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[Federal Register Volume 89, Number 240 (Friday, December 13, 2024)]
[Notices]
[Pages 101016-101017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29447]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-25-0556]

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 
April 5, 2024 to obtain comments from the public and affected agencies. 
CDC received two 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 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). CDC seeks to revise burden hour estimates, 
modify data elements collected, 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 two data elements no longer needed 
and add one new data element to reflect current clinical practice.
    The estimated number of respondents (ART programs or clinics) is 
453, based on the number of clinics that provided information in 2021; 
the estimated average number of responses (ART cycles) per respondent 
is 913. 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

[[Page 101017]]

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 an estimated 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
                                                                    respondents     respondent      (in hours)
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Private Sector--ART Programs..........  NASS Reporting..........             453             913           43/60
                                        Data Validation.........              35              70           23/60
                                        Feedback Survey.........             203               1            2/60
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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. 2024-29447 Filed 12-12-24; 8:45 am]
BILLING CODE 4163-18-P
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