Environmental Impact Considerations

ICR 202208-0910-001

OMB: 0910-0322

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-08-24
IC Document Collections
IC ID
Document
Title
Status
5900 Modified
ICR Details
0910-0322 202208-0910-001
Received in OIRA 202201-0910-004
HHS/FDA CROSS CENTER
Environmental Impact Considerations
Revision of a currently approved collection   No
Regular 08/24/2022
  Requested Previously Approved
36 Months From Approved 03/31/2025
30,423 39,252
325,404 314,736
0 0

This information collection supports FDA implementation of the National Environmental Policy Act (NEPA). . NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment or, in the alternative, the assertion of a categorical exclusion. Agency regulations governing NEPA compliance are found in 21 CFR part 25.

US Code: 42 USC 4321-4347 Name of Law: National Environmental Policy Act
  
None

Not associated with rulemaking

  86 FR 47501 08/25/2021
87 FR 48677 08/10/2022
Yes

1
IC Title Form No. Form Name
Enviornmental Impact Considerations

  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 30,423 39,252 0 0 -8,829 0
Annual Time Burden (Hours) 325,404 314,736 0 0 10,668 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
As a result of revising the information collection to include submissions made to CFSAN, there is an increase of burden by 108 responses and 10,668 hours annually. However, upon review of the ICR we noted an inadvertent calculation error in our previous submission with regard to the annual number of responses; we have corrected the error with this submission and thus the ICR reflects an adjustment of -8,829.

$1,440,000
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@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.
08/24/2022


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