[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Notices]
[Pages 20401-20402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-12-0556]
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 404-639-7570
and send comments to Ron Otten, at 1600 Clifton Road, MS-D74, Atlanta,
GA 30333 or send an email to [email protected].
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
exp. 9/30/2012--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 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 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. 9/30/2012). CDC seeks to extend OMB approval for a period of
three years and to implement a brief, one-time optional feedback survey
to clinics for each reporting year. The revised total burden estimate
includes an anticipated increase in the number of participating clinics
from 430 to 440 and an increase in the average number of responses per
respondent from 321 to 339. There is a 2-minute increase to the
estimated burden per response.
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
[[Page 20402]]
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 484 ART programs in the United States.
Approximately 440 clinics are expected to report an average of 339 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 ART cycle records.
All information is collected electronically. Respondents have the
option of entering data directly into a Web-based National ART
Surveillance System (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.
CDC, the data collection contractor, and partner organizations
engage in ongoing dialogue to identify opportunities for improvement in
NASS. During the period of this Revision request, minor changes to NASS
data definitions or similar technical adjustments may be proposed
through the Change Request mechanism.
Starting with 2012 data reporting year, CDC plans to implement a
brief, one-time optional feedback survey to clinics for each reporting
year. The purpose of this survey is to obtain insight into NASS
usability issues as well as respondents' perspectives on the usefulness
of the information collected.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Respondents Form name respondents responses per response (in (in hours)
respondent hours)
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ART Programs.................. NASS............ 440 339 39/60 96,954
Feedback Survey. 176 1 2/60 6
Total..................... ................ .............. .............. .............. 96,960
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Dated: March 29, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science (OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012-8067 Filed 4-3-12; 8:45 am]
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