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, 54363-54364 [2018-23547]

Download as PDF amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices issued a letter to Swedish Match North America Inc. that denied the MRTPAs, in part, and outlined deficiencies in the remaining portions of the MRTPAs that the applicant could address by submitting an amendment to the applications. FDA recently received an amendment to Swedish Match North America Inc.’s MRTPAs and is making the amendment available (except for matters in the amendment that are trade secrets or otherwise confidential commercial information) for public comment. FDA is reopening the period for public comment so that the public has the opportunity to review and comment on the amendment. FDA is required by section 911(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k(e)) to make an MRTPA available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying the application. The determination of whether an order is appropriate under section 911 of the FD&C Act is based on the scientific information submitted by the applicant as well as the scientific evidence and other information that is made available to the Agency, including through public comments. FDA has posted the application amendment for public comment, which has been redacted in accordance with applicable laws. FDA intends to establish a closing date for the comment period that is at least 30 days after the final documents from the application are made available for public comment and will announce the closing date at least 30 days in advance. FDA will notify the public about the availability of additional application documents, if any, and the closing date for the comment period via the Agency’s web page for the MRTPA (see section II) and by other means of public communication, such as by email to individuals who have signed up to receive email alerts. FDA does not intend to issue additional notices in the Federal Register regarding amendments or the comment period for these MRTPAs. To receive email alerts, visit FDA’s email subscription service management website (http://go.fda.gov/ subscriptionmanagement), provide an email address, scroll down to the ‘‘Tobacco’’ heading, select ‘‘Modified Risk Tobacco Product Application Updates’’, and click ‘‘Submit’’. To encourage public participation consistent with section 911(e) of the FD&C Act, FDA is making the redacted VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 MRTPAs that are the subject of this notice available electronically (see section II). II. Electronic Access Persons with access to the internet may obtain the documents at either https://www.fda.gov/TobaccoProducts/ Labeling/MarketingandAdvertising/ ucm533454.htm or https:// www.regulations.gov. Dated: October 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23524 Filed 10–26–18; 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 Client-Level Data Reporting System, OMB No. 0906–xxxx–NEW Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: 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. SUMMARY: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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 ADDRESSES: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 54363 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/communitybased 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 HIVrelated 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 E:\FR\FM\29OCN1.SGM 29OCN1 54364 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices 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 Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Form name RWHAP Parts A, B, C, and D Grant recipients. Recipient Report .. 475 1 475 11 5,225 Service Provider Report. Client Report ....... 2,079 1 2,079 13 27,027 1,607 1 1,607 113 181,591 .............................. 4,161 ........................ 4,161 ........................ 213,843 Total ............................................ Amy P. McNulty, Acting Director, Division of the Executive Secretariat. following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before December 28, 2018. [FR Doc. 2018–23547 Filed 10–26–18; 8:45 am] BILLING CODE 4165–15–P Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795–7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990–0302–60D and project title for reference, to Sherrette.funn@hhs.gov, or call the Reports Clearance Officer at 202–795– 7714. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0302] Agency Information Collection Request. 60-Day Public Comment Request amozie on DSK3GDR082PROD with NOTICES1 Total responses Type of respondents AGENCY: ACTION: Office of the Secretary, HHS. In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the SUMMARY: VerDate Sep<11>2014 17:48 Oct 26, 2018 Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information SUPPLEMENTARY INFORMATION: Notice. Jkt 247001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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. Title of the Collection: Medical Reserve Corps Unit Profile and Reports. Type of Collection: Revision. OMB No. 0990–0302. Abstract: Medical Reserve Corps Units are currently located in 889 communities across the United States and represent a resource of 188,229 volunteers. In order to continue to support MRC units detailed information about the MRC units, including unit demographics, contact information (regular and emergency), volunteer numbers and information about unit activities is needed by the MRC E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54363-54364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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