Food and Drug Administration Drug Educational Forum; Public Workshop, 5686-5687 [05-2098]
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5686
Federal Register / Vol. 70, No. 22 / Thursday, February 3, 2005 / Notices
Research Objectives
(1) Evaluate how mass casualty and
disaster situations impact the provision
of acute injury care.
(2) Evaluate strategies to translate,
disseminate and implement sciencebased recommendations and guidelines
for the care of the acutely injured.
(3) Develop and evaluate new or
existing health quality measures to
better assess outcomes for persons
treated in a pre-hospital or hospital
acute injury care setting.
(4) Identify individual, sociocultural
and community factors that impact on
the immediate and long-term care of the
acutely injured.
(5) Develop and evaluate acute injury
treatment strategies that will result in
evidence-based management for persons
who sustain a life-threatening injury or
one that could lead to significant
disability.
(6) Determine and evaluate the
components of pre-hospital and hospital
trauma systems that lead to
improvements in outcome for the
acutely injured.
Infrastructure Objective
(1) Build the acute injury care
research infrastructure through the
development of an Acute Injury Care
Research Network (AICRN).
(2) Determine how existing databases
can best be utilized to assess and
improve systems of acute injury care.
(3) Develop new training programs
and expand and restructure existing
training and education for health
professionals in injury care, prevention
and research.
(4) Determine, evaluate, and address
current obstacles in conducting acute
injury care research.
Interested persons are invited to
comment on the Draft Acute Injury Care
Research Agenda. NCIPC will not be
able to respond to individual comments,
but all comments received by March 3,
2005; will be considered before the final
Acute Injury Care Research Agenda is
published. A more detailed background
document is available upon request.
Send requests and comments
electronically to DARDInfo@cdc.gov.
Dated: January 27, 2005.
James D. Seligman,
Associate Director for Program Services,
Centers for Disease Control and Prevention.
[FR Doc. 05–2041 Filed 2–2–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10139]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Center for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review. We
are requesting an emergency review
because the collection of this
information is needed before the
expiration of the normal time limits
under OMB’s regulations at 5 CFR part
1320. This is necessary to ensure
compliance with an initiative of the
Administration. We cannot reasonably
comply with the normal clearance
procedures because the normal
procedures are likely to cause a
statutory deadline to be missed. It is
critical to complete the survey and
analysis for a Report to Congress due
June 2005.
Section 704(C)(2) requires CMS to
conduct a study on how non-Medicare/
Medicaid Outcome and Assessment
Information Set (OASIS) is used by large
and small home health agencies
(HHA’s). The study will investigate
whether there are unique benefits from
AGENCY:
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the analysis of such information, the
value of collecting such information by
small HHA’s compared to the
administrative burden, a comparison of
outcomes for non-Medicare/nonMedicaid patients and Medicare/
Medicaid patients, and obtain the
opinions of quality assessment experts.
The study will consist of a mailed
survey of 1200 home health agencies.
CMS is requesting OMB review and
approval of this collection by March 7,
2005, with a 180-day approval period.
Written comments and recommendation
will be accepted from the public if
received by the individuals designated
below by March 4, 2005.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
regulations/pra or e-mail your request,
including your address, phone number,
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
mailed and/or faxed to the designees
referenced below by March 4, 2005:
Centers for Medicare and Medicaid
Services, Office of Strategic Operations
and Regulatory Affairs, Room C5–13–27,
7500 Security Boulevard, Baltimore, MD
21244–1850, Fax Number: (410) 786–
0262, Attn: William N. Parham, III,
CMS–10139 and, OMB Human
Resources and Housing Branch,
Attention: Christopher Martin, New
Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: January 28, 2005.
John P. Burke, III,
CMS Paperwork Reduction Act Reports
Clearance Officer, Office of Strategic
Operations and Regulatory Affairs,
Regulations Development Group.
[FR Doc. 05–2074 Filed 2–2–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration Drug
Educational Forum; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\03FEN1.SGM
Notice of public workshop.
03FEN1
Federal Register / Vol. 70, No. 22 / Thursday, February 3, 2005 / Notices
SUMMARY: The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER), in
collaboration with FDA’s Office of
Regulatory Affairs (ORA), Southwest
Regional Office (SWRO), is announcing
a public workshop entitled ‘‘FDA Drug
Educational Forum.’’ This public
workshop is intended to provide
information about FDA’s premarket
requirements to the drug industry,
particularly small businesses, startups,
and entrepreneurs.
