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), 58522-58523 [2016-20344]

Download as PDF 58522 Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices thinking of FDA on human food byproducts for use as animal food. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 507 have been approved under OMB control number 0910–0789. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: August 19, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016–20302 Filed 8–24–16; 8:45 am] BILLING CODE 4164–01–P 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) National Institutes of Health, Department of Health and Human Services. AGENCY: ACTION: Notice. 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. Exposurerelated 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. 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, OIRA_submission@omb.eop.gov 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 nontoll-free number (240)-276–7371 or email your request, including your address to: ssimon@mail.nih.gov. 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. SUMMARY: ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Frequency of response Average time per response (in hours) Annual burden hours asabaliauskas on DSK3SPTVN1PROD with NOTICES Type of respondents Instrument Individuals ......................................... Screener ........................................... Consent Form .................................. Focus Groups ................................... Pre-Focus Group Guide ................... Key Informant and Academic Interview. 315 210 168 168 42 1 1 1 1 1 10/60 10/60 120/60 10/60 120/60 53 35 336 28 84 Totals ......................................... ........................................................... 210 525 ........................ 536 VerDate Sep<11>2014 18:54 Aug 24, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\25AUN1.SGM 25AUN1 Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Meeting asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 Board of Scientific Counselors, NIA. 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 meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE ON AGING, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, NIA. Date: October 11–13, 2016. Closed: October 11, 2016, 8:00 a.m. to 8:20 a.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Open: October 11, 2016, 8:20 a.m. to 11:50 a.m. Agenda: Committee discussion, individual presentations, laboratory overview. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 11, 2016, 11:50 a.m. to 1:05 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor VerDate Sep<11>2014 18:54 Aug 24, 2016 Jkt 238001 Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Open: October 11, 2016, 1:05 p.m. to 4:05 p.m. Agenda: Committee discussion, individual presentations, laboratory overview. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Open: October 11, 2016, 4:05 p.m. to 5:45 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 12, 2016, 8:00 a.m. to 8:20 a.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Open: October 12, 2016, 8:20 a.m. to 11:50 a.m. Agenda: Committee discussion, individual presentations, laboratory overview. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 12, 2016, 11:50 a.m. to 1:05 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Open: October 12, 2016, 1:05 p.m. to 3:05 p.m. Agenda: Committee discussion, individual presentations, laboratory overview. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 12, 2016, 3:05 p.m. to 3:55 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 12, 2016, 3:55 p.m. to 4:55 p.m. Agenda: Committee discussion, individual presentations, laboratory overview. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 12, 2016, 4:55 p.m. to 5:55 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 58523 Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 13, 2016, 8:00 a.m. to 8:20 a.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Open: October 13, 2016, 8:20 a.m. to 11:50 a.m. Agenda: Committee discussion, individual presentations, laboratory overview. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Closed: October 13, 2016, 11:50 a.m. to 12:50 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institute on Aging, Biomedical Research Center, 3rd Floor Conference Room, 251 Bayview Boulevard, Baltimore, MD 21224. Contact Person: Luigi Ferrucci, Ph.D., MD, Scientific Director, National Institute on Aging, 251 Bayview Boulevard, Suite 100, Room 4C225, Baltimore, MD 21224, 410– 558–8110, LF27Z@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 19, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–20347 Filed 8–24–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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. E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58522-58523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
OIRA_submission@omb.eop.gov 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: 
ssimon@mail.nih.gov.

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
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