Notice2024-07289
Proposed Data Collection Submitted for Public Comment and Recommendations
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
April 5, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 67 (Friday, April 5, 2024)</title>
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[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Pages 24005-24007]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="http://www.regulations.gov">www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#5e31333c1e3d3a3d70393128"><span class="__cf_email__" data-cfemail="1a7577785a797e79347d756c">[email protected]</span></a>.
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
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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
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