81_FR_59107 81 FR 58941 - Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation; Guidance for Industry; Availability

81 FR 58941 - Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 166 (August 26, 2016)

Page Range58941-58942
FR Document2016-20473

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Microbiology Data for Systemic Antibacterial Drugs--Development, Analysis, and Presentation.'' The purpose of this guidance is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. This guidance finalizes the draft guidance of the same name issued on September 17, 2009.

Federal Register, Volume 81 Issue 166 (Friday, August 26, 2016) 
[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Notices]
[Pages 58941-58942]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0408]


Microbiology Data for Systemic Antibacterial Drugs--Development, 
Analysis, and Presentation; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Microbiology 
Data for Systemic Antibacterial Drugs--Development, Analysis, and 
Presentation.'' The purpose of this guidance is to assist sponsors in 
the development, analysis, and presentation of microbiology data during 
antibacterial drug development. This guidance finalizes the draft 
guidance of the same name issued on September 17, 2009.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 comments, that information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2009-D-0408 for ``Microbiology Data for Systemic Antibacterial 
Drugs--Development, Analysis, and Presentation; Guidance for Industry; 
Availability.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1400.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Microbiology Data for Systemic Antibacterial Drugs--
Development, Analysis, and Presentation.'' The purpose of this guidance 
is to assist sponsors in the development, analysis, and presentation of 
microbiology data during antibacterial drug development. Microbiology 
data provide important information to guide clinical development of 
antibacterial drugs and guide clinicians on the use of an antibacterial 
drug for its intended indication.
    This guidance finalizes the draft guidance issued on September 17, 
2009

[[Page 58942]]

(74 FR 47804). After consideration of comments received in response to 
the draft guidance, the guidance was restructured to describe general 
approaches to microbiology data collection in the body of the guidance 
and to provide more specific recommendations in appendixes (e.g., the 
format for microbiology data presentation and an example for sections 
of labeling that pertain to microbiology).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the development, analysis, and presentation 
of microbiology data for systemic antibacterial drugs. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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).
    1. This guidance provides recommendations on the type of 
information to include in submissions of the clinical microbiology 
section of investigational new drug applications (INDs) and new drug 
applications (NDAs) for systemic antibacterial drugs. The microbiology 
section of an NDA is required under 21 CFR 314.50(d)(4) and this 
information collection is approved under OMB control number 0910-0001. 
For INDs, this information is required under 21 CFR 312.23(a) and 
approved under OMB control number 0910-0014.
    2. This guidance also recommends the types of data that should be 
submitted in a labeling supplement to update the microbiology 
information in approved labeling if an application holder chooses to 
update this information without relying on a standard recognized by 
FDA. The submission of labeling supplements is required under 21 CFR 
314.70(b)(2)(v) and 201.56(a)(2) and this information collection is 
approved under OMB control numbers 0910-0001 and 0910-0572, 
respectively.
    3. Appendix D of this guidance describes the content of the 
Microbiology subsection of labeling. This labeling is covered under 21 
CFR 201.57(c)(13)(i) and the information collection is approved under 
OMB control number 0910-0572.
    4. This guidance also references the guidance for industry entitled 
``Updating Labeling for Susceptibility Test Information in Systemic 
Antibacterial Drug Products and Antimicrobial Susceptibility Testing 
Devices'' for updating labeling information. The information collection 
in this guidance has been approved under OMB control number 0910-0638.

