Pediatric Advisory Committee; Notice of Meeting, 58311-58312 [E7-20304]
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sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
the Best Pharmaceuticals for Children
Act (BPCA), on adverse event reports for
Serevent (SALMETEROL), Provigil
(MODAFINIL), Azopt
(BRINZOLAMIDE), Bextaxon
(LEVOBETAXOLOL), Emtrivia
(EMTRICITABINE), and Gleevec
(IMATINAB MESYLATE). The Pediatric
Advisory Committee will also hear
about and discuss the Pediatric
Initiatives between FDA and the
European Medicines Agency.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee 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 November 5, 2007.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 2: p.m. on November 27, 2007
and 11 a.m. to 11:30 a.m. and 3 p.m. to
3:30 p.m. on November 28, 2007. Those
desiring to make 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 October
26, 2007. 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 October 29, 2007.
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 Dr. Carlos
VerDate Aug<31>2005
21:55 Oct 12, 2007
Jkt 214001
˜
Pena 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
athttps://www.fda.gov/oc/advisory/
default.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: October 8, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–20302 Filed 10–12–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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: Pediatric
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues. The committee
also advises and makes
recommendations to the Secretary of
Health and Human Services under 45
CFR 46.407 on research involving
children as subjects that is conducted or
supported by the Department of Health
and Human Services , when that
research is also regulated by FDA.
Date and Time: The meeting will be
held on Thursday, November 29, 2007,
from 8 a.m. to 4 p.m.
Location: Hilton, Washington DC
North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD.
˜
Contact Person: Carlos Pena, Office of
Science and Health Coordination, Office
of the Commissioner (HF–33), Food and
Drug Administration, 5600 Fishers Lane
(for express delivery, rm. 14B–08),
Rockville, MD 20857, 301–827–3340, e˜
mail: Carlos.Pena@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
8732310001. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
PO 00000
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58311
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 and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The Pediatric Advisory
Committee will hear and discuss issues
related to FDA’s draft guidance for
Industry entitled ‘‘Clinical Lactation
Studies—Study Design, Data Analysis,
and Recommendations for Labeling,’’
that published in the Federal Register of
Tuesday, February 8, 2005 (70 FR 6697).
As part of the review and consideration
of public comments received by FDA in
response to this draft guidance, the
Pediatric Advisory Committee will hear
and discuss information on: Labeling of
drugs for use by lactating women;
breastfeeding physiology, benefits, and
current research; the physiology and
pharmacology of drug transfer into
breast milk; and ethical issues related to
studying breastfeeding mother/infant
pairs.
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 will
be available at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the
appropriate advisory committee 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 November 5, 2007.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 2 p.m. Those desiring to make
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 October 26, 2007. 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
E:\FR\FM\15OCN1.SGM
15OCN1
58312
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 29, 2007.
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 Dr. Carlos
˜
Pena 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
athttps://www.fda.gov/oc/advisory/
default.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: October 8, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–20304 Filed 10–12–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0367]
Draft Guidance for Industry on
Antibacterial Drug Products: Use of
Noninferiority Studies to Support
Approval; Availability
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Antibacterial Drug
Products: Use of Noninferiority Studies
to Support Approval.’’ The purpose of
this guidance is to inform industry of
FDA’s current thinking regarding
appropriate clinical study designs to
evaluate antibacterial drugs, and to ask
sponsors to amend ongoing or
completed studies accordingly. This
guidance is in response to a number of
public discussions in recent years
regarding the use of active-controlled
studies designed to show noninferiority
as a basis for approval of antibacterial
drug products.
VerDate Aug<31>2005
21:55 Oct 12, 2007
Jkt 214001
Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by December 14, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Edward Cox, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6412, Silver Spring,
MD 20993–0002, 301–796–1300.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Antibacterial Drug Products: Use of
Noninferiority Studies to Support
Approval.’’ Most antibacterial drugs
have been approved based on activecontrolled noninferiority trials. There
have been a number of public
discussions in recent years on the use of
noninferiority studies to support
regulatory approval of antibacterial drug
products. Some of these discussions
have focused on specific diseases such
as acute bacterial sinusitis, acute
bacterial otitis media, and acute
bacterial exacerbation of chronic
bronchitis. These public discussions
have contributed to FDA’s evolving
understanding of the science of clinical
trials and, in particular, the appropriate
role of active-controlled studies
designed to show noninferiority in the
development of antibacterial drug
products.
This draft guidance recommends that
sponsors provide justification for the
treatment effect size and the proposed
noninferiority margin for all
antibacterial development programs for
which approval will rely on
noninferiority studies.
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This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the use of noninferiority studies to
support approval of antibacterial drug
products. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively, and the collection of
information under the guidance for
industry Special Protocol Assessment
has been approved under OMB control
number 0910–0470.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20282 Filed 10–12–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\15OCN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58311-58312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20304]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pediatric Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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: Pediatric Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues. The committee
also advises and makes recommendations to the Secretary of Health and
Human Services under 45 CFR 46.407 on research involving children as
subjects that is conducted or supported by the Department of Health and
Human Services , when that research is also regulated by FDA.
Date and Time: The meeting will be held on Thursday, November 29,
2007, from 8 a.m. to 4 p.m.
Location: Hilton, Washington DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Carlos Pe[ntilde]a, Office of Science and Health
Coordination, Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08),
Rockville, MD 20857, 301-827-3340, e-mail:
Carlos.Pe[ntilde]a@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
8732310001. Please call the Information Line for up-to-date information
on this meeting. 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 and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: The Pediatric Advisory Committee will hear and discuss
issues related to FDA's draft guidance for Industry entitled ``Clinical
Lactation Studies--Study Design, Data Analysis, and Recommendations for
Labeling,'' that published in the Federal Register of Tuesday, February
8, 2005 (70 FR 6697). As part of the review and consideration of public
comments received by FDA in response to this draft guidance, the
Pediatric Advisory Committee will hear and discuss information on:
Labeling of drugs for use by lactating women; breastfeeding physiology,
benefits, and current research; the physiology and pharmacology of drug
transfer into breast milk; and ethical issues related to studying
breastfeeding mother/infant pairs.
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 will be
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the appropriate advisory committee
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
November 5, 2007. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those desiring to make 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 October 26, 2007. 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
[[Page 58312]]
the speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by October 29, 2007.
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 Dr. Carlos
Pe[ntilde]a 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 athttps://www.fda.gov/oc/advisory/
default.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: October 8, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20304 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-S
