Methodological Challenges Related to Patient Experience Data; Summary of Received Comments, 86343-86344 [2023-27312]

Download as PDF Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices Portal: https://www.accessdata.fda.gov/ scripts/FACTRSPortal/FACTRS/ index.cfm or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993– 0002. Additional information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993–0002, 301– 796–8220, kimberly.hamilton@ fda.hhs.gov. For questions relating to the Genetic Metabolic Diseases Advisory Committee: Moon Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–2894, GEMDAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a voting consumer representative on the Genetic Metabolic Diseases Advisory Committee. Elsewhere in this Federal Register, FDA is publishing separate documents regarding: 1. Genetic Metabolic Diseases Advisory Committee; Notice of Establishment 2. Request for Nominations for Voting Members on a Public Advisory Committee: Genetic Metabolic Diseases Advisory Committee 3. Request for Nominations of Individuals and Industry Organizations for the Genetic Metabolic Diseases Advisory Committee khammond on DSKJM1Z7X2PROD with NOTICES I. Function and General Description of the Committee Duties Genetic Metabolic Diseases Advisory Committee The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug and biologic products for use in the treatment of genetic metabolic diseases and makes appropriate recommendations to the Commissioner of Food and Drugs. II. Criteria for Members Persons nominated for membership as a consumer representative on this committee should meet the following criteria: (1) demonstrate an affiliation with and/or active participation in VerDate Sep<11>2014 16:54 Dec 12, 2023 Jkt 262001 consumer or community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. III. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency’s selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document. Within the subsequent 60 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee’s current curriculum vitae or re´sume´. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee. IV. Nomination Procedures Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Genetic Metabolic Diseases Advisory Committee with the exception of the following: Individuals who are not U.S. citizens or nationals cannot be appointed as advisory committee members (42 U.S.C. 217(a)) in FDA. Self-nominations are also accepted. Nominations must include a current, complete re´sume´ or curriculum vitae for each nominee, including current business and/or home address, telephone number, and email address if available; a signed copy of the PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 86343 Acknowledgment and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES); and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations should also specify the advisory committee for which the nominee is recommended. In addition, nominations must also acknowledge that the nominee is aware of the nomination, unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. After selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting consumer representatives will not participate in the selection process. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory committees. Dated: December 7, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–27302 Filed 12–12–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–1506] Methodological Challenges Related to Patient Experience Data; Summary of Received Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a summary on the comments received for the ‘‘Methodological Challenges Related to SUMMARY: E:\FR\FM\13DEN1.SGM 13DEN1 86344 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices Patient Experience Data; Request for Information and Comments’’ notice published on May 2, 2023. The input received in response to the Request for Information will help FDA plan two public workshops focused on methodological challenges and will help FDA identify priorities for future work. FOR FURTHER INFORMATION CONTACT: Ethan Gabbour, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993, 301–796– 8112, Ethan.Gabbour@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Dated: December 8, 2023. Lauren K. Roth, Associate Commissioner for Policy. I. Background Under the seventh iteration of the Prescription Drug User Fee Act, incorporated as part of the FDA User Fee Reauthorization Act of 2022, FDA committed to facilitate the advancement and use of systematic approaches to collect and utilize robust and meaningful patient and caregiver input that can more consistently inform drug development and, as appropriate, regulatory decision making. This included issuing a Request for Information (RFI) available at https:// www.federalregister.gov/documents/ 2023/05/02/2023-09265/ methodological-challenges-related-topatient-experience-data-request-forinformation-and-comments to elicit public input on methodologic challenges related to patient experience data encountered by stakeholders, and other areas of greatest interest or concern to public stakeholders.1 The RFI was published on May 2, 2023, and the public comment period was open until July 3, 2023. A summary of the comments received can be found in the in the public docket or by going to https://www.regulations.gov and entering the following docket number: FDA–2023–N–1506. AGENCY: khammond on DSKJM1Z7X2PROD with NOTICES II. Electronic Access Persons with access to internet may obtain the summary within the public docket at https://www.regulations.gov/ docket/FDA-2023-N-1506. 1 The Federal Food, Drug, and Cosmetic Act, as amended by the 21st Century Cures Act (Pub. L. 114–255) and the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115–52), defines patient experience data as data that are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers and drug manufacturers) and are intended to provide information about patients’ experiences with a disease or condition, including the impact (including physical and psychosocial impacts) of such disease or condition or a related therapy or clinical investigation and patient preferences with respect to treatment of the disease or condition. VerDate Sep<11>2014 16:54 Dec 12, 2023 Jkt 262001 [FR Doc. 2023–27312 Filed 12–12–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–4917] Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Food and Drug Administration, HHS. ACTION: Notice of establishment. Under the Federal Advisory Committee Act, the Food and Drug Administration (FDA) is announcing the establishment of the Genetic Metabolic Diseases Advisory Committee. The Commissioner of Food and Drugs (Commissioner) has determined that it is in the public interest to establish such a committee. Duration of this committee is 2 years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest. DATES: Either electronic or written comments on the notice must be submitted by February 12, 2024. FDA is establishing a docket for public comment on this document. The docket number is FDA–2023–N–4917. The docket will close on February 12, 2024. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 12, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your 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, PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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– 2023–N–4917 for ‘‘Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment.’’ Received comments, those filed in a timely manner, 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, 240–402–7500. • 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 E:\FR\FM\13DEN1.SGM 13DEN1

