82 FR 14221 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 51 (March 17, 2017)

Page Range		14221-14223
FR Document		2017-05293

The Food and Drug Administration (FDA, Agency, or we) 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 the submission to the Agency of pharmacogenomic data during the drug development process.

Federal Register, Volume 82 Issue 51 (Friday, March 17, 2017)

[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14221-14223]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05293]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 the submission to the Agency of 
pharmacogenomic data during the drug development process.

DATES: Submit either electronic or written comments on the collection 
of information by May 16, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0536 for ``Guidance for Industry on Pharmacogenomic Data 
Submissions.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the

[[Page 14222]]

Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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 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 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 (approved under OMB 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 
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:

[[Page 14223]]



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


    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05293 Filed 3-16-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices 14223

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Hours per
Information collection activity responses per Total hours
respondents responses response
respondent

Voluntary Genomic Data Submissions ................................ 1 1 1 50 50
1 There are no capital costs or operating and maintenance costs associated with this collection.

Dated: March 13, 2017. Premarket Notification—21 CFR Part HDEs. Under § 807.87(h), each 510(k)
Leslie Kux, 807, Subpart E submitter must include in the 510(k)
Associate Commissioner for Policy. either a summary of the information in
OMB Control Number 0910–0120—
[FR Doc. 2017–05293 Filed 3–16–17; 8:45 am] the 510(k) as required by § 807.92
Reinstatement
BILLING CODE 4164–01–P
(510(k) summary) or a statement
Section 510(k) of the Federal Food, certifying that the submitter will make
Drug, and Cosmetic Act (the FD&C Act) available upon request the information
DEPARTMENT OF HEALTH AND (21 U.S.C. 360(k)) and the implementing in the 510(k) with certain exceptions as
HUMAN SERVICES regulation under part 807 (21 CFR part per § 807.93 (510(k) statement). If the
807, subpart E) require a person who 510(k) submitter includes a 510(k)
Food and Drug Administration intends to market a medical device to statement in the 510(k) submission,
submit a premarket notification § 807.93 requires that the official
[Docket No. FDA–2013–N–0804] submission to FDA at least 90 days correspondent of the firm make
before proposing to begin the available within 30 days of a request all
Agency Information Collection introduction, or delivery for information included in the submitted
Activities; Submission for Office of introduction into interstate commerce, premarket notification on safety and
Management and Budget Review; for commercial distribution of a device effectiveness. This information will be
Comment Request; Premarket intended for human use. Based on the provided to any person within 30 days
Notification information provided in the of a request if the device described in
notification, FDA must determine the 510(k) submission is determined to
AGENCY: Food and Drug Administration, whether the new device is substantially be substantially equivalent. The
HHS. equivalent to a legally marketed device, information provided will be a
ACTION: Notice. as defined in § 807.92(a)(3) (21 CFR duplicate of the 510(k) submission
807.92(a)(3)). If the device is determined including any safety and effectiveness
SUMMARY: The Food and Drug to be not substantially equivalent to a information, but excluding all patient
Administration (FDA) is announcing legally marketed device, it must have an identifiers and trade secret and
that a proposed collection of approved premarket approval commercial confidential information.
information has been submitted to the application (PMA), product Section 204 of the Food and Drug
Office of Management and Budget development protocol, humanitarian Administration Modernization Act
(OMB) for review and clearance under device exemption (HDE), petition for (FDAMA) (Pub. L. 105–115) amended
the Paperwork Reduction Act of 1995. Evaluation of Automatic Class III section 514 of the FD&C Act (21 U.S.C.
DATES: Fax written comments on the Designation (de novo), or be reclassified 360d). Amended section 514 allows
collection of information by April 17, into class I or class II before being FDA to recognize consensus standards
2017. marketed. FDA makes the final decision developed by international and national
ADDRESSES: To ensure that comments on of whether a device is substantially organizations for use in satisfying
the information collection are received, equivalent or not equivalent. portions of device premarket review
OMB recommends that written Section 807.81 states when a submissions including premarket
comments be faxed to the Office of premarket notification is required. A notifications or other requirements. FDA
Information and Regulatory Affairs, premarket notification is required to be has published and updated the list of
OMB, Attn: FDA Desk Officer, FAX: submitted by a person who is: (1) recognized standards regularly since
202–395–7285, or emailed to oira_ Introducing a device to the market for enactment of FDAMA and has allowed
submission@omb.eop.gov. All the first time; (2) introducing a device 510(k) submitters to certify conformance
comments should be identified with the into commercial distribution for the first to recognized standards to meet the
OMB control number 0910–0120. Also time by a person who is required to requirements of § 807.87. Form FDA
include the FDA docket number found register; and (3) introducing or 3654, the 510(k) Standards Data Form,
in brackets in the heading of this reintroducing a device which is standardizes the format for submitting
document. significantly changed or modified in information on consensus standards that
design, components, method of a 510(k) submitter chooses to use as a
FOR FURTHER INFORMATION CONTACT: FDA manufacturer, or the intended use that portion of their premarket notification
PRA Staff, Office of Operations, Food could affect the safety and effectiveness submission (Form FDA 3654 is not for
and Drug Administration, Three White of the device. declarations of conformance to a
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Flint North 10A63, 11601 Landsdown Form FDA 3514, a summary cover recognized standard). FDA believes that
St., North Bethesda, MD 20852, sheet form, assists respondents in use of this form will simplify the 510(k)
PRAStaff@fda.hhs.gov. categorizing administrative 510(k) preparation and review process for
SUPPLEMENTARY INFORMATION: In information for submission to FDA. This 510(k).
compliance with 44 U.S.C. 3507, FDA form also assists respondents in Under § 807.90, submitters may
has submitted the following proposed categorizing information for other FDA request information on their 510(k)
collection of information to OMB for medical device programs such as PMAs, review status 90 days after the initial
review and clearance. investigational device exemptions, and login date of the 510(k). Thereafter, the

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Document Created: 2017-03-17 02:48:55
Document Modified: 2017-03-17 02:48:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by May 16, 2017.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		82 FR 14221

82 FR 14221 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 51 (March 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration