[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86344-86345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27304]


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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.

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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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 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, 
<a href="/cdn-cgi/l/email-protection#5710121a13161417313336793f3f2479303821"><span class="__cf_email__" data-cfemail="5215171f161311123436337c3a3a217c353d24">[email protected]</span></a>.

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 consumer-oriented 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


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