Environmental Impact Considerations

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0322 4-12-2016.doc Supporting Statement A	2016-04-12

IC Document Collections

IC ID	Document Title	Status
5900	Enviornmental Impact Considerations	Modified

ICR Details

OMB Control No: 0910-0322	ICR Reference No: 201603-0910-011
Status: Historical Active	Previous ICR Reference No: 201302-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Environmental Impact Considerations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/18/2016
	Date Received in OIRA: 04/13/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2019	36 Months From Approved	05/31/2016
Responses	15,527	0	14,188
Time Burden (Hours)	231,224	0	188,430
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): US Code: 42 USC 4321-4347 Name of Law: National Environmental Policy Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 53807	09/08/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 15729	03/24/2016
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Enviornmental Impact Considerations

---

ICR Summary of Burden

	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	15,527	14,188	0	0	1,339	0
Annual Time Burden (Hours)	231,224	188,430	0	0	42,794	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The revised projected burden is expected to increase by 42,794 hours (231,224 projected burden hours minus 188,430 currently approved burden hours). (The revised estimates are the result of updated data from each of FDA’s Centers, and are based on the updated Center information summarized below for claims for categorical exclusions and EAs submitted during 2014 and on the addition of burden for environmental assessments for tobacco products added to this collection.

---

Annual Cost to Federal Government: $1,360,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/13/2016

---