National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 72412-72413 [2024-19967]
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Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Notices
Continuing this collection will enable
FDA to deepen our understanding of the
outsourcing facility sector and increase
our efficacy in developing a Center of
Excellence that is responsive to
outsourcing facilities’ needs. The
research results will inform FDA’s
future activities for the Center of
Excellence in the areas of
communication, education, training,
and other engagement with outsourcing
facilities to address challenges and
support advancement.
Researchers engage with pharmacists,
staff, and management from outsourcing
facilities and similar compounding
businesses, and related stakeholders and
use surveys to obtain information about
outsourcing facilities’ challenges and
opportunities. Within this context, we
may pose the following questions or
similar, related questions:
1. What financial and operational
considerations inform outsourcing
facility operational and business model
decisions?
2. What factors impact developing a
sustainable outsourcing facility
business?
3. What financial and operational
considerations inform outsourcing
facility product decisions?
4. Do outsourcing facilities
understand the Federal laws and
policies that apply to them? What, if
any, knowledge gaps do we need to
address?
5. What are outsourcing facilities’
challenges when implementing Federal
CGMP requirements?
6. How do outsourcing facilities
implement quality practices at their
facilities?
7. How do outsourcing facilities
develop CGMP and quality expertise?
How do they obtain this knowledge, and
what training do they need?
8. What are the economic
consequences of CGMP noncompliance
and product failures for outsourcing
facilities?
9. What are outsourcing facility
management and staff views on current
interactions with FDA? How do they
want the interactions to change?
10. What are outsourcing facilities’
understanding of how to engage with
FDA during and following an
inspection?
Respondents to this information
collection are employees at outsourcing
facilities and related human
prescription drug compounding
businesses.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Survey Invitation ..................................................................
250
1
250
Survey Questionnaire ..........................................................
250
1
250
Total ..............................................................................
........................
........................
500
1 There
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Number of
responses per
respondent
Average
burden per
response
0.0833
(5 mins)
0.75
(45 mins)
........................
Total hours
21
188
209
are no capital costs or operating and maintenance costs associated with this collection of information.
The universe of registered outsourcing
facilities and related human
prescription drug compounding
businesses known to the Center of
Excellence will be sent a survey
invitation. We reduced our estimate of
the number of respondents from 300 to
250. We estimate that approximately
250 respondents will receive an
invitation to participate in the survey
and will spend 5 minutes reading the
invitation and considering whether to
take the survey, for a total of 20.825
burden hours per year, rounded to 21
hours. Based on our historical
experience, we anticipate that all those
invited to participate in the survey will
complete the survey. We anticipate a
slight reduction in burden hours to 45
minutes (0.75 hour) per survey response
from our previous estimate of 1 hour per
response. We estimate that
approximately 250 respondents will
spend 45 minutes completing the
survey, for a total of 187.5 burden hours
per year, rounded to 188 hours.
Based on a review of the information
collection since our last request for
OMB approval, we have made
adjustments to our burden estimate. Our
estimated burden for the information
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22:19 Sep 04, 2024
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collection reflects an overall decrease of
391 hours and a corresponding decrease
of 100 responses. We have also reduced
our estimated burden per survey
response from 1 hour to 45 minutes.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19870 Filed 9–4–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
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confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Allergy, Immunology,
and Transplantation Research Committee.
Date: October 24–25, 2024.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G51,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Thomas F. Conway, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G51, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G51,
Rockville, MD 20892, 240–507–9685,
thomas.conway@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
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Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Notices
Dated: August 30, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–19967 Filed 9–4–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Eunice Kennedy
Shriver National Institute of Child Health and
Human Development Special Emphasis
Panel; Using Archived Data and Specimen
Collections to Advance Maternal and
Pediatric HIV/AIDS Research (R21 Clinical
Trial Not Allowed).
Date: October 31, 2024.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, 6710 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Vera A. Cherkasova, Ph.D.,
Scientific Review Branch (SRB), Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, National
Institutes of Health, 6710B Rockledge Drive,
Room 2137B, Bethesda, MD 20817, (240)
478–4580, vera.cherkasova@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: August 30, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
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National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
BILLING CODE 4140–01–P
[FR Doc. 2024–19966 Filed 9–4–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Maximizing Opportunities for Scientific and
Academic Independent Careers (MOSAIC)
Postdoctoral Career Transition Award to
Promote Diversity (K99/R00).
Date: October 4, 2024.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge I, 6705 Rockledge Drive, Bethesda,
MD 20892, (Virtual Meeting).
Contact Person: Nawazish Ali Naqvi,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung and
Blood Institute, National Institutes of Health,
6705 Rockledge Drive, Room 208–Y,
Bethesda, MD 20892, Phone: (301) 827–7911,
Email: nawazish.naqvi@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: August 29, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–19861 Filed 9–4–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Secretary; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Interagency Autism
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72413
Coordinating Committee (IACC or
Committee). The meeting will be
virtually held and is open to public
viewing. The connection information
and how to access the meeting will be
available on the IACC website (https://
iacc.hhs.gov). Advanced registration is
recommended. Individuals wishing to
participate that need special assistance
or other reasonable accommodations
should submit a request to the Contact
Person listed on this notice at least
seven (7) business days prior to the
meeting.
The purpose of this IACC meeting is
to discuss the draft 2024 IACC Strategic
Plan Update, which is focused on cooccurring conditions and their impacts
on health outcomes in autistic
individuals. This draft report
summarizes current knowledge of
several physical and mental health
conditions and identifies additional
research, services, and policy needs to
improve health outcomes related to
these conditions for autistic people in
all communities.
Name of Committee: Interagency Autism
Coordinating Committee.
Date: September 23, 2024.
Time: 9:00 a.m. to 11:00 a.m.
Agenda: To discuss the 2024 IACC
Strategic Plan Update, which is focused on
co-occurring conditions and the impacts on
health outcomes for autistic individuals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Cost: The meeting is free and open to the
public.
Registration: A registration web link will
be posted on the IACC website
(www.iacc.hhs.gov) prior to the meeting. Preregistration is recommended.
Contact Person: Ms. Rebecca Martin, Office
of National Autism Coordination, National
Institute of Mental Health, NIH.
Phone: 301–435–0886.
Email: IACCPublicInquiries@mail.nih.gov.
Technical issues: If you experience
any technical problems, please email
IACCPublicInquiries@mail.nih.gov.
Disability Accommodations: Closed
Captioning is provided by Zoom.
Individuals whose full virtual
participation in the meeting will require
special accommodations (e.g., sign
language or interpreting services, etc.)
must submit a request to the Contact
Person listed on the notice at least seven
(7) business days prior to the meeting.
Such requests should include a detailed
description of the accommodation
needed and a way for the IACC to
contact the requester if more
information is needed to fill the request.
Special requests should be made at least
seven (7) business days prior to the
meeting; last-minute requests may be
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]]>Agencies
[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Notices]
[Pages 72412-72413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19967]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Allergy, Immunology, and Transplantation
Research Committee.
Date: October 24-25, 2024.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G51,
Rockville, MD 20892 (Video Assisted Meeting).
Contact Person: Thomas F. Conway, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, Room 3G51, National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601 Fishers Lane, Room
3G51, Rockville, MD 20892, 240-507-9685, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
[[Page 72413]]
Dated: August 30, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-19967 Filed 9-4-24; 8:45 am]
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