Charging for Investigation Drugs under an IND

ICR 200909-0910-002

OMB: 0910-0651

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-12-16
IC Document Collections
IC ID
Document
Title
Status
190570
New
ICR Details
0910-0651 200909-0910-002
Historical Active
HHS/FDA
Charging for Investigation Drugs under an IND
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 12/22/2009
Retrieve Notice of Action (NOA) 09/08/2009
This ICR is approved for 2 years as revised. FDA is reminded that ICRs associated with proposed rules should be submitted twice -- once at the proposed rule stage and again at the final rule stage. FDA is also reminded that burdens should be appropriately classified and should not be attributed to statute if they stem from agency discretion. Finally, FDA agrees to fold the burden in this ICR into 0910-0014. At that time, FDA shall discontinue this ICR.
  Inventory as of this Action Requested Previously Approved
12/31/2011 36 Months From Approved
24 0 0
576 0 0
0 0 0

This rule clarifies the circumstancs in which charging for an investigational drug in a clincial trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use and clarifies what costs can be recovered.

US Code: 21 USC 312 Name of Law: FFDCA
   US Code: 21 USC 316 Name of Law: FFDCA
  
US Code: 21 USC 312 Name of Law: FFDCA

0910-AF13 Final or interim final rulemaking 71 FR 75168 12/14/2006

Yes

1
IC Title Form No. Form Name
Charging for Investigation Drugs under an IND

  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 24 0 0 24 0 0
Annual Time Burden (Hours) 576 0 0 576 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This rule replaces the previous charging regulation.

$0
No
No
Uncollected
Uncollected
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
09/08/2009


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