Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0607 CLIA - CDRH SSA 2022 Rev.docx	Supporting Statement A	Uploaded 2022-10-25	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
256591	CLIA waiver applications and associated records		New
180758	Request for CLIA categorization		Modified

ICR Details

OMB Control No: 0910-0607	ICR Reference No: 202210-0910-014
Status: Historical Active	Previous ICR Reference No: 201910-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
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: 11/29/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/26/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2025	36 Months From Approved	11/30/2022
Responses	413	0	400
Time Burden (Hours)	52,400	0	400
Cost Burden (Dollars)	115,750	0	2,000

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Abstract: This information collection helps support implementation of statutory provisions applicable to laboratories that conduct testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These requirements are codified in 42 U.S.C. 263a and implementing regulations are found in 42 CFR 493.

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Authorizing Statute(s): US Code: 42 USC 263a (353) Name of Law: Certification of laboratories
  

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:
	87 FR 36330	06/16/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 61029	10/07/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
CLIA waiver applications and associated records
Request for CLIA categorization

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ICR Summary of Burden

table that charts list 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	413	400	0	0	13	0
Annual Time Burden (Hours)	52,400	400	0	0	52,000	0
Annual Cost Burden (Dollars)	115,750	2,000	0	0	113,750	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: We have adjusted the information collection to reflect an increase of 26 records, 52,000 hours, and $113,750 annually, which corresponds with burden we attribute to activities associated with waivers and associated records, previously approved under control no. 0910-0598.

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Annual Cost to Federal Government: $3,093,475

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

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.     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? 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: 10/26/2022

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