80 FR 50298 - Proposed Collection; 60-Day Comment Request; National Toxicology Program (NTP) Level of Concern Categories Study (NIEHS)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 160 (August 19, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 160 (August 19, 2015)
| Page Range | 50298-50299 | |
| FR Document | 2015-20474 |
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)] [Notices] [Pages 50298-50299] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![50298 Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
While many clinical studies are about serious and frequent adverse NIH is continuing to review submitted
registered and submit results events. public comments as it prepares the final
information voluntarily, FDAAA This extension request does not rule. The NIH will make any
requires the registration of certain include any changes to the information corresponding changes to the
applicable clinical trials of drugs and submission requirements for ClinicalTrials.gov information
devices and the submission of results ClinicalTrials.gov that were proposed in collection via separate procedure.
information for completed applicable the Notice of Proposed Rulemaking on
clinical trials of drugs and devices that Clinical Trial Registration and Results OMB approval is requested for 3
are approved, licensed, or cleared by the Submission that was issued on years. There are no costs to respondents
Food and Drug Administration. November 21, 2014 and for which the other than there their time. The total
Beginning in 2009, results information public comment period closed on March estimated annualized burden hours are
was required to include information 23, 2015 (79 FR 225, Nov. 21, 2014). The 682,535.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time
Number of Total annual
Submission type responses per per response
respondents hour burden
respondent (in hours)
PRS Account ................................................................................................... 5,700 1 15/60 1,425
Initial Registration ............................................................................................ 23,000 1 7 161,000
Updates ............................................................................................................ 23,000 8 2 368,000
Initial Results ................................................................................................... 3,700 1 25 92,500
Updates ............................................................................................................ 3,700 2 8 59,200
Certification to Delay Results .......................................................................... 700 1 30/60 350
Extension Request ........................................................................................... 30 1 2 60
Dated: August 13, 2015. practical utility; (2) The accuracy of the Proposed Collection: National
David Sharlip, agency’s estimate of the burden of the Toxicology Program Level of Concern
Project Clearance Liaison, NLM, NIH. proposed collection of information, Categories, 0925–NEW, National
[FR Doc. 2015–20473 Filed 8–18–15; 8:45 am] including the validity of the Institute of Environmental Health
BILLING CODE 4140–01–P methodology and assumptions used; (3) Sciences (NIEHS), National Institutes of
Ways to enhance the quality, utility, and Health (NIH).
clarity of the information to be Need and Use of Information
DEPARTMENT OF HEALTH AND collected; and (4) Ways to minimize the Collection: The National Toxicology
HUMAN SERVICES burden of the collection of information Program (NTP) has used a 5-point level
on those who are to respond, including of concern (LoC) framework to
National Institutes of Health the use of appropriate automated, communicate NTP’s assessment of the
electronic, mechanical, or other degree of concern regarding the
Proposed Collection; 60-Day Comment technological collection techniques or potential human health effects of
Request; National Toxicology Program other forms of information technology. selected substances given what is
(NTP) Level of Concern Categories
To Submit Comments and for Further known about their toxicity, level of
Study (NIEHS)
Information: To obtain a copy of the human exposure, and pharmacokinetics.
Summary: In compliance with the data collection plans and instruments, As part of its systematic review
requirement of Section 3506(c)(2)(A) of submit comments in writing, or request methodologies, the NTP is updating its
the Paperwork Reduction Act of 1995, more information on the proposed LoC framework to enhance transparency
for opportunity for public comment on project, contact: Dr. Kristina Thayer, in what the LoC categories mean,
proposed data collection projects, the Director of the Office of Health describing the factors considered in
National Institute of Environmental Assessment and Translation, Division of reaching conclusions and identifying
Health Sciences (NIEHS), National National Toxicology Program, NIEHS, strategies for improving their use as a
Institutes of Health (NIH), will publish P.O. Box 12233, Mail Drop K2–04, risk communication tool. This study
periodic summaries of proposed Research Triangle Park, NC 27709, or will use expert solicitation from five
projects to be submitted to the Office of call non-toll-free number (919) 541– NTP stakeholder sectors (academia,
Management and Budget (OMB) for 5021, or Email your request, including industry, non-government
review and approval. your address to: thayer@niehs.nih.gov. organizations, and federal and state
Written comments and/or suggestions Formal requests for additional plans and agencies) to aid in determining the
from the public and affected agencies instruments must be requested in optimal number of LoC categories for an
are invited on one or more of the writing. updated LoC framework.
following points: (1) Whether the Comment Due Date: Comments OMB approval is requested for 3
proposed collection of information is regarding this information collection are years. There are no costs to respondents
necessary for the proper performance of best assured of having their full effect if other than their time. The total
the function of the agency, including received within 60 days of the date of estimated annualized burden hours are
tkelley on DSK3SPTVN1PROD with NOTICES
whether the information will have this publication. 300.
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![Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices 50299
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average burden
Number Total annual
Form name Type of respondent responses per per response
of respondents burden hour
respondent (in hours)
LoC ‘‘Cards’’ .................................................... Experts ....................... 200 2 90/60 600
Dated: August 11, 2015. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is
Joellen M. Austin, HUMAN SERVICES hereby given of the following meeting.
