82_FR_42994 82 FR 42819 - Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability

82 FR 42819 - Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 175 (September 12, 2017)

Page Range42819-42821
FR Document2017-19259

The Food and Drug Administration (FDA or Agency) is announcing the availability of the 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 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.

Federal Register, Volume 82 Issue 175 (Tuesday, September 12, 2017)
[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Pages 42819-42821]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19259]


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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; 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 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 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.

DATES: The announcement of the guidance is published in the Federal 
Register on September 12, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 42820]]

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-2016-D-0734 for ``Evaluation and Reporting of Age, Race, and 
Ethnicity Data in Medical Device Clinical Studies; Guidance for 
Industry and Food and Drug Administration Staff; Availability.'' 
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 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.thefederalregister.org/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.
    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 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 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: Katheryn O'Callaghan, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5418, 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 to improve 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 to 
improve 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 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.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of June 20, 2016 (81 FR 39927). FDA 
revised the guidance as appropriate in response to the comments. 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).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Evaluation and Reporting of Age, Race, and 
Ethnicity data in Medical Device Clinical

[[Page 42821]]

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. 
This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the 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/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 [email protected] to receive an electronic copy of 
the document. Please use the document number 1500626 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously 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. References

    The following references are on display in the Dockets Management 
Staff office (see ADDRESSES) and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, 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/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/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.

    Dated: September 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19259 Filed 9-11-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                                          Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices                                             42819

