Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees, 15959 [2024-04751]
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Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Rules and Regulations
30, 2022 (CBP Dec. 22–26), is adopted
as final, without change.
Robert F. Altneu,
Director, Regulations & Disclosure Law
Division, Regulations & Rulings, Office of
Trade, U.S. Customs and Border Protection.
Aviva R. Aron-Dine,
Acting Assistant Secretary of the Treasury
for Tax Policy.
[FR Doc. 2024–04711 Filed 3–5–24; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA–2024–N–0826]
Advisory Committee; Genetic
Metabolic Diseases Advisory
Committee; Addition to List of
Standing Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or Agency) is
amending the standing advisory
committee regulations to add the
establishment of the Genetic Metabolic
Diseases Advisory Committee (GeMDAC
or the Committee) to the list of standing
committees.
DATES: This rule is effective March 6,
2024.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Moon Choi, Center for Drugs Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993, 301–796–2894, GeMDAC@
fda.hhs.gov.
The
Committee was established on
December 12, 2023, and notice of
establishment was published in the
Federal Register on December 13, 2023
(88 FR 86344).
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 (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
ddrumheller on DSK120RN23PROD with RULES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:01 Mar 05, 2024
Jkt 262001
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
or ex 1652fficious. The core of voting
members may include one technically
qualified member, selected by the
Commissioner or designee, 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.
The Committee name and function
have been established with the
establishment of the Committee charter.
The change became effective December
12, 2023. Therefore, the Agency is
amending § 14.100 (21 CFR 14.100) to
add the Committee name and function
to its current list as set forth in the
regulatory text of this document.
Under 5 U.S.C. 553(b)(4)(B) and (d)
and 21 CFR 10.40(d) and ©, the Agency
finds good cause to dispense with notice
and public comment procedures and to
proceed to an immediate effective date
on this rule.
Notice and public comment and a
delayed effective date are unnecessary
and are not in the public interest as this
final rule is merely codifying the
addition of the name and function of the
GeMDAC to the list of standing FDA
advisory committees. The establishment
of the Committee is already effective,
and the name and function that will be
added to § 14.100 reflect the Committee
charter. The Agency is amending
§ 14.100(c)(18) as set forth in the
regulatory text of this document.
List of Subjects in 21 CFR Part 14
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 14 is
amended as follows:
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
1. The authority citation for part 14
continues to read as follows:
■
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
15959
Authority: 5 U.S.C. 1001 et seq.; 15 U.S.C.
1451–1461; 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264, 284m, 284m–1;
Pub. L. 107–109, 115 Stat. 1419.
2. Section 14.100 is amended by
adding paragraph (c)(18) to read as
follows:
■
§ 14.100 List of standing advisory
committees.
*
*
*
*
*
(c) * * *
(18) Genetic Metabolic Diseases
Advisory Committee.
(i) Date Established: December 12,
2023.
(ii) Function: 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.
*
*
*
*
*
Dated: March 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04751 Filed 3–5–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF TRANSPORTATION
Great Lakes St. Lawrence Seaway
Development Corporation
33 CFR Part 401
RIN 2135–AA55
Seaway Regulations and Rules:
Periodic Update, Various Categories
Great Lakes St. Lawrence
Seaway Development Corporation, DOT.
ACTION: Final rule.
AGENCY:
The Great Lakes St. Lawrence
Seaway Development Corporation (GLS)
and the St. Lawrence Seaway
Management Corporation (SLSMC) of
Canada, under international agreement,
jointly publish and presently administer
the St. Lawrence Seaway Regulations
and Rules (Practices and Procedures in
Canada) in their respective jurisdictions.
Under agreement with the SLSMC, the
GLS is amending the joint regulations
by updating the regulations and rules in
various categories. These changes are to
clarify existing requirements in the
regulations.
SUMMARY:
This rule is effective on March
22, 2024.
ADDRESSES: Docket: For access to the
docket to read background documents
or comments received, go to https://
DATES:
E:\FR\FM\06MRR1.SGM
06MRR1
]]>Agencies
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Rules and Regulations]
[Page 15959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04751]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA-2024-N-0826]
Advisory Committee; Genetic Metabolic Diseases Advisory
Committee; Addition to List of Standing Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
the standing advisory committee regulations to add the establishment of
the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the
Committee) to the list of standing committees.
DATES: This rule is effective March 6, 2024.
FOR FURTHER INFORMATION CONTACT: Moon Choi, Center for Drugs Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301-796-2894,
[email protected].
SUPPLEMENTARY INFORMATION: The Committee was established on December
12, 2023, and notice of establishment was published in the Federal
Register on December 13, 2023 (88 FR 86344).
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
(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 or ex 1652fficious.
The core of voting members may include one technically qualified
member, selected by the Commissioner or designee, 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.
The Committee name and function have been established with the
establishment of the Committee charter. The change became effective
December 12, 2023. Therefore, the Agency is amending Sec. 14.100 (21
CFR 14.100) to add the Committee name and function to its current list
as set forth in the regulatory text of this document.
Under 5 U.S.C. 553(b)(4)(B) and (d) and 21 CFR 10.40(d) and
(copyright), the Agency finds good cause to dispense with notice and
public comment procedures and to proceed to an immediate effective date
on this rule.
Notice and public comment and a delayed effective date are
unnecessary and are not in the public interest as this final rule is
merely codifying the addition of the name and function of the GeMDAC to
the list of standing FDA advisory committees. The establishment of the
Committee is already effective, and the name and function that will be
added to Sec. 14.100 reflect the Committee charter. The Agency is
amending Sec. 14.100(c)(18) as set forth in the regulatory text of
this document.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
0
1. The authority citation for part 14 continues to read as follows:
Authority: 5 U.S.C. 1001 et seq.; 15 U.S.C. 1451-1461; 21
U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C.
2112; 42 U.S.C. 201, 262, 263b, 264, 284m, 284m-1; Pub. L. 107-109,
115 Stat. 1419.
0
2. Section 14.100 is amended by adding paragraph (c)(18) to read as
follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(c) * * *
(18) Genetic Metabolic Diseases Advisory Committee.
(i) Date Established: December 12, 2023.
(ii) Function: 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.
* * * * *
Dated: March 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04751 Filed 3-5-24; 8:45 am]
BILLING CODE 4164-01-P
