[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Pages 6621-6622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2637]



Food and Drug Administration

[Docket No. FDA-2010-N-0536]

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.


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 March 
9, 2011.

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 [email protected]. 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: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
[email protected].

[[Page 6622]]

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 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.
    In the Federal Register of November 4, 2010 (75 FR 67983), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                        Number of      frequency per     Total annual      Hours per       Total hours
                                                                       Respondents        response        responses         response
Voluntary Genomic Data Submissions.................................               7                1                7               50              350
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2637 Filed 2-4-11; 8:45 am]