82 FR 50139 - Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 208 (October 30, 2017)

The Food and Drug Administration (FDA, the Agency, or we) is requesting information to assist in identifying standard development organizations (SDOs) that meet the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures Act), which was signed into law on December 13, 2016.

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50139-50141]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5925]


Standard Development Organizations Whose Susceptibility Test 
Interpretive Criteria Standards May Be Recognized by the Food and Drug 
Administration; Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for information.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
requesting information to assist in identifying standard development 
organizations (SDOs) that meet the requirements in the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures 
Act), which was signed into law on December 13, 2016.

DATES: Submit either electronic or written comments on the notice by 
November 29, 2017.

ADDRESSES:  You may submit comments and information as follows. Please 
note that late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before November 29, 2017. 
The https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of November 29, 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 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

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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 ``Standard Development Organizations Whose 
Susceptibility Test Interpretive Criteria Standards May Be Recognized 
by FDA; Request for Information.'' 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: 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 or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Antimicrobial susceptibility testing is used to determine if 
certain microorganisms that are isolated from a patient with an 
infection are likely to be killed or inhibited by a particular 
antimicrobial drug at the concentrations of the drug that are 
attainable at the site of infection. Historically, susceptibility test 
interpretive criteria has been contained in the Microbiology subsection 
of antimicrobial drug labeling, and there have been significant 
challenges associated with ensuring that this information is up-to-date 
for individual antimicrobial drug labels. For some time, FDA and other 
stakeholders have recognized that susceptibility test interpretive 
criteria standards established by nationally or internationally 
recognized SDOs can be useful sources of information to identify and 
update susceptibility test interpretive criteria.
    Section 511A of the FD&C Act (21 U.S.C. 360a) was added by section 
3044 of the Cures Act (Pub. L. 114-255), which was signed into law on 
December 13, 2016. This provision clarifies FDA's authority to identify 
and efficiently update susceptibility test interpretive criteria, 
including through the recognition by FDA of standards established by 
SDOs. It also clarifies that sponsors of antimicrobial susceptibility 
testing devices may rely upon listed susceptibility test interpretive 
criteria to support premarket authorization of their devices, provided 
they meet certain conditions, which provides for a more streamlined 
process for incorporating up-to-date information into such devices.
    Section 511A of the FD&C Act requires FDA to establish within 1 
year after the date of enactment of the Cures Act an interpretive 
criteria Web site containing a list of FDA-recognized susceptibility 
test interpretive criteria standards, as well as other susceptibility 
test interpretive criteria identified by FDA. The list of standards 
consists of new or updated susceptibility test interpretive criteria 
standards with respect to legally marketed antimicrobial drugs that 
have been: (1) Established by nationally or internationally recognized 
SDOs that meet the requirements under section 511A(b)(2)(A)(i) of the 
FD&C Act and (2) recognized, in whole or in part, by FDA, pursuant to 
section 511A(c) of the FD&C Act.
    Section 511A(b)(2)(A)(i) of the FD&C Act requires that in order for 
FDA to recognize, in whole or in part, new or updated susceptibility 
test interpretive criteria standards established by an SDO, the SDO 
must: (1) Be a nationally or internationally recognized SDO that 
establishes and maintains procedures to address potential conflicts of 
interest and ensure transparent decision making; (2) hold meetings to 
ensure that there is an opportunity for public input by interested 
parties, and establishes and maintains processes to ensure that such 
input is considered in decision making; and (3) permit its standards to 
be made publicly available, through the National Library of Medicine or 
a similar source acceptable to the Secretary of Health and Human 
Services.

II. Issues for Consideration and Request for Information

    FDA is currently identifying SDOs that meet the requirements under 
section 511A(b)(2)(A)(i) of the FD&C Act and invites submission of 
information relevant to this task. FDA is particularly interested in 
publicly available information illustrating how an SDO has national or 
international recognition, information illustrating an SDO's 
established and maintained procedures on how the SDO addresses 
potential conflicts of interest and ensures transparent decision-
making, information illustrating that an SDO holds open meetings and 
has established and maintained processes to ensure that public input by 
interested parties is considered in decision-making, and information 
illustrating that an SDO's standards are made publicly available 
through the National

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Institutes of Health/National Library of Medicine or a similar source. 
When providing this information, please provide weblinks to where this 
information is publicly available. This information may assist in FDA's 
determination of which SDOs may fulfill the statutory requirements.

    Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23519 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P