60dayFRN PDFgateAttachment3

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connection with the special elections
must simultaneously file FEC Form 3L
if they receive two or more bundled

contributions from lobbyists/registrants
or lobbyist/registrant PACs that
aggregate in excess of $16,000 during

the special election reporting periods
(see charts below for closing date of
each period). 11 CFR 104.22(a)(5)(v).

CALENDAR OF REPORTING DATES FOR INDIANA SPECIAL ELECTION COMMITTEES INVOLVED IN THE SPECIAL GENERAL
ELECTION (11/02/10) MUST FILE:
Close of books1

Report
Pre-General ...............................................................................................................
Post-General ..............................................................................................................
Year-End ....................................................................................................................

Reg./Cert. &
overnight mailing
deadline

10/13/10
11/22/10
12/31/10

Filing deadline

10/18/10
12/02/10
01/31/11

10/21/10.
12/02/10.
01/31/11.

1 The reporting period always begins the day after the closing date of the last report filed. If the committee is new and has not previously filed
a report, the first report must cover all activity that occurred before the committee registered as a political committee with the Commission up
through the close of books for the first report due.

Dated: June 11, 2010.
On behalf of the Commission.
Matthew S. Petersen,
Chairman, Federal Election Commission.

Synopsis: The agreement authorizes
the parties to share vessel space in the
trade between Hawaii and ports in
Japan, China, Korea, and Pacific Coasts
of Mexico, Colombia, and Ecuador.

[FR Doc. 2010–14568 Filed 6–16–10; 8:45 am]

By Order of the Federal Maritime
Commission.
Dated: June 14, 2010.
Rachel E. Dickon,
Assistant Secretary.

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FEDERAL MARITIME COMMISSION

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Notice of Agreements Filed

[FR Doc. 2010–14679 Filed 6–16–10; 8:45 am]

The Commission hereby gives notice
of the filing of the following agreements
under the Shipping Act of 1984.
Interested parties may submit comments
on the agreements to the Secretary,
Federal Maritime Commission,
Washington, DC 20573, within ten days
of the date this notice appears in the
Federal Register. Copies of the
agreements are available through the
Commission’s Web site (http://
www.fmc.gov) or by contacting the
Office of Agreements at (202)–523–5793
or [email protected].
Agreement No.: 012100.
Title: CMA CGM/CSAV Gulf Bridge
Express Vessel Sharing Agreement.
Parties: CMA CGM Antilles Guyane
and Compania Sud American de
Vapores S.A.
Filing Party: Draughn Arbona, Esq.;
Associate Counsel & Environmental
Officer; CMA CGM (America) LLC; 5701
Lake Wright Drive; Norfolk, VA 23502.
Synopsis: The agreement authorizes
the parties to share vessel space in the
trade between the U.S. Gulf coast and
Mexico, Jamaica, Colombia, and
Venezuela. The parties have requested
expedited review.
Agreement No.: 012101.
Title: NYK/‘‘K’’ Line/MOL Vessel
Sharing Agreement.
Parties: Kawasaki Kisen Kaisha, Ltd.;
Mitsui O.S.K. Lines, Ltd.; and Nippon
Yusen Kaisha.
Filing Party: Wayne R. Rohde, Esq.;
Sher & Blackwell LLP; 1850 M Street,
NW., Suite 900; Washington, DC 20036.

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
AGENCY: Department of Health and
Human Services, Office of Public Health
and Science, The Presidential
Commission for the Study of Bioethical
Issues.
ACTION: Notice.
SUMMARY: The Presidential Commission
for the Study of Bioethical Issues (Amy
Gutmann, PhD, Chair, and James
Wagner, PhD, Vice Chair), will conduct
its first meeting to discuss the
implications of synthetic biology.
DATES: The meeting will take place
Thursday, July 8, 2010, from 8:30 a.m.
to 5 p.m., ET; and Friday, July 9, 2010,
from 8:30 a.m. to 11:45 a.m., ET.
ADDRESSES: The Ritz-Carlton, 1150 22nd
Street, NW., Washington, DC 20037.
Phone 202–835–0500.
FOR FURTHER INFORMATION CONTACT: Ms.
Diane M. Gianelli, Acting Executive
Director, The Presidential Commission
for the Study of Bioethical Issues, 1425
New York Avenue, NW., Suite C–100,
Washington, DC 20005. Telephone: 202/
233–3960. E-mail: [email protected].
Web site: http://www.bioethics.gov.

