Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Alliance for Innovation on Maternal Health Biannual Survey, OMB No. 0915-xxxx-New, 85298-85299 [2023-26902]
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Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices
section 503A because they are not the
subject of an applicable USP or NF
monograph, components of FDAapproved drug products, or on the 503A
bulks list. One of those conditions is
that the bulk drug substance appears in
Category 1. If the 2023 503A Interim
Policy Draft Guidance is finalized in its
current form, a substance nominated on
or after the date of publication of that
final guidance would not be categorized
and would not be within the scope of
the policy for substances that appear in
Category 1.1 However, FDA would
consider the substance for inclusion on
the 503A bulks list in accordance with
the process and criteria established in
the FD&C Act and FDA regulations (see
section 503A(b)(1)(A) of the FD&C Act
and 21 CFR 216.23(c)). Substances that
already appear in Category 1 (including
substances nominated with adequate
supporting information prior to the date
of publication of the final guidance)
may continue to be eligible for the
policy that applies to Category 1
substances, as described in the final
guidance, until FDA promulgates a final
rule determining whether they will be
placed on the 503A bulks list in
accordance with section
503A(b)(1)(A)(i)(III) of the FD&C Act or
unless the Agency removes the
substances from Category 1 based on, for
example, information about safety risks.
FDA encourages interested parties to
focus their comments on the limited
revisions to the interim policy included,
for public comment, in the 2023 503A
Interim Policy Draft Guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Interim Policy on Compounding
Using Bulk Drug Substances Under
Section 503A of the Federal Food, Drug,
and Cosmetic Act.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
1 FDA recognizes that some compounders and
other stakeholders may currently be in the process
of compiling a nomination for the 503A bulks list
for submission to the Agency. FDA intends to
categorize nominations of bulk drug substances
received prior to the date in which FDA announces
the availability of the final guidance. FDA believes
that this will provide a sufficient amount of time
in which to submit nominations that are currently
in progress.
VerDate Sep<11>2014
20:23 Dec 06, 2023
Jkt 262001
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26886 Filed 12–6–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Alliance
for Innovation on Maternal Health
Biannual Survey, OMB No. 0915–
xxxx—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 5, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
SUMMARY:
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
Information Collection Request Title:
The Alliance for Innovation on Maternal
Health Biannual Survey, OMB No.
0915–xxxx—New.
Abstract: The Alliance for Innovation
on Maternal Health (AIM) program is
administered by HRSA and authorized
by 42 U.S.C. 254c–21 (Public Health
Service Act, title III section 330O), as
added by the Consolidated
Appropriations Act, 2022 (Pub. L. 117–
103).
The AIM program supports the
identification, development,
implementation, and dissemination of
maternal (patient) safety bundles to
promote safe care for every U.S. birth
and assist with addressing the complex
problem of high maternal mortality and
severe maternal morbidity rates within
the U.S. The mission of AIM is to
support best practices that make birth
safer, improve the quality of maternal
health care and outcomes, and save
lives. Maternal patient safety bundles
address topics commonly associated
with health complications or risks
related to prenatal, labor and delivery,
and postpartum care.
The AIM program consists of two
components: The AIM Capacity program
and the AIM Technical Assistance (TA)
Center. The AIM Capacity awards began
in fiscal year 2023 and directly fund 28
States and jurisdictions (including U.S.
Territories and the District of Columbia)
to implement AIM maternal patient
safety bundles. The second component,
the AIM TA Center, is funded through
a cooperative agreement to provide TA
to all 50 States, the District of Columbia,
jurisdictions, U.S. Territories, Tribal
communities, and birthing facilities
who participate in the AIM program.
The TA Center builds data capacity for
participating entities to track progress
on bundle implementation and support
improvement of data collection.
The funding amount for the AIM
program was increased in fiscal year
2023, which allowed HRSA to directly
fund States and Territories to support
AIM bundle implementation.
Previously, HRSA supported AIM
through one cooperative agreement to
develop maternal patient safety bundles,
provide TA on bundle implementation,
and enroll States and Territories in the
program. The shift to directly fund
States and jurisdictions for the work
makes the collection of information
about the reach of the program,
participation by birthing facilities, and
TA needs necessary. The AIM Biannual
Survey will be administered to AIM
State Teams (the State-or jurisdictionlevel entity leading AIM
implementation) twice a year in all
States and jurisdictions enrolled in
E:\FR\FM\07DEN1.SGM
07DEN1
85299
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices
AIM. Respondents will include AIM
State Teams that receive HRSA funding
through the AIM Capacity program, as
well as AIM State Teams that do not
receive HRSA funding to implement
AIM, to gauge the full reach of the
program.
Need and Proposed Use of the
Information: The information will be
used by the HRSA program team to
understand and report on AIM program
reach and potential growth regarding
participating birthing facilities and
patient safety bundles implemented,
inform development of resources and
types of TA offered, and develop
program targets. In addition,
Number of
respondents
Form name
AIM Biannual Survey ........................
Total ...........................................
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–P
Dated: December 4, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–26903 Filed 12–6–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Agency Information Collection
Activities; Revision of a Currently
Approved Collection: Application for
Travel Document
National Institutes of Health
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 60-Day notice.
AGENCY:
National Center for Advancing
Translational Sciences; Amended
Notice of Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
same as stated above. This meeting is
partially closed to the public.
[OMB Control Number 1615–0013]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice is hereby given of a change in
the meeting of the National Center for
Advancing Translational Sciences
Advisory Council, January 18, 2024,
11:00 a.m. to January 19, 2024, 6:00
p.m., National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 which
was published in the Federal Register
on November 03, 2023, FR Doc. 2023–
24224, 88 FR 75295.
