82 FR 52308 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Voluntary Partner Surveys To Implement Executive Order 12862 in the Health Resources and Services Administration, OMB No. 0915-0212-Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 217 (November 13, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 217 (November 13, 2017)
| Page Range | 52308-52309 | |
| FR Document | 2017-24492 |
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)] [Notices] [Pages 52308-52309] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24492] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Voluntary Partner Surveys To Implement Executive Order 12862 in the Health Resources and Services Administration, OMB No. 0915-0212--Extension AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR must be received no later than January 12, 2018. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, 14N39, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Lisa Wright- Solomon, 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, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995. Information Collection Request Title: Voluntary Partner Surveys to Implement Executive Order 12862 in the Health Resources and Services Administration OMB No. 0915-0212--Extension. Abstract: In response to Executive Order 12862, HRSA is proposing to conduct voluntary customer surveys of its partners to assess strengths and weaknesses in program services and processes. HRSA partners are typically state or local governments, health care facilities, health care consortia, health care providers, and researchers. HRSA is requesting continued approval for a generic clearance from OMB to conduct the partner surveys. Partner surveys to be conducted by HRSA might include, for example, mail or telephone surveys of grantees to determine satisfaction with grant processes or technical assistance provided by a contractor, or in-class evaluation forms completed by providers who receive training from HRSA grantees to measure satisfaction with the training experience. HRSA will use the results of these surveys to plan and redirect resources and efforts as needed to improve services and processes. HRSA may also use focus groups to gain partner input into the design of mail and telephone surveys. Focus groups, in-class evaluation forms, mail surveys, and telephone surveys are expected to be the preferred data collection methods. A generic approval allows HRSA to conduct a limited number of partner surveys without a full-scale OMB review of each survey. If this request receives continued approval, information on each individual partner survey will not be published in the Federal Register. 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 [[Page 52309]] 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 ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- In-class evaluations............ 40,000 1 40,000 .05 2,000 Mail/Telephone surveys.......... 12,000 1 12,000 .25 3,000 Focus groups.................... 250 1 250 1.5 375 ------------------------------------------------------------------------------- Total....................... 52,250 .............. 52,250 .............. 5,375 ---------------------------------------------------------------------------------------------------------------- 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. Amy McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2017-24492 Filed 11-9-17; 8:45 am] BILLING CODE 4165-15-P
![52308 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
Swissmedic. Any party eligible to on ‘‘S5(R3) Detection of Toxicity to Officer, 14N39, 5600 Fishers Lane,
become a member in accordance with Reproduction for Human Rockville, MD 20857.
the ICH Articles of Association can Pharmaceuticals.’’ It does not establish FOR FURTHER INFORMATION CONTACT: To
apply for membership in writing to the any rights for any person and is not request more information on the
ICH Secretariat. The ICH Secretariat, binding on FDA or the public. You can proposed project or to obtain a copy of
which coordinates the preparation of use an alternative approach if it satisfies the data collection plans and draft
documentation, operates as an the requirements of the applicable instruments, email paperwork@hrsa.gov
international nonprofit organization and statutes and regulations. This guidance or call Lisa Wright-Solomon, the HRSA
is funded by the members of the ICH is not subject to Executive Order 12866. Information Collection Clearance Officer
Association. at (301) 443–1984.
The ICH Assembly is the overarching II. Electronic Access
SUPPLEMENTARY INFORMATION: When
body of the Association and includes Persons with access to the internet submitting comments or requesting
representatives from each of the ICH may obtain the draft guidance at https:// information, please include the
members and observers. www.regulations.gov, https://
In August 2017, the ICH Assembly information request collection title for
www.fda.gov/Drugs/ reference, in compliance with Section
endorsed the draft guidance titled GuidanceCompliance
‘‘S5(R3) Detection of Toxicity to 3506(c)(2)(A) of the Paperwork
RegulatoryInformation/Guidances/ Reduction Act of 1995.
Reproduction for Human default.htm, or https://www.fda.gov/
Pharmaceuticals’’ and agreed that the Information Collection Request Title:
BiologicsBloodVaccines/ Voluntary Partner Surveys to Implement
guidance should be made available for GuidanceCompliance
public comment. The draft guidance is Executive Order 12862 in the Health
RegulatoryInformation/Guidances/ Resources and Services Administration
the product of the S5(R3) Safety Expert default.htm.
