Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation

ICR 201911-0910-004

OMB: 0910-0073

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-11-15
IC Document Collections
ICR Details
0910-0073 201911-0910-004
Active 201611-0910-002
HHS/FDA CDRH
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation
Extension without change of a currently approved collection   No
Regular
Approved without change 12/17/2019
Retrieve Notice of Action (NOA) 11/15/2019
  Inventory as of this Action Requested Previously Approved
12/31/2022 36 Months From Approved 01/31/2020
27,074 0 24,738
9,021,752 0 8,608,824
0 0 0

This ICR collects information from medical device manufacturers who must meet the Current Good Manufacturing Practice Quality System (CGMP/QS) requirements for purchasing and service controls; recordkeeping requirements for device failure and complaint investigations; requirements for verifying/validating production processes and process or product changes; and requirements for product acceptance activities, quality data evaluations, and corrections of nonconforming product/quality problems. CGMP/QS information collections assist FDA inspections of manufacturer compliance with quality system requirements encompassing design, production, installation, and servicing processes. Manufacturers must ensure that medical devices meet design specifications and that design specifications are effectively transferred from research and development to production.

US Code: 21 USC 351 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 374 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 381 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 384 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  84 FR 37317 07/31/2019
84 FR 62534 11/15/2019
No

1
IC Title Form No. Form Name
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation

  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 27,074 24,738 0 0 2,336 0
Annual Time Burden (Hours) 9,021,752 8,608,824 0 0 412,928 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have adjusted the number of respondents based on updated Registration and Listing data for FY2019 (previously 24,738 respondents per IC; updated to 27,074 respondents per IC). This caused a 412,928-hour increase in the total estimated burden. There are no program changes.

$51,357,950
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
11/15/2019


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