81 FR 58522 - Submission for OMB Review; 30-Day Comment Request Study To Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test-National Cancer Institute (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 165 (August 25, 2016)

Page Range		58522-58523
FR Document		2016-20344

In compliance with the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 13, 2016, p 29875 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

Federal Register, Volume 81 Issue 165 (Thursday, August 25, 2016)

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58522-58523]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20344]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Study To 
Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From 
the Trinity Nuclear Test--National Cancer Institute (NCI)

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Cancer Institute, the National Institutes of Health, has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on May 13, 2016, p 29875 and allowed 60-days for public 
comment. One public comment was received. The purpose of this notice is 
to allow an additional 30 days for public comment.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Steven L. Simon, Dosimetry Unit Head and Staff 
Scientist, Radiation Epidemiology Branch, Division of Cancer 
Epidemiology & Genetics, National cancer Institute, NIH, 9609 Medical 
Center Drive, MSC9778, Bethesda, MD 20892-9778 or call non-toll-free 
number (240)-276-7371 or email your request, including your address to: 
[email protected].

SUPPLEMENTARY INFORMATION: The National Cancer Institute, NCI, National 
Institutes of Health, may not conduct or sponsor, and the respondent is 
not required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.
    In compliance with section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: Study to Estimate Radiation Doses and Cancer 
Risks from Radioactive Fallout from the Trinity Nuclear Test, 0925-NEW, 
National Cancer Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This Information Collection 
Request is for a radiation-related cancer risk projection study for the 
residents of the state of New Mexico (NM) potentially exposed to 
radioactive fallout from the Trinity nuclear test conducted in 1945. 
Data will be collected on diet and lifestyle from three groups in NM 
(non-Hispanic white, Hispanic, and Native American) alive in the 1940s 
via focus groups and key informant interviews. These data will be used 
to derive means and ranges of exposure-related parameters. Little 
information is currently available about dietary patterns among Native 
American community members or Hispanics in New Mexico in the 1940s. 
Exposure-related parameter values will be used with historical fallout 
deposition data in fallout dose assessment models to estimate external 
and internal radiation doses to representative persons in all counties 
in New Mexico by ethnicity and age. The estimated doses will be used 
with literature-derived risk and parameter values on risk/unit dose to 
project the excess cancers expected (per 1,000 persons within each 
stratum) including uncertainty on each estimate. Endpoints are 
leukemia, thyroid cancer, stomach cancer, colon cancer, and all solid 
cancers combined.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 536.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
      Type of respondents          Instrument        Number of     Frequency of    per response    Annual burden
                                                    respondents      response       (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Individuals...................  Screener........             315               1           10/60              53
                                Consent Form....             210               1           10/60              35
                                Focus Groups....             168               1          120/60             336
                                Pre-Focus Group              168               1           10/60              28
                                 Guide.
                                Key Informant                 42               1          120/60              84
                                 and Academic
                                 Interview.
                                                 ---------------------------------------------------------------
    Totals....................  ................             210             525  ..............             536
----------------------------------------------------------------------------------------------------------------



[[Page 58523]]

    Dated: August 19, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-20344 Filed 8-24-16; 8:45 am]
BILLING CODE 4140-01-P

