Guidance for Industry - Pharmacogenomic Data Submissions

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT 0557 FINAL 4-23-14.doc	Supporting Statement A	Uploaded 2014-04-24	Repair queued
Pharmacogenomic data submissions 2005.doc	Supplementary Document	Uploaded 2011-05-04	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6279	Voluntary Genomic Data Submissions	Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0557	ICR Reference No: 201404-0910-013
Status: Historical Active	Previous ICR Reference No: 201102-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry - Pharmacogenomic Data Submissions
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/03/2014
	Date Received in OIRA: 05/08/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	07/31/2014
Responses	4	0	7
Time Burden (Hours)	200	0	350
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance provides recommendations to sponsors holding Investigational New Drugs, New Drug Applications, and Biologics License Applicatons on what pharmacogenomic data to submit to the Agency during the drug development process, the format of submissions, and how the data will be used in regulatory decisionmaking.

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Authorizing Statute(s): US Code: 21 USC 312 Name of Law: Investigational New Drug Apllication
  

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 7198	02/06/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 23359	04/28/2014
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
Voluntary Genomic Data Submissions

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ICR Summary of Burden

	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	4	7	0	0	-3	0
Annual Time Burden (Hours)	200	350	0	0	-150	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Based on our experience with the submission of voluntary genomic data submissions under this guidance over the past few years, the number of annual responses has been reduced from 7 to 4 because of reduced submissions. There are no other changes or adjustments.

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Annual Cost to Federal Government: $462,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 05/08/2014

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