52958 Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: Tim 

McGrath, Office of Regulatory Affairs, 

Food and Drug Administration, 5600 

Fishers Lane, rm. 12–41, Rockville, MD 

20857, 301–827–1028, email: 

timothy.mcgrath@fda.hhs.gov; or 

Camille R. Peake, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

2105, Rockville, MD 20857, 301–827– 

7168, FAX: 301–827–7101, email: 

Camille.Peake@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

For more information on the original 

funding opportunity announcement 

(FOA) for the FERN Microbiological 

Laboratories, please refer to the full 

FOA located at http://grants.nih.gov/ 

grants/guide/pa-files/PAR–09–215.html. 

The program is further described in the 

Catalog of Federal Domestic Assistance 

under 93.103. 

A. Background 

This Federal Register announcement 

issued by FDA under the FERN 

Microbiological Cooperative Agreement 

Program Grant mechanism (U18) is to 

solicit applications from existing FERN 

Microbiology Laboratories to enhance 

current Cooperative Agreement Program 

(CAP) capabilities. The FERN 

cooperative agreements are to enable the 

analyses of foods and food products in 

the event that laboratory surge capacity 

is needed by FERN and FDA for 

analyses related to microbiological 

contamination, either through 

intentional or unintentional means. The 

supplemental grant funds will enable 

analyses of human pathogenic bacteria 

found in animal feed, for samples 

collected by Federal, State, or local 

agencies. Numbers of samples and 

scheduling of samples will be done by 

the FERN National Program Office 

(NPO) in coordination with State/local 

lab authorities. 

These supplemental grant funds will 

also be utilized to enhance animal feed 

analysis results through the usage of 

standardized methods, equipment 

platforms (provided by the grant), 

analytical worksheets, and electronic 

reporting. The supplemental funds will 

also provide training and proficiency 

testing for each method/platform. 

Minimal quality management systems 

will be initiated for each lab, based on 

existing systems in place in each lab 

and consultations between the FERN 

NPO and each lab management group. 

Each laboratory shall develop its own 

consensus decisionmaking, size, and 

format. Federal agency representatives 

may be invited to be nonmember 

liaisons or advisors to the laboratory 

and its meetings. Supplemental funds 

may not be used for Federal employees 

to travel to or participate in these 

meetings. 

B. Research Objectives 

Selected FDA FERN Microbiological 

Cooperative Agreement Laboratories 

(CAP labs) will participate in a special 

Cooperative Agreement program to 

enhance their ability to handle human 

pathogenic bacteria in animal feed. This 

additional program will be compatible 

with other FERN Cooperative 

Agreement work that the selected 

laboratories will be performing. This 

special program will involve screening 

and detection studies for selected 

pathogens (Listeria, Salmonella, 

Escherichia coli O157:H7 and generic E. 

coli). The isolates will be tested using 

methods agreed upon in consultation 

with the Center for Veterinary 

Medicine’s (CVM) Office of Research, 

most of which are already being used to 

isolate these organisms from human 

foods. The selected labs will participate 

in FERN food defense/food safety 

assignments. The participation in this 

cooperative agreement will expand the 

ability of FERN to screen for potential 

foodborne pathogens in these feed 

matrices. In addition, this project will 

provide CVM with information needed 

to assess future testing needs. 

C. Eligibility Information 

These supplemental grant funds are 

only available to existing grant 

recipients from State, local, and tribal 

government FERN laboratories and are 

authorized by section 312 of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(Public Law 107–188) (42 U.S.C. 247b20). This program is described in the 

Catalog of Federal Assistance under 

number 93.448. All projects developed 

with these funds at State, local, and 

tribal levels must have national 

implication or application that can 

enhance Federal food and feed safety 

and security programs. 

D. Requirements 

Laboratories will be selected based on 

the following criteria: 

• If it’s an existing FDA FERN 

Microbiological Cooperative Agreement 

Laboratory; 

• If it has routine microbiological 

capabilities as demonstrated through 

established, ongoing State testing 

programs, preferably those involving 

animal feed testing; 

• If it participates in FERN Food 

Safety/Food Defense surveillance 

assignments; 

• If it participates in FERN proficiency 

testing; and 

• If it has a geographically balanced 

distribution of the selected laboratories. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing 

approximately $50,000 total costs 

(direct costs only) in support of this 

supplemental program in fiscal year 

2010. It is estimated that up to six 

microbiological laboratories will be 

supplemented at the level requested, but 

not exceeding $50,000 total costs (direct 

costs only) for a 1-year minor program 

expansion. 