58522 Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices

thinking of FDA on human food by- SUMMARY: In compliance with the In compliance with section
products for use as animal food. It does Paperwork Reduction Act of 1995, the 3507(a)(1)(D) of the Paperwork
not establish any rights for any person National Cancer Institute, the National Reduction Act of 1995, the National
and is not binding on FDA or the public. Institutes of Health, has submitted to the Institutes of Health (NIH) has submitted
You can use an alternative approach if Office of Management and Budget to the Office of management and Budget
it satisfies the requirements of the (OMB) a request for review and (OMB) a request for review and
applicable statutes and regulations. approval of the information collection approval of the information collection
listed below. This proposed information listed below.
III. Paperwork Reduction Act of 1995 collection was previously published in Proposed Collection: Study to
This draft guidance refers to the Federal Register on May 13, 2016, Estimate Radiation Doses and Cancer
previously approved collections of p 29875 and allowed 60-days for public Risks from Radioactive Fallout from the
information found in FDA regulations. comment. One public comment was Trinity Nuclear Test, 0925–NEW,
These collections of information are received. The purpose of this notice is National Cancer Institute (NCI),
subject to review by the Office of to allow an additional 30 days for public National Institutes of Health (NIH).
Management and Budget (OMB) under comment. Need and Use of Information
the Paperwork Reduction Act of 1995 DATES: Comments regarding this Collection: This Information Collection
(44 U.S.C. 3501–3520). The collections information collection are best assured Request is for a radiation-related cancer
of information in 21 CFR part 507 have of having their full effect if received risk projection study for the residents of
been approved under OMB control within 30-days of the date of this the state of New Mexico (NM)
number 0910–0789. publication potentially exposed to radioactive
ADDRESSES: Written comments and/or fallout from the Trinity nuclear test
IV. Electronic Access
suggestions regarding the item(s) conducted in 1945. Data will be
Persons with access to the Internet contained in this notice, especially collected on diet and lifestyle from three
may obtain the draft guidance at either regarding the estimated public burden groups in NM (non-Hispanic white,
http://www.fda.gov/AnimalVeterinary/ and associated response time, should be Hispanic, and Native American) alive in
GuidanceComplianceEnforcement/ directed to the: Office of Management the 1940s via focus groups and key
GuidanceforIndustry/default.htm or and Budget, Office of Regulatory Affairs, informant interviews. These data will be
http://www.regulations.gov. OIRA_submission@omb.eop.gov or by used to derive means and ranges of
fax to 202–395–6974, Attention: Desk exposure-related parameters. Little
Dated: August 19, 2016.
Officer for NIH. information is currently available about
Jeremy Sharp,
FOR FURTHER INFORMATION CONTACT: To dietary patterns among Native American
Deputy Commissioner for Policy, Planning, community members or Hispanics in
request more information on the
Legislation, and Analysis.
proposed project or to obtain a copy of New Mexico in the 1940s. Exposure-
[FR Doc. 2016–20302 Filed 8–24–16; 8:45 am] related parameter values will be used
the data collection plans and
BILLING CODE 4164–01–P
instruments, contact: Steven L. Simon, with historical fallout deposition data in
Dosimetry Unit Head and Staff Scientist, fallout dose assessment models to
Radiation Epidemiology Branch, estimate external and internal radiation
DEPARTMENT OF HEALTH AND Division of Cancer Epidemiology & doses to representative persons in all
HUMAN SERVICES Genetics, National cancer Institute, NIH, counties in New Mexico by ethnicity
National Institutes of Health 9609 Medical Center Drive, MSC9778, and age. The estimated doses will be
Bethesda, MD 20892–9778 or call non- used with literature-derived risk and
Submission for OMB Review; 30-Day toll-free number (240)-276–7371 or parameter values on risk/unit dose to
Comment Request Study To Estimate email your request, including your project the excess cancers expected (per
Radiation Doses and Cancer Risks address to: ssimon@mail.nih.gov. 1,000 persons within each stratum)
From Radioactive Fallout From the SUPPLEMENTARY INFORMATION: The including uncertainty on each estimate.
Trinity Nuclear Test—National Cancer National Cancer Institute, NCI, National Endpoints are leukemia, thyroid cancer,
Institute (NCI) Institutes of Health, may not conduct or stomach cancer, colon cancer, and all
sponsor, and the respondent is not solid cancers combined.
AGENCY: National Institutes of Health, required to respond to, an information OMB approval is requested for 3
Department of Health and Human collection that has been extended, years. There are no costs to respondents
Services. revised, or implemented on or after other than their time. The total
October 1, 1995, unless it displays a estimated annualized burden hours are
ACTION: Notice.
currently valid OMB control number. 536.

ESTIMATED ANNUALIZED BURDEN HOURS
Average time
Number of Frequency of Annual burden
Type of respondents Instrument per response
respondents response hours
(in hours)
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Individuals ......................................... Screener ........................................... 315 1 10/60 53
Consent Form .................................. 210 1 10/60 35
Focus Groups ................................... 168 1 120/60 336
Pre-Focus Group Guide ................... 168 1 10/60 28
Key Informant and Academic Inter- 42 1 120/60 84
view.

