[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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