02-9843. 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. CDC is requesting an emergency clearance from the Office of Management and Budget (OMB) to collect data under the Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992. Send comments to Anne O'Connor, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS D-24, Atlanta, GA 30333. Written comments should be received within 14 days of this notice. OMB is expected to act on the request of CDC within 21 days of publication of this notice.

Proposed Project

Assisted Reproductive Technology (ART) Program Reporting System—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background: Section 2(a) of Pub. L. 102-493 (known as the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-1(a)) requires that each assisted reproductive technology (ART) program shall annually report to the Secretary through the Centers for Disease Control and Prevention—(1) pregnancy success rates achieved by such ART program, and (2) the identity of each embryo laboratory used by such ART program and whether the laboratory is certified or has applied for such certification under this act.

The Centers for Disease Control and Prevention (CDC) is seeking approval of a reporting system for Assisted Reproductive Technology (ART)Program from the Office of Management and Budget (OMB). This reporting system has been designed in collaboration with the Society for Reproductive Technology to comply with the requirements of the FCSRCA. The reporting system includes all ART cycles initiated by any of the approximately 400 ART programs in the United States, and covers the pregnancy outcome of each cycle, as well as a number of data items deemed important to explain variability in success rates across clinics and across individuals. Data is to be collected through computer software developed by SART in consultation with CDC.

In developing the definition of pregnancy success rates and the list of data items to be reported, CDC has consulted with representatives of SART, the American Society for Reproductive Medicine, and RESOLVE, the National Infertility Association (a national, nonprofit consumer organization), as well as a variety of individuals with expertise and interest in this field. The average annual cost to the respondent, including data entry labor and fees, is estimated to be $2,140.

Respondents	Number of respondents	Number of responses/respondent	Average burden/response (in hours)	Total burden (in hours)
ART Clinics	400	220	5/60	7,333
Total				7,333

Dated: April 16, 2002.

Nancy E. Cheal,

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