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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
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:
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
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
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.
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
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
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:
02/25/2013
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