Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, 73028-73029 [E7-24927]
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Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices
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Dated: December 18, 2007.
Brendan Kelly,
Reports Clearance Officer.
[FR Doc. 07–6158 Filed 12–21–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24914 Filed 12–21–07; 8:45 am]
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Food and Drug Administration
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[Docket No. 2007C–0474]
DEPARTMENT OF HEALTH AND
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[Docket No. 2007N–0472]
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SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of December 12, 2007 (72 FR
70599). The document announced that a
proposed collection of information had
been submitted to the Office of
Management and Budget (OMB) for
emergency processing under the
Paperwork Reduction Act of 1995. The
document was published with an error.
This document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Planning,
and Preparedness (HF–27), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
7010.
SUPPLEMENTARY INFORMATION:IN FR DOC.
07–6023, APPEARING ON PAGE 70599 IN THE
Federal Register OF WEDNESDAY,
DECEMBER 12, 2007, THE FOLLOWING
CORRECTION IS MADE: 1. On page 70599, in
the third column, in the second full
paragraph, the second sentence is
corrected to read ‘‘Specifically, at the
VerDate Aug<31>2005
18:50 Dec 21, 2007
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Food and Drug Administration,
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SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
December 4, 2007 (72 FR 68166). The
document announced that DSM
Nutritional Products, Inc., has filed a
petition proposing that the color
additive regulations be amended to
provide for the safe use of astaxanthin
dimethyldisuccinate as a color additive
in the feed of salmonid fish to enhance
the color of their flesh.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Planning,
and Preparedness, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7010.
In FR Doc.
E7–23473, appearing on page 68166 in
the Federal Register of Tuesday,
December 4, 2007, the following
correction is made:
1. On page 68166, in the third
column, in the heading of the
document, ‘‘[Docket No. 2007N–0453]’’
is corrected to read ‘‘[Docket No.
2007C–0474]’’.
SUPPLEMENTARY INFORMATION:
Dated: December 17, 2007.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E7–24911 Filed 12–21–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Clinical Trial Design for CommunityAcquired Pneumonia; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop, cosponsored with the
Infectious Diseases Society of America
(IDSA), regarding scientific issues in
clinical trial design for communityacquired pneumonia. This public
workshop is intended to provide
information for and to gain perspective
from health care providers, academia,
and industry on various aspects of
antimicrobial drug development for
community-acquired pneumonia,
including diagnosis of communityacquired pneumonia, effect of
antimicrobial treatment for communityacquired pneumonia, endpoints for
trials of community-acquired
pneumonia, and statistical issues in
analysis of results of trials in
community-acquired pneumonia. The
input from this public workshop will
help in developing topics for further
discussion.
Date and Time: The public workshop
will be held on January 17, 2008, from
8 a.m. to 6 p.m. and on January 18,
2008, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel,
Kennedy Room, 8777 Georgia Ave.,
Silver Spring, MD 20910, 301–589–
0800. Seating is limited and available
only on a first-come, first-served basis.
Contact Person: Chris Moser or Lori
Benner, Center for Drug Evaluation and
Research, Office of Antimicrobial
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 6413, Silver Spring,
MD 20993–0002, 301–796–0767, or
301–796–0849.
Registration: There is no registration
fee for the public workshop. Space is
limited; therefore, interested parties are
encouraged to register early. Seating
will be available on a first-come, firstserved basis. To register electronically,
e-mail registration information
(including name, title, firm name,
address, telephone, and fax number) to
CAPwkshp@fda.hhs.gov by January 9,
2008. Persons without access to the
Internet can call 301–796–1300 to
register. Persons needing a sign
language interpreter or other special
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Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices
accommodations should notify Chris
Moser or Lori Benner (see Contact
Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop,
cosponsored with IDSA, regarding
antimicrobial drug development. This
public workshop will focus on scientific
considerations in designing clinical
trials for community-acquired
pneumonia. The topics for discussion
include approaches to the diagnosis of
community-acquired pneumonia, the
effect of antimicrobial treatment for
community-acquired pneumonia,
various endpoints that might be
considered as endpoints for trials of
community-acquired pneumonia, and
statistical issues in analysis of results
from trials in community-acquired
pneumonia. The input from this public
workshop will help in developing topics
for further discussion.
The agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 20 working days after the
public workshop, at a cost of 10 cents
per page.
Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24927 Filed 12–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0480]
Maximizing the Public Health Benefit of
Adverse Event Collection Throughout
a Product’s Marketed Life Cycle;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
pwalker on PROD1PC71 with NOTICES
ACTION:
SUMMARY: The Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) at the Food and Drug
Administration (FDA) are announcing a
public workshop entitled ‘‘Maximizing
the Public Health Benefit of Adverse
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Event Collection Throughout a
Product’s Marketed Life Cycle.’’ The
purpose of the public workshop is to
solicit information and views from
interested persons on research
approaches and methods associated
with the best ways to assess the public
health benefit of collecting and
reporting all adverse events (AEs). The
input from this workshop will be used
to publish a request for information to
determine the types of outside
organizations that would be interested
in, and have the capability to conduct,
the research described in this paragraph,
followed by a request for proposal
(RFP).
