Accreditation Scheme for Conformity Assessment Pilot Program

ICR 202109-0910-002

OMB: 0910-0889

Federal Form Document

Forms and Documents
Justification for No Material/Nonsubstantive Change
Supporting Statement A
ICR Details
0910-0889 202109-0910-002
Received in OIRA 202002-0910-010
Accreditation Scheme for Conformity Assessment Pilot Program
No material or nonsubstantive change to a currently approved collection   No
Regular 09/10/2021
  Requested Previously Approved
06/30/2023 06/30/2023
1,945 1,945
13,491 13,491
0 0

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.

PL: Pub.L. 115 - 52 514 Name of Law: FDARA
PL: Pub.L. 115 - 52 514 Name of Law: FDARA

Not associated with rulemaking

  84 FR 46737 09/05/2019
85 FR 23521 04/28/2020

IC Title Form No. Form Name
Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment

  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

Jonna Capezzuto 301 796-3794 [email protected]


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:
    (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;
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.

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