Document ID: FDA-2010-N-0536-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Pharmacogenomic Data Submissions
Posted Date: 2010-11-04T04:00Z

[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Notices]               
[Page 67983-67984]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no10-51]                         

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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, 
Elizabeth.Berbakos@fda.hhs.gov.

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]
BILLING CODE 4160-01-P