82 FR 29567 - Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 124 (June 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 124 (June 29, 2017)
| Page Range | 29567-29569 | |
| FR Document | 2017-13611 |
[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)] [Notices] [Pages 29567-29569] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13611] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3854] Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices.'' The purpose of this workshop is to discuss potential scientific and regulatory challenges associated with developing traditional antimicrobial susceptibility testing (AST) devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies, and to provide an overview of relevant provisions of the 21st Century Cures Act that may impact the development of such devices. Public input and feedback gained through this workshop will aid in the development of science-based approaches to regulatory decisionmaking regarding traditional and novel AST devices. Further, this workshop will explore opportunities for the efficient development and evaluation of AST devices, which may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. DATES: The public workshop will be held on September 13, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by October 20, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 20, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 public, 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 [[Page 29568]] 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-2017-N-3854 for ``Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices.'' Received comments, those filed in a timely manner (see ADDRESSES), 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.thefederalregister.org/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. FOR FURTHER INFORMATION CONTACT: Natasha Townsend, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5525, Silver Spring, MD 20993-0002, 301- 796-5927, email: natasha.townsend@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The accurate detection of antimicrobial resistance is important due to the emergence and spread of highly resistant pathogenic bacteria. Traditional AST systems continue to provide the bulk of antimicrobial susceptibility testing. However, the spread of antimicrobial resistance has spurred the development of a range of novel diagnostic technologies (e.g., detection of molecular resistance markers) that can provide more rapid bacterial identification and susceptibility testing results than is possible with current phenotypic methods. In light of the need for accurate susceptibility information and the development of these innovative diagnostic technologies, there is a need to explore and discuss new approaches for the efficient development and evaluation of AST devices--that are important to patient care and antibiotic stewardship--to allow for the timely availability of these devices. The purpose of the public workshop is to discuss potential scientific and regulatory challenges associated with developing traditional AST devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies, and to provide an overview of relevant provisions of the 21st Century Cures Act that may impact the development of such devices. Specifically, section 3044 of the 21st Century Cures Act, entitled ``Susceptibility Test Interpretive Criteria for Microorganisms; Antimicrobial Susceptibility Testing Devices,'' adds section 511A to the Federal Food, Drug, and Cosmetic Act, which creates a new regulatory framework for updating AST devices with current susceptibility test interpretive criteria for approved antimicrobial drugs. Further, this workshop will explore opportunities for the efficient development and evaluation of AST devices, including new science-based approaches to regulatory decisionmaking regarding traditional and novel AST devices. In addition, FDA is considering the development of a draft guidance, and will look to the meeting to help inform the Agency's thinking on relevant topics. Therefore, FDA seeks input and feedback from industry, other government agencies, standard-setting organizations, clinical laboratories, and patient care professionals with an interest in the future development of AST devices. II. Topics for Discussion at the Public Workshop This public workshop will consist of brief presentations providing information to frame interactive discussions via two panel sessions. The presentations and panel discussions will focus on: 1. Industry and FDA perspectives on AST device evaluation requirements, including opportunities to streamline the premarket review processes that may allow for more rapid availability of AST devices for new antimicrobial drugs; 2. Performance review of traditional AST devices; 3. An overview of relevant provisions of the 21st Century Cures Act that may impact the development of AST devices; 4. The clinical laboratory perspective on AST result interpretation and reporting; 5. Novel technologies for detection of resistance markers; 6. Standards-setting organization perspective on reference methods and organism resources; 7. The role of new technologies for promoting antibiotic stewardship, improving patient care, aiding the selection of appropriate antimicrobial therapy, and reducing the impact of antimicrobial resistance; and 8. Direct-from-specimen testing and the challenges of the clinical use and phenotypic interpretation of genotypic results. