Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74065 

of risk projected and different 

approaches taken by manufacturers 

seeking to meet those requirements. 

FDA would like to convene sessions of 

experts and hold focused meetings over 

the next 3 years to discuss REMS 

implementation to date, and explore 

practical policy approaches relevant to 

restricted distribution processes and 

quality care counseling. 

C. Eligibility Information 

This supplement is available only to 

the existing grant recipient, Brookings. 

D. Requirements of the Supplemental 

Application 

1. The application clearly 

demonstrates an understanding of the 

purpose and objectives of the program 

expansion as described in section B of 

this document. 

2. The application clearly describes 

the steps involved in a proposed 

schedule for planning, implementing, 

and accomplishing the activities to be 

carried out under the program 

expansion. 

3. The application establishes 

Brookings ability to perform the 

responsibilities under the program 

expansion including the availability of 

appropriate staff and sufficient funding. 

4. The application describes 

Brookings ability to act as a neutral, 

independent third party to convene a 

wide group of diverse stakeholders with 

relevant expertise related to selected 

topics. 

5. The application specifies the 

manner in which interaction with FDA 

will be maintained throughout the 

lifetime of the project. 

6. The application specifies how 

Brookings will monitor progress of the 

work under the program expansion and 

how progress will be reported to FDA. 

7. The application shall include a 

detailed budget that shows: (1) 

Anticipated costs for personnel, travel, 

communications and postage, and 

supplies and (2) the sources of funds to 

meet those needs, if other than FDA. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates supplementing this 

program expansion by providing 

approximate total cost of $501,534 

(direct costs only) in each budget period 

beginning in 2010, and the remaining 

budget periods (years: 2011, 2012, and 

2013). 

B. Length of Support 

The initial supplemental award will 

be awarded to correspond with the 2010 

budget period, and the remaining 

budget periods (2011, 2012, and 2013) 

will be dependant on the grantee’s 

successful performance, and financial 

management. 

III. Paper Application and Submission 

Information 

To submit a paper application in 

response to this supplemental notice, 

applicants should download the PHS– 

398 form at http://grants.nih.gov/grants/ 

funding/phs398/phs398.html. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

For all paper application submissions, 

the following steps are required: 

Submit paper via Express mail to (see 

the For Further Information and 

Additional Requirements Contact 

section of this document). 

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30054 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB), under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Ryan White HIV/ 

AIDS Program Core Medical Services 

Waiver Application Requirements 

(OMB No. 0915–0307)—Extension 

HRSA utilizes standards for granting 

waivers of the core medical services 

requirement for the Ryan White HIV/ 

AIDS Program. These standards meet 

the intent of the Ryan White HIV/AIDS 

Program to increase access to core 

medical services, including 

antiretroviral drugs, for persons with 

HIV/AIDS and to ensure that grantees 

receiving waivers demonstrate the 

availability of such services for 

individuals with HIV/AIDS who are 

identified and eligible under Title XXVI 

of the Public Health Service (PHS) Act. 

The core medical services waiver 

uniform standard and waiver request 

process will apply to Ryan White HIV/ 

AIDS Program Grant awards under Parts 

A, B, and C of Title XXVI of the PHS 

Act. Core medical services waivers will 

be effective for a 1-year period that is 

consistent with the grant award period. 

Title XXVI, Section 2671 of the PHS 

Act, as amended by the Ryan White 

HIV/AIDS Treatment Extension Act of 

2009, Public Law 111–87, (Ryan White 

HIV/AIDS Program), requires that 

grantees expend 75 percent of Parts A, 

B, and C funds on core medical services, 

including antiretroviral drugs, for 

individuals with HIV/AIDS who are 

identified and eligible under the 

legislation. In order for grantees under 

Parts A, B, and C to be exempt from the 

75 percent core medical services 

requirement, they must request and 

receive a waiver from HRSA. 

Grantees must submit the waiver 

request with the annual grant 

application that includes the 

certifications and documentation which 

will be utilized by HRSA in making 

determinations regarding waiver 

requests. Grantees must provide 

evidence that all of the core medical 

services listed in the statute, regardless 

of whether such services are funded by 

the Ryan White HIV/AIDS Program, are 

available to all individuals with HIV/ 

AIDS who are identified and eligible 

under Title XXVI of the PHS Act in the 

service area within 30 days. 

The annual estimate of burden is as 

follows: 


jdjones on DSK8KYBLC1PROD with NOTICES
74066 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 

Application Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Waiver Request ................................................................... 10 1 10 6.5 65 

Total .............................................................................. 10 1 10 6.5 65 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 30 days of 

this notice. 

Dated: November 23, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–30170 Filed 11–29–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Healthy Weight 

Collaborative (OMB No. 0915–NEW)— 

[NEW]. 

Background: The mission of the 

Healthy Weight Collaborative (HWC) is 

to discover, identify, develop, and 

disseminate both evidence-based and 

promising clinical and communitybased interventions to prevent and treat 

obesity. The HWC was funded by the 

Health Resources and Services 

Administration under Title V, Section 

501(a)(2) of the Social Security Act (42 

U.S.C. 701(a)(2)) and Section 4002 of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148). 

The goal of the HWC is to value and 

leverage each community team’s 

strengths, networks, grantees, and 

expertise towards the common goal of 

promoting healthy weight for all 

populations, especially those at high 

risk for overweight and obesity. 

The HWC is modeled after the 

Institute for Healthcare Improvement 

Collaborative Model for achieving 

breakthrough improvement. Also known 

as the Breakthrough Series, this model 

was developed in 1996 to help 

healthcare organizations make 

breakthrough improvements in quality 

while reducing costs. This model is 

designed to close the gap between 

science and practice by creating a 

structure in which organizations can 

easily learn from each other and from 

recognized experts in topic areas in 

which they want to make quality 

improvements. 

Approximately 50 community teams 

will be recruited to participate in the 

HWC. The intended beneficiaries of this 

program are children and their families, 

and teams in the HWC can include 

health departments, community-based 

organizations, HRSA and the 

Department of Health and Human 

Services (HHS) grantees; especially 

safety net providers and other 

stakeholders in the HRSA and HHS 

program network. Teams will be asked 

to report on non-personally identifiable 

aggregate information from clinical and 

public health or community 

interventions related to four domains, 

including clinical and public health: 

• Body Mass Index (BMI), collected 

from an electronic health record. 

• Nutrition, which includes measures 

related to change in knowledge, 

attitudes, behavior, and consumption. 

• Physical Activity, which includes 

measures related to change in 

knowledge, attitudes, behavior, and 

levels of activity. 

• Partnerships and Process 

Improvement, which includes measures 

related to linkages made between 

clinical and community-based or public 

health programs, increased efficiencies 

related to these linkages, and the 

number of people served by these 

linkages. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

BMI ....................................................................................... 50 30 1,500 .10 150 

Nutrition ................................................................................ 50 30 1,500 .20 300 

Physical Activity ................................................................... 50 30 1,500 .20 300 

Partnerships and Process Improvement ............................. 50 50 2,500 .20 500 

Total .............................................................................. 50 ........................ 7,000 ........................ 1,250 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 


jdjones on DSK8KYBLC1PROD with NOTICES