Assisted Reproductive Technology (ART) Program Reporting System

Forms and Documents

Document Name	Status
National ART Surveillance System Form and Instruction	Modified
Feedback Survey Form and Instruction	Modified
Att G. Non_Disclosure_Contractors.docx Supplementary Document	2021-07-16
Att F. Non_Disclosure_CDC_employees.docx Supplementary Document	2021-07-16
Att E4. Assurance_of_Confid_approval.pdf Supplementary Document	2021-07-16
privacy-narrative-form 6.17.2021 signed.pdf Supplementary Document	2021-07-16
Att E3 NASS 509 PIA Reauth 2018v2.1.pdf Supplementary Document	2021-07-16
Att E2. IRB_Approval_2020.docx Supplementary Document	2021-07-16
Att E1 Non-Research-Public Health Surveillance Determination .pdf Supplementary Document	2021-07-16
Att D. Publications.doc.docx Supplementary Document	2021-07-16
Att C3. NASS 2.0 Users Guide.pdf Supplementary Document	2021-07-16
Att C2. NASS Annual Submission Instructions v2.pdf Supplementary Document	2021-07-16
Att B 60 Day FRN 2021-05115.pdf Supplementary Document	2021-07-16
SS Part B 07-09-2021.docx Supporting Statement B	2021-07-16
SS Part A 07-09-2021.docx Supporting Statement A	2021-07-16
Att A2. Auth_Leg_Publ_Hlth_Svc_Act.doc Supplementary Document	2018-07-24
Att A1. Autho_Leg_FCSRCA.doc Supplementary Document	2018-07-24

IC Document Collections

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

ICR Details

OMB Control No: 0920-0556	ICR Reference No: 202107-0920-004
Status: Received in OIRA	Previous ICR Reference No: 201905-0920-001
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: 08/02/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2021
Responses	308,225	165,198
Time Burden (Hours)	219,904	114,631
Cost Burden (Dollars)	10,115,670	0

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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.

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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:
	86 FR 14117	03/12/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 40051	07/26/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Data Validation
Feedback Survey	n/a	NASS Clinic Feedback Survey
National ART Surveillance System	n/a	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	308,225	165,198	0	143,027	0	0
Annual Time Burden (Hours)	219,904	114,631	0	105,273	0	0
Annual Cost Burden (Dollars)	10,115,670	0	0	10,115,670	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: Each ART cycle is reported to CDC. Due to increased utilization of ART services, the number of reported cycles is expected to increase, resulting in an increase in total burden hours. There is no change to the estimated burden per response.

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Annual Cost to Federal Government: $1,389,656

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: 08/02/2021

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