83 FR 8883 - Susceptibility Test Interpretive Criteria Recognized and Listed on the Susceptibility Test Interpretive Web Page; Reopening of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 41 (March 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 41 (March 1, 2018)
| Page Range | 8883-8885 | |
| FR Document | 2018-04175 |
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)] [Notices] [Pages 8883-8885] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04175] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5925] Susceptibility Test Interpretive Criteria Recognized and Listed on the Susceptibility Test Interpretive Web Page; Reopening of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening a docket for public comment on the susceptibility test interpretive criteria for antibacterial and antifungal drugs provided by FDA on its Susceptibility Test Interpretive Criteria web page (Interpretive Criteria web page) established on December 13, 2017. On the Interpretive Criteria web page, FDA recognizes, in whole or in part, susceptibility test interpretive criteria standards established by Standard Development Organizations (SDOs) and lists other susceptibility test interpretive criteria identified by FDA outside of the SDO process. DATES: This notice is published in the Federal Register on March 1, 2018. ADDRESSES: You may submit either electronic or written comments and information 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:// [[Page 8884]] 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-2017-N-5925 for ``Susceptibility Test Interpretive Criteria Recognized and Listed on the Susceptibility Test Interpretive web page; Request for Comments.'' 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.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. You may submit comments to the docket at any time. FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301- 796-1182, [email protected]. SUPPLEMENTARY INFORMATION: I. Background On December 13, 2017, FDA established the Interpretive Criteria web page (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm) that contains a list of FDA- recognized susceptibility test interpretive criteria standards, established by an SDO that fulfills the requirements under section 511A(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360a-2(b)(2)(A)); identifies when FDA does not recognize, in whole or in part, susceptibility test interpretive criteria established by an SDO; and lists susceptibility test interpretive criteria identified by FDA outside the SDO process. The susceptibility test interpretive criteria standards recognized by FDA on the Interpretive Criteria web page are deemed to be recognized as a standard under section 514(c)(1) of the FD&C Act (21 U.S.C. 360d(c)(1)). At least every 6 months after the establishment of the Interpretive Criteria web page, FDA will publish on the Interpretive Criteria web page a notice recognizing new or updated susceptibility test interpretive criteria standards, or parts of standards; withdrawing recognition of susceptibility test interpretive criteria standards, or parts of standards; and making any other necessary updates to the lists published on the Interpretive Criteria web page. Once a year FDA will compile the notices from that year and publish them in the Federal Register and provide for public comment. If comments are received, FDA will review those comments and make any updates to the recognized standards or susceptibility test interpretive criteria as needed. II. Recommendation of New or Updated Susceptibility Test Interpretive Criteria for Listing by FDA This Federal Register notice is a request for comments by interested third parties on FDA's initial susceptibility test interpretive criteria recognition and listing determinations on the Interpretive Criteria web page. FDA may consider information provided by interested third parties as a basis for updating interpretive criteria standards. This notice allows interested third parties the opportunity to comment on FDA's recognition and listing determinations before the annual compilation of notices of susceptibility test interpretive criteria changes made that year. Interested third parties or drug sponsors may provide information that FDA could use as a basis for listing new or for updating susceptibility interpretive criteria. This information should be submitted to Docket No. FDA-2017-N-5925. If comments are received, FDA will review those comments and will make, as necessary, updates to the recognized standards or susceptibility test interpretive criteria. If preferred, application holders may submit data supporting changes to FDA's susceptibility test interpretive criteria recognition or listing determinations through the application holder's annual report under the new drug application. If submitting this data, application holders are encouraged to identify in the cover letter of the annual report that the enclosed submission includes data supporting changes to FDA's susceptibility test interpretive criteria recognition or listing determinations. FDA will review these annual report submissions and [[Page 8885]] determine whether changes or updates to the currently recognized susceptibility test interpretive criteria are appropriate. FDA will then update the Interpretive Criteria web page to reflect these changes, as needed. Dated: February 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04175 Filed 2-28-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices 8883
meetings designed to enhance guidance includes additions to ICH 21 CFR part 601 have been approved
harmonization, and FDA is committed E6(R1) that are identified as under OMB control number 0910–0338.
