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, 21982-21983 [2012-8823]
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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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: https://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
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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 https://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
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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
https://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.
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
SUMMARY:
E:\FR\FM\12APN1.SGM
12APN1
Federal Register / Vol. 77, No. 71 / Thursday, April 12, 2012 / Notices
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:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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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.
PO 00000
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21983
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
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Notices]
[Pages 21982-21983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8823]
-----------------------------------------------------------------------
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
[[Page 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
