Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions

ICR 200205-0910-004

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 200205-0910-004
Historical Active 200104-0910-002
HHS/FDA
Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/28/2002
Retrieve Notice of Action (NOA) 05/28/2002
  Inventory as of this Action Requested Previously Approved
05/31/2002 05/31/2002 07/31/2004
1,052 0 1,052
3,083 0 3,083
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 ANDA's; information for requests for marketing exclusivity for NDA's (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 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 1,052 1,052 0 0 0 0
Annual Time Burden (Hours) 3,083 3,083 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.
05/28/2002


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