States are the same, except for one racial
    designation: the racial designation is African American in the
    United States, whereas it is Black for studies conducted in foreign
    countries.

# PRESENTATION OF DEMOGRAPHIC TABULATIONS IN THE eCTD

For INDs, NDAs, BLAs and relevant device submissions we recommend the
submission of tabulated demographic data based on the Demographic Rule
for all clinical studies using the characterizations of race and
ethnicity described in this guidance.

For submitting an electronic application not in FDA\'s typical
application format (i.e., when using the ICH document for submitting a
marketing application to FDA and regulatory agencies in Japan and
Europe, the eCTD) presentation of demographic data is described in ICH
M4E eCTD Guidance (section 2.7.4.1.3 and table 2.7.4.2), which suggests
a tabular display of demographic characteristics (e.g., age, gender,
race) by treatment group (e.g., active drug, placebo). The document
suggests specific kinds of demographic information to be collected as a
part of a clinical trial, but does not provide rigid specifications on
how the data should be presented, noting, for example, that "if relative
exposure of demographic groups in the controlled trials differ from the
overall exposure, it may be useful to provide separate tables." Choices
of how best to summarize demographic data depend on the nature of the
data to be conveyed. For some trials, it may be useful to show the
distribution of one demographic characteristic within a second
demographic (e.g., the age distribution of men and women enrolled in a
set of controlled trials).

With regard to the description of race and ethnicity, the categories
that are suggested previously in this document (sections III and IV) are
preferable to those suggested in ICH M4E eCTD guidance.

# APPENDIX 1

# History of federal efforts In DATA collection on Race and ethnicity and other subpopulations

For more than 20 years, a number of U.S. Government initiatives have
tried to address questions related to whether to and how to collect race
and ethnicity data. Major initiatives are reviewed briefly here.

**Office of Management and Budget (OMB) Initiatives**

In May 1977, OMB issued "Statistical Policy Directive No. 15, Race and
Ethnic Standards for Federal Statistics and Administrative Reporting."
The standards were developed in response to the need to enforce civil
rights laws in education. These classifications were not to be
interpreted as being scientific or anthropological in nature, or to be
viewed as determinants of eligibility for participation in any Federal
program. They were developed in response to needs expressed by both the
Executive Branch and the Congress to provide for the collection and use
of compatible, nonduplicated, exchangeable race and ethnicity data by
Federal agencies. This Directive specified four categories for race:

-   American Indian or Alaskan Native

-   Asian or Pacific Islander

-   Black

-   White

    And two categories for ethnicity:

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-   Hispanic

-   Not of Hispanic origin

    The OMB Directive specified two questionnaire formats for data
    collection: (1) a format combining race and ethnicity, and (2) a
    preferred format with two separate questions for race and ethnicity.

    Since 1993, efforts have been under way to standardize the
    collection of race and ethnicity data to foster comparability across
    data collection and reporting systems. In 1997, OMB published
    Directive 15, "Revisions to the Standards for the Classification of
    Federal Data on Race and Ethnicity" (see Appendix 2). These
    revisions specified the minimum racial and ethnic diversity
    categories to be used when race and ethnicity are included in data
    collection and reporting for Federal programs. The Directive does
    not require that race and ethnicity be included in data collection
    and reporting; rather, it specifies what formats and categories to
    use when collecting this kind of data.

    The revised OMB standards made the following changes:

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-   Introduced the option of reporting more than one race for
    multiracial persons

-   Divided the Asian or Pacific Islander category into two --- one
    labeled Asian, the other Native Hawaiian or Other Pacific Islander

-   Changed Hispanic to Hispanic or Latino

-   Changed Black to Black or African-American

-   Strongly encouraged the use of self-identification

-   Maintained the two-question format for race and Hispanic ethnicity
    when self-identification is used (the Hispanic origin question
    should precede the race question)

    The revised categories were described in an OMB guidance entitled
    *Implementation of the 1997 Standards for Federal Data on Race and
    Ethnicity* (2000) as sociopolitical and intended for use in the
    collection of health data, among other types of statistics.

