Federal Register / Vol. 77, No. 56 / Thursday, March 22, 2012 / Notices 16841 

This meeting will include updates 

from NIOSH leadership on NORA as 

well as updates from approximately half 

of the NORA Sector Councils on their 

progress, priorities, and implementation 

plans to date, likely including the 

NORA Construction, Manufacturing, 

Public Safety, Services, and Wholesale 

and Retail Trade Sector Councils. 

Updates will also be given on at least 

one NIOSH Program that is working on 

several NORA priorities, e.g., the NIOSH 

Global Collaborations Program. After 

each update, there will be time to 

discuss partnership opportunities. 

Status: The meeting is open to the 

public, limited only by the capacities of 

the conference call and conference room 

facilities. There is limited space 

available in the meeting room (capacity 

34). Therefore, information to allow 

participation in the meeting through the 

Internet (to see the slides) and a 

teleconference call (capacity 50) will be 

provided to registered participants. 

Participants are encouraged to consider 

attending by this method. Each 

participant is requested to register for 

the free meeting by sending an email to 

noracoordinator@cdc.gov containing the 

participant’s name, organization name, 

contact telephone number on the day of 

the meeting, and preference for 

participation in-person or by Web 

meeting (requirements include: 

computer, Internet connection, and 

telephone, preferably with ‘mute’ 

capability). An email confirming 

registration will include the details 

needed to participate in the Web 

meeting. Non-U.S. citizens are 

encouraged to participate in the Web 

meeting. Non-U.S. citizens who do not 

register to attend in person on or before 

June 5, 2012, will not be granted access 

to the meeting site and will not be able 

to attend the meeting in-person due to 

mandatory security clearance 

procedures at the Patriots Plaza facility. 

Background: NORA is a partnership 

program to stimulate innovative 

research in occupational safety and 

health leading to improved workplace 

practices. Unveiled in 1996, NORA has 

become a research framework for the 

nation. Diverse parties collaborate to 

identify the most critical issues in 

workplace safety and health. Partners 

then work together to develop goals and 

objectives for addressing those needs 

and to move the research results into 

practice. The NIOSH role is facilitator of 

the process. For more information about 

NORA, see http://www.cdc.gov/niosh/ 

nora/about.html. 

Since 2006, NORA has been 

structured according to industrial 

sectors. Ten major sector groups have 

been defined using the North American 

Industrial Classification System 

(NAICS). After receiving public input 

through the Web and town hall 

meetings, ten NORA Sector Councils 

defined sector-specific strategic plans 

for conducting research and moving the 

results into widespread practice. To 

view the National Sector Agendas, see 

http://www.cdc.gov/niosh/nora/. 

FOR FURTHER INFORMATION CONTACT: 

Sidney C. Soderholm, Ph.D., NORA 

Coordinator, Email 

noracoordinator@cdc.gov, telephone 

(202) 245–0665. 

Dated: March 2, 2012. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2012–6771 Filed 3–21–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5052–N] 

Medicare Program; Solicitation for 

Proposals for the Medicare Graduate 

Nurse Education Demonstration 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS). 

ACTION: Notice. 

SUMMARY: This notice informs interested 

parties of an opportunity to apply to 

participate in the Medicare Graduate 

Nurse Education (GNE) Demonstration. 

The primary goal of the GNE 

Demonstration is to increase the number 

of advanced practice registered nurses 

(APRNs) in order to meet the health care 

needs of the growing Medicare 

population. 

DATES: Proposals will be considered 

timely if they are received on or before 

5 p.m., Eastern Standard Time (E.S.T.) 

on May 21, 2012. 

ADDRESSES: Proposals should be mailed 

to the following address: Centers for 

Medicare & Medicaid Services, Center 

for Medicare & Medicaid Innovation, 

Attention: Alexandre Laberge, Mail 

Stop: WB–06–05, 7500 Security 

Boulevard, Baltimore, Maryland 21244– 

1850. 

FOR FURTHER INFORMATION CONTACT: 

Alexandre Laberge (410) 786–8625 or by 

email at GNE@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

General Information: Please refer to 

file code (CMS–5052–N) on the 

application. Proposals (an unbound 

original and 10 electronic copies on CD– 

ROM) must be typed for clarity and 

should not exceed 50 double-spaced 

pages, exclusive of cover letter, the 

executive summary, resumes, forms, 

and no more than 15 pages supporting 

documentation. Because of staffing and 

resource limitations, we cannot accept 

proposals by facsimile (Fax) 

transmission. Applicants may, but are 

not required to, submit a total of 10 

copies to assure that each reviewer 

receive a proposal in the manner 

intended by the applicant (for example, 

collated, tabulated color copies). Hard 

copies and electronic copies must be 

identical. 

Eligible Organizations: As set forth in 

section 5509 of the Affordable Care Act 

(ACA) (Pub. L. 111–148, as amended by 

Pub. L. 111–152), an ‘‘eligible hospital’’ 

may apply to perform the 

responsibilities specified. Section 

5509(e)(5) of the ACA defines an 

‘‘eligible hospital’’ to mean a hospital 

(as defined in section 1861(e) of the 

Social Security Act (the Act) (42 U.S.C. 

