Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Parts A and B Unobligated Balances and Rebate Addendum Tables, OMB No. 0906-0047-Revision, 21197-21200 [2023-07410]
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Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Notices
Requests (PLAIR),’’ (March 2022).
Historically, when applicants with a
pending new drug application,
abbreviated new drug application, or
Center for Drug Evaluation and
Research-regulated biologics licensing
application (information collection
associated with these submissions is
currently approved under OMB control
number 0910–0001) sought to import
unapproved finished dosage form drug
products into the United States in
preparation for market launch, we
considered such requests, informally
referred to as ‘‘PLAIRs,’’ on a case-by-
case basis. Since implementing the
PLAIR program in 2013, interest
continues to increase, so we have
developed a more formalized process as
discussed in the guidance document.
The guidance is available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/prelaunch-activities-importation-requestsplair and was issued consistent with our
good guidance practice regulations in 21
CFR 10.115, which provide for public
comment on Agency guidance
documents at any time. The guidance
document instructs that PLAIR
submissions should be made using the
applicant’s letterhead and submitted by
email to CDER-OC-PLAIR@fda.hhs.gov
in a file compatible with Portable
Document Format (PDF).
Description of Respondents:
Respondents to the information
collection are domestic and foreign
importers of FDA-regulated articles
being imported or offered for import
into the United States and entry filers
who submit import entries on behalf of
these importers.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
21 CFR part 1, subpart D
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Importers submission of data elements (preparing the required
information).
Entry filers (unique lines only) ........................................................
WEF participants .............................................................................
ITACS; creation of new account .....................................................
Form FDA 766 as required under 21 CFR 1.95 ............................
Form FDA 5054 ..............................................................................
Submissions in accordance w/PLAIR .............................................
95,307
10.14
967,069
0.05576 (3.346 minutes) .....
53,924
4,133
10
500
324
1,000
80
10,804
1
1
1
1
4
44,656,657
10
1
324
1,000
320
0.04466 (2.68 minutes) .......
0.87 (52 minutes) ................
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
.083 (5 minutes) ..................
16 .........................................
1,994,336
9
250
81
83
5,120
Total .........................................................................................
........................
........................
45,625,381
..............................................
2,053,803
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded to reflect electronic submission data.
Table 1, rows 1 and 2, reflects annual
average filing submissions through
December 31, 2022. An IOR may be the
owner or purchaser of the article being
imported or offered for import, or a
customs broker licensed by CBP under
19 U.S.C. 1641 who has been designated
by the owner, purchaser, or consignee to
file the import entry. There is only one
IOR per entry.
As reflected in table 1, row 3, we
estimate 10 respondents will submit
WEFs. Persons wishing to file weekly
entries of FDA-regulated products are
encouraged to provide the information
identified so that FDA can conduct a
preliminary admissibility assessment of
the associated products and firms. This
submission typically contains the
information FDA requests for multiple
products (i.e., the respondent wishes to
file weekly entries for multiple products
and submits the information for each
product together). Generally,
submissions involving multiple
products are significantly less
burdensome on a per-product basis.
Depending on the product and scale of
submission, this estimated burden may
fluctuate. Filers submitting in ACE
typically use software that is developed
to specifically automate and expedite
the entry submission process and allows
filers to automatically upload entry
information. While the WEF submission
includes an initial one-time submission
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burden, we expect reduced burden over
a long term because filers can
subsequently submit one entry covering
multiple withdrawals from the FTZ in
any given 7-day period.
As reflected in table 1, row 4, we
estimate that 500 new ITACS accounts
will be created annually. Since
developing and implementing ITACS,
we have adjusted this estimate
downward to reflect the transition from
initial program interest to average
annual maintenance-level numbers.
As reflected in table 1, row 5, we
estimate the submission of 324 Forms
FDA 766 in conjunction with FDAregulated products. This figure is based
on Agency import data and our
experience with the information
collection. We assume it takes
respondents 15 minutes to complete and
submit Form FDA 766. Although
current instructions communicate that
four copies be submitted (one copy to be
returned to respondent), we plan to
update the form to reduce this number.
Based on inquiries already received
and processed by FDA, we anticipate
1,000 respondents will annually submit
Form 5054 pertaining to general drug
import information, as reflected in table
1, row 6.