    **Department of Health and Human Services Initiatives**

    In 1999, the Department of Health and Human Services (HHS) issued a
    report, *Improving the Collection and Use of Racial and Ethnic Data
    in HHS*. The report describes HHS policy on collecting and reporting
    data on race and ethnicity for HHS programs. The report asks for the
    inclusion of race and ethnicity categories in HHS funded and
    sponsored data collection and reporting systems in all HHS programs,
    including in both health and human services. This policy clearly
    states that the minimum standard categories in OMB Directive 15 and
    revisions should be used when collecting and reporting data in HHS
    data systems or reporting HHS funded statistics. The policy was
    developed to (1) help monitor HHS programs, (2) determine whether
    Federal funds are being used in a nondiscriminatory manner, and (3)
    promote the availability of standard race and ethnicity data across
    various agencies to facilitate HHS responses to major health and
    human services issues.

    **National Institutes of Health Initiatives**

    In 1993, the National Institutes of Health (NIH) Revitalization Act
    directed NIH to establish guidelines for including women and
    minorities in NIH-sponsored clinical research. NIH was directed to
    ensure that women and minorities were included as subjects, unless
    their exclusion was justified due to circumstances specified by NIH
    guidelines. Furthermore, clinical trials were to be designed and
    carried out in a manner that would elicit information about
    individuals of both genders and diverse racial and ethnic groups to
    examine differential effects on such groups. NIH guidelines
    stipulate that when proposing a Phase 3 clinical trial, evidence
    must be reviewed to establish whether or not there are potentially
    clinically important gender- and minority-based differences in the
    anticipated effects of the intervention. If previous studies support
    the existence of significant differences, the primary questions and
    design of the study must specifically accommodate this. For example,
    if men and women are thought to respond differently to an
    intervention, then the Phase 3 clinical trial must be designed to
    answer two separate primary questions, one for men, and the other
    for women. When prior studies support no significant differences for
    either gender or minorities with a given intervention, then gender
    and minority status will not be required as subject selection
    criteria, although the inclusion and analysis of both genders and
    minorities is strongly encouraged. When prior studies neither
    support nor negate significant differences, then the design of the
    Phase 3 clinical trial will be required to support sufficient
    representation of both genders and minorities to allow for valid
    analysis of the intervention effects across all groups. However, the
    trial will not be required to provide high statistical power for
    these comparisons.

    **Food and Drug Administration Initiatives**

    Beginning in the 1980s, FDA grew concerned about possible
    differences in drug safety and efficacy among different population
    subgroups. Because the origins of subpopulation issues stem from the
    identification of differences in response in women and geriatric
    populations, references to those initiatives are included below. In
    1983, the Agency initiated development of guidance on the study of
    drugs to be used in geriatric patients. FDA\'s *Guideline for the
    Study of Drugs Likely to be Used in the Elderly* was issued in 1989.

    The first regulation specifying the analysis of population subsets
    appeared in 1985 in 21 CFR 314.50, which called for evidence to
    support the "dosage and administration section of the labeling,
    including support for the dosage and dose interval recommended," and
    modifications for specific subgroups (e.g., pediatrics, geriatrics,
    patients with renal failure) (21 CFR 314.50(d)(5)(v)).

    In 1988, the Agency issued guidance describing elements of a new
    drug application\'s analysis of clinical study data. [*Guideline for
    the Format and Content of the Clinical and Statistical Sections of
    New Drug
    Applications*](http://www.fda.gov/cder/guidance/statnda.pdf)
    emphasized the importance of conducting subset analyses on data from
    clinical studies submitted in new drug applications (NDAs). This
    guidance specified race and ethnicity as types of population subsets
    for which separate analyses of data from clinical studies should be
    conducted for assessments of product safety and effectiveness.

    In July 1993, FDA published a guidance on the study of drugs in both
    genders entitled *Guideline for the Study and Evaluation of Gender
    Differences in the Clinical Evaluation of Drugs*. The guidance
    specifically called for analyzing trials by gender and for
    evaluating pharmacokinetics in women. In the *Federal Register*
    notice announcing the guidance, FDA also abandoned the policy
    explained in a 1977 guidance, excluding women of childbearing
    potential from participation in the earliest phases of clinical
    trials.

    In 1993, FDA also published *New Drug Evaluation Guidance Document:
    Refusal to File*, on the Agency\'s use of the refusal-to-file (RTF)
    option if certain analyses were not performed. The guidance states
    that the Agency can exercise its RTF authority under 21 CFR
    314.101(d)(3) if there is "inadequate evaluation for safety and/or
    effectiveness of the population intended to use the drug, including
    pertinent subsets, such as gender, age, and racial subsets."