1395x)) or a critical access hospital (as 

defined in section 1861(mm)(1) of the 

Act) that has a written agreement in 

place with—(A) 1 or more applicable 

schools of nursing; and (B) 2 or more 

applicable non-hospital communitybased care settings. The written 

agreement must meet specific 

requirements set forth in section 5509 of 

the ACA including—(1) the obligations 

of the eligible partners with respect to 

the provision of qualified training; and 

(2) the obligation of the eligible hospital 

to reimburse such eligible partners 

applicable (in a timely manner) for the 

costs of such qualified training 

attributable to partner. The 

demonstration will include up to five 

eligible hospitals. 

I. Provisions of This Notice 

We are seeking eligible hospital 

applicants, which includes critical 

access hospitals, to partner with one or 

more applicable schools of nursing 

(SONs) and two or more applicable 

nonhospital community-based care 

settings (CCSs) to provide advanced 

practice registered nurse (APRN) 

students with qualified training. See 

section 5509(e) of the ACA for the 

definitions of the terms used in the 

preceding sentence. At least half of the 

clinical training must be provided in 

non-hospital CCSs which may include 

federally qualified health centers 

(FQHCs), rural health clinics (RHCs), 

and other nonhospital settings as 

determined appropriate by the 

Secretary. However, the Secretary may 

waive the requirement under section 


tkelley on DSK3SPTVN1PROD with NOTICES
16842 Federal Register / Vol. 77, No. 56 / Thursday, March 22, 2012 / Notices 

5509(e)(7)(A)(ii) of the ACA with 

respect to eligible hospitals located in 

rural or medically underserved areas. 

In general terms, the demonstration 

provides a source of Medicare funding 

for the reasonable costs for clinical 

training attributable to the incremental 

increase in the number of APRN 

students enrolled in participating SONs 

during the demonstration relative to an 

established baseline. Section 5509 of the 

ACA sets forth limitations on the 

reasonable costs reimbursable under the 

demonstration. We will make interim 

payments to selected hospitals with a 

cost settlement process using Medicare 

reasonable cost principles. Participating 

eligible hospitals must establish written 

agreements with one or more applicable 

SONs and two or more applicable nonhospital CCSs that define the obligations 

of each partner with respect to the 

provision of qualified training and the 

corresponding eligible hospital’s 

obligation to reimburse eligible partners 

applicable (in a timely manner) for the 

costs of such qualified training 

attributable to the partner and the 

mechanism for partner reimbursement. 

As outlined in the GNE Solicitation, 

applicant hospitals may partner with 

other hospitals in the demonstration 

and we will support an expanded 

configuration of hospital relationships 

under certain circumstances. 

The GNE Demonstration will run for 

4 years. Applicants must identify how 

they propose to significantly increase 

the APRN student enrollment and 

graduation rates for clinical nurse 

specialist, nurse practitioner, certified 

registered nurse anesthetist, and 

certified nurse midwife specialty 

programs. The proposal must present 

evidence that the applicant hospital and 

partner organizations are not only 

capable of successfully recruiting 

students but also providing relevant 

clinical training programs responsive to 

our changing health care system due to 

the growing number of insured by 2014. 

Applicants will be required to provide 

a detailed budget and narrative 

describing the rationale for the proposed 

GNE payment rate and why this would 

be an efficient investment for CMS. 

A competitive process will be used to 

select eligible organizations. We will 

accept proposal applications in the 

standard format outlined in the GNE 

solicitation in order to be considered for 

review by an internal technical panel. 

Applications that are not received in 

this format will not be considered for 

review. 

For more specific details regarding the 

GNE demonstration, please refer to the 

informational materials on our Web site 

at http://www.cms.hhs.gov/ 

DemoProjectsEvalRpts/downloads/. 

II. Information Collection Requirements 

In accordance with section 5509(a)(4) 

of the ACA, this information collection 

requirement is not subject to the 

Paperwork Reduction Act of 1995. 

Consequently, it 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. Chapter 35). 

Authority: Section 5509 of the ACA (Pub. 

L. 111–148, as amended by Pub. L. 111–152) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: January 19, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–6940 Filed 3–21–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Draft and Revised Draft Guidances for 

Industry Describing Product-Specific 

Bioequivalence Recommendations; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of additional draft and 

revised draft product-specific 

bioequivalence (BE) recommendations. 

The recommendations provide productspecific guidance on the design of BE 

studies to support abbreviated new drug 

applications (ANDAs). In the Federal 

Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site. The BE 

recommendations identified in this 

notice were developed using the process 

described in that guidance. 

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 comments on these draft 

and revised draft guidances before it 

begins work on the final versions of the 

guidances, submit either electronic or 

written comments on the draft and 

revised draft product-specific BE 

recommendations listed in this notice 

by May 21, 2012. 

ADDRESSES: Submit written requests for 

single copies of the individual BE 

guidances 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 selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance recommendations. 

Submit electronic comments on the 

draft product-specific BE 

recommendations 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: 

Doan T. Nguyen, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855, (240) 

276–8608. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

http://www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm. As 

described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific BE recommendations and 

provide a meaningful opportunity for 

the public to consider and comment on 

those recommendations. Under that 

process, draft recommendations are 

posted on FDA’s Web site and 

announced periodically in the Federal 

Register. The public is encouraged to 

submit comments on those 

recommendations within 60 days of 

their announcement in the Federal 

Register. FDA considers any comments 

received and either publishes final 

recommendations, or publishes revised 

draft recommendations for comment. 

Recommendations were last announced 

in the Federal Register of January 25, 


tkelley on DSK3SPTVN1PROD with NOTICES