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
Federal Register / Vol. 77, No. 56 / Thursday, March 22, 2012 / Notices 16843 

2012 (77 FR 3777). This notice 

announces draft product-specific 

recommendations, either new or 

revised, that are being posted on FDA’s 

Web site concurrently with publication 

of this notice. 

II. Drug Products for Which New Draft 

Product-Specific 

BE Recommendations Are Available 

FDA is announcing new draft 

product-specific BE recommendations 

for drug products containing the 

following active ingredients: 

A 

Acyclovir (multiple reference listed drugs 

(RLDs), 

Amiloride, 

B 

Butenafine HCl (multiple 

RLDs),Chlorpromazine HCl, 

C 

Clindamycin Phosphate (multiple RLDs), 

D 

Dalfampridine, 

Dexmethylphenidate HCl, 

Dextromethorphan HBr; Quinidine Sulfate, 

Diclofenac Epolamine, 

Drospirenone Ethinyl Estradiol; 

Levomefolate, 

E 

Ethinyl Estradiol; Norethindrone, 

F 

Fenofibrate, 

Fludarabine, 

Fulvestrant, 

G 

Glyburide (multiple RLDs), 

Granisetron, 

I 

Ivermectin, 

K 

Ketoconazole (multiple RLDs), 

M 

Memantine HCl, 

Metformin Hydrochloride; Saxagliptin, 

N 

Naftifine HCl (multiple RLDs), 

Nitrofurantoin; Nitrofurantoin 

Macrocrystalline, 

O 

Ondansetron, 

Oxiconazole Nitrate (multiple RLDs), 

P 

Pimecrolimus, 

Procarbazine, 

Propylthiouracil, 

S 

Sumatriptan, 

T 

Tacrolimus (multiple strengths), 

Tolvaptan, 

Tretinoin (multiple RLDs), 

V 

Vardenafil HCl, 

III. Drug Products for Which Revised 

Draft Product-Specific BE 

Recommendations Are Available 

FDA is announcing revised draft 

product-specific BE recommendations 

for drug products containing the 

following active ingredients: 

B 

Benzoyl Peroxide; Clindamycin Phosphate 

(multiple RLDs), 

Bosentan, 

C 

Cholestyramine, 

Colesevelam, 

D 

Dexamethasone; Tobramycin (multiple 

RLDs), 

H 

Hydrochlorothiazide; Irbesartan, 

L 

Loteprednol, 

Loteprednol; Tobramycin, 

P 

Paliperidone 

For a complete history of previously 

published Federal Register notices 

relating to product-specific BE 

recommendations, please go to http:// 

www.regulations.gov and enter docket 

number FDA–2007–D–0369. 

These draft and revised draft 

guidances are being issued consistent 

with FDA’s good guidance practices 

regulation (21 CFR 10.115). The 

guidances represent the Agency’s 

current thinking on product-specific 

design of BE studies to support ANDAs. 

They do not create or confer any rights 

for or on any person and do 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. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments on any of the specific BE 

recommendations posted on FDA’s Web 

site. It is only necessary to send one set 

of comments. It is no longer necessary 

to send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. The 

guidance, notices, and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. 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: March 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6947 Filed 3–21–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Novel Clinical Trial Methods. 

Date: April 13, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Tony L. Creazzo, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7180, Bethesda, MD 20892–7924, 301–435– 

0725, creazzotl@mail.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Research Dissemination and Implementation. 

Date: April 16, 2012. 

Time: 11:30 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crystal Gateway Marriott, 1700 

Jefferson Davis Highway, Arlington, VA 

22202. 

Contact Person: Keith A. Mintzer, Ph.D., 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7186, 

Bethesda, MD 20892–7924, 301–435–0280, 

mintzerk@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

NHLBI Clinical Trials. 

Date: April 16, 2012. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Charles Joyce, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7196, Bethesda, MD 20892–7924, 301–435– 

0288, cjoyce@nhlbi.nih.gov. 


tkelley on DSK3SPTVN1PROD with NOTICES