02-31927. 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 the CDC Reports Clearance Officer on [phone].

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. Send comments to Seleda M. Perryman , CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice.

Proposed Project: Assessment of Methemoglobin Levels in Pregnancy—New—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

Background

Methemoglobinemia as a consequence of ingestion of nitrate-contaminated water has been well established. Methemoglobinemia is an acute and potentially fatal illness, the severity of which depends on the amount of methemoglobin (metHb) formed. Subclinical increases in metHb levels can occur in people exposed to low levels of nitrate in drinking water; however, metHb levels in such people have not been well characterized. Furthermore, very little is known about metHb levels in pregnant women, including whether drinking low levels of nitrate (below the maximum allowable contaminant level of 10 mg/L) affects blood metHb levels in pregnant women or their fetuses. We propose to study 330 pregnant women who consume water from public and private wells. We plan to follow them from their first prenatal visit until 2 weeks after delivery, when we will also measure metHb levels in their newborn infants. The study objectives are to (1) measure metHb levels throughout pregnancy and evaluate how metHb levels change during and just after pregnancy; (2) measure metHb levels within a population of women and their newborn infants who are served by either public or private water supplies and are exposed to a range of nitrate levels primarily below the maximum contaminant level for public water supplies; (3) provide additional medical care, education, and advice to women whose metHb levels are elevated (above 5% of the total hemoglobin); and (4) to provide education and advice to women whose water supplies have elevated nitrate levels with regard to the potential hazards of infant methemoglobinemia. There is no cost to respondents.

Respondents	Number of respondents	Number of responses/respondent	Average burden/response (in hours)	Total burden (in hours)
Recruiting	428	1	15/60	107
Personal Interview	330	1	1	330
Biological Specimen Collection:
Mother	330	6	45/60	1485
Infant	330	1	2/60	11
Total				1933

Dated: December 12, 2002.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.