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by September 1, 2017, 4 p.m. Eastern Time. Early registration is recommended because seating is [[Page 29569]] limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting/public workshop will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public workshop. If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321, Silver Spring, MD 20993-0002, 301-796-5661, email: susan.monahan@fda.hhs.gov no later than August 30, 2017. Requests for Oral Presentations: During online registration you may indicate if you wish to present during the public comment session, and which topic you wish to present. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and begin notifying participants by September 5, 2017. All requests to make oral presentations must be received by the close of registration on September 1, 2017. If selected for presentation, any presentation materials must be emailed to Natasha Townsend (see FOR FURTHER INFORMATION CONTACT) no later than September 8, 2017, 5 p.m. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by September 8, 2017, 4 p.m. The Webcast link will be available on the registration Web page after September 8, 2017. Organizations are requested to register all participants, but to view using one connection per location. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit: http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Dated: June 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13611 Filed 6-28-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices 29567
current regulatory framework is III. Electronic Access ADDRESSES: The public workshop will
adequate and sufficiently flexible to Persons with access to the Internet be held at the FDA White Oak Campus,
appropriately regulate medical gases. may obtain the draft guidance at either 10903 New Hampshire Ave., Bldg. 31,
FDA further explained that it can https://www.fda.gov/Drugs/ Rm. 1503 (The Great Room), Silver
continue to work within this framework GuidanceComplianceRegulator Spring, MD 20993. Entrance for the
to appropriately regulate these products. yInformation/Guidances/default.htm or public meeting participants (non-FDA
FDA issued a final rule promulgating https://www.regulations.gov. employees) is through Building 1 where
warning statements to be included in routine security check procedures will
Dated: June 23, 2017. be performed. For parking and security
the labeling of designated medical gases
Anna K. Abram, information, please refer to http://
on November 18, 2016 (81 FR 81685).
Deputy Commissioner for Policy, Planning, www.fda.gov/AboutFDA/
This final rule also imposes labeling,
Legislation, and Analysis. WorkingatFDA/BuildingsandFacilities/
design, and color requirements on
[FR Doc. 2017–13608 Filed 6–28–17; 8:45 am] WhiteOakCampusInformation/
medical gas containers and closures to
increase the likelihood that the contents BILLING CODE 4164–01–P ucm241740.htm.
of medical gas containers are accurately You may submit comments as
identified and reduce the likelihood of follows. Please note that late, untimely
DEPARTMENT OF HEALTH AND filed comments will not be considered.
the wrong gas being connected to a gas
HUMAN SERVICES Electronic comments must be submitted
supply system or container. FDA may
undertake additional targeted on or before October 20, 2017. The
Food and Drug Administration
rulemaking in the future on other https://www.regulations.gov electronic
specific issues if FDA determines that [Docket No. FDA–2017–N–3854] filing system will accept comments
such issues cannot be adequately until midnight Eastern Time at the end
addressed by other means. Antimicrobial Susceptibility and of October 20, 2017. Comments received
Resistance: Addressing Challenges of by mail/hand delivery/courier (for
In addition to the applicable Diagnostic Devices; Public Workshop;
regulations, FDA relies on guidance written/paper submissions) will be
Request for Comments considered timely if they are
documents (such as this one),
development of appropriate inspection AGENCY: Food and Drug Administration, postmarked or the delivery service
practices and inspector training, and HHS. acceptance receipt is on or before that
interaction with industry trade ACTION: Notice of public workshop; date.
associations, State regulators, and other request for comments. Electronic Submissions
stakeholders on an as-needed basis in
SUMMARY: The Food and Drug Submit electronic comments in the
regulating medical gases.
Administration (FDA, the Agency, or following way:
This draft guidance is being issued we) is announcing the following public • Federal eRulemaking Portal:
consistent with FDA’s good guidance workshop entitled ‘‘Antimicrobial https://www.regulations.gov. Follow the
practices regulation (21 CFR 10.115). Susceptibility and Resistance: instructions for submitting comments.
