Investigational New Drug Regulations

Forms and Documents

Document Name	Status
RevisedFinalPRA0014_SS_2009[1] Supporting Statement A	2009-07-23

IC Document Collections

IC ID	Document Title	Status
5669	Investigational New Drug Regulations	Modified
189367	Investigational New Drug Regulations	New
189366	Investigational New Drug Regulations	New
189365	Investigational New Drug Regulations	New
189364	Investigational New Drug Regulations	New
189363	Investigational New Drug Regulations	New
189362	Investigational New Drug Regulations	New
189361	Investigational New Drug Regulations	New
189360	Investigational New Drug Regulations	New
189359	Investigational New Drug Regulations	New
189358	Investigational New Drug Regulations	New
189357	Investigational New Drug Regulations	New
189356	Investigational New Drug Regulations	New
189355	Investigational New Drug Regulations	New
189354	Investigational New Drug Regulations	New
189353	Investigational New Drug Regulations	New
189352	Investigational New Drug Regulations	New
189351	Investigational New Drug Regulations	New
189350	Investigational New Drug Regulations	New
189349	Investigational New Drug Regulations	New
189348	Investigational New Drug Regulations	New
189347	Investigational New Drug Regulations	New
189346	Investigational New Drug Regulations	New
189345	Investigational New Drug Regulations	New
189344	Investigational New Drug Regulations	New
189343	Investigational New Drug Regulations	New
189342	Investigational New Drug Regulations	New
189341	Investigational New Drug Regulations	New
189340	Investigational New Drug Regulations	New
189339	Investigational New Drug Regulations	New
189338	Investigational New Drug Regulations	New
189337	Investigational New Drug Regulations	New
189336	Investigational New Drug Regulations	New
189335	Investigational New Drug Regulations	New
189334	Investigational New Drug Regulations	New
189333	Investigational New Drug Regulations	New
189332	Investigational New Drug Regulations	New
189331	Investigational New Drug Regulations	New
189330	Investigational New Drug Regulations	New
189329	Investigational New Drug Regulations	New
189328	Investigational New Drug Regulations	New
189327	Investigational New Drug Regulations	New
189326	Investigational New Drug Regulations	New
189325	Investigational New Drug Regulations	New
189324	Investigational New Drug Regulations	New
189323	Investigational New Drug Regulations	New
189322	Investigational New Drug Regulations	New
189321	Investigational New Drug Regulations	New
189320	Investigational New Drug Regulations	New
189319	Investigational New Drug Regulations	New
189318	Investigational New Drug Regulations	New
189317	Investigational New Drug Regulations	New
189316	Investigational New Drug Regulations	New
189315	Investigational New Drug Regulations	New
189314	Investigational New Drug Regulations	New
189313	Investigational New Drug Regulations	New
189312	Investigational New Drug Regulations	New
189311	Investigational New Drug Regulations	New

ICR Details

OMB Control No: 0910-0014	ICR Reference No: 200905-0910-005
Status: Historical Active	Previous ICR Reference No: 200602-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Investigational New Drug Regulations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/06/2009
	Date Received in OIRA: 05/28/2009
Terms of Clearance: This ICR is approved consistent with revised supporting statement. This ICR does not reflect any burden changes as a result of the expanded access or charging final rules. We understand that FDA plans to cover those incremental burden changes in a separate ICR. Prior to next submission, FDA agrees to reconcile the cost and burden estimates in that separate ICR with the cost and burden estimates in this ICR, and then discontinue that separate ICR.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2011	36 Months From Approved	08/31/2009
Responses	2,744,640	0	1,277,517
Time Burden (Hours)	141,492,162	0	71,369,525
Cost Burden (Dollars)	0	0	0

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Abstract: Information collection from applicants who apply for approval of an investigational new drug application in order to develop a drug for marketing.

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Authorizing Statute(s): US Code: 21 USC 355(i) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 6889	02/11/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 21690	05/08/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 58

IC Title	Form No.	Form Name
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
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Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
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Investigational New Drug Regulations
Investigational New Drug Regulations
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Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
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Investigational New Drug Regulations
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Investigational New Drug Regulations
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Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations
Investigational New Drug Regulations

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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	2,744,640	1,277,517	0	0	1,467,123	0
Annual Time Burden (Hours)	141,492,162	71,369,525	0	0	70,122,637	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $63,679,000

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: 05/28/2009

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