to seeking scientifically based ‘‘ADDENDUM’’ and are marked with
III. Electronic Access
harmonized technical procedures for vertical lines on both sides of the text.
pharmaceutical development. One of The additions to ICH E6(R1) are Persons with access to the internet
the goals of harmonization is to identify intended to encourage implementation may obtain the document at https://
and then reduce differences in technical of the described approaches and www.regulations.gov, https://
requirements for drug development processes to improve clinical trial www.fda.gov/Drugs/Guidance
among regulatory agencies. quality and efficiency while ComplianceRegulatoryInformation/
ICH was established to provide an maintaining human subject protection Guidances/default.htm, or https://
opportunity for harmonization and reliability of trial results. Evolutions www.fda.gov/BiologicsBloodVaccines/
initiatives to be developed with input in technology and risk management GuidanceComplianceRegulatory
from both regulatory and industry processes offer new opportunities to Information/Guidances/default.htm.
representatives. FDA also seeks input increase clinical trial efficiency, in part Dated: February 23, 2018.
from consumer representatives and by focusing on trial activities essential Leslie Kux,
others. ICH is concerned with to ensuring human subject protection
harmonization of technical Associate Commissioner for Policy.
and the reliability of trial results. For
requirements for the registration of example, the guidance recommends [FR Doc. 2018–04154 Filed 2–28–18; 8:45 am]
pharmaceutical products for human use sponsors implement a system to manage BILLING CODE 4164–01–P
among regulators around the world. The quality throughout clinical trials and
six founding members of the ICH are the recommends sponsors develop a
European Commission; the European systematic, prioritized, risk-based DEPARTMENT OF HEALTH AND
Federation of Pharmaceutical Industries approach to monitoring clinical trials. HUMAN SERVICES
Associations; FDA; the Japanese The guidance provides additional detail Food and Drug Administration
Ministry of Health, Labour, and Welfare; regarding recommendations for use of
the Japanese Pharmaceutical electronic records and essential [Docket No. FDA–2017–N–5925]
Manufacturers Association; and the documents. The final guidance includes
Pharmaceutical Research and clarifications and additional detail on Susceptibility Test Interpretive Criteria
Manufacturers of America. The topics including, for example, Recognized and Listed on the
Standing Members of the ICH validation of computerized systems and Susceptibility Test Interpretive Web
Association include Health Canada and centralized monitoring. Page; Reopening of a Public Docket;
Swissmedic. Any party eligible as a This guidance is being issued Request for Comments
Member in accordance with the ICH consistent with FDA’s good guidance AGENCY: Food and Drug Administration,
Articles of Association can apply for practices regulation (21 CFR 10.115). HHS.
membership in writing to the ICH The guidance represents the current
Secretariat. The ICH Secretariat, which thinking of FDA on ‘‘E6(R2) Good ACTION: Notice; reopening of a public
coordinates the preparation of Clinical Practice: Integrated Addendum docket; request for comments.
documentation, operates as an to E6(R1).’’ It does not establish any SUMMARY: The Food and Drug
international nonprofit organization and rights for any person and is not binding Administration (FDA or the Agency) is
is funded by the Members of the ICH on FDA or the public. You can use an reopening a docket for public comment
Association. alternative approach if it satisfies the on the susceptibility test interpretive
The ICH Assembly is the overarching requirements of the applicable statutes criteria for antibacterial and antifungal
body of the Association and includes and regulations. drugs provided by FDA on its
representatives from each of the ICH
II. Paperwork Reduction Act of 1995 Susceptibility Test Interpretive Criteria
members and observers. The Assembly
This guidance contains information web page (Interpretive Criteria web
is responsible for the endorsement of
collection provisions that are subject to page) established on December 13, 2017.
draft guidelines and adoption of final
review by the Office of Management and On the Interpretive Criteria web page,
guidelines. FDA publishes ICH
Budget (OMB) under the Paperwork FDA recognizes, in whole or in part,
guidelines as FDA guidance.
