83_FR_27899 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

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)

Page Range27784-27785
FR Document2018-12782

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 Issue 115 (Thursday, June 14, 2018) 
[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 OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Zika Data Collection Tool.......              20              58         1,160 *            .508             589
                                 -------------------------------------------------------------------------------
    Total.......................              20  ..............         1,160 *  ..............             589
----------------------------------------------------------------------------------------------------------------
* 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

27784 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices DEPARTMENT OF HEALTH AND withdrawing approval of two MD 20993–0002, 240–402–7945, HUMAN SERVICES abbreviated new drug applications Trang.Tran@fda.hhs.gov. (ANDAs) from Ferring Pharmaceuticals, Food and Drug Administration SUPPLEMENTARY INFORMATION: Ferring Inc. (Ferring). Ferring notified the has informed FDA that the drug [Docket No. FDA–2018–N–2156] Agency in writing that the drug products listed in the table are no longer products were no longer marketed and marketed and has requested that FDA Ferring Pharmaceuticals, Inc.; requested that the approval of the withdraw approval of the applications Withdrawal of Approval of Two applications be withdrawn. under the process described in Abbreviated New Drug Applications DATES: Approval is withdrawn as of July § 314.150(c) (21 CFR 314.150(c)). AGENCY: Food and Drug Administration, 16, 2018. Ferring has also, by its request, waived HHS. FOR FURTHER INFORMATION CONTACT: its opportunity for a hearing. ACTION: Notice. Trang Tran, Center for Drug Evaluation Withdrawal of approval of an and Research, Food and Drug application or abbreviated application SUMMARY: The Food and Drug Administration, 10903 New Hampshire under § 314.150(c) is without prejudice Administration (FDA or Agency) is Ave., Bldg. 75, Rm. 1671, Silver Spring, to refiling. Application No. Drug Applicant ANDA 073598 ..... Menotropins (follicle-stimulating hormone (FSH)/luteinizing hormone Ferring Pharmaceuticals, Inc., 100 Interpace Pkwy., (LH)) for Injection, 75 international units (IU)/75 IU per vial. Parsippany, NJ 07054. ANDA 073599 ..... Menotropins (FSH/LH) for Injection, 150 IU/150 IU per vial ................. Do. Therefore, approval of the Management and Budget (OMB) for drug application for use on a voluntary applications listed in the table, and all review and approval. Comments basis in the evaluation of deceased amendments and supplements thereto, submitted during the first public review persons as potential solid organ donors. is hereby withdrawn as of July 16, 2018. of this ICR will be provided to OMB. OPTN will conduct an analysis of the Introduction or delivery for introduction OMB will accept further comments from data collected under this project to into interstate commerce of products the public during the review and determine the potential effect of making without approved new drug approval period. available screening tests for ZIKV, when applications violates section 301(a) and DATES: Comments on this ICR should be appropriate, to improve transplant (d) of the Federal Food, Drug, and received no later than July 16, 