Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 7164-7165 [2012-3114]
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Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices
CFR part 225) to engage de novo, or to
acquire or control voting securities or
assets of a company, including the
companies listed below, that engages
either directly or through a subsidiary or
other company, in a nonbanking activity
that is listed in § 225.28 of Regulation Y
(12 CFR 225.28) or that the Board has
determined by Order to be closely
related to banking and permissible for
bank holding companies. Unless
otherwise noted, these activities will be
conducted throughout the United States.
Each notice is available for inspection
at the Federal Reserve Bank indicated.
The notice also will be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
question whether the proposal complies
with the standards of section 4 of the
BHC Act.
Unless otherwise noted, comments
regarding the applications must be
received at the Reserve Bank indicated
or the offices of the Board of Governors
not later than February 27, 2012.
A. Federal Reserve Bank of Richmond
(Adam M. Drimer, Assistant Vice
President) 701 East Byrd Street,
Richmond, Virginia 23261–4528:
1. Live Oak Bancshares, Inc.,
Wilmington, North Carolina; to engage
de novo through its subsidiary, BANKR,
LLC, Wilmington, North Carolina, in
data processing activities, pursuant to
section 225.28(b)(14)(i) of Regulation Y.
B. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Waytru Bancorp, Cambridge City,
Indiana; to continue to engage in
extending credit and servicing loans,
pursuant to section 225.28(b)(1) of
Regulation Y.
Dated: Board of Governors of the Federal
Reserve System, February 7, 2012.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. 2012–3130 Filed 2–9–12; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK4SPTVN1PROD with NOTICES
Meeting of the National Biodefense
Science Board
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
SUMMARY:
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National Biodefense Science Board
(NBSB) will be holding a closed session
by teleconference under exemption 9(B)
of the Government in Sunshine Act, 5
U.S.C. 552b(c).
DATES: The February 28, 2012 NBSB
closed session by teleconference is
tentatively scheduled from 9 a.m. to 1
p.m. The agenda and time is subject to
change as priorities dictate.
ADDRESSES: The closed session will
occur by teleconference and will not be
open to the public as stipulated under
exemption 9(B) of the Government in
Sunshine Act, 5 U.S.C. 552b(c).
FOR FURTHER INFORMATION CONTACT:
MacKenzie Robertson, Acting Executive
Director, NBSB, Office of the Assistant
Secretary for Preparedness and
Response, U.S. Department of Health
and Human Services; 202–260–0447; fax
202–205–8508; Email:
NBSB@HHS.GOV.
SUPPLEMENTARY INFORMATION: Pursuant
to section 319M of the Public Health
Service Act (42 U.S.C. 247d–7f) and
section 222 of the Public Health Service
Act (42 U.S.C. 217a), the Department of
Health and Human Services established
the National Biodefense Science Board.
The Board shall provide expert advice
and guidance to the Secretary on
scientific, technical, and other matters
of special interest to the Department of
Health and Human Services regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate. The Board may also
provide advice and guidance to the
Secretary and/or the Assistant Secretary
for Preparedness and Response on other
matters related to public health
emergency preparedness and response.
Background: The Board is being asked
to review and evaluate the 2012 Public
Health Emergency Medical
Countermeasures Enterprise (PHEMCE)
Strategy and Implementation Plan (SIP).
Until a final document is approved by
the Secretary of the Department of
Health and Human Services (HHS), the
development of PHEMCE SIP requires
consideration and discussion of
procurement-sensitive information that
should not be released to the public
prior to the Secretary’s final decision.
Premature public disclosure of the draft
PHEMCE SIP would limit the
Secretary’s decision-making ability to
effectively prioritize HHS expenditures
on critical medical countermeasures.
Therefore, the Board’s deliberations on
the new task will be conducted in
closed session in accordance with
provisions set forth under exemption
9(B) of the Government in Sunshine
Act, 5 U.S.C. section 552b(c), and with
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approval by the Assistant Secretary for
Preparedness and Response.
Availability of Materials: The meeting
materials will be posted on the NBSB
Web site at www.phe.gov/nbsb.
Procedures for Providing Public Input:
All written comments should be sent by
email to NBSB@HHS.GOV with ‘‘NBSB
Public Comment’’ as the subject line.
Dated: February 6, 2012.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2012–3127 Filed 2–9–12; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Member Conflict Review,
Program Announcement (PA) 07–318,
initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 1 p.m.–3 p.m., March 7,
2012 (Closed).
Place: National Institute for Occupational
Safety and Health (NIOSH), CDC, 1095
Willowdale Road Morgantown, West Virginia
26506, Telephone: (304) 285–6143.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Member Conflict Review, PA
07–318.’’
