State Enforcement Notifications

ICR 202105-0910-007

OMB: 0910-0275

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-06-14
IC Document Collections
IC ID
Document
Title
Status
5842
Modified
ICR Details
0910-0275 202105-0910-007
Received in OIRA 201806-0910-004
HHS/FDA CFSAN
State Enforcement Notifications
Extension without change of a currently approved collection   No
Regular 06/16/2021
  Requested Previously Approved
36 Months From Approved 07/31/2021
1 1
10 10
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

  85 FR 81932 12/17/2020
86 FR 26046 05/12/2021
No

1
IC Title Form No. Form Name
State Enforcement Notifications

  Total Request 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

$3,974
No
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
06/16/2021


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