Assisted Reproductive Technology (ART) Program Reporting System

Forms and Documents

Document Name	Status
Form 0920-0556 National ART Surveillance System Form and Instruction	Modified
Form 0920-0556 Feedback Survey Form and Instruction	Modified
AttachmentsAtt G. Non_Disclosure_Contractors.docx Supplementary Document	2024-12-20
AttachmentsAtt F. Non_Disclosure_CDC_employees.docx Supplementary Document	2024-12-20
AttachmentsAtt E4. Assurance_of_Confid_approvalMemo.NC.Director ART 2024.docx Supplementary Document	2024-12-20
privacy-narrative-form 6.17.2021 signed.pdf Supplementary Document	2024-12-20
AttachmentsAtt E3. NASS_509_PIA_Signed.pdf Supplementary Document	2024-12-20
AttachmentsAtt E2. IRB_Approval_2020.docx Supplementary Document	2024-12-20
AttachmentsAtt E1. Non research Public Health Surveillance determination.pdf Supplementary Document	2024-12-20
AttachmentsAtt D. ART Publications.docx Supplementary Document	2024-12-20
AttachmentsAtt B2. Program Response to Comments to 60 Day FRN.pdf Supplementary Document	2024-12-20
0556_SS Part B NASS 2024_11-4-24.docx Supporting Statement B	2024-12-20
0556_SS Part A NASS 2024_11-7-24.docx Supporting Statement A	2024-12-20
Att A2. AUTHO LEG Publ_Hlt SA.pdf Supplementary Document	2024-12-20
Att A1. Autho_Leg_FCSRCA.pdf Supplementary Document	2024-12-20

IC Document Collections

IC ID	Document Title	Status
43614	National ART Surveillance System Form and Instruction	Modified
232351	Data Validation Description Instruction	Modified
203355	Feedback Survey Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0556	ICR Reference No: 202412-0920-017
Status: Received in OIRA	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	Date Submitted to OIRA: 12/20/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2024
Responses	416,242	308,225
Time Burden (Hours)	297,352	219,904
Cost Burden (Dollars)	43,512	10,115,670

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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]

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ICR Summary of Burden

	Total Request	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.

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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

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Common Form ICR:  No

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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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