2016-20344. 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, [e-mail] 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: [e-mail].

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

Type of respondents	Instrument	Number of respondents	Frequency of response	Average time per response (in hours)	Annual burden 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 Guide	168	1	10/60	28
	Key Informant and Academic Interview	42	1	120/60	84
Totals		210	525		536

Dated: August 19, 2016.

Karla Bailey,

Project Clearance Liaison, National Cancer Institute, NIH.