Assisted Reproductive Technology (ART) Program Reporting System

Forms and Documents

Document Name	Status
Form 0920-0556 National ART Surveillance System Form and Instruction	Modified
ONe-time System Deployment Form	Removed
Form 0920-0556 Feedback Survey Form and Instruction	Modified
Att G. Non_Disclosure_Contractors.doc Supplementary Document	2018-07-24
Att F. Non_Disclosure_CDC_employees.doc Supplementary Document	2018-07-24
Att E4. Assurance_of_Confid_approval.pdf Supplementary Document	2018-07-24
NASS PIA_24JUL2018.pdf Supplementary Document	2018-07-24
Att E2 IRB_Approval_2017.doc.docx Supplementary Document	2018-07-24
Att E1 Non-Research-Public Health Surveillance Determination .pdf Supplementary Document	2018-07-24
Att C3. NASS 2.0 Users Guide.pdf Supplementary Document	2018-07-24
Att C2. NASS Annual Submission Instructions.pdf Supplementary Document	2018-07-24
Att B. 0920-0556 60 day FRN.pdf Supplementary Document	2018-07-24
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
OMB 0920-0556_change request 05.4.17.docx Justification for No Material/Nonsubstantive Change	2017-05-17
OMB 0920-0556_change request 05.4.17.docx Justification for No Material/Nonsubstantive Change	2017-05-16
0920-0556 Change Request Justification_09-16-2015.docx Justification for No Material/Nonsubstantive Change	2015-10-07
SS Part B_NASS_07-10-2018.docx Supporting Statement B	2018-07-24
SS Part A_NASS_07-10-2018.docx Supporting Statement A	2018-07-24

IC Document Collections

IC ID	Document Title	Status
43614	National ART Surveillance System Form and Instruction	Modified
232351	Data Validation Instruction	New
214986	ONe-time System Deployment Form	Removed
203355	Feedback Survey Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0556	ICR Reference No: 201807-0920-008
Status: Historical Active	Previous ICR Reference No: 201705-0920-009
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 with change	Conclusion Date: 08/29/2018
	Date Received in OIRA: 07/27/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	08/31/2018
Responses	165,198	0	158,275
Time Burden (Hours)	114,631	0	117,740
Cost Burden (Dollars)	0	0	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. CDC seeks OMB approval on n Revision request to continue information collection for an additional 3 years. Compared to the burden previously approved, the annualized burden requested is lower, due to the burden that was associated with a one-time system upgrade that is no longer needed. However, some of this reduction will be offset by an increase in the number of ART clinics and cycles reported, due to an increase in the utilization of ART in the United States.

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Authorizing Statute(s): PL: Pub.L. 102 - 493 2 (a) Name of Law: Fertility Clinic Success Rate and Certification Act
   US Code: 42 USC 301 Name of Law: Public Health Service 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:
	83 FR 21779	05/10/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 35645	07/27/2018
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
National ART Surveillance System	0920-0556	National ART Surveillance System (NASS)
Feedback Survey	0920-0556	NASS Clinic Feedback Survey
ONe-time System Deployment	none	NASS

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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	165,198	158,275	0	2,301	4,622	0
Annual Time Burden (Hours)	114,631	117,740	0	-5,021	1,912	0
Annual Cost Burden (Dollars)	0	0	0	0	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: Changing Forms

Short Statement: Revision of 0920-0556 results in an overall decrease in 3,109 Burden Hours due to the removal of burden associated with a one-time system upgrade, and an increase in the number of ART clinics and cycles reported.

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Annual Cost to Federal Government: $1,207,632

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? Uncollected

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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: 07/27/2018

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