# Proposed Data Collections Submitted for Public Comment and Recommendations

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URL: https://www.frixlaw.com/law-library/documents/fr%3A97-29438

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** November 7, 1997
- **Citation:** 62 FR 60248

## Text

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]
BILLING CODE 4163-18-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-29438. Public record. Not legal advice.