Totals ......................................... ........................................................... 210 525 ........................ 536

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Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices 58523

Dated: August 19, 2016. Conference Room, 251 Bayview Boulevard, Place: National Institute on Aging,
Karla Bailey, Baltimore, MD 21224. Biomedical Research Center, 3rd Floor
Open: October 11, 2016, 1:05 p.m. to 4:05 Conference Room, 251 Bayview Boulevard,
Project Clearance Liaison, National Cancer
p.m. Baltimore, MD 21224.
Institute, NIH.
Agenda: Committee discussion, individual Closed: October 13, 2016, 8:00 a.m. to 8:20
[FR Doc. 2016–20344 Filed 8–24–16; 8:45 am]
presentations, laboratory overview. a.m.
BILLING CODE 4140–01–P Place: National Institute on Aging, Agenda: To review and evaluate personal
Biomedical Research Center, 3rd Floor qualifications and performance, and
Conference Room, 251 Bayview Boulevard, competence of individual investigators.
DEPARTMENT OF HEALTH AND Baltimore, MD 21224. Place: National Institute on Aging,
HUMAN SERVICES Open: October 11, 2016, 4:05 p.m. to 5:45 Biomedical Research Center, 3rd Floor
p.m. Conference Room, 251 Bayview Boulevard,
National Institutes of Health Agenda: To review and evaluate personal Baltimore, MD 21224.
qualifications and performance, and Open: October 13, 2016, 8:20 a.m. to 11:50
National Institute on Aging; Notice of competence of individual investigators. a.m.
Meeting Place: National Institute on Aging, Agenda: Committee discussion, individual
Biomedical Research Center, 3rd Floor presentations, laboratory overview.
Pursuant to section 10(d) of the Conference Room, 251 Bayview Boulevard, Place: National Institute on Aging,
Federal Advisory Committee Act, as Baltimore, MD 21224. Biomedical Research Center, 3rd Floor
amended (5 U.S.C. App.), notice is Closed: October 12, 2016, 8:00 a.m. to 8:20 Conference Room, 251 Bayview Boulevard,
hereby given of a meeting of the Board a.m. Baltimore, MD 21224.
of Scientific Counselors, NIA. Agenda: To review and evaluate personal
Closed: October 13, 2016, 11:50 a.m. to
The meeting will be open to the qualifications and performance, and
12:50 p.m.
public as indicated below, with competence of individual investigators.
Agenda: To review and evaluate personal
Place: National Institute on Aging,
attendance limited to space available. Biomedical Research Center, 3rd Floor
qualifications and performance, and
Individuals who plan to attend and Conference Room, 251 Bayview Boulevard, competence of individual investigators.
need special assistance, such as sign Baltimore, MD 21224. Place: National Institute on Aging,
language interpretation or other Biomedical Research Center, 3rd Floor
Open: October 12, 2016, 8:20 a.m. to 11:50 Conference Room, 251 Bayview Boulevard,
reasonable accommodations, should a.m. Baltimore, MD 21224.
notify the Contact Person listed below Agenda: Committee discussion, individual Contact Person: Luigi Ferrucci, Ph.D., MD,
in advance of the meeting. presentations, laboratory overview.
Scientific Director, National Institute on
The meeting will be closed to the Place: National Institute on Aging,
Aging, 251 Bayview Boulevard, Suite 100,
public as indicated below in accordance Biomedical Research Center, 3rd Floor
Room 4C225, Baltimore, MD 21224, 410–
Conference Room, 251 Bayview Boulevard,
with the provisions set forth in section Baltimore, MD 21224.
558–8110, LF27Z@nih.gov.
552b(c)(6), Title 5 U.S.C., as amended (Catalogue of Federal Domestic Assistance
Closed: October 12, 2016, 11:50 a.m. to
for the review, discussion, and 1:05 p.m. Program Nos. 93.866, Aging Research,
evaluation of individual intramural Agenda: To review and evaluate personal National Institutes of Health, HHS)
programs and projects conducted by the qualifications and performance, and
Dated: August 19, 2016.
NATIONAL INSTITUTE ON AGING, competence of individual investigators.
