National Institute on Drug Abuse; Notice of Closed Meeting, 42104-42105 [2010-17670]
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Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
regulatory approaches, and optimal
solutions to prevent, diagnose, and treat
neglected tropical diseases.
The scope of this public hearing
includes the issues described in sections
IV.A and IV.B of this document. In
addressing these issues, we ask that
your comments focus particularly on
preclinical studies, trial design,
regulatory approaches, and optimal
solutions as they relate to the
prevention, diagnosis, and treatment of
neglected tropical diseases. We are also
providing a few examples of discussion
items that would apply to each issue.
However, we encourage you to comment
on any subject related to the headings of
sections IV.A and IV.B of this
document.
IV. Issues for Discussion
A. What are the challenges to
developing drugs, biological products,
and medical devices used to prevent,
diagnose, and treat neglected tropical
diseases? What are the specific areas
and diseases where progress is needed?
At a minimum, consider the
following:
• Preclinical testing
• Trial design
• Regulatory approaches
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B. What can be done to advance the
development of products used to
prevent, diagnose, and treat neglected
tropical diseases in the developing
world?
At a minimum, consider the
following:
• The perceived challenges in
obtaining FDA approval or clearance of
a premarket submission for a product
used to prevent, diagnose, or treat a
neglected tropical disease
• The perceived benefit or nonbenefit of:
Æ orphan status designation
Æ the priority review voucher
program under section 524 of the
Federal Food, Drug and Cosmetic Act
(21 U.S.C. 360n)
Æ the humanitarian use device (HUD)
and the humanitarian device exemption
(HDE) program
Æ other potential incentives
• Novel approaches to advance the
development of products for neglected
tropical diseases and regulatory
approaches
• New strategies for international
cooperation, consultation, and
collaboration in the review and
approval of these products
• Training or guidance necessary to
support the development of products for
neglected tropical diseases
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V. Notice of Hearing Under Part 15
The Commissioner is announcing that
the public hearing will be held in
accordance with part 15. The hearing
will be conducted by a presiding officer,
who will be accompanied by FDA
senior management from the Office of
the Commissioner, the Economics Staff,
the Center for Drug Evaluation and
Research, the Center for Biologics
Evaluation and Research, the Center for
Devices and Radiological Health, and
the Office of the Chief Counsel.
Persons who wish to participate in the
part 15 hearing must file a written or
electronic notice of participation with
the Division of Dockets Management
(see ADDRESSES and DATES). Requests to
make a presentation should contain the
potential presenter’s name and title;
address; telephone number; e-mail
address; affiliation, if any; the sponsor
of the presentation (e.g., the
organization paying travel expenses or
fees), if any; and a brief summary of the
presentation, including the discussion
topic(s) that will be addressed.
Under § 15.30(f), the hearing is
informal, and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation.
Public hearings under part 15 are
subject to FDA’s policy and procedures
for electronic media coverage of FDA’s
public administrative proceedings (part
10, subpart C (21 CFR part 10, subpart
C)). Under § 10.205, representatives of
the electronic media may be permitted,
subject to certain limitations, to
videotape, film, or otherwise record
FDA’s public administrative
proceedings, including presentations by
participants.
To the extent that the conditions for
the hearing, as described in this
document, conflict with any provisions
set out in part 15, this document acts as
a waiver of those provisions as specified
in § 15.30(h).
VI. Requests for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
notices of participation and comments
for consideration at the hearing. To
permit time for all interested persons to
submit data, information, or views on
this subject, the administrative record of
the hearing will remain open until
October 20, 2010. You should annotate
and organize your comments to identify
the specific issues to which they refer
(see section IV of this document). It is
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only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify submissions 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.
VII. Transcripts
The hearing will be transcribed as
stipulated in § 15.30(b). Please be
advised that as soon as a transcript is
available, it will be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, Rm. 6–30, Rockville, MD 20857.
Dated: July 14, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17619 Filed 7–19–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel Systems
Biology, HIV/AIDS, and Substance Abuse
(R01).
Date: July 27, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
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Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
Place: Sofitel Washington DC Lafayette
Square, 806 15th Street, NW., Washington,
DC 20005.