This notice is being amended to
change the meeting date from January
18, 2024, to January 19, 2024. The
meeting times and location remain the
Jkt 262001
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration (USCIS) invites the general
public and other Federal agencies to
comment upon this proposed extension
of a currently approved collection of
information. In accordance with the
Paperwork Reduction Act (PRA) of
1995, the information collection notice
is published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
burden (i.e., the time, effort, and
SUMMARY:
PO 00000
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden
Hours:
Total
responses
1 per survey; 2 surveys per year .....
1 per survey; 2 surveys per year .....
U.S. Citizenship and Immigration
Services
[FR Doc. 2023–26902 Filed 12–6–23; 8:45 am]
20:23 Dec 06, 2023
Number of responses
per respondent
52
52
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
VerDate Sep<11>2014
information on the number of
participating birthing facilities and
patient safety bundles being
implemented is shared on the HRSA
and ACOG AIM websites. The biannual
survey is the only place this information
is collected.
Likely Respondents: Respondents are
AIM State Teams in all States and
jurisdictions enrolled in AIM, including
AIM Capacity award recipients and AIM
State Teams that do not receive direct
funding from HRSA.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
Frm 00096
Fmt 4703
Sfmt 4703
104
104
Average
burden per
response
(in hours)
Total burden
hours
1
1
104
104
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until
February 5, 2024.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0013 in the body of the letter, the
agency name and Docket ID USCIS–
2007–0045. Comments must be
submitted in English, or an English
translation must be provided. Submit
comments via the Federal eRulemaking
Portal website at https://
www.regulations.gov under e-Docket ID
number USCIS–2007–0045.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, telephone
number (240) 721–3000 (This is not a
toll-free number. Comments are not
accepted via telephone message). Please
note contact information provided here
is solely for questions regarding this
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS website
at https://www.uscis.gov, or call the
USCIS Contact Center at 800–375–5283
(TTY 800–767–1833).
SUPPLEMENTARY INFORMATION:
Comments
You may access the information
collection instrument with instructions,
or additional information by visiting the
E:\FR\FM\07DEN1.SGM
07DEN1
]]>Agencies
[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Notices]
[Pages 85298-85299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26902]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: The
Alliance for Innovation on Maternal Health Biannual Survey, OMB No.
0915-xxxx--New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than February
5, 2024.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: The Alliance for Innovation
on Maternal Health Biannual Survey, OMB No. 0915-xxxx--New.
Abstract: The Alliance for Innovation on Maternal Health (AIM)
program is administered by HRSA and authorized by 42 U.S.C. 254c-21
(Public Health Service Act, title III section 330O), as added by the
Consolidated Appropriations Act, 2022 (Pub. L. 117-103).
The AIM program supports the identification, development,
implementation, and dissemination of maternal (patient) safety bundles
to promote safe care for every U.S. birth and assist with addressing
the complex problem of high maternal mortality and severe maternal
morbidity rates within the U.S. The mission of AIM is to support best
practices that make birth safer, improve the quality of maternal health
care and outcomes, and save lives. Maternal patient safety bundles
address topics commonly associated with health complications or risks
related to prenatal, labor and delivery, and postpartum care.
The AIM program consists of two components: The AIM Capacity
program and the AIM Technical Assistance (TA) Center. The AIM Capacity
awards began in fiscal year 2023 and directly fund 28 States and
jurisdictions (including U.S. Territories and the District of Columbia)
to implement AIM maternal patient safety bundles. The second component,
the AIM TA Center, is funded through a cooperative agreement to provide
TA to all 50 States, the District of Columbia, jurisdictions, U.S.
Territories, Tribal communities, and birthing facilities who
participate in the AIM program. The TA Center builds data capacity for
participating entities to track progress on bundle implementation and
support improvement of data collection.
The funding amount for the AIM program was increased in fiscal year
2023, which allowed HRSA to directly fund States and Territories to
support AIM bundle implementation. Previously, HRSA supported AIM
through one cooperative agreement to develop maternal patient safety
bundles, provide TA on bundle implementation, and enroll States and
Territories in the program. The shift to directly fund States and
jurisdictions for the work makes the collection of information about
the reach of the program, participation by birthing facilities, and TA
needs necessary. The AIM Biannual Survey will be administered to AIM
State Teams (the State-or jurisdiction-level entity leading AIM
implementation) twice a year in all States and jurisdictions enrolled
in
[[Page 85299]]
AIM. Respondents will include AIM State Teams that receive HRSA funding
through the AIM Capacity program, as well as AIM State Teams that do
not receive HRSA funding to implement AIM, to gauge the full reach of
the program.
Need and Proposed Use of the Information: The information will be
used by the HRSA program team to understand and report on AIM program
reach and potential growth regarding participating birthing facilities
and patient safety bundles implemented, inform development of resources
and types of TA offered, and develop program targets. In addition,
information on the number of participating birthing facilities and
patient safety bundles being implemented is shared on the HRSA and ACOG
AIM websites. The biannual survey is the only place this information is
collected.
Likely Respondents: Respondents are AIM State Teams in all States
and jurisdictions enrolled in AIM, including AIM Capacity award
recipients and AIM State Teams that do not receive direct funding from
HRSA.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
AIM Biannual Survey........... 52 1 per survey; 2 104 1 104
surveys per
year.
Total..................... 52 1 per survey; 2 104 1 104
surveys per
year.
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-26902 Filed 12-6-23; 8:45 am]
BILLING CODE 4165-15-P
