Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 1152-1153 [2019-00569]

Download as PDF 1152 Federal Register / Vol. 84, No. 22 / Friday, February 1, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Food and Drug Administration 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/201523389.pdf. Docket: For access to the docket to read background documents or the [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. 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: SUMMARY: 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 VerDate Sep<11>2014 21:23 Jan 31, 2019 Jkt 247001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01FEN1.SGM 01FEN1 Federal Register / Vol. 84, No. 22 / Friday, February 1, 2019 / Notices 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/ GuidanceCompliance RegulatoryInformation/Guidances/ 1153 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 CDRH-Guidance@ fda.hhs.gov or druginfo@fda.hhs.gov 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: OMB control No. 21 CFR part or guidance Topic 807, subpart E .............................................................................................................. 812 ................................................................................................................................ ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. 312 ................................................................................................................................ 314 ................................................................................................................................ Premarket notification ............................... Investigational Device Exemption ............. Q-submissions .......................................... 0910–0120 0910–0078 0910–0756 Investigational New Drug Regulations ..... Applications for FDA Approval to Market a New Drug. 0910–0014 0910–0001 Dated: January 15, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–00569 Filed 1–31–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–4628] Risk Evaluation and Mitigation Strategies Assessment: Planning and Reporting; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the assessment of risk evaluation and mitigation strategies (REMS) entitled ‘‘REMS Assessment: Planning and Reporting; Draft Guidance for Industry.’’ The draft guidance is one of several guidance SUMMARY: VerDate Sep<11>2014 21:23 Jan 31, 2019 Jkt 247001 documents being developed to fulfill performance goals under the fifth authorization of the prescription drug user fee program, the Prescription Drug User Fee Act V. This draft guidance describes how to develop a REMS Assessment Plan; specifically, how the REMS program goals, objectives, and REMS design may impact the selection of metrics and data sources, which will be used to assess whether the REMS is meeting its risk mitigation goals. The draft guidance recommends assessing the REMS using both process measures and outcome measures and provides examples of metrics by assessment categories, as well as data sources that may be utilized to evaluate the performance of the REMS. The draft guidance also discusses considerations for assessing the impact of REMS on patient access to the drug or its burden to the healthcare delivery system. Finally, this draft guidance provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report. Submit either electronic or written comments on the draft guidance DATES: PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 by April 2, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. You may submit comments on any guidance at any time as follows: ADDRESSES: 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 E:\FR\FM\01FEN1.SGM 01FEN1

Agencies

[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]]

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

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.

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

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

[[Page 1153]]

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 CDRH-Guidance@fda.hhs.gov or druginfo@fda.hhs.gov 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:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


    Dated: January 15, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00569 Filed 1-31-19; 8:45 am]
 BILLING CODE 4164-01-P