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)
Health Resources and Services Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5794-5795 | |
| FR Document | 2018-02586 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 paperwork@hrsa.gov 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 paperwork@hrsa.gov 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 ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per Total per response Total burden respondents respondent responses (in hours) hours ---------------------------------------------------------------------------------------------------------------- ZIKV Data Collection Tool....... 20 167 3,340 .508 1,696.7 ------------------------------------------------------------------------------- Total....................... 20 .............. 3,340 .............. 1,696.7 ---------------------------------------------------------------------------------------------------------------- * 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
![5794 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
as the average response will be 0.1 hour increase organ donor registration and age of 18 with a higher number of
shorter, and the cost of online survey donation in the United States. This responses from populations of interest
can range $3–$4 per survey compared to survey is the primary method by which such as racial-ethnic minorities,
$50-$100 for a high quality phone HRSA can obtain information from including African American, Asian,
survey. Americans about organ donation Native American, and Hispanic
To improve the relevance of the data attitudes and beliefs. OMB previously respondents, as well as respondents of
collected, HRSA solicited approved this survey and HRSA fielded all age groups and education levels.
approximately 40 organ donation it during 2005 and 2012. Results of the Burden Statement: Burden in this
subject matter experts for their feedback data collected from this survey will context means the time expended by
on making changes to the survey. Based inform the development of appropriate persons to generate, maintain, retain,
on their expert advice, HRSA is revising messages for future public outreach and disclose, or provide the information
the instrument to add, remove, or edit educational initiatives. Increasing the requested. This includes the time
a few questions as noted in the draft number of completed cases via a web needed to review instructions; to
survey instrument. Example changes panel for online survey completion and develop, acquire, install, and utilize
include removing certain questions that modifying the survey instrument technology and systems for the purpose
were only relevant for a random-digit- without increasing the survey length of collecting, validating and verifying
dialing sample design, editing certain will dramatically improve the quality information, processing and
questions to add clarity, and adding and accuracy of the results while maintaining information, and disclosing
questions to highlight emerging topics minimizing respondent burden as much and providing information; to train
such as receiving organ donation as possible. The revised instrument and personnel and to be able to respond to
information through a hand-held device survey fielding methods will allow a collection of information; to search
or mobile apps. research on the attitudes and behaviors data sources; to complete and review
Need and Proposed Use of the of important subgroups of Americans as the collection of information; and to
Information: HRSA is the primary well as research on emerging topics transmit or otherwise disclose the
federal entity responsible for oversight related to organ donation. information. A summary of the total
of the solid organ and blood stem cell Likely Respondents: A nationally annual burden hours estimated for this
transplant systems and initiatives to representative sample of adults over the ICR is 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)
NSODAP Revised Survey—Telephone ............................... 2,000 1 2,000 0.3 600
NSODAP Revised Survey—Online Panel ........................... 8,000 1 8,000 0.2 1,600
Total .............................................................................. 10,000 ........................ 10,000 ........................ 2,200
HRSA specifically requests comments DEPARTMENT OF HEALTH AND public regarding the burden estimate,
on (1) the necessity and utility of the HUMAN SERVICES below, or any other aspect of the ICR.
proposed information collection for the DATES: Comments on this ICR must be
proper performance of the agency’s Health Resources and Services received no later than April 10, 2018.
functions; (2) the accuracy of the Administration
ADDRESSES: Submit your comments to
estimated burden; (3) ways to enhance
Agency Information Collection paperwork@hrsa.gov or mail the HRSA
the quality, utility, and clarity of the Information Collection Clearance
information to be collected; and (4) the Activities: Proposed Collection: Public
Comment Request Information Officer, Room 14N39, 5600 Fishers
use of automated collection techniques Lane, Rockville, MD 20857.
Collection Request Title: Zika Virus
or other forms of information
Pilot Project, OMB No. 0906–XXXX— FOR FURTHER INFORMATION CONTACT: To
technology to minimize the information
New request more information on the
collection burden.
proposed project or to obtain a copy of
Amy McNulty, AGENCY: Health Resources and Services the data collection plans and draft
Acting Director, Division of the Executive
Administration (HRSA), Department of instruments, email paperwork@hrsa.gov
Secretariat. Health and Human Services. or call Lisa Wright-Solomon, the HRSA
[FR Doc. 2018–02595 Filed 2–8–18; 8:45 am] ACTION: Notice. Information Collection Clearance Officer
BILLING CODE 4165–15–P
at (301) 443–1984.
SUMMARY: In compliance with the SUPPLEMENTARY INFORMATION: When
requirement for opportunity for public submitting comments or requesting
comment on proposed data collection information, please include the
sradovich on DSK3GMQ082PROD with NOTICES
projects of the Paperwork Reduction Act information request collection title for
of 1995, HRSA announces plans to reference, in compliance with Section
submit an Information Collection 3506(c)(2)(A) of the Paperwork
Request (ICR), described below, to the Reduction Act of 1995.