Working Group of the ICH. Comments OMB No. 0915–0212—Extension.
about this draft will be considered by Dated: November 2, 2017. Abstract: In response to Executive
FDA and the S5(R3) Safety Expert Anna K. Abram, Order 12862, HRSA is proposing to
Working Group. Deputy Commissioner for Policy, Planning, conduct voluntary customer surveys of
The draft guidance replaces the Legislation, and Analysis. its partners to assess strengths and
existing guidance entitled ‘‘S5(R2) [FR Doc. 2017–24483 Filed 11–9–17; 8:45 am] weaknesses in program services and
Detection of Toxicity to Reproduction BILLING CODE 4164–01–P processes. HRSA partners are typically
for Human Pharmaceuticals.’’ The state or local governments, health care
guidance has undergone major revisions facilities, health care consortia, health
to align with other ICH guidances, DEPARTMENT OF HEALTH AND care providers, and researchers. HRSA
elaborate on concepts to consider when HUMAN SERVICES is requesting continued approval for a
designing studies, and identify potential generic clearance from OMB to conduct
circumstances in which a risk Health Resources and Services the partner surveys.
assessment can be made based on Administration Partner surveys to be conducted by
preliminary studies. It also clarifies the HRSA might include, for example, mail
qualification and potential use of Agency Information Collection or telephone surveys of grantees to
alternative assays. Activities: Proposed Collection: Public determine satisfaction with grant
To support using alternative assays, Comment Request; Information processes or technical assistance
compounds that are either positive or Collection Request Title: Voluntary provided by a contractor, or in-class
negative in their ability to induce Partner Surveys To Implement evaluation forms completed by
embryolethality or malformations are Executive Order 12862 in the Health providers who receive training from
used in the process of qualifying the Resources and Services HRSA grantees to measure satisfaction
assays. Although a number of Administration, OMB No. 0915–0212— with the training experience. HRSA will
compounds have been identified in the Extension use the results of these surveys to plan
draft guidance’s Annex, section 11.3.4, AGENCY: Health Resources and Services and redirect resources and efforts as
Tables 9–6 and 9–7, with the type of Administration (HRSA), Department of needed to improve services and
information for the compounds, the list Health and Human Services. processes.
is not complete; therefore, FDA is HRSA may also use focus groups to
requesting data in the form of public ACTION: Notice. gain partner input into the design of
comments to the docket for additional mail and telephone surveys. Focus
SUMMARY: In compliance with the
positive and negative reference groups, in-class evaluation forms, mail
requirement for opportunity for public
compounds for potential inclusion into surveys, and telephone surveys are
comment on proposed data collection
the list. These compounds can be either expected to be the preferred data
projects of the Paperwork Reduction Act
pharmaceuticals or non- collection methods.
of 1995, HRSA announces plans to
pharmaceuticals and should be A generic approval allows HRSA to
submit an Information Collection
commercially available. For additional conduct a limited number of partner
Request (ICR), described below, to the
guidance, please refer to Endnote 3 in surveys without a full-scale OMB
Office of Management and Budget
the S5(R3) guidance. This is not a review of each survey. If this request
(OMB). Prior to submitting the ICR to
asabaliauskas on DSKBBXCHB2PROD with NOTICES
request for data for the compounds receives continued approval,
OMB, HRSA seeks comments from the
already listed in Table 9–6, nor is this information on each individual partner
public regarding the burden estimate,
a request for examples of assays that survey will not be published in the
below, or any other aspect of the ICR.
could be used. Federal Register.
This draft guidance is being issued DATES: Comments on this ICR must be Burden Statement: Burden in this
consistent with FDA’s good guidance received no later than January 12, 2018. context means the time expended by
practices regulation (21 CFR 10.115). ADDRESSES: Submit your comments to persons to generate, maintain, retain,
The draft guidance, when finalized, will paperwork@hrsa.gov or mail the HRSA disclose or provide the information
represent the current thinking of FDA Information Collection Clearance requested. This includes the time
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![Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices 52309
needed to review instructions; to maintaining information, and disclosing the collection of information; and to
develop, acquire, install and utilize and providing information; to train transmit or otherwise disclose the
technology and systems for the purpose personnel and to be able to respond to information. The total annual burden
of collecting, validating and verifying a collection of information; to search hours estimated for this ICR are
information, processing and data sources; to complete and review 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)
In-class evaluations ............................................................. 40,000 1 40,000 .05 2,000
Mail/Telephone surveys ....................................................... 12,000 1 12,000 .25 3,000
Focus groups ....................................................................... 250 1 250 1.5 375
Total .............................................................................. 52,250 ........................ 52,250 ........................ 5,375
HRSA specifically requests comments DATES: Comments on this ICR should be treatment for HIV has been shown to
on (1) the necessity and utility of the received no later than December 13, greatly reduce associated morbidity and
proposed information collection for the 2017. mortality, and prevents transmission of
proper performance of the agency’s ADDRESSES: Submit your comments, HIV. In spite of the known benefit of
functions, (2) the accuracy of the including the ICR Title, to the desk treatment, many individuals remain out
estimated burden, (3) ways to enhance officer for HRSA, either by email to of care or access care only
the quality, utility, and clarity of the OIRA_submission@omb.eop.gov or by intermittently; the CDC estimated that
information to be collected, and (4) the fax to 202–395–5806. in 2013, approximately 45 percent of
use of automated collection techniques people living with HIV (PLWH) in the
FOR FURTHER INFORMATION CONTACT: To
or other forms of information United States were not virally
request a copy of the clearance requests suppressed, indicating a significant gap
technology to minimize the information
submitted to OMB for review, email Lisa in the percentage of PLWH who are
collection burden.
