Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: HRSA AIDS Drug Assistance Program (ADAP) Data Report, 67702-67703 [2022-24461]
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Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Notices
FOR FURTHER INFORMATION CONTACT:
khammond on DSKJM1Z7X2PROD with NOTICES
Susan Levine, Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1674, Silver Spring,
MD 20993–0002, 240–402–7936.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Sameness Evaluations in an ANDA—
Active Ingredients.’’ This guidance is
intended to assist applicants preparing
an ANDA by providing
recommendations on demonstrating
sameness between the active ingredient
in a proposed generic drug product and
its RLD as required under section
505(j)(2)(ii) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)(2)(ii)) and FDA’s regulations at 21
CFR 314.94(a)(3)(i).
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) (Hatch-Waxman
Amendments) created an approval
pathway for generic drug products
under which applicants can submit an
ANDA under section 505(j) of the FD&C
Act. An ANDA relies on the Agency’s
previous finding of safety and
effectiveness for an RLD and, as a result,
may be approved without submission of
the same type and extent of information
that is required for approval of a new
drug application to establish the safety
and effectiveness of the proposed
product. Among other things, an ANDA
must contain information to show that
the active ingredient of the proposed
generic drug product is the ‘‘same as’’
that of the RLD (21 U.S.C.
355(j)(2)(A)(ii); 21 CFR 314.94(a)(5)).
FDA may not approve an ANDA unless
the ANDA contains sufficient
information to show that, among other
things, the active ingredient is the same
as that of the reference listed drug (21
CFR 314.127(a)(3)). Accordingly, the
ANDA applicant is responsible for
providing sufficient information to
demonstrate that the proposed generic
drug product is the ‘‘same as’’ the RLD
with respect to the active ingredient. To
assist prospective applicants in
evaluating and demonstrating sameness,
this guidance provides information on
active ingredient sameness
considerations.
This draft guidance is being issued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 ‘‘Sameness Evaluations in an
ANDA—Active Ingredients.’’ It does not
establish any rights for any person and
VerDate Sep<11>2014
17:09 Nov 08, 2022
Jkt 259001
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.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
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: November 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24432 Filed 11–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0345 Revision]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: HRSA AIDS
Drug Assistance Program (ADAP) Data
Report
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.
SUMMARY:
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Comments on this ICR should be
received no later than January 9, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 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 Samantha Miller, the HRSA
Information Collection Clearance
Officer, at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
HRSA Ryan White HIV/AIDS Program
(RWHAP) AIDS Drug Assistance
Program (ADAP) Data Report: (OMB No.
0915–0345).
Abstract: HRSA’s RWHAP ADAP is
authorized under Part B of the RWHAP
legislation, codified in sections 2611 to
2631 of the Public Health Service Act,
which provides grants to U.S. states and
territories. RWHAP ADAP is a state and
territory-administered program that
provides Food and Drug
Administration-approved medications
to low-income people with HIV who
have limited or no health coverage from
private insurance, Medicaid, or
Medicare. RWHAP ADAP funds may
also be used to purchase health care
coverage for eligible clients and for
services that enhance access, adherence,
and monitoring of drug treatments.
All 50 states, the District of Columbia,
Puerto Rico, Guam, the U.S. Virgin
Islands, and the five U.S. Pacific
Territories or Associated Jurisdictions
receive RWHAP Part B grant awards,
including funds for RWHAP ADAP.
RWHAP Part B reporting requirements
include the annual submission of an
ADAP Data Report (ADR), including a
Recipient Report and a Client Report.
The Recipient Report is a collection of
basic information about grant recipient
characteristics and policies including
program administration, purchasing
mechanisms, funding, and
expenditures. The Client Report is a
collection of client-level records (one
record for each client enrolled in the
RWHAP ADAP), which includes the
client’s encrypted unique identifier,
basic demographic data, enrollment
information, services received, and
clinical data.
HRSA is proposing two revisions and
one re-installment of questions to the
ADR Recipient and Client Reports to
DATES:
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67703
Federal Register / Vol. 87, No. 216 / Wednesday, November 9, 2022 / Notices
reflect program practices and support
HRSA’s analysis and understanding of
program impact. Specifically, the
Recipient Report includes the following
proposed changes:
• Replacement of the Recertification
Date variable with the Last Date of
Eligibility Confirmation will remove the
previous 6-month recertification
requirement, which is no longer
required by policy, see Policy
Clarification Notice 21–02, and allow
Recipients to report the latest eligibility
confirmation date for existing clients;
• Reinstate a question that was
inadvertently removed from the 2021
ADR that is needed to assess the quality
of medication data; and
• Change the DUNS number variable
to Unique Entity Identifier. On April 4,
2022, the federal government stopped
using DUNs numbers, making it less
burdensome for entities to do business
with the federal government. As a
result, Recipients no longer have to
report the DUNs number in the ADR.
HRSA does not anticipate these
proposed revisions resulting in a change
in the reporting burden. New and
revised data elements require reporting
of information that should already be
collected by recipients to meet
legislative or programmatic
requirements for the proper oversight
and administration of the program.
Need and Proposed Use of the
Information: RWHAP requires the
submission of annual reports by the
Secretary of Health and Human Services
to the appropriate committees of
Congress. HRSA uses the ADR to
evaluate the national impact of the
RWHAP ADAP by providing
deidentified client-level data on
individuals being served, services being
delivered, and costs associated with
these services. The client-level data is
used to monitor health outcomes of
people with HIV receiving care and
treatment through the RWHAP ADAP,
to monitor the use of RWHAP ADAP
funds in addressing the HIV epidemic
and its impact on communities, and to
track progress toward achieving the
goals identified in the National HIV/
AIDS Strategy.
