Environmental Impact Considerations

ICR 201810-0910-007

OMB: 0910-0322

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-12-13
IC Document Collections
IC ID
Document
Title
Status
5900
Modified
ICR Details
0910-0322 201810-0910-007
Active 201603-0910-011
HHS/FDA CTP
Environmental Impact Considerations
Revision of a currently approved collection   No
Regular
Approved without change 02/22/2019
Retrieve Notice of Action (NOA) 12/13/2018
  Inventory as of this Action Requested Previously Approved
02/28/2022 36 Months From Approved 04/30/2019
16,852 0 15,527
220,658 0 231,224
0 0 0

The National Environmental Policy Act (NEPA) states national environmental objectives and imposes upon each Federal agency the duty to consider the environmental effects of its actions. 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. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse effects cannot be avoided, the agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a Federal Register notices also filed for comment at the Environmental Protection Agency (EPA). If the agency finds that no significant environmental effects are expected, the agency prepares a finding of no significant impact. This collection of information is used by FDA to assess the environmental impact of agency actions. The final EIS, including the comments received, is reviewed by the agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact.

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

Not associated with rulemaking

  83 FR 26477 06/07/2018
83 FR 63179 12/07/2018
Yes

1
IC Title Form No. Form Name
Enviornmental Impact Considerations

  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 16,852 15,527 0 0 1,325 0
Annual Time Burden (Hours) 220,658 231,224 0 0 -10,566 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Our estimated burden for the information collection reflects an overall decrease of 10,566 hours (currently approved 231,224) and a corresponding increase of 1,325 annual responses (currently approved 15,527). The new estimated totals are 220,658 hours and 4,163 annual responses (as shown in table 6). We attribute this adjustment to the number of EA submissions, and categorical exclusions we received since the last extension, and the adjustment of burden for the agencies centers. In reporting burden for Human Foods, CFSAN is no longer a part of this information collection. The burden has now been incorporated into OMB control number 0910-0541.

$1,360,000
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
12/13/2018


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