[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39927-39929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14461]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0734]
Evaluation and Reporting of Age, Race, and Ethnicity Data in
Medical Device Clinical Studies; Draft Guidance for Industry and Food
and Drug Administration Staff; 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the availability of the draft guidance entitled ``Evaluation and
Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical
Studies.'' The purpose of this document is to outline FDA's proposed
recommendations and expectations for the evaluation and reporting of
age, race, and ethnicity data in medical device clinical studies. The
primary intent of these recommendations is to improve the quality,
consistency, and transparency of data regarding the performance of
medical devices within specific age, race, and ethnic groups. This
draft guidance is not final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 19, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-0734 for ``Evaluation and Reporting of Age, Race, and
Ethnicity Data in Medical Device Clinical Studies.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical
Device Clinical Studies'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and
[[Page 39928]]
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, 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 request.
FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5428, Silver Spring, MD 20993-0002,
301-796-6349; 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
Section 907 of the Food and Drug Administration Safety and
Innovation Act (Pub. L 112-144) (FDASIA) directed the Agency to publish
and provide to Congress a report describing the extent to which
clinical trial participation and safety and effectiveness data by
demographic subgroups, including sex, age, race, and ethnicity, is
included in applications submitted to FDA (Ref 1). Section 907 also
directed FDA to publish and provide to Congress an action plan
outlining recommendations for improving the completeness and quality of
analyses of data on demographic subgroups in summaries of product
safety and effectiveness data and in labeling; on the inclusion of such
data, or the lack of availability of such data, in labeling; and on
improving the public availability of such data to patients health care
providers and researchers, and to indicate the applicability of these
recommendations to the types of medical products addressed in section
907. In the Action Plan, FDA committed to developing this draft
guidance as part of the strategy to fulfill FDASIA requirements (Ref.
2).
This guidance outlines FDA's recommendations and expectations for
patient enrollment, data analysis, and reporting of age, race, and
ethnicity data in medical device clinical studies. Specific objectives
of this guidance are to (1) encourage the collection and consideration
of age, race, ethnicity, and associated covariates (e.g., body size,
biomarkers, bone density) during the study design stage; (2) outline
recommended analyses of study subgroup data with a framework for
considering demographic data when interpreting overall study outcomes;
and (3) specify FDA's recommendations for reporting age, race, and
ethnicity-specific information in summaries and labeling for approved
or cleared medical devices. FDA believes these recommendations will
help improve the quality, consistency, and transparency of data
regarding the performance of medical devices within specific age, race,
and ethnic groups as well as encourage appropriate enrollment of
diverse populations including relevant age, race, and ethnic groups.
Proper evaluation and reporting of these data can benefit patients,
clinicians, researchers, regulators, and other stakeholders.
This document extends the policy established in FDA's guidance
entitled ``Evaluation of Sex-Specific Data in Medical Device Clinical
Studies'' to additional demographic subgroups of age, race, and
ethnicity (Ref. 3). Upon finalization of this draft guidance, FDA
intends to integrate the content of both guidances into one document.
II. Significance of Guidance
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 the evaluation
and reporting of age, race, and ethnicity data in medical device
clinical studies. 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.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to
download an electronic copy of ``Evaluation and Reporting of Age, Race,
and Ethnicity Data in Medical Device Clinical Studies'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1500026 to
identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
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). These
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subparts A
through E, have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814, subpart H, have been
approved under OMB control number 0910-0332; the collections of
information in 21 CFR part 822 have been approved under OMB control
number 0910-0449; and the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485.
V. Reference
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. FDA Report: Collection, Analysis, and Availability of Demographic
Subgroup Data for FDA-Approved Medical Products, issued August 2013,
required under FDASIA section 907, available at http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf.
2. FDA's Action Plan to Enhance the Collection and Availability of
Demographic Subgroup Data (August, 2014), available at http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf.
3. FDA's guidance entitled ``Evaluation of Sex-Specific Data in
Medical Device Clinical Studies'' (August 22, 2014), available at
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283707.pdf.
[[Page 39929]]
Dated: June 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14461 Filed 6-17-16; 8:45 am]
BILLING CODE 4164-01-P