Notice2024-29447
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 13, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 240 (Friday, December 13, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a> 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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