Office of Minority Health and Health Equity Strategic Priorities; Establishment of a Public Docket; Request for Comments
| Published date | 03 January 2020 |
| Citation | 85 FR 316 |
| Record Number | 2019-28417 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 85 Issue 2 (Friday, January 3, 2020)
[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 316-318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28417]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4824]
Office of Minority Health and Health Equity Strategic Priorities;
Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
opening a public docket to solicit input and comments from interested
stakeholders, including racial and ethnic minority, underrepresented,
and underserved populations in establishing strategic priorities for
the Office of Minority Health and Health Equity (OMHHE). This will help
the Agency ensure that important health concerns are carefully
considered in establishing priorities.
DATES: Submit either electronic or written comments by February 28,
2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 28, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-4824 for ``Office of Minority Health and Health Equity
Strategic Priorities; Establishment of a Public Docket; Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for
[[Page 317]]
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.govinfo.gov/content/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.
FOR FURTHER INFORMATION CONTACT: Christine Merenda, Food and Drug
Administration, Office of Minority Health and Health Equity, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2382, Silver Spring, MD 20993, 301-796-
8453, Fax: 301-847-8601, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA's OMHHE serves to promote and protect the health of diverse
populations through research and communication of science that
addresses health disparities and health equity. Established in 2010,
OMHHE provides leadership and policy direction for FDA regarding issues
relating to the health of racial and ethnic minority, underrepresented,
and underserved populations. OMHHE's stakeholders reflect the diversity
of the U.S. population, including individuals of low socioeconomic
status and historically underrepresented populations.
Currently OMHHE has program areas that focus on outreach and
communication, as well as research and collaboration. The outreach and
communication program strives to improve FDA communication with racial
and ethnic minority populations and leads the Agency's Language Access
program that provides consumers (including those with limited English
proficiency) information that is easy to read, culturally competent,
and available in multiple languages and formats. The research and
collaboration program supports research projects that study health
disparities that disproportionately affect racial and ethnic minority,
underrepresented, and underserved populations, as well as projects that
analyze data that can answer regulatory science questions. To aid data
analysis, OMHHE issued a final guidance in October 2016 entitled
``Collection of Race and Ethnicity Data in Clinical Trials'' (available
at https://www.fda.gov/media/75453/download) to ensure that
subpopulation data are collected consistently by industry.
OMHHE also works with academic institutions as part of the Centers
of Excellence in Regulatory Science and Innovation, which are
collaborations between FDA and academic institutions to advance
regulatory science through innovative research, education, and
scientific exchanges. In addition, OMHHE supports and collaborates with
academic institutions and other stakeholders through the Broad Agency
Announcement (available at https://www.fda.gov/science-research/advancing-regulatory-science/regulatory-science-extramural-research-and-development-projects) to spur innovation in the field of regulatory
science.
OMHHE recognizes that more needs to be done to reach the goal of
health equity and eliminating health disparities. Multiple complex
factors can affect the health of racial and ethnic minority,
underrepresented, and underserved populations, some of which are
outside the purview of FDA, so it is important for OMHHE to develop a
list of priorities to focus our efforts where FDA engagement can have
the most impact.
FDA believes it is crucial to ask for input from the public,
through Federal Register notices, public meetings, and workshops. OMHHE
would like to have input from interested stakeholders including, racial
and ethnic minority, underrepresented, and underserved populations in
establishing strategic priorities for the office. This will help ensure
that important health concerns are carefully considered in establishing
priorities. Therefore, FDA is issuing this Federal Register notice to
open a docket (FDA-2019-N-4824) for the public to submit comments on
priorities for FDA's OMHHE. FDA will take the suggestions and
information submitted to the docket into consideration when developing
the priorities for OMHHE.
II. Request for Comments
FDA engagement can have a direct impact on advancing health equity
in a number of areas, such as:
Efforts that generate clinical evidence to improve
generalizability of clinical trial findings and bridge the knowledge
gap about the medical products' performance in racial and ethnic
minority populations.
Direct outreach to racial and ethnic minority,
underrepresented, and underserved populations to promote access to
relevant information on medical products to improve safety and
efficacy.
Coordination with other Federal Agencies and external
stakeholders to support research on medical products that can address
health disparities.
Performing direct outreach to racial and ethnic minority,
underrepresented, and underserved populations (e.g., raising awareness
on inclusion of racial and ethnic minority populations in clinical
trials).
Leading the identification of regulatory decisions that
can benefit from participation of racial and ethnic minority,
underrepresented, and underserved populations.
Generating research topics/interests and areas of focus
that predominantly affect racial and ethnic minority populations.
Identification of opportunities of collaboration to
generate efforts to address research gaps that predominantly affect
racial and ethnic minority populations.
We encourage interested stakeholders to submit comments on the
areas and types of engagement FDA's OMHHE should prioritize in the
coming year(s), and potential mechanisms that can be used to implement
them (e.g., through collaborations and partnerships).
[[Page 318]]
Dated: December 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28417 Filed 1-2-20; 8:45 am]
BILLING CODE 4164-01-P