As shown in table 1, row 7, we
estimate 80 respondents to the PLAIR
program annually, an increase of 10
since our last evaluation of the
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information collection. At the same
time, we estimate one fewer submission
per respondent to correspond with a
decrease in submissions received by
FDA.
Cumulatively these changes and
adjustments result in an increase of
3,067,493 responses and 137,719 hours
annually.
Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07442 Filed 4–7–23; 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 Parts A and B Unobligated
Balances and Rebate Addendum
Tables, OMB No. 0906–0047—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
SUMMARY:
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Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Notices
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 May 10, 2023.
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
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 594–
4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Ryan White HIV/AIDS Program Parts A
and B Unobligated Balances and Rebate
Addendum Tables—OMB No. 0906–
0047—Revision.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states and
territories, and local clinics/communitybased organizations to deliver efficient
and effective HIV care, treatment, and
support to low-income people
diagnosed with HIV. Nearly two-thirds
of RWHAP clients (patients) live at or
below 100 percent of the federal poverty
level and approximately three-quarters
of RWHAP clients are racial and ethnic
minorities. Since 1990, RWHAP has
developed a comprehensive system of
HIV service providers who deliver high
quality direct health care and support
services to over half a million people
diagnosed with HIV—more than 50
percent of all people diagnosed with
HIV in the United States.
Grant recipients funded under parts A
and B of RWHAP (codified under title
XXVI of the Public Health Service Act)
are required to report financial data to
HRSA annually in their Federal
Financial Report (FFR SF–425). In
addition to the FFR, RWHAP parts A
and B grant recipients are required to
identify and report the unobligated
balance (UOB) by itemized subprogram/
funding stream source (Formula,
Minority AIDS Initiative (MAI), AIDS
Drug Assistance Program (ADAP), etc.).
As of April 22, 2021, grant recipients
must submit the subprogram breakdown
of the UOB on their FFR in the Payment
Management System. Grant recipients
are also required to specify RWHAP
Rebate Funding received in the fiscal
year in the UOB table. HRSA uses the
UOB and rebate addendum financial
information to determine formula
funding as directed by the RWHAP
statute. These data were previously
collected when grant recipients
submitted their annual FFR SF–425 in
hard copy only to HRSA, which then
combined the FFR SF–425 data with the
UOB and rebate addendum tables that
are submitted by recipients on a
suggested format through the HRSA
Electronic Handbook (EHBs). The
purpose of this financial data collection
is to streamline the process for the grant
recipients by collecting financial
information in the same location and at
the same time. The FFR SF–425 is now
completed in the Payment Management
System and is exported automatically to
the HRSA EHBs when the recipient
completes the FFR. The UOB tables for
RWHAP parts A and B will continue to
collect the same information with the
addition of one column on prior year
(fiscal year (FY) 20XX) information.
This one column will impact seven
recipients out of 111 RWHAP part A
and part B recipients in total, annually.
Recipients that need to submit data to
the added column need to complete one
or several fields at the most. (See tables
below for reference). The UOB and
rebate addendum data tables will be
collected in the HRSA EHBs below the
FFR SF–425 control number and the
Paperwork Burden Statement.
A 60-day notice published in the
Federal Register on January 24, 2023, 88
FR 4190–4192. There were no public
comments.
Need and Proposed Use of the
Information: RWHAP part A and part B
recipients complete the UOB and rebate
addendum tables as a part of their FFR
SF–425 submission. This process has
decreased administrative burden,
increased transparency, and improved
the quality of data submitted to HRSA.
These UOB and rebate addendum tables
are essential for allowing HRSA to
ensure that RWHAP recipients are
meeting the goal of accountability to
Congress, clients, advocacy groups, and
the general public. Information
provided in the UOB and rebate
addendum tables is critical for HRSA,
states and territories, local clinics, and
individual providers to evaluate the
effectiveness of these programs.
Likely Respondents: HRSA RWHAP
parts A and 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
ddrumheller on DSK120RN23PROD with NOTICES1
Form name
Number of
responses per
respondent
Total
responses
Average
burden
per response
(in hours)
Total burden
hours
Part A UOB Table ................................................................
