Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop, 51824-51825 [2010-20834]
Download as PDF
<![CDATA[
51824
Federal Register / Vol. 75, No. 162 / Monday, August 23, 2010 / Notices
Licensing Contact: Suryanarayana
Vepa, PhD, J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Environmental
Health Sciences, Laboratory of
Molecular Carcinogenesis, Cell
Adhesion Group, is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact Elizabeth M. Denholm, PhD at
919–541–0981 or
denholme@mail.nih.gov for more
information.
Matrix Metalloproteinase-9 Blade-1
Region Peptides: Use as Cell Migration
Modulators
erowe on DSK5CLS3C1PROD with NOTICES
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Melanocyte Pigmentation or
Proliferation With Neuregulin:
Compositions and Methods to Treat
Skin Disorders, Including Skin Cancer
Description of Invention: Human skin
pigmentation is regulated by complex
and intricate interactions among
melanocytes and keratinocytes in the
epidermis and fibroblasts in the dermis.
A number of factors secreted from
keratinocytes and/or from fibroblasts
have been shown to be involved in
regulating skin pigmentation after UV
exposure. NIH investigators have
previously demonstrated that the less
pigmented and thicker skin on the
palms and soles is regulated by
underlying fibroblasts in those areas,
specifically via a secreted factor (DKK1)
that modulates Wnt signaling. Now,
using microarray analysis to compare
gene expression patterns in 15 different
primary dermal fibroblast populations
derived from the dorsal trunk skin of
three different skin phototypes (I, III and
VI), these investigators have identified a
number of genes that differ dramatically
in expression. One among them,
neuregulin 1 (NRG–1), secreted by
fibroblasts derived from dark skin,
effectively increases the pigmentation of
melanocytes in tissue culture and in an
artificial skin model and regulates their
growth, suggesting it is one of the major
factors determining human skin color.
NRG-l was observed to be highly
expressed by fibroblasts derived from
darker skin. NIH investigators believe
that NRG–1 increases the proliferation
of human melanocytes via the
phosphorylation of Akt. These results
suggest a potential role for NRG–1 in
regulating constitutive human skin color
and perhaps its dysfunction in
pigmentary skin diseases. Based on
these observations, NIH investigators are
currently developing compositions and
methods of modulating pigmentation
and proliferation of a melanocyte to
prevent or treat skin disorders,
including skin cancer.
Applications:
Description of Technology: Matrix
metalloproteinase-9 (MMP–9) is an
enzyme integrally involved in many
normal physiological processes that
require degradation and remodeling of
the extracellular matrix, such as cell
migration and invasion, wound repair,
bone remodeling, angiogenesis, and
embryonic growth. MMP–9 is shown to
be involved in the progression of several
diseases including many cancers,
cardiovascular diseases, CNS diseases,
respiratory diseases, and arthritis. In
cancer, MMP–9 is thought to promote
growth, migration, and spread of cancer
cells by catalyzing the degradation of
extracellular matrix proteins, releasing
bound growth factors, and allowing
cancer cells to escape from the primary
tumor.
NIH Inventors have discovered that
specific polypeptides corresponding to
Blade-1 region of MMP–9 hemopexin
domain can stimulate migration of cells,
specifically the migration of cells
expressing b1 integrin. The present
technology can be used to develop novel
therapeutic candidates for the
prevention and treatment of human
disease conditions mediated by MMP–9
promoted cell migration, e.g., cancer,
inflammation, fibrotic diseases,
cardiovascular diseases, CNS diseases,
respiratory diseases, angiogenesis and
arthritis.
Applications: Development of
therapeutics for treating or preventing
human diseases (cancer) using MMP–9
Blade-1 domain polypeptides or peptide
analogs.
Development Status: Early-stage.
Inventors: SK Akiyama et al. (NIEHS)
Patent Status: U.S. Provisional
Application No. 61/360,328 filed 30 Jun
2010 (HHS Reference No. E–146–2010/
0–US–01)
Licensing Status: Available for
licensing.
