Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8325 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–03144 Filed 2–13–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0148] 

Complicated Urinary Tract Infections: 

Developing Drugs for Treatment; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Complicated Urinary Tract 

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 urinary tract 

infections (cUTIs). This guidance 

finalizes the revised draft guidance of 

the same name issued on February 24, 

2012. 

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, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993. 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 http://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 guidance for industry entitled 

‘‘Complicated Urinary Tract Infections: 

Developing Drugs for Treatment.’’ The 

purpose of this guidance is to assist 

sponsors in the development of drugs 

for the treatment of cUTIs. 

This guidance includes 

recommendations for an efficacy 

endpoint and noninferiority trial design. 

The efficacy endpoint, based on 

resolution of clinical symptoms and 

eradication of bacteria from the urinary 

tract, was derived from previously 

conducted clinical trials for the 

treatment of cUTI. The guidance 

provides a scientific justification for a 

noninferiority margin based on 

historical observational data compared 

to the results of previously conducted 

clinical trials. After careful 

consideration of comments received in 

response to the revised draft guidance 

issued on February 24, 2012, important 

clarifications about trial populations 

and endpoints for cUTI were included 

in this guidance. In addition, this 

guidance reflects recent developments 

in scientific information that pertain to 

drugs being developed for the treatment 

of cUTI. 

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 (Pub. L. 112–144), which requires 

FDA to review and, as appropriate, 

revise not fewer than three guidance 

documents per year for the conduct of 

clinical trials with respect to 

antibacterial and antifungal drugs. 

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 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 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. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://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 http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03100 Filed 2–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Society of Clinical Research 

Associates—Food and Drug 

Administration; ‘‘Food and Drug 

Administration Clinical Trial 

Requirements, Regulations, 

Compliance and Good Clinical 

Practice’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of Public Workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following conference: Educational 

Conference co-sponsored with the 

Society of Clinical Research Associates 

(SOCRA). The public workshop FDA’s 

clinical trial requirements is designed to 

aid the Clinical Research Professional’s 

understanding of the mission, 

responsibilities and authority of the 

FDA and to facilitate interaction with 

FDA representatives. The program will 

focus on the relationships among the 

FDA and clinical trial staff, investigators 

and institutional review boards (IRB). 

Individual FDA representatives will 

discuss the informed consent process 

and informed consent documents; 

regulations relating to drugs, devices 

and biologics, as well as inspections of 


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