Proposed Collection; 60-Day Comment Request; Continuation of Use of the Early Career Reviewer Program Online Application and Vetting System-Center for Scientific Review (CSR), 96020-96021 [2016-31543]
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96020
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
contain any recommendations that
exceed the requirements in those
regulations. FDA has estimated the
information collection requirements
resulting from the preparation and
submission of an IND under part 312,
and OMB has approved the reporting
and recordkeeping burden under OMB
control number 0910–0014.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Continuation of Use of the
Early Career Reviewer Program Online
Application and Vetting System—
Center for Scientific Review (CSR)
National Institutes of Health,
HHS.
ACTION:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Monica Basco, Early Career
Reviewer Program Coordinator, Center
for Scientific Review, 6701 Rockledge
Drive, Room 3030, Bethesda, Maryland
20892 or call non-toll-free number
(301)–300–3839 or Email your request,
including your address to:
CSRearlyCareerReviewer@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Early
Career Reviewer Program Online
Application and Vetting System—
Center for Scientific Review (CSR),
0925—Extension of Information
Collection Request, Center for Scientific
Review (CSR), National Institutes of
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–31627 Filed 12–28–16; 8:45 am]
AGENCY:
Health (NIH) (OMB Control Number:
0925–0695; Expiration: 04/30/2017).
Need and Use of Information
Collection: The Center for Scientific
Review (CSR) is the portal for NIH grant
applications and their review for
scientific merit. Our mission is to see
that NIH grant applications receive fair,
independent, expert, and timely
reviews—free from inappropriate
influences—so NIH can fund the most
promising research. To accomplish this
goal, Scientific Review Officers (SRO)
form study sections consisting of
scientists who have the technical and
scientific expertise to evaluate the merit
of grant applications. Study section
members are generally scientists who
have established independent programs
of research as demonstrated by their
publications and their grant award
experiences.
The CSR Early Career Reviewer
program was developed to identify and
train qualified scientists who are early
in their scientific careers and who have
not had prior CSR review experience.
The goals of the program are to expose
these early career scientists to the peer
review experience so that they become
more competitive as applicants as well
as to enrich the existing pool of NIH
reviewers. Currently, online application
software, the Early Career Reviewer
Application and Vetting System, is
accessed online by applicants to the
Early Career Reviewer Program who
provide their names, contact
information, a description of their areas
of expertise, their study section
preferences, professional Curriculum
Vitae and links to their professional
Web site. This Information Collection
Request (ICR) is to continue to use the
Early Career Reviewer Application and
Vetting System to process applications
for the Early Career Reviewer program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
450.
within 60 days of the date of this
publication.
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects,
Center for Scientific Review, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
SUMMARY:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hour
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Applicants ........................................................................................................
1,080
1
25/60
450
Total ..........................................................................................................
1,080
1,080
........................
450
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29DEN1
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
Dated: December 21, 2016.
Joanna Bare,
Executive Officer, Division of Management
Services, Center for Scientific Review, NIH.
[FR Doc. 2016–31543 Filed 12–28–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the National Vaccine Advisory
Committee (NVAC). The meeting will be
open to the public; public comment
sessions will be held during the
meeting.
SUMMARY:
The meeting will be held on
February 7 and 8, 2017. The meeting
times and agenda will be posted on the
NVAC Web site at https://www.hhs.gov/
nvpo/nvac/meetings/ as soon
as they become available.
ADDRESSES: Pre-registration is required
for members of the public who wish to
attend the meeting and who wish to
participate in the public comment
session. Individuals who wish to attend
the meeting and/or participate in the
public comment session should register
at https://www.hhs.gov/nvpo/nvac/
meetings/. Participants may
also register by emailing nvpo@hhs.gov
or by calling (202) 690–5566 and
providing their name, organization, and
email address.
U.S. Department of Health and Human
Services, Hubert H. Humphrey
Building, Great Hall, 200
Independence Avenue SW.,
Washington, DC 20201.
The meeting can also be accessed
through a live webcast on both days of
the meeting. For more information, visit
https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT:
National Vaccine Program Office, U.S.
Department of Health and Human
Services, Room 715H, Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Washington, DC 20201.
Phone: (202) 690–5566; email: nvpo@
hhs.gov.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of Health and Human Services
was mandated to establish the National
Vaccine Program to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccines. The NVAC was
established to provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
During the February 2017 NVAC
meeting, there will be a discussion of
the 21st Century Cures Act and
vaccines; an update on the recent
mumps outbreaks in the US;
presentations on Zika virus disease and
the status of Zika vaccine development;
presentations on vaccine adverse events
and insights from personalized
medicine; and the NVAC’s Mid-course
Review Working Group will present its
findings and draft recommendations for
deliberation and vote by the Committee.
Please note that agenda items are subject
to change as priorities dictate.
Information on the final meeting agenda
will be posted prior to the meeting on
the NVAC Web site: https://
www.hhs.gov/nvpo/nvac/.
Public attendance at the meeting is
limited to the available space.
