Expanded Access to Investigational Drugs for Treatment Use

ICR 200909-0910-001

OMB: 0910-0653

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0653 200909-0910-001
Historical Active
Expanded Access to Investigational Drugs for Treatment Use
New collection (Request for a new OMB Control Number)   No
Approved with change 12/23/2009
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
342 0 0
4,192 0 0
0 0 0

The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND).

US Code: 21 USC 305 Name of Law: FFDCA
US Code: 21 USC 312 Name of Law: FFDCA

0910-AF14 Final or interim final rulemaking 71 FR 75147 12/14/2006


IC Title Form No. Form Name
Expanded Access to Investigational Drugs for Treatment Use
Expanded Access to Investigational Drugs for Treatment Use

  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 342 0 0 342 0 0
Annual Time Burden (Hours) 4,192 0 0 4,192 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Changing Regulations
The purpose of this final rule is to expland access to investigational drugs for patients with serious and life-threatening conditions.

Eliazabeth Berbakos 3018271482


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.

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