Part B UOB Table ................................................................
52
59
1
1
52
59
0.5
0.5
26
29.5
Total ..............................................................................
111
........................
111
........................
55.5
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Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Notices
Note: Beginning in July 2021, information
related to prior year UOB was collected in
addition to the existing data in the approved
ICR. The additional information collected
does not impact all 111 respondents; in FY
2020, seven respondents reported prior year
UOB, which equates to only 6 percent of
respondents impacted. The estimated burden
to potentially impacted respondents is
negligible. See the tables below for
comparison of the added data point for prior
year UOB. No changes were made to the
approved ICR for the RWHAP part B rebate
table.
2019 APPROVED ICR TABLE FOR RWHAP PART A
UOB of federal funds by subprogram
Category
Federal funds authorized
Current year
(FY 20XX)
Unexpended carryover
Part A Formula ...............................
Part A Supplemental ......................
Part A MAI .....................................
REVISED RWHAP PART A TABLE
UOB of federal funds by subprogram
Category
Federal funds authorized
Unexpended carryover
Prior year
(FY 20XX)
Current year
(FY 20XX)
Part A Formula ..................
Part A Supplemental .........
Part A MAI .........................
2019 APPROVED ICR TABLE FOR RWHAP PART B
UOB of federal funds by subprogram
Category
Part
Part
Part
Part
Part
Part
B
B
B
B
B
A
Federal funds authorized
Current year
(FY 20XX)
Unexpended carryover
Base ...................................
ADAP ..................................
Emerging Communities ......
MAI .....................................
ADAP Supplemental ...........
Transfer ..............................
REVISED RWHAP PART B TABLE
UOB of federal funds by subprogram
Category
Federal funds authorized
Unexpended carryover
Prior year
(FY 20XX)
Current year
(FY 20XX)
Part B Base .......................
Part B ADAP .....................
Part B Emerging Communities.
Part B MAI .........................
Part B ADAP Supplemental.
Part A Transfer ..................
RWHAP PART B REBATES TABLE
ddrumheller on DSK120RN23PROD with NOTICES1
Ryan White rebate funding
Total Rebates Available.
Expended Rebate Amount .................................................................................................................................................................
Unexpended Rebate ..........................................................................................................................................................................
Expended Rebate Amount to be Used to Reduce UOB ...................................................................................................................
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
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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
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use of automated collection techniques
or other forms of information
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Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Notices
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
National Institutes of Health
[FR Doc. 2023–07410 Filed 4–7–23; 8:45 am]
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
Pursuant to section 10(d) 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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Populationbased Research in Vector-borne Disease.
Date: April 17, 2023.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Lisa Steele, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 257–
2638, steeleln@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 4, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–07404 Filed 4–7–23; 8:45 am]
BILLING CODE 4140–01–P
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, NIAMS.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), title 5 U.S.C., as amended for
the review, discussion, and evaluation
of individual intramural programs and
projects conducted by the NATIONAL
INSTITUTE OF ARTHRITIS AND
MUSCULOSKELETAL AND SKIN
DISEASES, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NIAMS.
Date: May 2–3, 2023.
Closed: May 02, 2023, 2:00 p.m. to 4:00
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Porter Neuroscience Research
Center, Building 35A, 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Closed: May 03, 2023, 10:00 a.m. to 4:00
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Porter Neuroscience Research
Center, Building 35A, 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Contact Person: John J. O’Shea, MD,
Scientific Director of Intramural Research,
National Institute of Arthritis &
Musculoskeletal and Skin Diseases, Building
10, Bethesda, MD 20892, (301) 496–2612,
osheaj@mail.nih.gov.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Additional Health and Safety Guidance:
Before attending a meeting at an NIH facility,
it is important that visitors review the NIH
COVID–19 Safety Plan at https://
ors.od.nih.gov/sr/dohs/safety/NIH-covid-19-
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safety-plan/Pages/default.aspx and the NIH
testing and assessment web page at https://
ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/COVID-assessment-testing/Pages/
visitor-testing-requirement.aspx for
information about requirements and
procedures for entering NIH facilities,
especially when COVID–19 community
levels are medium or high. In addition, the
Safer Federal Workforce website has FAQs
for visitors at https://www.saferfederal
workforce.gov/faq/visitors/. Please note that
if an individual has a COVID–19 diagnosis
within 10 days of the meeting, that person
must attend virtually. (For more information
please read NIH’s Requirements for Persons
after Exposure at https://ors.od.nih.gov/sr/
dohs/safety/NIH-covid-19-safety-plan/
COVID-assessment-testing/Pages/personsafter-exposure.aspx and What Happens
When Someone Tests Positive at https://
ors.od.nih.gov/sr/dohs/safety/NIH-covid-19safety-plan/COVID-assessment-testing/Pages/
test-positive.aspx. Anyone from the public
can attend the open portion of the meeting
virtually via the NIH Videocasting website
(https://videocast.nih.gov). Please continue
checking these websites, in addition to the
committee website listed below, for the most
up to date guidance as the meeting date
approaches.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: April 4, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–07403 Filed 4–7–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, 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/).
