Expanded Access to Investigational Drugs for Treatment Use

Forms and Documents

Document Name	Status
praExpandedAccessFR SS Incremental#1.doc Supporting Statement A	2009-12-16

IC Document Collections

IC ID	Document Title	Status
190569	Expanded Access to Investigational Drugs for Treatment Use	New
190568	Expanded Access to Investigational Drugs for Treatment Use	New

ICR Details

OMB Control No: 0910-0653	ICR Reference No: 200909-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Expanded Access to Investigational Drugs for Treatment Use
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/23/2009
	Date Received in OIRA: 09/08/2009
Terms of Clearance: 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
Expiration Date	12/31/2011	36 Months From Approved
Responses	342	0	0
Time Burden (Hours)	4,192	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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).

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Authorizing Statute(s): US Code: 21 USC 305 Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 312 Name of Law: FFDCA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF14	Final or interim final rulemaking	71 FR 75147	12/14/2006

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The purpose of this final rule is to expland access to investigational drugs for patients with serious and life-threatening conditions.

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Annual Cost to Federal Government: $1,300,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 09/08/2009

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