Training Program for Regulatory Project Managers; Information Available to Industry, 77168-77169 [E5-8017]
Download as PDF
<![CDATA[
77168
Federal Register / Vol. 70, No. 249 / Thursday, December 29, 2005 / Notices
wwhite on PROD1PC65 with NOTICES
efficient and effective acquisition and
grant programs.
• Advises and assists the
Administrator, senior staff, and Agency
components on acquisition and grant
related issues.
• Plans, develops, and interprets
comprehensive policies, procedures,
regulations, and directives for CMS
acquisition functions.
• Represents CMS at departmental
acquisition and grant forums and
functions, such as the Executive Council
on Acquisition and the Executive
Council for Grants Administration
Policy.
• Serves as the CMS contact point
with HHS and other Federal agencies
relative to grant and cooperative
agreement policy matters.
• Coordinates and/or conducts
training for contracts and grant
personnel, as well as project officers in
CMS components.
• Develops agency-specific
procurement guidelines for the
utilization of small and disadvantaged
business concerns in achieving an
equitable percentage of CMS’
contracting requirements.
• Provides cost/price analyses and
evaluations required for the review,
negotiation, award, administration, and
closeout of grants and contracts.
Provides support for field audit
capability during the pre-award and
closeout phases of contract and grant
activities.
• Develops and maintains the OAGM
automated procurement management
system. Manages procurement
information activities (i.e., collecting,
reporting, and analyzing procurement
data).
26. Office of Policy (FLA)
• Assists the Policy Council with
immediate/rapid response on timely
issues and transform concepts into
institutionalized processes.
• Assists the MMA Council as
requested to develop, implement, and
coordinate a policy process for the
agency for key major cross-cutting and
policy issues resulting from MMA
legislation and subsequent issues.
• Advises the Administrator on
medical technical innovation and health
information technology matters.
• Plans and develops future CMS
program policy. Assists OL in the
development of legislative strategies by
providing analytic support for
legislative options and proposals.
Conducts legislative, economic, and
policy analyses related to the overall
structure of health care financing.
Translates research findings into policy
applications.
VerDate Aug<31>2005
18:56 Dec 28, 2005
Jkt 208001
• Performs environmental scanning,
identifying, evaluating, and reporting
emerging trends to health care delivery
and financing. Works with Agency
components and outside organizations
to obtain relevant information on
emerging trends. Analyzes trends for
their interactions with Agency programs
and implications for future policy
development and planning. Identifies
emerging trends and policy issues that
would benefit the Office of Research,
Development, and Information’s
research, evaluation, and survey
enterprises.
• Conducts management and
development of the long-term strategic
plan for the Agency. Provides analytic
support and information to the
Administrator and Senior Leadership
needed to establish the Agency’s goals
and directions. Conducts special studies
and analyses concerning Agency-wide
planning issues.
• Provides data analyses, graphics
presentations, briefing materials, and
analyses on short notice to support the
immediate needs of the Administrator
and Senior Leadership.
• Manages strategic, cross-cutting
initiatives as assigned by the Office of
the Administrator.
• Facilitates policy development by
providing analytic liaison with other
components in HHS and elsewhere in
the Administration.
• Serves as CMS’ contact for
international visitors. Responds to
requests from intergovernmental
agencies and the international
community for information related to
the United States health care system.
Dated: December 20, 2005.
Karen Pelham O’Steen,
Director, Office of Operations Management,
Centers for Medicare & Medicaid Services.
[FR Doc. E5–8073 Filed 12–28–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Program (the Site Tours Program). The
purpose of this notice is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
submit proposed agendas to the agency
by February 27, 2006.
FOR FURTHER INFORMATION CONTACT: Beth
Duvall-Miller, Office of New Drugs
(HFD–020), Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg 22, rm. 6466, Silver Spring,
MD 20903, 301–796–0700, FAX: 301–
796–9858.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, the Center has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) First hand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. Regulatory Project Management Site
Tours and Regulatory Interaction
Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
E:\FR\FM\29DEN1.SGM
29DEN1
Federal Register / Vol. 70, No. 249 / Thursday, December 29, 2005 / Notices
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations.
The overall benefit to regulatory
project managers will be exposure to
project management, team techniques,
and processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the site tours will be the responsibility
of CDER, therefore, selection will be
based on the availability of funds and
resources for each fiscal year.
Firms interested in offering a site tour
or learning more about this training
opportunity should respond within 60
days of this notice by submitting a
proposed agenda to Beth Duvall-Miller
(see FOR FURTHER INFORMATION CONTACT).
Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–8017 Filed 12–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–23422]
Collection of Information Under
Review by Office of Management and
Budget: OMB Control Number 1625–
0073
Coast Guard, DHS.
Request for comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to seek the
approval of OMB for the renewal of an
Information Collection Request (ICR).
The ICR is 1625–0073, Alteration of
Unreasonably Obstructive Bridges
Under the Truman-Hobbs (T–H) Act.
Before submitting the ICR to OMB, the
Coast Guard is inviting comments on
them as described below.
DATES: Comments must reach the Coast
Guard on or before February 27, 2006.
ADDRESSES: To make sure that your
comments and related material do not
enter the docket [USCG–2005–23422]
more than once, please submit them by
only one of the following means:
wwhite on PROD1PC65 with NOTICES
SUMMARY:
VerDate Aug<31>2005
18:56 Dec 28, 2005
Jkt 208001
77169
(1) By mail to the Docket Management
Facility, U.S. Department of
Transportation (DOT), room PL–401,
400 Seventh Street, SW., Washington,
DC 20590–0001.