A portion of this meeting will be
closed to the public in accordance with
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]]>Agencies
[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Notices]
[Pages 21197-21200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07410]
-----------------------------------------------------------------------
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 Parts A and B Unobligated Balances and Rebate Addendum Tables,
OMB No. 0906-0047--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
[[Page 21198]]
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 May 10,
2023.
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 Samantha Miller, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 594-4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Ryan White HIV/AIDS Program
Parts A and B Unobligated Balances and Rebate Addendum Tables--OMB No.
0906-0047--Revision.
Abstract: HRSA's Ryan White HIV/AIDS Program (RWHAP) funds and
coordinates with cities, states and territories, and local clinics/
community-based organizations to deliver efficient and effective HIV
care, treatment, and support to low-income people diagnosed with HIV.
Nearly two-thirds of RWHAP clients (patients) live at or below 100
percent of the federal poverty level and approximately three-quarters
of RWHAP clients are racial and ethnic minorities. Since 1990, RWHAP
has developed a comprehensive system of HIV service providers who
deliver high quality direct health care and support services to over
half a million people diagnosed with HIV--more than 50 percent of all
people diagnosed with HIV in the United States.
Grant recipients funded under parts A and B of RWHAP (codified
under title XXVI of the Public Health Service Act) are required to
report financial data to HRSA annually in their Federal Financial
Report (FFR SF-425). In addition to the FFR, RWHAP parts A and B grant
recipients are required to identify and report the unobligated balance
(UOB) by itemized subprogram/funding stream source (Formula, Minority
AIDS Initiative (MAI), AIDS Drug Assistance Program (ADAP), etc.). As
of April 22, 2021, grant recipients must submit the subprogram
breakdown of the UOB on their FFR in the Payment Management System.
Grant recipients are also required to specify RWHAP Rebate Funding
received in the fiscal year in the UOB table. HRSA uses the UOB and
rebate addendum financial information to determine formula funding as
directed by the RWHAP statute. These data were previously collected
when grant recipients submitted their annual FFR SF-425 in hard copy
only to HRSA, which then combined the FFR SF-425 data with the UOB and
rebate addendum tables that are submitted by recipients on a suggested
format through the HRSA Electronic Handbook (EHBs). The purpose of this
financial data collection is to streamline the process for the grant
recipients by collecting financial information in the same location and
at the same time. The FFR SF-425 is now completed in the Payment
Management System and is exported automatically to the HRSA EHBs when
the recipient completes the FFR. The UOB tables for RWHAP parts A and B
will continue to collect the same information with the addition of one
column on prior year (fiscal year (FY) 20XX) information. This one
column will impact seven recipients out of 111 RWHAP part A and part B
recipients in total, annually. Recipients that need to submit data to
the added column need to complete one or several fields at the most.
(See tables below for reference). The UOB and rebate addendum data
tables will be collected in the HRSA EHBs below the FFR SF-425 control
number and the Paperwork Burden Statement.
A 60-day notice published in the Federal Register on January 24,
2023, 88 FR 4190-4192. There were no public comments.
