[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Notices]
[Pages 46636-46638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0317]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the

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PRA), Federal agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection resulting from 
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.

DATES: Submit written or electronic comments on the collection of 
information by October 22, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 
Submit written comments on the collection of information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

    The guidance provides recommendations to sponsors submitting or 
holding INDs, NDAs, or 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.

                                 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.



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    Dated: August 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16470 Filed 8-20-07; 8:45 am]
BILLING CODE 4160-01-S