VerDate Mar<15>2010
15:31 Aug 20, 2010
Jkt 220001
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
• Therapeutics for skin disorders.
• Therapeutics for skin cancer.
Development Status: Early stage and
studies on reconstructed skin model and
in melanocytes.
Inventors: Vincent J. Hearing and
Wonseon Choi (NCI)
Related Publications:
1. Choi W, Wolber R, Gerwat W,
Mann T, Hearing VJ. Characterization of
the influence of fibroblasts on
melanocyte function and pigmentation.
In: Proc. XXth Intl. Pigment Cell Conf.,
edited by K. Jimbow, Bologna, Italy:
Medimond, 2008, p. 79–82.
2. Choi W, Wolber R, Gerwat W,
Mann T, Batzer J, Smuda C, Liu H,
Kolbe L, Hearing VJ. A novel fibroblastderived melanogenic paracrine factor
neuregulin-1 (NRG–1) that modulates
the constitutive color and melanocyte
function in human skin. J. Cell Sci. in
press, 2010.
Patent Status: U.S. Provisional
Application No. 61/357,846 filed 23 Jun
2010 (HHS Reference No. E–100–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Suryanarayana
Vepa, PhD, J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Laboratory of Cell Biology, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize the use of NRG–1 (or
modifiers of its function) to regulate
skin pigmentation. Please contact John
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: August 17, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–20862 Filed 8–20–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Food and Drug Administration Clinical
Trial Requirements, Regulations,
Compliance, and Good Clinical
Practice; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\23AUN1.SGM
Notice of public workshop.
23AUN1
Federal Register / Vol. 75, No. 162 / Monday, August 23, 2010 / Notices
The Food and Drug
Administration (FDA) New Jersey
District Office, in cosponsorship with
the Society of Clinical Research
Associates (SoCRA) is announcing a
public workshop. The public workshop
on FDA’s clinical trial requirements is
designed to aid the clinical research
professional’s understanding of the
mission, responsibilities, and authority
of FDA and to facilitate interaction with
FDA representatives. The program will
focus on the relationships among FDA
and clinical trial staff, investigators, and
institutional review boards (IRBs).
Individual FDA representatives will
discuss the informed consent process
and informed consent documents;
regulations relating to drugs, devices,
and biologics; as well as inspections of
clinical investigators, IRBs, and research
sponsors.
Date and Time: The public workshop
will be held on November 4 and 5, 2010,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Hyatt Regency Jersey City,
Two Exchange Pl., Jersey City, NJ 07302,
1–800–233–1234. (The hotel is
connected to the PATH Train to New
York City). Attendees are responsible for
their own accommodations. Please
mention SoCRA to receive the hotel
room rate of $169 plus applicable taxes
(available until October 20, 2010, or
until the SoCRA room block is filled).
Contact: Joan Lytle, Food and Drug
Administration, 120 North Central Dr.,
North Brunswick, NJ 08902, 732–940–
8946 ext. 33, FAX: 732–940–8936, or
Society of Clinical Research Associates
(SoCRA), 530 West Butler Ave., suite
109, Chalfont, PA 18914, 800–762–7292,
FAX: 215–822–8633, email:
SoCRAmail@aol.com, Web site: https://
www.SoCRA.org.
Registration: The registration fee
covers the cost of actual expenses,
including refreshments, lunch,
materials, and speaker expenses. Seats
are limited; please submit your
registration as soon as possible.
Workshop space will be filled in order
or receipt of registration. Those
accepted into the workshop will receive
confirmation. The cost of registration is
as follows: SoCRA member ($575.00),
SoCRA nonmember (includes
membership) ($650.00), FDA/Federal
Government member ($450.00), FDA/
Federal Government nonmember
($525.00).
If you need special accommodations
due to a disability, please contact
SoCRA (see Contact) at least 10 days in
advance.