    In the Food and Drug Administration Modernization Act of 1997 (the
    Modernization Act), Congress directed FDA to examine issues related
    to the inclusion of racial and ethnic groups in clinical trials of
    new drugs. Section 115(b) of the Modernization Act required the
    Secretary, "in consultation with the Director of the National
    Institutes of Health and with representatives of the drug
    manufacturing industry, \[to\] review and develop guidance, as
    appropriate, on the inclusion of women and minorities in clinical
    trials. . . ." (codified at 21 U.S.C. 355(b)(1)). In response, FDA
    established the Women and Minorities Working Group to review and
    implement this section of the Modernization Act. In a report issued
    on July 20, 1998, the Working Group concluded that the Agency would
    implement procedures to enhance its ability to gather and evaluate
    demographic data, and then decide whether additional guidance should
    be developed in the future. 

    In 1998, the Agency published the Demographic Rule, which amended
    the language in 21 CFR 312.33(a)(2) and 314.50(d)(5), requiring
    sponsors to (1) tabulate the numbers of participants in clinical
    trials by age group, gender, and race in investigational new drug
    application (IND) annual reports, (2) characterize the data in NDAs
    according to these same subgroups, and (3) when appropriate, present
    safety data from other subgroups of the population of patients, such
    as for patients with hepatic or renal failure or patients with
    different levels of severity of the disease.

    In 1999, a guidance for industry entitled [*Population
    Pharmacokinetics*](http://www.fda.gov/cder/guidance/1852fnl.pdf)
    made recommendations on the use of population pharmacokinetics in
    the drug development process to help identify differences in drug
    safety and efficacy among population subgroups, including race and
    ethnicity. This guidance recommended that industry conduct clinical
    studies in subjects representative of the population to be treated
    with the drug.

    In 2002, the Best Pharmaceuticals for Children Act (Public Law
    107-109, January 4, 2002) directed FDA to monitor the racial and
    ethnic designations of children participating in clinical studies
    for pharmaceutical products.

    **ICH E5 - Guidance on Ethnic Factors in the Acceptability of
    Foreign Clinical Data**

    In 1999, as part of an international effort by Japan, the European
    Union, and the United States to harmonize technical requirements for
    pharmaceutical drug development and regulation (the International
    Conference on Harmonization (ICH)), the FDA published a guidance
    entitled *E5 Guidance on Ethnic Factors in the Acceptability of
    Foreign Clinical Data* (63 FR 31790, June 10, 1999), to permit the
    clinical data collected in one region to be used in the registration
    or approval of a drug or biological product in another region, while
    allowing for the influence of ethnic factors. The *E5* guidance
    defines ethnic factors that affect response in terms of both
    intrinsic and extrinsic issues. Because differences in ethnic
    factors have the potential to affect responses in some
    subpopulations, the *E5* guidance provides a general framework for
    evaluating medicines with regard to their sensitivity to ethnic
    factors.

# Appendix 2

# 

# Revised Directive 15

**OMB Standards for Maintaining, Collecting, and Presenting**

**Federal Data on Race and Ethnicity**

*(Adopted on October 30, 1997)*

This classification provides a minimum standard for maintaining,
collecting, and presenting data on race and ethnicity for all Federal
reporting purposes. The categories in this classification are
social-political constructs and should not be interpreted as being
scientific or anthropological in nature. They are not to be used as
determinants of eligibility for participation in any Federal program.
The standards have been developed to provide a common language for
uniformity and comparability in the collection and use of data on race
and ethnicity by Federal agencies.

The standards have five categories for data on race: American Indian or
Alaska Native, Asian, Black or African American, Native Hawaiian or
Other Pacific Islander, and White. There are two categories for data on
ethnicity: Hispanic or Latino, and Not Hispanic or Latino.

1.  **Categories and Definitions**

    The minimum categories for data on race and ethnicity for Federal
    statistics, program administrative reporting, and civil rights
    compliance reporting are defined as follows:

    **American Indian or Alaska Native.** A person having origins in any
    of the original peoples of North and South America (including
    Central America), and who maintains tribal affiliation or community
    attachment.

