State Enforcement Notifications

ICR 201506-0910-008

OMB: 0910-0275

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-06-04
IC Document Collections
IC ID
Document
Title
Status
5842
Unchanged
ICR Details
0910-0275 201506-0910-008
Historical Active 201203-0910-003
HHS/FDA CFSAN
State Enforcement Notifications
Extension without change of a currently approved collection   No
Regular
Approved without change 07/07/2015
Retrieve Notice of Action (NOA) 06/08/2015
  Inventory as of this Action Requested Previously Approved
07/31/2018 36 Months From Approved 07/31/2015
1 0 1
10 0 10
0 0 0

Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections of the act in their own names, but provides that States must notify FDA before doing so. Section 100.2(d) (21 CFR 100.2 (d)) sets forth the information that a State must provide to FDA in a letter of notification when it intends to take enforcement action under the act against a particular food located in the State.

US Code: 21 USC 337 Name of Law: FFDCA
  
None

Not associated with rulemaking

  80 FR 13392 03/13/2015
80 FR 29012 05/20/2015
No

1
IC Title Form No. Form Name
State Enforcement Notifications

  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) 10 10 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$3,481
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.
06/08/2015


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