83 FR 27784 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 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 115 (June 14, 2018)

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.

[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Pages 27784-27785]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12782]


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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; 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 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 July 16, 
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: 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
    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

[[Page 27785]]

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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Zika Data Collection Tool.......              20              58         1,160 *            .508             589
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    Total.......................              20  ..............         1,160 *  ..............             589
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* Total number of responses determined by applying the percentage of OPOs participating to the total number of
  deceased donors during 2016. In addition, donors screened for Zika will be based on OPO specific screening
  criteria. Since all donors will not be screened, this number represents 35% of the donors recovered at the 20
  OPOs. Based on OPTN Data as of November 9, 2017.


Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-12782 Filed 6-13-18; 8:45 am]
 BILLING CODE 4165-15-P