                                                third party may not wish to be posted,                  https://www.regulations.gov. Submit                   DEPARTMENT OF HEALTH AND
                                                such as medical information, your or                    both copies to the Dockets Management                 HUMAN SERVICES
                                                anyone else’s Social Security number, or                Staff. If you do not wish your name and
                                                confidential business information, such                 contact information to be made publicly               Food and Drug Administration
                                                as a manufacturing process. Please note                 available, you can provide this                       [Docket No. FDA–2016–D–0734]
                                                that if you include your name, contact                  information on the cover sheet and not
                                                information, or other information that                  in the body of your comments and you                  Evaluation and Reporting of Age,
                                                identifies you in the body of your                      must identify this information as                     Race, and Ethnicity Data in Medical
                                                comments, that information will be                      ‘‘confidential.’’ Any information marked              Device Clinical Studies; Guidance for
                                                posted on https://www.regulations.gov.                  as ‘‘confidential’’ will not be disclosed             Industry and Food and Drug
                                                  • If you want to submit a comment                     except in accordance with 21 CFR 10.20                Administration Staff; Availability
                                                with confidential information that you                  and other applicable disclosure law. For
                                                do not wish to be made available to the                                                                       AGENCY:    Food and Drug Administration,
                                                                                                        more information about FDA’s posting
                                                public, submit the comment as a                                                                               HHS.
                                                                                                        of comments to public dockets, see 80
                                                written/paper submission and in the                     FR 56469, September 18, 2015, or access               ACTION:   Notice of availability.
                                                manner detailed (see ‘‘Written/Paper                    the information at: https://www.gpo.gov/
                                                Submissions’’ and ‘‘Instructions’’).                                                                          SUMMARY:    The Food and Drug
                                                                                                        fdsys/pkg/FR-2015-09-18/pdf/2015-                     Administration (FDA or Agency) is
                                                Written/Paper Submissions                               23389.pdf.                                            announcing the availability of the
                                                   Submit written/paper submissions as                     Docket: For access to the docket to                guidance entitled ‘‘Evaluation and
                                                follows:                                                read background documents or the                      Reporting of Age, Race, and Ethnicity
                                                   • Mail/Hand delivery/Courier (for                    electronic and written/paper comments                 Data in Medical Device Clinical
                                                written/paper submissions): Dockets                     received, go to https://                              Studies.’’ The purpose of this document
                                                Management Staff (HFA–305), Food and                    www.regulations.gov and insert the                    is to outline FDA’s recommendations
                                                Drug Administration, 5630 Fishers                       docket number, found in brackets in the               and expectations for the evaluation and
                                                Lane, Rm. 1061, Rockville, MD 20852.                    heading of this document, into the                    reporting of age, race, and ethnicity data
                                                   • For written/paper comments                         ‘‘Search’’ box and follow the prompts                 in medical device clinical studies. The
                                                submitted to the Dockets Management                     and/or go to the Dockets Management                   primary intent of these
                                                Staff, FDA will post your comment, as                   Staff, 5630 Fishers Lane, Rm. 1061,                   recommendations is to improve the
                                                well as any attachments, except for                     Rockville, MD 20852.                                  quality, consistency, and transparency
                                                information submitted, marked and                                                                             of data regarding the performance of
                                                identified, as confidential, if submitted               FOR FURTHER INFORMATION CONTACT:                      medical devices within specific age,
                                                as detailed in ‘‘Instructions.’’                        James R. Hunter, Center for Drug                      race, and ethnic groups.
                                                   Instructions: All submissions received               Evaluation and Research, Controlled                   DATES: The announcement of the
                                                must include the Docket No. FDA–                        Substance Staff, Food and Drug                        guidance is published in the Federal
                                                2017–N–4515 for ‘‘International Drug                    Administration, 10903 New Hampshire                   Register on September 12, 2017.
                                                Scheduling; Convention on                               Ave., Bldg. 51, Rm. 5150, Silver Spring,              ADDRESSES: You may submit either
                                                Psychotropic Substances; Single                         MD 20993–0002, 301–796–3156, email:                   electronic or written comments on
                                                Convention on Narcotic Drugs;                           james.hunter@fda.hhs.gov.                             Agency guidances at any time as
                                                Ocfentanil, Carfentanil, Pregabalin,                    SUPPLEMENTARY INFORMATION:     In the                 follows:
                                                Tramadol, Cannabidiol, Ketamine, and                    Federal Register of August 14, 2017,
                                                Eleven Other Substances; Extension of                                                                         Electronic Submissions
                                                                                                        FDA published a notice with a 30-day
                                                Comment Period.’’ Received comments,                    comment period to request comments                      Submit electronic comments in the
                                                those filed in a timely manner (see                     on abuse potential, actual abuse,                     following way:
                                                ADDRESSES), will be placed in the docket                medical usefulness, trafficking, and                    • Federal eRulemaking Portal:
                                                and, except for those submitted as                      impact of scheduling changes on                       https://www.regulations.gov. Follow the
                                                ‘‘Confidential Submissions,’’ publicly                  availability for medical use of 17 drug               instructions for submitting comments.
                                                viewable at https://www.regulations.gov                 substances.                                           Comments submitted electronically,
                                                or at the Dockets Management Staff                                                                            including attachments, to https://
                                                Office between 9 a.m. and 4 p.m.,                          The Agency has received requests for               www.regulations.gov will be posted to
                                                Monday through Friday.                                  an extension of the comment period for                the docket unchanged. Because your
                                                   • Confidential Submissions—To                        the notice. Each request conveyed                     comment will be made public, you are
                                                submit a comment with confidential                      concern that the current 30-day                       solely responsible for ensuring that your
                                                information that you do not wish to be                  comment period does not allow                         comment does not include any
                                                made publicly available, submit your                    sufficient time to develop a meaningful               confidential information that you or a
                                                comments only as a written/paper                        or thoughtful response to the notice.                 third party may not wish to be posted,
                                                submission. You should submit two                          FDA has considered the requests and                such as medical information, your or
                                                copies total. One copy will include the                 is extending the comment period for the               anyone else’s Social Security number, or
                                                information you claim to be confidential                notice until September 20, 2017. The                  confidential business information, such
                                                with a heading or cover note that states                Agency believes this extension allows                 as a manufacturing process. Please note
                                                ‘‘THIS DOCUMENT CONTAINS                                adequate time for interested persons to               that if you include your name, contact
pmangrum on DSK3GDR082PROD with NOTICES1