Agencies

[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86343-86344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1506]


Methodological Challenges Related to Patient Experience Data; 
Summary of Received Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a summary on the comments received for the 
``Methodological Challenges Related to

[[Page 86344]]

Patient Experience Data; Request for Information and Comments'' notice 
published on May 2, 2023. The input received in response to the Request 
for Information will help FDA plan two public workshops focused on 
methodological challenges and will help FDA identify priorities for 
future work.

FOR FURTHER INFORMATION CONTACT: Ethan Gabbour, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993, 301-796-
8112, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under the seventh iteration of the Prescription Drug User Fee Act, 
incorporated as part of the FDA User Fee Reauthorization Act of 2022, 
FDA committed to facilitate the advancement and use of systematic 
approaches to collect and utilize robust and meaningful patient and 
caregiver input that can more consistently inform drug development and, 
as appropriate, regulatory decision making. This included issuing a 
Request for Information (RFI) available at https://www.federalregister.gov/documents/2023/05/02/2023-09265/methodological-challenges-related-to-patient-experience-data-request-for-information-and-comments to elicit public input on methodologic challenges related 
to patient experience data encountered by stakeholders, and other areas 
of greatest interest or concern to public stakeholders.\1\ The RFI was 
published on May 2, 2023, and the public comment period was open until 
July 3, 2023. A summary of the comments received can be found in the in 
the public docket or by going to https://www.regulations.gov and 
entering the following docket number: FDA-2023-N-1506.
---------------------------------------------------------------------------

    \1\ The Federal Food, Drug, and Cosmetic Act, as amended by the 
21st Century Cures Act (Pub. L. 114-255) and the FDA Reauthorization 
Act of 2017 (FDARA) (Pub. L. 115-52), defines patient experience 
data as data that are collected by any persons (including patients, 
family members and caregivers of patients, patient advocacy 
organizations, disease research foundations, researchers and drug 
manufacturers) and are intended to provide information about 
patients' experiences with a disease or condition, including the 
impact (including physical and psychosocial impacts) of such disease 
or condition or a related therapy or clinical investigation and 
patient preferences with respect to treatment of the disease or 
condition.
---------------------------------------------------------------------------

II. Electronic Access

    Persons with access to internet may obtain the summary within the 
public docket at https://www.regulations.gov/docket/FDA-2023-N-1506.

    Dated: December 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27312 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P

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