Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability, 26257-26258 [2014-10409]

Download as PDF Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Notices Dated: May 1, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–10410 Filed 5–6–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0589] Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Hospital-Acquired Bacterial Pneumonia and VentilatorAssociated Bacterial Pneumonia: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published November 29, 2010. SUMMARY: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 5, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, pmangrum on DSK3VPTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 15:11 May 06, 2014 Jkt 232001 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 draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 draft guidance for industry entitled ‘‘Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of HABP/VABP. Issues in HABP/VABP clinical trials were discussed at a 2009 workshop cosponsored by FDA and professional societies. Recently, there have been additional discussions about clinical trial design and endpoints for HABP/ VABP at a meeting of the Anti-Infective Drugs Advisory Committee. As a result of these public discussions, the science of clinical trial design and our understanding of endpoints and approaches to clinical development have advanced. This draft guidance revises the draft guidance published in November 2010 (75 FR 73107) and informs sponsors of the changes in our recommendations. We acknowledge the challenges in conducting clinical trials of investigational antibacterial drugs in HABP/VABP. This revised draft guidance incorporates changes intended to attain a greater degree of balance between the practicability of conducting HABP/VABP clinical trials and the trial procedures needed for a scientifically sound and interpretable trial. We are requesting input from the public on these changes, for consideration before finalizing the guidance. Specifically, the changes from the 2010 draft guidance include: • A description of two potential primary efficacy endpoints for HABP/ VABP clinical trials: (1) All-cause PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 26257 mortality and (2) all-cause mortality or disease-related complications. • A justification for a noninferiority margin based on all-cause mortality. • Suggestions for efficacy analyses based on: (1) An overall ITT population and (2) a microbiological ITT population consisting of those patients who have a documented bacterial pathogen known to cause HABP/VABP. • Recommendations for enrolling patients who have received prior effective antibacterial drug therapy. Issuance of this guidance fulfills a portion of the requirements of title VIII, section 804 of the Food and Drug Administration Safety and Innovation Act of 2012 (Pub. L. 112–144), which requires FDA to ‘‘review and, as appropriate, revise not fewer than 3 guidance documents per year . . . for the conduct of clinical trials with respect to antibacterial and antifungal drugs. . . . ’’ 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. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulation. 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). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014 and the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments 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, and will be posted to the docket at https:// www.regulations.gov. E:\FR\FM\07MYN1.SGM 07MYN1 26258 Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Notices IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: May 1, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–10409 Filed 5–6–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. pmangrum on DSK3VPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including those in regulatory science; and input into the Agency’s research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. Date and Time: The meeting will be held on June 4, 2014, from approximately 8:30 a.m. until 4:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/Advisory Committees/default.htm; under the VerDate Mar<15>2010 15:11 May 06, 2014 Jkt 232001 heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Martha Monser, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4286, Silver Spring, MD 20993, 301–796–4627, martha.monser@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On June, 4, 2014, the Science Board will discuss and make recommendations on the draft final report from the Center for Biologics Evaluation and Research’s postmarketing safety review subcommittee. The committee will be asked to support forming a new subcommittee to evaluate the Commissioner’s Fellowship Program. The committee will be presented with an overview of current issues surrounding heparin sourcing issues for discussion. A recipient of one of the fiscal year 2013 Scientific Achievement Awards (selected by the Science Board) will provide an overview of the activities for which the award was given. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 person on or before May 28, 2014. Oral presentations from the public will be scheduled between approximately 3 p.m. and 4 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 20, 2014. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 21, 2014. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Martha Monser at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 1, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–10436 Filed 5–6–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Notices]
[Pages 26257-26258]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10409]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0589]

Draft Guidance for Industry on Hospital-Acquired Bacterial
Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing
Drugs for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Hospital-
Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial
Pneumonia: Developing Drugs for Treatment.'' The purpose of this draft
guidance is to assist clinical trial sponsors and investigators in the
development of antibacterial drugs for the treatment of hospital-
acquired bacterial pneumonia and ventilator-associated bacterial
pneumonia (HABP/VABP). The science of clinical trial design and our
understanding of this disease have advanced in recent years, and this
draft guidance informs sponsors of our current recommendations for
clinical development. FDA is specifically requesting comment on
critical areas of scientific interest including the appropriate primary
efficacy endpoints, the use of an intent-to-treat (ITT) population for
the primary analysis population, and the use of antibacterial therapy
by patients before participating in clinical trials. This draft
guidance revises the draft guidance of the same name that published
November 29, 2010.

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 comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 5, 2014.

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. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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 draft guidance for industry
entitled ``Hospital-Acquired Bacterial Pneumonia and Ventilator-
Associated Bacterial Pneumonia: Developing Drugs for Treatment.'' The
purpose of this draft guidance is to assist clinical trial sponsors and
investigators in the development of antibacterial drugs for the
treatment of HABP/VABP. Issues in HABP/VABP clinical trials were
discussed at a 2009 workshop cosponsored by FDA and professional
societies. Recently, there have been additional discussions about
clinical trial design and endpoints for HABP/VABP at a meeting of the
Anti-Infective Drugs Advisory Committee. As a result of these public
discussions, the science of clinical trial design and our understanding
of endpoints and approaches to clinical development have advanced.
This draft guidance revises the draft guidance published in
November 2010 (75 FR 73107) and informs sponsors of the changes in our
recommendations. We acknowledge the challenges in conducting clinical
trials of investigational antibacterial drugs in HABP/VABP. This
revised draft guidance incorporates changes intended to attain a
greater degree of balance between the practicability of conducting
HABP/VABP clinical trials and the trial procedures needed for a
scientifically sound and interpretable trial. We are requesting input
from the public on these changes, for consideration before finalizing
the guidance. Specifically, the changes from the 2010 draft guidance
include:
A description of two potential primary efficacy endpoints
for HABP/VABP clinical trials: (1) All-cause mortality and (2) all-
cause mortality or disease-related complications.
A justification for a noninferiority margin based on all-
cause mortality.
Suggestions for efficacy analyses based on: (1) An overall
ITT population and (2) a microbiological ITT population consisting of
those patients who have a documented bacterial pathogen known to cause
HABP/VABP.
Recommendations for enrolling patients who have received
prior effective antibacterial drug therapy.
Issuance of this guidance fulfills a portion of the requirements of
title VIII, section 804 of the Food and Drug Administration Safety and
Innovation Act of 2012 (Pub. L. 112-144), which requires FDA to
``review and, as appropriate, revise not fewer than 3 guidance
documents per year . . . for the conduct of clinical trials with
respect to antibacterial and antifungal drugs. . . . ''
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. The Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information found in FDA regulation. 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). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014 and the collections of information in 21
CFR part 314 have been approved under OMB control number 0910-0001.

III. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at https://www.regulations.gov.

[[Page 26258]]

IV. 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: May 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10409 Filed 5-6-14; 8:45 am]
BILLING CODE 4160-01-P

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