Document ID: FDA-2007-N-0220-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Guidance for
Industry on Pharmacogenomic Data Submissions
Posted Date: 2014-04-28T04:00Z

[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Pages 23359-23360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09470]

[[Page 23359]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0220]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

DATES: Fax written comments on the collection of information by May 28, 
2014.

ADDRESSES: 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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0557. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 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 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 (21 CFR 312.22, 
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).
    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 these submissions 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 four sponsors will submit approximately one VGDS each, 
and that, on average, each VGDS will take approximately 50 hours to 
prepare and submit to FDA.
    In the Federal Register of February 6, 2014 (79 FR 7198), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Voluntary Genomic Data                         4               1               4              50             200
 Submissions....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 23360]]

    Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09470 Filed 4-25-14; 8:45 am]
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