In the Federal Register of September Reduction Act of 1995 (21 U.S.C. 3501– susceptibility test interpretive criteria
29, 2015 (80 FR 58492), FDA published 3520). The collections of information in standards established by Standard
a notice announcing the availability of this guidance were approved under Development Organizations (SDOs) and
a draft guidance entitled ‘‘E6(R2) Good 0910–0843. This guidance also refers to lists other susceptibility test interpretive
Clinical Practice.’’ The notice gave previously approved collections of criteria identified by FDA outside of the
interested persons an opportunity to information found in FDA regulations. SDO process.
submit comments on the The collections of information found in DATES: This notice is published in the
‘‘ADDENDUM’’ text added to ICH 21 CFR part 11 have been approved Federal Register on March 1, 2018.
E6(R1) by November 30, 2015. under OMB control number 0910–0303; ADDRESSES: You may submit either
After consideration of the comments the collections of information found in electronic or written comments and
received and revisions to the guidance, 21 CFR part 56 have been approved information as follows:
a final draft of the guidance was under OMB control numbers 0910–
0755; the collections of information Electronic Submissions
submitted to the ICH Assembly and
amozie on DSK30RV082PROD with NOTICES
endorsed by the regulatory agencies in found in 21 CFR part 312 have been Submit electronic comments in the
November 2016. approved under OMB control numbers following way:
The guidance discusses approaches to 0910–0014 and 0910–0733; the • Federal eRulemaking Portal:
clinical trial design, conduct, oversight, collections of information found in 21 https://www.regulations.gov. Follow the
recording, and reporting as well as CFR part 314 have been approved under instructions for submitting comments.
updated standards regarding electronic OMB control number 0910–0001; and Comments submitted electronically,
records and essential documents. This the collections of information found in including attachments, to https://
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![Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices 8885
determine whether changes or updates enough to provide timely notice. receiving intensive medical
to the currently recognized Therefore, you should always check the intervention/therapy and patients with
susceptibility test interpretive criteria Agency’s website at https:// decreased peripheral blood flow, such
are appropriate. FDA will then update www.fda.gov/AdvisoryCommittees/ as with severe hypotension, shock,
the Interpretive Criteria web page to default.htm and scroll down to the hyperosmolar-hyperglycemia and severe
reflect these changes, as needed. appropriate advisory committee meeting dehydration (e.g., patients in intensive
Dated: February 22, 2018. link, or call the advisory committee care settings). Currently, FDA has
Leslie Kux, information line to learn about possible cleared one glucose meter for use all
modifications before coming to the over the hospital using venous and
Associate Commissioner for Policy.
meeting. arterial blood. FDA understands that
[FR Doc. 2018–04175 Filed 2–28–18; 8:45 am]
being able to make capillary blood
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION:
measurements in all hospitalized
Agenda: On March 29, 2018, the
patients using FDA cleared and Clinical
committee will discuss, make
Laboratory Improvement Amendments
DEPARTMENT OF HEALTH AND recommendations, and vote on
(CLIA) waived (i.e., designated as
HUMAN SERVICES information regarding a premarket
waived per the standards in the CLIA)
approval application to market a novel
Food and Drug Administration glucose meters would be more
continuous glucose monitoring (CGM)
convenient and timely for hospital staff.
[Docket No. FDA–2018–N–0627] device system, the Senseonics, Inc.
FDA would like to present new data
Eversense CGM System. This device from capillary blood measurements on
Clinical Chemistry and Clinical requires minor surgery to implant and glucose meters in patients receiving
Toxicology Devices Panel of the remove, and if approved, would provide intensive medical intervention/therapy
Medical Devices Advisory Committee; 90 days of sensor glucose values from to the Clinical Chemistry and Clinical
Notice of Meeting each implanted sensor. Toxicology Devices Panel. FDA would
The Eversense CGM System measures like to receive feedback from the
AGENCY: Food and Drug Administration, patients’ glucose concentrations from
HHS. advisory panel on the benefits and risks
subcutaneous interstitial fluid similar to of measuring capillary blood using
ACTION: Notice. approved CGM systems. All CGM blood glucose meters in this intended
SUMMARY: The Food and Drug devices currently or previously use population, and the considerations
Administration (FDA) announces a marketed used electrochemistry to for CLIA waiver for this use.
forthcoming public advisory committee measure glucose in interstitial fluids, FDA intends to make background
meeting of the Clinical Chemistry and last for 3 to 11 days and are inserted via material available to the public no later
Clinical Toxicology Devices Panel of the a small-gauge needle by the end user. than 2 business days before the meeting.
