[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8883-8885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04175]


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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.

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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.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 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

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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