Abbreviated New Drug Application Regulations, Patent and Exclusivity Provision

ICR 199803-0910-004

OMB: 0910-0305

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0305 199803-0910-004
Historical Active 199411-0910-003
HHS/FDA
Abbreviated New Drug Application Regulations, Patent and Exclusivity Provision
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 05/19/1998
Retrieve Notice of Action (NOA) 03/20/1998
  Inventory as of this Action Requested Previously Approved
07/31/2001 07/31/2001
772 0 0
1,731 0 0
0 0 0

The regulations provide instructions for NDA applicants (including 505(b)(2) applicants) and ANDA applicants on how to file patent information and request marketing exclusivity. The regulations require patent certification information for 505(b)(2) applications and ANDAs; information for requests for marketing exclusivity for NDAs (including 505(b)(2) applications and certain NDA supplements); and patent NDA information.

None
None


No

1
IC Title Form No. Form Name
Abbreviated New Drug Application Regulations, Patent and Exclusivity Provision

  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 772 0 0 772 0 0
Annual Time Burden (Hours) 1,731 0 0 1,731 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.
03/20/1998


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