82 FR 6578 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Ryan White HIV/AIDS Program: Allocation and Expenditure Forms
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6578-6579 | |
| FR Document | 2017-01220 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Notices] [Pages 6578-6579] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01220] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Ryan White HIV/AIDS Program: Allocation and Expenditure Forms 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, 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 must be received no later than March 20, 2017. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N-39, 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 the HRSA Information Collection Clearance Officer at (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Ryan White HIV/AIDS Program: Allocation and Expenditure Forms. OMB No. 0915-0318--Revision. Abstract: HRSA's HIV/AIDS Bureau (HAB) administers the Ryan White HIV/AIDS Program authorized under Title XXVI of the Public Health Service Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009. The Ryan White HIV/AIDS Program Allocation and Expenditure Reports (A&E Reports), in conjunction with the Consolidated List of Contractors (CLC), enables HRSA to monitor and track the use of grant funds for compliance with program and grants policies and requirements under the statute. By regulation, recipients are required to submit financial reports annually to HRSA and the A&E Reports and the CLC are HAB's mechanism to implement that requirement. Recipients funded under Parts A, B, C, and D of the Ryan White HIV/AIDS Program (codified under Title XXVI of the Public Health Service Act) are required to report financial data to HRSA at the beginning (Allocations Report) and at the end of their grant cycle (Expenditures Report). Recipients funded under Parts A and B are required to report information about their service provider contracts in the CLC. The forms will continue to require recipients to report on how funds are allocated and spent on core medical and non-core services for persons living with HIV, and on various program components, such as administration, planning and evaluation, and quality management. The A & E Reports are identical in the types of information they collect. However, the first report tracks the allocation of the award at the beginning of the grant cycle and the second report tracks actual expenditures (including carryover dollars) at the end of the grant cycle. The CLC form identifies a recipient's contracts with service providers for the current grant year, the contract amount, and the types of services being provided. Need and Proposed Use of the Information: Accurate allocation, expenditure, and service contract records of the recipients receiving Ryan White HIV/AIDS Program funding are critical to the implementation of the law and thus are necessary for HRSA to fulfill its responsibilities. The primary [[Page 6579]] purposes of these forms are to provide information on the number of grant dollars spent on various services and program components and oversee compliance with the intent of Congressional appropriations in a timely manner. In addition to meeting the goal of accountability to the Congress, clients, and the general public, information collected on these reports is critical for HRSA, state and local grantees, and individual providers to evaluate the effectiveness of these programs. Likely Respondents: Ryan White HIV/AIDS Program 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 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 Allocations Report....... 52 1 52 4 208 Part A Expenditures Report...... 52 1 52 4 208 Part A CLC...................... 52 1 52 2 104 Part B Allocations Report....... 54 1 54 6 324 Part B Expenditures Report...... 54 1 54 6 324 Part B CLC...................... 54 1 54 2 108 Part C Allocations Report....... 346 1 346 4 1,384 Part C Expenditures Report...... 346 1 346 4 1,384 Part D Allocations Report....... 116 1 116 4 464 Part D Expenditures Report...... 116 1 116 4 464 ------------------------------------------------------------------------------- Total....................... .............. .............. 1,294 .............. 4,972 ---------------------------------------------------------------------------------------------------------------- Note: Recipients are required to fill out an allocation report, expenditure report, and CLC for each Ryan White HIV/AIDS Program award received. 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. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2017-01220 Filed 1-18-17; 8:45 am] BILLING CODE 4165-15-P
![6578 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices
observed in clinical trials to provide (or 324) of the firms. Anticipating the third party disclosures. Based on our
context). number of these FDA-regulated experience reviewing FDA-regulated
According to FDA data, promotional materials will soon promotional materials for medical
approximately 162,000 FDA-regulated increase to 6 percent, we estimate the products, we estimate it will take
promotional materials are prepared by 324 firms will prepare and disseminate respondents approximately 4 hours per
approximately 500 firms annually. Of annually 9,720 FDA-regulated unique presentation to prepare and
these materials, we estimate promotional materials that contain incorporate the disclosures
approximately 5 percent contain unique unique presentations of information that recommended in the draft guidance, if
presentations of information consistent is consistent with FDA-required they choose to disseminate this
with FDA-required labeling, as that term labeling, as that term is described in the information.
