Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Advanced Nursing Education Program Specific Form OMB No. 0915-0375-Revision, 16584-16585 [2024-04848]
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16584
Federal Register / Vol. 89, No. 46 / Thursday, March 7, 2024 / Notices
In the Federal Register of August 29,
2022 (87 FR 52784), FDA published a
notice announcing the availability of the
draft guidances entitled ‘‘Q2(R2)
Validation of Analytical Procedures’’
and ‘‘Q14 Analytical Procedure
Development.’’ The notice gave
interested persons an opportunity to
submit comments by September 28,
2022.
After consideration of the comments
received and revisions to the guideline,
final drafts of the guidelines were
submitted to the ICH Assembly and
endorsed by the regulatory agencies in
November 2023.
These guidances finalize the draft
guidances issued on August 29, 2022.
The final ‘‘Q2(R2) Validation of
Analytical Procedures’’ guidance
resolves issues on range, response,
reference material, biologics, replicates,
and dissolution. In addition, guidance
on data requirements for accuracy,
precision, and the combined approach
(e.g., confidence intervals) were refined.
The final ‘‘Q14 Analytical Procedure
Development’’ guidance includes
further clarification of concepts like
minimum versus enhanced approach,
the definition and description of the
analytical targeting profile, and
established conditions.
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Q2(R2) Validation
of Analytical Procedures’’ and ‘‘Q14
Analytical Procedure Development.’’
These guidances do not establish any
rights for any person and are not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
khammond on DSKJM1Z7X2PROD with NOTICES
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information for investigational new drug
applications have been approved under
OMB control number 0910–0014; the
collections of information for review of
new drug applications have been
approved under OMB control number
0910–0001; and the collections of
information for review of biologics
license applications have been approved
under OMB control number 0910–0338.
VerDate Sep<11>2014
16:13 Mar 06, 2024
Jkt 262001
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Dated: March 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04834 Filed 3–6–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Advanced Nursing
Education Program Specific Form
OMB No. 0915–0375—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than April 8, 2024.
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 Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Advanced Nursing Education (ANE)
Program Specific Form OMB No. 0915–
0375—Revision.
Abstract: HRSA provides advanced
nursing education grants to educational
institutions to increase the supply,
distribution, quality of, and access to
advanced education nurses through the
ANE Programs. The ANE Programs are
authorized by section 811 of the Public
Health Service Act (42 U.S.C. 296j), as
amended. This clearance request is for
continued approval of the information
collection OMB No. 0915–0375 with
revisions. This revision request seeks to
add the ANE-Nurse Practitioner
Residency and Fellowship Program and
the Maternity Care Nursing Workforce
Expansion Program to the ANE Program
Specific Form, and to remove programs
that have closed, which include the
ANE-Nurse Practitioner Residency
Program and the ANE-Nurse
Practitioner Residency Integration
Program. The activities previously
supported under the ANE Nurse
Practitioner Residency Program and the
ANE-Nurse Practitioner Residency
Integration Program are now supported
under the ANE-Nurse Practitioner
Residency and Fellowship Program.
A 60-day notice published in the
Federal Register on December 28, 2023,
88 FR 89709–10. There were no public
comments.
Need and Proposed Use of the
Information: Section 811 of the Public
Health Service Act provides the
Secretary of Health and Human Services
with the authority to award grants to
and enter into contracts with eligible
entities to meet the costs of: (1) projects
that support the enhancement of
advanced nursing education and
practice; and (2) traineeships for
individuals in advanced nursing
education programs. Under this section,
HRSA makes awards to entities who
train and support nurses characterized
as ‘‘advanced education nurses.’’ In
awarding such grants, funding
preference is given to applicants with
projects that will substantially benefit
rural or underserved populations, or
help meet public health nursing needs
in state or local health departments;
special consideration is given to an
eligible entity that agrees to extend the
award to train advanced education
nurses who will practice in designated
Health Professional Shortage Areas.
The ANE Program Specific Form
allows HRSA to effectively target
E:\FR\FM\07MRN1.SGM
07MRN1
16585
Federal Register / Vol. 89, No. 46 / Thursday, March 7, 2024 / Notices
funding and measure the impact of the
ANE Programs in meeting the legislative
intent and program goals of supporting
the enhancement of advanced nursing
education and creating opportunities for
individuals in advanced nursing
education programs to increase the
number of advanced practice nurses,
especially in rural and underserved
areas. Additionally, collecting this data
assists HRSA in carrying out the most
impactful program and ensuring
resources are used responsibly. The
proposed updates to this information
collection are to accurately list the
current ANE Programs.
Likely Respondents: Likely
respondents will be current ANE
Programs awardees and new applicants
to ANE Programs.
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
Form name (includes the ANE program specific tables and
attachments)
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total
burden
hours
Advanced Nursing Education Workforce .............................
Nurse Anesthetist Traineeship .............................................
ANE—Sexual Assault Nurse Examiners .............................
ANE—Nurse Practitioner Residency and Fellowship ..........
Maternity Care Nursing Workforce Expansion ....................
156
64
54
64
10
1
1
1
1
1
156
64
54
64
10
7
7
7
7
7
1,092
448
378
448
70
Total ..............................................................................
348
........................
348
........................
2,436
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; National Health Service
Corps Scholar/Students to Service
Travel Worksheet, OMB No. 0915–
0278—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
VerDate Sep<11>2014
16:13 Mar 06, 2024
Comments on this ICR should be
received no later than April 8, 2024.