                                                CONFIDENTIAL INFORMATION.’’ The                         submit comments.                                      information, or other information that
                                                Agency will review this copy, including                                                                       identifies you in the body of your
                                                                                                          Dated: September 7, 2017.
                                                the claimed confidential information, in                                                                      comments, that information will be
                                                its consideration of comments. The                      Anna K. Abram,
                                                                                                                                                              posted on https://www.regulations.gov.
                                                second copy, which will have the                        Deputy Commissioner for Policy, Planning,               • If you want to submit a comment
                                                claimed confidential information                        Legislation, and Analysis.                            with confidential information that you
                                                redacted/blacked out, will be available                 [FR Doc. 2017–19261 Filed 9–11–17; 8:45 am]           do not wish to be made available to the
                                                for public viewing and posted on                        BILLING CODE 4164–01–P                                public, submit the comment as a


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                                                42820                     Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices

                                                written/paper submission and in the                     fdsys/pkg/FR-2015-09-18/pdf/2015-                     the completeness and quality of
                                                manner detailed (see ‘‘Written/Paper                    23389.pdf.                                            analyses of data on demographic
                                                Submissions’’ and ‘‘Instructions’’).                       Docket: For access to the docket to                subgroups in summaries of product
                                                                                                        read background documents or the                      safety and effectiveness data and in
                                                Written/Paper Submissions                               electronic and written/paper comments                 labeling; on the inclusion of such data,
                                                   Submit written/paper submissions as                  received, go to https://                              or the lack of availability of such data,
                                                follows:                                                www.regulations.gov and insert the                    in labeling, and to improve the public
                                                   • Mail/Hand delivery/Courier (for                    docket number, found in brackets in the               availability of such data to patients
                                                written/paper submissions): Dockets                     heading of this document, into the                    health care providers and researchers,
                                                Management Staff (HFA–305), Food and                    ‘‘Search’’ box and follow the prompts                 and to indicate the applicability of these
                                                Drug Administration, 5630 Fishers                       and/or go to the Dockets Management                   recommendations to the types of
                                                Lane, Rm. 1061, Rockville, MD 20852.                    Staff, 5630 Fishers Lane, Rm. 1061,                   medical products addressed in section
                                                   • For written/paper comments                         Rockville, MD 20852.                                  907. In the Action Plan, FDA committed
                                                submitted to the Dockets Management                        An electronic copy of the guidance                 to developing this guidance as part of
                                                Staff, FDA will post your comment, as                   document is available for download                    the strategy to fulfill FDASIA
                                                well as any attachments, except for                     from the internet. See the                            requirements (Ref. 2).
                                                information submitted, marked and                       SUPPLEMENTARY INFORMATION section for                   This guidance outlines FDA’s
                                                identified, as confidential, if submitted               information on electronic access to the               recommendations and expectations for
                                                as detailed in ‘‘Instructions.’’                        guidance. Submit written requests for a               patient enrollment, data analysis, and
                                                   Instructions: All submissions received               single hard copy of the guidance                      reporting of age, race, and ethnicity data
                                                must include the Docket No. FDA–                        document entitled ‘‘Evaluation and                    in medical device clinical studies.
                                                2016–D–0734 for ‘‘Evaluation and                        Reporting of Age, Race, and Ethnicity                 Specific objectives of this guidance are
                                                Reporting of Age, Race, and Ethnicity                   Data in Medical Device Clinical                       to (1) encourage the collection and
                                                Data in Medical Device Clinical Studies;                Studies’’ to the Office of the Center                 consideration of age, race, ethnicity, and
                                                                                                        Director, Guidance and Policy                         associated covariates (e.g., body size,
                                                Guidance for Industry and Food and
                                                                                                        Development, Center for Devices and                   biomarkers, bone density) during the
                                                Drug Administration Staff;
                                                                                                        Radiological Health, Food and Drug                    study design stage; (2) outline
                                                Availability.’’ Received comments will