III. Electronic Access

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

    Dated: August 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20473 Filed 8-25-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices 58941 technological collection techniques or solely responsible for ensuring that your www.regulations.gov. Submit both other forms of information technology. comment does not include any copies to the Division of Dockets Obtaining Copies of Proposals: confidential information that you or a Management. If you do not wish your Requesters may obtain a copy of the third party may not wish to be posted, name and contact information to be information collection documents from such as medical information, your or made publicly available, you can the General Services Administration, anyone else’s Social Security number, or provide this information on the cover Regulatory Secretariat Division (MVCB), confidential business information, such sheet and not in the body of your 1800 F Street NW., Washington, DC as a manufacturing process. Please note comments and you must identify this 20405, telephone 202–501–4755. Please that if you include your name, contact information as ‘‘confidential.’’ Any cite OMB Control No. 9000–0090, Rights information, or other information that information marked as ‘‘confidential’’ in Data and Copyrights, in all identifies you in the body of your will not be disclosed except in correspondence. comments, that information will be accordance with 21 CFR 10.20 and other Dated: August 22, 2016. posted on http://www.regulations.gov. applicable disclosure law. For more • If you want to submit a comment information about FDA’s posting of Lorin S. Curit, with confidential information that you comments to public dockets, see 80 FR Director, Federal Acquisition Policy Division, do not wish to be made available to the 56469, September 18, 2015, or access Office of Governmentwide Acquisition Policy, public, submit the comment as a Office of Acquisition Policy, Office of the information at: http://www.fda.gov/ Governmentwide Policy. written/paper submission and in the regulatoryinformation/dockets/ manner detailed (see ‘‘Written/Paper default.htm. [FR Doc. 2016–20443 Filed 8–25–16; 8:45 am] Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to BILLING CODE 6820–EP–P read background documents or the Written/Paper Submissions electronic and written/paper comments Submit written/paper submissions as received, go to http:// DEPARTMENT OF HEALTH AND follows: www.regulations.gov and insert the HUMAN SERVICES • Mail/Hand delivery/Courier (for docket number, found in brackets in the written/paper submissions): Division of heading of this document, into the Food and Drug Administration Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts [Docket No. FDA–2009–D–0408] and Drug Administration, 5630 Fishers and/or go to the Division of Dockets Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Microbiology Data for Systemic • For written/paper comments 1061, Rockville, MD 20852. Antibacterial Drugs—Development, submitted to the Division of Dockets Submit written requests for single Analysis, and Presentation; Guidance Management, FDA will post your copies of this guidance to the Division for Industry; Availability comment, as well as any attachments, of Drug Information, Center for Drug except for information submitted, Evaluation and Research, Food and AGENCY: Food and Drug Administration, marked and identified, as confidential, Drug Administration, 10001 New HHS. if submitted as detailed in Hampshire Ave., Hillandale Building, ACTION: Notice of availability. ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– Instructions: All submissions received 0002. Send one self-addressed adhesive SUMMARY: The Food and Drug must include the Docket No. FDA– label to assist that office in processing Administration (FDA or Agency) is 2009–D–0408 for ‘‘Microbiology Data for your requests. See the SUPPLEMENTARY announcing the availability of a Systemic Antibacterial Drugs— INFORMATION section for electronic guidance for industry entitled Development, Analysis, and access to the guidance document. ‘‘Microbiology Data for Systemic Presentation; Guidance for Industry; FOR FURTHER INFORMATION CONTACT: Antibacterial Drugs—Development, Availability.’’ Received comments will Analysis, and Presentation.’’ The Joseph G. Toerner, Center for Drug be placed in the docket and, except for Evaluation and Research, Food and purpose of this guidance is to assist those submitted as ‘‘Confidential sponsors in the development, analysis, Drug Administration, 10903 New Submissions,’’ publicly viewable at Hampshire Ave, Bldg. 22, Rm. 6244, and presentation of microbiology data http://www.regulations.gov or at the Silver Spring, MD 20993–0002, 301– during antibacterial drug development. Division of Dockets Management 796–1400. This guidance finalizes the draft between 9 a.m. and 4 p.m., Monday guidance of the same name issued on SUPPLEMENTARY INFORMATION: through Friday. September 17, 2009. • Confidential Submissions—To I. Background DATES: Submit either electronic or submit a comment with confidential FDA is announcing the availability of written comments on Agency guidances information that you do not wish to be a guidance for industry entitled at any time. made publicly available, submit your ‘‘Microbiology Data for Systemic ADDRESSES: You may submit comments comments only as a written/paper Antibacterial Drugs—Development, as follows: submission. You should submit two Analysis, and Presentation.’’ The copies total. One copy will include the purpose of this guidance is to assist Electronic Submissions information you claim to be confidential sponsors in the development, analysis, Submit electronic comments in the with a heading or cover note that states and presentation of microbiology data following way: ‘‘THIS DOCUMENT CONTAINS during antibacterial drug development. • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The mstockstill on DSK3G9T082PROD with NOTICES Microbiology data provide important www.regulations.gov. Follow the Agency will review this copy, including information to guide clinical instructions for submitting comments. the claimed confidential information, in development of antibacterial drugs and Comments submitted electronically, its consideration of comments. The guide clinicians on the use of an including attachments, to http:// second copy, which will have the antibacterial drug for its intended www.regulations.gov will be posted to claimed confidential information indication. the docket unchanged. Because your redacted/blacked out, will be available This guidance finalizes the draft comment will be made public, you are for public viewing and posted on http:// guidance issued on September 17, 2009 VerDate Sep<11>2014 21:17 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1

