NATIONAL ENVIRONMENTAL POLICY ACT: POLICIES AND PROCEDURES 21 CFR PART 25

ICR 199107-0910-001

OMB: 0910-0190

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0190 199107-0910-001
Historical Active 198904-0910-029
HHS/FDA
NATIONAL ENVIRONMENTAL POLICY ACT: POLICIES AND PROCEDURES 21 CFR PART 25
Extension without change of a currently approved collection   No
Regular
Approved without change 09/24/1991
Retrieve Notice of Action (NOA) 07/24/1991
  Inventory as of this Action Requested Previously Approved
09/30/1994 09/30/1994 09/30/1991
1 0 1
1 0 1
0 0 0

THE NATIONAL ENVIRONMENTAL POLICY ACT REQUIRES EACH FEDERAL AGENCY TO CONSIDER THE ENVIRONMENTAL EFFECTS OF ITS ACTIONS. FIRMS WISHING TO MARKET NEW PRODUCTS REGULATED BY FDA MUST SUBMIT APPLICATIONS REQUESTING APPROVAL CERTAIN APPLICATIONS MUST CONTAIN ENVIRONMENTAL INFORMATION FOR DETERMINING WHETHER THE PROPOSED ACTION WILL HAVE A SIGNIFICANT ENVIRONMENTAL IMPACT.

None
None


No

1
IC Title Form No. Form Name
NATIONAL ENVIRONMENTAL POLICY ACT: POLICIES AND PROCEDURES 21 CFR PART 25

  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 1 1 0 0 0 0
Annual Time Burden (Hours) 1 1 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
07/24/1991


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