(2) By delivery to room PL–401 on the
Plaza level of the Nassif Building, 400
Seventh Street. SW., Washington, DC,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The telephone number is 202–366–
9329.
(3) By fax to the Docket Management
Facility at 202–493–2251.
(4) Electronically through the Web
Site for the Docket Management System
at https://dms.dot.gov.
The Docket Management Facility
maintains the public docket for this
notice. Comments and material received
from the public, as well as documents
mentioned in this notice as being
available in the docket, will become part
of this docket and will be available for
inspection or copying at room PL–401
on the Plaza level of the Nassif Building,
400 Seventh Street, SW., Washington,
DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
You may also find this docket on the
Internet at https://dms.dot.gov.
Copies of the complete ICR is
available through this docket on the
Internet at https://dms.dot.gov, and also
from Commandant (CG–611), U.S. Coast
Guard Headquarters, room 1236 (Attn:
Mr. Arthur Requina), 1900 Half Street,
SW., Washington, DC 20593–0001. The
telephone number is 202–475–3523.
FOR FURTHER INFORMATION CONTACT: Mr.
Arthur Requina, Office of Information
Management, telephone 202–475–3523,
or fax 202–475–3929, for questions on
these documents; or telephone Ms.
Renee V. Wright, Program Manager,
Docket Operations, 202–493–0402, for
questions on the docket.
SUPPLEMENTARY INFORMATION:
the document to which each comment
applies, and give the reason for each
comment. You may submit your
comments and material by electronic
means, mail, fax, or delivery to the
Docket Management Facility at the
address under ADDRESSES; but please
submit them by only one means. If you
submit them by mail or delivery, submit
them in an unbound format, no larger
than 81⁄2 by 11 inches, suitable for
copying and electronic filing. If you
submit them by mail and would like to
know that they reached the Facility,
please enclose a stamped, self-addressed
postcard or envelope. We will consider
all comments and material received
during the comment period. We may
change the documents supporting this
collection of information or even the
underlying requirements in view of
them.
Public Participation and Request for
Comments
Information Collection Request
Title: Alteration of Unreasonably
Obstructive Bridges Under the TrumanHobbs (T–H) Act.
OMB Control Number: 1625–0073.
Summary: The collection of
information is a request to determine if
a bridge is unreasonably obstructive to
navigation.
Need: 33 U.S.C. 494, 502, 511, 513,
514, 516 and 517 authorize the Coast
Guard to alter bridges and causeways
that go over navigable waters of the
United States deemed to be
unreasonably obstructive.
Respondents: Public and private
owners of bridges over navigable waters
of the United States.
Frequency: On occasion.
We encourage you to respond to this
request for comments by submitting
comments and related materials. We
will post all comments received,
without change, to https://dms.dot.gov;
they will include any personal
information you have provided. We
have an agreement with DOT to use the
Docket Management Facility. Please see
the paragraph on DOT’s ‘‘Privacy Act
Policy’’ below.
Submitting Comments
If you submit a comment, please
include your name and address, identify
the docket number [USCG–2005–
23422], indicate the specific section of
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Viewing Comments and Documents
To view comments, as well as
documents mentioned in this notice as
being available in the docket, go to
https://dms.dot.gov at any time and
conduct a simple search using the
docket number. You may also visit the
Docket Management Facility in room
PL–401 on the Plaza level of the Nassif
Building, 400 Seventh Street SW.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
Privacy Act
Anyone can search the electronic
form of all comments received in
dockets by the name of the individual
submitting the comment (or signing the
comment, if submitted on behalf of an
association, business, labor union, etc.).
You may review the Privacy Act
Statement of DOT in the Federal
Register published on April 11, 2000
(65 FR 19477), or you may visit
https://dms.dot.gov.
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 70, Number 249 (Thursday, December 29, 2005)]
[Notices]
[Pages 77168-77169]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER) is announcing the continuation of the
Regulatory Project Management Site Tours and Regulatory Interaction
Program (the Site Tours Program). The purpose of this notice is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.
DATES: Pharmaceutical companies may submit proposed agendas to the
agency by February 27, 2006.
FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Office of New
Drugs (HFD-020), Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg 22, rm. 6466, Silver
Spring, MD 20903, 301-796-0700, FAX: 301-796-9858.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this primary goal, the
Center has initiated various training and development programs to
promote high performance in its regulatory project management staff.
CDER seeks to significantly enhance review efficiency and review
quality by providing the staff with a better understanding of the
pharmaceutical industry and its operations. To this end, CDER is
continuing its training program to give regulatory project managers the
opportunity to tour pharmaceutical facilities. The goals are to provide
the following: (1) First hand exposure to industry's drug development
processes and (2) a venue for sharing information about project
management procedures (but not drug-specific information) with industry
representatives.
II. Regulatory Project Management Site Tours and Regulatory Interaction
Program
In this program, over a 2- to 3-day period, small groups (five or
less) of regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and
[[Page 77169]]
industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations.
The overall benefit to regulatory project managers will be exposure
to project management, team techniques, and processes employed by the
pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the site tours will be the
responsibility of CDER, therefore, selection will be based on the
availability of funds and resources for each fiscal year.
Firms interested in offering a site tour or learning more about
this training opportunity should respond within 60 days of this notice
by submitting a proposed agenda to Beth Duvall-Miller (see FOR FURTHER
INFORMATION CONTACT).
Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8017 Filed 12-28-05; 8:45 am]
BILLING CODE 4160-01-S
