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
16844 Federal Register / Vol. 77, No. 56 / Thursday, March 22, 2012 / Notices 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: March 15, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6962 Filed 3–21–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; 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 Institute of 

Environmental Health Sciences Special 

Emphasis Panel; Oceans, Great Lakes, and 

Human Health Review Meeting. 

Date: April 24–25, 2012. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Chapel Hill, One Europa 

Drive, Chapel Hill, NC 27517. 

Contact Person: Linda K. Bass, Ph.D., 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat. Institute 

Environmental Health Sciences, P.O. Box 

12233, MD EC–30, Research Triangle Park, 

NC 27709, (919) 541–1307, 

bass@niehs.nih.gov. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; Marine Toxins and Public 

Health Review Committee Review Meeting. 

Date: April 25–27, 2012. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Imperial Center, One 

Europa Drive, Chapel Hill, NC 27517. 

Contact Person: Linda K. Bass, Ph.D., 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat. Institute 

Environmental Health Sciences, P.O. Box 

12233, MD EC–30, Research Triangle Park, 

NC 27709, (919) 541–1307, 

bass@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: March 16, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6958 Filed 3–21–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the Sleep 

Disorders Research Advisory Board. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Sleep Disorders 

Research Advisory Board. 

Date: April 30, 2012. 

Time: 3 p.m. to 5 p.m. 

Agenda: To discuss and provide updates 

on sleep and circadian research 

developments and the NIH sleep research 

plan. Public meeting observers should call 1– 

800–791–5525 to access the teleconference 

and the observer passcode is 5500669#. 

Members of the public unable to access the 

meeting by phone may attend in person. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Conference Room 10167, 

Bethesda, MD 20892, (Telephone Conference 

Call). 

Contact Person: Michael J. Twery, Ph.D., 

Director, National Center on Sleep Disorders 

Research, Division of Lung Diseases, National 

Heart, Lung, and Blood Institute, National 

Institutes of Health, 6701 Rockledge Drive, 

Suite 10038, Bethesda, MD 20892–7952, 301– 

435–0199, twerym@nhlbi.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nhlbi.nih.gov/meetings/index.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: March 15, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6955 Filed 3–21–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

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 meeting. 

The meeting 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; 

Resource-related Application in Congenital 

Heart Diseases (R24). 

Date: April 17, 2012. 

Time: 1 p.m. to 3 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: Keary A Cope, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive Room 

7190, Bethesda, MD 20892–7924, 301–435– 

2222, copeka@mail.nih.gov 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 


tkelley on DSK3SPTVN1PROD with NOTICES