GFI: Controlled Correspondence Related to Generic Drug Development

ICR 201808-0910-003

OMB: 0910-0797

Federal Form Document

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
Modified
ICR Details
0910-0797 201808-0910-003
Historical Inactive 201507-0910-003
HHS/FDA CDER
GFI: Controlled Correspondence Related to Generic Drug Development
Extension without change of a currently approved collection   No
Regular
Improperly submitted and continue 08/22/2018
Retrieve Notice of Action (NOA) 08/21/2018
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
09/30/2018 36 Months From Approved 10/31/2018
1,020 0 1,020
5,100 0 5,100
0 0 0

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.

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
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  83 FR 23692 05/22/2018
83 FR 41077 08/17/2018
No

1
IC Title Form No. Form Name
Submitting Controlled Correspondence

No
No

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/21/2018


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