is described in the draft guidance, draft guidance, and that therefore are We estimate the burden of this
submitted by approximately 64 percent recommended to include the proposed collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
Type of information disclosures per burden per Total hours
respondents disclosures
respondent disclosure
Recommended information to be included when firms
choose to disseminate communications that are con-
sistent with the FDA-required labeling ............................. 324 30 9,720 4 38,880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access comment on proposed data collection program and grants policies and
Persons with access to the Internet projects, HRSA announces plans to requirements under the statute. By
may obtain the draft guidance at either submit an Information Collection regulation, recipients are required to
Request (ICR), described below, to the submit financial reports annually to
http://www.fda.gov/Drugs/Guidance Office of Management and Budget HRSA and the A&E Reports and the CLC
ComplianceRegulatoryInformation/ (OMB). Prior to submitting the ICR to are HAB’s mechanism to implement that
Guidances/default.htm, OMB, HRSA seeks comments from the requirement. Recipients funded under
http://www.fda.gov/BiologicsBlood public regarding the burden estimate, Parts A, B, C, and D of the Ryan White
Vaccines/GuidanceCompliance below, or any other aspect of the ICR. HIV/AIDS Program (codified under Title
RegulatoryInformation/Guidances/ DATES: Comments on this ICR must be XXVI of the Public Health Service Act)
default.htm, received no later than March 20, 2017. are required to report financial data to
http://www.fda.gov/MedicalDevices/ HRSA at the beginning (Allocations
ADDRESSES: Submit your comments to
DeviceRegulationandGuidance/ Report) and at the end of their grant
GuidanceDocuments/default.htm, paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance cycle (Expenditures Report). Recipients
http://www.fda.gov/AnimalVeterinary/ funded under Parts A and B are required
GuidanceComplianceEnforcement/ Officer, Room 14N–39, 5600 Fishers
Lane, Rockville, MD 20857. to report information about their service
GuidanceforIndustry/default.htm, or provider contracts in the CLC.
https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: To
request more information on the The forms will continue to require
Dated: January 6, 2017. proposed project or to obtain a copy of recipients to report on how funds are
Jeremy Sharp, the data collection plans and draft allocated and spent on core medical and
Deputy Commissioner for Policy, Planning, instruments, email paperwork@hrsa.gov non-core services for persons living
Legislation, and Analysis. or call the HRSA Information Collection with HIV, and on various program
[FR Doc. 2017–01012 Filed 1–18–17; 8:45 am] Clearance Officer at (301) 443–1984. components, such as administration,
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: When planning and evaluation, and quality
submitting comments or requesting management. The A & E Reports are
information, please include the identical in the types of information
DEPARTMENT OF HEALTH AND information request collection title for they collect. However, the first report
HUMAN SERVICES reference. tracks the allocation of the award at the
Information Collection Request Title: beginning of the grant cycle and the
Health Resources and Services second report tracks actual expenditures
Ryan White HIV/AIDS Program:
Administration (including carryover dollars) at the end
Allocation and Expenditure Forms.
OMB No. 0915–0318—Revision. of the grant cycle. The CLC form
Agency Information Collection identifies a recipient’s contracts with
Abstract: HRSA’s HIV/AIDS Bureau
Activities: Proposed Collection: Public service providers for the current grant
(HAB) administers the Ryan White HIV/
Comment Request; Ryan White HIV/ year, the contract amount, and the types
AIDS Program authorized under Title
AIDS Program: Allocation and of services being provided.
XXVI of the Public Health Service Act
Expenditure Forms
as amended by the Ryan White HIV/ Need and Proposed Use of the
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY: Health Resources and Services AIDS Treatment Extension Act of 2009. Information: Accurate allocation,
Administration (HRSA), Department of The Ryan White HIV/AIDS Program expenditure, and service contract
Health and Human Services. Allocation and Expenditure Reports records of the recipients receiving Ryan
ACTION: Notice. (A&E Reports), in conjunction with the White HIV/AIDS Program funding are
Consolidated List of Contractors (CLC), critical to the implementation of the law
SUMMARY: In compliance with the enables HRSA to monitor and track the and thus are necessary for HRSA to
requirement for opportunity for public use of grant funds for compliance with fulfill its responsibilities. The primary
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![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6579
purposes of these forms are to provide to evaluate the effectiveness of these of collecting, validating, and verifying
information on the number of grant programs. information, processing and
dollars spent on various services and Likely Respondents: Ryan White HIV/ maintaining information, and disclosing
program components and oversee AIDS Program recipients. and providing information; to train
compliance with the intent of Burden Statement: Burden in this personnel and be able to respond to a
Congressional appropriations in a context means the time expended by collection of information; to search data
timely manner. In addition to meeting persons to generate, maintain, retain, sources; to complete and review the
the goal of accountability to the disclose, or provide the information collection of information; and to
Congress, clients, and the general requested. This includes the time transmit or otherwise disclose the
public, information collected on these needed to review instructions; to information. The total annual burden
reports is critical for HRSA, state and develop, acquire, install, and utilize hours estimated for this ICR are
local grantees, and individual providers technology and systems for the purpose summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Part A Allocations Report .................................................... 52 1 52 4 208
Part A Expenditures Report ................................................. 52 1 52 4 208
Part A CLC ........................................................................... 52 1 52 2 104
Part B Allocations Report .................................................... 54 1 54 6 324
Part B Expenditures Report ................................................. 54 1 54 6 324
Part B CLC ........................................................................... 54 1 54 2 108
Part C Allocations Report .................................................... 346 1 346 4 1,384
Part C Expenditures Report ................................................. 346 1 346 4 1,384
Part D Allocations Report .................................................... 116 1 116 4 464
Part D Expenditures Report ................................................. 116 1 116 4 464
Total .............................................................................. ........................ ........................ 1,294 ........................ 4,972
Note: Recipients are required to fill out an allocation report, expenditure report, and CLC for each Ryan White HIV/AIDS Program award
received.
