Prescription Drug User Fee Cover Sheet; Form FDA 3397

Forms and Documents

Document	Type	Status	Availability
Form 3397 Prescription Drug User Fee Cover Sheet; Form FDA 3397	Form and Instruction	Modified	Repair queued
SUPPORTING STATEMENT PDUFCS FORM FDA 3397 # 18 10-22-12.doc	Supporting Statement A	Uploaded 2012-10-22	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
5861	Prescription Drug User Fee Cover Sheet; Form FDA 3397	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0297	ICR Reference No: 201211-0910-001
Status: Historical Active	Previous ICR Reference No: 200911-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Prescription Drug User Fee Cover Sheet; Form FDA 3397
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 without change	Conclusion Date: 12/27/2012
	Date Received in OIRA: 11/06/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	36 Months From Approved	01/31/2013
Responses	4,131	0	3,917
Time Burden (Hours)	2,066	0	1,959
Cost Burden (Dollars)	0	0	0

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Abstract: Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and collect user fees for certain drug and biologics license applications and supplements. The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is required to be included with each applicable new drug application (NDA), biologics license application (BLA), and supplemental application to an NDA or BLA submitted to FDA for review. The Prescription Drug User Fee Cover Sheet is designed to provide the minimum necessary information to determine whether a fee is required for the review of an application, to determine the amount of the fee required, and to account for and track user fees. The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new drug applications, biologics license applications and/or supplemental applications to those applications.

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Authorizing Statute(s): US Code: 21 USC 379 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:
	77 FR 29663	05/18/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 64523	10/22/2012
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
Prescription Drug User Fee Cover Sheet; Form FDA 3397	3397	Prescription Drug User Fee Cover Sheet

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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	4,131	3,917	0	0	214	0
Annual Time Burden (Hours)	2,066	1,959	0	0	107	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: $198,288

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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: 11/06/2012

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