83 FR 54363 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0906-xxxx-NEW
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 209 (October 29, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 209 (October 29, 2018)
| Page Range | 54363-54364 | |
| FR Document | 2018-23547 |
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)] [Notices] [Pages 54363-54364] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23547] ----------------------------------------------------------------------- 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 Client-Level Data Reporting System, OMB No. 0906-xxxx-NEW 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 has 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. DATES: Comments on this ICR should be received no later than November 28, 2018. ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to [email protected] or by fax to (202) 395-5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443-1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Client-Level Data Reporting System. OMB No. 0906-xxxx-NEW. Abstract: The Ryan White HIV/AIDS Program's (RWHAP) client-level data reporting system, entitled the RWHAP Services Report or the Ryan White Services Report (RSR), is designed to collect information from grant recipients, as well as their subrecipients, funded under Parts A, B, C, and D of the RWHAP statute. The RWHAP, authorized under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009, is administered by HRSA HIV/ AIDS Bureau (HAB). The HRSA RWHAP funds and coordinates with cities, states, and local clinics/community-based organizations to deliver efficient and effective HIV care, treatment, and support to low-income people living with HIV (PLWH). Need and Proposed Use of the Information: The RWHAP statute requires HRSA to monitor the administration of grant funds, allocation of funding, service utilization, and client demographic and HIV health outcome data (e.g., viral suppression). The RSR collects data on the characteristics of RWHAP-funded recipients, subrecipients, and the patients or clients served. The RSR system consists of two online data forms: the Recipient Report and the Service Provider Report; and the Client Report, which is a data file containing the client-level data elements. Data are submitted annually. The RWHAP statute specifies the importance of recipient accountability and linking performance to budget. The RSR is used to ensure recipient compliance with the statute, including evaluating the effectiveness of programs, monitoring recipient and subrecipient performance, and informing annual reports to Congress. Information collected through the RSR is critical for HRSA, state/local grant recipients, and individual service providers to understand existing HIV-related service delivery systems and the clients served. Information in the RSR is used to assess trends in service utilization and HIV health outcomes for clients served. Data from the RSR is analyzed to identify disparities and gaps within the service delivery systems. The 60-day notice published on November 27, 2017 (Vol. 82, No. 226). This new ICR is being developed to replace the existing ICR (OMB control number 0915-0323), for which HRSA has collected RSR data since 2009. As more recipients fully fund services using other RWHAP-related funding streams, such as pharmacy rebate dollars, HRSA HAB receives less information on RWHAP eligible clients, which reduces HRSA HAB's ability to measure the investment and impact of all RWHAP-related expenditures at state [[Page 54364]] and local levels. Revisions in this new package will account for the funding decisions made by recipients and will now include reporting of eligible clients who receive HRSA RWHAP allowable services using RWHAP- related funding (e.g., program income and pharmacy rebates) starting with the 2019 RSR, submitted in March 2020. The proposed change may require recipients to collect additional data, either on clients or outcome measures. To decrease burden in collecting these additional data, HRSA HAB proposes a phased approach to allow time for recipients to expand their systems to collect the data. HRSA HAB expects that some recipients already receive this information from subrecipients for monitoring purposes. However, with respect to those subrecipients who are not collecting these data, such subrecipients would be required to collect additional client level information. In an effort to increase HRSA HAB's ability to understand coverage areas for RWHAP provider sites and the population that provider sites serve, this new ICR will ask recipients to provide zip codes for RWHAP clients receiving outpatient ambulatory health services, in addition to asking them to list the number of