[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67983-67984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27847]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0536]
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 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 drug applications (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 either electronic or written comments on the collection
of information by January 3, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to 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
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
[email protected].
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
[[Page 67984]]
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).
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 decision-
making, 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 seven sponsors will submit approximately one VGDS and
that, on average, each VGDS will take approximately 50 hours to prepare
and submit to FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Annual
Number of frequency per Total annual Hours per Total hours
respondents response responses response
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Voluntary Genomic Data Submissions Total........................... 7 1 7 50 350
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Dated: October 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-27847 Filed 11-3-10; 8:45 am]
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