Submission for Office of Management and Budget Review; Community-Based Child Abuse Prevention Program (Office of Management and Budget #: 0970-0155), 11835-11836 [2024-03107]
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11835
Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices
Closed captioning will be provided
during the meeting. If another
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than
Thursday, February 29, 2024. The
agenda, roster, and minutes will be
available from Jenny Griffith, Committee
Management Officer, Agency for
Healthcare Research and Quality, 5600
Fishers Lane, Rockville, Maryland
20857. Jenny Griffith’s phone number is
(240) 446–6799.
SUPPLEMENTARY INFORMATION:
I. Purpose
In accordance with the Federal
Advisory Committee Act, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality (the Council). 5
U.S.C. 1009. The Council is authorized
by section 941 of the Public Health
Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director of AHRQ on
matters related to AHRQ’s conduct of its
mission including providing guidance
on (A) priorities for health care research,
(B) the field of health care research
including training needs and
information dissemination on health
care quality and (C) the role of the
Agency in light of private sector activity
and opportunities for public private
partnerships. The Council is composed
of members of the public, appointed by
the Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Thursday, March 14, 2024, NAC
members will meet to conduct
preparatory work prior to convening the
Council meeting at 11:15 a.m., with the
call to order by the Council Chair, an
introduction of NAC members, and
approval of previous Council summary
notes. The NAC members will then
receive an update from the AHRQ
Director. The agenda will also include
updates on the Subcommittee of the
National Advisory Council (SNAC) for
AHRQ’s Patient-Centered Outcomes
Research Trust Fund (PCORTF)
Investments, the 20th Anniversary of
Digital Healthcare, an update on the
National Action Alliance to Advance
Patient and Workforce Safety, and a
discussion on diagnostic safety. The
meeting is open to the public and will
adjourn at 4 p.m. For information
regarding how to access the meeting as
well as other meeting details, including
information on how to make a public
comment, please go to https://www.
ahrq.gov/news/events/nac/. The final
agenda will be available on the AHRQ
website no later than Thursday, March
7, 2024.
grant award. There are no changes
requested to the information collection
process.
DATES: Comments due within 30 days of
publication. OMB must make a decision
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.
Dated: February 12, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–03155 Filed 2–14–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget Review; Community-Based
Child Abuse Prevention Program
(Office of Management and Budget #:
0970–0155)
Children’s Bureau,
Administration on Children, Youth and
Families, Administration for Children
and Families, Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Children’s Bureau,
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
requesting a three-year extension of the
Program Instruction (PI) for the
Community-Based Child Abuse
Prevention (CBCAP) program (Office of
Management and Budget (OMB) #:
0970–0155, expiration June 30, 2024),
which outlines information collection
requirements pursuant to receiving a
SUMMARY:
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.
SUPPLEMENTARY INFORMATION:
Description: The PI, prepared in
response to the enactment of the CBCAP
program, as set forth in Title II of the
Child Abuse Prevention and Treatment
Reauthorization Act of 2010 (Pub. L.
111–320) or CAPTA, provides direction
to the states and territories to
accomplish the purposes of (1)
supporting community-based efforts to
develop, operate, expand, and where
appropriate to network, initiatives
aimed at the prevention of child abuse
and neglect, and to support networks of
coordinated resources and activities to
better strengthen and support families to
reduce the likelihood of child abuse and
neglect and (2) fostering an
understanding, appreciation, and
knowledge of diverse populations in
order to be effective in preventing and
treating child abuse and neglect. This PI
contains information collection
requirements that are found in CAPTA
and pursuant to receiving a grant award.
The information submitted will be used
by the agency to ensure compliance
with the statute, complete the
calculation of the grant award
entitlement, and provide training and
technical assistance to the grantee.
Respondents: State governments,
quasi-public entities, and non-profit
private agencies.
ADDRESSES:
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
Application .......................................................................................................
Annual Report ..................................................................................................
52
52
1
1
40
24
2,080
1,248
Totals ........................................................................................................
........................
........................
........................
