Proposed Collection; 60-Day Comment Request; National Toxicology Program (NTP) Level of Concern Categories Study (NIEHS), 50298-50299 [2015-20474]
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50298
Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
While many clinical studies are
registered and submit results
information voluntarily, FDAAA
requires the registration of certain
applicable clinical trials of drugs and
devices and the submission of results
information for completed applicable
clinical trials of drugs and devices that
are approved, licensed, or cleared by the
Food and Drug Administration.
Beginning in 2009, results information
was required to include information
NIH is continuing to review submitted
public comments as it prepares the final
rule. The NIH will make any
corresponding changes to the
ClinicalTrials.gov information
collection via separate procedure.
OMB approval is requested for 3
years. There are no costs to respondents
other than there their time. The total
estimated annualized burden hours are
682,535.
about serious and frequent adverse
events.
This extension request does not
include any changes to the information
submission requirements for
ClinicalTrials.gov that were proposed in
the Notice of Proposed Rulemaking on
Clinical Trial Registration and Results
Submission that was issued on
November 21, 2014 and for which the
public comment period closed on March
23, 2015 (79 FR 225, Nov. 21, 2014). The
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Submission type
PRS Account ...................................................................................................
Initial Registration ............................................................................................
Updates ............................................................................................................
Initial Results ...................................................................................................
Updates ............................................................................................................
Certification to Delay Results ..........................................................................
Extension Request ...........................................................................................
Dated: August 13, 2015.
David Sharlip,
Project Clearance Liaison, NLM, NIH.
[FR Doc. 2015–20473 Filed 8–18–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
Proposed Collection; 60-Day Comment
Request; National Toxicology Program
(NTP) Level of Concern Categories
Study (NIEHS)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Environmental
Health Sciences (NIEHS), 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.
Written comments and/or suggestions
from the public and affected agencies
are invited on 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
VerDate Sep<11>2014
19:14 Aug 18, 2015
Jkt 235001
5,700
23,000
23,000
3,700
3,700
700
30
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.
To Submit Comments and for Further
Information: 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. Kristina Thayer,
Director of the Office of Health
Assessment and Translation, Division of
National Toxicology Program, NIEHS,
P.O. Box 12233, Mail Drop K2–04,
Research Triangle Park, NC 27709, or
call non-toll-free number (919) 541–
5021, or Email your request, including
your address to: thayer@niehs.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
8
1
2
1
1
Average time
per response
(in hours)
15/60
7
2
25
8
30/60
2
Total annual
hour burden
1,425
161,000
368,000
92,500
59,200
350
60
Proposed Collection: National
Toxicology Program Level of Concern
Categories, 0925–NEW, National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Toxicology
Program (NTP) has used a 5-point level
of concern (LoC) framework to
communicate NTP’s assessment of the
degree of concern regarding the
potential human health effects of
selected substances given what is
known about their toxicity, level of
human exposure, and pharmacokinetics.
As part of its systematic review
methodologies, the NTP is updating its
LoC framework to enhance transparency
in what the LoC categories mean,
describing the factors considered in
reaching conclusions and identifying
strategies for improving their use as a
risk communication tool. This study
will use expert solicitation from five
NTP stakeholder sectors (academia,
industry, non-government
organizations, and federal and state
agencies) to aid in determining the
optimal number of LoC categories for an
updated LoC framework.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
300.
E:\FR\FM\19AUN1.SGM
19AUN1
50299
Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Type of respondent
Number
of respondents
Number of
responses per
respondent
Average burden
per response
(in hours)
Total annual
burden hour
LoC ‘‘Cards’’ ....................................................
Experts .......................
200
2
90/60
600
Dated: August 11, 2015.
Joellen M. Austin,
Associate Director for Management, NIEHS,
NIH.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–20474 Filed 8–18–15; 8:45 am]
National Human Genome Research
Institute; Notice of Closed Meeting
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging: Notice of
Closed Meeting
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 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 material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
tkelley on DSK3SPTVN1PROD with NOTICES
Name of Committee: National Institute on
Aging Initial Review Group; Neuroscience of
Aging Review Committee.
Date: October 1–2, 2015.
Time: 8 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Jeannette L. Johnson,
Deputy Review Branch Chief, National
Institutes of Health, National Institute on
Aging, Gateway Building, Bethesda, MD
20892, 301–402–7705, johnsonj9@
nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 13, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–20453 Filed 8–18–15; 8:45 am]
BILLING CODE 4140–01–P
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19:14 Aug 18, 2015
Jkt 235001
National Institutes of Health
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 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 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 Inherited
Disease Research Access Committee.
Date: September 17–18, 2015.
Time: 5 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Camilla E. Day, Ph.D.,
Scientific Review Officer, CIDR, National
Human Genome Research Institute, National
Institutes of Health, 5635 Fishers Lane, Suite
4075, Bethesda, MD 20892, 301–402–8837,
camilla.day@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: August 13, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–20451 Filed 8–18–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
amended (5 U.S.C. App.), 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 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: National Institute on
Aging Special Emphasis Panel; Integrative
Perspectives in Early Life.
Date: September 21, 2015.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Carmen Moten, Ph.D.,
MPH., National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7703,
cmoten@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 13, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–20452 Filed 8–18–15; 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 (5 U.S.C. App.), notice is
hereby given of a meeting of the
Recombinant DNA Advisory Committee.
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
E:\FR\FM\19AUN1.SGM
19AUN1
]]>Agencies
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50298-50299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20474]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; National Toxicology
Program (NTP) Level of Concern Categories Study (NIEHS)
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity
for public comment on proposed data collection projects, the National
Institute of Environmental Health Sciences (NIEHS), 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.
Written comments and/or suggestions from the public and affected
agencies are invited on 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.
To Submit Comments and for Further Information: 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.
Kristina Thayer, Director of the Office of Health Assessment and
Translation, Division of National Toxicology Program, NIEHS, P.O. Box
12233, Mail Drop K2-04, Research Triangle Park, NC 27709, or call non-
toll-free number (919) 541-5021, or Email your request, including your
address to: thayer@niehs.nih.gov. Formal requests for additional plans
and instruments must be requested in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: National Toxicology Program Level of Concern
Categories, 0925-NEW, National Institute of Environmental Health
Sciences (NIEHS), National Institutes of Health (NIH).
Need and Use of Information Collection: The National Toxicology
Program (NTP) has used a 5-point level of concern (LoC) framework to
communicate NTP's assessment of the degree of concern regarding the
potential human health effects of selected substances given what is
known about their toxicity, level of human exposure, and
pharmacokinetics. As part of its systematic review methodologies, the
NTP is updating its LoC framework to enhance transparency in what the
LoC categories mean, describing the factors considered in reaching
conclusions and identifying strategies for improving their use as a
risk communication tool. This study will use expert solicitation from
five NTP stakeholder sectors (academia, industry, non-government
organizations, and federal and state agencies) to aid in determining
the optimal number of LoC categories for an updated LoC framework.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 300.
[[Page 50299]]
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of respondent Number of responses per per response (in Total annual
respondents respondent hours) burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
LoC ``Cards''................................. Experts......................... 200 2 90/60 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: August 11, 2015.
Joellen M. Austin,
Associate Director for Management, NIEHS, NIH.
[FR Doc. 2015-20474 Filed 8-18-15; 8:45 am]
BILLING CODE 4140-01-P