    **Asian.** A person having origins in any of the original peoples of
    the Far East, Southeast Asia, or the Indian subcontinent, including,
    for example, Cambodia, China, India, Japan, Korea, Malaysia,
    Pakistan, the Philippine Islands, Thailand, and Vietnam.

    **Black or African American.** A person having origins in any of the
    black racial groups of Africa. Terms such as "Haitian" or "Negro"
    can be used in addition to "Black or African American."

    **Hispanic or Latino.** A person of Cuban, Mexican, Puerto Rican,
    South or Central American, or other Spanish culture or origin,
    regardless of race. The term, "Spanish origin," can be used in
    addition to "Hispanic or Latino."

    **Native Hawaiian or Other Pacific Islander.** A person having
    origins in any of the original peoples of Hawaii, Guam, Samoa, or
    other Pacific Islands.

    **White.** A person having origins in any of the original peoples of
    Europe, the Middle East, or North Africa.

    Respondents shall be offered the option of selecting one or more
    racial designations. Recommended forms for the instruction
    accompanying the multiple response question are "Mark one or more"
    and "Select one or more."

2.  **Data Formats**

    The standards provide two formats that may be used for data on race
    and ethnicity. Self-reporting or self-identification using two
    separate questions is the preferred method for collecting data on
    race and ethnicity. In situations where self-reporting is not
    practicable or feasible, the combined format may be used.

    In no case shall the provisions of the standards be construed to
    limit the collection of data to the categories described above. The
    collection of greater detail is encouraged; however, any collection
    that uses more detail shall be organized in such a way that the
    additional categories can be aggregated into these minimum
    categories for data on race and ethnicity.

    With respect to tabulation, the procedures used by Federal agencies
    shall result in the production of as much detailed information on
    race and ethnicity as possible. However, Federal agencies shall not
    present data on detailed categories if doing so would compromise
    data quality or confidentiality standards.

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a.  **Two-question format**

    To provide flexibility and ensure data quality, separate questions
    shall be used wherever feasible for reporting race and ethnicity.
    When race and ethnicity are collected separately, ethnicity shall be
    collected first. If race and ethnicity are collected separately, the
    minimum designations are:

    **Race:**

    American Indian or Alaska Native

    Asian

    Black or African American

    Native Hawaiian or Other Pacific Islander

    White

    **Ethnicity**:

    Hispanic or Latino

    Not Hispanic or Latino

    When data on race and ethnicity are collected separately, provision
    shall be made to report the number of respondents in each racial
    category who are Hispanic or Latino. When aggregate data are
    presented, data producers shall provide the number of respondents
    who marked (or selected) only one category, separately for each of
    the five racial categories. In addition to these numbers, data
    producers are strongly encouraged to provide the detailed
    distributions, including all possible combinations of multiple
    responses to the race question. If data on multiple responses are
    collapsed, at a minimum the total number of respondents reporting
    "more than one race" shall be made available.

b.  **Combined format**

    The combined format may be used, if necessary, for
    observer-collected data on race and ethnicity. Both race (including
    multiple responses) and ethnicity shall be collected when
    appropriate and feasible, although the selection of one category in
    the combined format is acceptable. If a combined format is used,
    there are six minimum categories:

    American Indian or Alaska Native

    Asian

    Black or African American

    Hispanic or Latino

    Native Hawaiian or Other Pacific Islander

    White

    When aggregate data are presented, data producers shall provide the
    number of respondents who marked (or selected) only one category,
    separately for each of the six categories. In addition to these
    numbers, data producers are strongly encouraged to provide the
    detailed distributions, including all possible combinations of
    multiple responses. In cases where data on multiple responses are
    collapsed, the total number of respondents reporting "Hispanic or
    Latino and one or more races" and the total number of respondents
    reporting "more than one race" (regardless of ethnicity) shall be
    provided.

