Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 11133 

survey to State and local health and 

agriculture agencies. In doing so, this 

team will be able to analyze the gaps 

and trends to occur at these respective 

levels which will allow FSMA 

counterparts to develop ways to 

enhance food safety and food defense. 

In developing these strategies, FDA will 

be able to work with other Federal 

Agencies to improve and expand food 

safety and defense to ultimately reach a 

state of an integrated food safety system. 

FDA will conduct the survey 

electronically which allows FDA to 

conduct streamlines analysis while 

creating a low-burden, user-friendly 

environment for respondents to 

complete the survey. Once the results 

have been tabulated, a report will be 

generated and given to FSMA section 

110 to present to Congress as well as 

FSMA section 205(c)1 to develop the 

strategies to leverage and enhance 

current State and local capacities. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Current State and local government employees ................. 1,400 1 1,400 1 1,400 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

This survey is slated to be a one-time 

survey. Through testing on six FDA 

employees who were formerly State 

employees, the survey development 

team has come to the conclusion that it 

should take no longer than 1 hour for 

the 1,400 current State and local 

government employees to complete the 

survey. FDA is requesting this data 

collection burden so as not to restrict 

the Agency’s ability to gather 

information on public sentiment for its 

proposals in its regulatory and 

communications programs. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4289 Filed 2–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0148] 

Draft Guidance for Industry on 

Complicated Urinary Tract 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 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). Specifically, this 

guidance addresses FDA’s current 

thinking regarding the overall drug 

development program for the treatment 

of cUTIs, 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 May 24, 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 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 draft guidance for industry entitled 

‘‘Complicated Urinary Tract 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 cUTIs. This draft guidance revises 

and replaces the draft guidance for 

industry entitled ‘‘Complicated Urinary 

Tract Infections and Pyelonephritis— 

Developing Antimicrobial Drugs for 

Treatment’’ published in 1998. 

Infections of the urinary tract 

occurring in patients with underlying 

functional or anatomic abnormalities of 

the urinary tract are defined as cUTIs. 

Infections of the kidney, called 

pyelonephritis, can occur in persons 

without underlying abnormalities of the 

urinary tract, but are also considered to 

be a subset of cUTI. Different types of 

bacteria can cause cUTI, but Gramnegative bacteria are most often 

associated with cUTI. 

This draft 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 trials for the treatment of 

cUTI. The draft guidance provides a 

scientific justification for a 

noninferiority margin based on 

historical observational data compared 

to the results of previously conducted 

clinical trials. 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. 

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. 


srobinson on DSK4SPTVN1PROD with NOTICES
11134 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

II. The Paperwork Reduction Act of 

1995 

This draft 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. 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 

OMB control number 0910–0581. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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. 

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 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4290 Filed 2–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0610] 

Guidance for Industry on 

Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic; 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 ‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic.’’ The guidance 

discusses FDA’s intended approach to 

enforcement of adverse event reporting 

requirements for drugs, biologics, 

medical devices, and dietary 

supplements during an influenza 

pandemic. The Agency makes 

recommendations to industry for 

focusing limited resources on reports 

related to products indicated for the 

prevention and treatment of influenza 

and other specific types of reports 

indicated in the guidance. 

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 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: 

Regarding pandemic influenza: 

Carmen Maher, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

4146, Silver Spring, MD 20993–0002, 

301–796–8510. 

Regarding human drug products: Toni 

Piazza-Hepp, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4480, Silver Spring, 

MD 20993–0002, 301–796–0520. 

Regarding human biological products: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–6210. 

Regarding medical device products: 

Deborah Moore, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3230, Silver Spring, 

MD 20993–0002, 301–796–6106. 

Regarding dietary supplements: John 

Sheehan, Center for Food Safety and 

Applied Nutrition (HFS–315), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1488. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic.’’ FDA anticipates 

that during an influenza pandemic, 

industry and FDA workforces may be 

reduced while reporting of adverse 

events related to widespread use of 

medical products indicated for the 

treatment and prevention of influenza 

may increase, although the extent of 

these possible changes is unknown. The 

guidance discusses FDA’s intended 

approach to enforcement of adverse 

event reporting requirements for drugs, 

biologics, medical devices, and dietary 

supplements during an influenza 

pandemic. 

The guidance provides 

recommendations for planning, 

notification, and documentation for 

firms that report postmarketing adverse 

events. The guidance recommends that 

each firm’s pandemic influenza 

continuity of operations plan include 

instructions for reporting adverse events 

and a plan for the submission of stored 

reports that were not submitted within 

regulatory timeframes. The guidance 

recommends that firms that are unable 

to fulfill normal adverse event reporting 

requirements during an influenza 

pandemic do the following: 

• Document the conditions that 

prevent them from meeting normal 

reporting requirements, 

• Notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when these conditions exist and when 

the reporting process is restored, and 

• Maintain records to identify what 

reports have been stored. 

This guidance does not address 

monitoring and reporting of adverse 

events that might be imposed as a 

condition of authorization for products 

authorized for emergency use under 

section 564 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 360bbb–3). This guidance also 

does not address monitoring and 

reporting of adverse events as required 

by regulations establishing the 

conditions for investigational use of 

drugs, biologics, and devices. (See 21 

CFR parts 312 and 812.) 

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 postmarketing 

adverse event reporting for medical 

products and dietary supplements 

during pandemic influenza. It does not 


srobinson on DSK4SPTVN1PROD with NOTICES