unduplicated clients residing in each zip code. Additional modifications will be made to several variables within the client report to reduce burden, improve data quality, and align data collection efforts with Policy Clarification Notice Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds (PCN 16-02). These modifications will include the removal of 14 variables in the Client, Service Provider, and Recipient Reports. HRSA will continue to collect and report the client-level data elements supplied by the existing ICR through 2019. In 2019, HRSA will discontinue use of the existing ICR and will collect and report on the data elements defined in the new ICR. While there will be no overlap in the data collected and reported between the existing and new ICR, HRSA is submitting this new ICR in tandem with the existing ICR to allow recipients the ability to make modifications to their RSR systems between the two reporting periods. This will allow recipients to continue collecting and reporting on both the old and new variables without interruption. Likely Respondents: RWHAP Part A, Part B, Part C, and Part D recipients and their subrecipients. 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 (1) review instructions; (2) 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; (3) train personnel and respond to a collection of information; (4) search data sources; (5) complete and review the collection of information; and (6) 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 burden Type of respondents Form name respondents responses per responses response (in hours respondent hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- RWHAP Parts A, B, C, and D Grant Recipient Report............ 475 1 475 11 5,225 recipients. Service Provider Report..... 2,079 1 2,079 13 27,027 Client Report............... 1,607 1 1,607 113 181,591 ------------------------------------------------------------------------------- Total................................. ............................ 4,161 .............. 4,161 .............. 213,843 -------------------------------------------------------------------------------------------------------------------------------------------------------- Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018-23547 Filed 10-26-18; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices 54363
issued a letter to Swedish Match North MRTPAs that are the subject of this reporting system, entitled the RWHAP
America Inc. that denied the MRTPAs, notice available electronically (see Services Report or the Ryan White
in part, and outlined deficiencies in the section II). Services Report (RSR), is designed to
remaining portions of the MRTPAs that collect information from grant
II. Electronic Access
the applicant could address by recipients, as well as their
submitting an amendment to the Persons with access to the internet subrecipients, funded under Parts A, B,
applications. FDA recently received an may obtain the documents at either C, and D of the RWHAP statute. The
amendment to Swedish Match North https://www.fda.gov/TobaccoProducts/ RWHAP, authorized under Title XXVI
America Inc.’s MRTPAs and is making Labeling/MarketingandAdvertising/ of the Public Health Service Act, as
the amendment available (except for ucm533454.htm or https:// amended by the Ryan White HIV/AIDS
matters in the amendment that are trade www.regulations.gov. Treatment Extension Act of 2009, is
secrets or otherwise confidential Dated: October 23, 2018. administered by HRSA HIV/AIDS
commercial information) for public Leslie Kux, Bureau (HAB). The HRSA RWHAP
comment. FDA is reopening the period funds and coordinates with cities,
Associate Commissioner for Policy.
for public comment so that the public states, and local clinics/community-
[FR Doc. 2018–23524 Filed 10–26–18; 8:45 am]
has the opportunity to review and based organizations to deliver efficient
comment on the amendment. BILLING CODE 4164–01–P and effective HIV care, treatment, and
FDA is required by section 911(e) of support to low-income people living
the Federal Food, Drug, and Cosmetic with HIV (PLWH).
Act (FD&C Act) (21 U.S.C. 387k(e)) to DEPARTMENT OF HEALTH AND Need and Proposed Use of the
make an MRTPA available to the public HUMAN SERVICES Information: The RWHAP statute
(except for matters in the application requires HRSA to monitor the
Health Resources and Services
that are trade secrets or otherwise administration of grant funds, allocation
Administration
confidential commercial information) of funding, service utilization, and
and to request comments by interested Agency Information Collection client demographic and HIV health
persons on the information contained in Activities: Submission to OMB for outcome data (e.g., viral suppression).
