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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.


Fax written comments on the collection of information by January 10, 2008.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to All comments should be identified with the OMB control number 0910-0557. Also Start Printed Page 70331include the FDA docket number found in brackets in the heading of this document.

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Karen L. Nelson, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4816.

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Guidance for Industry on Pharmacogenomic Data Submissions (OMB Control Number 0910-0557)—Extension

The guidance provides recommendations to sponsors submitting or holding investigational new drugs (INDs), new drug applications (NDAs), or biologic licensing 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 (§§ 312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).

Description of Respondents: Sponsors submitting or holding INDs, NDAs, or BLAs for human drugs and biologics.

Burden Estimate: The guidance interprets FDA regulations for IND, NDA, or BLA submissions, clarifying when the regulations require pharmacogenomics data to be submitted and when the submission of such data is voluntary. The pharmacogenomic data submissions described in the guidance that are required to be submitted to an IND, NDA, BLA, or annual report are covered by the information collection requirements under parts 312, 314, and 601 (21 CFR parts 312, 314, and 601) and are approved by OMB under control numbers 0910-0014 (part 312—INDs); 0910-0001 (part 314—NDAs and annual reports); and 0910-0338 (part 601—BLAs).

The guidance distinguishes between pharmacogenomic tests that may be considered valid biomarkers appropriate for regulatory decisionmaking, and other, less well developed exploratory tests. The submission of exploratory pharmacogenomic data is not required under the regulations, although the agency encourages the voluntary submission of such data.

The guidance describes the voluntary genomic data submission (VGDS) that can be used for such a voluntary submission. The guidance does not recommend a specific format for the VGDS, except that such a voluntary submission be designated as a VGDS. The data submitted in a VGDS and the level of detail should be sufficient for FDA to be able to interpret the information and independently analyze the data, verify results, and explore possible genotype-phenotype correlations across studies. FDA does not want the VGDS to be overly burdensome and time-consuming for the sponsor.

FDA has estimated the burden of preparing a voluntary submission described in the guidance that should be designated as a VGDS. Based on FDA's experience with this guidance over the past few years, and on FDA's familiarity with sponsors' interest in submitting pharmacogenomic data during the drug development process, FDA estimates that approximately 8 sponsors will submit approximately 10 VGDSs and that, on average, each VGDS will take approximately 50 hours to prepare and submit to FDA.

In the Federal Register of August 21, 2007 (72 FR 46636), FDA published a 60-day notice requesting public comment on the information collection provisions. We received one comment which requested clarification of how the confidential information received in a VGDS will remain outside the public domain and not end up being cited in a publicly posted submission review.

FDA Response: Information received as part of a VGDS not to be used for regulatory decisionmaking and received in confidence is covered by the same confidentiality levels of INDs, NDAs, and BLAs. There is no publicly posted submission review associated with the data in a VGDS, and release of information associated with a VGDS is exclusively up to the sponsor of the VGDS and not to FDA.

Table 1.—Estimated Annual Reporting Burden1

Number of RespondentsNumber of Responses per RespondentTotal Annual ResponsesHours per ResponseTotal Hours
Voluntary Genomic Data Submissions81.251050500
1 There are no capital costs or operating and maintenance costs associated with this collection.
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Dated: December 5, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-23996 Filed 12-10-07; 8:45 am]