Orphan Drug Regulations

ICR 201306-0910-009

OMB: 0910-0702

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-06-11
IC Document Collections
ICR Details
0910-0702 201306-0910-009
Historical Active 201110-0910-007
HHS/FDA 19743
Orphan Drug Regulations
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 09/16/2013
Retrieve Notice of Action (NOA) 06/18/2013
  Inventory as of this Action Requested Previously Approved
09/30/2016 36 Months From Approved
30 0 0
64 0 0
0 0 0

Amendments to these regulations are intended to clarify regulatory provisions and make minor improvements to address isues that have arisen since the issuance of the regulations in 1992. They are intended to assist sponsors who are seeking and who have obtained orphan--drug designations, as well as FDA in its administration of the orphan drug program.

US Code: 21 USC 525-528 Name of Law: FFDCA
  
None

0910-AG72 Final or interim final rulemaking 78 FR 35117 06/12/2013

Yes

2
IC Title Form No. Form Name
Content and format of a request for orphan-drug designation
Granting orphan-drug designation

  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 30 0 0 30 0 0
Annual Time Burden (Hours) 64 0 0 64 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
This is a new information collection resulting from amending current regulations intended to assist sponsors who are seeking and who have obtain orphan-drug designations.

$650
No
No
No
No
No
Uncollected
JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@fda.hhs.gov

  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.
06/18/2013


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