58942 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices (74 FR 47804). After consideration of collection is approved under OMB ADDRESSES: You may submit comments comments received in response to the control number 0910–0572. as follows: draft guidance, the guidance was 4. This guidance also references the Electronic Submissions restructured to describe general guidance for industry entitled approaches to microbiology data ‘‘Updating Labeling for Susceptibility Submit electronic comments in the collection in the body of the guidance Test Information in Systemic following way: and to provide more specific Antibacterial Drug Products and • Federal eRulemaking Portal: http:// recommendations in appendixes (e.g., Antimicrobial Susceptibility Testing www.regulations.gov. Follow the the format for microbiology data Devices’’ for updating labeling instructions for submitting comments. presentation and an example for information. The information collection Comments submitted electronically, sections of labeling that pertain to in this guidance has been approved including attachments, to http:// microbiology). under OMB control number 0910–0638. www.regulations.gov will be posted to This guidance is being issued the docket unchanged. Because your III. Electronic Access comment will be made public, you are consistent with FDA’s good guidance practices regulation (21 CFR 10.115). Persons with access to the Internet solely responsible for ensuring that your The guidance represents the current may obtain the guidance at either http:// comment does not include any thinking of FDA on the development, www.fda.gov/Drugs/Guidance confidential information that you or a analysis, and presentation of ComplianceRegulatoryInformation/ third party may not wish to be posted, microbiology data for systemic Guidances/default.htm or http:// such as medical information, your or antibacterial drugs. It does not establish www.regulations.gov. anyone else’s Social Security number, or any rights for any person and is not confidential business information, such Dated: August 22, 2016. binding on FDA or the public. You can as a manufacturing process. Please note Leslie Kux, use an alternative approach if it satisfies that if you include your name, contact Associate Commissioner for Policy. information, or other information that the requirements of the applicable [FR Doc. 2016–20473 Filed 8–25–16; 8:45 am] statutes and regulations. identifies you in the body of your BILLING CODE 4164–01–P comments, that information will be II. The Paperwork Reduction Act of posted on http://www.regulations.gov. 1995 • If you want to submit a comment DEPARTMENT OF HEALTH AND with confidential information that you This guidance refers to previously HUMAN SERVICES approved collections of information do not wish to be made available to the found in FDA regulations. These public, submit the comment as a Food and Drug Administration written/paper submission and in the collections of information are subject to review by the Office of Management and [Docket No. FDA–2016–N–2496] manner detailed (see ‘‘Written/Paper Budget (OMB) under the Paperwork Submissions’’ and ‘‘Instructions’’). Agency Information Collection Reduction Act of 1995 (44 U.S.C. 3501– Written/Paper Submissions Activities; Proposed Collection; 3520). Comment Request; User Account Submit written/paper submissions as 1. This guidance provides Management Function for the Import follows: recommendations on the type of Trade Auxiliary Communication • Mail/Hand delivery/Courier (for information to include in submissions System written/paper submissions): Division of of the clinical microbiology section of Dockets Management (HFA–305), Food investigational new drug applications AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers (INDs) and new drug applications HHS. Lane, Rm. 1061, Rockville, MD 20852. (NDAs) for systemic antibacterial drugs. ACTION: Notice. • For written/paper comments The microbiology section of an NDA is submitted to the Division of Dockets required under 21 CFR 314.50(d)(4) and SUMMARY: The Food and Drug Management, FDA will post your this information collection is approved Administration (FDA) is announcing an comment, as well as any attachments, under OMB control number 0910–0001. opportunity for public comment on the except for information submitted, For INDs, this information is required proposed collection of certain marked and identified, as confidential, under 21 CFR 312.23(a) and approved information by the Agency. Under the if submitted as detailed in under OMB control number 0910–0014. Paperwork Reduction Act of 1995 (the ‘‘Instructions.’’ 2. This guidance also recommends the PRA), Federal Agencies are required to Instructions: All submissions received types of data that should be submitted publish notice in the Federal Register must include the Docket No. FDA– in a labeling supplement to update the concerning each proposed collection of 2016–N–2496 for ‘‘Agency Information microbiology information in approved information, and to allow 60 days for Collection Activities; Proposed labeling if an application holder chooses public comment in response to the Collection; Comment Request; User to update this information without notice. This notice solicits comments on Account Management Function for the relying on a standard recognized by the collection of information required to Import Trade Auxiliary Communication FDA. The submission of labeling implement user account management System.’’ Received comments will be supplements is required under 21 CFR function in FDA’s Import Trade placed in the docket and, except for 314.70(b)(2)(v) and 201.56(a)(2) and this Auxiliary Communication System those submitted as ‘‘Confidential information collection is approved (ITACS). Secure user accounts will Submissions,’’ publicly viewable at mstockstill on DSK3G9T082PROD with NOTICES under OMB control numbers 0910–0001 allow import trade users to receive http://www.regulations.gov or at the and 0910–0572, respectively. Notices of FDA Action and requests for Division of Dockets Management 3. Appendix D of this guidance specific information via email or via between 9 a.m. and 4 p.m., Monday describes the content of the download within ITACS. through Friday. Microbiology subsection of labeling. DATES: Submit either electronic or • Confidential Submissions—To This labeling is covered under 21 CFR written comments on the collection of submit a comment with confidential 201.57(c)(13)(i) and the information information by October 25, 2016. information that you do not wish to be VerDate Sep<11>2014 21:17 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1


Document Created: 2016-08-26 10:40:22
Document Modified: 2016-08-26 10:40:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactJoseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301- 796-1400.
FR Citation81 FR 58941 
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