[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Pages 24005-24007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-0556; Docket No. CDC-2024-0025]


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 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 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 June 4, 2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0025 by either of the following methods:
    [squ] Federal eRulemaking Portal: www.regulations.gov. Follow the 
instructions for submitting comments.
    [squ] Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.

    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 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;

[[Page 24006]]

    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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Assisted Reproductive Technology (ART) Program Reporting System 
(OMB Control No. 0920-0556, Exp. 12/31/2024)--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. 12/31/2024). The current revision seeks to revise 
burden hour estimates, modify data elements collected, implement a new 
process for sharing data externally, and to extend OMB approval for a 
period of three years. The revised total burden estimate is higher than 
the previous approval, due to an increase in the utilization of ART in 
the United States and the number of reported cycles. Data elements 
collected will be modified to remove five data elements no longer 
needed and add one new data element to reflect current clinical 
practice. The average estimated burden for reporting information 
related to each cycle is not anticipated to change from the time burden 
previously approved (43 minutes). Data will be made available in the 
National Center for Health Statistics Research Data Center to increase 
accessibility of Assisted Reproductive Technology (ART) Program 
Reporting System data for secondary epidemiological analyses.
    The currently approved program reporting system, also known as the 
National ART Surveillance System (NASS), collects information about all 
ART cycles initiated by 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 several data elements 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, ART programs that submit their data in mid-December 2021 will 
include all ART cycles that were initiated between January 1, 2020, and 
December 31, 2020.
    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 (ASRM), 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 
453, based on the number of clinics that provided information in 2021. 
This number is lower than the previous number of reporting clinics 
(456). The estimated average number of responses (ART cycles) per 
respondent is 913. The total burden estimate is higher than the 
previous approval due to an increase in the utilization of ART in the 
United States. 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. Due to this lower 
response rate and reduced number of reporting clinics, CDC estimates 
203 clinics will respond to voluntary feedback survey.
    The collection of ART cycle information allows CDC to publish 
clinic-specific success rates annually as specified by the FCSRCA and 
to provide information needed by consumers. OMB approval is requested 
for three years. CDC requests approval for 297,352 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
                                                    respondents     respondent      (in hours)      (in hours)
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ART Program/Clinic............  NASS Reporting               453             913           43/60         296,406
                                 Form.
                                Data Validation.              35              70           23/60             939
                                Feedback Survey.             203               1            2/60               7
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............         297,352
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[[Page 24007]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-07289 Filed 4-4-24; 8:45 am]
BILLING CODE 4163-18-P