[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 <a href="/cdn-cgi/l/email-protection#2f40424d6f4c4b4c01484059"><span class="__cf_email__" data-cfemail="17787a755774737439707861">[email protected]</span></a>. 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
ART Clinics...........................  NASS....................             464             350           42/60
                                        Data Validation.........              35              70           23/60
                                        Feedback Survey.........             348               1            2/60
----------------------------------------------------------------------------------------------------------------


 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


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