Guidance for Industry on Controlled Correspondence Related to Generic Drug Development

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT Controlled Correspondence FINAL 7-8-15.doc Supporting Statement A	2015-07-08

IC Document Collections

IC ID	Document Title	Status
217370	Generic Drug Manufacturers, Related Industry and Their Represenatives Other-Guidance	New

ICR Details

OMB Control No: 0910-0797	ICR Reference No: 201507-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Controlled Correspondence Related to Generic Drug Development
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 without change	Conclusion Date: 09/22/2015
	Date Received in OIRA: 07/09/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved
Responses	1,020	0	0
Time Burden (Hours)	5,100	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This Information Collection Request (ICR) collects information from generic drug manufacturers and related industry that wish to submit a controlled correspondence to which the Food and Drug Administration (FDA) will apply a goal date for a response, consistent with FDA's commitments under the Generic Drug User Fee Amendments of 2012 (GDUFA). The purpose of the controlled correspondence process is to provide a mechanism for direct inquiry on FDA's position with respect to a particular element of generic drug development, and for FDA's direct response, in order to facilitate the submission of high quality abbreviated new drug applications (ANDAs). Respondents submit information as outlined in the guidance for industry entitled Controlled Correspondence Related to Generic Drug Development, including name, title, address, phone number, and entity of the person submitting the inquiry, an email address, an FDA-assigned control number and the submission date of any previous related correspondence, the relevant reference listed drug (RLD), a concise statement of the inquiry, etc. FDA will use this information to facilitate its prompt consideration of the controlled correspondence and response. FDA highly encourages email submission of the requested information and is currently developing an electronic submission form to facilitate review of the submitted information.

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Authorizing Statute(s): PL: Pub.L. 112 - 133 Title III Name of Law: Generic Drug User Fee Amendments for 2012
  

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:
	79 FR 51180	08/27/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 38211	07/02/2015
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Generic Drug Manufacturers, Related Industry and Their Represenatives

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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	1,020	0	0	1,020	0	0
Annual Time Burden (Hours)	5,100	0	0	5,100	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $0

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: 07/09/2015

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