Notice: Guidance for Industry on Updating Labeling for Susceptibility 
Test Information in Systemic Antibacterial Drug Products and 
Antimicrobial Susceptibility Testing Devices; Availability

Federal Register: July 2, 2009 (Volume 74, Number 126)          
                  Page 31740-31741

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Updating Labeling 
for Susceptibility Test Information in Systemic Antibacterial Drug 
Products and Antimicrobial Susceptibility Testing Devices.'' The Food 
and Drug Administration Amendments Act of 2007 (FDAAA) includes a 
requirement that FDA identify and periodically update susceptibility 
test interpretive criteria for antibacterial drug products and make 
those findings publicly available. This guidance describes how FDA will 
comply with the FDAAA requirement and procedures for application 
holders to update the labeling of antibacterial drug products and 
antimicrobial susceptibility testing (AST) devices.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002 or the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850-4307. Send one self-addressed adhesive label to assist that 
office in processing your requests. Submit written comments on the 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding antibacterial drug products: Edward Cox, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6212, Silver Spring, MD 20993-0002, 301-
796-1300; or
    Regarding AST devices: Freddie Poole, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0712.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Updating Labeling for Susceptibility Test Information in 
Systemic Antibacterial Drug Products and Antimicrobial Susceptibility 
Testing Devices.'' Antibacterial susceptibility testing is used to 
determine if bacteria that are isolated from a patient with an 
infection are likely to be killed or inhibited by a particular 
antibacterial drug product at the concentrations of the drug that are 
attainable at the site of infection using the dosing regimen(s) 
indicated in the drug product's labeling. The results from 
antibacterial susceptibility testing generally categorize bacteria as 
``susceptible,'' ``intermediate,'' or ``resistant'' to each 
antibacterial drug tested. When available, culture and susceptibility 
testing results are one of the factors that physicians consider when 
selecting an antimicrobial drug product for treating a

[[Page 31741]]

patient. The numerical values generated by susceptibility testing to 
determine whether a particular microorganism is susceptible to a 
particular antimicrobial drug--the antimicrobial susceptibility test 
interpretive criteria--are commonly referred to as breakpoints. These 
breakpoints are specified in the antimicrobial drug product's label. 
The antimicrobial susceptibility test interpretive criteria can be used 
to interpret results from either manual or automated AST devices.
    On September 27, 2007, FDAAA (Public Law 110-85) was signed into 
law. Section 1111 of FDAAA requires FDA to identify and periodically 
update susceptibility test interpretive criteria for antibacterial drug 
products and to make those findings publicly available. By enacting 
section 1111 of FDAAA, Congress recognized the importance of 
maintaining updated susceptibility test interpretive criteria.
    In the Federal Register of June 12, 2008 (73 FR 33438), FDA issued 
a draft guidance entitled ``Updating Labeling for Susceptibility Test 
Information in Systemic Antibacterial Drug Products and Antimicrobial 
Susceptibility Testing Devices.'' The draft guidance described 
procedures for FDA, drug application holders, and AST device 
manufacturers to ensure that updated susceptibility test information is 
available to health care providers. The draft guidance explained that 
where appropriate, FDA intends to identify susceptibility test 
interpretive criteria, quality control parameters, and susceptibility 
test methods by recognizing annually, in a Federal Register notice, 
standards developed by one or more nationally or internationally 
recognized standard development organizations. The draft guidance 
described, for holders of applications for approved antibacterial drug 
products, the option of relying on such standards to update their 
product labeling. The draft guidance explained that the agency intends 
to make the updated information available by publicly posting changes 
to the drug product labeling within 30 days following approval of a 
supplement that includes a change to the Microbiology subsection of the 
product labeling. The draft guidance also described, for manufacturers 
of in vitro diagnostic AST devices, the process for updating the 
susceptibility test information in their labeling to conform with 
updated labeling for a relevant antibacterial drug product.
    FDA has carefully reviewed comments received on the draft guidance 
(11 comments were submitted to the public docket). This final version 
of the guidance reflects our consideration of these comments, as well 
as our experience updating the labeling of susceptibility test 
information in systemic antibacterial drug products and AST devices. 
Most of the changes to the guidance were made to clarify statements in 
the draft guidance. The following changes in the final version of the 
guidance are noteworthy:
     The guidance clarifies that FDA is not imposing new 
requirements by recommending that drug application holders submit 
revised labeling or an explanation of why revisions are not needed 
within a specific time period after FDA recognizes a standard that is 
different from the information in the Microbiology subsection of the 
labeling for the application holder's drug product. (See 21 CFR 
201.56(a)(2).)
     The agency revised the recommended time period for 
submitting revised labeling by extending the period from 60 days to 90 
days.
    Certain requests that the guidance provide greater detail regarding 
the procedures for updating in vitro AST devices have not been 
addressed in this guidance but will be addressed when FDA updates 
``Class II Special Controls Guidance Document: Antimicrobial 
Susceptibility Test (AST) Systems; Guidance for Industry and FDA.'' 
This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on this topic. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0638.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: June 26, 2009.
David Horowitz,
Assitant Commissioner for Policy
[FR Doc. E9-15682 Filed 7-1-09; 8:45 am]

BILLING CODE 4160-01-S