82 FR 58617 - 21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 238 (December 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 238 (December 13, 2017)
| Page Range | 58617-58618 | |
| FR Document | 2017-26790 |
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)] [Notices] [Pages 58617-58618] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26790] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5925] 21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act). 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 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. It is important that the in vitro susceptibility test methods and susceptibility test interpretive criteria for systemic antibacterial or antifungal drugs be reviewed on a regular basis and updated to reflect the most current information. The development of new mechanisms of resistance in bacteria or fungi may result in decreased susceptibility to a particular drug. Decreased susceptibility may raise efficacy or safety concerns when out-of-date susceptibility test interpretive criteria are used in guiding the treatment of patients. Historically, susceptibility test interpretive criteria have 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 in 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 standard development organizations (SDOs) can be useful sources of information to identify and update susceptibility test interpretive criteria. Section 511A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360a-2), as added by section 3044 of the Cures Act (Pub. L. 114-255), 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 AST devices may rely upon listed susceptibility 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. II. Susceptibility Test Interpretive Criteria Website 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 Website that contains a list of FDA-recognized susceptibility test interpretive criteria standards, as well as other susceptibility test interpretive criteria identified by FDA. FDA is announcing the establishment of this Interpretive Criteria Website, which can be found here: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm. This website recognizes susceptibility test interpretive criteria established by an SDO that fulfills the requirements under section 511A(b)(2)(A) of the FD&C Act; 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 listed by FDA on the Interpretive Criteria Website 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 Website, FDA will publish on the Interpretive Criteria Website 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 Website. 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 [[Page 58618]] needed. In addition to this statutorily required annual notice, FDA intends to publish a Federal Register notice within the next few months to allow for public comment on the initial recognition of susceptibility test interpretive criteria. Dated: December 7, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26790 Filed 12-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices 58617
refused for filing because it is the Susceptibility Test Interpretive was signed into law on December 13,
incomplete. This guidance includes Criteria Website. The Susceptibility Test 2016. This provision clarifies FDA’s
procedures for certain BLAs and Interpretive Criteria Website will help to authority to identify and efficiently
supplemental BLAs, given that CDER efficiently update susceptibility test update susceptibility test interpretive
has regulatory responsibility for certain interpretive criteria for antimicrobial criteria, including through the
therapeutic biological products subject drugs when necessary for public health recognition by FDA of standards
to licensing under the Public Health and may allow for more efficient established by SDOs. It also clarifies
Service Act. development and evaluation of that sponsors of AST devices may rely
This draft guidance is being issued antimicrobial susceptibility test (AST) upon listed susceptibility interpretive
consistent with FDA’s good guidance devices. These changes may lead to criteria to support premarket
practices regulation (21 CFR 10.115). better patient care and reduce authorization of their devices, provided
The draft guidance, when finalized, will antimicrobial resistance through they meet certain conditions, which
represent the current thinking of FDA improved antibiotic stewardship. FDA provides for a more streamlined process
on refusal to file NDA and BLA is publishing this notice in accordance for incorporating up-to-date information
submissions to CDER. It does not with procedures established by the 21st into such devices.
establish any rights for any person and Century Cures Act (Cures Act). II. Susceptibility Test Interpretive
is not binding on FDA or the public. FOR FURTHER INFORMATION CONTACT: Criteria Website
You can use an alternative approach if Katherine Schumann, Center for Drug
it satisfies the requirements of the Section 511A of the FD&C Act
Evaluation and Research, Food and
applicable statutes and regulations. This requires FDA to establish within 1 year
Drug Administration, 10903 New
guidance is not subject to Executive after the date of enactment of the Cures
Hampshire Ave., Bldg. 22, Rm. 6242,
Order 12866. Act an Interpretive Criteria Website that
Silver Spring, MD 20993–0002, 301–
contains a list of FDA-recognized
II. The Paperwork Reduction Act of 796–1182, Katherine.Schumann@
susceptibility test interpretive criteria
1995 fda.hhs.gov. standards, as well as other susceptibility
This guidance refers to previously SUPPLEMENTARY INFORMATION: test interpretive criteria identified by
approved collections of information that I. Background FDA. FDA is announcing the
are subject to review by the Office of establishment of this Interpretive
Management and Budget (OMB) under Antimicrobial susceptibility testing is Criteria Website, which can be found
the Paperwork Reduction Act of 1995 used to determine if certain here: https://www.fda.gov/Drugs/
(44 U.S.C. 3501–3520). The collections microorganisms that are isolated from a DevelopmentApprovalProcess/
of information in 21 CFR part 314 have patient with an infection are likely to be DevelopmentResources/
been approved under OMB control killed or inhibited by a particular ucm410971.htm.
