Labeling Requirements for Color Additives (Other Than Hair Dyes) and Petitions (Formerly Color Additive Petitions)

ICR 199609-0910-001

OMB: 0910-0185

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0185 199609-0910-001
Historical Active 199509-0910-001
HHS/FDA
Labeling Requirements for Color Additives (Other Than Hair Dyes) and Petitions (Formerly Color Additive Petitions)
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 10/18/1996
Retrieve Notice of Action (NOA) 09/06/1996
  Inventory as of this Action Requested Previously Approved
10/31/1999 10/31/1999
2 0 0
3,415 0 0
6,000,000 0 0

Color Additive petitions are reviewed by the Food and Drug Administration (FDA) scientific personnel to assure the identity of the substance; its use in or on drugs, medical devices, foods, or cosmetics; and that the intended use is safe. The color additive petitions provide the only method for premarket review and approval of color additives, without which there would be no legal way to bring new products to market. The labeling requirements require that color additives used in drugs, devices, foods, or cosmetics be labeled with sufficient information to ensure their safe use.

None
None


No

1
IC Title Form No. Form Name
Labeling Requirements for Color Additives (Other Than Hair Dyes) and Petitions (Formerly Color Additive Petitions)

  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 2 0 0 2 0 0
Annual Time Burden (Hours) 3,415 0 0 3,415 0 0
Annual Cost Burden (Dollars) 6,000,000 0 0 6,000,000 0 0
Yes
No

$0
No
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.
09/06/1996


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