81 FR 46084 - Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.'' This draft guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product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 This draft guidance is also intended to assist FDA staff participating in the review of such IVD companion diagnostics or their associated therapeutic products. This draft guidance is not final nor is it in effect at this time.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Device With a Therapeutic Product; Draft Guidance for Industry and Food 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

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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availability of the draft guidance entitled ``Principles for 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 This draft guidance is intended to be a 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 This draft guidance is also intended to assist FDA staff 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 This draft guidance is not final nor 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

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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@

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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