Need and Proposed Use of the Information: RWHAP part A and part B
recipients complete the UOB and rebate addendum tables as a part of
their FFR SF-425 submission. This process has decreased administrative
burden, increased transparency, and improved the quality of data
submitted to HRSA. These UOB and rebate addendum tables are essential
for allowing HRSA to ensure that RWHAP recipients are meeting the goal
of accountability to Congress, clients, advocacy groups, and the
general public. Information provided in the UOB and rebate addendum
tables is critical for HRSA, states and territories, local clinics, and
individual providers to evaluate the effectiveness of these programs.
Likely Respondents: HRSA RWHAP parts A and 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
----------------------------------------------------------------------------------------------------------------
Part A UOB Table................ 52 1 52 0.5 26
Part B UOB Table................ 59 1 59 0.5 29.5
-------------------------------------------------------------------------------
Total....................... 111 .............. 111 .............. 55.5
----------------------------------------------------------------------------------------------------------------
[[Page 21199]]
Note: Beginning in July 2021, information related to prior year
UOB was collected in addition to the existing data in the approved
ICR. The additional information collected does not impact all 111
respondents; in FY 2020, seven respondents reported prior year UOB,
which equates to only 6 percent of respondents impacted. The
estimated burden to potentially impacted respondents is negligible.
See the tables below for comparison of the added data point for
prior year UOB. No changes were made to the approved ICR for the
RWHAP part B rebate table.
2019 Approved ICR Table for RWHAP Part A
----------------------------------------------------------------------------------------------------------------
UOB of federal funds by subprogram
-----------------------------------------------------------------------------------------------------------------
Category Federal funds authorized Unexpended carryover Current year (FY 20XX)
----------------------------------------------------------------------------------------------------------------
Part A Formula...................... ........................ ....................... .......................
Part A Supplemental................. ........................ ....................... .......................
Part A MAI.......................... ........................ ....................... .......................
----------------------------------------------------------------------------------------------------------------
Revised RWHAP Part A Table
----------------------------------------------------------------------------------------------------------------
UOB of federal funds by subprogram
-----------------------------------------------------------------------------------------------------------------
Federal funds Unexpended Prior year (FY Current year (FY
Category authorized carryover 20XX) 20XX)
----------------------------------------------------------------------------------------------------------------
Part A Formula................. ................... .................. .................. ..................
Part A Supplemental............ ................... .................. .................. ..................
Part A MAI..................... ................... .................. .................. ..................
----------------------------------------------------------------------------------------------------------------
2019 Approved ICR Table for RWHAP Part B
----------------------------------------------------------------------------------------------------------------
UOB of federal funds by subprogram
-----------------------------------------------------------------------------------------------------------------
Category Federal funds authorized Unexpended carryover Current year (FY 20XX)
----------------------------------------------------------------------------------------------------------------
Part B Base......................... ........................ ....................... .......................
Part B ADAP......................... ........................ ....................... .......................
Part B Emerging Communities......... ........................ ....................... .......................
Part B MAI.......................... ........................ ....................... .......................
Part B ADAP Supplemental............ ........................ ....................... .......................
Part A Transfer..................... ........................ ....................... .......................
----------------------------------------------------------------------------------------------------------------
Revised RWHAP Part B Table
----------------------------------------------------------------------------------------------------------------
UOB of federal funds by subprogram
-----------------------------------------------------------------------------------------------------------------
Federal funds Unexpended Prior year (FY Current year (FY
Category authorized carryover 20XX) 20XX)
----------------------------------------------------------------------------------------------------------------
Part B Base.................... ................... .................. .................. ..................
Part B ADAP.................... ................... .................. .................. ..................
Part B Emerging Communities.... ................... .................. .................. ..................
Part B MAI..................... ................... .................. .................. ..................
Part B ADAP Supplemental....... ................... .................. .................. ..................
Part A Transfer................ ................... .................. .................. ..................
----------------------------------------------------------------------------------------------------------------
RWHAP Part B Rebates Table
------------------------------------------------------------------------
------------------------------------------------------------------------
Ryan White rebate funding
------------------------------------------------------------------------
Total Rebates Available............................
Expended Rebate Amount............................. ...................
Unexpended Rebate.................................. ...................
Expended Rebate Amount to be Used to Reduce UOB.... ...................
------------------------------------------------------------------------
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
[[Page 21200]]
technology to minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-07410 Filed 4-7-23; 8:45 am]
BILLING CODE 4165-15-P
