Prescription Drug User Fee Cover Sheet; Form FDA 3397

Forms and Documents

Document Name	Status
Form 3397 Prescription Drug User Fee Cover Sheet; Form FDA 3397 Form and Instruction	Unchanged
User fee cover sheet change request 2017.pdf Justification for No Material/Nonsubstantive Change	2017-08-08
SUPPORTING STATEMENT FINAL 0297 10-23-2015.docx Supporting Statement A	2015-10-23

IC Document Collections

IC ID	Document Title	Status
5861	Prescription Drug User Fee Cover Sheet; Form FDA 3397 Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0297	ICR Reference No: 201708-0910-004
Status: Historical Active	Previous ICR Reference No: 201510-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Prescription Drug User Fee Cover Sheet; Form FDA 3397
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/11/2017
	Date Received in OIRA: 08/08/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	03/31/2019	03/31/2019
Responses	3,709	0	3,709
Time Burden (Hours)	1,855	0	1,855
Cost Burden (Dollars)	0	0	0

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Abstract: 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 for FDA 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 form provides a cross-reference of the fee submitted for an application or supplement utilizing a unique number tracking system. It also identifies pertinent statutory provisions under which the application may qualify for a fee exemption. 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 NDAs, BLAs 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:
	80 FR 20232	04/15/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 63227	10/19/2015
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	3,709	3,709	0	0	0	0
Annual Time Burden (Hours)	1,855	1,855	0	0	0	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: The previous burden estimate was 2,066 hours. The current decrease in burden to 1,855 hours (-211 hours) is mostly attributed to the decrease in the number of certain supplements (mostly manufacturing supplements submitted to CDER) submitted to FDA under total annual responses. The overall decrease is due to the normal variation in the submission of applications and supplements to FDA.

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Annual Cost to Federal Government: $200,340

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 08/08/2017

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