including consideration of personnel Place: National Institute on Aging, Melanie J. Gray,
qualifications and performance, and the Biomedical Research Center, 3rd Floor Program Analyst, Office of Federal Advisory
competence of individual investigators, Conference Room, 251 Bayview Boulevard, Committee Policy.
Baltimore, MD 21224. [FR Doc. 2016–20347 Filed 8–24–16; 8:45 am]
the disclosure of which would
constitute a clearly unwarranted Open: October 12, 2016, 1:05 p.m. to 3:05 BILLING CODE 4140–01–P
p.m.
invasion of personal privacy.
Agenda: Committee discussion, individual
Name of Committee: Board of Scientific presentations, laboratory overview. DEPARTMENT OF HEALTH AND
Counselors, NIA. Place: National Institute on Aging,
Date: October 11–13, 2016. Biomedical Research Center, 3rd Floor
HUMAN SERVICES
Closed: October 11, 2016, 8:00 a.m. to 8:20 Conference Room, 251 Bayview Boulevard,
a.m. Baltimore, MD 21224. National Institutes of Health
Agenda: To review and evaluate personal Closed: October 12, 2016, 3:05 p.m. to 3:55
qualifications and performance, and National Institute of General Medical
p.m.
competence of individual investigators. Sciences; Notice of Closed Meeting
Agenda: To review and evaluate personal
Place: National Institute on Aging, qualifications and performance, and
Biomedical Research Center, 3rd Floor Pursuant to section 10(d) of the
competence of individual investigators.
Conference Room, 251 Bayview Boulevard, Place: National Institute on Aging,
Federal Advisory Committee Act, as
Baltimore, MD 21224. Biomedical Research Center, 3rd Floor amended (5 U.S.C. App.), notice is
Open: October 11, 2016, 8:20 a.m. to 11:50 Conference Room, 251 Bayview Boulevard, hereby given of the following meeting.
a.m. Baltimore, MD 21224. The meeting will be closed to the
Agenda: Committee discussion, individual Closed: October 12, 2016, 3:55 p.m. to 4:55 public in accordance with the
presentations, laboratory overview. p.m. provisions set forth in sections
Place: National Institute on Aging, Agenda: Committee discussion, individual 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Biomedical Research Center, 3rd Floor presentations, laboratory overview. as amended. The grant applications and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Conference Room, 251 Bayview Boulevard, Place: National Institute on Aging, the discussions could disclose
Baltimore, MD 21224. Biomedical Research Center, 3rd Floor
Conference Room, 251 Bayview Boulevard,
confidential trade secrets or commercial
Closed: October 11, 2016, 11:50 a.m. to property such as patentable material,
1:05 p.m. Baltimore, MD 21224.
Agenda: To review and evaluate personal Closed: October 12, 2016, 4:55 p.m. to 5:55
and personal information concerning
qualifications and performance, and p.m. individuals associated with the grant
competence of individual investigators. Agenda: To review and evaluate personal applications, the disclosure of which
Place: National Institute on Aging, qualifications and performance, and would constitute a clearly unwarranted
Biomedical Research Center, 3rd Floor competence of individual investigators. invasion of personal privacy.

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Document Created: 2016-08-25 00:34:37
Document Modified: 2016-08-25 00:34:37

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
Action		Notice.
Dates		Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication
Contact		To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Steven L. Simon, Dosimetry Unit Head and Staff Scientist, Radiation Epidemiology Branch, Division of Cancer Epidemiology & Genetics, National cancer Institute, NIH, 9609 Medical Center Drive, MSC9778, Bethesda, MD 20892-9778 or call non-toll-free
FR Citation		81 FR 58522

81 FR 58522 - Submission for OMB Review; 30-Day Comment Request Study To Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test-National Cancer Institute (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 165 (August 25, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health