83 FR 5794 - Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Zika Virus Pilot Project, OMB No. 0906-XXXX-New

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

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.

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5794-5795]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: Zika Virus 
Pilot Project, OMB No. 0906-XXXX--New

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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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 April 10, 
2018.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 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: Zika Virus Pilot Project, OMB 
No. 0906-XXXX--New.

[[Page 5795]]

    Abstract: HRSA is requesting the Organ Procurement and 
Transplantation Network (OPTN) perform a federally sponsored data 
collection as part of a pilot project to monitor the testing of 
deceased potential donors possibly exposed to the Zika virus (ZIKV). 
The Zika Pilot Project will have a 12-month performance period enabling 
OPTN to develop a plan to collect data on ways for organ procurement 
organizations (OPOs) to deploy ZIKV donor screening tests of blood 
products. The testing is available under an investigational new drug 
application for use on a voluntary basis in the evaluation of deceased 
persons as potential solid organ donors. OPTN will conduct an analysis 
of the data collected under this project to determine the potential 
effect of making available screening tests for ZIKV, when appropriate, 
to improve transplant safety. OPTN will convene a group of stakeholders 
to provide guidance and monitor progress on the ZIKV pilot project.
    Need and Proposed Use of the Information: ZIKV is prevalent in 
several areas of the United States. Currently, there is not a ZIKV 
screening procedure for OPOs to implement during the organ allocation 
process. HRSA requested OPTN to conduct a pilot project to monitor the 
testing of deceased donors potentially exposed to ZIKV. The goals of 
the pilot project are to:
     Collaborate with experts to define necessary data elements 
to understand the impact of ZIKV testing in deceased organ donors;
     Deploy a data collection tool to a limited number of OPOs 
that agree to participate in the pilot project; and
     Assess the ability of OPTN to respond to a public health 
situation by collecting data from impacted members of the transplant 
community to assess the national experience.
    Likely Respondents: Organ Procurement Organizations.
    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
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                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
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ZIKV Data Collection Tool.......              20             167           3,340            .508         1,696.7
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    Total.......................              20  ..............           3,340  ..............         1,696.7
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* Total number of responses determined by applying the percentage of OPOs participating to the total number of
  deceased donors in 2016. Based on OPTN Data as of 11/09/2017.
** Donors screened for ZIKV will be based on OPO specific screening criteria.

    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. 2018-02586 Filed 2-8-18; 8:45 am]
 BILLING CODE 4165-15-P