Survey of Manufacturing Practices in the Dietary Supplement Industry

ICR 199910-0910-001

OMB: 0910-0422

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0422 199910-0910-001
Historical Active
HHS/FDA
Survey of Manufacturing Practices in the Dietary Supplement Industry
New collection (Request for a new OMB Control Number)   No
Emergency 11/07/1999
Approved without change 11/22/1999
Retrieve Notice of Action (NOA) 10/04/1999
This collection is approved consistent with FDA's memoranda of 10/26/99 and 11/22/99. In addition, FDA shall ensure that the compilation and reporting of the survey findings shall note limitations in the design and generalizability, as discussed with OMB.
  Inventory as of this Action Requested Previously Approved
04/30/2000 04/30/2000
1 0 0
452 0 0
0 0 0

The proposed collection of information concerns the current good manufacturing practices of dietary supplement establishments. The objectives are to (1) learn about existing practices and (2) help FDA formulate a policy to ensure that dietary supplements are produced under conditions that will result in a safe and properly labeled product without unnecessary costs to the industry. The survey will provide an understanding of the economic impact that any proposed regulations will have on the industry.

None
None


No

1
IC Title Form No. Form Name
Survey of Manufacturing Practices in the Dietary Supplement Industry

  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) 452 0 0 452 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
Yes Part B of Supporting Statement
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
10/04/1999


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