Extended periods of question and
answer and discussion have been
included in the program schedule. This
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:31 Aug 20, 2010
Jkt 220001
program offers 13.3 hours of continuing
medical education (CME) and
continuing nursing education (CNE)
credit. CME for Physicians: SoCRA is
accredited by the Accreditation Council
for Continuing Medical Education to
provide continuing medical education
for physicians. CNE for Nurses: SoCRA
is an approved provider of continuing
nursing education by the Pennsylvania
State Nurses Association (PSNA), an
accredited approver by the American
Nurses Credentialing Center’s
Commission on Accreditation (ANCC).
ANCC/PSNA Provider Reference
Number: 205–3–A–09.
Registration instructions: To register,
please submit a registration form with
your name, affiliation, mailing address,
phone, fax number, and email, along
with a check or money order payable to
‘‘SoCRA’’. Mail to: SoCRA (see Contact
for address). To register via the Internet,
go to https://www.socra.org/html/
FDA_Conference.htm. (FDA has verified
the Web site address, but we are not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register.)
Payment by major credit card is
accepted (Visa/MasterCard/AMEX
only). For more information on the
meeting registration, or for questions on
the workshop, contact SoCRA (see
Contacts).
The
public conference helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, IRB inspections,
electronic record requirements, and
investigator initiated research. Topics
for discussion include the following: (1)
What FDA expects in a pharmaceutical
clinical trial; (2) adverse event
reporting—science, regulation, error,
and safety; (3) Part 11 Compliance—
Electronic signatures; (4) informed
consent regulations; (5) IRB regulations
and FDA inspections; (6) keeping
informed and working together; (7) FDA
conduct of clinical investigator
inspections; (8) meetings with FDA:
why, when, and how; (9) investigator
initiated research; (10) medical device
aspects of clinical research; (11)
working with FDA’s Center for Biologics
Evaluation and Research; (12) the
inspection is over—what happens next?
Possible FDA compliance actions.
FDA has made education of the drug
and device manufacturing community a
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
51825
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393) which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The public workshop also is
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121) as outreach
activities by Government agencies to
small businesses.
Dated: August 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–20834 Filed 8–20–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Quality and Compliance in Merging
and Emerging Cultures; Public
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) is announcing a
public conference entitled ‘‘The New
Paradigm: Quality and Compliance in
Merging and Emerging Cultures.’’ The
conference, cosponsored with the
Parenteral Drug Association (PDA), will
focus on challenges facing the medical
products industry in navigating
regulatory compliance, achieving
worldwide quality improvement, and
enhancing quality system controls in an
environment of merging and emerging
cultures.
Date and Time: The public conference
will be held on Monday, September 13,
2010, from 7 a.m. to 6 p.m.; Tuesday,
September 14, 2010, from 7:30 a.m. to
6:30 p.m.; and Wednesday, September
15, 2010, from 7:30 a.m. to 12:15 p.m.
Location: The public conference will
be held at the Renaissance Hotel, 999
9th St., NW., Washington, DC 20001,
202–898–9000, FAX: 202–289–0947.
Contact: Wanda Neal, Parenteral Drug
Association, PDA Global Headquarters,
Bethesda Towers, 4350 East-West Hwy.,
suite 200, Bethesda, MD 20814, 301–
656–5900, FAX: 301–986–1093, email:
info@pda.org.
Accommodations: Attendees are
responsible for their own
SUMMARY:
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Notices]
[Pages 51824-51825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20834]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance, and Good Clinical Practice; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
[[Page 51825]]
SUMMARY: The Food and Drug Administration (FDA) New Jersey District
Office, in cosponsorship with the Society of Clinical Research
Associates (SoCRA) is announcing a public workshop. The public workshop
on FDA's clinical trial requirements is designed to aid the clinical
research professional's understanding of the mission, responsibilities,
and authority of FDA and to facilitate interaction with FDA
representatives. The program will focus on the relationships among FDA
and clinical trial staff, investigators, and institutional review
boards (IRBs). Individual FDA representatives will discuss the informed
consent process and informed consent documents; regulations relating to
drugs, devices, and biologics; as well as inspections of clinical
investigators, IRBs, and research sponsors.
