Assisted Reproductive Technology (ART) Program Reporting System

Forms and Documents

Document Name	Status
National ART Surveillance System Form	Modified
ONe-time System Deployment Form	New
Feedback Survey Form	Modified
Att C8b. Success Rate Measurements and Calculations.docx Supplementary Document	2015-07-23
Att C8a. Success rate calculations_07 13 2015.docx Supplementary Document	2015-07-23
Att C7b. Draft 2015 Update to FRN.docx Supplementary Document	2015-02-12
Att C7a. FRN 09 01 2000 Reporting under FCSRCA.pdf Supplementary Document	2015-02-12
Att H. Validation Description.docx Supplementary Document	2015-02-12
Att G. Non-Disclosure_Contractors.doc Supplementary Document	2015-02-12
Att F. Non-Disclosure_CDC employees.doc Supplementary Document	2015-02-12
Att E2. Assurance of Confidentiality approval.pdf Supplementary Document	2015-02-12
Att E1. IRB Approval 2014.docx Supplementary Document	2015-02-12
Att D. Publications.doc Supplementary Document	2015-02-12
Att B2. Summary of Public Comments_01 22 2015.doc Supplementary Document	2015-02-12
Att B1. FRN 07 21 2014 Proposed Changes.pdf Supplementary Document	2015-02-12
SS Part B_01 23 2015.docx Supporting Statement B	2015-02-12
SS Part A_rev_07 13 2015.clean.docx Supporting Statement A	2015-07-23
Att A2_Autho Leg FCSRCA.doc Supplementary Document	2012-06-29
Att H. ART Validation Description.docx Supplementary Document	2012-06-29
Att A1_Auth Leg Publ Hlth Svc Act.doc Supplementary Document	2012-06-29

IC Document Collections

IC ID	Document Title	Status
43614	National ART Surveillance System Form	Modified
214986	ONe-time System Deployment Form	New
203355	Feedback Survey Form	Modified

ICR Details

OMB Control No: 0920-0556	ICR Reference No: 201502-0920-007
Status: Historical Active	Previous ICR Reference No: 201207-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No:
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: 07/24/2015
	Date Received in OIRA: 02/24/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2018	36 Months From Approved	08/31/2015
Responses	158,275	0	149,336
Time Burden (Hours)	116,425	0	96,960
Cost Burden (Dollars)	0	0	0

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Abstract: As required by law (FCSRCA), CDC collects information needed to calculate the annual pregnancy success rate of each clinic that provides assisted reproductive technology (ART) services. Information collection will continue with changes that reflect changes in medical practice and improve data quality.

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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:
	79 FR 42328	07/21/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 8659	02/18/2015
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
ONe-time System Deployment	none	NASS
National ART Surveillance System	none, none	National ART Surveillance System ,   NASS 2016
Feedback Survey	none	Feedback Survey

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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	158,275	149,336	0	8,939	0	0
Annual Time Burden (Hours)	116,425	96,960	0	19,465	0	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: No

Burden Reduction Due to:

Short Statement: Estimated burden will increase to anticipated increases in the number of respondents, the number of responses per respondent, and the burden per response. There is also a one-time allocation associated with training and deployment of updated reporting requirements.

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Annual Cost to Federal Government: $1,141,579

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 02/24/2015

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