Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Zika Virus Pilot Project, OMB No. 0906-xxxx-NEW, 27784-27785 [2018-12782]
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2156]
Ferring Pharmaceuticals, Inc.;
Withdrawal of Approval of Two
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
withdrawing approval of two
abbreviated new drug applications
(ANDAs) from Ferring Pharmaceuticals,
Inc. (Ferring). Ferring notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of July
16, 2018.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
Ferring
has informed FDA that the drug
products listed in the table are no longer
marketed and has requested that FDA
withdraw approval of the applications
under the process described in
§ 314.150(c) (21 CFR 314.150(c)).
Ferring has also, by its request, waived
its opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 073598 .....
Menotropins (follicle-stimulating hormone (FSH)/luteinizing hormone
(LH)) for Injection, 75 international units (IU)/75 IU per vial.
Menotropins (FSH/LH) for Injection, 150 IU/150 IU per vial .................
Ferring Pharmaceuticals, Inc., 100 Interpace Pkwy.,
Parsippany, NJ 07054.
Do.
ANDA 073599 .....
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 16, 2018.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on July 16, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12762 Filed 6–13–18; 8:45 am]
BILLING CODE 4164–01–P
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
daltland on DSKBBV9HB2PROD with NOTICES
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
SUMMARY:
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16:38 Jun 13, 2018
Jkt 244001
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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
E:\FR\FM\14JNN1.SGM
14JNN1
27785
Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
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
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
daltland on DSKBBV9HB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Cancer Institute
Council of Research Advocates.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://
videocast.nih.gov).
Name of Committee: National Cancer
Institute Council of Research Advocates.
Date: June 21, 2018.
Time: 9:30 a.m. to 4:00 p.m.
Agenda: Welcome and Chairman’s
Remarks, NCI Updates, Legislative Update,
Budget Update, and Director’s Update.
Place: National Institutes of Health, 31
Center Drive, Building 31, 11A01, Bethesda,
MD 20892.
Contact Person: Amy Williams, NCI Office
of Advocacy Relations, National Cancer
Institute, NIH, 31 Center Drive, Building 31,
Room 10A28, Bethesda, MD 20892, 240–781–
3360, williaam@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
difficulties.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
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16:38 Jun 13, 2018
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this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: NCRA: https://
deainfo.nci.nih.gov/advisory/ncra/ncra.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: June 8, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–12730 Filed 6–13–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
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552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Hepatology.
Date: July 10, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Jonathan K Ivins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2190,
MSC 7850, Bethesda, MD 20892, (301) 594–
1245, ivinsj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Tumor Signaling and Biology.
Date: July 11, 2018.
Time: 11:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ola Mae Zack Howard,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4192,
MSC 7806, Bethesda, MD 20892, 301–451–
4467, howardz@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Infectious Diseases and Microbiology.
Date: July 12–13, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin Westminster, 10600
Westminster Blvd., Westminster, CO 80020.
Contact Person: Tamara Lyn McNealy,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
E:\FR\FM\14JNN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Pages 27784-27785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