B. Length of Support 

The initial award will be for a 1-year 

performance period and any additional 

funding related to this supplement will 

be dependant on successful 

performance and fiscal appropriations. 

III. Paper Application and Submission 

Information 

To submit an application in response 

to this supplemental notice, applicants 

should download the PHS–398 form at 

http://grants.nih.gov/grants/funding/ 

phs398/phs398.html. 

Submit the paper application to: 

Camille R. Peake, Food and Drug 

Administration, 5630 Fishers Lane, 

rm. 2105, Rockville, MD 20857, 

301–827–7168; and 

Jenny Gabb, Office of Regulatory 

Affairs (HFC–150), Food and Drug 

Administration, 5600 Fishers Lane, 

rm. 12–07, Rockville, MD 20857, 

301–827–8299. 

Dated: August 24, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21480 Filed 8–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Solicitation for Nominations for 

Members of the U.S. Preventive 

Services Task Force (USPSTF) 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Solicits nominations for new 

members of USPSTF. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) invites 

nominations of individuals qualified to 

serve as members of the U.S. Preventive 

Services Task Force (USPSTF). 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 52959 

The USPSTF, a standing, independent 

panel of non-Federal experts that makes 

evidence-based recommendations to the 

health care community and the public 

regarding the provision of clinical 

preventive services, see 42 U.S.C. 299b– 

4(a), is composed of members appointed 

to serve for four-year terms with an 

option for reappointment. New 

members are selected each year to 

replace approximately one fourth of the 

USPSTF members, i.e., those who are 

completing their appointments. 

Individuals nominated but not 

appointed in previous years, as well as 

those newly nominated, are considered 

in the annual selection process. 

USPSTF members meet three times a 

year for two days in the Washington, DC 

area. Between meetings, member duties 

include reviewing and preparing 

comments (off site) on systematic 

evidence reviews prior to discussing 

and making recommendations on 

preventive services, drafting final 

recommendation documents, and 

participating in workgroups on specific 

topics or methods. 

A diversity of perspectives is valuable 

to the work of the USPSTF. To help 

obtain a diversity of perspectives among 

nominees, AHRQ particularly 

encourages nominations of women, 

members of minority populations, and 

persons with disabilities. Interested 

individuals can self nominate. 

Organizations and individuals may 

nominate one or more persons qualified 

for membership on the USPSTF. 

Qualification Requirements: The 

mission of the USPSTF is to review the 

scientific evidence related to the 

effectiveness and appropriateness of 

clinical preventive services for the 

purpose of developing 

recommendations for the health care 

community. Therefore, in order to 

qualify for the USPSTF, an applicant or 

nominee MUST demonstrate the 

following: 

1. Knowledge and experience in the 

critical evaluation of research published 

in peer reviewed literature and in the 

methods of evidence review; 

2. Understanding and experience in 

the application of synthesized evidence 

to clinical decisionmaking and/or 

policy; 

3. Expertise in disease prevention and 

health promotion; 

4. Ability to work collaboratively with 

peers; and 

5. Clinical expertise in the primary 

health care of children and/or adults, 

and/or expertise in counseling and 

behavioral interventions for primary 

care patients. 

Some USPSTF members without 

primary health care clinical experience 

may be selected based on their expertise 

in methodological issues such as 

medical decisionmaking, clinical 

epidemiology, behavioral medicine, 

health equity, and health economics. 

For individuals with clinical expertise 

in primary health care, additional 

qualifications in one or more of these 

areas would enhance their candidacy. 

Consideration will be given to 

individuals who are recognized 

nationally for scientific leadership 

within their field of expertise. 

Applicants must have no substantial 

conflicts of interest, whether financial, 

professional, or other conflicts, that 

would impair the scientific integrity of 

the work of the USPSTF. 

DATES: All nominations submitted in 

writing or electronically, and received 

by Friday, October 1, 2010, will be 

considered for appointment to the 

USPSTF. 

Nominated individuals will be 

selected for the USPSTF on the basis of 

their qualifications (in particular, those 

that address the required qualifications, 

outlined above) and the current 

expertise needs of the USPSTF. It is 

anticipated that two or three individuals 

will be invited to serve on the USPSTF 

beginning in January, 2011. All 

individuals will be considered; 

however, strongest consideration will be 

given to individuals with demonstrated 

training and expertise in a specific area 

such as family medicine, internal 

medicine, obstetrics/gynecology, 

pediatrics, nursing, behavioral 

medicine, health equity or methodology. 

AHRQ will retain and consider for 

future vacancies the nominations of 

those not selected during this cycle. 

