82_FR_36120 82 FR 35973 - Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Guidance for Industry; Availability

82 FR 35973 - Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 147 (August 2, 2017)

Page Range35973-35974
FR Document2017-16228

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' The purpose of the guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance of the same name issued July 2, 2013.

Federal Register, Volume 82 Issue 147 (Wednesday, August 2, 2017) 
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35973-35974]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16228]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0744]


Antibacterial Therapies for Patients With an Unmet Medical Need 
for the Treatment of Serious Bacterial Diseases; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Antibacterial 
Therapies for Patients With an Unmet Medical Need for the Treatment of 
Serious Bacterial Diseases.'' The purpose of the guidance is to assist 
sponsors in the development of new antibacterial drugs to treat serious 
bacterial diseases in patients with an unmet medical need, including 
patients who have a serious bacterial disease for which effective 
antibacterial drugs are limited or lacking. This guidance finalizes the 
draft guidance of the same name issued July 2, 2013.

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2013-D-0744 for ``Antibacterial Therapies for Patients With an 
Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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-
796-1300.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Antibacterial Therapies for Patients With an Unmet Medical 
Need for the Treatment of Serious Bacterial Diseases.'' The purpose of 
this guidance is to assist sponsors in the development of new 
antibacterial drugs for the treatment of serious bacterial diseases in 
patients with an unmet medical need, including patients who have a 
serious bacterial disease for which effective antibacterial drugs are 
limited or lacking.
    Efforts to develop new antibacterial drugs have diminished in the 
past few decades. Because bacteria continue to develop resistance to 
available antibacterial drugs, a situation of unmet medical need has 
arisen in which patients with serious bacterial diseases have limited 
or in some cases no alternative antibacterial drugs available for 
treatment. To foster new antibacterial drug development that will have 
the potential to keep pace with continued selective pressures of 
antibacterial resistance, FDA is exploring approaches to help 
streamline development programs for new

[[Page 35974]]

antibacterial drugs. This guidance outlines approaches for streamlined 
development programs that are consistent with FDA's longstanding 
commitment to regulatory flexibility regarding the evidence required to 
support drug approval for patient populations with serious disease and 
limited or no treatment options, while meeting appropriate standards 
for safety and effectiveness (see, for example, 21 CFR 312, subpart E, 
Drugs Intended to Treat Life-threatening and Severely-debilitating 
Illnesses).
    This guidance finalizes the draft guidance of the same name issued 
July 2, 2013 (78 FR 39737). After consideration of comments received in 
response to the draft guidance, FDA updated the guidance to include 
clarifications about trial designs for streamlined development programs 
and statistical approaches. In addition, the guidance outlines 
development approaches for antibacterial drugs that are pathogen-
focused (i.e., drugs that are intended to treat a single species or a 
few species of bacteria) and, accordingly, fulfills the requirements of 
section 806(a), Title VIII (entitled ``Generating Antibiotic Incentives 
Now'') of the Food and Drug Administration Safety and Innovation Act 
(Pub. L. 112-144).
    FDA notes that section 3042 of the 21st Century Cures Act (Pub. L. 
114-255), which establishes a limited population pathway for certain 
antibacterial and antifungal drugs (LPAD) that are intended to treat a 
serious or life-threatening infection in a limited population of 
patients with unmet needs, was enacted shortly before publication of 
this guidance. Some antibacterial drugs that are candidates for a 
streamlined development program may also be candidates for LPAD. FDA 
intends to issue separate guidance regarding LPAD. Sponsors are 
encouraged to discuss proposed approaches with the Division of Anti-
Infective Products.
    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 this topic. 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. This is not a significant regulatory action 
subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information 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 collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Electronic Access