Date and Time: The public workshop
will be held on May 11, 2005, from 8
a.m. to 5 p.m.
Location: The public workshop will
be held at the Kansas City Health
Department Auditorium, 2400 Troost
Ave., Kansas City, MO 64108–2666. For
directions to the facility, please call
816–513–6008, e-mail:
health@kcmo.org, or visit https://
www.kcmo.org/health.nsf/web/
healthmap?opendocument. (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.)
Contact: David Arvelo or Cassandra
Davis, Food and Drug Administration,
4040 N. Central Expressway, suite 900,
Dallas, TX 75204–3128, 214–253–4952
or 214–253–4951, FAX: 214–253–4970,
e-mail: oraswrsbr@ora.fda.gov.
Registration: Registration begins on
April 6, 2005, and ends May 6, 2005.
Registration is free. Seats are limited,
please register as soon as possible.
Space will be filled in order of receipt
of registration. Those registered will
receive confirmation. Registration will
close after available space fills.
Registration at the site will be based on
space availability on the day of the
event starting at 8 a.m.
If you need special accommodations
due to disability, please contact David
Arvelo or Cassandra Davis (see
CONTACT) at least 7 days in advance.
Registration Form Instructions: To
register, complete the following
registration form and submit via:
• E-mail: oraswrsbr@ora.fda.gov,
• FAX: 214–253–4970, or
• Mail to: Food and Drug
Administration, Southwest Regional
Office, Small Business Representative,
4040 N. Central Expressway, suite 900,
Dallas, TX 75204–3128.
Name:
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Mailing Address:
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City: llllll State:llll
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19:18 Feb 02, 2005
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Zip Code:
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Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
12A–16, Rockville, MD 20857,
approximately 15 working days after the
public workshop at cost of 10 cents per
page.
SUPPLEMENTARY INFORMATION: The
public workshop is being held in
response to the interest in the topics
discussed from small drug
manufacturers, startups, and
entrepreneurs in the FDA Southwest
Region area. FDA, CDER, and ORA
present this public workshop to help
achieve objectives set forth in section
406 of the Food and Drug
Administration Modernization Act of
1997 (21 U.S.C. 393), which include
working closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. This is also consistent with the
purposes of FDA’s Regional Small
Business Program, which are in part to
respond to industry inquiries, develop
educational materials, sponsor
workshops and conferences to provide
firms, particularly small businesses,
with firsthand working knowledge of
FDA’s requirements and compliance
policies. This public workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as outreach
activities by Government agencies to
small businesses.
The goal of the public workshop is to
present information that will enable
manufacturers and regulated industry to
better comply with the new drug
approval process (21 CFR part 314).
Information presented will be based on
agency position as articulated through
regulation, compliance policy guides,
and information previously made
available to the public. Topics to be
discussed at the public workshop
include the following: (1) Planning for
successful, efficient, pharmaceutical
product approval; (2) current challenges
and concerns for generic abbreviated
new animal drug applications (ANDAs);
(3) regulatory aspects and challenges in
the development of over-the-counter
(OTC) Drugs; (4) the basics of chemistry,
manufacturing and control; (5) FDA 483
PO 00000
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5687
issues; (6) mastering regulatory
compliance; and (7) incentives for small
businesses.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2098 Filed 2–2–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0036]
Use of Color on Pharmaceutical
Product Labels, Labeling and
Packaging; Public Hearing
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
SUMMARY: The Center for Drug
Evaluation and Research (CDER) of the
Food and Drug Administration (FDA) is
announcing a public hearing on the
current practice of applying color to
pharmaceutical product packaging and
labeling to help identify, classify, and
differentiate those drug products. To
date, there is little scientific evidence
that applying color is effective in
reducing medication errors.
Furthermore, there is no validated
scientific method to corroborate the
benefits of using colors on
pharmaceuticals in this fashion. FDA
does not have a policy pertaining to the
use of colors on drug product packaging.
The purpose of the hearing is to obtain
public input on the benefits and
potential drawbacks of applying color to
drug packaging and labeling to help
identify, classify, or differentiate those
products.
DATES: The public hearing will be held
on March 7, 2005, from 8 a.m. to 4:30
p.m. Submit written or electronic
notices of participation and comments
for consideration at the hearing by
February 11, 2005. Written or electronic
comments will be accepted after the
hearing until April 7, 2005. The
administrative record of the hearing will
remain open until April 7, 2005.
