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 201411-0910-012

OMB: 0910-0608

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-05-26
ICR Details
0910-0608 201411-0910-012
Historical Active 201009-0910-008
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
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 07/07/2015
Retrieve Notice of Action (NOA) 05/26/2015
  Inventory as of this Action Requested Previously Approved
07/31/2018 36 Months From Approved
1 0 0
8 0 0
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

  80 FR 12491 03/09/2015
80 FR 29716 05/22/2015
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 1 0 0 1 0 0
Annual Time Burden (Hours) 8 0 0 8 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Burden for collection remains unchanged, but collection was discontinued when furlough prevented timely renewal. Agency has not sponsored or collected information under this control number during the interim period.

$3,906
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.
05/26/2015


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