State Petitions for Exemption from Preemption

ICR 201410-0910-012

OMB: 0910-0277

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-10-20
IC Document Collections
IC ID
Document
Title
Status
5846
Unchanged
ICR Details
0910-0277 201410-0910-012
Historical Active 201108-0910-011
HHS/FDA CFSAN
State Petitions for Exemption from Preemption
Extension without change of a currently approved collection   No
Regular
Approved without change 11/24/2014
Retrieve Notice of Action (NOA) 10/27/2014
  Inventory as of this Action Requested Previously Approved
11/30/2017 36 Months From Approved 11/30/2014
1 0 1
40 0 40
0 0 0

Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption from Federal preemption of State food labeling and standard of identity requirements. The information required under 21 CFR 100.1(d) enables FDA to determine whether the State food labeling or standard of identity requirement satisfies the criteria of section 403A(b) of the act for granting exemption from Federal preemption.

US Code: 21 USC 343-1(b) Name of Law: null
  
None

Not associated with rulemaking

  79 FR 46269 08/07/2014
79 FR 63128 10/22/2014
No

1
IC Title Form No. Form Name
Reporting - State Petitions for Exemption from Preemption

  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) 40 40 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$3,447
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
10/27/2014


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