21982 Federal Register / Vol. 77, No. 71 / Thursday, April 12, 2012 / Notices 

Community Bank, Cranston, Rhode 

Island. 

B. Federal Reserve Bank of Dallas (E. 

Ann Worthy, Vice President) 2200 

North Pearl Street, Dallas, Texas 75201– 

2272: 

1. Cadence Bancorp, LLC, Houston, 

Texas; to acquire 100 percent of the 

voting shares of Encore Bancshares, Inc., 

and thereby indirectly acquire Encore 

Bank, N.A., both in Houston, Texas. 

Board of Governors of the Federal Reserve 

System, April 9, 2012. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2012–8832 Filed 4–11–12; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Cardiovascular and Renal Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Cardiovascular 

and Renal Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 23, 2012, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Kristina Toliver, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: 

CRDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: The committee will discuss 

supplemental new drug application 

(sNDA) 202439/S–002, XARELTO 

(rivaroxaban), submitted by Janssen 

Pharmaceuticals, Inc., to reduce the risk 

of thrombotic cardiovascular events in 

patients with acute coronary syndrome 

(ACS) [ST elevation myocardial 

infarction (STEMI), non-ST elevation 

myocardial infarction (NSTEMI), or 

unstable angina (UA)] in combination 

with aspirin alone or with aspirin plus 

clopidogrel or ticlopidine. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 9, 2012. Oral 

presentations from the public will be 

scheduled between approximately 

1 p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before May 1, 

2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by May 2, 2012. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Kristina 

Toliver at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: April 9, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–8824 Filed 4–11–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Request for Notification From Industry 

Organizations Interested in 

Participating in the Selection Process 

for Nonvoting Industry Representative 

on the Blood Products Advisory 

Committee, and Request for 

Nominations for Nonvoting Industry 

Representatives on the Blood 

Products Advisory Committee 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of a 

nonvoting industry representative to 

serve on the Blood Products Advisory 

Committee for the Center for Biologics 

Evaluation and Research (CBER) notify 

FDA in writing. FDA is also requesting 

nominations for a nonvoting industry 

representative to serve on the Blood 

Products Advisory Committee. A 

nominee may either be self-nominated 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 71 / Thursday, April 12, 2012 / Notices 21983 

or nominated by an organization to 

serve as a nonvoting industry 

representative. Nominations will be 

accepted for current vacancies effective 

with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by May 14, 2012, for the vacancy 

listed in this notice. Concurrently, 

nomination materials for prospective 

candidates should be sent to FDA by 

May 14, 2012. 

ADDRESSES: All letters of interest and 

nominations should be submitted in 

writing to Bryan Emery (see: FOR

FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Bryan Emery, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 Rockville 

Pike (HFM–71), Rockville, MD 20852– 

1448, 301–827–1277, Fax: 301–827– 

0294, email: bryan.emery@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative to the following 

advisory committee: 

I. Blood Products Advisory Committee 

for the Center for Biologics Evaluation 

and Research 

Members are selected by the 

Commissioner of Food and Drugs (the 

Commissioner) or designee from among 

authorities knowledgeable in the fields 

of clinical and administrative medicine, 

hematology, immunology, blood 

banking, surgery, internal medicine, 

biochemistry, engineering, biological 

and physical sciences, biotechnology, 

computer technology, statistics, 

epidemiology, sociology/ethics, and 

other related professions. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner will select the nonvoting 

member to represent industry interests. 

III. Application Procedure 

Individuals may self nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Contact 

information, a current curriculum vitae, 

and the name of the committee of 

interest should be sent to the FDA 

contact person (see FOR FURTHER

INFORMATION CONTACT) within 30 days of 

publication of this document (see 

DATES). FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process for the committee. 

(Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process). 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities, 

and small businesses are adequately 

represented on its advisory committees, 

and therefore, encourages nominations 

for appropriately qualified candidates 

from these groups. Specifically, in this 

document, nominations for nonvoting 

representatives of industry interests are 

encouraged from the blood and blood 

products manufacturing industry. 

This notice is issued under the 

Federal Advisory Committee Act 

(5 U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: April 9, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–8823 Filed 4–11–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities; Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Notification of Intent To Use 

Schedule III, IV, or V Opioid Drugs for 

the Maintenance and Detoxification 

Treatment of Opiate Addiction Under 

21 U.S.C. 823(g)(2) (OMB No. 0930– 

0234)—Extension 

The Drug Addiction Treatment Act of 

2000 (‘‘DATA,’’ Pub. L. 106–310) 

amended the Controlled Substances Act 

(21 U.S.C. 823(g)(2)) to permit 

practitioners (physicians) to seek and 

obtain waivers to prescribe certain 

approved narcotic treatment drugs for 

the treatment of opiate addiction. The 

legislation sets eligibility requirements 

and certification requirements as well as 

an interagency notification review 

process for physicians who seek 

waivers. The legislation was amended 

in 2005 to eliminate the patient limit for 

physicians in group practices, and in 

2006, to permit certain physicians to 

treat up to 100 patients. 

To implement these provisions, 

SAMHSA developed a notification form 

(SMA–167) that facilitates the 

submission and review of notifications. 

The form provides the information 

necessary to determine whether 

practitioners (i.e., independent 

physicians) meet the qualifications for 

waivers set forth under the new law. 

Use of this form will enable physicians 

to know they have provided all 

information needed to determine 

whether practitioners are eligible for a 

waiver. 

However, there is no prohibition on 

use of other means to provide requisite 

information. The Secretary will convey 

notification information and 

determinations to the Drug Enforcement 

Administration (DEA), which will 

assign an identification number to 

qualifying practitioners; this number 

will be included in the practitioner’s 

registration under 21 U.S.C. 823(f). 

Practitioners may use the form for 

three types of notification: (a) New, (b) 

immediate, and (c) to notify of their 

intent to treat up to 100 patients. Under 

‘‘new’’ notifications, practitioners may 

make their initial waiver requests to 

SAMHSA. ‘‘Immediate’’ notifications 

inform SAMHSA and the Attorney 

General of a practitioner’s intent to 

prescribe immediately to facilitate the 

treatment of an individual (one) patient 

under 21 U.S.C. 823(g)(2)(E)(ii). Finally, 

the form may be used by physicians 

with waivers to certify their need and 

intent to treat up to 100 patients. 

The form collects data on the 

following items: Practitioner name; state 

medical license number and DEA 

registration number; address of primary 

location, telephone and fax numbers; 

email address; name and address of 

mstockstill on DSK4VPTVN1PROD with NOTICES