Agency Information Collection Request; 60-Day Public Comment Request, 9325-9326 [2018-04386]
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Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenneth Quinto, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5145, Silver Spring,
MD 20993, 240–402–2221,
kenneth.quinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
responsible for protecting the public
health by assuring the safety, efficacy,
and security of human and veterinary
drugs, biological products, medical
devices, our Nation’s food supply,
cosmetics, and products that emit
radiation.
FDA is establishing a public docket,
Docket No. FDA–2017–N–7022, to
receive input on post-marketing
pediatric-focused safety reviews of
products posted between October 23,
2017, and March 16, 2018, available on
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/Committees
MeetingMaterials/PediatricAdvisory
Committee/ucm510701.htm but not
presented at the March 23, 2018, PAC
meeting. FDA welcomes comments by
members of the PAC, as mandated by
the Best Pharmaceuticals for Children
Act (Pub. L. 107–109) and the Pediatric
Research Equity Act of 2003 (Pub. L.
108–155), interested parties (such as
academic researchers, regulated
industries, consortia, and patient
groups), and the general public. The
docket number is FDA–2017–N–7022.
The docket will open on March 19,
2018, and remain open until March 30,
2018. The post-marketing pediatricfocused safety reviews are for the
following products from the following
centers at FDA:
Center for Biologics Evaluation and
Research
1. EPICEL (cultured epidermal
autographs) (humanitarian device
exemption (HDE))
2. GARDASIL 9 (Human
Papillomavirus 9-valent Vaccine,
Recombinant)
3. TRUMENBA (Meningococcal
Group B Vaccine)
sradovich on DSK3GMQ082PROD with NOTICES
Center for Drug Evaluation and
Research
1. ATROPINE SULFATE
OPHTHALMIC SOLUTION, USP
1%
2. DYMISTA (azelastine
hydrochloride/fluticasone
propionate)
3. EDURANT (rilpivirine);
COMPLERA (emtricitabine,
rilpivirine, tenofovir disoproxil
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19:25 Mar 02, 2018
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fumarate); ODEFSEY (emtricitabine,
rilpivirine, tenofovir alafenamide)
4. EMEND (aprepitant) capsule and
oral suspension
5. EPIDUO FORTE (adapalene/
benzoyl peroxide, 0.3%/2.5%) gel
6. GADAVIST (gadobutrol); EOVIST
(Primovist; gadoxetate disodium)
7. GENVOYA (elvitegravir, cobicistat,
emtricitabine, and tenofovir
alafenamide) oral tablets
8. KAPVAY (clonidine extendedrelease) tablets
9. MERREM IV (meropenem for
injection)
10. NAFTIN (naftifine hydrochloride)
11. NUCALA (mepolizumab)
12. OTIPRIO (6% ciprofloxacin otic
suspension)
13. PAZEO (olopatadine
hydrochloride ophthalmic solution)
0.7%
14. QNASL (beclomethasone
dipropionate) nasal aerosol
15. SAPHRIS (asenapine)
16. TIVICAY (dolutegravir)
17. TREXIMET (naproxen sodium;
sumatriptan succinate)
18. VALCYTE (valganciclovir)
Center for Devices and Radiological
Health
1. FLOURISH PEDIATRIC
ESOPHAGEAL ATRESIA DEVICE
(HDE)
Dated: February 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04400 Filed 3–2–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 4, 2018.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
202–795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
SUMMARY:
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9325
the document identifier 0990–New–60D
and project title for reference to
Sherrette.funn@hhs.gov or call the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: Trafficking
Victim Assistance Program Social
Network Analysis—Network Survey.
Type of Collection: New.
OMB No. 0990–NEW-Office of the
Assistant Secretary for Planning and
Evaluation–Administration for Children
and Families’ Trafficking Victim
Assistance Program
Abstract
The Office of the Assistant Secretary
for Planning and Evaluation (ASPE), in
partnership with the Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS) is requesting Office of
Management and Budget (OMB)
approval for a new information
collection request, ‘‘Trafficking Victim
Assistance Program (TVAP) Network
Survey.’’ ICF has been contracted to
carry out this project under the
guidance of ASPE and ACF.
TVAP, as authorized by the
Trafficking Victims Protection Act of
2000, provides comprehensive case
management services to foreign-born
victims of human trafficking residing in
the United States. Since its inception,
TVAP funding and infrastructure have
remained relatively unchanged: Services
are paid on a per capita basis, and funds
are managed through three primary
grantees that enter into cooperative
agreements with service providers
(subrecipients). Given the changing
landscape and the greater understanding
of the nature and extent of trafficking,
HHS is undertaking a program
assessment to understand whether any
efficiencies can be gained in the
program administration and structure.
Building on an earlier fiscal year 2018
assessment to solicit qualitative
feedback from a range of program
stakeholders, the information collected
for this program survey aims to help
HHS determine if efficiencies can be
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Federal Register / Vol. 83, No. 43 / Monday, March 5, 2018 / Notices
gained through improved coordination
among TVAP grantees, TVAP
subrecipients, and other service
providers.
The data collected and analyzed
under this submission will help HHS
better understand the type and extent of
the relationships between the TVAP
grantees, TVAP subrecipients, and other
service providers operating in TVAP
subrecipient areas. This information
will enable HHS to understand the
structure of the grantee/subrecipient
network and inform recommendations
for more efficient network management
and distribution of support.
