[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]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
ART Programs.................. NASS............ 450 360 40/60 108,000
Feedback Survey. 338 1 2/60 11
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 108,011
----------------------------------------------------------------------------------------------------------------
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