                                                                                                        Administration, 10903 New Hampshire                   recommended analyses of study
                                                be placed in the docket and, except for
                                                                                                        Ave., Bldg. 66, Rm. 5431, Silver Spring,              subgroup data with a framework for
                                                those submitted as ‘‘Confidential
                                                                                                        MD 20993–0002 or the Office of                        considering demographic data when
                                                Submissions,’’ publicly viewable at
                                                                                                        Communication, Outreach, and                          interpreting overall study outcomes; and
                                                https://www.regulations.gov or at the
                                                                                                        Development, Center for Biologics                     (3) specify FDA’s recommendations for
                                                Dockets Management Staff between 9
                                                                                                        Evaluation and Research, Food and                     reporting age, race, and ethnicity-
                                                a.m. and 4 p.m., Monday through
                                                                                                        Drug Administration, 10903 New                        specific information in summaries and
                                                Friday.
                                                                                                        Hampshire Ave., Bldg. 71, Rm. 3128,                   labeling for approved or cleared medical
                                                   • Confidential Submissions—To                                                                              devices. FDA believes these
                                                submit a comment with confidential                      Silver Spring, MD 20993–0002. Send
                                                                                                        one self-addressed adhesive label to                  recommendations will help improve the
                                                information that you do not wish to be                                                                        quality, consistency, and transparency
                                                made publicly available, submit your                    assist that office in processing your
                                                                                                        request.                                              of data regarding the performance of
                                                comments only as a written/paper                                                                              medical devices within specific age,
                                                submission. You should submit two                       FOR FURTHER INFORMATION CONTACT:                      race, and ethnic groups as well as
                                                copies total. One copy will include the                 Katheryn O’Callaghan, Center for                      encourage appropriate enrollment of
                                                information you claim to be confidential                Devices and Radiological Health, Food                 diverse populations including relevant
                                                with a heading or cover note that states                and Drug Administration, 10903 New                    age, race, and ethnic groups. Proper
                                                ‘‘THIS DOCUMENT CONTAINS                                Hampshire Ave., Bldg. 66, Rm. 5418,                   evaluation and reporting of these data
                                                CONFIDENTIAL INFORMATION.’’ The                         Silver Spring, MD 20993–0002, 301–                    can benefit patients, clinicians,
                                                Agency will review this copy, including                 796–6349; or Stephen Ripley, Center for               researchers, regulators, and other
                                                the claimed confidential information, in                Biologics Evaluation and Research,                    stakeholders.
                                                its consideration of comments. The                      Food and Drug Administration, 10903                     FDA considered comments received
                                                second copy, which will have the                        New Hampshire Ave., Bldg. 71, Rm.                     on the draft guidance that appeared in
                                                claimed confidential information                        7301, Silver Spring, MD 20993–0002,                   the Federal Register of June 20, 2016
                                                redacted/blacked out, will be available                 240–402–7911.                                         (81 FR 39927). FDA revised the
                                                for public viewing and posted on                        SUPPLEMENTARY INFORMATION:                            guidance as appropriate in response to
                                                https://www.regulations.gov. Submit                                                                           the comments. This document extends
                                                both copies to the Dockets Management                   I. Background
                                                                                                                                                              the policy established in FDA’s
                                                Staff. If you do not wish your name and                    Section 907 of the Food and Drug                   guidance entitled ‘‘Evaluation of Sex-
                                                contact information to be made publicly                 Administration Safety and Innovation                  Specific Data in Medical Device Clinical
                                                available, you can provide this                         Act (Pub. L. 112–144) (FDASIA)                        Studies’’ to additional demographic
                                                information on the cover sheet and not                  directed the Agency to publish and                    subgroups of age, race, and ethnicity
                                                in the body of your comments and you                    provide to Congress a report describing               (Ref. 3).
                                                must identify this information as                       the extent to which clinical trial
pmangrum on DSK3GDR082PROD with NOTICES1