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The
meeting agenda will be posted at
http://www.bioethics.gov. The
Commission encourages public
comment, either in person or in writing.
Interested members of the public may
address the Commission at select times
to be announced at the meeting.
Comments are limited to no more than
five minutes per speaker or
organization. As a courtesy, please
inform Ms. Diane M. Gianelli, Acting
Executive Director, in advance, of your
intention to make a public statement,
and give your name and affiliation. To
submit a written statement, mail or email it to Ms. Gianelli at one of her
contact addresses given above.

SUPPLEMENTARY INFORMATION:

Dated: June 9, 2010.
Diane M. Gianelli,
Acting Executive Director, The Presidential
Commission for the Study of Bioethical Issues.
[FR Doc. 2010–14577 Filed 6–16–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–10–10ES]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects.
Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road,

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34452

Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Notices

NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by e-mail to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have a
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarify of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
LRN Special Data Calls—Existing
Collection in Use Without an OMB

Background and Brief Description
The Laboratory Response Network
(LRN) was established by the
Department of Health and Human
Services, Centers for Disease Control
and Prevention (CDC) in accordance
with Presidential Decision Directive 39,
which outlined national anti-terrorism
policies and assigned specific missions
to Federal departments and agencies.
The LRN’s mission is to maintain an
integrated national and international
network of laboratories that can respond
to acts of biological, chemical, or
radiological terrorism and other public
health emergencies. Federal, state and

local public health laboratories
voluntarily join the LRN.
The LRN Program Office maintains a
database of information for each
member laboratory that includes contact
information as well as staff and
equipment inventories. However,
semiannually or during emergency
response the LRN Program Office may
conduct a Special Data Call to obtain
additional information from LRN
Member Laboratories in regards to
biological or chemical terrorism
preparedness. Special Data Calls may be
conducted via queries that are
distributed by broadcast emails or by
survey tools (i.e. Survey Monkey). This
is a request for a generic clearance. The
only cost to respondents is their time to
respond to the data call.
Estimate of Annualized Burden Hours

Forms

Number of
respondents

Average
number of responses per
respondent

Average
burden per
response
(hours)

Total burden
hours

Special Data Call .............................................................................................

200

4

30/60

400

Dated: June 10, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–14625 Filed 6–16–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0279]

Center for Drug Evaluation and
Research Data Standards Plan;
Availability for Comment
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

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Control Number—National Center for
Emerging and Zoonotic Infectious
Diseases (proposed) (NCEZID, Centers
for Disease Control and Prevention
(CDC).

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability for public comment of the
draft document entitled ‘‘CDER Data
Standards Plan Version 1.0’’ (draft plan).
The draft plan outlines the general
approach proposed for development of
a comprehensive data standards
program in the Center for Drug
Evaluation and Research (CDER). The
draft plan identifies key objectives for a
data standards program at CDER,
processes to be developed to ensure
successful use of those standardized
data, and a set of recommended projects
to begin in calendar year (CY) 2010.

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DATES: Submit either electronic or
written comments on the draft plan by
September 15, 2010.
ADDRESSES: Submit written requests for
single copies of the draft plan 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 self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft plan.
Submit electronic comments on the
draft plan 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:
Ranjit Thomas, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 1166,
Silver Spring, MD 20993–0002, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:

I. Background
FDA receives an enormous and
growing amount of data in regulatory
submissions in a variety of formats from
many sources. This wealth of data holds
great potential to advance CDER’s

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regulatory and scientific work, but the
present lack of standardized data creates
significant challenges to realizing that
potential. A data standards plan would
enhance CDER’s ability to efficiently
and effectively perform its critical
public health mission.
At present, the lack of standardized
data affects CDER’s review processes by
curtailing a reviewer’s ability to perform
integral tasks such as rapid acquisition,
analysis, storage, and reporting of
regulatory data. Standardized data will
allow reviewers to increase review
consistency and perform evaluations
across the drug lifecycle. Improved data
quality, accessibility, and predictability
will give reviewers more time to carry
out complex analyses, ask in-depth
questions, and address late-emerging
issues.
Standardization of data submissions,
a requirement for electronic
submissions, and a robust
computational infrastructure would
make significant improvements
possible. Facilitating improvements
requires careful analysis, advanced
planning, project management, expert
input, and effective communication
among all key stakeholders. To be
successful, a plan is required to identify,
develop, adopt, and maintain data
standards that meet CDER ‘‘end user’’
needs.
FDA is making available for public
comment the draft plan entitled ‘‘CDER

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