2018. safety. OPTN will convene a group of Cosmetic Act (21 U.S.C. 331(a) and (d)). ADDRESSES: Submit your comments, stakeholders to provide guidance and Drug products that are listed in the table including the ICR Title, to the desk monitor progress on the ZIKV pilot that are in inventory on July 16, 2018 officer for HRSA, either by email to project. may continue to be dispensed until the OIRA_submission@omb.eop.gov or by Need and Proposed Use of the inventories have been depleted or the fax to 202–395–5806. Information: ZIKV is prevalent in drug products have reached their FOR FURTHER INFORMATION CONTACT: To several areas of the United States. expiration dates or otherwise become request a copy of the clearance requests Currently, there is not a ZIKV screening violative, whichever occurs first. submitted to OMB for review, email Lisa procedure for OPOs to implement Dated: June 8, 2018. Wright-Solomon, the HRSA Information during the organ allocation process. Leslie Kux, Collection Clearance Officer at HRSA requested OPTN to conduct a paperwork@hrsa.gov or call (301) 443– pilot project to monitor the testing of Associate Commissioner for Policy. 1984. deceased donors potentially exposed to [FR Doc. 2018–12762 Filed 6–13–18; 8:45 am] SUPPLEMENTARY INFORMATION: When ZIKV. The goals of the pilot project are BILLING CODE 4164–01–P to: submitting comments or requesting information, please include the • Collaborate with experts to define information request collection title for necessary data elements to understand DEPARTMENT OF HEALTH AND the impact of ZIKV testing in deceased HUMAN SERVICES reference, in compliance with Section 3506(c)(2)(A) of the Paperwork organ donors; Health Resources and Services Reduction Act of 1995. • Deploy a data collection tool to a Administration Information Collection Request Title: limited number of OPOs that agree to Zika Virus Pilot Project, OMB No. 0906– participate in the pilot project; and Agency Information Collection xxxx—NEW • Assess the ability of OPTN to Activities: Submission to OMB for Abstract: HRSA is requesting the respond to a public health situation by Review and Approval; Public Comment Organ Procurement and Transplantation collecting data from impacted members Request; Zika Virus Pilot Project, OMB Network (OPTN) perform a federally of the transplant community to assess No. 0906–xxxx—NEW sponsored data collection as part of a the national experience. pilot project to monitor the testing of Likely Respondents: Organ AGENCY: Health Resources and Services deceased potential donors possibly Procurement Organizations. Administration (HRSA), Department of exposed to the Zika virus (ZIKV). The Burden Statement: Burden in this daltland on DSKBBV9HB2PROD with NOTICES Health and Human Services. Zika Pilot Project will have a 12-month context means the time expended by ACTION: Notice. performance period enabling OPTN to persons to generate, maintain, retain, develop a plan to collect data on ways disclose or provide the information SUMMARY: In compliance with the for organ procurement organizations requested. This includes the time Paperwork Reduction Act of 1995, (OPOs) to deploy ZIKV donor screening needed to review instructions; to HRSA has submitted an Information tests of blood products. The testing is develop, acquire, install and utilize Collection Request (ICR) to the Office of available under an investigational new technology and systems for the purpose VerDate Sep<11>2014 16:38 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1

Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 27785 of collecting, validating and verifying personnel and to be able to respond to transmit or otherwise disclose the information, processing and a collection of information; to search information. The total annual burden maintaining information, and disclosing data sources; to complete and review hours estimated for this ICR are and providing information; to train the collection of information; and to 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) Zika Data Collection Tool .................................................... 20 58 1,160 * .508 589 Total .............................................................................. 20 ........................ 1,160 * ........................ 589 * 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, this notice. The statement should include the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Acting Director, Division of the Executive name, address, telephone number and when as amended. The grant applications and Secretariat. applicable, the business or professional the discussions could disclose [FR Doc. 2018–12782 Filed 6–13–18; 8:45 am] affiliation of the interested person. confidential trade secrets or commercial In the interest of security, NIH has BILLING CODE 4165–15–P instituted stringent procedures for entrance property such as patentable material, onto the NIH campus. All visitor vehicles, and personal information concerning including taxicabs, hotel, and airport shuttles individuals associated with the grant DEPARTMENT OF HEALTH AND will be inspected before being allowed on applications, the disclosure of which HUMAN SERVICES campus. Visitors will be asked to show one would constitute a clearly unwarranted form of identification (for example, a invasion of personal privacy. National Institutes of Health government-issued photo ID, driver’s license, Name of Committee: Center for Scientific or passport) and to state the purpose of their National Cancer Institute; Notice of Review Special Emphasis Panel; Member visit. Meeting Conflict: Topics in Hepatology. Information is also available on the Date: July 10, 2018. Institute’s/Center’s home page: NCRA: http:// Time: 1:00 p.m. to 4:00 p.m. Pursuant to section 10(d) of the deainfo.nci.nih.gov/advisory/ncra/ncra.htm, Federal Advisory Committee Act, as Agenda: To review and evaluate grant where an agenda and any additional applications. amended, notice is hereby given of a information for the meeting will be posted Place: National Institutes of Health, 6701 meeting of the National Cancer Institute when available. Rockledge Drive, Bethesda, MD 20892 Council of Research Advocates. (Catalogue of Federal Domestic Assistance (Telephone Conference Call). The meeting will be open to the Program Nos. 93.392, Cancer Construction; Contact Person: Jonathan K Ivins, Ph.D., public, with attendance limited to space 93.393, Cancer Cause and Prevention Scientific Review Officer, Center for available. Individuals who plan to Research; 93.394, Cancer Detection and Scientific Review, National Institutes of attend and need special assistance, such Diagnosis Research; 93.395, Cancer Health, 6701 Rockledge Drive, Room 2190, as sign language interpretation or other Treatment Research; 93.396, Cancer Biology MSC 7850, Bethesda, MD 20892, (301) 594– reasonable accommodations, should Research; 93.397, Cancer Centers Support; 1245, ivinsj@csr.nih.gov. notify the Contact Person listed below 93.398, Cancer Research Manpower; 93.399, Name of Committee: Center for Scientific Cancer Control, National Institutes of Health, Review Special Emphasis Panel; Member in advance of the meeting. The open HHS) Conflict: Tumor Signaling and Biology. session will be videocast and can be Dated: June 8, 2018. Date: July 11, 2018. accessed from the NIH Videocasting and Time: 11:30 a.m. to 5:30 p.m. Podcasting website (http:// Michelle D. Trout, Agenda: To review and evaluate grant videocast.nih.gov). Program Analyst, Office of Federal Advisory applications. Committee Policy. Place: National Institutes of Health, 6701 Name of Committee: National Cancer Institute Council of Research Advocates. [FR Doc. 2018–12730 Filed 6–13–18; 8:45 am] Rockledge Drive, Bethesda, MD 20892 Date: June 21, 2018. BILLING CODE 4140–01–P (Virtual Meeting). Time: 9:30 a.m. to 4:00 p.m. Contact Person: Ola Mae Zack Howard, Agenda: Welcome and Chairman’s Ph.D., Scientific Review Officer, Center for Remarks, NCI Updates, Legislative Update, DEPARTMENT OF HEALTH AND Scientific Review, National Institutes of Budget Update, and Director’s Update. Health, 6701 Rockledge Drive, Room 4192, HUMAN SERVICES MSC 7806, Bethesda, MD 20892, 301–451– Place: National Institutes of Health, 31 Center Drive, Building 31, 11A01, Bethesda, 4467, howardz@mail.nih.gov. National Institutes of Health MD 20892. Name of Committee: Center for Scientific Contact Person: Amy Williams, NCI Office Review Special Emphasis Panel; Fellowship: Center for Scientific Review; Notice of of Advocacy Relations, National Cancer Infectious Diseases and Microbiology. Institute, NIH, 31 Center Drive, Building 31, Closed Meetings Date: July 12–13, 2018. daltland on DSKBBV9HB2PROD with NOTICES Room 10A28, Bethesda, MD 20892, 240–781– Pursuant to section 10(d) of the Time: 8:00 a.m. to 5:00 p.m. 3360, williaam@mail.nih.gov. Agenda: To review and evaluate grant Federal Advisory Committee Act, as This notice is being published less than 15 applications. amended (5 U.S.C. App.), notice is Place: The Westin Westminster, 10600 days prior to the meeting due to scheduling difficulties. hereby given of the following meetings. Westminster Blvd., Westminster, CO 80020. Any interested person may file written The meetings will be closed to the Contact Person: Tamara Lyn McNealy, comments with the committee by forwarding public in accordance with the Ph.D., Scientific Review Officer, Center for the statement to the Contact Person listed on provisions set forth in sections Scientific Review, National Institutes of VerDate Sep<11>2014 16:38 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1


Document Created: 2018-06-14 01:38:58
Document Modified: 2018-06-14 01:38:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this ICR should be received no later than July 16, 2018.
ContactTo 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.
FR Citation83 FR 27784 
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