Document ID: FDA-2010-N-0536-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Guidance for
Industry on Pharmacogenomic Data Submission
Posted Date: 2017-06-19T04:00Z

[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27841-27842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12604]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 Submission

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 July 
19, 2017.

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 oira_submission@omb.eop.gov. 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.

[[Page 27842]]

FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezutto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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 collection of information supports Agency guidance entitled, 
``Guidance for Industry on Pharmacogenomic Data Submissions.'' 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 21 CFR parts 
312, 314, and 601 (approved under OMB control numbers 0910-0014 (part 
312, INDs); 0910-0001 (part 314, NDAs and annual reports); and 0910-
0338 (part 601, BLAs)), respectively.
    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.
    In the Federal Register of March 17, 2017 (82 FR 14221), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. One comment was received, 
however it was not responsive to the four information collection topics 
solicited in the notice and therefore is not addressed here.
    FDA has estimated the burden of preparing a voluntary submission 
described in the guidance that should be designated as a VGDS based on 
our experience with these submissions over the past few years, and on 
our familiarity with sponsors' interest in submitting pharmacogenomic 
data during the drug development process. In 2013, we received three 
VGDS. Since 2013, there have been no submission of VGDS; however, for 
purposes of this information collection approval, we are estimating 
that we may receive one submission annually. We estimate each 
submission requires approximately 50 hours to prepare and submit to 
FDA.
    We therefore estimate the burden of this collection of information 
as follows:

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

    Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12604 Filed 6-16-17; 8:45 am]
 BILLING CODE 4164-01-P