Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Core Medical Services Waiver Form, 53110-53112 [2024-13857]
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Federal Register / Vol. 89, No. 122 / Tuesday, June 25, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
manufacturer of the IVD is a laboratory.
The final rule, which is codified at 21
CFR 809.3, is effective July 5, 2024. In
conjunction with this amendment, the
FDA is phasing out its general
enforcement discretion approach for
LDTs so that IVDs manufactured by a
laboratory will generally fall under the
same enforcement approach as other
IVDs. This phaseout policy includes
enforcement discretion policies for
specific categories of IVDs
manufactured by a laboratory, including
currently marketed IVDs offered as
LDTs and LDTs for unmet needs. This
phaseout policy is intended to better
protect the public health by helping to
assure the safety and effectiveness of
IVDs offered as LDTs, while also
accounting for other important public
health considerations such as patient
access and reliance. FDA has prepared
this SECG to assist small entities in
complying with the requirements
established in FDA regulations, as they
apply to IVDs, including LDTs.
This level 2 guidance is being issued
consistent with our good guidance
practices regulation (21 CFR
10.115(c)(2)). The SECG represents the
current thinking of FDA on this topic.
It does not establish any rights for any
person and is not binding on FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Laboratory
Developed Tests: Small Entity
Compliance Guide; Guidance for
Laboratory Manufacturers and Food and
Drug Administration Staff’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number GUI00007036 and
complete title to identify the guidance
you are requesting.
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III. Paperwork Reduction Act of 1995
ACTION:
While this guidance contains no new
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 following collections
of information have been approved by
OMB: OMB control number 0910–0437,
Medical Device Reporting; OMB control
number 0910–0359, Corrections and
Removals; OMB control number 0910–
0625, Device Registration and Listing;
OMB control number 0910–0485,
Device Labeling; OMB control number
0910–0078, Investigational Device
Exemption; OMB control number 0910–
0073, Quality Systems, including
§ 820.198 (complaint files); OMB control
number 0910–0231, Premarket
Approval; OMB control number 0910–
0332, Humanitarian Device Exemption;
OMB control number 0910–0120,
Premarket Notification; OMB control
number 0910–0844 De Novo Requests;
OMB control number 0910–0338,
Biologics License Applications
Procedures & Requirements; OMB
control number 0910–0052, Blood
Establishment Registration and Product
Listing for Manufacturers of Human
Blood and Blood Products and Licensed
Devices; OMB control number 0910–
0014, Investigational use requirements
under 42 U.S.C. 262 and 21 CFR part
312 for certain devices that are
biological products; and OMB control
number 0910–0756, FDA’s final
guidance document entitled ‘‘Requests
for Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program.’’
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 July 25, 2024. The
form will become effective on October 1,
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:
Ryan White HIV/AIDS Program Core
Medical Services Waiver Form, OMB
No. 0906–0065—Revision
Abstract: In accordance with sections
2604(c), 2612(b), and 2651(c) of the
Public Health Service Act, recipients are
required to spend not less than 75
percent of funds on core medical
services for individuals identified with
HIV and who are eligible under the
statute, after reserving permissible
amounts for administrative and clinical
quality management (CQM) costs. The
statute also grants the Secretary
authority to waive this requirement for
a Ryan White HIV/AIDS Program
(RWHAP) Part A, B, or C recipient if
certain requirements are met, and a
waiver request is submitted to HRSA for
approval.
As currently implemented by HRSA,
in order to be approved, (1) core
medical services must be available and
accessible to all individuals identified
and eligible for the RWHAP in the
recipient’s service area within 30 days.
This access must be without regard to
payer source, and without the need to
spend at least 75 percent of funds
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13872 Filed 6–24–24; 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; Ryan White HIV/AIDS
Program Core Medical Services Waiver
Form
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
PO 00000
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Notice.
SUMMARY:
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Federal Register / Vol. 89, No. 122 / Tuesday, June 25, 2024 / Notices
remaining from the recipient’s RWHAP
award after statutorily permissible
amounts for administrative and CQM
costs are reserved; (2) the recipient must
ensure there are no AIDS Drug
Assistance Program (ADAP) waiting
lists in its service area; and (3) a public
process to obtain input on the waiver
request must have occurred. This
process must seek input from impacted
communities, including clients and
RWHAP-funded core medical services
providers, on the availability of core
medical services, and the decision to
request the waiver. The public process
may be a part of the same one used by
recipients to seek input on community
needs as part of the annual priority
setting and resource allocation,
comprehensive planning, statewide
coordinated statement of need, public
planning, and/or needs assessment
processes. RWHAP Parts A, B, and C
core medical services waiver requests
must include funds awarded under the
Minority AIDS Initiative. Core medical
services waivers are effective for a 1year period.
The process for RWHAP Parts A, B,
and C grant recipients to request a
waiver of the minimum expenditure
amount requirements for core medical
services is outlined in Policy Notice 21–
01, Waiver of the Ryan White HIV/AIDS
Program Core Medical Services
Expenditure Requirement. Policy Notice
21–01 is currently being revised and
will be effective October 1, 2024.
