[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1152-1153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00569]
[[Page 1152]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2561]
Coordinated Development of Antimicrobial Drugs and Antimicrobial
Susceptibility Test Devices; 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 or Agency) is announcing
the availability of a final guidance entitled ``Coordinated Development
of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.''
This guidance is intended to assist drug sponsors and device
manufacturers who are planning to develop new antimicrobial drugs and
antimicrobial susceptibility test (AST) devices and who seek to
coordinate development of these products such that the AST device could
be cleared either at the time of new drug approval or shortly
thereafter.
DATES: The announcement of the guidance is published in the Federal
Register on February 1, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2561 for ``Coordinated Development of Antimicrobial Drugs
and Antimicrobial Susceptibility Test Devices.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is 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 guidance document entitled
``Coordinated Development of Antimicrobial Drugs and Antimicrobial
Susceptibility Test Devices'' 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 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: Ribhi Shawar, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4604, Silver Spring, MD 20993-0002, 301-796-6694;
or Joseph Toerner, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993, 301-796-
1400.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance is intended to assist drug sponsors and device
manufacturers who are planning to develop new antimicrobial drugs and
AST devices and who seek to coordinate development of these products
such that the AST device could be cleared either at the time of new
drug approval or shortly thereafter. Specifically, the guidance
describes interactions between drug sponsors and device manufacturers
for coordinated development of a new antimicrobial drug and an AST
device. The guidance also explains the considerations for submitting
separate applications to the Center for Drug
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Evaluation and Research and the Center for Devices and Radiological
Health when seeking clearance of an AST device coincident with, or soon
following, antimicrobial drug approval. Finally, the guidance clarifies
that the review of the new antimicrobial drug product and AST device(s)
will remain independent, and that coordinated development does not
influence the Medical Device User Fee Act and the Prescription Drug
User Fee Act review timelines for either product.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of September 21, 2016 (81 FR 64913).
FDA revised the guidance as appropriate in response to the comments.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Coordinated Development of Antimicrobial
Drugs and Antimicrobial Susceptibility Test Devices.'' 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. This guidance
is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Persons unable to download an electronic copy of
``Coordinated Development of Antimicrobial Drugs and Antimicrobial
Susceptibility Test Devices'' may send an email request to [email protected] or [email protected] to receive an electronic
copy of the document. Please use the document number 1400061 and the
guidance title to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. 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
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
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OMB control
21 CFR part or guidance Topic No.
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807, subpart E.................... Premarket 0910-0120
notification.
812............................... Investigational 0910-0078
Device Exemption.
``Requests for Feedback on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff''.
312............................... Investigational New 0910-0014
Drug Regulations.
314............................... Applications for FDA 0910-0001
Approval to Market
a New Drug.
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Dated: January 15, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00569 Filed 1-31-19; 8:45 am]
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