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)
Health Resources and Services Administration
Federal Register Volume 83, Issue 115 (June 14, 2018)
| Page Range | 27784-27785 | |
| FR Document | 2018-12782 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 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
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![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
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Document Created: 2018-06-14 01:38:58
Document Modified: 2018-06-14 01:38:58
| 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 should be received no later than July 16, 2018. | |
| 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. | |
| FR Citation | 83 FR 27784 |
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