GFI: Controlled Correspondence Related to Generic Drug Development

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
217370	Submitting Controlled Correspondence	Modified

ICR Details

OMB Control No: 0910-0797	ICR Reference No: 201808-0910-003
Status: Historical Inactive	Previous ICR Reference No: 201507-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: GFI: Controlled Correspondence Related to Generic Drug Development
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 08/22/2018
	Date Received in OIRA: 08/21/2018
Terms of Clearance: According to the supporting statement, the information collection reflects an increase in the number of annual responses based on submissions received, a revision of the companion guidance to align with GDUFA II commitments regarding timeframes and agency goals, AND the establishment of an electronic submission portal to replace submissions by e-mail. As such, this should be submitted as a revision request and not an extension without change. The portal must also be included as an IC in the revision request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	10/31/2018
Responses	1,020	0	1,020
Time Burden (Hours)	5,100	0	5,100
Cost Burden (Dollars)	0	0	0

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Abstract: This Information Collection Request (ICR) supports agency guidance. The guidance document provides recommendations for generic drug manufacturers and related industry who wish to submit a controlled correspondence related to generic drug development to the Food and Drug Administration (FDA). The guidance document supports FDA's commitments under the Generic Drug User Fee Amendments of 2012 (GDUFA) and Reauthorization of 2017.

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Authorizing Statute(s): PL: Pub.L. 112 - 133 Title III Name of Law: Generic Drug User Fee Amendments for 2012
   US Code: 21 USC 301 et. seq. Name of Law: FFDCA
   US Code: 21 USC 355 Name of Law: New Drugs
  

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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 23692	05/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 41077	08/17/2018
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
Submitting Controlled Correspondence

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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: $0

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: 08/21/2018

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