[Federal Register Volume 62, Number 216 (Friday, November 7, 1997)]
[Notices]
[Page 60248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29438]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-98-03]


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 (404) 639-7090.
    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 for other 
forms of information technology. Send comments to Wilma Johnson, CDC 
Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 
30333. Written comments should be received within 60 days of this 
notice.

Proposed Project

1. Survey of Assisted Reproductive Technology Embryo Laboratory 
Procedures and Practices--New

    In October 1992, Congress passed the Fertility Clinic Success Rate 
and Certification Act of 1992 (FCSRCA). In accordance with this 
statute, the CDC has been tasked with developing a model certification 
program for assisted reproductive technologies (ART) embryo 
laboratories that are providing services to human fertility specialists 
in the U.S. This model certification program is to be voluntarily 
implemented by States or by independent certifying agencies such as the 
College of American Pathologists (CAP) which are approved by the State. 
The model certification program is to include a set of quality 
standards for the performance of laboratory procedures, maintenance of 
records, qualifications of laboratory personnel, and criteria for the 
inspection and certification of embryo laboratories. Other than a 
General Accounting Office Survey conducted in 1988, no current survey 
of ART laboratory procedures and practices is available. The proposed 
information collection will use a paper survey to provide an 
enumeration of these ART laboratory procedures, equipment maintenance 
practices, and personnel qualifications. This information is required 
to finalize the development of the model certification program and also 
provide a baseline study for evaluating its impact and effectiveness.
    The intended population is ART laboratory directors at all 
facilities with human embryo laboratories in the U.S. The estimated 
time for completion of this survey is expected to be approximately one 
hour per response. This estimate includes the time needed to review 
instructions, gather the relevant information, complete the form, and 
review the collected data. The total estimated cost to respondents is 
$15,750.

Respondents:                                                            
  ART Laboratory Directors:                                             
      No. of Respondents...........................................  300
      No. of Responses/Respondent..................................    1
      Average Burden/Response (in hrs.)............................    1
                                                                    ----
          Total Burden (hrs.)......................................  300
                                                                        

    Dated: October 30, 1997.
Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 97-29438 Filed 11-6-97; 8:45 am]
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