[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65403-65405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0341]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Updating Labeling for Susceptibility Test Information in Systemic 
Antibacterial Drug Products and Antimicrobial Susceptibility Testing 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 65404]]

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 4, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#640b0d16053b171106090d17170d0b0a240b09064a010b144a030b12"><span class="__cf_email__" data-cfemail="137c7a61724c6066717e7a60607a7c7d537c7e713d767c633d747c65">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0638. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#e5b5b7a4b691848383a5838184cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="6f3f3d2e3c1b0e09092f090b0e4107071c41080019">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Updating Labeling for Susceptibility Test 
Information in Systemic Antibacterial Drug Products and Antimicrobial 
Susceptibility Testing Devices--(OMB Control Number 0910-0638)--
Extension

    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. As a result of 
this provision, the guidance explains the importance of making 
available to health care providers the most current information 
regarding susceptibility test interpretive criteria for antibacterial 
drug products. 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, the guidance describes procedures for FDA, applications 
holders, and antimicrobial susceptibility testing device manufacturers 
to ensure that updated susceptibility test information is available to 
health care providers. Where appropriate, FDA will 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. FDA 
recognized standards will be available to application holders of 
approved antibacterial drug products for updating their product 
labeling.
    Application holders can use one of the following approaches to meet 
their responsibilities to update their product labeling under the 
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 whether changes are needed. This 
information collection is already approved by OMB under control numbers 
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 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 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 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 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 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, and 
our experience with the FDAAA requirement and the guidance 
recommendations during the past 16 months, we estimate that, annually, 
approximately two applicants will submit the written justification 
described previously and in the guidance, and that each justification 
will take approximately 16 hours to prepare and submit to FDA as 
general correspondence and as part of the annual report.
    In the Federal Register of April 7, 2014 (79 FR 19099), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. The comment 
expressed support for FDA's efforts to review updated breakpoints 
published by appropriate nationally or internationally recognized 
standard setting bodies, and then determine whether to recognize these 
recommendations in an annual Federal Register notice based upon the 
best available scientific and clinical evidence. The comment also urged 
FDA and outside organizations to prioritize the harmonization of 
breakpoints, taking into account possible differences in doses and 
dosing schedules used in different parts of the world. The comment also 
expressed support for the provisions in the Antibiotic Development to 
Advance Patient Treatment (ADAPT) Act, H.R. 3742. The comment said that 
the ADAPT Act would direct FDA to publish quarterly on its Web site new 
or updated breakpoints set by an appropriate standard setting 
organization and recognized by the Agency. The comment said it would 
also support additional statutory changes to remove breakpoint 
information from the paper labeling of antibacterial drugs and 
establish a scheme whereby FDA may clear antimicrobial susceptibility 
testing devices that incorporate breakpoints that have been set by an 
outside standard setting body and recognized by the FDA.
    FDA appreciates the comment and we will continue our efforts on 
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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 65405]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Justification Submitted as                     2               1               2              16              32
 General Correspondence and in
 the Annual Report..............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26140 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P


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