the application and on the label, Review and Approval; Public Comment The RSR collects data on the
labeling, and advertising accompanying Request; Ryan White HIV/AIDS characteristics of RWHAP-funded
the application. The determination of Program Client-Level Data Reporting recipients, subrecipients, and the
whether an order is appropriate under System, OMB No. 0906–xxxx–NEW patients or clients served. The RSR
section 911 of the FD&C Act is based on system consists of two online data
the scientific information submitted by AGENCY: Health Resources and Services forms: the Recipient Report and the
the applicant as well as the scientific Administration (HRSA), Department of Service Provider Report; and the Client
evidence and other information that is Health and Human Services. Report, which is a data file containing
made available to the Agency, including ACTION: Notice. the client-level data elements. Data are
through public comments. submitted annually. The RWHAP
FDA has posted the application SUMMARY: In compliance with the statute specifies the importance of
amendment for public comment, which Paperwork Reduction Act of 1995, recipient accountability and linking
has been redacted in accordance with HRSA has submitted an Information performance to budget. The RSR is used
applicable laws. FDA intends to Collection Request (ICR) to the Office of to ensure recipient compliance with the
establish a closing date for the comment Management and Budget (OMB) for statute, including evaluating the
period that is at least 30 days after the review and approval. Comments effectiveness of programs, monitoring
final documents from the application submitted during the first public review recipient and subrecipient performance,
are made available for public comment of this ICR will be provided to OMB. and informing annual reports to
and will announce the closing date at OMB will accept further comments from Congress. Information collected through
least 30 days in advance. FDA will the public during the review and the RSR is critical for HRSA, state/local
notify the public about the availability approval period. grant recipients, and individual service
of additional application documents, if DATES: Comments on this ICR should be providers to understand existing HIV-
any, and the closing date for the received no later than November 28, related service delivery systems and the
comment period via the Agency’s web 2018. clients served. Information in the RSR is
page for the MRTPA (see section II) and used to assess trends in service
by other means of public ADDRESSES: Submit your comments,
utilization and HIV health outcomes for
communication, such as by email to including the ICR Title, to the desk
clients served. Data from the RSR is
individuals who have signed up to officer for HRSA, either by email to
analyzed to identify disparities and gaps
receive email alerts. FDA does not OIRA_submission@omb.eop.gov or by within the service delivery systems. The
intend to issue additional notices in the fax to (202) 395–5806. 60-day notice published on November
Federal Register regarding amendments FOR FURTHER INFORMATION CONTACT: To 27, 2017 (Vol. 82, No. 226).
or the comment period for these request a copy of the clearance requests This new ICR is being developed to
MRTPAs. To receive email alerts, visit submitted to OMB for review, email Lisa replace the existing ICR (OMB control
FDA’s email subscription service Wright-Solomon, the HRSA Information number 0915–0323), for which HRSA
management website (http://go.fda.gov/ Collection Clearance Officer at has collected RSR data since 2009. As
subscriptionmanagement), provide an paperwork@hrsa.gov or call (301) 443– more recipients fully fund services
amozie on DSK3GDR082PROD with NOTICES1
email address, scroll down to the 1984. using other RWHAP-related funding
‘‘Tobacco’’ heading, select ‘‘Modified SUPPLEMENTARY INFORMATION: streams, such as pharmacy rebate
Risk Tobacco Product Application Information Collection Request Title: dollars, HRSA HAB receives less
Updates’’, and click ‘‘Submit’’. To Client-Level Data Reporting System. information on RWHAP eligible clients,
encourage public participation OMB No. 0906–xxxx–NEW. which reduces HRSA HAB’s ability to
consistent with section 911(e) of the Abstract: The Ryan White HIV/AIDS measure the investment and impact of
FD&C Act, FDA is making the redacted Program’s (RWHAP) client-level data all RWHAP-related expenditures at state
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![54364 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
and local levels. Revisions in this new zip codes for RWHAP clients receiving between the two reporting periods. This
package will account for the funding outpatient ambulatory health services, will allow recipients to continue
decisions made by recipients and will in addition to asking them to list the collecting and reporting on both the old
now include reporting of eligible clients number of unduplicated clients residing and new variables without interruption.
who receive HRSA RWHAP allowable in each zip code.
Additional modifications will be Likely Respondents: RWHAP Part A,
services using RWHAP-related funding
made to several variables within the Part B, Part C, and Part D recipients and
(e.g., program income and pharmacy
rebates) starting with the 2019 RSR, client report to reduce burden, improve their subrecipients.
