Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization

Forms and Documents

Document Name	Status
0607_Supporting Statement_2019.doc Supporting Statement A	2019-10-23

IC Document Collections

IC ID	Document Title	Status
180758	Request for CLIA categorization Other-Guidance; Administrative Procedures for CLIA Categorizatio	Modified

ICR Details

OMB Control No: 0910-0607	ICR Reference No: 201910-0910-003
Status: Active	Previous ICR Reference No: 201608-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/26/2019
	Date Received in OIRA: 10/29/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	12/31/2019
Responses	400	0	900
Time Burden (Hours)	400	0	900
Cost Burden (Dollars)	2,000	0	46,800

---

Abstract: This ICR describes the burden to manufacturers when they request Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic (IVD) tests when a premarket review is not needed (for example, devices exempt from premarket notification). In these cases, FDA recommends that manufacturers submit to FDA a brief description of why CLIA categorization is requested (e.g., exempt from 510(k), name change for a previously cleared device), the name of the device, the package insert (instructions for use), the product code, and regulation number. FDA will use the information collected to determine device complexity. There are three categories of test complexity: waived tests, moderate complexity tests, and high complexity tests. Laboratories performing only waived tests are subject to minimal regulation. Laboratories performing moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 30127	06/26/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 57443	10/25/2019
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Request for CLIA categorization

---

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	400	900	0	0	-500	0
Annual Time Burden (Hours)	400	900	0	0	-500	0
Annual Cost Burden (Dollars)	2,000	46,800	0	0	-44,800	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: Our estimated burden for the information collection reflects an overall decrease of 500 hours. We attribute this adjustment to a decrease in the number of submissions we received over the last few years. Also, upon review of this information collection, we believe the previous estimate may have included requests for categorization associated with a premarket submission, the burden estimate of which is included under the OMB approval for the applicable premarket submission. We have therefore revised the number of respondents/responses to include only those that are separate from a product application, consistent with the scope of this information collection.

---

Annual Cost to Federal Government: $1,351,525

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? Uncollected

---

Common Form ICR:  No

---

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: 10/29/2019

---