Accreditation Scheme for Conformity Assessment Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0889_Supporting Statement_2026.docx	Supporting Statement A	Uploaded 2026-10-28	Available
0889_Comment 2.pdf	Public Comments	Uploaded 2026-10-19	Available
0889_Comment 1.pdf	Public Comments	Uploaded 2026-10-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
240128	CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0889	ICR Reference No: 202606-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202212-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Accreditation Scheme for Conformity Assessment Program
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/29/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	1,717	0
Time Burden (Hours)	9,523	0
Cost Burden (Dollars)	0	0

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Abstract: This information collection helps support implementation of sections 514 and 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d and 360d(d)) which provide for the establishment of performance standards and authorizes the Accreditation Scheme for Conformity Assessment Program (ASCA Program). The ASCA program allows testing laboratories to be accredited by ASCA-recognized accreditation bodies to assess the conformance of a device to certain FDA-recognized standards.

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Authorizing Statute(s): PL: Pub.L. 115 - 52 514; 514(d) Name of Law: FDARA
  

Citations for New Statutory Requirements: PL: Pub.L. 115 - 52 514 Name of Law: FDARA

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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:
	91 FR 44854	07/17/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 66845	10/23/2026
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements

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ICR Summary of Burden

table that charts list of burden

	Total Request	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	1,717	0	0	0	-322	2,039
Annual Time Burden (Hours)	9,523	0	0	0	-839	10,362
Annual Cost Burden (Dollars)	0	0	0	0	0	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 decreased the estimated annual burden by 839 hours to reflect updated participation and completion-time estimates as the ASCA Program has matured. This decrease is attributable to adjustments in estimates rather than a program change. The estimated recordkeeping and third-party disclosure burdens remain unchanged. The reporting burden decrease includes: • 48 hours from removing initial applications for ASCA Recognition; • 400 hours from reducing anticipated applications for ASCA Accreditation from 150 to 50 annually; • 225 hours from reducing the estimated time for TL continuation requests from 4 hours to 1 hour; • 12 hours from reducing estimated AB participation in annual status reports and notifications of change from 8 to 5; • 75 hours from reducing the estimated burden for TL annual status reports from 225 to 150 hours; and • 79 hours from removing feedback questionnaires used during the pilot.

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Annual Cost to Federal Government: $362,272

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.     No

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: 10/29/2026

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