81 FR 46084 - Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 136 (July 15, 2016)

Page Range		46084-46086
FR Document		2016-16735

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.'' This draft guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. This draft guidance is also intended to assist FDA staff participating in the review of such IVD companion diagnostics or their associated therapeutic products. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 81 Issue 136 (Friday, July 15, 2016)

[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46084-46086]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-16735]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1703]

Principles for Codevelopment of an In Vitro Companion Diagnostic
Device With a Therapeutic Product; Draft Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Principles for
Codevelopment of an In Vitro Companion Diagnostic Device with a
Therapeutic Product.'' This draft guidance is intended to be a
practical guide to assist therapeutic product sponsors and in vitro
diagnostic device (IVD) sponsors in developing a therapeutic product
with an accompanying IVD companion diagnostic, a process referred to as
codevelopment. This draft guidance is also intended to assist FDA staff
participating in the review of such IVD companion diagnostics or their
associated therapeutic products. This draft guidance is not final nor
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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

[[Page 46085]]

identifies you in the body of your comments, that information will be
posted on http://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-2016-D-1703 for ``Principles for Codevelopment of an In Vitro
Companion Diagnostic Device with a Therapeutic Product; Draft Guidance
for Industry and Food and Drug Administration Staff.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the 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 http://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 http://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.
An electronic copy of the draft guidance s available for download
from the Internet. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance entitled
``Principles for Codevelopment of an In Vitro Companion Diagnostic
Device with a Therapeutic Product'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or the Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
Office of Communications, Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your request.

FOR FURTHER INFORMATION CONTACT: Pamela Bradley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993-0002, 240-731-3734; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993, 240-402-7911; or Christopher Leptak, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Rm. 6462,
Silver Spring, MD 20993, 301-796-0017.

SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance is intended to be a practical guide to assist
therapeutic product sponsors and IVD sponsors in developing a
therapeutic product, with an accompanying IVD companion diagnostic, a
process referred to as codevelopment. This draft guidance is also
intended to assist FDA staff participating in the review of such IVD
companion diagnostics or their associated therapeutic products.
This draft guidance describes general principles to guide
codevelopment to support obtaining contemporaneous marketing
authorization for a therapeutic product and its corresponding IVD
companion diagnostic; certain regulatory requirements that sponsors
should be aware of as they develop such products; considerations for
planning and executing a therapeutic product clinical trial that also
includes the investigation of an IVD companion diagnostic; and
administrative issues in the submission process for the therapeutic
product and the IVD companion diagnostic.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on ``Principles
for Codevelopment of an In Vitro Companion Diagnostic Device with a
Therapeutic Product.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of
``Principles for Codevelopment of an In Vitro Companion Diagnostic
Device with a Therapeutic Product'' may send an email request to CDRH-
Guidance@

[[Page 46086]]

fda.hhs.gov to receive an electronic copy of the document. Please use
the document number 1400027 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR parts
801 and 809 have been approved under OMB control number 0910-0485; the
collections of information in parts 50 and 56 have been approved under
OMB control number 0910-0130; the collections of information in 21 CFR
part 812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 814 subparts B and E have
been approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 814, subpart H, have been approved under OMB
control number 0910-0332; the collections of information in 21 CFR part
807, subpart E, have been approved under OMB control number 0901-0120;
the collections of information in 21 CFR part 820 have been approved
under OMB control number 0910-0073; the collections of information in
21 CFR part 601 have been approved under OMB control number 0910-0338;
the collections of information in 21 CFR part 312 have been approved
under OMB control number 0910-0014; the collections of information in
21 CFR part 314 have been approved under OMB control number 0910-0001;
and the collections of information resulting from special protocol
assessments have been approved under OMB control number 0910-0470.

Dated: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16735 Filed 7-14-16; 8:45 am]
BILLING CODE 4164-01-P

