Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

ICR 202010-0910-003

OMB: 0910-0614

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-11-25
ICR Details
0910-0614 202010-0910-003
Active 201706-0910-018
HHS/FDA CBER
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Extension without change of a currently approved collection   No
Regular
Approved without change 12/30/2020
Retrieve Notice of Action (NOA) 11/25/2020
  Inventory as of this Action Requested Previously Approved
12/31/2023 36 Months From Approved 12/31/2020
2 0 2
32 0 32
0 0 0

This information collection supports agency regulations pertaining to Exceptions or Alternatives to Labeling Requirements for Products Held By the Strategic National Stockpile (SNS). The regulations require certain reporting by respondents who make requests for such exceptions for alternatives. Requests granted under the regulations may include conditions or safeguards so that the labeling for such products includes appropriate information necessary for the safe and effective use of the product under its anticipated circumstances of use. This facilitates the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency.

PL: Pub.L. 107 - 188 121 Name of Law: PHS and Bioterrorism Preparedness and Response Act
   US Code: 42 USC 201 et seq. Name of Law: PHS Act
   US Code: 21 USC 301 et seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  85 FR 39914 07/02/2020
85 FR 70180 11/04/2020
Yes

  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 2 0 0 0 0
Annual Time Burden (Hours) 32 32 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$3,160
No
    No
    No
No
No
No
No
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.
11/25/2020


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