[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41591-41593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14878]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1391]


Office of Women's Health 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is opening a 
public docket to solicit input and comments from stakeholders 
interested in informing strategic priorities for the Office of Women's 
Health (OWH). This will help the Agency ensure that important health 
concerns are carefully considered in establishing OWH's scientific, 
educational, and outreach priorities.

DATES: Submit either electronic or written comments by September 8, 
2020.

ADDRESSES: You may submit comments as follows. Please note that 
untimely comments will not be considered. Electronic comments must be 
submitted on or before September 8, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 8, 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,

[[Page 41592]]

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-2020-N-1391 for ``Office of Women's Health 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 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.'' FDA 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 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 the 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: Lisa Lineberger, Food and Drug 
Administration, Office of the Commissioner, Office of Women's Health, 
10903 New Hampshire Ave., Bldg. 32, Rm. 2333, Silver Spring, MD 20993, 
301-796-8751, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's OWH was established by Congressional mandate in 1994 as part 
of the Office of the Commissioner. The mission of the OWH is to:
     Provide leadership and policy direction for the Agency 
related to women's health and coordinate efforts to establish and 
advance a women's health agenda for the Agency.
     promote the inclusion of women in clinical trials, the 
implementation of guidelines concerning the representation of women in 
clinical trials, and the incorporation of sex and gender considerations 
into clinical trial data analysis.
     identify and monitor the progress of crosscutting and 
multidisciplinary women's health initiatives including changing needs, 
areas that require study, and new challenges to the health of women as 
they relate to FDA's mission.
     serve as the Agency's liaison with other agencies, 
industry, professional associations, and advocacy groups with regards 
to the health of women.
    OWH achieves its mission through the foundational principle that 
sex as a biological variable should be factored into research design, 
analysis, reporting, and education. To this end, OWH supports FDA's 
regulatory mission by funding and engaging in intramural and extramural 
scientific research and collaborating with stakeholders on educational 
and outreach projects. More information on OWH research and educational 
activities is available at https://www.fda.gov/science-research/science-and-research-special-topics/womens-health-research.
    OWH recognizes the unique role FDA can play in protecting and 
promoting women's health and the value of considering input from 
consumers, health professionals, and other stakeholders as it works 
toward this goal. Therefore, FDA is issuing this Federal Register 
notice to open Docket No. FDA-2020-N-1391 for the public to submit 
comments. FDA will take the suggestions and information submitted to 
the docket into consideration when developing OWH scientific, 
educational, and outreach priorities.

II. Issues for Consideration

    To maximize FDA OWH's ability to promote, protect, and advance the 
health of women, we are seeking input on research priorities driven by 
data gaps and areas of unmet need; topics for education among 
consumers, health professionals, and other stakeholders; and outreach 
to women, especially underserved and diverse populations. We are also 
interested in proposed methods for acting on these priorities, such as 
collaborations and partnerships. In particular, OWH requests comments 
on:
     Efforts to encourage analysis and detection of potential 
sex and gender differences in the safety, efficacy, and use of FDA-
regulated products.
     efforts to anticipate, meet, and respond to existing and 
emerging issues related to women's health and FDA-regulated products.
     direct outreach to diverse groups of women to promote 
access to relevant information about FDA-regulated products, encourage 
participation in clinical trials, and maintain dialogue about critical 
women's health topics.
     coordination and collaboration with other Federal Agencies 
and external stakeholders to support research and programming on 
women's health topics.
     identification of regulatory decisions that can benefit 
from participation of women across the lifespan (e.g., reproductive-age 
women, pregnant women, post-menopausal women, and elderly women) and 
women with certain health conditions.
     generation of research and programming topics, interests, 
and areas of focus that predominantly affect

[[Page 41593]]

women and/or would benefit from sex- and gender-related analyses.

    Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14878 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P