Wright-Solomon, the HRSA Information being successfully engaged and retained
Amy McNulty, Collection Clearance Officer at in care. In spite of the increased
Acting Director, Division of the Executive paperwork@hrsa.gov or call (301) 443– attention on retention in care and the
Secretariat. 1984. overarching goal of viral suppression,
[FR Doc. 2017–24492 Filed 11–9–17; 8:45 am] SUPPLEMENTARY INFORMATION: little data exist regarding the specific
BILLING CODE 4165–15–P Information Collection Request Title: individual factors that are associated
Assessing Client Factors Associated with sub-optimal viral suppression.
with Detectable HIV Viral Loads and Such information is valuable for
DEPARTMENT OF HEALTH AND Models of Care and the Ryan White targeting programs to reach populations
HUMAN SERVICES HIV/AIDS Program. that are currently not achieving HIV
OMB No.: 0906–xxxx—NEW. viral suppression.
Health Resources and Services Abstract: The Ryan White HIV/AIDS The second evaluation study, Models
Administration Program (RWHAP), first authorized by of Care and the Ryan White HIV/AIDS
the U.S. Congress in 1990, is Program, seeks to answer the critical
Agency Information Collection administered by HRSA’s HIV/AIDS questions of what individual and
Activities: Submission to OMB for Bureau (HAB). The RWHAP provides system-wide factors, including the
Review and Approval; Public Comment medical services, treatment, and/or models of care employed among
Request; Assessing Client Factors support services to 533,036 clients in RWHAP provider sites, contribute to
Associated With Detectable HIV Viral 2015; 97.0 percent of these clients were better health outcomes for PLWH. While
Loads; and Models of Care and the living with HIV. This information advances in treatment have improved
Ryan White HIV/AIDS Program collection request covers two distinct survival in patients with HIV, longer
evaluation studies with RWHAP lives are associated with increased
AGENCY: Health Resources and Services
provider sites that will share prevalence of adverse effects of HIV
Administration (HRSA), Department of
components of data collection infection and therapeutic complications,
Health and Human Services.
instruments through shared variables. concurrent with medical conditions
ACTION: Notice. Sharing data collection instruments will related to aging processes that would
minimize burden for RWHAP provider occur in the absence of HIV. These long-
SUMMARY: In compliance with the sites collecting this data and will term complications amplify chronic
Paperwork Reduction Act of 1995, increase the sample size for data disease management as a major issue for
asabaliauskas on DSKBBXCHB2PROD with NOTICES
HRSA has submitted an Information analysis thus resulting in more robust the HIV population and a challenge for
Collection Request (ICR) to the Office of data and greater generalizability of the delivery of effective health care. Yet
Management and Budget (OMB) for results. little is known about how the method of
review and approval. Comments The first evaluation study, Assessing health services delivery (the ‘‘model of
submitted during the first public review Client Factors Associated with care’’) contributes to better health
of this ICR will be provided to OMB. Detectable HIV Viral Loads, will explore outcomes, including HIV-related
OMB will accept further comments from individuals’ specific facilitators and outcomes. For example, does it make a
the public during the review and barriers to achieving and sustaining difference if a patient receives HIV care
approval period. viral suppression. Early and effective from a primary care provider, a
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Document Created: 2017-11-10 01:18:14
Document Modified: 2017-11-10 01:18:14
| 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 January 12, 2018. | |
| 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 Lisa Wright- Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 82 FR 52308 |
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