Contact Person for More Information:
Bernadine Kuchinski, Ph.D., Scientific
Review Administrator, Office of Extramural
Programs, National Institute for Occupational
Safety and Health, CDC, Robert A. Taft
Laboratories, 4676 Columbia Pkwy, MS C–7,
Cincinnati, Ohio 45226; Telephone: (513)
533–8511.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
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Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices
Dated: February 6, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office Centers for Disease Control and
Prevention.
[FR Doc. 2012–3114 Filed 2–9–12; 8:45 am]
OMB control number 0910–0432. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0793]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Recall Authority
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Device Recall Authority—21
CFR Part 810 (OMB Control Number
0910–0432)—Extension
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 12,
2012.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
SUMMARY:
This collection of information
implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360h(e)) and part
810 (21 CFR part 810), medical device
recall authority provisions. Section
518(e) of the FD&C Act provides FDA
with the authority to issue an order
requiring an appropriate person,
including manufacturers, importers,
distributors, and retailers of a device, if
FDA finds that there is reasonable
probability that the device intended for
human use would cause serious adverse
health consequences or death, to: (1)
Immediately cease distribution of such
device, (2) immediately notify health
professionals and device-user facilities
of the order, and (3) instruct such
professionals and facilities to cease use
of such device.
Further, the provisions under section
518(e) of the FD&C Act set out the
following three-step procedure for
issuance of a mandatory device recall
order:
1. If there is a reasonable probability
that a device intended for human use
would cause serious, adverse health
consequences or death, FDA may issue
a cease distribution and notification
order requiring the appropriate person
to immediately:
• Cease distribution of the device,
• Notify health professionals and
device user facilities of the order, and
• Instruct those professionals and
facilities to cease use of the device;
2. FDA will provide the person named
in the cease distribution and
notification order with the opportunity
for an informal hearing on whether the
order should be modified, vacated, or
amended to require a mandatory recall
of the device; and
3. After providing the opportunity for
an informal hearing, FDA may issue a
mandatory recall order if the Agency
determines that such an order is
necessary.
The information collected under the
recall authority provisions will be used
by FDA to do the following: (1) Ensure
that all devices entering the market are
safe and effective, (2) accurately and
immediately detect serious problems
with medical devices, and (3) remove
dangerous and defective devices from
the market.
In the Federal Register of November
16, 2011 (76 FR 71041), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
srobinson on DSK4SPTVN1PROD with NOTICES
810.10(d) ..............................................................................
810.11(a) ..............................................................................
810.12(a) and (b) .................................................................
810.14 ..................................................................................
810.15(a), (b), and (c) ..........................................................
810.15(d) ..............................................................................
810.15(e) ..............................................................................
810.16(a) and (b) .................................................................
810.17(a) ..............................................................................
2
1
1
2
2
2
10
2
2
1
1
1
1
1
1
1
12
1
2
1
1
2
2
2
10
24
2
8
8
8
16
12
4
1
40
8
16
8
8
32
24
8
10
960
16
Total Hours ...................................................................
........................
........................
........................
........................
1,082
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7164-7165]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3114]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below concerns Member Conflict Review,
Program Announcement (PA) 07-318, initial review.
In accordance with Section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the aforementioned meeting:
Time and Date: 1 p.m.-3 p.m., March 7, 2012 (Closed).
Place: National Institute for Occupational Safety and Health
(NIOSH), CDC, 1095 Willowdale Road Morgantown, West Virginia 26506,
Telephone: (304) 285-6143.
Status: The meeting will be closed to the public in accordance
with provisions set forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director, Management Analysis
and Services Office, CDC, pursuant to Public Law 92-463.
Matters To Be Discussed: The meeting will include the initial
review, discussion, and evaluation of applications received in
response to ``Member Conflict Review, PA 07-318.''
Contact Person for More Information: Bernadine Kuchinski, Ph.D.,
Scientific Review Administrator, Office of Extramural Programs,
National Institute for Occupational Safety and Health, CDC, Robert
A. Taft Laboratories, 4676 Columbia Pkwy, MS C-7, Cincinnati, Ohio
45226; Telephone: (513) 533-8511.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities, for both the Centers for Disease Control and Prevention,
and the Agency for Toxic Substances and Disease Registry.
[[Page 7165]]
Dated: February 6, 2012.
Elaine L. Baker,
Director, Management Analysis and Services Office Centers for Disease
Control and Prevention.
[FR Doc. 2012-3114 Filed 2-9-12; 8:45 am]
BILLING CODE 4163-18-P