number 0910–0001. The collections of antimicrobial drug. It is important that This website recognizes susceptibility
information in 21 CFR part 601 have the in vitro susceptibility test methods test interpretive criteria established by
been approved under OMB control and susceptibility test interpretive an SDO that fulfills the requirements
number 0910–0338. criteria for systemic antibacterial or under section 511A(b)(2)(A) of the
antifungal drugs be reviewed on a FD&C Act; identifies when FDA does
III. Electronic Access regular basis and updated to reflect the not recognize, in whole or in part,
Persons with access to the internet most current information. The susceptibility test interpretive criteria
may obtain the draft guidance at either development of new mechanisms of established by an SDO; and lists
https://www.fda.gov/Drugs/Guidance resistance in bacteria or fungi may result susceptibility test interpretive criteria
ComplianceRegulatoryInformation/ in decreased susceptibility to a identified by FDA outside the SDO
Guidances/default.htm or https:// particular drug. Decreased susceptibility process. The susceptibility test
www.regulations.gov. may raise efficacy or safety concerns interpretive criteria listed by FDA on
when out-of-date susceptibility test the Interpretive Criteria Website are
Dated: December 7, 2017.
interpretive criteria are used in guiding deemed to be recognized as a standard
Leslie Kux,
the treatment of patients. under section 514(c)(1) of the FD&C Act
Associate Commissioner for Policy. Historically, susceptibility test (21 U.S.C. 360d(c)(1)).
[FR Doc. 2017–26791 Filed 12–12–17; 8:45 am] interpretive criteria have been contained At least every 6 months after the
BILLING CODE 4164–01–P in the Microbiology subsection of establishment of the Interpretive Criteria
antimicrobial drug labeling, and there Website, FDA will publish on the
have been significant challenges Interpretive Criteria Website a notice
DEPARTMENT OF HEALTH AND associated with ensuring that this recognizing new or updated
HUMAN SERVICES information is up-to-date in individual susceptibility test interpretive criteria
antimicrobial drug labels. For some standards, or parts of standards;
Food and Drug Administration
time, FDA and other stakeholders have withdrawing recognition of
[Docket No. FDA–2017–N–5925] recognized that susceptibility test susceptibility test interpretive criteria
interpretive criteria standards standards, or parts of standards; and
21st Century Cures Act: Announcing established by nationally or making any other necessary updates to
the Establishment of the Susceptibility internationally recognized standard the lists published on the Interpretive
Test Interpretive Criteria Website Criteria Website. Once a year FDA will
sradovich on DSK3GMQ082PROD with NOTICES
development organizations (SDOs) can
AGENCY: Food and Drug Administration, be useful sources of information to compile the notices from that year and
HHS. identify and update susceptibility test publish them in the Federal Register
ACTION: Notice. interpretive criteria. and provide for public comment. If
Section 511A of the Federal Food, comments are received, FDA will
SUMMARY: The Food and Drug Drug, and Cosmetic Act (the FD&C Act) review those comments and make any
Administration (FDA, the Agency, or (21 U.S.C. 360a–2), as added by section updates to the recognized standards or
we) is announcing the establishment of 3044 of the Cures Act (Pub. L. 114–255), susceptibility test interpretive criteria as
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![58618 Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
needed. In addition to this statutorily comment will be made public, you are Staff. If you do not wish your name and
required annual notice, FDA intends to solely responsible for ensuring that your contact information to be made publicly
publish a Federal Register notice within comment does not include any available, you can provide this
the next few months to allow for public confidential information that you or a information on the cover sheet and not
comment on the initial recognition of third party may not wish to be posted, in the body of your comments and you
susceptibility test interpretive criteria. such as medical information, your or must identify this information as
Dated: December 7, 2017. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
confidential business information, such as ‘‘confidential’’ will not be disclosed
Leslie Kux,
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
Associate Commissioner for Policy.
that if you include your name, contact and other applicable disclosure law. For
[FR Doc. 2017–26790 Filed 12–12–17; 8:45 am] information, or other information that more information about FDA’s posting
BILLING CODE 4164–01–P identifies you in the body of your of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
DEPARTMENT OF HEALTH AND • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
HUMAN SERVICES with confidential information that you 23389.pdf.
do not wish to be made available to the Docket: For access to the docket to
Food and Drug Administration public, submit the comment as a read background documents or the
[Docket No. FDA–2017–D–6352] written/paper submission and in the electronic and written/paper comments
manner detailed (see ‘‘Written/Paper received, go to https://
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DATES: Submit either electronic or submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
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Agency considers your comment on this comments only as a written/paper Drug Administration, 10903 New
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ADDRESSES: You may submit comments information you claim to be confidential 796–0600; or Stephen Ripley, Center for
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sradovich on DSK3GMQ082PROD with NOTICES
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instructions for submitting comments. claimed confidential information I. Background
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Document Created: 2017-12-13 01:23:50
Document Modified: 2017-12-13 01:23:50
| 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. | |
| 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 | 82 FR 58617 |
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