Medical Devices Advisory Committee. The proposed CGM system uses a If FDA is unable to post the background
The general function of the committee is fluorescence-based measurement material on its website prior to the
to provide advice and recommendations technique, requires minor surgery for meeting, the background material will
to the Agency on FDA’s regulatory subcutaneous implantation, and will be made publicly available at the
issues. The meeting will be open to the have a 90-day sensor wear period. The location of the advisory committee
public. proposed CGM sensor also includes a meeting, and the background material
DATES: The meeting will be held on
drug component (dexamethasone will be posted on FDA’s website after
March 29 and 30, 2018, from 8 a.m. to acetate) intended to mitigate negative the meeting. Background material is
6 p.m. effects on sensor accuracy and sensor available at https://www.fda.gov/
life from the foreign body response at AdvisoryCommittees/Calendar/
ADDRESSES: Hilton Washington DC
the sensor insertion site. The proposed default.htm. Scroll down to the
North/Gaithersburg; Salons A, B, C, and
intended use, as stated by the sponsor, appropriate advisory committee meeting
D; 620 Perry Pkwy., Gaithersburg, MD
is as follows: link.
20877. The hotel’s telephone number is The Eversense CGM System Procedure: Interested persons may
301–977–8900. Answers to commonly continually measures glucose levels in present data, information, or views,
asked questions including information adults (age 18 and older) with diabetes orally or in writing, on issues pending
regarding special accommodations due for the operating life of the sensor. before the committee. Written
to a disability, visitor parking, and The system is intended to: submissions may be made to the contact
transportation may be accessed at: • Aid in the management of diabetes. person on or before March 22, 2018.
https://www.fda.gov/Advisory • Provide real-time glucose readings. Oral presentations from the public will
Committees/AboutAdvisoryCommittees/ • Provide glucose trend information. be scheduled on March 29 and 30, 2018,
ucm408555.htm. • Provide alerts for the detection and between approximately 1 p.m. and 2
FOR FURTHER INFORMATION CONTACT: prediction of episodes of low blood p.m. Those individuals interested in
Patricio Garcia, Center for Devices and glucose (hypoglycemia) and high blood making formal oral presentations should
Radiological Health, Food and Drug glucose (hyperglycemia). notify the contact person and submit a
Administration, 10903 New Hampshire The system is a prescription device. brief statement of the general nature of
Ave., Bldg. 66, Rm. G610, Silver Spring, Historical data from the system can be the evidence or arguments they wish to
MD 20993, patricio.garcia@fda.hhs.gov; interpreted to aid in providing therapy present, the names and addresses of
301–796–6875, or FDA Advisory adjustments. These adjustments should proposed participants, and an
amozie on DSK30RV082PROD with NOTICES
Committee Information Line, 1–800– be based on patterns seen over time. indication of the approximate time
741–8138 (301–443–0572 in the On March 30, 2018, the committee requested to make their presentation on
Washington, DC area). A notice in the will discuss and make or before March 14, 2018. Time allotted
Federal Register about last minute recommendations regarding measuring for each presentation may be limited. If
modifications that impact a previously blood glucose using capillary blood the number of registrants requesting to
announced advisory committee meeting with blood glucose meters in all speak is greater than can be reasonably
cannot always be published quickly hospital patients, including those accommodated during the scheduled
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Document Created: 2018-02-28 23:58:42
Document Modified: 2018-02-28 23:58:42
| 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; reopening of a public docket; request for comments. | |
| Dates | This notice is published in the Federal Register on March 1, 2018. | |
| Contact | Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301- 796-1182, [email protected] | |
| FR Citation | 83 FR 8883 |
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