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

    Dated: July 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16228 Filed 8-1-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35973 Dated July 27, 2017. comments, that information will be of comments to public dockets, see 80 Anna K. Abram, posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access Deputy Commissioner for Policy, Planning, • If you want to submit a comment the information at: https://www.gpo.gov/ Legislation, and Analysis. with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- [FR Doc. 2017–16230 Filed 8–1–17; 8:45 am] do not wish to be made available to the 23389.pdf. BILLING CODE 4164–01–P public, submit the comment as a Docket: For access to the docket to written/paper submission and in the read background documents or the manner detailed (see ‘‘Written/Paper electronic and written/paper comments DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). received, go to https:// HUMAN SERVICES Written/Paper Submissions www.regulations.gov and insert the docket number, found in brackets in the Food and Drug Administration Submit written/paper submissions as heading of this document, into the follows: ‘‘Search’’ box and follow the prompts [Docket No. FDA–2013–D–0744] • Mail/Hand delivery/Courier (for and/or go to the Dockets Management Antibacterial Therapies for Patients written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, With an Unmet Medical Need for the Management Staff (HFA–305), Food and Rockville, MD 20852. Treatment of Serious Bacterial Drug Administration, 5630 Fishers Submit written requests for single Diseases; Guidance for Industry; Lane, Rm. 1061, Rockville, MD 20852. copies of this guidance to the Division • For written/paper comments Availability of Drug Information, Center for Drug submitted to the Dockets Management Evaluation and Research, Food and AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as Drug Administration, 10001 New HHS. well as any attachments, except for information submitted, marked and Hampshire Ave., Hillandale Building., ACTION: Notice of availability. 4th Floor, Silver Spring, MD 20993– identified, as confidential, if submitted SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’ 0002. Send one self-addressed adhesive Administration (FDA or Agency) is Instructions: All submissions received label to assist that office in processing announcing the availability of a must include the Docket No. FDA– your requests. See the SUPPLEMENTARY guidance for industry entitled 2013–D–0744 for ‘‘Antibacterial INFORMATION section for electronic ‘‘Antibacterial Therapies for Patients Therapies for Patients With an Unmet access to the guidance document. With an Unmet Medical Need for the Medical Need for the Treatment of FOR FURTHER INFORMATION CONTACT: Treatment of Serious Bacterial Serious Bacterial Diseases.’’ Received Joseph G. Toerner, Center for Drug Diseases.’’ The purpose of the guidance comments will be placed in the docket Evaluation and Research, Food and is to assist sponsors in the development and, except for those submitted as Drug Administration, 10903 New of new antibacterial drugs to treat ‘‘Confidential Submissions,’’ publicly Hampshire Ave., Bldg. 22, Rm. 6244, serious bacterial diseases in patients viewable at https://www.regulations.gov Silver Spring, MD 20993–0002, 301– with an unmet medical need, including or at the Dockets Management Staff 796–1300. patients who have a serious bacterial between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: disease for which effective antibacterial through Friday. drugs are limited or lacking. This • Confidential Submissions—To I. Background guidance finalizes the draft guidance of submit a comment with confidential FDA is announcing the availability of the same name issued July 2, 2013. information that you do not wish to be a guidance for industry entitled DATES: Submit either electronic or made publicly available, submit your ‘‘Antibacterial Therapies for Patients written comments on Agency guidances comments only as a written/paper With an Unmet Medical Need for the at any time. submission. You should submit two Treatment of Serious Bacterial ADDRESSES: You may submit comments copies total. One copy will include the Diseases.’’ The purpose of this guidance as follows: information you claim to be confidential is to assist sponsors in the development with a heading or cover note that states of new antibacterial drugs for the Electronic Submissions ‘‘THIS DOCUMENT CONTAINS treatment of serious bacterial diseases in Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The patients with an unmet medical need, following way: Agency will review this copy, including including patients who have a serious • Federal eRulemaking Portal: the claimed confidential information, in bacterial disease for which effective https://www.regulations.gov. Follow the its consideration of comments. The antibacterial drugs are limited or instructions for submitting comments. second copy, which will have the lacking. Comments submitted electronically, claimed confidential information Efforts to develop new antibacterial including attachments, to https:// redacted/blacked out, will be available drugs have diminished in the past few www.regulations.gov will be posted to for public viewing and posted on decades. Because bacteria continue to the docket unchanged. Because your https://www.regulations.gov. Submit develop resistance to available comment will be made public, you are both copies to the Dockets Management antibacterial drugs, a situation of unmet solely responsible for ensuring that your Staff. If you do not wish your name and medical need has arisen in which comment does not include any contact information to be made publicly patients with serious bacterial diseases confidential information that you or a available, you can provide this have limited or in some cases no third party may not wish to be posted, information on the cover sheet and not alternative antibacterial drugs available sradovich on DSKBCFCHB2PROD with NOTICES such as medical information, your or in the body of your comments and you for treatment. To foster new anyone else’s Social Security number, or must identify this information as antibacterial drug development that will confidential business information, such ‘‘confidential.’’ Any information marked have the potential to keep pace with as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed continued selective pressures of that if you include your name, contact except in accordance with 21 CFR 10.20 antibacterial resistance, FDA is information, or other information that and other applicable disclosure law. For exploring approaches to help streamline identifies you in the body of your more information about FDA’s posting development programs for new VerDate Sep<11>2014 19:43 Aug 01, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\02AUN1.SGM 02AUN1

