Training Program for Regulatory Project Managers; Information Available to Industry, 6731-6732 [2015-02426]
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Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices
docket opened on November 19, 2014,
and closed on December 19, 2014. We
are no longer seeking comment on the
‘‘first generic’’ review prioritization
category at this time.
III. How To Submit Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02401 Filed 2–5–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0824]
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK5VPTVN1PROD 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: Anesthetic and
Analgesic Drug Products 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 March 18, 2015, from 8 a.m. to
5 p.m.
Location: Holiday Inn Gaithersburg,
Grand Ballroom, 2 Montgomery Village
Ave., Gaithersburg, MD 20879. The
hotel’s telephone number is 301–948–
8900. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
VerDate Sep<11>2014
18:52 Feb 05, 2015
Jkt 235001
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Stephanie L.
Begansky, 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: AADPAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 022225,
sugammadex sodium injection,
submitted by Organon USA Inc., for the
proposed indication of reversal of
moderate or deep neuromuscular
blockade induced by rocuronium or
vecuronium.
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 meeting
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 March 4, 2015. 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 February
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6731
24, 2015. 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 February 25, 2015.
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 Stephanie L.
Begansky 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: February 2, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–02408 Filed 2–5–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0179]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA’s) 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 document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
SUMMARY:
E:\FR\FM\06FEN1.SGM
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6732
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices
Pharmaceutical companies may
submit proposed agendas to the Agency
by April 7, 2015.
FOR FURTHER INFORMATION CONTACT: Dan
Brum, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5480, Silver Spring,
MD 20993–0002, 301–796–0578,
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
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, CDER 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) Firsthand 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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. The Site Tours 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
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
VerDate Sep<11>2014
18:52 Feb 05, 2015
Jkt 235001
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 Program will be the
responsibility of CDER; therefore,
selection will be based on the
availability of funds and resources for
each fiscal year. Selection will also be
based on firms having a favorable
facility status as determined by FDA’s
Office of Regulatory Affairs District
Offices in the firms’ respective regions.
Firms interested in offering a site tour
or learning more about this training
opportunity should respond by
submitting a proposed agenda to Dan
Brum (see DATES and FOR FURTHER
INFORMATION CONTACT).
Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02426 Filed 2–5–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than April 7, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, Parklawn
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Nurse Corps Scholarship Program, OMB
No. 0915–0301—Revision.
Abstract: The Nurse Corps
Scholarship Program (Nurse Corps SP)
is a competitive Federal program, which
awards scholarships to individuals for
attendance at accredited schools of
nursing. The Bureau of Health
Workforce (BHW) in HRSA administers
the program. The scholarship consists of
payment of tuition, fees, other
reasonable educational costs, and a
monthly support stipend. In return, the
students agree to provide a minimum of
2 years of full-time clinical service (or
an equivalent part-time commitment, as
approved by the Nurse Corps SP) at a
health care facility with a critical
shortage of nurses as defined by the
program. Nurse Corps SP recipients
must be willing to (and are required to)
fulfill their Nurse Corps SP service
commitment at a health care facility
with a critical shortage of nurses in the
United States, which includes, in
addition to the several states, only: The
District of Columbia, Guam, the
Commonwealth of Puerto Rico, the
Northern Mariana Islands, the U.S.
Virgin Islands, American Samoa, the
Federated States of Micronesia, the
Republic of the Marshall Islands, and
the Republic of Palau.
Students who are uncertain of their
commitment to provide nursing care in
a health care facility with a critical
shortage of nurses in the United States
or these territories are advised not to
participate in the program.
Need and Proposed Use of the
Information: The Nurse Corps
Scholarship Program needs to collect
data to determine an applicant’s
eligibility for the program, to monitor a
participant’s continued enrollment in a
school of nursing, to monitor the
participant’s compliance with the Nurse
Corps Scholarship Program service
obligation, and to obtain data on its
program to ensure compliance with
statutory mandates and prepare annual
reports to Congress. The following
information will be collected: (1) From
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6731-6732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0179]
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) 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 document is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.
[[Page 6732]]
DATES: Pharmaceutical companies may submit proposed agendas to the
Agency by April 7, 2015.
FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002, 301-796-0578,
dan.brum@fda.hhs.gov.
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, CDER
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)
Firsthand 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. The Site Tours 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 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 Program will be
the responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms interested in offering a site tour
or learning more about this training opportunity should respond by
submitting a proposed agenda to Dan Brum (see DATES and FOR FURTHER
INFORMATION CONTACT).
Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02426 Filed 2-5-15; 8:45 am]
BILLING CODE 4164-01-P