ADDRESSES: Submit your responses 

either in writing or electronically to: 

Gloria Washington, ATTN: USPSTF 

Nominations, Center for Primary Care, 

Prevention, and Clinical Partnerships, 

Agency for Healthcare Research and 

Quality, 540 Gaither Road, Rockville, 

Maryland 20850, 

uspstfnominations@AHRQ.hhs.gov. 

Nomination Submissions 

Nominations may be submitted in 

writing or electronically, but must 

include: 

(1) The applicant’s current curriculum 

vitae and contact information, including 

mailing address, e-mail address, and 

telephone number and 

(2) A letter explaining how this 

individual meets the qualification 

requirements and how he/she would 

contribute to the USPSTF. The letter 

should also attest to the nominee’s 

willingness to serve as a member of the 

USPSTF. 

AHRQ will later ask persons under 

serious consideration for membership to 

provide detailed information that will 

permit evaluation of possible significant 

conflicts of interest. Such information 

will concern matters such as financial 

holdings, consultancies, and research 

grants or contracts. 

Nominee Selection 

Appointments to the USPSTF will be 

made on the basis of qualifications as 

outlined above (see Qualification 

Requirements) and the current expertise 

needs of the USPSTF. 

Arrangement for Public Inspection 

Nominations and applications are 

kept on file at the Center for Primary 

Care, Prevention, and Clinical 

Partnerships, AHRQ, and are available 

for review during business hours. AHRQ 

does not reply to individual 

nominations, but considers all 

nominations in selecting members. 

Information regarded as private and 

personal, such as a nominee’s social 

security number, home and e-mail 

addresses, home telephone and fax 

numbers, or names of family members 

will not be disclosed to the public. This 

is in accord with AHRQ confidentiality 

policies and Department of Health and 

Human Services regulations (45 CFR 

5.67). 

FOR FURTHER INFORMATION CONTACT: 

Gloria Washington at 

uspstfnominations@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Under Title IX of the Public Health 

Service Act, AHRQ is charged with 

enhancing the quality, appropriateness, 

and effectiveness of health care services 

and access to such services. 42 U.S.C. 

299(b). AHRQ accomplishes these goals 

through scientific research and 

promotion of improvements in clinical 

practice, including clinical prevention 

of diseases and other health conditions, 

and improvements in the organization, 

financing, and delivery of health care 

services. See 42 U.S.C. 299(b). 

The USPSTF is a panel of non-Federal 

experts that makes independent 

evidence-based recommendations 

regarding the provision of clinical 

preventive services. See 42 U.S.C. 299b– 

4(a). The USPSTF was first established 

in 1984 under the auspices of the U.S. 

Public Health Service. Currently, the 

USPSTF is convened by the Director of 

AHRQ, and AHRQ provides ongoing 

administrative, research and technical 

support for the USPSTF’s operation. 

The USPSTF is charged with rigorously 

evaluating the effectiveness and 


jlentini on DSKJ8SOYB1PROD with NOTICES
52960 Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices 

appropriateness of clinical preventive 

services and formulating or updating 

recommendations for primary care 

clinicians regarding the appropriate 

provision of preventive services. See 42 

U.S.C. 299b–4(a)(1). AHRQ is charged 

with the dissemination of 

recommendations. In addition to hard 

copy materials (that may be obtained 

from the Publications Clearing house), 

current USPSTF recommendations and 

associated evidence reviews are 

available on the Internet (http:// 

www.preventiveservices@AHRQ.gov). 

Dated: August 18, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–21500 Filed 8–27–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5051–N] 

Medicare Program; Rural Community 

Hospital Demonstration Program: 

Solicitation of Additional Participants 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS). 

ACTION: Notice. 

SUMMARY: This notice announces a 

solicitation for up to 20 additional 

eligible hospitals to participate in the 

Rural Community Hospital 

Demonstration program for a 5-year 

period. 

DATES: Application Submission 

Deadline: Applications must be received 

by 5 p.m. on or before October 14, 2010. 

Only applications that are considered 

‘‘timely’’ will be reviewed and 

considered by the technical panel. 

ADDRESSES: The applications should be 

mailed or sent by an overnight delivery 

service to the following address: Centers 

for Medicare & Medicaid Services, 

ATTN: Sid Mazumdar, Rural 

Community Hospital Demonstration, 

Medicare Demonstrations Program 

Group, Mail Stop C4–17–27, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

Please allow sufficient time for mailed 

information to be received in a timely 

manner in the event of delivery delays. 

Because of staffing and resource 

limitations, and because we require an 

application containing an original 

signature, we cannot accept applications 

by facsimile (Fax) transmission. 

