11132 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

Conditions for Coverage and 

Requirements for Outpatient Diabetes 

Self-Management Training Services 

The regulations specifying the 

Medicare conditions for coverage for 

outpatient diabetes self-management 

training services are located in 42 CFR 

parts 410, subpart H. These conditions 

implement section 1861(qq) of the Act, 

which provides for Medicare Part B 

coverage of outpatient DSMT services 

specified by the Secretary. 

Under section 1865(a)(2) of the Act 

and our regulations at § 410.142 (CMS 

process for approving national 

accreditation organizations) and 

§ 410.143 (Requirements for approved 

accreditation organizations), we review 

and evaluate a national accreditation 

organization based on (but not 

necessarily limited to) the criteria set 

forth in § 410.142(b). 

We may conduct on-site inspections 

of a national accreditation 

organization’s operations and office to 

verify information in the organization’s 

application and assess the 

organization’s compliance with its own 

policies and procedures. The onsite 

inspection may include, but is not 

limited to, reviewing documents, 

auditing documentation of meetings 

concerning the accreditation process, 

evaluating accreditation results or the 

accreditation status decision making 

process, and interviewing the 

organization’s staff. 

Notice Upon Completion of Evaluation 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a notice in the Federal 

Register announcing the result of our 

evaluation. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare-Hospital 

Insurance Program; and No. 93.774, 

Medicare-Supplementary Medical Insurance 

Program) 

Dated: February 10, 2012. 

Marilyn Tavenner, 

Acting CMS Administrator, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2012–4277 Filed 2–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0145] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Improving Food 

Safety and Defense Capacity of the 

State and Local Level: Review of State 

and Local Capacities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a survey entitled ‘‘Improving Food 

Safety and Defense Capacity of the State 

and Local Level: Review of State and 

Local Capacities.’’ The data collection 

will obtain knowledge of State and local 

capacities including food safety defense 

staffing and expertise, laboratory 

capacities, and information systems to 

support food and feed safety and 

defense. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 24, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Ila S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 

301–796–7726, 

Ila.Mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Improving Food Safety and Defense 

Capacity at the State and Local Level: 

Review of State and Local Capacities— 

(OMB Control Number 0910—New) 

The Food Safety Modernization Act 

(FSMA) (Pub. L. 111–353) states that a 

review must be conducted to assess the 

State and local capacities to show needs 

for enhancement in the areas or staffing 

levels, laboratory capacities, and 

information technology systems. This 

mandate is referenced again in FSMA 

section 110 stating that a review of 

current food safety and food defense 

capabilities must be presented to 

Congress no later than 2 years after the 

date of enactment (enactment date 

January 4, 2011). In order to facilitate 

this review, this team must distribute a 


srobinson on DSK4SPTVN1PROD with NOTICES
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