Draft Guidance for Industry and FDA Staff; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability

Forms and Documents

Document	Type	Status	Availability
SS CLIA.DOC	Supporting Statement A	Uploaded 2006-11-18	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
46257	Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications		New

ICR Details

OMB Control No: 0910-0598	ICR Reference No: 200611-0910-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance for Industry and FDA Staff; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/21/2007
	Date Received in OIRA: 11/30/2006
Terms of Clearance: This information collection request is approved with the following term of clearance: FDA will add the PRA-mandated burden statement somewhere in the first few pages of the guidance document.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2010	36 Months From Approved
Responses	40	0	0
Time Burden (Hours)	143,200	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Clinical Laboratory Improvements of 1988 ( CLIA ), established quality standards for all laboratory testing. Laboratories that perform only tests that are "simplesimple and that have an "insignificant risk of an erroneous result" may obtain a certificate of waiver. The guidance describes recommendations for device manufacturers submitting to FDA an application for determination that a cleared or approved device meets this CLIA standard.

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Authorizing Statute(s): None

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:
	70 FR 53231	09/07/2005
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 56153	09/26/2006
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
Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications

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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	40	0	0	40	0	0
Annual Time Burden (Hours)	143,200	0	0	143,200	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: There were no adjustment or program changes associated with this collection of information.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

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]? 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)? Uncollected

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: 11/21/2006

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