Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 39927-39929 [2016-14461]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices
B. Annual Reporting Burden
Respondents: 160,082.
Responses per Respondent: 1.
Total Annual Responses: 160,082.
Hours per response: 3.8386 minutes.
Total Burden hours: 10,241.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 3090–0297,
Generic Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery, in all correspondence.
Dated: June 14, 2016.
David A. Shive,
Chief Information Officer.
[FR Doc. 2016–14509 Filed 6–17–16; 8:45 am]
BILLING CODE 6820–34–P
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Device Clinical Studies; Draft
Guidance for Industry and Food and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.
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announcing the availability of the draft
guidance entitled ‘‘Evaluation and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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:05 Jun 17, 2016
Jkt 238001
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This draft guidance is not final nor is it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: 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): 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
39927
Studies.’’ 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
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 https://
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: https://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 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 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
E:\FR\FM\20JNN1.SGM
20JNN1
39928
Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
17:05 Jun 17, 2016
Jkt 238001
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 ethnicityspecific 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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
Regulatoryinformation/Guidances/
default.htm or https://
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 CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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 https://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
https://www.fda.gov/downloads/
RegulatoryInformation/Legislation/
FederalFoodDrugand
CosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/
FDASIA/UCM365544.pdf.
2. FDA’s Action Plan to Enhance the
Collection and Availability of
Demographic Subgroup Data (August,
2014), available at https://www.fda.gov/
downloads/RegulatoryInformation/
Legislation/FederalFoodDrug
andCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/
FDASIA/UCM410474.pdf.
3. FDA’s guidance entitled ‘‘Evaluation of
Sex-Specific Data in Medical Device
Clinical Studies’’ (August 22, 2014),
available at https://www.fda.gov/
downloads/medicaldevices/
deviceregulationandguidance/
guidancedocuments/ucm283707.pdf.
E:\FR\FM\20JNN1.SGM
20JNN1
Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–1026]
Medical Devices; Exemption From
Premarket Notification: Method,
Metallic Reduction, Glucose (Urinary,
Non-Quantitative) Test System in a
Reagent Tablet Format; Republication
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; republication.
The Food and Drug
Administration (FDA) is republishing in
its entirety a notice entitled ‘‘Medical
Devices; Exemption from Premarket
Notification: Method, Metallic
Reduction, Glucose (Urinary, NonQuantitative) Test System in a Reagent
Tablet Format’’ that published in the
Federal Register on May 4, 2016 (81 FR
26802). FDA is republishing to correct
an inadvertent error in the Docket
Number and to announce a revised
comment period. FDA is announcing
that it has received a petition requesting
exemption from the premarket
notification requirements for a method,
metallic reduction, glucose (urinary,
non-quantitative) test system in a
reagent tablet format that is intended to
measure glucosuria (glucose in urine).
Method, metallic reduction, glucose
(urinary, non-quantitative) test systems
in a reagent tablet format are used in the
diagnosis and treatment of carbohydrate
metabolism disorders including diabetes
mellitus, hypoglycemia, and
hyperglycemia. FDA is publishing this
notice to obtain comments in
accordance with procedures established
by the Food and Drug Administration
Modernization Act of 1997 (FDAMA).
DATES: Submit either electronic or
written comments by July 20, 2016.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:05 Jun 17, 2016
Jkt 238001
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): 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–P–1026 for ‘‘Medical Devices;
Exemption From Premarket
Notification: Method, Metallic
Reduction, Glucose (Urinary, NonQuantitative) Test System in a Reagent
Tablet Format.’’ 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
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
39929
redacted/blacked out, will be available
for public viewing and posted on https://
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: https://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 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ana
Loloei Marsal, Center for Devices and
Radiological Health (CDRH), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4552,
Silver Spring, MD 20993–0002, 301–
796–8774, anahita.loloeimarsal@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Under section 513 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must
classify devices into one of three
regulatory classes: Class I, class II, or
class III. FDA classification of a device
is determined by the amount of
regulation necessary to provide a
reasonable assurance of safety and
effectiveness. Under the Medical Device
Amendments of 1976 (1976
amendments) (Pub. L. 94–295), as
amended by the Safe Medical Devices
Act of 1990 (Pub. L. 101–629), devices
are to be classified into class I (general
controls) if there is information showing
that the general controls of the FD&C
Act are sufficient to assure safety and
effectiveness; into class II (special
controls) if general controls, by
themselves, are insufficient to provide
reasonable assurance of safety and
effectiveness, but there is sufficient
information to establish special controls
to provide such assurance; and into
E:\FR\FM\20JNN1.SGM
20JNN1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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): 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 https://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 https://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: https://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 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 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or https://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 CDRH-Guidance@fda.hhs.gov 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 https://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 https://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 https://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
https://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