FOR FURTHER INFORMATION CONTACT: Sid 

Mazumdar at (410) 786–6673 or by 

e-mail at 

Siddhartha.mazumdar@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 410A(a) of Public Law 108– 

173 required the Secretary to establish 

a demonstration program to test the 

feasibility and advisability of 

establishing cost-based reimbursement 

for ‘‘rural community hospitals’’ to 

furnish covered inpatient hospital 

services to Medicare beneficiaries. The 

demonstration pays rural community 

hospitals for such services under a costbased methodology for Medicare 

payment purposes for covered inpatient 

hospital services furnished to Medicare 

beneficiaries. A rural community 

hospital, as defined in section 

410A(f)(1) of Public Law 108–173, is a 

hospital that— 

• Has fewer than 51 acute care 

inpatient beds (excluding beds in a 

distinct psychiatric or rehabilitation 

unit of the hospital) as reported in its 

most recent cost report; 

• Provides 24-hour emergency care 

services; and 

• Is not designated or eligible for 

designation as a critical access hospital 

under section 1820 of the Social 

Security Act (the Act). 

Section 410A(a)(4) of Public Law 108– 

173 specified that the Secretary was to 

select for participation from among the 

applicants no more than 15 rural 

community hospitals in rural areas of 

States that the Secretary identified as 

having low population densities. Using 

2002 data from the U.S. Census Bureau, 

we identified the 10 States with the 

lowest population density in which 

rural community hospitals were to be 

located in order to participate in the 

demonstration: Alaska, Idaho, Montana, 

Nebraska, Nevada, New Mexico, North 

Dakota, South Dakota, Utah, and 

Wyoming. (Source: U.S. Census Bureau, 

Statistical Abstract of the United States: 

2003). We solicited eligible hospitals 

among these States in 2004 and again in 

2008. There are currently 10 hospitals 

participating in the demonstration. 

The demonstration is designed to test 

the feasibility and advisability of 

reasonable cost reimbursement for 

inpatient services to small rural 

hospitals. The demonstration is aimed 

at increasing the capability of the 

selected rural hospitals to meet the 

needs of their service areas. 

Section 410A(a)(5) of Public Law 108– 

173 required a 5-year demonstration 

period of participation. The 5-year 

periods of performance for the hospitals 

originally selected will end by June 30, 

2010. For the hospitals selected in 2008, 

the initial period of performance is 

scheduled to end on September 30, 

2010. Section 10313 of the Patient 

Protection and Affordable Care Act 

(ACA), (Pub. L. 111–148) mandates an 

extension and expansion of the Rural 

Community Hospital demonstration for 

5 years. In order for other hospitals to 

begin participation in this new 

demonstration for the 5-year extension 

period, rural community hospitals must 

be located among the 20 States with the 

lowest population density—according to 

the same criteria and data as the original 

demonstration. These States are: Alaska, 

Arizona, Arkansas, Colorado, Idaho, 

Iowa, Kansas, Maine, Minnesota, 

Mississippi, Montana, Nebraska, 

Nevada, New Mexico, North Dakota, 

Oklahoma, Oregon, South Dakota, Utah, 

and Wyoming. (Source: U.S. Census 

Bureau, Statistical Abstract of the 

United States: 2003). The statute States 

that no more than 30 rural community 

hospitals can participate, and that those 

hospitals participating in the 

demonstration program as of the date of 

the last day of the initial 5-year period 

will be allowed to continue in the 

program. Up to 20 additional hospitals 

will be able to begin participation in the 

demonstration. 

II. Provisions of the Notice 

This notice announces the solicitation 

for up to 20 additional hospitals to 

participate in the Rural Community 

Hospital Demonstration Program. 

Hospitals that enter the demonstration 

under this solicitation will be able to 

participate for 5 years. 

A. Demonstration Payment Methodology 

Hospitals selected for the 

demonstration will be paid the 

reasonable costs of providing covered 

inpatient hospital services, with the 

exclusion of services furnished in a 

psychiatric or rehabilitation unit that is 

a distinct part of the hospital, using the 

following rules. For discharges 

occurring— 

• In the first cost report period upon 

the hospital’s participation in the 

demonstration, reasonable costs for 

covered inpatient services; or 

• During the second or subsequent 

cost reporting period, the lesser of their 

reasonable costs or a target amount. The 

target amount in the second cost 

reporting period is defined as the 

reasonable costs of providing covered 

inpatient hospital services in the first 

cost reporting period, increased by the 

inpatient prospective payment system 

update factor (as defined in section 

1886(b)(3)(B) of the Act) for that 

particular cost reporting period. The 

target amount in subsequent cost 


jlentini on DSKJ8SOYB1PROD with NOTICES