[Federal Register: January 13, 2009 (Volume 74, Number 8)]
[Notices]               
[Page 1688-1689]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja09-54]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-09-0556]

 
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 404-639-5960 
and send comments to Maryam I. Daneshvar, CDC Acting 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--
Revision--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 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

[[Page 1689]]

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 the Act. The required information is currently 
reported by ART programs to CDC as specified in the Assisted 
Reproductive Technology (ART) Program Reporting System (OMB No. 0920-
0556, exp. 9/30/2009). CDC seeks to extend OMB approval for a period of 
three years and incorporate a minor change in wording to one question. 
In addition, the revised total burden estimate includes an anticipated 
increase in the number of respondents and a slight decrease in the 
average number of responses per respondent. The burden estimate per 
response has also been revised to include an adjustment for data 
validation procedures.
    The currently approved program reporting system, also known as the 
National ART Surveillance System (NASS), includes information about all 
ART cycles initiated by any of the ART programs in the United States. 
An ART cycle is considered to begin when a woman begins taking ovarian 
stimulatory drugs or starts ovarian monitoring with the intent of 
having embryos transferred. The system also collects information about 
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. Data elements and definitions 
currently in use reflect CDC's consultations with representatives of 
the Society for Assisted Reproductive Technology (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.
    Respondents are the 480 ART programs in the United States. 
Approximately 420 clinics are expected to report an average of 286 ART 
cycles each. Ten percent of responding clinics will be randomly 
selected to participate in full validation of selected ART cycle 
records and an abbreviated validation of selected cycles resulting in 
live birth. All information is collected electronically. Respondents 
have the option of entering data directly into a Web-based NASS 
interface or of transmitting system-compatible files extracted from 
other record systems. The ART program reporting system allows CDC to 
publish an annual report to Congress as specified by the FCSRCA and to 
provide information needed by consumers.
    There are no costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                     Number of        Average burden
                 Respondents                             Form name                Number of        responses per     per response (in   Total burden (in
                                                                                 respondents         respondent           hours)             hours)
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ART Programs................................  NASS..........................                420                286              38/60             76,076
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    Dated: January 2, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E9-405 Filed 1-12-09; 8:45 am]

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