Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal, 60896-60897 [2024-16629]
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60896
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget Review; Community
Services Block Grant (CSBG) Model
Tribal Plan Applications (New
Collection)
Office of Community Services,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Community
Services (OCS), Administration for
Children and Families (ACF), requests
an approval of the Community Services
Block Grant (CSBG) Model Tribal Plan.
DATES: Comments due within 30 days of
publication. OMB must make a decision
SUMMARY:
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: Section 677 of the CSBG
Act requires Indian tribes or tribal
organizations to submit an application
and plan (CSBG Model Tribal Plan). The
CSBG Model Tribal Plan must meet
statutory requirements prior to OCS
awarding CSBG tribal grant recipients
with CSBG funds. Tribal grant
recipients have the option to submit a
detailed plan annually or biannually.
Tribal grant recipients that submit a
biannual plan must provide an
abbreviated plan the following year if
substantial changes to the initial plan
will occur. The CSBG Model Tribal Plan
has been used in previous years without
OMB approval. To come into
compliance with the PRA, ACF is
submitting the CSBG Model Tribal Plan
as a new request to OMB.
Respondents: Tribal grant recipients
(tribes and tribal organizations)
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
CSBG Model Tribal Plan .................................................................................
66
1
10
660
Authority: Sec. 677, Pub. L. 105–285,
112 Stat. 2742 (42 U.S.C. 9911).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–16595 Filed 7–26–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0622]
Advisory Committee; PulmonaryAllergy 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
Pulmonary-Allergy 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
Pulmonary-Allergy Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
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new charter will be in effect until the
May 30, 2026, expiration date.
DATES: Authority for the PulmonaryAllergy Drugs Advisory Committee will
expire on May 30, 2026, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 240–
402–2507, PADAC@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 Pulmonary-Allergy 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
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investigational human drug products for
use in the treatment of pulmonary
disease and diseases with allergic and/
or immunologic mechanisms and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
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 pulmonary medicine, allergy, clinical
immunology, and epidemiology or
statistics. Members will be invited to
serve for overlapping terms of up to 4
years. Non-Federal members of this
committee will serve as Special
Government Employees or
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.
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Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
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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/
pulmonary-allergy-drugs-advisorycommittee/pulmonary-allergy-advisorycommittee-charter 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 as
amended (5 U.S.C. 1001 et seq.). For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16629 Filed 7–26–24; 8:45 am]
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60897
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
You may submit comments as
follows:
Food and Drug Administration
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’’).
[Docket No. FDA–2024–N–3294]
Pediatric Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Pediatric Advisory Committee (PAC).
The general function of the committee is
to provide advice and recommendations
to the FDA on pediatric regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held
virtually on September 18, 2024, from
10 a.m. to 4 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be joining this advisory committee
meeting via an online platform and
heard, viewed, captioned, and recorded
via an online and/or video conferencing
platform. Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–3294.
The docket will close on September 17,
2024. Submit either electronic or
written comments on this public
meeting by September 17, 2024. 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
September 17, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or the delivery service acceptance
receipt is before or on that date.
Comments received on or before
September 9, 2024, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is canceled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
SUMMARY:
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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–
2024–N–3294 for ‘‘Pediatric Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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. EST, 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
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]]>Agencies
[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60896-60897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16629]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0622]
Advisory Committee; Pulmonary-Allergy 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 Pulmonary-Allergy 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 Pulmonary-Allergy Drugs Advisory Committee for an additional 2
years beyond the charter expiration date. The new charter will be in
effect until the May 30, 2026, expiration date.
DATES: Authority for the Pulmonary-Allergy Drugs Advisory Committee
will expire on May 30, 2026, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, [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 Pulmonary-Allergy
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 pulmonary disease and diseases
with allergic and/or immunologic mechanisms and makes appropriate
recommendations to the Commissioner of Food and Drugs.
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 pulmonary medicine, allergy, clinical
immunology, and epidemiology or statistics. Members will be invited to
serve for overlapping terms of up to 4 years. Non-Federal members of
this committee will serve as Special Government Employees or
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.
[[Page 60897]]
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/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-advisory-committee-charter 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 as
amended (5 U.S.C. 1001 et seq.). For general information related to FDA
advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16629 Filed 7-26-24; 8:45 am]
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