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 Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
National Health Service Corps Scholar/
Students to Service Travel Worksheet,
OMB No. 0915–0278—Revision.
Abstract: Clinicians participating in
the HRSA National Health Service
Corps (NHSC) Scholarship Program and
the Students to Service (S2S) Loan
Repayment Program use the online
Travel Request Worksheet to request
and receive travel funds from the
Federal Government to visit eligible
NHSC sites to which they may be
assigned in accordance with the Public
Health Service Act, section 331(c)(1).
The travel approval process is
initiated when an NHSC scholar or S2S
participant notifies the NHSC of an
DATES:
[FR Doc. 2024–04848 Filed 3–6–24; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
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:
Jkt 262001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
impending interview at one or more
NHSC-approved practice sites. The
Travel Request Worksheet is also used
to initiate the relocation process after an
NHSC scholar or S2S participant has
successfully been matched to an
approved practice site in accordance
with the Public Health Service Act,
section 331(c)(3). Upon receipt of a
completed Travel Request Worksheet,
the NHSC will review and approve or
disapprove the request and promptly
notify the NHSC scholar or S2S
participant and the NHSC logistics
contractor regarding travel arrangements
and authorization of the funding for the
site visit or relocation.
A 60-day notice published in the
Federal Register on December 29, 2023,
88 FR 90190–91. There were no public
comments.
Need and Proposed Use of the
Information: This information will
facilitate NHSC scholar and S2S
participants’ receipt of Federal travel
funds that are used to visit high-need
NHSC-approved practice sites. The
Travel Request Worksheet is also used
to initiate the relocation process after a
NHSC scholar or S2S participant has
successfully been matched to an
approved practice site.
Likely Respondents: Clinicians
participating in the NHSC Scholarship
Program and the S2S Loan Repayment
Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
E:\FR\FM\07MRN1.SGM
07MRN1
]]>Agencies
[Federal Register Volume 89, Number 46 (Thursday, March 7, 2024)]
[Notices]
[Pages 16584-16585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04848]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request Title: Advanced Nursing Education Program Specific Form OMB No.
0915-0375--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than April 8,
2024.
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 Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Joella Roland, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Advanced Nursing Education
(ANE) Program Specific Form OMB No. 0915-0375--Revision.
Abstract: HRSA provides advanced nursing education grants to
educational institutions to increase the supply, distribution, quality
of, and access to advanced education nurses through the ANE Programs.
The ANE Programs are authorized by section 811 of the Public Health
Service Act (42 U.S.C. 296j), as amended. This clearance request is for
continued approval of the information collection OMB No. 0915-0375 with
revisions. This revision request seeks to add the ANE-Nurse
Practitioner Residency and Fellowship Program and the Maternity Care
Nursing Workforce Expansion Program to the ANE Program Specific Form,
and to remove programs that have closed, which include the ANE-Nurse
Practitioner Residency Program and the ANE-Nurse Practitioner Residency
Integration Program. The activities previously supported under the ANE
Nurse Practitioner Residency Program and the ANE-Nurse Practitioner
Residency Integration Program are now supported under the ANE-Nurse
Practitioner Residency and Fellowship Program.
A 60-day notice published in the Federal Register on December 28,
2023, 88 FR 89709-10. There were no public comments.
Need and Proposed Use of the Information: Section 811 of the Public
Health Service Act provides the Secretary of Health and Human Services
with the authority to award grants to and enter into contracts with
eligible entities to meet the costs of: (1) projects that support the
enhancement of advanced nursing education and practice; and (2)
traineeships for individuals in advanced nursing education programs.
Under this section, HRSA makes awards to entities who train and support
nurses characterized as ``advanced education nurses.'' In awarding such
grants, funding preference is given to applicants with projects that
will substantially benefit rural or underserved populations, or help
meet public health nursing needs in state or local health departments;
special consideration is given to an eligible entity that agrees to
extend the award to train advanced education nurses who will practice
in designated Health Professional Shortage Areas.
The ANE Program Specific Form allows HRSA to effectively target
[[Page 16585]]
funding and measure the impact of the ANE Programs in meeting the
legislative intent and program goals of supporting the enhancement of
advanced nursing education and creating opportunities for individuals
in advanced nursing education programs to increase the number of
advanced practice nurses, especially in rural and underserved areas.
Additionally, collecting this data assists HRSA in carrying out the
most impactful program and ensuring resources are used responsibly. The
proposed updates to this information collection are to accurately list
the current ANE Programs.
Likely Respondents: Likely respondents will be current ANE Programs
awardees and new applicants to ANE Programs.
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:
----------------------------------------------------------------------------------------------------------------
Form name (includes the ANE Number of Average burden
program specific tables and Number of responses per Total per response Total burden
attachments) respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Advanced Nursing Education 156 1 156 7 1,092
Workforce......................
Nurse Anesthetist Traineeship... 64 1 64 7 448
ANE--Sexual Assault Nurse 54 1 54 7 378
Examiners......................
ANE--Nurse Practitioner 64 1 64 7 448
Residency and Fellowship.......
Maternity Care Nursing Workforce 10 1 10 7 70
Expansion......................
-------------------------------------------------------------------------------
Total....................... 348 .............. 348 .............. 2,436
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-04848 Filed 3-6-24; 8:45 am]
BILLING CODE 4165-15-P