Individuals who plan to attend in
person and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the National Vaccine
Program Office at the address/phone
listed above at least one week prior to
the meeting. For those unable to attend
in person, a live webcast will be
available. More information on
registration and accessing the webcast
can be found at https://www.hhs.gov/
nvpo/nvac/meetings/.
Members of the public will have the
opportunity to provide comments at the
NVAC meeting during the public
comment periods designated on the
agenda. Public comments made during
the meeting will be limited to three
minutes per person to ensure time is
allotted for all those wishing to speak.
Individuals are also welcome to submit
their written comments. Written
comments should not exceed three
pages in length. Individuals submitting
written comments should email their
comments to the National Vaccine
Program Office (nvpo@hhs.gov) at least
five business days prior to the meeting.
SUPPLEMENTARY INFORMATION:
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96021
Dated: December 21, 2016.
Bruce Gellin,
Designated Federal Officer, National Vaccine
Advisory Committee, Deputy Assistant
Secretary for Health.
[FR Doc. 2016–31530 Filed 12–28–16; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of a meeting of the NIH
Clinical Center Research Hospital
Board.
The meeting will be open to the
public as indicated below, 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 portions of the meeting devoted
to the Anonymous Safety Hotline and
the laboratories or units and staff
involved in the individual reports to the
Hotline, staff, as well as discussions
regarding non-executive employees
holding specific positions in the
Clinical Center will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(9)(B) and 552b(c)(6), Title 5
U.S.C., as amended. Premature
disclosure of the laboratories or units
and staff involved in the individual
reports could significantly limit the
Hotline’s purpose by compromising
anonymity. Discussion of specific nonexecutive employees would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: NIH Clinical Center
Research Hospital Board.
Date: January 13, 2017.
Open: 8:30 a.m. to 12:30 p.m.
Agenda: Board Chair’s Overview, Remarks
from the NIH Director and the New CEO,
Clinical Center Focus Groups, Improving the
Clinical Center’s Census, Clinical Center
Patient and Worker Safety Metrics.
Open: 1:30 p.m. to 3:30 p.m.
Agenda: IT Infrastructure and Security,
Audits of Delayed Reporting—Self-Audit
Results and Formal Audit Planning, Facilities
Update.
Closed: 3:45 p.m. to Adjournment.
Agenda: Anonymous Safety Hotline,
Clinical Center Employees.
E:\FR\FM\29DEN1.SGM
29DEN1
Agencies
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96020-96021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31543]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Continuation of Use
of the Early Career Reviewer Program Online Application and Vetting
System--Center for Scientific Review (CSR)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, Center for Scientific Review, the National
Institutes of Health (NIH) will publish periodic summaries of proposed
projects to be submitted to the Office of Management and Budget (OMB)
for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Dr. Monica
Basco, Early Career Reviewer Program Coordinator, Center for Scientific
Review, 6701 Rockledge Drive, Room 3030, Bethesda, Maryland 20892 or
call non-toll-free number (301)-300-3839 or Email your request,
including your address to: CSRearlyCareerReviewer@mail.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Early Career Reviewer Program Online
Application and Vetting System--Center for Scientific Review (CSR),
0925--Extension of Information Collection Request, Center for
Scientific Review (CSR), National Institutes of Health (NIH) (OMB
Control Number: 0925-0695; Expiration: 04/30/2017).
Need and Use of Information Collection: The Center for Scientific
Review (CSR) is the portal for NIH grant applications and their review
for scientific merit. Our mission is to see that NIH grant applications
receive fair, independent, expert, and timely reviews--free from
inappropriate influences--so NIH can fund the most promising research.
To accomplish this goal, Scientific Review Officers (SRO) form study
sections consisting of scientists who have the technical and scientific
expertise to evaluate the merit of grant applications. Study section
members are generally scientists who have established independent
programs of research as demonstrated by their publications and their
grant award experiences.
The CSR Early Career Reviewer program was developed to identify and
train qualified scientists who are early in their scientific careers
and who have not had prior CSR review experience. The goals of the
program are to expose these early career scientists to the peer review
experience so that they become more competitive as applicants as well
as to enrich the existing pool of NIH reviewers. Currently, online
application software, the Early Career Reviewer Application and Vetting
System, is accessed online by applicants to the Early Career Reviewer
Program who provide their names, contact information, a description of
their areas of expertise, their study section preferences, professional
Curriculum Vitae and links to their professional Web site. This
Information Collection Request (ICR) is to continue to use the Early
Career Reviewer Application and Vetting System to process applications
for the Early Career Reviewer program.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 450.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Applicants...................................... 1,080 1 25/60 450
---------------------------------------------------------------
Total....................................... 1,080 1,080 .............. 450
----------------------------------------------------------------------------------------------------------------
[[Page 96021]]
Dated: December 21, 2016.
Joanna Bare,
Executive Officer, Division of Management Services, Center for
Scientific Review, NIH.
[FR Doc. 2016-31543 Filed 12-28-16; 8:45 am]
BILLING CODE 4140-01-P