DATES: The public workshop will be
held on January 29, 2008, from 8:30 a.m.
to 5 p.m. Individuals who wish to speak
during the public workshop must
register on or before January 15, 2008.
See section III of this document for
information on how to attend or present
at the meeting.
We are opening a docket to receive
your written or electronic comments.
Written or electronic comments must be
submitted to the docket by February 29,
2008.
ADDRESSES: The public workshop will
be held at The Conference Facility
(terrace level) located at 5635 Fishers
Lane, Rockville, MD 20857 (Metro:
Twinbrook Station on the Red Line).
Submit written or electronic
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified 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.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
FOR FURTHER INFORMATION CONTACT:
Lana Pauls, Center for Drug Evaluation
and Research (HFD–006), Food and
PO 00000
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73029
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–796–
0518, FAX: 301–827–1069, e-mail:
lana.pauls@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The collection of information relating
to AEs is an integral part of
understanding the safety of a product
throughout its marketed life cycle. FDA
is committed to maximizing the public
health benefit of collecting and
reporting serious and non-serious AEs.
Central to addressing this question is
determining the number and type of
safety concerns discovered by AE
collection, the age of products at the
time safety concerns are detected by AE
collection, and the types of actions that
are subsequently taken to protect patient
safety.
The workshop objectives are as
follows: (1) Initiate constructive
dialogue and information-sharing
among regulators, researchers, the
pharmaceutical industry, health
organizations, and individuals affected
by postmarketing AE collection,
reporting, and evaluation; (2) share
current FDA practices regarding
postmarketing AE collection and
reporting; and (3) obtain input on the
questions and methods that will be used
to conduct research on this topic.
Two panel discussions will focus on
how FDA currently uses spontaneous
reports and other methods of signal
detection, the key research questions
that should be addressed by the RFP,
and appropriate research approaches
and methods including, but not limited
to, hypothesis, study design, data
sources, outcome measures, and
analytic methods. Panel one will focus
on the key research questions; panel two
will discuss research approaches and
methods.
Some of the key questions to be
addressed in the RFP include the
following:
(1) What is the value to patient safety
of collecting AEs through a passive
surveillance system over the marketed
life cycle of a product? How are these
data best used in regulatory decisionmaking?
(2) How can safety issue identification
and subsequent regulatory action be
characterized in relation to time elapsed
following product approval? Is this
influenced by the type of regulatory
action and/or the nature of the safety
signal?
(3) What are the roles of serious and
non-serious outcome reports in safety
issue identification and subsequent
regulatory action? How do the roles of
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]]>Agencies
[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Notices]
[Pages 73028-73029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Clinical Trial Design for Community-Acquired Pneumonia; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop, cosponsored with the Infectious Diseases Society of America
(IDSA), regarding scientific issues in clinical trial design for
community-acquired pneumonia. This public workshop is intended to
provide information for and to gain perspective from health care
providers, academia, and industry on various aspects of antimicrobial
drug development for community-acquired pneumonia, including diagnosis
of community-acquired pneumonia, effect of antimicrobial treatment for
community-acquired pneumonia, endpoints for trials of community-
acquired pneumonia, and statistical issues in analysis of results of
trials in community-acquired pneumonia. The input from this public
workshop will help in developing topics for further discussion.
Date and Time: The public workshop will be held on January 17,
2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5
p.m.
Location: The public workshop will be held at the Crowne Plaza
Hotel, Kennedy Room, 8777 Georgia Ave., Silver Spring, MD 20910, 301-
589-0800. Seating is limited and available only on a first-come, first-
served basis.
Contact Person: Chris Moser or Lori Benner, Center for Drug
Evaluation and Research, Office of Antimicrobial Products, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413,
Silver Spring, MD 20993-0002, 301-796-0767, or 301-796-0849.
Registration: There is no registration fee for the public workshop.
Space is limited; therefore, interested parties are encouraged to
register early. Seating will be available on a first-come, first-served
basis. To register electronically, e-mail registration information
(including name, title, firm name, address, telephone, and fax number)
to CAPwkshp@fda.hhs.gov by January 9, 2008. Persons without access to
the Internet can call 301-796-1300 to register. Persons needing a sign
language interpreter or other special
[[Page 73029]]
accommodations should notify Chris Moser or Lori Benner (see Contact
Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop,
cosponsored with IDSA, regarding antimicrobial drug development. This
public workshop will focus on scientific considerations in designing
clinical trials for community-acquired pneumonia. The topics for
discussion include approaches to the diagnosis of community-acquired
pneumonia, the effect of antimicrobial treatment for community-acquired
pneumonia, various endpoints that might be considered as endpoints for
trials of community-acquired pneumonia, and statistical issues in
analysis of results from trials in community-acquired pneumonia. The
input from this public workshop will help in developing topics for
further discussion.
The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 20 working days after the public workshop, at a cost of
10 cents per page.
Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24927 Filed 12-21-07; 8:45 am]
BILLING CODE 4160-01-S
