Guidance for Industry - Pharmacogenomic Data Submissions

ICR 200712-0910-010

OMB: 0910-0557

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2007-11-21
IC Document Collections
IC ID
Document
Title
Status
6279
Modified
ICR Details
0910-0557 200712-0910-010
Historical Active 200409-0910-005
HHS/FDA
Guidance for Industry - Pharmacogenomic Data Submissions
Extension without change of a currently approved collection   No
Regular
Approved without change 02/08/2008
Retrieve Notice of Action (NOA) 12/19/2007
  Inventory as of this Action Requested Previously Approved
02/28/2011 36 Months From Approved 02/29/2008
10 0 80
500 0 6,400
0 0 0

This guidance provides recommendations to sponsors submitting or holding investigational new drug applications (INDs), new drug applications (NDAs), or biologics license applications (BLAs) on what pharmacogenomic data should be submitted to the agency during the drug development process. Sponsors holding and applicants submitting INDs, NDAs, or BLAs are subject to FDA requirements for submitting to the agency data relevant to drug safety and efficacy (SS 312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).

US Code: 21 USC 312 Name of Law: Investigational New Drug Apllication
  
None

Not associated with rulemaking

  72 FR 46636 08/21/2007
72 FR 70330 12/11/2007
Yes

1
IC Title Form No. Form Name
Guidance for Industry - Pharmacogenomic Data Submissions

  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 10 80 0 0 -70 0
Annual Time Burden (Hours) 500 6,400 0 0 -5,900 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$330,000
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Eliazabeth Berbakos 3018271482

  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.
12/19/2007


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