ADDRESSES: The public hearing will be
held at Lister Hill Auditorium, Building
38A, on the campus of the National
Institutes of Health, Bethesda, MD
(Metro stop: Medical Center Station on
the Red Line). Submit written or
electronic notices of participation and
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 70, Number 22 (Thursday, February 3, 2005)]
[Notices]
[Pages 5686-5687]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration Drug Educational Forum; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
[[Page 5687]]
SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER), in collaboration with FDA's Office of
Regulatory Affairs (ORA), Southwest Regional Office (SWRO), is
announcing a public workshop entitled ``FDA Drug Educational Forum.''
This public workshop is intended to provide information about FDA's
premarket requirements to the drug industry, particularly small
businesses, startups, and entrepreneurs.
Date and Time: The public workshop will be held on May 11, 2005,
from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Kansas City
Health Department Auditorium, 2400 Troost Ave., Kansas City, MO 64108-
2666. For directions to the facility, please call 816-513-6008, e-mail:
health@kcmo.org, or visit https://www.kcmo.org/health.nsf/web/
healthmap?opendocument. (FDA has verified the Web site address, but FDA
is not responsible for any subsequent changes to the Web site after
this document publishes in the Federal Register.)
Contact: David Arvelo or Cassandra Davis, Food and Drug
Administration, 4040 N. Central Expressway, suite 900, Dallas, TX
75204-3128, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail:
oraswrsbr@ora.fda.gov.
Registration: Registration begins on April 6, 2005, and ends May 6,
2005. Registration is free. Seats are limited, please register as soon
as possible. Space will be filled in order of receipt of registration.
Those registered will receive confirmation. Registration will close
after available space fills. Registration at the site will be based on
space availability on the day of the event starting at 8 a.m.
If you need special accommodations due to disability, please
contact David Arvelo or Cassandra Davis (see CONTACT) at least 7 days
in advance.
Registration Form Instructions: To register, complete the following
registration form and submit via:
E-mail: oraswrsbr@ora.fda.gov,
FAX: 214-253-4970, or
Mail to: Food and Drug Administration, Southwest Regional
Office, Small Business Representative, 4040 N. Central Expressway,
suite 900, Dallas, TX 75204-3128.
Name: ________________
Company Name: ________________
Mailing Address: ________________
City: ______ State:____
Zip Code: ________________
Phone: ( ) _______
Fax: ( ) ________________
E-mail: ( ) ________________
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop. Course handouts may be
requested in writing from the Freedom of Information Office (HFI-35),
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville,
MD 20857, approximately 15 working days after the public workshop at
cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The public workshop is being held in
response to the interest in the topics discussed from small drug
manufacturers, startups, and entrepreneurs in the FDA Southwest Region
area. FDA, CDER, and ORA present this public workshop to help achieve
objectives set forth in section 406 of the Food and Drug Administration
Modernization Act of 1997 (21 U.S.C. 393), which include working
closely with stakeholders and maximizing the availability and clarity
of information to stakeholders and the public. This is also consistent
with the purposes of FDA's Regional Small Business Program, which are
in part to respond to industry inquiries, develop educational
materials, sponsor workshops and conferences to provide firms,
particularly small businesses, with firsthand working knowledge of
FDA's requirements and compliance policies. This public workshop is
also consistent with the Small Business Regulatory Enforcement Fairness
Act of 1996 (Public Law 104-121), as outreach activities by Government
agencies to small businesses.
The goal of the public workshop is to present information that will
enable manufacturers and regulated industry to better comply with the
new drug approval process (21 CFR part 314). Information presented will
be based on agency position as articulated through regulation,
compliance policy guides, and information previously made available to
the public. Topics to be discussed at the public workshop include the
following: (1) Planning for successful, efficient, pharmaceutical
product approval; (2) current challenges and concerns for generic
abbreviated new animal drug applications (ANDAs); (3) regulatory
aspects and challenges in the development of over-the-counter (OTC)
Drugs; (4) the basics of chemistry, manufacturing and control; (5) FDA
483 issues; (6) mastering regulatory compliance; and (7) incentives for
small businesses.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2098 Filed 2-2-05; 8:45 am]
BILLING CODE 4160-01-S
