86344 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

1The 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. 

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: 

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. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4917] 

Advisory Committee; Genetic 

Metabolic Diseases Advisory 

Committee; Establishment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of establishment. 

SUMMARY: 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. 

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– 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86345 

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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

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: The 

Genetic Metabolic Diseases Advisory 

Committee (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. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of medical 

genetics, manifestations of inborn errors 

of metabolism, small population trial 

design, translational science, pediatrics, 

epidemiology, or statistics and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Non-Federal members of this 

committee will serve either as special 

government employees or non-voting 

representatives. Federal members will 

serve as regular government employees. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who serves as an 

individual, but who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. 

In addition to the voting members, the 

Committee may include one non-voting 

representative member who is identified 

with industry interests. There may also 

be an alternate industry representative. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing separate 

documents regarding: (1) Genetic 

Metabolic Diseases Advisory 

Committee: Request for Nominations for 

Voting Members on a Public Advisory 

Committee: Genetic Metabolic Diseases 

Advisory Committee; (2) Request for 

Nomination of Individuals and 

Consumer Organizations for the Genetic 

Metabolic Diseases Advisory 

Committee; and (3) Request for 

Nomination of Individuals and Industry 

Organizations for the Genetic Metabolic 

Diseases Advisory Committee. 

FDA intends to publish in the Federal 

Register a final rule adding the Genetic 

Metabolic Diseases Advisory Committee 

to 21 CFR 14.100. 

Dated: December 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27304 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–0008] 

Request for Nominations of Individuals 

and Industry Organizations for the 

Genetic Metabolic Diseases Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting that industry organizations 

interested in participating in the 

selection of a nonvoting industry 

representative to serve on the Genetic 

Metabolic Diseases Advisory Committee 

(the Committee) in the Center for Drug 

Evaluation and Research notify FDA in 

writing. FDA is also requesting 

nominations for a nonvoting industry 

representative to serve on the 

Committee. Nominees recommended to 

serve as a nonvoting industry 

representative may either be selfnominated or nominated by an industry 

organization. Nominations will be 

accepted for the current vacancy 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interest, 

must send a letter stating that interest to 

the FDA by February 12, 2024, (see 

sections I and II of this document for 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by February 12, 

2024. 

ADDRESSES: All statements of interest 

from interested industry organizations 

interested in participating in the 

selection process of a nonvoting 

industry representative should be sent 

electronically to Nicholas Marsh (see 

FOR FURTHER INFORMATION CONTACT). All 

nominations for the nonvoting industry 

representative may be submitted 

electronically by accessing the FDA 

Advisory Committee Membership 

Nomination Portal: https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. 

Information about becoming a 

member on 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: 

Nicolas Marsh, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2418, 

Silver Spring, MD 20993–0002, 240– 

402–5357, email: nicholas.marsh@

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, email: 

GEMDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for a nonvoting 

industry representative for the Genetic 

Metabolic Diseases Advisory 

Committee. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing separate 

documents regarding: 

1. Genetic Metabolic Diseases Advisory 

Committee; Notice of Establishment 

2. Request for Nominations for Voting 

Members for the Genetic Metabolic 

Diseases Advisory Committee 

3. Request for Nominations of 

Individuals and Consumer 

Organizations for the Genetic 

Metabolic Diseases Advisory 

Committee 


khammond on DSKJM1Z7X2PROD with NOTICES