Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements

ICR 201806-0910-005

OMB: 0910-0608

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-07-14
ICR Details
0910-0608 201806-0910-005
Historical Active 201411-0910-012
HHS/FDA CFSAN
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
Extension without change of a currently approved collection   No
Regular
Approved without change 08/17/2018
Retrieve Notice of Action (NOA) 07/16/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved 08/31/2018
1 0 1
8 0 8
0 0 0

This request solicits information from respondents who petition the agency to request an exemption from 100% identity testing of a dietary ingredient. Relevant regulations are found at 21 CFR 111.75(a)(1) and respondents are firms in the dietary supplement industry, including dietary supplement manufacturers, packagers and re-packagers, holders, labelers and re-labelers, distributors, warehouses, exporters, importers, large businesses, and small businesses.

US Code: 21 USC 342 Name of Law: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
  
None

Not associated with rulemaking

  83 FR 15159 04/09/2018
83 FR 32880 07/16/2018
Yes

  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 1 0 0 0 0
Annual Time Burden (Hours) 8 8 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$4,212
No
    No
    No
No
No
No
Uncollected
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.
07/16/2018


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