Orphan Drug Act Regulations -- 21 CFR Part 316

ICR 199805-0910-002

OMB: 0910-0167

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5768
Migrated
ICR Details
0910-0167 199805-0910-002
Historical Active 199302-0910-004
HHS/FDA
Orphan Drug Act Regulations -- 21 CFR Part 316
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 07/06/1998
Retrieve Notice of Action (NOA) 05/11/1998
  Inventory as of this Action Requested Previously Approved
07/31/2001 07/31/2001
620 0 0
20,964 0 0
0 0 0

The regulation defines the process and procedures whereby sponsors of drugs for rare diseases/conditions may access the incentives of the Act for written communications for conducting clinical testing, obtaining designated orphan drug status, and obtaining exclusive marketing approval for a designated orphan drug.

None
None


No

1
IC Title Form No. Form Name
Orphan Drug Act Regulations -- 21 CFR Part 316

  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 620 0 0 620 0 0
Annual Time Burden (Hours) 20,964 0 0 20,964 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.
05/11/1998


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