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3.  **Use of the Standards for Record Keeping and Reporting**

    The minimum standard categories shall be used for reporting as
    follows:

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a.  **Statistical reporting**

    These standards shall be used at a minimum for all federally
    sponsored statistical data collections that include data on race
    and/or ethnicity, except when the collection involves a sample of
    such size that the data on the smaller categories would be
    unreliable, or when the collection effort focuses on a specific
    racial or ethnic group. Any other variation will have to be
    specifically authorized by the OMB through the information
    collection clearance process. In those cases where the data
    collection is not subject to the information collection clearance
    process, a direct request for a variance shall be made to OMB.

b.  **General program administrative and grant reporting**

    These standards shall be used for all Federal administrative
    reporting or record keeping requirements that include data on race
    and ethnicity. Agencies that cannot follow these standards must
    request a variance from OMB. Variances will be considered if the
    agency can demonstrate that it is not reasonable for the primary
    reporter to determine racial or ethnic background in terms of the
    specified categories, that determination of racial or ethnic
    background is not critical to the administration of the program in
    question, or that the specific program is directed to only one or a
    limited number of racial or ethnic groups.

c.  **Civil rights and other compliance reporting**

    These standards shall be used by all Federal agencies in either the
    separate or combined format for civil rights and other compliance
    reporting from the public and private sectors and all levels of
    government. Any variation requiring less detailed data or data which
    cannot be aggregated into the basic categories must be specifically
    approved by OMB for executive agencies. More detailed reporting
    which can be aggregated to the basic categories may be used at the
    agencies\' discretion.

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4.  **Presentation of Data on Race and Ethnicity**

    Displays of statistical, administrative, and compliance data on race
    and ethnicity shall use the categories listed above. The term
    "nonwhite" is not acceptable for use in the presentation of Federal
    Government data. It shall not be used in any publication or in the
    text of any report. In cases where the standard categories are
    considered inappropriate for presentation of data on particular
    programs or for particular regional areas, the sponsoring agency may
    use:

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a.  The designations "Black or African American and Other Races" or "All
    Other Races" as collective descriptions of minority races when the
    most summary distinction between the majority and minority races is
    appropriate;

b.  The designations "White," "Black or African American," and "All
    Other Races" when the distinction among the majority race, the
    principal minority race, and other races is appropriate; or

c.  The designation of a particular minority race or races, and the
    inclusion of "Whites" with "All Other Races" when such a collective
    description is appropriate. In displaying detailed information that
    represents a combination of race and ethnicity, the description of
    the data being displayed shall clearly indicate that both bases of
    classification are being used.

    When the primary focus of a report is on two or more specific
    identifiable groups in the population, one or more of which is
    racial or ethnic, it is acceptable to display data for each of the
    particular groups separately and to describe data relating to the
    remainder of the population by an appropriate collective
    description.

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5.  **Effective Date**

    The provisions of these standards are effective immediately for all
    new and revised record keeping or reporting requirements that
    include racial and/or ethnic information. All existing record
    keeping or reporting requirements shall be made consistent with
    these standards at the time they are submitted for extension, or not
    later than January 1, 2003.

# REFERENCES

Exner, D., D. Dries, M. Donamski, and J. Cohn, 2001, "Lesser Response to
Angiotensin-Converting-Enzyme Inhibitor Therapy in Black as Compared
with White Patients With Left Ventricular Dysfunction," *N Engl J Med*,
344: 1351-1357.

Freedman, L.S., R.M. Simon, M.A. Foulkes, L.M. Freedman, N.L. Gordon, et
al., 1995, "Inclusion of Women and Minorities in Clinical Trials and the
NIH Revitalization Act --- the Perspective of NIH Clinical Trialists,"
*Control Clin Trials,* 16(5):277-285, 310-312.

McHutchison, J., T. Poynard, S. Pianko, S. Gordon, A. Reid, et al.,
2000, "The Impact of Interferon Alpha Plus Ribavirin on Response to
Therapy in Black Patients with Chronic Hepatitis C. The International
Hepatitis Interventional Therapy Group," *Gastroenterology*, 119:
1317-23.

Reddy, K. R., J. Hoofnagle, M. Tong, W. Lee, P. Pockros, et al., 1999,
"Racial Differences in Responses to Therapy with Interferon in Chronic
Hepatitis C. Consensus Interferon Study Group," *Hepatology*, 30:
787-93.

Taylor, S., 2002, "Skin of Color: Biology, Structure, Function, and
Implications for Dermatologic Disease," *Journal of American Academy of
Dermatology*, 46:S41-62.

