[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Notices]
[Pages 21779-21780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-FY-0556; Docket No. CDC-2018-0037]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Assisted Reproductive 
Technology (ART) Program Reporting'' that collects information on ART 
cycles to publish information on pregnancy success rates as required 
under Section 2(a) of the Federal Clinic Success Rate and Certification 
Act (FCSRCA).

DATES: CDC must receive written comments on or before July 9, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0037 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:

[[Page 21780]]

    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Assisted Reproductive Technology (ART) Program Reporting System--
Extension--(OMB# 0920-0556, exp. 7/31/2018). 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 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 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 respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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(ART programs or clinics......  NASS............             464             350           42/60         113,680
                                Data Validation.              35              70           23/60             939
                                Feedback Survey.             348               1            2/60              12
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    Total.....................  ................  ..............  ..............  ..............         114,631
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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. 2018-09916 Filed 5-9-18; 8:45 am]
 BILLING CODE 4163-18-P