Date and Time: The public workshop will be held on November 4 and
5, 2010, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Hyatt Regency
Jersey City, Two Exchange Pl., Jersey City, NJ 07302, 1-800-233-1234.
(The hotel is connected to the PATH Train to New York City). Attendees
are responsible for their own accommodations. Please mention SoCRA to
receive the hotel room rate of $169 plus applicable taxes (available
until October 20, 2010, or until the SoCRA room block is filled).
Contact: Joan Lytle, Food and Drug Administration, 120 North
Central Dr., North Brunswick, NJ 08902, 732-940-8946 ext. 33, FAX: 732-
940-8936, or Society of Clinical Research Associates (SoCRA), 530 West
Butler Ave., suite 109, Chalfont, PA 18914, 800-762-7292, FAX: 215-822-
8633, email: SoCRAmail@aol.com, Web site: https://www.SoCRA.org.
Registration: The registration fee covers the cost of actual
expenses, including refreshments, lunch, materials, and speaker
expenses. Seats are limited; please submit your registration as soon as
possible. Workshop space will be filled in order or receipt of
registration. Those accepted into the workshop will receive
confirmation. The cost of registration is as follows: SoCRA member
($575.00), SoCRA nonmember (includes membership) ($650.00), FDA/Federal
Government member ($450.00), FDA/Federal Government nonmember
($525.00).
If you need special accommodations due to a disability, please
contact SoCRA (see Contact) at least 10 days in advance.
Extended periods of question and answer and discussion have been
included in the program schedule. This program offers 13.3 hours of
continuing medical education (CME) and continuing nursing education
(CNE) credit. CME for Physicians: SoCRA is accredited by the
Accreditation Council for Continuing Medical Education to provide
continuing medical education for physicians. CNE for Nurses: SoCRA is
an approved provider of continuing nursing education by the
Pennsylvania State Nurses Association (PSNA), an accredited approver by
the American Nurses Credentialing Center's Commission on Accreditation
(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09.
Registration instructions: To register, please submit a
registration form with your name, affiliation, mailing address, phone,
fax number, and email, along with a check or money order payable to
``SoCRA''. Mail to: SoCRA (see Contact for address). To register via
the Internet, go to https://www.socra.org/html/FDA_Conference.htm. (FDA
has verified the Web site address, but we are not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)
Payment by major credit card is accepted (Visa/MasterCard/AMEX
only). For more information on the meeting registration, or for
questions on the workshop, contact SoCRA (see Contacts).
SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The workshop will provide those engaged in
FDA-regulated (human) clinical trials with information on a number of
topics concerning FDA requirements related to informed consent,
clinical investigation requirements, IRB inspections, electronic record
requirements, and investigator initiated research. Topics for
discussion include the following: (1) What FDA expects in a
pharmaceutical clinical trial; (2) adverse event reporting--science,
regulation, error, and safety; (3) Part 11 Compliance--Electronic
signatures; (4) informed consent regulations; (5) IRB regulations and
FDA inspections; (6) keeping informed and working together; (7) FDA
conduct of clinical investigator inspections; (8) meetings with FDA:
why, when, and how; (9) investigator initiated research; (10) medical
device aspects of clinical research; (11) working with FDA's Center for
Biologics Evaluation and Research; (12) the inspection is over--what
happens next? Possible FDA compliance actions.
FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The public workshop helps to achieve objectives set
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C.
393) which includes working closely with stakeholders and maximizing
the availability and clarity of information to stakeholders and the
public. The public workshop also is consistent with the Small Business
Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) as
outreach activities by Government agencies to small businesses.
Dated: August 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20834 Filed 8-20-10; 8:45 am]
BILLING CODE 4160-01-S