HRSA specifically requests comments ACTION: Notice. Information Collection Request Title:
on (1) the necessity and utility of the Evaluation of the Maternal and Child
proposed information collection for the SUMMARY: In compliance with the Health Bureau’s Autism CARES Act
proper performance of the agency’s Paperwork Reduction Act of 1995, Initiative OMB No. 0915–0335,
functions, (2) the accuracy of the HRSA has submitted an Information Revision.
estimated burden, (3) ways to enhance Collection Request (ICR) to the Office of Abstract: In response to the growing
the quality, utility, and clarity of the Management and Budget (OMB) for need for research and resources devoted
information to be collected, and (4) the review and approval. Comments to autism spectrum disorder (ASD) and
use of automated collection techniques submitted during the first public review other developmental disabilities (DDs),
or other forms of information of this ICR will be provided to OMB. the U.S. Congress passed the Combating
technology to minimize the information OMB will accept further comments from Autism Act in 2006 (Pub. L. 109–416);
collection burden. the public during the review and it was reauthorized by the Combating
approval period. Autism Reauthorization Act of 2011
Jason E. Bennett, DATES: Comments on this ICR should be (Pub. L. 112–32) and the Autism CARES
Director, Division of the Executive Secretariat. received no later than February 21, (Collaboration, Accountability,
[FR Doc. 2017–01220 Filed 1–18–17; 8:45 am] 2017. Research, Education, and Support) Act
BILLING CODE 4165–15–P ADDRESSES: Submit your comments, of 2014 (Pub. L. 113–157). Through
including the ICR Title, to the desk Autism CARES, HRSA is tasked with
increasing awareness of ASD and other
officer for HRSA, either by email to
DEPARTMENT OF HEALTH AND DDs, reducing barriers to screening and
OIRA_submission@omb.eop.gov or by
HUMAN SERVICES diagnosis, promoting evidence-based
fax to 202–395–5806.
interventions, and training health care
FOR FURTHER INFORMATION CONTACT: To professionals in the use of valid and
Health Resources and Services
Administration request a copy of the clearance requests reliable diagnostic tools. To address
submitted to OMB for review, email the these goals, HRSA awards grants to
Agency Information Collection HRSA Information Collection Clearance various programs through the Maternal
Activities: Submission to OMB for Officer at paperwork@hrsa.gov or call and Child Health Bureau (MCHB).
(301) 443–1984. Need and Proposed Use of the
mstockstill on DSK3G9T082PROD with NOTICES
Review and Approval; Public Comment
Request; Evaluation of the Maternal SUPPLEMENTARY INFORMATION: When Information: The purpose of this
and Child Health Bureau’s Autism submitting comments or requesting information collection is to describe the
CARES Act Initiative information, please include the accomplishments of MCHB’s grant
information request collection title for programs in implementing the
AGENCY: Health Resources and Services reference, in compliance with Section provisions of the Autism CARES Act.
Administration (HRSA), Department of 3506(c)(2)(A), the Paperwork Reduction This ICR is a revision to an existing
Health and Human Services. Act of 1995. package; this study is the third
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Document Created: 2018-02-01 15:16:00
Document Modified: 2018-02-01 15:16:00
| 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 must be received no later than March 20, 2017. | |
| 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 the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 82 FR 6578 |
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