Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA

Forms and Documents

Document	Type	Status	Availability
0910-0518_guidance_for_industry.htm	Supplementary Document	Uploaded 2007-08-09	Available
PRACMA2 ss.doc	Supporting Statement A	Uploaded 2007-06-13	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6234	Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA		Modified

ICR Details

OMB Control No: 0910-0518	ICR Reference No: 200706-0910-005
Status: Historical Active	Previous ICR Reference No: 200402-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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: 09/26/2007
	Date Received in OIRA: 06/28/2007
Terms of Clearance: OMB notes that previous terms of clearance mandated that, "FDA shall revise the guidance to display the OMB control number, expiration date and the burden statement." Based on the guidance document submitted as part of this package, OMB does not find these items displayed. As expeditiously as possible, FDA is to revise the guidance to comply with the previous terms of clearance and is to report to OMB when this is done.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2010	36 Months From Approved	09/30/2007
Responses	8	0	125
Time Burden (Hours)	640	0	10,000
Cost Burden (Dollars)	0	0	0

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Abstract: This guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of certain Fast Track drug and biological products. Applicants are being asked to apply to participate in the Pilot program.

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Authorizing Statute(s): US Code: 21 USC 355(a) Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	71 FR 41819	08/24/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 28495	05/21/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA

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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	8	125	0	0	-117	0
Annual Time Burden (Hours)	640	10,000	0	0	-9,360	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: $16,000

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)? Uncollected

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: 06/28/2007

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