46086 Federal Register / Vol. 81, No. 136 / Friday, July 15, 2016 / Notices

fda.hhs.gov to receive an electronic ACTION: Notice. industry representatives to the following
copy of the document. Please use the advisory committee.
document number 1400027 to identify SUMMARY: The Food and Drug
Administration (FDA) is requesting that I. CTP Advisory Committee, Tobacco
the guidance you are requesting.
any industry organizations interested in Products Scientific Advisory Committee
IV. Paperwork Reduction Act of 1995 participating in the selection of a The Tobacco Products Scientific
This draft guidance refers to nonvoting industry representative of the Advisory Committee (the Committee)
previously approved collections of tobacco manufacturing industry to serve advises the Commissioner of Food and
information found in FDA regulations on the Tobacco Products Scientific Drugs (the Commissioner) or designee in
and guidance documents. These Advisory Committee for the Center for discharging responsibilities related to
collections of information are subject to Tobacco Products (CTP), notify FDA in the regulation of tobacco products. The
review by the Office of Management and writing. FDA is also requesting Committee reviews and evaluates safety,
Budget (OMB) under the Paperwork nominations for a nonvoting industry dependence, and health issues relating
Reduction Act of 1995 (44 U.S.C. 3501– representative of the tobacco to tobacco products and provides
3520). The collections of information in manufacturing industry to serve on the appropriate advice, information, and
21 CFR parts 801 and 809 have been Tobacco Products Scientific Advisory recommendations to the Commissioner.
approved under OMB control number Committee, and an alternate to this II. Selection Procedure
0910–0485; the collections of representative. A nominee may either be
information in parts 50 and 56 have self-nominated or nominated by an Any industry organization interested
been approved under OMB control organization to serve as a nonvoting in participating in the selection of an
number 0910–0130; the collections of industry representative. Nominations appropriate nonvoting member to
information in 21 CFR part 812 have will be accepted for current vacancies represent industry interests should send
been approved under OMB control effective with this notice. a letter stating that interest to the FDA
number 0910–0078; the collections of contact (see FOR FURTHER INFORMATION
DATES: Any industry organization CONTACT) within 30 days of publication
information in 21 CFR part 814 subparts interested in participating in the
B and E have been approved under of this document (see DATES). Within the
selection of an appropriate nonvoting subsequent 30 days, FDA will send a
OMB control number 0910–0231; the member to represent industry interests
collections of information in 21 CFR letter to each organization that has
must send a letter stating that interest to expressed an interest, attaching a
part 814, subpart H, have been approved the FDA by August 15, 2016 (see
under OMB control number 0910–0332; complete list of all such organizations
sections I and II of this document for and a list of all nominees along with
the collections of information in 21 CFR further details). Concurrently,
part 807, subpart E, have been approved their current resumes. The letter will
nomination materials for prospective also state that it is the responsibility of
under OMB control number 0901–0120; candidates should be sent to FDA by
the collections of information in 21 CFR the interested organizations to confer
August 15, 2016. with one another and to select a
part 820 have been approved under
ADDRESSES: All statements of interest candidate, within 60 days after the
OMB control number 0910–0073; the
from industry organizations interested receipt of the FDA letter, to serve as the
collections of information in 21 CFR
in participating in the selection process nonvoting member to represent industry
part 601 have been approved under
should be sent to Caryn Cohen (see FOR interests for the committee. The
OMB control number 0910–0338; the
FURTHER INFORMATION CONTACT). All interested organizations are not bound
collections of information in 21 CFR
nominations for nonvoting industry by the list of nominees in selecting a
part 312 have been approved under
representatives should be submitted candidate. However, if no individual is
OMB control number 0910–0014; the
electronically by accessing the FDA selected within 60 days, the
collections of information in 21 CFR
Advisory Committee Membership Commissioner will select the nonvoting
part 314 have been approved under
Nomination Portal: https:// member to represent industry interests.
OMB control number 0910–0001; and
www.accessdata.fda.gov/scripts/
the collections of information resulting III. Application Procedure
FACTRSPortal/FACTRS/index.cfm or by
from special protocol assessments have Individuals may self-nominate and/or
mail to Advisory Committee Oversight
been approved under OMB control an organization may nominate one or
and Management Staff, Food and Drug
number 0910–0470. more individuals to serve as a nonvoting
Administration, 10903 New Hampshire
Dated: July 11, 2016. Ave., Bldg. 32, Rm. 5103, Silver Spring, industry representative. Contact
Leslie Kux, MD 20993–0002. Information about information, current curriculum vitae,
Associate Commissioner for Policy. becoming a member of an FDA advisory and the name of the committee of
[FR Doc. 2016–16735 Filed 7–14–16; 8:45 am] committee can also be obtained by interest should be sent to the FDA
BILLING CODE 4164–01–P visiting FDA’s Web site http:// Advisory Committee Membership
www.fda.gov/AdvisoryCommittees/ Nomination Portal (see ADDRESSES)
default.htm. within 30 days of publication of this
DEPARTMENT OF HEALTH AND document (see DATES). FDA will forward
FOR FURTHER INFORMATION CONTACT: all nominations to the organizations
HUMAN SERVICES
Caryn Cohen, Office of Science, Center expressing interest in participating in
Food and Drug Administration for Tobacco Products, Food and Drug the selection process for the committee.
Administration, Center for Tobacco
sradovich on DSK3GMQ082PROD with NOTICES

(Persons who nominate themselves as
[Docket No. FDA–2016–N–1984] Products Document Control Center, nonvoting industry representatives will
Bldg. 71, Rm. G335, 10903 New not participate in the selection process.)
Request for Nominations on the Hampshire Ave., Silver Spring, MD
Tobacco Products Scientific Advisory FDA seeks to include the views of
20993–0002, 1–877–287–1373 (choose women and men, members of all racial
Committee Option 5), email: TPSAC@fda.hhs.gov. and ethnic groups, and individuals with
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: The and without disabilities on its advisory
HHS. Agency intends to add nonvoting committees and, therefore, encourages

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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 of availability.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 13, 2016.
Contact		Pamela Bradley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 240-731-3734; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911; or Christopher Leptak, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Rm. 6462, Silver Spring, MD 20993, 301-796-0017.
FR Citation		81 FR 46084

81 FR 46084 - Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 136 (July 15, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration