[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Notices]
[Pages 26687-26688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1264]


Enhancing the Diversity of Clinical Trial Populations--
Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Enhancing 
the Diversity of Clinical Trial Populations--Eligibility Criteria, 
Enrollment Practices, and Trial Designs.'' This draft guidance 
recommends approaches that sponsors of clinical trials to support a new 
drug application or a biologics license application can take to broaden 
eligibility criteria, when scientifically and clinically appropriate, 
and increase enrollment of underrepresented populations in their 
clinical trials. The draft guidance reflects FDA policy encouraging 
inclusion in clinical trials of participants representative of the 
broad population of patients who will be exposed to a marketed drug and 
is being issued to satisfy the FDA Reauthorization Act of 2017 (FDARA) 
mandate.

DATES: Submit either electronic or written comments on the draft 
guidance by August 6, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-1264 for ``Enhancing the Diversity of Clinical Trial 
Populations--Eligibility Criteria, Enrollment Practices, and Trial 
Designs.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and

[[Page 26688]]

contact information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ebla Ali-Ibrahim, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301-796-
3691; or Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Enhancing the Diversity of Clinical Trial Populations--
Eligibility Criteria, Enrollment Practices, and Trial Designs.'' This 
draft guidance recommends approaches that sponsors of clinical trials 
to support a new drug application or a biologics license application 
can take to broaden eligibility criteria, when scientifically and 
clinically appropriate, and increase enrollment of underrepresented 
populations in their clinical trials. This draft guidance reflects FDA 
policy encouraging inclusion in clinical trials of participants 
representative of the broad population of patients who will be exposed 
to a marketed drug. FDA is also issuing this guidance to satisfy the 
mandates under section 610(a)(3) of FDARA (Pub. L. 115-52).
    Certain populations are often excluded from trials without strong 
clinical or scientific justification (e.g., the elderly, those at the 
extremes of the weight range, individuals with organ dysfunction, those 
with malignancies or certain infections such as HIV, and children). In 
addition, participants with multiple concomitant illnesses and those 
receiving other drugs often do not meet eligibility criteria because of 
concerns that such conditions or other drugs could affect a 
determination of an investigational drug's safety or effectiveness. 
Pregnant women are also frequently excluded out of concern for fetal 
health. This draft guidance provides recommendations for more inclusive 
trial practices, trial designs, and methodological approaches sponsors 
can take to broaden eligibility criteria for clinical trials.
    Aspects of clinical trial recruitment practices, logistics, site 
selection, and design may affect the ability to recruit certain 
participants or to retain them in clinical trials. For example, a trial 
requiring participants to make frequent visits to specific sites may 
result in added burden for participants, including the elderly, 
children, disabled and cognitively impaired individuals who require 
transportation or caregiver assistance, or participants who live far 
from research facilities, such as those in rural or remote locations. 
For individuals under current clinical care on a regularly scheduled 
basis (e.g., individuals with multiple chronic conditions), additional 
clinical trial study visits may be burdensome and a disincentive for 
enrollment in clinical trials. This draft guidance provides 
recommendations on approaches sponsors can take to improve the 
diversity of enrolled participants in clinical trials by making trial 
participation less burdensome for participants and by adopting 
enrollment practices that enhance inclusiveness.
    Clinical trials of investigational drugs intended to treat rare 
diseases or conditions present a unique set of challenges. Because rare 
diseases often affect small, geographically dispersed patient 
populations with disease-related travel limitations, special efforts 
may be necessary to enroll and retain these patients to ensure that a 
broad spectrum of the patient population is represented in clinical 
trials. This draft guidance provides recommendations on approaches 
sponsors can take to broaden the eligibility criteria for clinical 
trials of investigational drugs intended to treat rare diseases and to 
improve the enrollment and retention of participants with rare 
diseases.
    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 current thinking of FDA on ``Enhancing 
the Diversity of Clinical Trial Populations--Eligibility Criteria, 
Enrollment Practices, and Trial Designs.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: June 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11978 Filed 6-6-19; 8:45 am]
 BILLING CODE 4164-01-P