The draft guidance, when finalized, will Addressing Challenges of Diagnostic Comments submitted electronically,
represent the current thinking of FDA Devices.’’ The purpose of this workshop including attachments, to https://
on current good manufacturing practice is to discuss potential scientific and www.regulations.gov will be posted to
for medical gases. It does not establish regulatory challenges associated with the docket unchanged. Because your
any rights for any person and is not developing traditional antimicrobial comment will be made public, you are
binding on FDA or the public. You can susceptibility testing (AST) devices and solely responsible for ensuring that your
use an alternative approach if it satisfies devices that detect antimicrobial comment does not include any
the requirements of the applicable resistance markers by molecular or confidential information that you or a
statutes and regulations. novel diagnostic technologies, and to third party may not wish to be public,
II. Paperwork Reduction Act of 1995 provide an overview of relevant such as medical information, your or
provisions of the 21st Century Cures Act anyone else’s Social Security number, or
This revised draft guidance includes that may impact the development of confidential business information, such
information collection provisions that such devices. Public input and feedback as a manufacturing process. Please note
are subject to review by the Office of gained through this workshop will aid that if you include your name, contact
Management and Budget (OMB) under in the development of science-based information, or other information that
the Paperwork Reduction Act of 1995 approaches to regulatory identifies you in the body of your
(PRA) (44 U.S.C. 3501–3520). In decisionmaking regarding traditional comments, that information will be
accordance with the PRA, before and novel AST devices. Further, this posted on https://www.regulations.gov.
publication of the final guidance workshop will explore opportunities for • If you want to submit a comment
document, FDA intends to solicit public the efficient development and with confidential information that you
comment and obtain OMB approval for evaluation of AST devices, which may do not wish to be made available to the
any information collections lead to better patient care and reduce public, submit the comment as a
recommended in this guidance that are antimicrobial resistance through written/paper submission and in the
new or that would represent material improved antibiotic stewardship. manner detailed (see ‘‘Written/Paper
modifications to previously approved Submissions’’ and ‘‘Instructions’’).
sradovich on DSK3GMQ082PROD with NOTICES
DATES: The public workshop will be
collections of information found in FDA held on September 13, 2017, from 8:30
regulations. Written/Paper Submissions
a.m. to 5 p.m.
Submit either electronic or written Submit written/paper submissions as
503(b)(4); (2) a warning statement concerning the comments on this public workshop by follows:
use of the medical gas as determined by the
Secretary by regulation; and (3) appropriate
October 20, 2017. See the • Mail/Hand delivery/Courier (for
directions and warnings concerning storage and SUPPLEMENTARY INFORMATION section for written/paper submissions): Dockets
handling. registration date and information. Management Staff (HFA–305), Food and
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![Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices 29569
limited; therefore, FDA may limit the Transcripts: Please be advised that as PrescriptionDrugUserFee/
number of participants from each soon as a transcript of the public UCM559341.pdf. Public comments will
organization. Registrants will receive workshop is available, it will be be accepted through July 31, 2017. See
confirmation when they have been accessible at https:// ADDRESSES section below for
accepted. If time and space permit, www.regulations.gov. It may be viewed information about submitting comments
onsite registration on the day of the at the Dockets Management Staff (see to the public docket.
public meeting/public workshop will be ADDRESSES). A link to the transcript will ADDRESSES: You may submit comments
provided beginning at 8 a.m. We will let also be available approximately 45 days as follows. Please note that late,
registrants know if registration closes after the public workshop on the untimely filed comments will not be
before the day of the public workshop. Internet at http://www.fda.gov/ considered. Electronic comments must
If you need special accommodations MedicalDevices/NewsEvents/ be submitted on or before July 31, 2017.
due to a disability, please contact Susan WorkshopsConferences/default.htm. The https://www.regulations.gov
Monahan, Center for Devices and (Select this public workshop from the electronic filing system will accept
Radiological Health, Food and Drug posted events list). comments until midnight Eastern Time
Administration, 10903 New Hampshire at the end of July 31, 2017. Comments
Dated: June 23, 2017.
Ave., Bldg. 66, Rm. 4321, Silver Spring, received by mail/hand delivery/courier
MD 20993–0002, 301–796–5661, email: Anna K. Abram,
(for written/paper submissions) will be
susan.monahan@fda.hhs.gov no later Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
considered timely if they are
than August 30, 2017. postmarked or the delivery service
Requests for Oral Presentations: [FR Doc. 2017–13611 Filed 6–28–17; 8:45 am]
acceptance receipt is on or before that
During online registration you may BILLING CODE 4164–01–P
date.
indicate if you wish to present during
the public comment session, and which Electronic Submissions
topic you wish to present. We will do DEPARTMENT OF HEALTH AND Submit electronic comments in the
our best to accommodate requests to HUMAN SERVICES following way:
make public comments. Individuals and • Federal eRulemaking Portal:
organizations with common interests are Food and Drug Administration https://www.regulations.gov. Follow the
urged to consolidate or coordinate their [Docket No. FDA–2017–N–3199] instructions for submitting comments.
