Assisted Reproductive Technology (ART) Program Reporting System

Forms and Documents

Document Name	Status
0920-0556 Supporting Statement Part B 3-31-09.doc Supporting Statement B	2009-07-01
Att H. ART Validation Description.doc Supplementary Document	2009-07-01
Att G. Non Disclosure Contractors.doc Supplementary Document	2009-07-01
Att F. Non Disclosure CDC employees.doc Supplementary Document	2009-07-01
Att E IRB Approval .doc Supplementary Document	2009-07-01
Att E1 Assurance of Confid approval.doc Supplementary Document	2009-07-01
Att D. Publications.doc Supplementary Document	2009-07-01
Att A1. Authorizing Legislation Public Health Service Act.doc Supplementary Document	2009-07-01
Att A2. Authorizing Legislation FCSRCA.doc Supplementary Document	2009-07-01
Att C2 NASS Users Manual.pdf Supplementary Document	2009-07-01
Att C1. NASS Annual Submission Instructions.pdf Supplementary Document	2009-07-01
Att C3. NASS PGD Screens.doc Supplementary Document	2009-07-01
0920-0556 Supporting Statement Part A.doc Supporting Statement A	2009-07-01

IC Document Collections

IC ID	Document Title	Status
43614	Assisted Reproductive Technology (ART) Program Reporting System Instruction	Modified

ICR Details

OMB Control No: 0920-0556	ICR Reference No: 200907-0920-003
Status: Historical Active	Previous ICR Reference No: 200604-0920-001
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 without change	Conclusion Date: 09/15/2009
	Date Received in OIRA: 07/21/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved	09/30/2009
Responses	138,030	0	400
Time Burden (Hours)	89,720	0	72,313
Cost Burden (Dollars)	0	0	0

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Abstract: The Assisted Reproductive Technology (ART) Program Reporting System has been designed to comply with the requirements of Section 2(a) of Pub. L. 102-493 (known as the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-1(a). This Act requires that each ART program shall annually report to the Secretary through CDC - (1) pregnancy success rates achieved by such ART program, and (2) the identify of each embryo laboratory used by such ART program whether the laboratory is certified or has applied for such certification under this Act. CDC currently collects and reports information from all clinics that offer assisted reproductive technology (ART) services, as required by the Fertility Clinic Success Rate and Certification Act (FCSRCA). CDC seeks to renew OMB approval for an additional three years.

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Authorizing Statute(s): US Code: 42 USC 241 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:
	74 FR 1688	01/13/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 31961	07/06/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Assisted Reproductive Technology (ART) Program Reporting System

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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	138,030	400	0	137,630	0	0
Annual Time Burden (Hours)	89,720	72,313	0	17,407	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: This revision request includes one minor change to the information collection instrument and an increase in the total estimated burden hours.

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Annual Cost to Federal Government: $1,002,859

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? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 07/21/2009

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