Likely Respondents: State ADAPs of
RWHAP Part B recipients.
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
Form name
Average
burden per
response
(in hours)
Total
responses
Total
burden
hours
Grantee Report ....................................................................
Client-Level Report ..............................................................
54
54
1
1
54
54
6
81
324
4,374
Total ..............................................................................
54
........................
54
........................
4,698
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. 2022–24461 Filed 11–8–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
VerDate Sep<11>2014
17:09 Nov 08, 2022
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meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
The meeting will be held as a virtual
meeting and is open to the public as
indicated below. Individuals who plan
to view the virtual meeting and need
special assistance or other reasonable
accommodations to view the meeting,
should notify the Contact Person listed
below in advance of the meeting. The
open session will be videocast and can
be accessed from the NIH Videocasting
and Podcasting website (https://
videocast.nih.gov/).
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 intramural programs
and projects as well as the grant
applications and/or contract proposals
and the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with intramural
programs and projects as well as the
grant applications and/or contract
PO 00000
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proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Date: February 9, 2023.
Closed: 11:00 a.m. to 11:30 a.m.
Agenda: Presentation of AABSC Report.
Closed: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Open: 12:45 p.m. to 5:30 p.m.
Agenda: Presentations and other business
of the Council.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Abraham P. Bautista,
Ph.D., Executive Secretary, National
Advisory Council Director, Office of
Extramural Activities, National Institute on
Alcohol Abuse and Alcoholism, National
Institutes of Health, 6700 B Rockledge Drive,
Room 1458, MSC 6902, Bethesda, MD 20892,
301–443–9737, bautista@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
E:\FR\FM\09NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Notices]
[Pages 67702-67703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0915-0345 Revision]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: HRSA AIDS
Drug Assistance Program (ADAP) Data Report
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 January 9,
2023.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 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 Samantha Miller,
the HRSA Information Collection Clearance Officer, at (301) 443-9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: HRSA Ryan White HIV/AIDS
Program (RWHAP) AIDS Drug Assistance Program (ADAP) Data Report: (OMB
No. 0915-0345).
Abstract: HRSA's RWHAP ADAP is authorized under Part B of the RWHAP
legislation, codified in sections 2611 to 2631 of the Public Health
Service Act, which provides grants to U.S. states and territories.
RWHAP ADAP is a state and territory-administered program that provides
Food and Drug Administration-approved medications to low-income people
with HIV who have limited or no health coverage from private insurance,
Medicaid, or Medicare. RWHAP ADAP funds may also be used to purchase
health care coverage for eligible clients and for services that enhance
access, adherence, and monitoring of drug treatments.
All 50 states, the District of Columbia, Puerto Rico, Guam, the
U.S. Virgin Islands, and the five U.S. Pacific Territories or
Associated Jurisdictions receive RWHAP Part B grant awards, including
funds for RWHAP ADAP. RWHAP Part B reporting requirements include the
annual submission of an ADAP Data Report (ADR), including a Recipient
Report and a Client Report. The Recipient Report is a collection of
basic information about grant recipient characteristics and policies
including program administration, purchasing mechanisms, funding, and
expenditures. The Client Report is a collection of client-level records
(one record for each client enrolled in the RWHAP ADAP), which includes
the client's encrypted unique identifier, basic demographic data,
enrollment information, services received, and clinical data.
HRSA is proposing two revisions and one re-installment of questions
to the ADR Recipient and Client Reports to
[[Page 67703]]
reflect program practices and support HRSA's analysis and understanding
of program impact. Specifically, the Recipient Report includes the
following proposed changes:
Replacement of the Recertification Date variable with the
Last Date of Eligibility Confirmation will remove the previous 6-month
recertification requirement, which is no longer required by policy, see
Policy Clarification Notice 21-02, and allow Recipients to report the
latest eligibility confirmation date for existing clients;
Reinstate a question that was inadvertently removed from
the 2021 ADR that is needed to assess the quality of medication data;
and
Change the DUNS number variable to Unique Entity
Identifier. On April 4, 2022, the federal government stopped using DUNs
numbers, making it less burdensome for entities to do business with the
federal government. As a result, Recipients no longer have to report
the DUNs number in the ADR.
HRSA does not anticipate these proposed revisions resulting in a
change in the reporting burden. New and revised data elements require
reporting of information that should already be collected by recipients
to meet legislative or programmatic requirements for the proper
oversight and administration of the program.
Need and Proposed Use of the Information: RWHAP requires the
submission of annual reports by the Secretary of Health and Human
Services to the appropriate committees of Congress. HRSA uses the ADR
to evaluate the national impact of the RWHAP ADAP by providing
deidentified client-level data on individuals being served, services
being delivered, and costs associated with these services. The client-
level data is used to monitor health outcomes of people with HIV
receiving care and treatment through the RWHAP ADAP, to monitor the use
of RWHAP ADAP funds in addressing the HIV epidemic and its impact on
communities, and to track progress toward achieving the goals
identified in the National HIV/AIDS Strategy.
Likely Respondents: State ADAPs of RWHAP Part B recipients.
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
----------------------------------------------------------------------------------------------------------------
Grantee Report.................. 54 1 54 6 324
Client-Level Report............. 54 1 54 81 4,374
-------------------------------------------------------------------------------
Total....................... 54 .............. 54 .............. 4,698
----------------------------------------------------------------------------------------------------------------
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. 2022-24461 Filed 11-8-22; 8:45 am]
BILLING CODE 4165-15-P