HRSA proposes to modify the onepage form to include the proposed
percentages of HIV service dollars
allocated to core medical and support
services. Under the proposed changes, a
field will be added to the form to
capture the proposed percentages. This
information will inform HRSA whether
recipients are able to meet the statutory
requirements in sections 2604(c),
2612(b), and 2651(c) of the Public
Health Service Act and will clarify what
proposed portion of funds will be
allocated to core medical and support
services. Minor changes will also be
made to the form to increase readability.
Summary of Proposed Changes:
Sections 2604(c), 2612(b), and 2651(c) of
the Public Health Service Act require
recipients to spend not less than 75
percent of funds on core medical
services after reserving statutorily
permissible amounts for administrative
and CQM costs. However, on the current
version of the form, the portion of HIV
service dollars to be allocated to core
medical and support services was
sometimes unclear. The suggested
change to the form adds a requirement
to include the proposed percentages of
HIV service dollars allocated to core
medical and support services. The table
on the current form is expanded to
allow for the insertion of the proposed
percentages for core medical and
support services. Instructions at the top
of the new form are updated to indicate
where to insert the proposed
percentages. Language within the table
is also updated to increase readability.
The proposed changes do not modify
the underlying requirements necessary
to obtain a waiver: all core medical
services are available and accessible
within 30 days in the jurisdiction or
service area; ensuring that the state
ADAP has no waiting lists; and that the
recipient has used a public process to
determine the need for a waiver.
Recipients may still need to provide
supportive evidence to HRSA upon
request.
A 60-day notice published in the
Federal Register on February 27, 2024,
vol. 89, No. 39; pp. 14507–14508. There
were no public comments.
Need and Proposed Use of the
Information: HRSA uses the
documentation submitted in core
medical services waiver requests to
determine if the RWHAP Parts A, B, and
C grant applicant or recipient meets the
statutory requirements for waiver
eligibility including: (1) no waiting lists
for ADAP services; and (2) evidence of
core medical services availability within
the grant recipient’s jurisdiction, state,
or service area to all persons identified
with HIV and eligible under Title XXVI
of the Public Health Service Act.
Likely Respondents: HRSA expects
responses from RWHAP Parts A, B, and
C grant applicants and recipients. The
number of grant recipients requesting
waivers fluctuates annually and has
ranged up to 23 per year since its
implementation in fiscal year 2007. In
light of recent trends, HRSA anticipates
receiving possibly up to 23 applications
in a given year.
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
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
RWHAP Core medical Services Waiver request Attestation
Form .................................................................................
23
1
23
0.49
11.27
Total ..............................................................................
23
........................
23
........................
11.27
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Federal Register / Vol. 89, No. 122 / Tuesday, June 25, 2024 / Notices
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.
Dated: June 18, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–13838 Filed 6–24–24; 8:45 am]
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4140–01–P
[FR Doc. 2024–13857 Filed 6–24–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4165–15–P
National Institutes of Health
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Fishers Lane, Room 3G21A, Rockville, MD
20852, 240.627.3219, shiv.prasad@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)
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01 Clinical
Trial Not Allowed).
Date: July 18, 2024.
Time: 1:00 p.m. to 4:00 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 3G21A,
Rockville, MD 20852 (Video Assisted
Meeting).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
VerDate Sep<11>2014
17:03 Jun 24, 2024
Jkt 262001
Submission for OMB Review; 30-Day
Comment Request Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
(NIH)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Ms. Mikia Currie,
Project Clearance Officer, Office of
Policy for Extramural Research
Administration, 6705 Rockledge Drive,
Suite 350, Bethesda, Maryland 20892 or
call non-toll-free number (301) 435–
ADDRESSES:
PO 00000
Frm 00075
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0941 or email your request, including
your address to: curriem@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on April 10th, 2024 (89 FR
25275) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
The National Institutes of Health
(NIH) may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
Office of Management and Budget
(OMB) control number.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, NIH has
submitted to OMB a request for review
and approval of the information
collection listed below.
Proposed Collection: Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery, EXTENSION, 0925–0648,
expiration date 06/30/2024, National
Institutes of Health (NIH).
Need and Use of Information
Collection: There are no substantive
changes being requested for this
submission. The information collection
activity will garner qualitative customer
and stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. This generic
clearance will continue to provide
information about the NIH Institutes
and Centers customer or stakeholder
perceptions, experiences, and
expectations, provide an early warning
of issues with service, or focus attention
on areas where communication,
training, or changes in operations might
improve delivery of products or
services. It will also allow feedback to
contribute directly to the improvement
of program management. Feedback
collected under this generic clearance
will provide useful information, but it
will not yield data that can be
generalized to the overall population.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
103,083.
