Enviornmental Impact Considerations

Forms and Documents

Document	Type	Status	Availability
0322 CoverMemo Aug2006.doc	Supplementary Document	Uploaded 2006-08-22	Repair queued
oc0659.pdf	Supplementary Document	Uploaded 2006-08-22	Repair queued
0322-ss-Aug2006.doc	Supporting Statement A	Uploaded 2006-08-22	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5900	Enviornmental Impact Considerations		Modified

ICR Details

OMB Control No: 0910-0322	ICR Reference No: 200610-0910-003
Status: Historical Active	Previous ICR Reference No: 200307-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 without change	Conclusion Date: 01/04/2007
	Date Received in OIRA: 10/13/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	2,982	0	10,748
Time Burden (Hours)	170,332	0	210,182
Cost Burden (Dollars)	0	0	0

---

Abstract: This collection of information is used by FDA to assess the environmental impact of agency actions and to ensure that the pubic is informed of environmental analyses.

---

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:
	71 FR 15753	03/29/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 55484	09/22/2006
Did the Agency receive public comments on this ICR? Yes

---

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	2,982	10,748	0	-7,766	0	0
Annual Time Burden (Hours)	170,332	210,182	0	-39,850	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The revised burden estimates is due to the decreased number of claims for categorical exclusions and EAs submitted during 2004-2005.

---

Annual Cost to Federal Government: $2

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/25/2006

---