submitted in March 2020. The proposed data quality, and align data collection Burden Statement: Burden in this
change may require recipients to collect efforts with Policy Clarification Notice context means the time expended by
additional data, either on clients or Ryan White HIV/AIDS Program persons to generate, maintain, retain,
outcome measures. To decrease burden Services: Eligible Individuals and disclose or provide the information
in collecting these additional data, Allowable Uses of Funds (PCN 16–02). requested. This includes the time
HRSA HAB proposes a phased approach These modifications will include the needed to (1) review instructions; (2)
to allow time for recipients to expand removal of 14 variables in the Client, develop, acquire, install, and utilize
their systems to collect the data. HRSA Service Provider, and Recipient Reports. technology and systems for the purpose
HAB expects that some recipients HRSA will continue to collect and of collecting, validating, and verifying
already receive this information from report the client-level data elements information, processing and
subrecipients for monitoring purposes. supplied by the existing ICR through
maintaining information, and disclosing
However, with respect to those 2019. In 2019, HRSA will discontinue
and providing information; (3) train
subrecipients who are not collecting use of the existing ICR and will collect
and report on the data elements defined personnel and respond to a collection of
these data, such subrecipients would be
required to collect additional client in the new ICR. While there will be no information; (4) search data sources; (5)
level information. overlap in the data collected and complete and review the collection of
In an effort to increase HRSA HAB’s reported between the existing and new information; and (6) transmit or
ability to understand coverage areas for ICR, HRSA is submitting this new ICR otherwise disclose the information. The
RWHAP provider sites and the in tandem with the existing ICR to allow total annual burden hours estimated for
population that provider sites serve, this recipients the ability to make this ICR are summarized in the table
new ICR will ask recipients to provide modifications to their RSR systems below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of Total burden per Total burden
Type of respondents Form name responses per
respondents responses response hours
respondent (in hours)
RWHAP Parts A, B, C, and D Grant Recipient Report .. 475 1 475 11 5,225
recipients.
Service Provider 2,079 1 2,079 13 27,027
Report.
Client Report ....... 1,607 1 1,607 113 181,591
Total ............................................ .............................. 4,161 ........................ 4,161 ........................ 213,843
Amy P. McNulty, following summary of a proposed collection for the proper performance of
Acting Director, Division of the Executive collection for public comment. the agency’s functions; (2) the accuracy
Secretariat. DATES: Comments on the ICR must be of the estimated burden; (3) ways to
[FR Doc. 2018–23547 Filed 10–26–18; 8:45 am] received on or before December 28, enhance the quality, utility, and clarity
BILLING CODE 4165–15–P 2018. of the information to be collected; and
(4) the use of automated collection
ADDRESSES: Submit your comments to
techniques or other forms of information
DEPARTMENT OF HEALTH AND Sherrette.Funn@hhs.gov or by calling
technology to minimize the information
HUMAN SERVICES (202) 795–7714.
collection burden.
FOR FURTHER INFORMATION CONTACT: Title of the Collection: Medical
When submitting comments or Reserve Corps Unit Profile and Reports.
[Document Identifier: OS–0990–0302]
requesting information, please include Type of Collection: Revision.
Agency Information Collection the document identifier 0990–0302–60D OMB No. 0990–0302.
Request. 60-Day Public Comment and project title for reference, to Abstract: Medical Reserve Corps
Request Sherrette.funn@hhs.gov, or call the Units are currently located in 889
Reports Clearance Officer at 202–795– communities across the United States
AGENCY: Office of the Secretary, HHS. 7714. and represent a resource of 188,229
amozie on DSK3GDR082PROD with NOTICES1
ACTION: Notice. SUPPLEMENTARY INFORMATION: Interested volunteers. In order to continue to
persons are invited to send comments support MRC units detailed information
SUMMARY: In compliance with the regarding this burden estimate or any about the MRC units, including unit
requirement of the Paperwork other aspect of this collection of demographics, contact information
Reduction Act of 1995, the Office of the information, including any of the (regular and emergency), volunteer
Secretary (OS), Department of Health following subjects: (1) The necessity and numbers and information about unit
and Human Services, is publishing the utility of the proposed information activities is needed by the MRC
VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1](https://thefederalregister.org/doc/83_FR_54572/page/2.svg)
Document Created: 2018-10-27 01:09:03
Document Modified: 2018-10-27 01:09:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than November 28, 2018. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443-1984. | |
| FR Citation | 83 FR 54363 |
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