View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-0556
ICR Reference No:
202412-0920-017
Status:
Active
Previous ICR Reference No:
202107-0920-004
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-0556
Title:
Assisted Reproductive Technology (ART) Program Reporting System
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/07/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/20/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2028
36 Months From Approved
03/31/2025
Responses
416,242
0
308,225
Time Burden (Hours)
297,352
0
219,904
Cost Burden (Dollars)
43,512
0
10,115,670
Abstract:
The Centers for Disease Control and Prevention (CDC) is currently approved to collect information needed to determine the annual pregnancy success rate of each clinic that provides assisted reproductive technology (ART) services (“Assisted Reproductive Technology Program Reporting System,” OMB No. 0920-0556, exp. 7/31/2018). This data collection is required by The Fertility Clinic Success Rate and Certification Act (FCSRCA), Section 2(a) of P.L. 102-493(42 USC 263 (a)-1) which mandates ART clinics to submit information to CDC and requires CDC to publish pregnancy success rates. CDC seeks OMB approval on a revision request to revise burden estimates, modify data elements to align with current clinical practice, and extend information collection for an additional three years. Compared to the burden previously approved, the total annualized burden requested is higher due to an increase in the average number of ART cycles performed per clinic, due to an overall increase in the utilization of ART in the United States.
Authorizing Statute(s):
US Code:
42 USC 301
Name of Law: Public Health Service Act
PL:
Pub.L. 102 - 493 2 (a)
Name of Law: Fertility Clinic Success Rate and Certification Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 24005
04/05/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 101016
12/13/2024
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Data Validation Description
Feedback Survey
0920-0556
NASS Clinic Feedback Survey
National ART Surveillance System
0920-0556
National ART Surveillance System (NASS) [screen captures]
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
416,242
308,225
0
108,017
0
0
Annual Time Burden (Hours)
297,352
219,904
0
77,448
0
0
Annual Cost Burden (Dollars)
43,512
10,115,670
0
-10,072,158
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
CDC revised burden hour estimates and modify data elements collected. 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. CDC will remove the requirement for clinics to report dosage information for long-acting FSH because they are not approved for use in the United States. CDC will remove the requirement for clinics to report the research cycle study type because additional information on research cycle study type is not necessary to report pregnancy success rates. CDC will add the requirement for clinics to report date of fresh embryo cryopreservation for all frozen embryo transfer procedures because it will improve reporting of factors that impact ART success rates. A revised data collection form is provided in Attachment C1. The proposed changes are not anticipated to impact the burden hours to report data for ART cycles.
Annual Cost to Federal Government:
$1,850,669
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Thelma Sims 4046394771
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
12/20/2024
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