[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35645-35646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16091]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0556]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Assisted Reproductive Technology (ART)
Program Reporting System to the Office of Management and Budget (OMB)
for review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
May 10, 2018 to obtain comments from the public and affected agencies.
CDC did not receive comments related to the previous notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Assisted Reproductive Technology (ART) Program Reporting System
(OMB No. 0920-0556, expires 7/31/2018)--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. 7/31/2018). CDC seeks to extend OMB approval for a period of
three years. The revised total burden estimate is lower than under the
previous approval, due to removal of the burden associated with a one-
time system upgrade that was completed under the prior approval.
However, some of this burden reduction will be offset by an increase in
the number of ART clinics and cycles reported, due to an increase in
the utilization of ART in the United States.
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; for each cycle, CDC collects information
about the pregnancy outcome, as well as a number of data items deemed
by experts in the field to be important to explain
[[Page 35646]]
variability in success rates across ART programs and 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 2017 reports described ART cycles that were
initiated between January 1, 2016, and December 31, 2016. 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.
The estimated number of respondents (ART programs or clinics) is
464, based on the number of clinics that provided information in 2015;
the estimated average number of responses (ART cycles) per respondent
is 350. Additionally, approximately 5-10% of responding clinics will be
randomly selected each year to participate in data validation and
quality control activities; an estimated 35 clinics will be selected to
report validation data on 70 cycles each on average. Finally,
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. 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. OMB approval is requested for three
years. The estimated annualized Burden Hours are 114,631 which is a
decrease of 1,794 from the current OMB-approved collection. There are
no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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ART Clinics........................... NASS.................... 464 350 42/60
Data Validation......... 35 70 23/60
Feedback Survey......... 348 1 2/60
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Jeffrey M. Zirger,
Acting 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. 2018-16091 Filed 7-26-18; 8:45 am]
BILLING CODE 4163-18-P