Office of Women's Health Strategic Priorities; Establishment of a Public Docket; Request for Comments, 41591-41593 [2020-14878]

Download as PDF 41591 Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices three requests for documentation of successful completion of staff training using the CFP Training Plan and Log for a total of 1,500 annual responses. Each submission is estimated to take 0.1 hour (or 6 minutes) per response for a total of 150 hours. Thus, the total reporting burden for this information collection is 200 hours. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: July 6, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. AGENCY: [FR Doc. 2020–14879 Filed 7–9–20; 8:45 am] Food and Drug Administration [Docket Nos. FDA–2018–N–2434, FDA– 2016–N–3535, FDA–2013–N–1619, FDA– 2016–N–0736, FDA–2019–N–3885, FDA– 2013–N–1423, FDA–2013–N–0804, FDA– 2016–N–3995, FDA–2018–D–1592, FDA– 2016–N–2066, and FDA–2017–N–0366] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: BILLING CODE 4164–01–P Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Formal Meetings Between the Food and Drug Administration and Sponsors and Applicants of Prescription Drug User Fee Act Products ................................................................................................................................ Special Protocol Assessments ................................................................................................................................ Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements ........................................................................................................................................................ Tracking Network for PETNet, LivestockNet, and SampleNet ................................................................................ Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey ........................... Importer’s Entry Notice ............................................................................................................................................ Premarket Notification Submission 510(k), Subpart E ............................................................................................ Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations ........................................................................................................................................................... Controlled Correspondence Related to Generic Drug Development ...................................................................... Certification of Identity for Freedom of Information Act and Privacy Act Requests ............................................... FDA Advisory Committee Membership Nominations .............................................................................................. Dated: July 6, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–14875 Filed 7–9–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jbell on DSKJLSW7X2PROD with NOTICES [Docket No. FDA–2020–N–1391] Office of Women’s Health Strategic Priorities; Establishment of a Public Docket; Request for Comments AGENCY: Notice; establishment of a public docket; request for comments. ACTION: VerDate Sep<11>2014 18:28 Jul 09, 2020 Jkt 250001 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 ADDRESSES: Food and Drug Administration, HHS. 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. SUMMARY: PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 Date approval expires 0910–0429 0910–0470 5/31/2023 5/31/2023 0910–0606 0910–0680 0910–0887 0910–0046 0910–0120 5/31/2023 5/31/2023 5/31/2023 6/30/2023 6/30/2023 0910–0748 0910–0797 0910–0832 0910–0833 6/30/2023 6/30/2023 6/30/2023 6/30/2023 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, E:\FR\FM\10JYN1.SGM 10JYN1 41592 Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 18:28 Jul 09, 2020 Jkt 250001 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-201509-18/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, lisa.lineberger@ fda.hhs.gov. 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 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 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 FDAregulated 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 E:\FR\FM\10JYN1.SGM 10JYN1 41593 Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices women and/or would benefit from sexand 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–1066] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by August 10, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information SUMMARY: collection is 0910–0767. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Annual Reporting for Custom Device Exemption OMB Control Number 0910–0767— Extension The custom device exemption is set forth at section 520(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(b)(2)(B)). A custom device is in a narrow category of device that, by virtue of the rarity of the patient’s medical condition or physician’s special need the device is designed to treat, it would be impractical for the device to comply with premarket review regulations and performance standards. The Food and Drug Administration Safety and Innovation Act (FDASIA) implemented changes to the custom device exemption contained in section 520(b) of the FD&C Act. The new provision amended the existing custom device exemption and introduced new concepts and procedures for custom devices, such as: • Devices created or modified to comply with the order of an individual physician or dentist; • the potential for multiple units of a device type (limited to no more than five units per year) qualifying for the custom device exemption; and • annual reporting requirements by the manufacturer to FDA about devices manufactured and distributed under section 520(b) of the FD&C Act. Under FDASIA, ‘‘devices’’ that qualify for the custom device exemption contained in section 520(b) of the FD&C Act were clarified to include no more than ‘‘five units per year of a particular device type’’ that otherwise meet all the requirements necessary to qualify for the custom device exemption. In the Federal Register of September 24, 2014 (79 FR 57112), FDA announced the availability of the guidance entitled ‘‘Custom Device Exemption.’’ FDA has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in the FD&C Act. The intent of the guidance is to define terms used in the custom device exemption, explain how to interpret the ‘‘five units per year of a particular device type’’ language contained in the FD&C Act, describe information that FDA proposes manufacturers should submit in the custom device annual report, and provide recommendations on how to submit an annual report for devices distributed under the custom device exemption. In the Federal Register of February 21, 2020 (85 FR 10175), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Annual reporting for custom devices ................................... 34 1 34 40 1,360 jbell on DSKJLSW7X2PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 18:28 Jul 09, 2020 Jkt 250001 PO 00000 Frm 00079 Fmt 4703 Sfmt 9990 E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.