Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal, 16581-16582 [2024-04845]
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Federal Register / Vol. 89, No. 46 / Thursday, March 7, 2024 / Notices
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
May 6, 2024.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10440 Data Collection to
Support Eligibility Determinations for
Insurance Affordability Programs and
Enrollment through Health Benefits
Exchanges, Medicaid and CHIP
Agencies
Under the PRA (44 U.S.C. 3501–
3520), Federal agencies must obtain
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approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires Federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Data Collection
to Support Eligibility Determinations for
Insurance Affordability Programs and
Enrollment through Health Benefits
Exchanges, Medicaid and CHIP
Agencies; Use: Section 1413 of the
Affordable Care Act directs the
Secretary of Health and Human Services
to develop and provide to each state a
single, streamlined application form
that may be used to apply for coverage
through a Marketplace and for APTC/
CSR, Medicaid, and CHIP (which we
refer to collectively as insurance
affordability programs). The application
must be structured to maximize an
applicant’s ability to complete the form
satisfactorily, taking into account the
characteristics of individuals who may
qualify for the programs by developing
materials at appropriate literacy levels
and ensuring accessibility.
45 CFR 155.405(a) provides more
detail about the application that must be
used by Marketplaces to determine
eligibility and to collect information
necessary for enrollment. Eligibility
standards for the Marketplace are set
forth in 45 CFR 155.305. The
information will be required of each
applicant upon initial application, with
some subsequent information
collections for the purposes of
confirming accuracy of previous
submissions and for changes in an
applicant’s circumstances. 42 CFR
435.907 and 457.330 establish the
standards for state Medicaid and CHIP
agencies related to the use of the
application. CMS has designed a
dynamic electronic application that will
tailor the amount of data required from
an applicant based on the applicant’s
circumstances and responses to
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16581
particular questions in the FFM (please
note SBM implementations may vary
but the essence of the data collection
must adhere to the same parameters).
The paper version of the application
will not be tailored in the same way but
will require only the data necessary to
determine eligibility.
Information collected by the
Marketplace, Medicaid or CHIP agency
will be used to determine eligibility for
coverage through the Marketplace and
insurance affordability programs (i.e.,
Medicaid, CHIP, and APTC), and assist
consumers in enrolling in a QHP if
eligible. Applicants include anyone who
may be eligible for coverage through any
of these programs. Additionally, this
application provides consumers
interested in voting resources. Form
Number: CMS–10440 (OMB control
number: 0938–1191); Frequency:
Annually; Affected Public: Private
Sector (Business or other for-profits,
Not-for-Profit Institutions); Number of
Respondents: 5,550,000; Total Annual
Responses: 5,550,000; Total Annual
Hours: 2,446,440. (For policy questions
regarding this collection contact Erin
Richardson at 202–619–0630.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–04878 Filed 3–6–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Advisory Committee; Gastrointestinal
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Gastrointestinal Drugs Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Gastrointestinal Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
March 3, 2026, expiration date.
DATES: Authority for the Gastrointestinal
Drugs Advisory Committee will expire
on March 3, 2026, unless the
SUMMARY:
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16582
Federal Register / Vol. 89, No. 46 / Thursday, March 7, 2024 / Notices
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Jessica Seo, Center for Drug Evaluation
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001,
GIDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Gastrointestinal Drugs
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of gastrointestinal
diseases and makes appropriate
recommendations to the Commissioner.
Pursuant to its charter, the Committee
shall consist of a core of 11 voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of gastroenterology, endocrinology,
surgery, clinical pharmacology,
physiology, pathology, liver function,
motility, esophagitis, and statistics.
Members will be invited to serve for
overlapping terms of up to 4 years. NonFederal 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-Officios. 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 Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
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temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
gastrointestinal-drugs-advisorycommittee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: March 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04845 Filed 3–6–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1503]
Q2(R2) Validation of Analytical
Procedures and Q14 Analytical
Procedure Development; International
Council for Harmonisation; Guidances
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of final
guidances for industry entitled ‘‘Q2(R2)
Validation of Analytical Procedures’’
and ‘‘Q14 Analytical Procedure
Development.’’ The guidances were
prepared under the auspices of the
International Council for Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use (ICH).
The guidance entitled ‘‘Q2(R2)
Validation of Analytical Procedures’’
provides a general framework for the
principles of analytical procedure
validation, including validation
principles that cover the analytical use
of spectroscopic data. The guidance
entitled ‘‘Q14 Analytical Procedure
Development’’ provides harmonized
guidance on scientific approaches for
analytical procedure development and
describes principles to facilitate more
efficient, science-based, and risk-based
postapproval change management. The
guidances are intended to facilitate
regulatory evaluations and potential
flexibility in postapproval change
management of analytical procedures
when scientifically justified. The
guidances replace the draft guidances
‘‘Q2(R2) Validation of Analytical
Procedures’’ and’’ Q14 Analytical
Procedure Development’’ issued on
August 29, 2022.
DATES: The announcement of the
guidances is published in the Federal
Register on March 7, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
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]]>Agencies
[Federal Register Volume 89, Number 46 (Thursday, March 7, 2024)]
[Notices]
[Pages 16581-16582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04845]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Advisory Committee; Gastrointestinal Drugs Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Gastrointestinal Drugs Advisory Committee
by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Gastrointestinal Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until the March 3, 2026, expiration date.
DATES: Authority for the Gastrointestinal Drugs Advisory Committee will
expire on March 3, 2026, unless the
[[Page 16582]]
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Jessica Seo, Center for Drug
Evaluation Research, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Gastrointestinal
Drugs Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises the Commissioner or designee
in discharging responsibilities as they relate to helping to ensure
safe and effective drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of gastrointestinal diseases and
makes appropriate recommendations to the Commissioner.
Pursuant to its charter, the Committee shall consist of a core of
11 voting members including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of gastroenterology, endocrinology,
surgery, clinical pharmacology, physiology, pathology, liver function,
motility, esophagitis, and statistics. 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-Officios. 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 Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/gastrointestinal-drugs-advisory-committee or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: March 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04845 Filed 3-6-24; 8:45 am]
BILLING CODE 4164-01-P
