Notice of a Claim for GRAS exemption based on a GRAS Determination

ICR 200003-0910-006

OMB: 0910-0342

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
0910-0342 200003-0910-006
Historical Active 199704-0910-003
HHS/FDA
Notice of a Claim for GRAS exemption based on a GRAS Determination
Extension without change of a currently approved collection   No
Regular
Approved without change 05/12/2000
Retrieve Notice of Action (NOA) 03/29/2000
This collection is approved at this time. FDA must seek PRA approval for any changes made to this information collection that are necessary to conform with its final rule. The changed information collection requirements, once approved, will replace this current collection.
  Inventory as of this Action Requested Previously Approved
05/31/2003 05/31/2003 06/30/2000
60 0 60
9,900 0 9,900
0 0 0

Section 409 of the Federal Food, Drug, and Cosmetic Act establishes a premarket approval requirement for "food additives;" section 201(s) of that act provides an exemption from the definition of "food additive" and thus from the premarket approval requirement, for uses of substances that are generally recognized as safe (GRAS) by qualified experts. FDA has proposed a voluntary procedure whereby members of the food industry who determine that use of a substance satisfies the statutory exemption may notify FDA of that determination. The notice would include a detailed summary of the data and.....

None
None


No

1
IC Title Form No. Form Name
Notice of a Claim for GRAS exemption based on a GRAS Determination

  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 60 60 0 0 0 0
Annual Time Burden (Hours) 9,900 9,900 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
03/29/2000


© 2024 OMB.report | Privacy Policy