8324 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 

OCM will also provide an opportunity 

for participating practices to receive 

retrospective episode-based 

performance payments. After 

calculating the benchmark for each 

OCM participant, CMS will set a target 

price for chemotherapy episodes, which 

includes a discount. Participants whose 

Medicare expenditures are below the 

target price may receive semi-annual 

lump-sum performance-based 

payments, subject to the achievement of 

quality measures. In addition to the 

performance-based payments, 

participants will receive a PerBeneficiary-Per-Month payment (PBPM) 

for Medicare beneficiaries with nearly 

all cancer types for each of the 6 months 

of the episode. The monthly PBPM 

payment is intended to pay for the 

enhanced services driven by the 

practice requirements, aimed at 

transforming practices towards 

comprehensive, person-centered, and 

coordinated care. The OCM PBPM is 

$160 per OCM beneficiary per month for 

the duration of each 6-month episode, 

and will remain constant for the 5-year 

model. 

OCM also aims to incorporate other 

payers in addition to Medicare, such as 

commercial insurers and state Medicaid 

agencies. Payers must also be able to 

meet the following requirements for 

participation in the model: 

1. Commit to participation in OCM for 

its 5-year duration, and start 

performance period no later than 90 

days after OCM–FFS’ performance 

period. 

2. Sign a Memorandum of 

Understanding with the Innovation 

Center. 

3. Enter into agreements with 

physician practices participating in 

OCM that include requirements to 

provide high quality care. 

4. Share model methodologies with 

the Innovation Center. 

5. Provide payments to practices for 

enhanced services and performance as 

required in the RFA. 

6. Align practice quality and 

performance measures with OCM, when 

possible. 

7. Provide participating practices with 

aggregate and patient-level data about 

payment and utilization for their 

patients receiving care in OCM, at 

regular intervals. 

The OCM start date is expected to be 

in spring 2016. 

For more specific details regarding 

OCM (including the RFA), we refer 

applicants to the informational 

materials on the Innovation Center Web 

site at: http://innovation.cms.gov/ 

initiatives/Oncology-Care/. Applicants 

are responsible for monitoring the Web 

site to obtain the most current 

information available. 

III. Collection of Information 

Requirements 

Section 1115A(d)(3) of the Act, as 

added by section 3021 of the Affordable 

Care Act (Pub. L. 111–148), states that 

chapter 35 of title 44, United States 

Code (the Paperwork Reduction Act of 

1995), shall not apply to the testing and 

evaluation of models or expansion of 

such models under this section. 

Consequently, this document need not 

be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 35). 

Dated: December 22, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2015–03060 Filed 2–12–15; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Uniform Project Description 

(UPD) Program Narrative Format for 

Discretionary Grant Application Forms. 

OMB No.: 0970–0139. 

Description: The proposed 

information collection would renew the 

Administration for Children and 

Families (ACF) Uniform Project 

Description (UPD). The UPD provides a 

uniform grant application format for 

applicants to submit project information 

in response to ACF discretionary 

funding opportunity announcements. 

ACF uses this information, along with 

other OMB-approved information 

collections (Standard Forms), to 

evaluate and rank applications. Use of 

the UPD helps to protect the integrity of 

ACF’s award selection process. All ACF 

discretionary grant programs are 

required to use this application format. 

An ACF application consists of general 

information and instructions; the 

Standard Form 424 series, which 

requests basic information, budget 

information, and assurances; the Project 

Description that requests the applicant 

to describe how program objectives will 

be achieved; a rationale for the project’s 

budgeted costs; and other assurances 

and certifications. Guidance for the 

content of information requested in the 

Project Description is based in OMB 

Circular 45 CFR 75.203. 

Respondents: Applicants to ACF 

Discretionary Funding Opportunity 

Announcements. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ACF Uniform Project Description ..................................................................... 4,850 1 60 291,000 

Estimated Total Annual Burden 

Hours: 291,000. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

ACF specifically requests comments 

on: (a) Whether the proposed collection 

of information is necessary for the 

proper performance of the functions of 

the agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden information to be collected; and 

(d) ways to minimize the burden of the 

collection of information on 

respondents, including through the use 


tkelley on DSK3SPTVN1PROD with NOTICES
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 


tkelley on DSK3SPTVN1PROD with NOTICES