Proposed Data Collections Submitted for Public Comment and Recommendations

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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