Accreditation Scheme for Conformity Assessment Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0889 CDRH Conformity Assessment SSA 2023 REV.docx	Supporting Statement A	Uploaded 2023-06-29	Repair queued
0889 CDRH Conformity Assessment SSA 2023 REV.docx	Supporting Statement A	Uploaded 2023-06-29	Repair queued
0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-09-10	Repair queued
0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-09-10	Repair queued

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: 202212-0910-012
Status: Historical Active	Previous ICR Reference No: 202109-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Accreditation Scheme for Conformity Assessment Program
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: 08/01/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/30/2023
Terms of Clearance: The word "Pilot" has been removed from the ICR title in line with information provided in the supporting statement.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	07/31/2023
Responses	2,039	0	1,945
Time Burden (Hours)	10,362	0	13,491
Cost Burden (Dollars)	0	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:
	88 FR 3419	01/19/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 42076	06/28/2023
Did the Agency receive public comments on this ICR? No

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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 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	2,039	1,945	0	0	94	0
Annual Time Burden (Hours)	10,362	13,491	0	0	-3,129	0
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: Our estimated burden for the information collection reflects an overall decrease of 3,129 hours and an increase of 94 responses/records. We attribute this adjustment to an increase in renewal requests since the program was initiated.

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Annual Cost to Federal Government: $4,368,293

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: 06/30/2023

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