                                                ‘‘confidential.’’ Any information marked                participation and safety and                          II. Significance of Guidance
                                                as ‘‘confidential’’ will not be disclosed               effectiveness data by demographic                        This guidance is being issued
                                                except in accordance with 21 CFR 10.20                  subgroups, including sex, age, race, and              consistent with FDA’s good guidance
                                                and other applicable disclosure law. For                ethnicity, is included in applications                practices regulation (21 CFR 10.115).
                                                more information about FDA’s posting                    submitted to FDA (Ref. 1). Section 907                The guidance represents the current
                                                of comments to public dockets, see 80                   also directed FDA to publish and                      thinking of FDA on ‘‘Evaluation and
                                                FR 56469, September 18, 2015, or access                 provide to Congress an action plan                    Reporting of Age, Race, and Ethnicity
                                                the information at: https://www.gpo.gov/                outlining recommendations to improve                  data in Medical Device Clinical


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                                                                          Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices                                           42821

                                                Studies.’’ It does not establish any rights             www.regulations.gov. FDA has verified                 DATES:   Comments on this ICR must be
                                                for any person and is not binding on                    the Web site addresses, as of the date                received no later than November 13,
                                                FDA or the public. You can use an                       this document publishes in the Federal                2017.
                                                alternative approach if it satisfies the                Register, but Web sites are subject to                ADDRESSES: Submit your comments to
                                                requirements of the applicable statutes                 change over time.                                     paperwork@hrsa.gov or mail to the
                                                and regulations. This guidance is not                   1. FDA Report: Collection, Analysis, and              HRSA Information Collection Clearance
                                                subject to Executive Order 12866.                           Availability of Demographic Subgroup              Officer, 14N39, 5600 Fishers Lane,
                                                III. Electronic Access                                      Data for FDA-Approved Medical                     Rockville, MD 20857.
                                                                                                            Products, issued August 2013, required            FOR FURTHER INFORMATION CONTACT: To
                                                   Persons interested in obtaining a copy                   under FDASIA section 907, available at
                                                of the guidance may do so by                                                                                  request more information on the
                                                                                                            http://www.fda.gov/downloads/
                                                downloading an electronic copy from                         RegulatoryInformation/Legislation/
                                                                                                                                                              proposed project or to obtain a copy of
                                                the internet. A search capability for all                   SignificantAmendmentstotheFDCAct/                 the data collection plans and draft
                                                Center for Devices and Radiological                         FDASIA/UCM365544.pdf.                             instruments, email paperwork@hrsa.gov
                                                Health guidance documents is available                  2. FDA’s Action Plan to Enhance the                   or call the HRSA Information Collection
                                                at https://www.fda.gov/MedicalDevices/                      Collection and Availability of                    Clearance Officer at (301) 443–1984.
                                                DeviceRegulationandGuidance/                                Demographic Subgroup Data (August,                SUPPLEMENTARY INFORMATION: When
                                                GuidanceDocuments/default.htm.                              2014), available at https://www.fda.gov/          submitting comments or requesting
                                                Guidance documents are also available                       downloads/RegulatoryInformation/                  information, please include the
                                                                                                            Legislation/                                      information request collection title for
                                                at https://www.fda.gov/BiologicsBlood
                                                                                                            SignificantAmendmentstotheFDCAct/                 reference, in compliance with Section
                                                Vaccines/GuidanceCompliance                                 FDASIA/UCM410474.pdf.
                                                RegulatoryInformation/default.htm or                    3. FDA’s guidance entitled ‘‘Evaluation of
                                                                                                                                                              3506(c)(2)(A) of the Paperwork
                                                https://www.regulations.gov. Persons                        Sex-Specific Data in Medical Device               Reduction Act of 1995.
                                                unable to download an electronic copy                       Clinical Studies’’ (August 22, 2014),                Information Collection Request Title:
                                                of ‘‘Evaluation and Reporting of Age,                       available at https://www.fda.gov/                 National Practitioner Data Bank for
                                                Race, and Ethnicity Data in Medical                         downloads/MedicalDevices/Device                   Adverse Information on Physicians and
                                                Device Clinical Studies’’ may send an                       RegulationandGuidance/Guidance                    Other Health Care Practitioners—45
                                                email request to CDRH-Guidance@                             Documents/UCM283707.pdf.                          CFR part 60 Regulations and Forms,
                                                fda.hhs.gov to receive an electronic                      Dated: September 7, 2017.                           OMB No. 0915–0126—Revision.
                                                copy of the document. Please use the                                                                             Abstract: This is a request for a
                                                                                                        Leslie Kux,
