Accreditation Scheme for Conformity Assessment Pilot Program

Forms and Documents

Document Name	Status
0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx Justification for No Material/Nonsubstantive Change	2021-09-10
ASCA Pilot ss 4-22-20.docx Supporting Statement A	2020-05-01

IC Document Collections

IC ID	Document Title	Status
240128	Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment Other-instructions for filing an application for accreditation b	Modified

ICR Details

OMB Control No: 0910-0889	ICR Reference No: 202109-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202002-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Accreditation Scheme for Conformity Assessment Pilot Program
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/10/2021

	Requested	Previously Approved
Expiration Date	06/30/2023	06/30/2023
Responses	1,945	1,945
Time Burden (Hours)	13,491	13,491
Cost Burden (Dollars)	0	0

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Abstract: This ICR includes information collection from accreditation bodies (ABs) who wish to obtain recognition from the Agency so that they can accredit testing laboratories (TLs) for the voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The ICR also includes information collection from TLs who wish to obtain ASCA Accreditation from the Agency so that they can conduct testing under the ASCA Pilot. The ASCA Pilot Program, under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d(d)), supports the Agency’s continued efforts to effectively use its scientific resources to protect and promote public health by simplifying certain aspects of premarket review, thereby reducing burdens on the Agency for individual submissions.

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Authorizing Statute(s): PL: Pub.L. 115 - 52 514 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:
	84 FR 46737	09/05/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 23521	04/28/2020
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
Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment

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ICR Summary 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	1,945	1,945	0	0	0	0
Annual Time Burden (Hours)	13,491	13,491	0	0	0	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:

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Annual Cost to Federal Government: $1,791,525

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? 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: 09/10/2021

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