Data will be collected through an
electronic survey of fiscal year 2016
TVAP grantees and subrecipients. Key
staff at grantee sites and subrecipient
organizations will complete a selfadministered online survey that will
include questions for each respondent
about services for which referrals are
made, estimated costs of services,
service coordination between grantees
or subrecipients, and type and strength
of relationships between grantees and
subrecipients. With this data, ICFwill
build a social/organizational network
for HHS to depict how grantee and
subrecipient organizations collaborate
with one another through TVAP to
better understand the existing network
and identify potential opportunities for
improving the efficiency of the network.
ASPE anticipates completion of all data
collection activities by October 2018.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Number of
responses
per
respondents
Average
burden per
response
Total burden
hours
Forms
Respondents
TVAP Network Survey ......................
TVAP Network Survey ......................
TVAP grantees .................................
TVAP subrecipients ..........................
3
253
1
1
45/60
45/60
2.25
189.75
Total ...........................................
...........................................................
256
........................
........................
192
Terry S. Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2018–04386 Filed 3–2–18; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Closed Meetings
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
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 materials,
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: National Library of
Medicine Special Emphasis Panel; COI/
Career Award.
Date: March 23, 2018.
Time: 12:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine/Center
for Scientific Review, 6701 Rockledge Drive,
Room 2141, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Zoe E. Huang, MD,
Scientific Review Officer, Extramural
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Programs, National Library of Medicine, NIH,
6705 Rockledge Drive, Suite 301, Bethesda,
MD 20892–7968, 301–594–4937, huangz@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: February 27, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–04346 Filed 3–2–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office Of The Director, National
Institutes Of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Office of AIDS Research
Advisory Council.
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.
Name of Committee: Office of AIDS
Research Advisory Council.
Date: March 27, 2018.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: OAR Director’s Report; Review of
the DHHS HIV/AIDS Treatment and
Prevention Guidelines; and, updates on the
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NIH AIDS Study Sections, the OAR Task
Force on Cost-Sharing, the FY2020 TransNIH Plan for HIV-Related Research, and on
HIV/AIDS research activities from NIH
Institutes.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892.
Contact Person: Elizabeth S Church, Ph.D.,
Executive Secretary, Office of AIDS Research,
DPCPSI, Office of the Director, 5601 Fishers
Lane, Room 2E–60, Rockville, MD, 20852–
9830, 240–627–3201, elizabeth.church@
nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page:
www.oar.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: February 27, 2018.
Natasha Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–04348 Filed 3–2–18; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)]
[Notices]
[Pages 9325-9326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04386]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-New]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before May 4, 2018.
ADDRESSES: Submit your comments to [email protected] or by calling
202-795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-New-60D and
project title for reference to [email protected] or call the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (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.
Title of the Collection: Trafficking Victim Assistance Program
Social Network Analysis--Network Survey.
Type of Collection: New.
OMB No. 0990-NEW-Office of the Assistant Secretary for Planning and
Evaluation-Administration for Children and Families' Trafficking Victim
Assistance Program
Abstract
The Office of the Assistant Secretary for Planning and Evaluation
(ASPE), in partnership with the Administration for Children and
Families (ACF), U.S. Department of Health and Human Services (HHS) is
requesting Office of Management and Budget (OMB) approval for a new
information collection request, ``Trafficking Victim Assistance Program
(TVAP) Network Survey.'' ICF has been contracted to carry out this
project under the guidance of ASPE and ACF.
TVAP, as authorized by the Trafficking Victims Protection Act of
2000, provides comprehensive case management services to foreign-born
victims of human trafficking residing in the United States. Since its
inception, TVAP funding and infrastructure have remained relatively
unchanged: Services are paid on a per capita basis, and funds are
managed through three primary grantees that enter into cooperative
agreements with service providers (subrecipients). Given the changing
landscape and the greater understanding of the nature and extent of
trafficking, HHS is undertaking a program assessment to understand
whether any efficiencies can be gained in the program administration
and structure. Building on an earlier fiscal year 2018 assessment to
solicit qualitative feedback from a range of program stakeholders, the
information collected for this program survey aims to help HHS
determine if efficiencies can be
[[Page 9326]]
gained through improved coordination among TVAP grantees, TVAP
subrecipients, and other service providers.
The data collected and analyzed under this submission will help HHS
better understand the type and extent of the relationships between the
TVAP grantees, TVAP subrecipients, and other service providers
operating in TVAP subrecipient areas. This information will enable HHS
to understand the structure of the grantee/subrecipient network and
inform recommendations for more efficient network management and
distribution of support.
Data will be collected through an electronic survey of fiscal year
2016 TVAP grantees and subrecipients. Key staff at grantee sites and
subrecipient organizations will complete a self-administered online
survey that will include questions for each respondent about services
for which referrals are made, estimated costs of services, service
coordination between grantees or subrecipients, and type and strength
of relationships between grantees and subrecipients. With this data,
ICFwill build a social/organizational network for HHS to depict how
grantee and subrecipient organizations collaborate with one another
through TVAP to better understand the existing network and identify
potential opportunities for improving the efficiency of the network.
ASPE anticipates completion of all data collection activities by
October 2018.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average
Forms Respondents Number of responses per burden per Total burden
respondents respondents response hours
----------------------------------------------------------------------------------------------------------------
TVAP Network Survey........... TVAP grantees... 3 1 45/60 2.25
TVAP Network Survey........... TVAP 253 1 45/60 189.75
subrecipients.
---------------------------------------------------------------
Total..................... ................ 256 .............. .............. 192
----------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2018-04386 Filed 3-2-18; 8:45 am]
BILLING CODE 4150-05-P
