2012-23203. Proposed Data Collections Submitted for Public Comment and Recommendations

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 Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 and send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Anniston Community Health Survey: Follow-up and Dioxin Analyses (ACHS-II)—New—Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS) Centers for Disease Control and Prevention (CDC).

Background and Brief Description

In the past, polychlorinated biphenyls (PCBs) were used as coolants and lubricants in electrical equipment. They didn't burn easily and were good insulators. PCBs are no longer made in the U.S. They were banned in 1977 because they persist in the environment. Concerns grew about harm to health.

The City of Anniston, AL, was the site of the former Monsanto facility. PCBs were made there from 1929 to 1971. For decades, PCBs were released into the local air, soil, and surface water. In 1996, residents found out they were exposed. Concerns grew and led to litigation. In 2003, a settlement in favor of the residents was reached in state and federal courts.

The Anniston Environmental Health Research Consortium (AEHRC) was funded by the Agency for Toxic Substances and Disease Registry (ATSDR). The AEHRC conducted the Anniston Community Health Survey (ACHS) from 2005 to 2007. Serum PCB levels in 766 Anniston adults were found to be three to seven times higher than in U.S. adults. Also, higher PCB levels were found in Anniston adults who had high blood pressure and diabetes.

The ATSDR and the National Institutes of Health (NIH) plan to continue the work of the first ACHS. These agencies will conduct a follow-up study called the ACHS-II. It will be a repeated cross-sectional study. Data collection will be managed by the University of Alabama at Birmingham (UAB) and the Calhoun County Health Department (CCHD).

A sample of 500 adults will be selected from the first ACHS cohort. After informed consent, clinical assessments will be done. These will be for blood pressure, height, weight, and body girth. A questionnaire will be answered by computer-assisted personal interviews (CAPIs). Questions will be asked for health, demographic, diet, and lifestyle factors. The self-reported responses will be compared to laboratory analytes. For these, blood samples will be drawn and analyzed.

The ACHS-II will measure the same serum PCBs as in the first Anniston survey. In this way, changes in PCB levels can be studied. The ACHS-II will also include serum analytes for dioxins, furans, dioxin-like PCBs, and other similar chemicals. Additional analytes include blood measures of heavy metals. Clinical biomarkers will include measures for thyroid, diabetes, lipids, and immune function. This will give a more complete profile of human exposures and health in Anniston, AL.

The ATSDR is requesting a two-year approval for this information collection.

There are no costs to respondents other than their time. In total, they will spend 2 hours in the study.

Exhibit 1—Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Avg. burden per response (in hrs)	Total burden hours
Adults who took part in first Anniston Community Health Survey	Telephone Recruitment Script	333	1	2/60	11
	Survey for Refusals	165	1	1/60	3
	Informed Consent	250	1	1/60	4
	Update Contact Information Form	250	1	1/60	4
	Medications Form	250	1	3/60	12
	Blood Draw Form	250	1	2/60	8
	Questionnaire	250	1	45/60	188
Total					230

Dated: September 14, 2012.

Ron A. Otten,

Director, Office of Scientific Integrity (OSI), Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.