                                                document number 1500626 to identify                                                                           revision of OMB approval of the
                                                                                                        Associate Commissioner for Policy.                    information collection contained in
                                                the guidance you are requesting.
                                                                                                        [FR Doc. 2017–19259 Filed 9–11–17; 8:45 am]           regulations found at 45 CFR part 60
                                                IV. Paperwork Reduction Act of 1995                     BILLING CODE 4164–01–P                                governing the National Practitioner Data
                                                  This guidance refers to previously                                                                          Bank (NPDB) and the forms to be used
                                                approved collections of information                                                                           in registering with, reporting
                                                found in FDA regulations. These                         DEPARTMENT OF HEALTH AND                              information to, and requesting
                                                collections of information are subject to               HUMAN SERVICES                                        information from the NPDB.
                                                review by the Office of Management and                                                                        Administrative forms are also included
                                                                                                        Health Resources and Services
                                                Budget (OMB) under the Paperwork                                                                              to aid in monitoring compliance with
                                                                                                        Administration
                                                Reduction Act of 1995 (44 U.S.C. 3501–                                                                        Federal reporting and querying
                                                3520). These collections of information                 Agency Information Collection                         requirements. Responsibility for NPDB
                                                in 21 CFR part 812 have been approved                   Activities: Proposed Collection: Public               implementation and operation resides
                                                under OMB control number 0910–0078;                     Comment Request; Information                          in HRSA’s Bureau of Health Workforce.
                                                the collections of information in 21 CFR                Collection Request Title: National                       The intent of the NPDB is to improve
                                                part 807, subpart E, have been approved                 Practitioner Data Bank for Adverse                    the quality of health care by
                                                under OMB control number 0910–0120;                     Information on Physicians and Other                   encouraging hospitals, State licensing
                                                the collections of information in 21 CFR                Health Care Practitioners—45 CFR Part                 boards, professional societies, and other
                                                part 814, subparts A through E, have                    60 Regulations and Forms, OMB No.                     entities providing health care services to
                                                been approved under OMB control                         0915–0126—Revision                                    identify and discipline those who
                                                number 0910–0231; the collections of                                                                          engage in unprofessional behavior, and
                                                information in 21 CFR part 814, subpart                 AGENCY: Health Resources and Services                 to restrict the ability of incompetent
                                                H, have been approved under OMB                         Administration (HRSA), Department of                  health care practitioners, providers, or
                                                control number 0910–0332; the                           Health and Human Services (HHS).                      suppliers to move from State to State
                                                collections of information in 21 CFR                                                                          without disclosure of previous
                                                part 822 have been approved under                       ACTION:   Notice.                                     damaging or incompetent performance.
                                                OMB control number 0910–0449; and                                                                             It also serves as a fraud and abuse
                                                the collections of information in 21 CFR                SUMMARY:   In compliance with the                     clearinghouse for the reporting and
                                                part 801 have been approved under                       requirement for opportunity for public                disclosing of certain final adverse
                                                OMB control number 0910–0485.                           comment on proposed data collection                   actions (excluding settlements in which
                                                                                                        projects of the Paperwork Reduction Act               no findings of liability have been made)
pmangrum on DSK3GDR082PROD with NOTICES1




                                                V. References                                           of 1995, HRSA announces plans to                      taken against health care practitioners,
                                                  The following references are on                       submit an Information Collection                      providers, or suppliers by health plans,
                                                display in the Dockets Management                       Request (ICR), described below, to the                Federal agencies, and State agencies.
                                                Staff office (see ADDRESSES) and are                    Office of Management and Budget                          The reporting forms, request for
                                                available for viewing by interested                     (OMB). Prior to submitting the ICR to                 information forms (query forms), and
                                                persons between 9 a.m. and 4 p.m.,                      OMB, HRSA seeks comments from the                     administrative forms (used to monitor
                                                Monday through Friday; they are also                    public regarding the burden estimate,                 compliance) are accessed, completed,
                                                available electronically at https://                    below, or any other aspect of the ICR.                and submitted to the NPDB


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Document Created: 2018-10-24 14:15:56
Document Modified: 2018-10-24 14:15:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on September 12, 2017.
ContactKatheryn O'Callaghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5418, 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.
FR Citation82 FR 42819 

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