35974 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices antibacterial drugs. This guidance are subject to review by the Office of 103 of the Pandemic and All-Hazards outlines approaches for streamlined Management and Budget (OMB) under Preparedness Reauthorization Act of development programs that are the Paperwork Reduction Act of 1995 2013 (Pub. L. 113–5), the HHS consistent with FDA’s longstanding (44 U.S.C. 3501–3520). The collections Secretary, in consultation with the commitment to regulatory flexibility of information in 21 CFR parts 312 and Secretary of the U.S. Department of regarding the evidence required to 314 have been approved under OMB Homeland Security, established the support drug approval for patient control numbers 0910–0014 and 0910– NACCD. The purpose of the NACCD is populations with serious disease and 0001, respectively. to provide advice and consultation to limited or no treatment options, while the HHS Secretary with respect to the meeting appropriate standards for safety III. Electronic Access medical and public health needs of and effectiveness (see, for example, 21 Persons with access to the Internet children in relation to disasters. CFR 312, subpart E, Drugs Intended to may obtain the document at either Background: The NACCD public Treat Life-threatening and Severely- https://www.fda.gov/Drugs/ meeting on September 7, 2017, is debilitating Illnesses). GuidanceCompliance dedicated to the deliberation and vote This guidance finalizes the draft RegulatoryInformation/Guidances/ on the Human Services Working Group guidance of the same name issued July default.htm or https:// Report. We will post modifications to 2, 2013 (78 FR 39737). After www.regulations.gov. the agenda on the NACCD September 7, consideration of comments received in Dated: July 27, 2017. 2017 meeting Web page, which is response to the draft guidance, FDA located at https://www.phe.gov/naccd. Anna K. Abram, updated the guidance to include Availability of Materials: We will post clarifications about trial designs for Deputy Commissioner for Policy, Planning, Legislation, and Analysis. all meeting materials prior to the streamlined development programs and meeting on the NACCD September 7, [FR Doc. 2017–16228 Filed 8–1–17; 8:45 am] statistical approaches. In addition, the 2017 meeting Web page located at guidance outlines development BILLING CODE 4164–01–P https://www.phe.gov/naccd. approaches for antibacterial drugs that Procedures for Providing Public Input: are pathogen-focused (i.e., drugs that are Members of the public attend by intended to treat a single species or a DEPARTMENT OF HEALTH AND teleconference via a toll-free call-in few species of bacteria) and, HUMAN SERVICES phone number, which is available on accordingly, fulfills the requirements of Meeting of the National Advisory the NACCD Web site at http:// section 806(a), Title VIII (entitled Committee on Children and Disasters www.phe.gov/naccd. ‘‘Generating Antibiotic Incentives We encourage members of the public Now’’) of the Food and Drug AGENCY: Office of the Secretary, to provide written comments that are Administration Safety and Innovation Department of Health and Human relevant to the NACCD teleconference Act (Pub. L. 112–144). Services. prior to September 7, 2017. Send FDA notes that section 3042 of the ACTION: Notice. written comments by email via the 21st Century Cures Act (Pub. L. 114– ‘‘Contact Us’’ link on https:// 255), which establishes a limited SUMMARY: As stipulated by the Federal www.phe.gov/naccd with ‘‘NACCD population pathway for certain Advisory Committee Act, the Public Comment’’ in the subject line. antibacterial and antifungal drugs Department of Health and Human The NACCD will respond to comments (LPAD) that are intended to treat a Services (HHS) is hereby giving notice received by close-of-business September serious or life-threatening infection in a that the National Advisory Committee 7, 2017, during the meeting. limited population of patients with on Children and Disasters (NACCD) will Dated: July 13, 2017. unmet needs, was enacted shortly before hold a public meeting on September 7, publication of this guidance. Some 2017. George W. Korch Jr., antibacterial drugs that are candidates DATES: The NACCD meeting is Acting Assistant Secretary for Preparedness for a streamlined development program and Response. September 7, 2017, from 3:00 p.m. to may also be candidates for LPAD. FDA [FR Doc. 2017–15853 Filed 8–1–17; 8:45 am] 4:00 p.m. EST. intends to issue separate guidance ADDRESSES: We encourage members of BILLING CODE P regarding LPAD. Sponsors are the public to attend the teleconference. encouraged to discuss proposed To register, go to https://www.phe.gov/ approaches with the Division of Anti- DEPARTMENT OF HEALTH AND naccd and click on the Contact Us link HUMAN SERVICES Infective Products. to open the Contact NACCD form, and This guidance is being issued then fill out the form with NACCD Solicitation of Nominations for consistent with FDA’s good guidance Registration in the subject line. Submit Membership on the Secretary’s practices regulation (21 CFR 10.115). your comments on the NACCD Contact Advisory Committee on Human The guidance represents the current Form located at https://www.phe.gov/ Research Protections thinking of FDA on this topic. It does NACCDComments. not establish any rights for any person AGENCY: Office of the Assistant and is not binding on FDA or the public. FOR FURTHER INFORMATION CONTACT: CDR Secretary for Health, Office for Human You can use an alternative approach if Evelyn Seel, (202) 205–7960, Research Protections, Office of the it satisfies the requirements of the evelyn.seel@hhs.gov. Visit the NACCD Secretary, Department of Health and Web site located at https:// sradovich on DSKBCFCHB2PROD with NOTICES applicable statutes and regulations. This Human Services. is not a significant regulatory action www.phe.gov/naccd. ACTION: Notice. subject to Executive Order 12866. SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee Act SUMMARY: The Office for Human II. The Paperwork Reduction Act of (FACA) of 1972 (5 U.S.C., Appendix, as Research Protections (OHRP), a program 1995 amended), and section 2811A of the office in the Office of the Assistant This guidance refers to previously Public Health Service (PHS) Act (42 Secretary for Health, Department of approved collections of information that U.S.C. 300hh–10a), as added by section Health and Human Services (HHS), is VerDate Sep<11>2014 19:43 Aug 01, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\02AUN1.SGM 02AUN1


Document Created: 2017-08-02 07:09:54
Document Modified: 2017-08-02 07:09:54
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- 796-1300.
FR Citation82 FR 35973 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR