[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70330-70331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0317]


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

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 January 
10, 2008.

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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0557. Also

[[Page 70331]]

include the FDA docket number found in brackets in the heading of this 
document.

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

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 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 (Sec. Sec.  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 Burden\1\
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                          Number of       Number of Responses     Total Annual       Hours per
                         Respondents        per Respondent         Responses         Response       Total Hours
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Voluntary Genomic                     8                  1.25                 10              50             500
 Data Submissions
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.


    Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23996 Filed 12-10-07; 8:45 am]
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