Notice2023-27304
Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 238 (Wednesday, December 13, 2023)</title>
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[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86344-86345]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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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