Controlled Correspondence Related to Generic Drug Development

ICR 202002-0910-011

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
ICR Details
0910-0797 202002-0910-011
Active 201808-0910-011
HHS/FDA CDER
Controlled Correspondence Related to Generic Drug Development
Revision of a currently approved collection   No
Regular
Approved with change 06/02/2020
Retrieve Notice of Action (NOA) 04/28/2020
  Inventory as of this Action Requested Previously Approved
06/30/2023 36 Months From Approved 10/31/2021
1,482 0 1,482
7,480 0 7,480
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.

US Code: 21 USC 301 et. seq. Name of Law: FFDCA
   US Code: 21 USC 355 Name of Law: New Drugs
   PL: Pub.L. 115 - 52 Title VI Name of Law: FDARA of 2017; Improvements Related to Drugs
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  83 FR 23692 05/22/2018
84 FR 61062 11/12/2019
No

1
IC Title Form No. Form Name
Controlled Correspondence Related to Generic Drug Development

  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 1,482 1,482 0 0 0 0
Annual Time Burden (Hours) 7,480 7,480 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    Yes
    No
No
No
No
No
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.
04/28/2020


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