Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002

ICR 202101-0910-004

OMB: 0910-0510

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-01-14
Supporting Statement A
2021-01-14
ICR Details
0910-0510 202101-0910-004
Received in OIRA 201907-0910-007
HHS/FDA CDRH
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
No material or nonsubstantive change to a currently approved collection   No
Regular 01/14/2021
  Requested Previously Approved
08/31/2022 08/31/2022
11 1
230 80
0 0

Information from this collection will be used by FDA to implement an Inspection by Accredited Persons program that will train and accredit persons that wish to conduct inspections of eligible manufacturers of class II and class III medical devices. This action is required by MDUFMA. This ICR collects information from manufactures of class II or class III medical devices who meet certain eligibility criteria and who intend to use an "accredited person" to conduct an inspection of their establishment. Under the Inspection by Accredited Persons Program, eligible manufacturers may elect to have third parties that have been accredited by FDA conduct some of their inspections instead of FDA. This program allows manufacturers greater control over the timing of their inspections and, in some cases, may reduce the need for multiple inspections of the same establishment.

US Code: 21 USC 374 Name of Law: Food and Drug Cosmetic Act.
  
None

Not associated with rulemaking

  84 FR 9352 03/14/2019
84 FR 34401 07/18/2019
No

  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 11 1 0 0 10 0
Annual Time Burden (Hours) 230 80 0 0 150 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
FDA has requested consolidation of OMB Control Nos. 0910-0510 and 0910-0569. The estimated hour burden has increased by 150 hours as the result of adding the approved burden from OMB Control No. 0910-0569 to this ICR. Because these two information collections are related to the same program, authorized under section 704(g) of the FD&C Act, we believe the estimated burdens described above are most appropriately expressed under one ICR. Additionally, this consolidation may increase administrative efficiency by reducing FDA’s active ICR inventory. Therefore, we request the addition of the information collection in OMB Control No. 0910-0569 to OMB Control No. 0910-0510. Upon approval of this consolidation, we would then terminate OMB Control No. 0910-0569.

$540,610
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
01/14/2021


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