Xie, H., R. Kim, A. Wood, and C. Stein, 2001, "Molecular Basis of Ethnic
Differences in Drug Disposition and Response," *Annu Rev Pharmacol
Toxicol*, 41:815-50.

Yancy, C., M. Fowler, W. Colucci, E. Gilbert, M. Bristow, et al., 2001,
"Race and the Response to Adrenergic Blockade with Carvedilol in
Patients with Chronic Heart Failure," *N Engl J Med*, 344: 1358-1365.

# BIBLIOGRAPHY

**DHHS Policy and Reports**

Department of Health and Human Services (DHHS), 1997, *Policy For
Improving Race and Ethnicity Data, October 24, 1997,*
<http://www.hhs.gov/oirm/infocollect/nclusion.html>*.*

DHHS, 1999, *Improving the Collection and Use of Racial and Ethnic Data
in HHS*, joint report of the HHS Data Council Working Group on Racial
and Ethnic Data and the Data Work Group of the HHS Initiative to
Eliminate Racial and Ethnic Disparities in Health, December 1999,
<http://aspe.hhs.gov/datacncl/racerpt/index.htm>.

**FDA Regulations**

Food and Drug Administration (FDA), 1998, "Investigational New Drug
Applications and New Drug Applications," Final Rule, *Federal Register*
(63 FR 6854, February 11, 1998).

FDA, *Content and Format for Human Prescription Drugs; Addition of
"Geriatric Use" Subsection in the Labeling*, Final Rule, *Federal
Register* (62 FR 45313, August 27, 1997).

**FDA Guidance for Industry**

*Clinical Studies Section of Labeling for Prescription Drugs and
Biologics* (Draft)[^17]

*Content and Format for Geriatric Labeling*

*Content and Format of the Adverse Reactions Section of Labeling for
Human Prescription Drugs and Biologics* (Draft)

*General Considerations for Pediatric Pharmacokinetic Studies for Drugs
and Biological Products* (Draft)

*General Considerations for the Clinical Evaluation of Drugs*

*Format and Content of the Clinical and Statistical Sections of an
Application*

*Study and Evaluation of Gender Differences in the Clinical Evaluation
of Drugs*

*Study of Drugs Likely to be Used in the Elderly*

*In Vivo Drug Metabolism/Drug Interaction Studies --- Study Design, Data
Analysis, and Recommendations for Dosing and Labeling*

*Pharmacokinetics in Patients with Impaired Hepatic Function: Study
Design, Data Analysis, and Impact on Dosing and Labeling*

*Pharmacokinetics in Patients with Impaired Renal Function: Study
Design, Data Analysis and Impact on Dosing and Labeling*

*Population Pharmacokinetics*

*Refusal to File*

**ICH Guidances**

ICH, *E4 Dose Response Information to Support Drug Registration*

ICH, *E5 Ethnic Factors in the Acceptability Of Foreign Data*

ICH, *E7 Studies in Support of Special Populations: Geriatrics*

ICH, *E11 Clinical Investigation of Medicinal Products in the Pediatric
Population*

ICH, *M4 Common Technical Document for the Registration of
Pharmaceuticals for Human Use*

**Other Sources**

Office of Management and Budget, 1994, Standards for the Classification
of Federal Data on Race and Ethnicity,
<http://www.whitehouse.gov/omb/fedreg/notice_15.html>.

General Accounting Office, *FDA Needs to Ensure More Study of Gender
Differences in Prescription Drug Testing*, GAO/HFD-93-17.

NIH Revitalization Act of 1993, (PL 103-43).

NIH Guidelines on the Inclusion of Women and Minorities as Subjects in
Clinical Research- Updated August 1, 2000. Available at
<http://grants.nih.gov/grants/funding/women_min/women_min.htm>.

Food and Drug Administration Modernization Act of 1997 (Public Law
105-115).

Best Pharmaceuticals Act for Children of 2002 (Public Law 107-109).

[^1]: This guidance has been developed by the Agency-wide Race and
    Ethnicity Working Group from the Office of the Commissioner (OC),
    the Center for Biologics Evaluation and Research (CBER), the Center
    for Drug Evaluation and Research (CDER), and the Center for Devices
    and Radiological Health (CDRH) of the Food and Drug Administration
    (FDA).

