Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

ICR 202004-0910-003

OMB: 0910-0606

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-04-26
ICR Details
0910-0606 202004-0910-003
Active 201703-0910-016
HHS/FDA CFSAN
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Revision of a currently approved collection   No
Regular
Approved without change 05/29/2020
Retrieve Notice of Action (NOA) 04/27/2020
  Inventory as of this Action Requested Previously Approved
05/31/2023 36 Months From Approved 05/31/2020
719,041 0 719,040
929,148 0 929,140
0 0 0

This information collection provides for documenting procedures and maintaining records pertaining to the production of dietary supplements. Products that do not meet CGMP requirements may be deemed to be in violation of the Federal Food, Drug, and Cosmetic Act. The information collection also covers regulations pertaining to exemptions from testing requirements applicable to these products and how petitions should be filed with FDA.

US Code: 21 USC 342(g) Name of Law: FFDCA
  
None

Not associated with rulemaking

  84 FR 66678 12/05/2019
85 FR 18998 04/03/2020
No

  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 719,041 719,040 0 0 1 0
Annual Time Burden (Hours) 929,148 929,140 0 0 8 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have made no changes to our estimate of the information collection based on our most recent review. However, in consolidating burden from OMB control number 0910-0608, the information collection reflects an increase of 8 hours and one response annually applicable to petitions under 21 CFR 111.75. We have also consolidated previously itemized elements found at Question 12 of this supporting statement into a single, cumulative estimate we attribute to the recordkeeping requirements found in 21 CFR part 111.

$49,190
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@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.
04/27/2020


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