[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14117-14119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05115]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-2021-0556; Docket No. CDC-2021-0022]


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 continuing 
information collection project titled Assisted Reproductive Technology 
(ART) Program Reporting System. This study is designed to collect 
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 May 11, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0022 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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

[[Page 14118]]

instruments, contact Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; 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:
    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 
(OMB Control No. 0920-0556, Exp. 8/31/2021)--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 Control No. 
0920-0556, Exp. 8/31/2021). CDC seeks to extend OMB approval for a 
period of three years.
    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. 
The start of an ART cycle is considered when a woman begins taking 
medication to stimulate egg production or begins 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 2020 reports described ART cycles that were 
initiated between January 1, 2018, and December 31, 2018. 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 
456, based on the number of clinics that provided information in 2018; 
the estimated average number of responses (ART cycles) per respondent 
is 670. The total burden estimate is higher than the previous approval 
due to an increase in the utilization of ART in the United States and, 
thus, an increase in the number of ART cycles on which respondents 
report. 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 50% 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. CDC requests approval for 219,904 annual burden hours. 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 (in
                                                                                      respondents     respondent      (in hours)           hours)
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                                                 NASS Reporting Form..............             456             670           43/60               218,956
                                                 Data Validation..................              35              70           23/60                   939
                                                 Feedback Survey..................             255               1            2/60                     9
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    Total......................................  .................................  ..............  ..............  ..............               219,904
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[[Page 14119]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-05115 Filed 3-11-21; 8:45 am]
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