E:\FR\FM\25JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 122 (Tuesday, June 25, 2024)]
[Notices]
[Pages 53110-53112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13857]
-----------------------------------------------------------------------
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; Ryan White HIV/AIDS
Program Core Medical Services Waiver Form
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 July 25,
2024. The form will become effective on October 1, 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: Ryan White HIV/AIDS Program
Core Medical Services Waiver Form, OMB No. 0906-0065--Revision
Abstract: In accordance with sections 2604(c), 2612(b), and 2651(c)
of the Public Health Service Act, recipients are required to spend not
less than 75 percent of funds on core medical services for individuals
identified with HIV and who are eligible under the statute, after
reserving permissible amounts for administrative and clinical quality
management (CQM) costs. The statute also grants the Secretary authority
to waive this requirement for a Ryan White HIV/AIDS Program (RWHAP)
Part A, B, or C recipient if certain requirements are met, and a waiver
request is submitted to HRSA for approval.
As currently implemented by HRSA, in order to be approved, (1) core
medical services must be available and accessible to all individuals
identified and eligible for the RWHAP in the recipient's service area
within 30 days. This access must be without regard to payer source, and
without the need to spend at least 75 percent of funds
[[Page 53111]]
remaining from the recipient's RWHAP award after statutorily
permissible amounts for administrative and CQM costs are reserved; (2)
the recipient must ensure there are no AIDS Drug Assistance Program
(ADAP) waiting lists in its service area; and (3) a public process to
obtain input on the waiver request must have occurred. This process
must seek input from impacted communities, including clients and RWHAP-
funded core medical services providers, on the availability of core
medical services, and the decision to request the waiver. The public
process may be a part of the same one used by recipients to seek input
on community needs as part of the annual priority setting and resource
allocation, comprehensive planning, statewide coordinated statement of
need, public planning, and/or needs assessment processes. RWHAP Parts
A, B, and C core medical services waiver requests must include funds
awarded under the Minority AIDS Initiative. Core medical services
waivers are effective for a 1-year period.
The process for RWHAP Parts A, B, and C grant recipients to request
a waiver of the minimum expenditure amount requirements for core
medical services is outlined in Policy Notice 21-01, Waiver of the Ryan
White HIV/AIDS Program Core Medical Services Expenditure Requirement.
Policy Notice 21-01 is currently being revised and will be effective
October 1, 2024.
HRSA proposes to modify the one-page form to include the proposed
percentages of HIV service dollars allocated to core medical and
support services. Under the proposed changes, a field will be added to
the form to capture the proposed percentages. This information will
inform HRSA whether recipients are able to meet the statutory
requirements in sections 2604(c), 2612(b), and 2651(c) of the Public
Health Service Act and will clarify what proposed portion of funds will
be allocated to core medical and support services. Minor changes will
also be made to the form to increase readability.
Summary of Proposed Changes: Sections 2604(c), 2612(b), and 2651(c)
of the Public Health Service Act require recipients to spend not less
than 75 percent of funds on core medical services after reserving
statutorily permissible amounts for administrative and CQM costs.
However, on the current version of the form, the portion of HIV service
dollars to be allocated to core medical and support services was
sometimes unclear. The suggested change to the form adds a requirement
to include the proposed percentages of HIV service dollars allocated to
core medical and support services. The table on the current form is
expanded to allow for the insertion of the proposed percentages for
core medical and support services. Instructions at the top of the new
form are updated to indicate where to insert the proposed percentages.
Language within the table is also updated to increase readability.
The proposed changes do not modify the underlying requirements
necessary to obtain a waiver: all core medical services are available
and accessible within 30 days in the jurisdiction or service area;
ensuring that the state ADAP has no waiting lists; and that the
recipient has used a public process to determine the need for a waiver.
Recipients may still need to provide supportive evidence to HRSA upon
request.
A 60-day notice published in the Federal Register on February 27,
2024, vol. 89, No. 39; pp. 14507-14508. There were no public comments.
Need and Proposed Use of the Information: HRSA uses the
documentation submitted in core medical services waiver requests to
determine if the RWHAP Parts A, B, and C grant applicant or recipient
meets the statutory requirements for waiver eligibility including: (1)
no waiting lists for ADAP services; and (2) evidence of core medical
services availability within the grant recipient's jurisdiction, state,
or service area to all persons identified with HIV and eligible under
Title XXVI of the Public Health Service Act.
Likely Respondents: HRSA expects responses from RWHAP Parts A, B,
and C grant applicants and recipients. The number of grant recipients
requesting waivers fluctuates annually and has ranged up to 23 per year
since its implementation in fiscal year 2007. In light of recent
trends, HRSA anticipates receiving possibly up to 23 applications in a
given year.
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
----------------------------------------------------------------------------------------------------------------
RWHAP Core medical Services 23 1 23 0.49 11.27
Waiver request Attestation Form
-------------------------------------------------------------------------------
Total....................... 23 .............. 23 .............. 11.27
----------------------------------------------------------------------------------------------------------------
[[Page 53112]]
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. 2024-13857 Filed 6-24-24; 8:45 am]
BILLING CODE 4165-15-P
