Guidance for Industry - Pharmacogenomic Data Submissions

ICR 201706-0910-004

OMB: 0910-0557

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
6279
Modified
ICR Details
0910-0557 201706-0910-004
Historical Active 201404-0910-013
HHS/FDA CDER
Guidance for Industry - Pharmacogenomic Data Submissions
Extension without change of a currently approved collection   No
Regular
Approved without change 09/18/2017
Retrieve Notice of Action (NOA) 07/18/2017
  Inventory as of this Action Requested Previously Approved
09/30/2020 36 Months From Approved 09/30/2017
1 0 4
50 0 200
0 0 0

The information collection supports agency guidance. Respondents to the collections are sponsors holding Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applicatons (BLAs). The guidance makes recommendations to respondents with regarding what pharmacogenomic data to submit to FDA during the drug development process, the format of submissions, and how the data will be used in regulatory decisionmaking.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 14221 03/17/2017
82 FR 27841 06/19/2017
No

1
IC Title Form No. Form Name
Voluntary Genomic 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 1 4 0 0 -3 0
Annual Time Burden (Hours) 50 200 0 0 -150 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
07/18/2017


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