Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program Core Medical Services Waiver Form, OMB No. 0906-0065-Revision, 14507-14508 [2024-03952]
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Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices
receipt of the IND that the
investigational studies were allowed to
proceed.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): November 24, 2020. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for Rybrevant (BLA B761210) was
initially submitted on November 24,
2020.
3. The date the application was
approved: May 21, 2021. FDA has
verified the applicant’s claim that BLA
B761210 was approved on May 21,
2021.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 546 days of patent
term extension.
lotter on DSK11XQN23PROD with NOTICES1
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–03961 Filed 2–26–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Ryan White
HIV/AIDS Program Core Medical
Services Waiver Form, OMB No. 0906–
0065—Revision
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 April 29, 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.
Information Collection Request Title:
Ryan White HIV/AIDS Program Core
Medical Services Waiver Form, OMB
No. 0915–0065—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 with HIV
identified and eligible under the statute,
after reserving permissible amounts for
administrative and clinical quality
management (CQM) costs. The statute
also grants the Secretary of Health and
Human Services authority to waive this
requirement for a Ryan White HIV/AIDS
Program (RWHAP) Part A, B, or C
recipient if certain requirements are
SUMMARY:
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14507
met, and a waiver request is submitted
to HRSA for approval.
As currently implemented by HRSA,
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
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 their 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.
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 requires
recipients to spend not less than 75
percent of funds on core medical
services after reserving statutorily
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27FEN1
14508
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices
permissible amounts for administrative
and CQM costs. However, on the prior
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 adds a requirement to include
the proposed percentages of HIV service
dollars allocated to core medical and
support services on the form. The table
on the prior 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.
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 with HIV
identified and eligible under Title XXVI
of the Public Health Service Act.1
Likely Respondents: HRSA expects
responses from RWHAP Parts A, B, and
C grant applicants and recipients. The
number of grant recipients requesting
waivers has fluctuated annually and
ranged up to 23 per year since its
implementation in fiscal year 2007. In
Number of
respondents
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
1
23
0.49
11.27
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. 2024–03952 Filed 2–26–24; 8:45 am]
BILLING CODE 4165–15–P
lotter on DSK11XQN23PROD with NOTICES1
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Risk, Prevention and
Health Behavior Integrated Review Group;
HIV/AIDS Intra- and Inter-personal
Determinants and Behavioral Interventions
Study Section.
Date: March 20–21, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW, Washington, DC 20036.
Contact Person: Mark P Rubert, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–806–
6596, rubertm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Aging and Development, Auditory
Vision and Low Vision Technologies.
Date: March 20–21, 2024.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Barbara Susanne Mallon,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 480–8992, mallonb@
mail.nih.gov.
1 Sections 2604(c)(2), 2612(b)(2), and 2651(c)(2) of
the PHS Act.
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]]>Agencies
[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Notices]
[Pages 14507-14508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03952]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Ryan
White HIV/AIDS Program Core Medical Services Waiver Form, OMB No. 0906-
0065--Revision
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 April 29,
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: Ryan White HIV/AIDS Program
Core Medical Services Waiver Form, OMB No. 0915-0065--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
with HIV identified and eligible under the statute, after reserving
permissible amounts for administrative and clinical quality management
(CQM) costs. The statute also grants the Secretary of Health and Human
Services 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, 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 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 their 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.
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 requires recipients to spend not less
than 75 percent of funds on core medical services after reserving
statutorily
[[Page 14508]]
permissible amounts for administrative and CQM costs. However, on the
prior 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 adds a requirement to include the proposed
percentages of HIV service dollars allocated to core medical and
support services on the form. The table on the prior 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.
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 with HIV identified and eligible under
Title XXVI of the Public Health Service Act.\1\
---------------------------------------------------------------------------
\1\ Sections 2604(c)(2), 2612(b)(2), and 2651(c)(2) of the PHS
Act.
---------------------------------------------------------------------------
Likely Respondents: HRSA expects responses from RWHAP Parts A, B,
and C grant applicants and recipients. The number of grant recipients
requesting waivers has fluctuated annually and 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:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total
Form name respondents responses per responses response (in burden
respondent hours) hours
----------------------------------------------------------------------------------------------------------------
RWHAP................................. 23 1 23 0.49 11.27
Core Medical Services Waiver Request
Attestation Form.....................
-------------------------------------------------------------------------
Total............................. 23 1 23 0.49 11.27
----------------------------------------------------------------------------------------------------------------
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. 2024-03952 Filed 2-26-24; 8:45 am]
BILLING CODE 4165-15-P