Office of Management and Budget Information Collection Request Title:
(OMB). Prior to submitting the ICR to Zika Virus Pilot Project, OMB No. 0906–
OMB, HRSA seeks comments from the XXXX—New.
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![Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5795
Abstract: HRSA is requesting the monitor progress on the ZIKV pilot of the transplant community to assess
Organ Procurement and Transplantation project. the national experience.
Network (OPTN) perform a federally Need and Proposed Use of the Likely Respondents: Organ
sponsored data collection as part of a Information: ZIKV is prevalent in Procurement Organizations.
pilot project to monitor the testing of several areas of the United States. Burden Statement: Burden in this
deceased potential donors possibly Currently, there is not a ZIKV screening context means the time expended by
exposed to the Zika virus (ZIKV). The procedure for OPOs to implement persons to generate, maintain, retain,
Zika Pilot Project will have a 12-month during the organ allocation process. disclose, or provide the information
performance period enabling OPTN to HRSA requested OPTN to conduct a requested. This includes the time
develop a plan to collect data on ways pilot project to monitor the testing of needed to review instructions; to
for organ procurement organizations deceased donors potentially exposed to develop, acquire, install, and utilize
(OPOs) to deploy ZIKV donor screening ZIKV. The goals of the pilot project are technology and systems for the purpose
tests of blood products. The testing is to: of collecting, validating, and verifying
available under an investigational new information, processing and
• Collaborate with experts to define
drug application for use on a voluntary maintaining information, and disclosing
necessary data elements to understand
basis in the evaluation of deceased and providing information; to train
the impact of ZIKV testing in deceased
persons as potential solid organ donors. personnel and to be able to respond to
organ donors;
OPTN will conduct an analysis of the a collection of information; to search
data collected under this project to • Deploy a data collection tool to a data sources; to complete and review
determine the potential effect of making limited number of OPOs that agree to the collection of information; and to
available screening tests for ZIKV, when participate in the pilot project; and transmit or otherwise disclose the
appropriate, to improve transplant • Assess the ability of OPTN to information. The total annual burden
safety. OPTN will convene a group of respond to a public health situation by hours estimated for this ICR are
stakeholders to provide guidance and collecting data from impacted members 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)
ZIKV Data Collection Tool ................................................... 20 167 3,340 .508 1,696.7
Total .............................................................................. 20 ........................ 3,340 ........................ 1,696.7
* 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 2018, 08:30 a.m. to January 22, 2018, The meetings will be closed to the
on: (1) The necessity and utility of the 05:00 p.m., Hilton Garden Inn Bethesda, public in accordance with the
proposed information collection for the 7301 Waverly Street, Bethesda, MD provisions set forth in sections
proper performance of the agency’s 20814 which was published in the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
functions; (2) the accuracy of the Federal Register on December 28, 2017, as amended. The grant applications and
estimated burden; (3) ways to enhance 82 FR 61577. This meeting is being the discussions could disclose
the quality, utility, and clarity of the amended to change the date from confidential trade secrets or commercial
information to be collected; and (4) the January 22, 2018 to February 23, 2018. property such as patentable material,
use of automated collection techniques The time has not changed. The meeting and personal information concerning
or other forms of information is closed to the public. individuals associated with the grant
technology to minimize the information Dated: February 5, 2018. applications, the disclosure of which
collection burden. Natasha M. Copeland,
would constitute a clearly unwarranted
invasion of personal privacy.
Amy McNulty, Program Analyst, Office of Federal Advisory
Acting Director, Division of the Executive Committee Policy. Name of Committee: National Institute on
Secretariat. [FR Doc. 2018–02565 Filed 2–8–18; 8:45 am] Drug Abuse Special Emphasis Panel; Multi-
site Clinical Trials.
[FR Doc. 2018–02586 Filed 2–8–18; 8:45 am] BILLING CODE 4140–01–P
Date: February 16, 2018.
BILLING CODE 4165–15–P Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
DEPARTMENT OF HEALTH AND applications.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Place: National Institutes of Health,
HUMAN SERVICES Neuroscience Center, 6001 Executive
National Institutes of Health Boulevard, Rockville, MD 20852 (Telephone
sradovich on DSK3GMQ082PROD with NOTICES
National Institutes of Health Conference Call).
National Institute on Drug Abuse; Contact Person: Hiromi Ono, Ph.D.,
National Eye Institute; Amended Notice Notice of Closed Meetings Scientific Review Officer, Office of
of Meeting Extramural Policy and Review, National
Pursuant to section 10(d) of the Institute on Drug Abuse, National Institutes
Notice is hereby given of a change in Federal Advisory Committee Act, as of Health, DHHS, 6001 Executive Boulevard,
the meeting of the National Eye Institute amended, notice is hereby given of the Room 4238, MSC 9550, Bethesda, MD 20892,
Special Emphasis Panel, January 22, following meetings. 301–827–5820, hiromi.ono@nih.gov.
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Document Created: 2018-02-09 00:12:12
Document Modified: 2018-02-09 00:12:12
| 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 April 10, 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 | 83 FR 5794 |
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