[^2]: See CDISC standardized Study Data Tabulation Model (SDTM),
    Analysis Data Model (ADaM), Operational Data Model (ODM) at
    http://www.cdisc.org.

[^3]: See FDA\'s guidance for industry titled *M4 Common Technical
    Document for the Registration of Pharmaceuticals for Human Use*
    (eCTD guidance) for the submission file location of the table format
    presented in section V of this guidance. Available at
    <http://www.fda.gov/cder/regulatory/ersr/ectd.htm>.

[^4]: 63 FR 6854 (February 11, 1998) (codified at 21 CFR 312.33(a)(2)
    and 21 CFR 314.50(d)(5)).

[^5]: 21 CFR 312.33(a)(2). See also 21 CFR 314.50(d)(5)(v) and (vi)(*a*)
    regarding demographic data submission in NDAs.

[^6]: Under 21 CFR 314.101(d)(3), the Agency may refuse to file an NDA
    if it is incomplete because it does not contain information required
    by 21 CFR 314.50. Thus, if there is an inadequate evaluation for
    safety and/or effectiveness of the population intended to use the
    drug, including pertinent subsets, such as gender, age, and racial
    subsets the Agency may refuse to file the application. See FDA\'s
    guidance for industry titled *New Drug Evaluation Guidance Document:
    Refusal to File,* available on the Internet at
    <http://www.fda.gov/cder/guidance/index.htm>.

[^7]: Statistical Policy Directive No. 15, Race and Ethnic Standards for
    Federal Statistics and Administrative Reporting, 1997 (reprinted in
    Appendix 2). See also the OMB guidance entitled *Provisional
    Guidance on the Implementation of the 1997 Standards for Federal
    Data on Race and Ethnicity* (2000), available at
    <http://www.whitehouse.gov/omb/bulletins/b00-02.html>.

[^8]: In fact, in June of 2005, FDA approved BiDil, the first drug
    approved by the Agency to treat a disease in patients identified by
    race. The drug was approved for the treatment of heart failure in
    black patients. The company conducted two trials in the general
    population that failed to show a benefit, but suggested a benefit of
    BiDil in black patients. The company then studied the drug in 1,050
    self-identified black patients and it was shown to be safe and
    effective.

[^9]: The terms used in this guidance to describe the various racial and
    ethnic groups are those used by OMB.

[^10]: 63 FR 6854 at 6855, February 11, 1998.

[^11]: In the preamble to the final rule, FDA stated that it did not
    believe it was necessary to define specific racial categories in the
    rule itself because drug sponsors have been successful in
    identifying the relevant racial categories to examine safety and
    efficacy profiles of drugs (63 FR 6854 at 6859). However, FDA now
    believes that using uniform categories will enhance the consistency
    and comparability of data across studies submitted in marketing
    applications and other government reported statistics.

[^12]: Memorandum issued by HHS Sec. Donna Shalala on October 24, 1997
    reaffirming HHS' commitment to the inclusion of data on minority
    groups in research, services and related activities. Effective as of
    November 1,1997. Available at
    <http://aspe.hhs.gov/datacncl/inclusn.htm>.

[^13]: OMB directed these activities to begin by January 1, 2003, in all
    Federal programs, including HHS. Although in the past FDA sought and
    received a variance from OMB exempting the Agency from reporting
    data using the Directive 15 categories, FDA now recommends the use
    of the categories to enhance data consistency. To view the policy
    memorandum see: http://www.hhs.gov/oirm/infocollect/nclusion.html

[^14]: To identify ancestral origins for each of the named categories
    see OMB Directive 15 (Appendix 2).

[^15]: Health Level Seven (HL7), an American National Standards
    Institute (ANSI) accredited organization, has been designated by the
    Department as a Standards Development Organization for the
    development of interoperability standards for health care and health
    related information, and is available at
    [http://hl7.org](http://hl7.org/).

[^16]: These tables are located at [http://hl7.org](http://hl7.org/). To
    locate the tables from HL7's home page click on HL7 Standards under
    Resources, then RIMS, HL7 Reference Model Structured Vocabulary
    Tables in HTML, 2.1 HL7 Vocabulary Domain Values and select either
    the Race or Ethnicity table from the list.

[^17]: Draft guidances are included for completeness only. As draft
    documents, they are not intended to be implemented until published
    in final form.