3,328
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11836
Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices
Authority: The CAPTA
Reauthorization Act of 2010; Title II of
the CAPTA, Pub. L. 115–271 (42 U.S.C.
5116 et seq.).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–03107 Filed 2–14–24; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0447]
Charging for Investigational Drugs
Under an Investigational New Drug
Application: Questions and Answers;
Guidance 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 a final
guidance for industry entitled ‘‘Charging
for Investigational Drugs Under an IND:
Questions and Answers.’’ This guidance
addresses frequently asked questions
related to the implementation of FDA’s
regulation on charging for
investigational drugs under an
investigational new drug application
(IND) for the purpose of either clinical
trials or expanded access for treatment
use. This guidance finalizes the revised
draft guidance of the same title issued
on August 23, 2022, and replaces the
final guidance issued on June 3, 2016.
DATES: The announcement of the
guidance is published in the Federal
Register on February 15, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
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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’’).
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–
2013–D–0447 for ‘‘Charging for
Investigational Drugs Under an IND:
Questions and Answers’’ Received
comments 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., 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
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.’’ The
Agency 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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
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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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Dat
Doan, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3334, Silver Spring,
MD 20993–0002, 240–402–8926,
Dat.Doan@fda.hhs.gov; or James Myers,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Charging for Investigational Drugs
Under an IND: Questions and Answers.’’
FDA’s regulation on charging for
investigational drugs under an IND (21
CFR 312.8) for the purpose of either
clinical trials or expanded access for
treatment use allows sponsors to charge
for investigational drugs under certain
circumstances.
FDA issued a final guidance on June
3, 2016 entitled ‘‘Charging for
E:\FR\FM\15FEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 32 (Thursday, February 15, 2024)]
[Notices]
[Pages 11835-11836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03107]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget Review; Community-
Based Child Abuse Prevention Program (Office of Management and Budget
#: 0970-0155)
AGENCY: Children's Bureau, Administration on Children, Youth and
Families, Administration for Children and Families, Department of
Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Children's Bureau, Administration for Children and
Families (ACF), U.S. Department of Health and Human Services (HHS), is
requesting a three-year extension of the Program Instruction (PI) for
the Community-Based Child Abuse Prevention (CBCAP) program (Office of
Management and Budget (OMB) #: 0970-0155, expiration June 30, 2024),
which outlines information collection requirements pursuant to
receiving a grant award. There are no changes requested to the
information collection process.
DATES: Comments due within 30 days of publication. OMB must make a
decision 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.
ADDRESSES: 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.
SUPPLEMENTARY INFORMATION:
Description: The PI, prepared in response to the enactment of the
CBCAP program, as set forth in Title II of the Child Abuse Prevention
and Treatment Reauthorization Act of 2010 (Pub. L. 111-320) or CAPTA,
provides direction to the states and territories to accomplish the
purposes of (1) supporting community-based efforts to develop, operate,
expand, and where appropriate to network, initiatives aimed at the
prevention of child abuse and neglect, and to support networks of
coordinated resources and activities to better strengthen and support
families to reduce the likelihood of child abuse and neglect and (2)
fostering an understanding, appreciation, and knowledge of diverse
populations in order to be effective in preventing and treating child
abuse and neglect. This PI contains information collection requirements
that are found in CAPTA and pursuant to receiving a grant award. The
information submitted will be used by the agency to ensure compliance
with the statute, complete the calculation of the grant award
entitlement, and provide training and technical assistance to the
grantee.
Respondents: State governments, quasi-public entities, and non-
profit private agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Average burden
Instrument Total number of responses hours per Annual burden
of respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
Application..................................... 52 1 40 2,080
Annual Report................................... 52 1 24 1,248
---------------------------------------------------------------
Totals...................................... .............. .............. .............. 3,328
----------------------------------------------------------------------------------------------------------------
[[Page 11836]]
Authority: The CAPTA Reauthorization Act of 2010; Title II of the
CAPTA, Pub. L. 115-271 (42 U.S.C. 5116 et seq.).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-03107 Filed 2-14-24; 8:45 am]
BILLING CODE 4184-01-P