Contact Person: Eliane Lazar-Wesley, PhD,
Health Scientist Administrator, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Boulevard, Bethesda,
MD 20892–8401, 301–451–4530,
elazarwe@nida.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel 2010
NIDA Translational Avant-Garde Award
Interviews (DP1).
Date: July 27, 2010.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Grand, 2350 M Street, NW.,
Washington, DC 20037.
Contact Person: Scott Chen, PhD, Scientific
Review Officer, Office of Extramural Affairs,
National Institute on Drug Abuse, National
Institutes of Health, DHHS, 6101 Executive
Boulevard, Room 220, MSC 8401, Bethesda,
MD 20892, 301–443–9511,
chensc@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: July 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–17670 Filed 7–19–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0004]
[FDA–225–10–0015]
Memorandum of Understanding: Food
and Drug Administration and the
National Institutes of Health, National
Institutes of Environmental Health
Sciences, National Toxicology
Program; and the National Institutes of
Health, National Human Genome
Research Institute, National Institutes
of Health, Chemical Genomics Center;
and the Environmental Protection
Agency, Office of Research and
Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the National Institutes of Health (NIH),
National Institutes of Environmental
Health Sciences (NIEHS), National
Toxicology Program (NTP); and the NIH,
National Human Genome Research
Institute (NHGRI), NIH Chemical
Genomics Center (NCGC); and the
Environmental Protection Agency,
Office of Research and Development.
This four-party Memorandum of
Understanding (MOU) sets in place
mechanisms to strengthen the existing
collaborations that utilize the
complementary expertise and
capabilities of the NIEHS/NTP, the
NCGC of the NHGRI, the Office of
Research and Development (ORD) of the
EPA, and the FDA in the research,
development, validation, and
translation of new and innovative test
methods that characterize key steps in
toxicity pathways. This MOU amends
and supersedes an MOU between the
first three named parties for the same
purposes. A central component of this
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MOU is the exploration of high
throughput screening (HTS) assays and
tests using phylogenetically lower
animal species (e.g., fish, worms), as
well as high throughput whole genome
analytical methods, to evaluate
mechanisms of toxicity. Ultimately, the
data generated by these new tools is to
be provided to risk assessors to use in
the protection of human health and the
environment. The goals of this MOU are
to investigate the use of these new tools
to: (1) Identify mechanisms of
chemically induced biological activity,
(2) prioritize chemicals for more
extensive toxicological evaluation, and
(3) develop more predictive models of
in vivo biological response. Success in
achieving these goals is expected to
result in test methods for toxicity testing
that are more scientifically and
economically efficient and models for
risk assessment that are more
biologically based. As a consequence, a
reduction or replacement of animals in
regulatory testing is anticipated to occur
in parallel with an increased ability to
evaluate the large numbers of chemicals
that currently lack adequate
toxicological evaluation.
DATES: The agreement became effective
June 4, 2010.
FOR FURTHER INFORMATION CONTACT:
David Jacobson-Kram, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 22, rm. 6488,
Food and Drug Administration, Silver
Spring, MD 20993, 301–796–0175,
david.jacobsonkram@fda.hhs.gov.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: July 14, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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]]>Agencies
[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42104-42105]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17670]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable materials, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel Systems Biology, HIV/AIDS, and Substance Abuse (R01).
Date: July 27, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
[[Page 42105]]
Place: Sofitel Washington DC Lafayette Square, 806 15th Street,
NW., Washington, DC 20005.
Contact Person: Eliane Lazar-Wesley, PhD, Health Scientist
Administrator, Office of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Boulevard,
Bethesda, MD 20892-8401, 301-451-4530, elazarwe@nida.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel 2010 NIDA Translational Avant-Garde Award Interviews
(DP1).
Date: July 27, 2010.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Westin Grand, 2350 M Street, NW., Washington, DC 20037.
Contact Person: Scott Chen, PhD, Scientific Review Officer,
Office of Extramural Affairs, National Institute on Drug Abuse,
National Institutes of Health, DHHS, 6101 Executive Boulevard, Room
220, MSC 8401, Bethesda, MD 20892, 301-443-9511,
chensc@mail.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: July 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-17670 Filed 7-19-10; 8:45 am]
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