ABBREVIATED NEW DRUG APPLICATION REGULATIONS, PATENT AND EXCLUSIVITY PROVISIONS

ICR 199411-0910-003

OMB: 0910-0305

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
0910-0305 199411-0910-003
Historical Active
HHS/FDA
ABBREVIATED NEW DRUG APPLICATION REGULATIONS, PATENT AND EXCLUSIVITY PROVISIONS
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/20/1995
Retrieve Notice of Action (NOA) 11/14/1994
  Inventory as of this Action Requested Previously Approved
01/31/1998 01/31/1998
596 0 0
1,529 0 0
0 0 0

THESE REGULATIONS PROVIDE INSTRUCTIONS ON HOW TO FILE PATENT INFORMATION, REQUEST MARKET EXCLUSIVITY, AND DESCRIBE FDA'S GUIDELINES REGARDING PATENTS AND EXCLUSIVITY.

None
None


No

1
IC Title Form No. Form Name
ABBREVIATED NEW DRUG APPLICATION REGULATIONS, PATENT AND EXCLUSIVITY PROVISIONS

  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 596 0 0 596 0 0
Annual Time Burden (Hours) 1,529 0 0 1,529 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
11/14/1994


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