Accreditation Scheme for Conformity Assessment Pilot Program

ICR 202002-0910-010

OMB: 0910-0889

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-05-01
ICR Details
0910-0889 202002-0910-010
Active
HHS/FDA CDRH
Accreditation Scheme for Conformity Assessment Pilot Program
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 06/19/2020
Retrieve Notice of Action (NOA) 05/01/2020
  Inventory as of this Action Requested Previously Approved
06/30/2023 36 Months From Approved
1,945 0 0
13,491 0 0
0 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
No

1
IC Title Form No. Form Name
Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment

  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 1,945 0 0 1,795 150 0
Annual Time Burden (Hours) 13,491 0 0 12,103 1,388 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection.

$1,791,525
No
    Yes
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 [email protected]

  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:
 
 
 
 
 
 
 
    (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.
05/01/2020


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