Enviornmental Impact Considerations

Forms and Documents

Document Name	Status
OMB 0910_0322 Environmental Impact Considerations SS Final.doc Supporting Statement A	2013-02-21

IC Document Collections

IC ID	Document Title	Status
5900	Enviornmental Impact Considerations	Modified

ICR Details

OMB Control No: 0910-0322	ICR Reference No: 201302-0910-005
Status: Historical Active	Previous ICR Reference No: 201001-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: 18881
Title: Enviornmental Impact Considerations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/23/2013
	Date Received in OIRA: 02/25/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved	05/31/2013
Responses	14,188	0	11,916
Time Burden (Hours)	188,430	0	193,817
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information "Environmental Impact Considerations." The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal agency the duty to consider the environmental effects of its actions that will significantly affect the quality of the human environment. The FDA NEPA regulations are contained in 21 CFR part 25. All applications or petitions requesting Agency action require the submission of a claim for a categorical exclusion or an environmental assessment (EA). This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. 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 notice 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 FONSI. The respondents to this collection are primarily from the private sector businesses.

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

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 59619	09/28/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 11892	02/20/2013
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Enviornmental Impact Considerations

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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	14,188	11,916	0	0	2,272	0
Annual Time Burden (Hours)	188,430	193,817	0	0	-5,387	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The revised projected burden is expected to decrease by 5,387 hours (193,817 currently approved burden hours minus 188,430 projected 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 2011 and on the addition of burden for environmental assessments for tobacco products added to this collection. A summary of the changes is discussed in the supporting statement in detail.

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Annual Cost to Federal Government: $1,160,000

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

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Common Form ICR:  No

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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: 02/25/2013

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