[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Pages 33438-33440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0339]


Draft Guidance for Industry on Updating Labeling for 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Updating 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 This draft guidance informs industry 
of how FDA intends to comply with the FDAAA requirement. Specifically, 
the draft guidance describes procedures and responsibilities for 
updating information on susceptibility test interpretive criteria, 
susceptibility test methods, and quality control parameters in the 
labeling for systemic antibacterial drug products for human use. This 
draft guidance also describes procedures for making corresponding 
changes to susceptibility test interpretive criteria for antimicrobial 
susceptibility testing (AST) devices.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by August 11, 2008. Submit written comments on the proposed collection 
of information by August 11, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 draft guidance, including comments regarding proposed 
collection of information, 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 draft 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. 6414, 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

    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 of the antibacterial drugs that are 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 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, the President signed FDAAA (Public Law 110-
85) 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.
    FDA is announcing the availability of a draft guidance for industry 
entitled ``Updating Labeling for Susceptibility Test Information in 
Systemic Antibacterial Drug Products and Antimicrobial Susceptibility 
Testing Devices'' to inform industry of how FDA intends to comply with 
section 1111 of FDAAA. The draft guidance explains

[[Page 33439]]

the importance of making available to health care providers the most 
current information regarding susceptibility test interpretive criteria 
for antibacterial drug products. The draft guidance describes 
procedures for FDA, drug application holders, and AST device 
manufacturers to ensure that updated susceptibility test information is 
available to health care providers for the following reasons: (1) To 
address concerns about antibacterial drug product labeling with out-of-
date information on susceptibility test interpretive criteria, quality 
control parameters, and susceptibility test methods and (2) to comply 
with the new requirements of section 1111 of FDAAA. 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. Drug application holders of approved 
antibacterial drug products will then have the option of relying on FDA 
recognized standards to update their product labeling.
    The draft guidance describes possible approaches that holders of 
new drug applications (NDAs) and those abbreviated new drug 
applications (ANDAs) that are designated as a reference listed drug can 
use to meet their responsibilities to update their product labeling for 
systemic antibacterial drug products. Application holders can use the 
following approaches:
    <bullet> Submit a labeling supplement that relies upon a standard 
recognized by the agency.
    <bullet> Submit a labeling supplement that includes data supporting 
a proposed change to the microbiology information in the labeling that 
differs from the agency's recognized standard.
    Alternatively, in the event that application holders do not believe 
that any labeling changes are necessary, they should provide written 
justification in support of the current information in the Microbiology 
subsection of the product labeling.
    The agency will make the updated information available by publicly 
posting changes to the product labeling within 30 days of approval of a 
supplement that includes a change to the Microbiology subsection of the 
product labeling.
    The draft guidance also describes how manufacturers of in vitro 
diagnostic AST devices should update the susceptibility test 
information in their labeling to incorporate an FDA recognized standard 
or a change in labeling for a relevant antibacterial drug product.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information that 
they conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on the following topics: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of FDA's functions, including whether the 
information will have practical utility; (2) the accuracy of FDA's 
estimated burden of the proposed collection of information, including 
the validity of the methodology and assumptions used; (3) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.
    Application holders can use one of the following approaches to meet 
their responsibilities to update their product labeling under the draft 
guidance and FDA regulations: Submit a labeling supplement that relies 
upon a standard recognized by FDA in a Federal Register notice, or 
submit a labeling supplement that includes data supporting a proposed 
change to the microbiology information in the labeling. In addition, 
application holders should include in their annual report an assessment 
of whether the information in the Microbiology subsection of their 
product labeling is current or changes are needed. This information 
collection is already approved by OMB under control number 0910-0572 
(the requirement in 21 CFR 201.56(a)(2) to update labeling when new 
information becomes available that causes the labeling to become 
inaccurate, false, or misleading) and control number 0910-0001 (the 
requirement in 21 CFR 314.70(b)(2)(v) to submit labeling supplements 
for certain changes in the product's labeling, and the requirement in 
21 CFR 314.81(b)(2)(i) to include in the annual report a brief summary 
of significant new information from the previous year that might affect 
the labeling of the drug product).
    In addition, under the draft guidance, if the information in the 
applicant's product labeling differs from the standards recognized by 
FDA in the Federal Register notice, and the applicant believes that 
changes to the labeling are not needed, the applicant should provide 
written justification to FDA. This justification should explain why the 
recognized standard does not apply to its drug product and why changes 
are not needed to the Microbiology subsection of the product's 
labeling. This justification should also be submitted as general 
correspondence to the product's application, and a statement indicating 
that no change is currently needed and the supporting justification 
should be included in the

[[Page 33440]]

annual report. Based on our knowledge of the need to update information 
on susceptibility test interpretive criteria, susceptibility test 
methods, and quality control parameters in the labeling for systemic 
antibacterial drug products for human use, we estimate that, annually, 
only 2 applicants will submit the written justification described 
previously and in the draft guidance. We also estimate that each 
justification will take approximately 16 hours to prepare and submit to 
FDA as general correspondence and as part of the annual report.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of          No. of Responses                          Hours Per
                                                           Respondents        per  Respondent     Total Responses        Response         Total Hours
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Justification submitted as general correspondence and                   2                     1                  2                 16                 32
 in the annual report
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: June 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1350 Filed 6-10-08; 11:31 am]
BILLING CODE 4160-01-S