Associate Director for Management, NIEHS, The meeting will be closed to the
NIH. National Institutes of Health public in accordance with the
[FR Doc. 2015–20474 Filed 8–18–15; 8:45 am] provisions set forth in sections
National Human Genome Research 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
BILLING CODE 4140–01–P Institute; Notice of Closed Meeting as amended. The grant applications and
the discussions could disclose
Pursuant to section 10(d) of the
DEPARTMENT OF HEALTH AND confidential trade secrets or commercial
Federal Advisory Committee Act, as
HUMAN SERVICES property such as patentable material,
amended (5 U.S.C. App.), notice is
and personal information concerning
hereby given of the following meeting.
National Institutes of Health individuals associated with the grant
The meeting will be closed to the applications, the disclosure of which
National Institute on Aging: Notice of public in accordance with the would constitute a clearly unwarranted
Closed Meeting provisions set forth in sections invasion of personal privacy.
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Name of Committee: National Institute on
Pursuant to section 10(d) of the as amended. The grant applications and Aging Special Emphasis Panel; Integrative
Federal Advisory Committee Act, as the discussions could disclose Perspectives in Early Life.
amended (5 U.S.C. App.), notice is confidential trade secrets or commercial Date: September 21, 2015.
hereby given of the following meeting. property such as patentable material, Time: 1 p.m. to 4 p.m.
and personal information concerning Agenda: To review and evaluate grant
The meeting will be closed to the individuals associated with the grant applications.
public in accordance with the applications, the disclosure of which Place: National Institute on Aging,
provisions set forth in sections would constitute a clearly unwarranted Gateway Building, Suite 2C212, 7201
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy. Wisconsin Avenue, Bethesda, MD 20892,
as amended. The grant applications and (Telephone Conference Call).
Name of Committee: Center for Inherited Contact Person: Carmen Moten, Ph.D.,
the discussions could disclose Disease Research Access Committee. MPH., National Institute on Aging, Gateway
confidential trade secrets or commercial Date: September 17–18, 2015. Building, 7201 Wisconsin Avenue, Suite
property such as patentable material, Time: 5 p.m. to 4 p.m. 2C212, Bethesda, MD 20892, 301–402–7703,
and personal information concerning Agenda: To review and evaluate grant cmoten@mail.nih.gov.
individuals associated with the grant applications. (Catalogue of Federal Domestic Assistance
Place: Embassy Suites at the Chevy Chase Program Nos. 93.866, Aging Research,
applications, the disclosure of which
Pavilion, 4300 Military Road NW., National Institutes of Health, HHS)
would constitute a clearly unwarranted Washington, DC 20015.
invasion of personal privacy. Contact Person: Camilla E. Day, Ph.D., Dated: August 13, 2015.
Name of Committee: National Institute on Scientific Review Officer, CIDR, National Melanie J. Gray,
Aging Initial Review Group; Neuroscience of Human Genome Research Institute, National Program Analyst, Office of Federal Advisory
Institutes of Health, 5635 Fishers Lane, Suite Committee Policy.
Aging Review Committee.
4075, Bethesda, MD 20892, 301–402–8837,
Date: October 1–2, 2015. [FR Doc. 2015–20452 Filed 8–18–15; 8:45 am]
camilla.day@nih.gov.
Time: 8 a.m. to 1 p.m. BILLING CODE 4140–01–P
(Catalogue of Federal Domestic Assistance
Agenda: To review and evaluate grant
Program Nos. 93.172, Human Genome
applications. Research, National Institutes of Health, HHS)
Place: Doubletree Hotel Bethesda, 8120 DEPARTMENT OF HEALTH AND
Wisconsin Avenue, Bethesda, MD 20814. Dated: August 13, 2015. HUMAN SERVICES
Contact Person: Jeannette L. Johnson, Melanie J. Gray,
Deputy Review Branch Chief, National Program Analyst, Office of Federal Advisory National Institutes of Health
Institutes of Health, National Institute on Committee Policy.
Aging, Gateway Building, Bethesda, MD [FR Doc. 2015–20451 Filed 8–18–15; 8:45 am]
Office of the Director, National
20892, 301–402–7705, johnsonj9@ Institutes of Health: Notice of Meeting
BILLING CODE 4140–01–P
nia.nih.gov. Pursuant to section 10(a) of the
(Catalogue of Federal Domestic Assistance Federal Advisory Committee Act, as
Program Nos. 93.866, Aging Research, DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is
National Institutes of Health, HHS) HUMAN SERVICES hereby given of a meeting of the
tkelley on DSK3SPTVN1PROD with NOTICES
Dated: August 13, 2015.
National Institutes of Health Recombinant DNA Advisory Committee.
Melanie J. Gray, The meeting will be open to the
Program Analyst, Office of Federal Advisory National Institute on Aging; Notice of public, with attendance limited to space
Committee Policy. Closed Meeting available. Individuals who plan to
[FR Doc. 2015–20453 Filed 8–18–15; 8:45 am] attend and need special assistance, such
Pursuant to section 10(d) of the as sign language interpretation or other
BILLING CODE 4140–01–P
Federal Advisory Committee Act, as reasonable accommodations, should
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Document Created: 2015-12-15 11:58:31
Document Modified: 2015-12-15 11:58:31
| 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 | |
| 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. | |
| FR Citation | 80 FR 50298 |
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