70 FR 238 pgs. 73773-73774 - Proposed Data Collections Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 70Number: 238Pages: 73773 - 73774
Docket number: [60Day-06-0556]
FR document: [FR Doc. E5-7258 Filed 12-12-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-06-0556]
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 404-639-4766 or send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov .
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
Assisted Reproductive Technology (ART) Program Reporting System-Extension-National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 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 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 Act defines ART as all treatments and procedures that include the handling of human oocytes and sperm or embryos for the purpose of establishing a pregnancy.
The Centers for Disease Control and Prevention seeks to extend approval of a reporting system for the Assisted Reproductive Technology (ART) Program from the Office of Management and Budget (OMB) for a period of 3 years. 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 ART programs and across individuals. An ART cycle is started when a woman begins taking medication to stimulate the ovaries to develop eggs or starts ovarian monitoring with the intent of having embryos transferred. Data will be collected through a Web-based data collection system, developed by Westat in consultation with CDC, that complies with FCSRCA requirements.
In developing the definition of pregnancy success rates and the list of data items to be reported, CDC has consulted with representatives of the Society for Assisted Reproductive Technology (SART), the American Society for Reproductive Medicine (ASRM), 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 each ART program responding to the survey, including data entry and validation, is estimated to be $6,720.
Estimated Annualized Burden Table
| Respondents | Number of respondents | Number of responses per respondent | Average burden per response (in hrs.) | Total burden (in hours) |
|---|---|---|---|---|
| ART Programs (data entry) | *400 | *288 | 37/60 | 71,040 |
| ART Programs (selected for data validation) | **40 | **83 | 23/60 | 1,273 |
| Total | 72,313 | |||
| *Approximately 400 ART programs (respondents) reported data in 2002. The average number of ART cycles (responses) per ART program was 288. | ||||
| **Approximately 10% of the ART programs are selected for validation. An average of 83 ART cycles per ART program were selected for validation in 2002. | ||||
Dated: December 7, 2005.
Joan F. Karr,
Acting Reports Clearance Officer,Centers for Disease Control and Prevention.
[FR Doc. E5-7258 Filed 12-12-05; 8:45 am]
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