presentations, and request time for a Comments submitted electronically,
joint presentation. Following the close Program for Enhanced Review including attachments, to https://
of registration, we will determine the Transparency and Communication for www.regulations.gov will be posted to
amount of time allotted to each Original 351(k) Biologics License the docket unchanged. Because your
presenter and the approximate time Applications in Biosimilar User Fee Act comment will be made public, you are
each oral presentation is to begin, and II solely responsible for ensuring that your
will select and begin notifying comment does not include any
participants by September 5, 2017. All AGENCY: Food and Drug Administration,
HHS. confidential information that you or a
requests to make oral presentations third party may not wish to be posted,
must be received by the close of ACTION: Notice; establishment of docket; such as medical information, your or
registration on September 1, 2017. If request for comments. anyone else’s Social Security number, or
selected for presentation, any confidential business information, such
SUMMARY: The Food and Drug
presentation materials must be emailed as a manufacturing process. Please note
to Natasha Townsend (see FOR FURTHER Administration (FDA) is announcing an
opportunity for public comment on the that if you include your name, contact
INFORMATION CONTACT) no later than information, or other information that
September 8, 2017, 5 p.m. No statement of work for an assessment of
the Program for Enhanced Review identifies you in the body of your
commercial or promotional material comments, that information will be
will be permitted to be presented or Transparency and Communication for
original biologics license applications posted on https://www.regulations.gov.
distributed at the public workshop.
(BLAs) (351(k)s) submitted under the • If you want to submit a comment
Streaming Webcast of the Public with confidential information that you
Workshop: This public workshop will Public Health Service Act (hereafter
referred to as 351(k) applications) do not wish to be made available to the
also be Webcast. Persons interested in public, submit the comment as a
viewing the Webcast must register (hereafter referred to as the Program).
The Program is part of the FDA written/paper submission and in the
online by September 8, 2017, 4 p.m. The manner detailed (see ‘‘Written/Paper
Webcast link will be available on the performance commitments under the
proposed reauthorization of the Submissions’’ and ‘‘Instructions’’).
registration Web page after September 8,
2017. Organizations are requested to Biosimilar User Fee Act (BsUFA), Written/Paper Submissions
register all participants, but to view which, if enacted into law, will allow Submit written/paper submissions as
using one connection per location. FDA to collect user fees for the review follows:
If you have never attended a Connect of 351(k) applications for fiscal years • Mail/Hand delivery/Courier (for
Pro event before, test your connection at (FYs) 2018–2022. As part of the FDA written/paper submissions): Dockets
https://collaboration.fda.gov/common/ performance commitments described in Management Staff (HFA–305), Food and
help/en/support/meeting_test.htm. To this document, the Program will be Drug Administration, 5630 Fishers
get a quick overview of the Connect Pro evaluated by an independent contractor
sradovich on DSK3GMQ082PROD with NOTICES
Lane, Rm. 1061, Rockville, MD 20852.
program, visit: http://www.adobe.com/ in an interim and final assessment. • For written/paper comments
go/connectpro_overview. FDA has DATES: FDA is providing a period of 30 submitted to the Dockets Management
verified the Web site addresses in this days for public comment on the Staff, FDA will post your comment, as
document, as of the date this document statement of work before beginning the well as any attachments, except for
publishes in the Federal Register, but assessment. The statement of work can information submitted, marked and
Web sites are subject to change over be accessed at https://www.fda.gov/ identified, as confidential, if submitted
time. downloads/ForIndustry/UserFees/ as detailed in ‘‘Instructions.’’
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Document Created: 2018-11-14 10:17:23
Document Modified: 2018-11-14 10:17:23
| 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 public workshop; request for comments. | |
| Dates | The public workshop will be held on September 13, 2017, from 8:30 a.m. to 5 p.m. | |
| Contact | Natasha Townsend, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5525, Silver Spring, MD 20993-0002, 301- 796-5927, email: [email protected] | |
| FR Citation | 82 FR 29567 |
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