Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for Treatment; Availability, 59928-59929 [2012-24036]

Download as PDF 59928 Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Type of respondent Average burden per response Total annual responses Total hours Requests to Issue an EUA or a Substantive Amendment to an Existing EUA ........................................................... FDA Review of a Pre-EUA Package or an Amendment Thereto ............................................................................. Manufacturers of an Unapproved EUA Product .................. Public Health Authorities; Unapproved EUA Product .......... 9 1.33 12 33 396 11 5 30 1.45 1.6 3 16 8 90 35 2 2 560 16 180 Total .............................................................................. ........................ ........................ ........................ ........................ 1,152 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Type of respondent Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Manufacturers of an Unapproved EUA Product .................. Public Health Authorities; Unapproved EUA Product .......... 5 30 1.6 3 8 90 25 3 200 270 Total .............................................................................. ........................ ........................ ........................ ........................ 470 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 25, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–24043 Filed 9–28–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0973] Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Complicated IntraAbdominal Infections: Developing Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intraabdominal infections (cIAIs). Specifically, this guidance addresses FDA’s current thinking regarding the overall drug development program for the treatment of cIAIs, including clinical trial designs to support approval of drugs. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency DATES: VerDate Mar<15>2010 16:48 Sep 28, 2012 Jkt 226001 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 December 31, 2012. 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 ‘‘Complicated Intra-Abdominal Infections: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist sponsors and PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 investigators in the development of drugs for the treatment of cIAIs. Intra-abdominal infections are common in clinical practice and comprise a wide variety of clinical presentations and differing sources of infection. The infections can be diffuse across the entire peritoneal cavity or retroperitoneal spaces, or can be localized with one or more abscesses surrounding diseased or perforated viscera. A wide variety of bacterial pathogens are responsible for cIAIs, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft guidance includes recommendations for an efficacy endpoint and a non-inferiority trial design. The efficacy endpoint of clinical success represents the desired outcome of an antibacterial treatment of a cIAI and has been used in previously conducted trials of treatment for cIAI. Clinical success is defined as the complete resolution of the baseline signs and symptoms attributable to cIAI at a fixed time point approximately 28 days following randomization. The draft guidance provides scientific support for a noninferiority margin based on the results of previously conducted clinical trials with various effective antibiotics. The draft guidance also provides a discussion about patients with unmet need who have an infection caused by bacterial pathogens that show resistance to most antibacterial drugs on in vitro susceptibility testing. E:\FR\FM\01OCN1.SGM 01OCN1 Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices 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 an approach satisfies the requirements of the applicable statutes and regulations. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. The Paperwork Reduction Act of 1995 AGENCY: Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: September 25, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–24036 Filed 9–28–12; 8:45 am] BILLING CODE 4160–01–P Guidance for Industry on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment; Availability ACTION: III. Comments 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. [Docket No. FDA–2008–D–0419] Food and Drug Administration, HHS. 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, and the collections of information referred to in the guidance for clinical trial sponsors ‘‘Establishment and Operation of Clinical Trial Data Monitoring Committees’’ have been approved under 0910–0581. IV. Electronic Access Food and Drug Administration Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.’’ This guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB– COPD), and finalizes the revised draft guidance issued on August 22, 2008. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: 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, 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 guidance document. Submit electronic comments on the 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: SUMMARY: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Acute VerDate Mar<15>2010 16:48 Sep 28, 2012 Jkt 226001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 59929 Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the overall clinical development program of drugs to support an indication for the treatment of ABECB–COPD. This guidance finalizes the revised draft guidance published on August 22, 2008 (73 FR 49684), which in turn revised the draft guidance for industry entitled ‘‘Acute Bacterial Exacerbations of Chronic Bronchitis—Developing Antimicrobial Drugs for Treatment’’ published in 1998. Changes from the revised draft guidance are incorporated into the appropriate sections of the guidance and were based on comments submitted to the docket for the draft guidance. In addition, developments in scientific and medical information and technology in the treatment of ABECB– COPD are reflected in this guidance. This guidance fulfills the requirement set forth in the Food and Drug Administration Amendments Act of 2007 that directed FDA to update the ABECB–COPD guidance within 5 years.1 This guidance also responds to the requirement set forth in the Food and Drug Administration Safety and Innovation Act of 2012 that FDA review guidances for the conduct of clinical trials with respect to antibacterial and antifungal drugs and revise such guidances as appropriate.2 This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on developing drugs for the treatment of ABECB–COPD. 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 guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget 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 0910–0014; the collections of information in 21 CFR 1 See Title IX, section 911, of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110–85). 2 See Title VIII, section 804(a)(1), of the Food and Drug Administration Safety and Innovation Act of 2012 (Pub. L. 112–144). E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59928-59929]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24036]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0973]


Draft Guidance for Industry on Complicated Intra-Abdominal 
Infections: 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 ``Complicated 
Intra-Abdominal Infections: Developing Drugs for Treatment.'' The 
purpose of this guidance is to assist sponsors in the clinical 
development of drugs for the treatment of complicated intra-abdominal 
infections (cIAIs). Specifically, this guidance addresses FDA's current 
thinking regarding the overall drug development program for the 
treatment of cIAIs, including clinical trial designs to support 
approval of drugs.

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 December 31, 2012.

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 ``Complicated Intra-Abdominal Infections: Developing Drugs for 
Treatment.'' The purpose of this draft guidance is to assist sponsors 
and investigators in the development of drugs for the treatment of 
cIAIs.
    Intra-abdominal infections are common in clinical practice and 
comprise a wide variety of clinical presentations and differing sources 
of infection. The infections can be diffuse across the entire 
peritoneal cavity or retroperitoneal spaces, or can be localized with 
one or more abscesses surrounding diseased or perforated viscera. A 
wide variety of bacterial pathogens are responsible for cIAIs, 
including Gram-negative aerobic bacteria, Gram-positive bacteria, and 
anaerobic bacteria, and there are also mixed infections.
    This draft guidance includes recommendations for an efficacy 
endpoint and a non-inferiority trial design. The efficacy endpoint of 
clinical success represents the desired outcome of an antibacterial 
treatment of a cIAI and has been used in previously conducted trials of 
treatment for cIAI. Clinical success is defined as the complete 
resolution of the baseline signs and symptoms attributable to cIAI at a 
fixed time point approximately 28 days following randomization. The 
draft guidance provides scientific support for a noninferiority margin 
based on the results of previously conducted clinical trials with 
various effective antibiotics. The draft guidance also provides a 
discussion about patients with unmet need who have an infection caused 
by bacterial pathogens that show resistance to most antibacterial drugs 
on in vitro susceptibility testing.

[[Page 59929]]

    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 an approach 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 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, and the collections of information referred to in the 
guidance for clinical trial sponsors ``Establishment and Operation of 
Clinical Trial Data Monitoring Committees'' have been approved under 
0910-0581.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to https://www.regulations.gov. 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.

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: September 25, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24036 Filed 9-28-12; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.