30 Day FRN

Billing Code: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-15-14ATA]

Agency Forms Undergoing Paperwork Reduction Act Review

The Agency for Toxic Substances and Disease Registry (ATSDR) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

Proposed Project

Biomonitoring of Great Lakes Populations Program II – New – Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS).

Background and Brief Description

The Great Lakes Basin has suffered decades of pollution and ecosystem damage. Many chemicals persist in Great Lakes sediments, as well as in wildlife and humans. These chemicals can build up in the aquatic food chain. Eating contaminated fish is a known route of human exposure.

In 2009, the Great Lakes Restoration Initiative (GLRI) was enacted by Public Law 111-88. The GLRI FY2010–FY2014 Action Plan makes Great Lakes restoration a national priority for 12 Federal Agencies. The GLRI is led by the U.S. Environmental Protection Agency (US EPA). Under a 2013 interagency agreement with the US EPA, the Agency for Toxic Substances and Disease Registry (ATSDR) announced a funding opportunity called the “Biomonitoring of Great Lakes Populations” (CDC-RFA-TS13-1302).

This applied public health program aims to measure Great Lakes chemicals in human blood and urine. These measures will be a baseline for current and future restoration activities. The measures will be compared to available national estimates. This program also aims to take these measures from people who may be at higher risk of harm from chemical exposures.

This project will provide additional public health information to supplement the FY2010 CDC-RFA-TS10-1001 cooperative agreement program, “Biomonitoring of Great Lakes Populations,” hereafter referred to as “Program I” (OMB Control Number 0923-0044). The purpose of the current announcement is to evaluate body burden levels of priority contaminants in additional Great Lakes residents and susceptible populations who are at highest exposure risk and who are living in an area that was not previously addressed in Program I.

The New York State Department of Health (NYSDOH) received funding for the current program. NYSDOH will look at two subpopulations of adults living in Syracuse, NY, who are known to eat fish from Onondaga Lake. Onondaga Lake is a highly polluted Great Lakes Basin water body in Central New York located northwest of Syracuse. The target subpopulations are: (1) Burmese and Bhutanese refugees who are known to eat a substantial amount of fish from Onondaga Lake (300 people); (2) an urban population who rely on fish from Onondaga Lake as a source of food (100 people). Trained NYSDOH study staff will work closely with local refugee and citizen support organizations to get people to take part in the study. Formative research will be conducted to determine the best method for recruiting these Syracuse populations who eat fish from Onondaga Lake.

All respondents who consent will give blood and urine specimens. Their blood will be tested for polychlorinated biphenyls (PCBs), mercury, lead, cadmium, polybrominated diphenyl ethers (PBDEs), perfluorinated compounds (PFCs), toxaphene, chlordane, oxychlordane and trans-nonachlor, dieldrin, dechlorane plus, omega-3 fatty acids, blood lipids, and pesticides. Pesticides will include mirex, hexachlorobenzene, dichlorodiphenyltrichloroethane (DDT) and dichlorodiphenyldichloroethylene (DDE). Their urine will be tested for creatinine.

Respondents will also be interviewed. They will be asked about demographic and lifestyle factors, hobbies, and types of jobs which can contribute to chemical exposure. Some diet questions will be asked, too, with a focus on eating Great Lakes fish. There is no cost to respondents other than their time spent in the study.

The ATSDR is requesting a two-year OMB approval for a total of 188 burden hours per year. The agency is authorized to conduct this program under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA).

Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden per Response (in hrs.)
Refugees from Burma and Bhutan living in Syracuse, NY	Eligibility Screening Survey	250	1	5/60
	Informed Consent	150	1	1/60
	Interview Questionnaire	150	1	45/60
	Network Size Questions for Respondent Driven Sampling	150	1	5/60
Urban subsistence anglers living in Syracuse, NY	Eligibility Screening Survey	92	1	5/60
	Informed Consent	50	1	1/60
	Interview Questionnaire	50	1	30/60
	Network Size Questions for Respondent Driven Sampling	50	1	5/60

DATE:

______________________________________

Leroy Richardson

Chief, Information Collection Review Office

Office of Scientific Integrity

Office of the Associate Director for Science

Office of the Director

Centers for Disease Control and Prevention

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