[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42328-42329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17033]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-14-0556]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, invites the general 
public and other Federal agencies to take this opportunity to comment 
on proposed and/or continuing information collections, as required by 
the Paperwork Reduction Act of 1995. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 or send comments to 
Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send 
an email to [email protected].
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. Written comments should be received within 60 
days of this notice.

Proposed Project

    Assisted Reproductive Technology (ART) Program Reporting System 
(OMB No. 0920-0556, expires 8/31/2015)--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 reported by ART programs to CDC as specified in the Assisted 
Reproductive Technology (ART) Program Reporting System (OMB No. 0920-
0556, exp. 8/31/2015).
    The currently approved program reporting system, also known as the

[[Page 42329]]

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 be initiated when a woman begins taking 
ovarian stimulatory drugs or starts ovarian monitoring with the intent 
of transferring one or more embryos. CDC also collects information 
about the pregnancy outcome of each cycle, as well as a number of data 
items deemed important to explain variability in success rates across 
ART programs and across individuals.
    Each ART program reports its annual ART cycle data to CDC in mid-
December. The annual data reporting consists of information about all 
ART cycles that were initiated in the previous calendar year. For 
example, the December 2013 reports described ART cycles that were 
initiated between January 1, 2012, and December 31, 2012. Data elements 
and definitions currently in use reflect CDC's prior 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.
    CDC, the data collection contractor, and partner organizations 
engage in ongoing dialogue to identify opportunities for improvement. 
As a result of these discussions, a number of changes to the NASS data 
elements and the NASS reporting platform are under consideration and 
will be submitted to OMB for approval. Changes to the NASS data 
elements are essential to keep pace with changes in medical practice, 
ensure that reported success rates reflect standardized definitions, 
and provide additional insight into factors that may affect success 
rates. Specific changes to the NASS data elements include the addition 
of new items as well as modification or discontinuation of selected 
items. CDC also plans to redesign the graphical interface for NASS. In 
addition to reflecting the changes in data items, NASS data entry pages 
will be redesigned for more intuitive grouping of data items and will 
employ embedded skip logic to route users to the minimum number of 
applicable questions. Respondents will have the option of entering data 
directly into the Web-based NASS interface or of transmitting system-
compatible files extracted from other record systems. On an annual 
basis, approximately ten percent of responding clinics are also 
selected to participate in data validation and quality control 
activities.
    Implementation of these changes for ART cycles initiated on or 
after January 1, 2015, is under consideration, but may be deferred 
until January 1, 2016. During the period of this revision, the 
estimated number of respondents (ART programs or clinics) will increase 
from 440 to 450; the estimated number of ART cycles reported by each 
clinic will increase from 339 to 360; and the estimated burden per 
response will increase from 39 minutes to 40 minutes.
    In addition, respondents may provide feedback to CDC about the 
usability and utility of the reporting system. The option to 
participate in the feedback survey is presented to respondents when 
they complete their required data submission. However, participation in 
the feedback survey is voluntary and is not required by the FCSRCA. CDC 
estimates that 75% of ART programs will participate in the feedback 
survey.
    The collection of ART cycle information allows CDC to publish an 
annual report to Congress as specified by the FCSRCA and to provide 
information needed by consumers. Overall, the proposed changes will 
support CDC's ability to generate timely, accurate, and relevant 
information about fertility clinic success rates and improve user 
satisfaction with the NASS interface.
    OMB approval is requested for three years and there are no costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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ART Programs..................  NASS............             450             360           40/60         108,000
                                Feedback Survey.             338               1            2/60              11
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............         108,011
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Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-17033 Filed 7-18-14; 8:45 am]
BILLING CODE 4163-18-P