Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance For Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation, 65535-65536 [E6-18911]
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Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Notices
The number of respondents in Table
1 of this document is the number of
sponsors registered to make electronic
submissions (25). The number of total
annual responses is based on a review
of the actual number of such
submissions made between July 1, 2005,
and June 30, 2006. 103 x hours per
response (.20) = 20.6 total hours.
with animal drug sponsors studies to be
conducted and how to meet the
statutory requirements for drug approval
under the Federal Food, Drug, and
Cosmetic Act. Requests for meetings
about new animal drug submissions
were previously submitted on paper
copy to the Center for Veterinary
Medicine (CVM).
Dated: November 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18908 Filed 11–7–06; 8:45 am]
DATES:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0434]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance For
Industry on How to Use E-Mail to
Submit a Request for a Meeting or
Teleconference to the Office Of New
Animal Drug Evaluation
AGENCY:
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
ACTION:
Submit written or electronic
comments on the collection of
information by January 8, 2007.
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from
OMB for each collection of information
they conduct or sponsor. ‘‘Collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
SUPPLEMENTARY INFORMATION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
extending Office of Management and
Budget (OMB) approval of existing
reporting requirements on electronic
submission of requests for meetings, in
person or via teleconference, to discuss
65535
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
How to Use E-Mail to Submit a Request
for a Meeting or Teleconference to the
Office Of New Animal Drug
Evaluation—21 CFR 10.65 (OMB
Control Number—(0910–0452)—
Extension
CVM holds meetings and/or
teleconferences when a sponsor requests
a presubmission conference under 21
CFR 514.5, or requests a meeting to
discuss general questions. Generally,
meeting requests are submitted to CVM
on paper. However, CVM now allows
registered sponsors to submit
information electronically, and to
request meetings electronically, if they
determine this is more efficient and
time saving for them. CVM’s guidance
entitled ‘‘How to Use E-Mail to Submit
a Request for a Meeting or
Teleconference to the Office of New
Animal Drug Evaluation’’ provides
sponsors with the option to submit a
request for a meeting or teleconference
as an e-mail attachment by the Internet.
The likely respondents are sponsors
for new animal drug applications.
CVM estimates the burden for this
information collection activity as
follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section/FDA
Form #
No. of
Respondents
cprice-sewell on PRODPC62 with NOTICES
10.65/FDA
Form 3489
1 There
Annual Frequency
per Response
25
Total Annual Responses2
6.24
Hours per
Respondent
156
Total Hours
.08
12.5
are no capital costs or operating and maintenance costs associated with this collection of information.
submissions received between July 1, 2005, and June 30, 2006.
2 Electronic
The number of respondents in table 1
of this document is the number of
sponsors registered to make electronic
VerDate Aug<31>2005
15:11 Nov 07, 2006
Jkt 211001
submissions (25). The number of total
annual responses is based on a review
of the actual number of such
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
submissions made between July 1, 2005,
and June 30, 2006. (156 x hours per
response (.08) = 12.5 total hours).
E:\FR\FM\08NON1.SGM
08NON1
65536
Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Notices
Dated: November 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18911 Filed 11–7–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
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.
cprice-sewell on PRODPC62 with NOTICES
Mice Lacking Expression of Chemokine
Receptor CCR9 Generated by Gene
Targeting (CCR9 KO Mice)
Description of Technology:
Chemokines and their receptors are key
regulators of thymocytes migration and
maturation in normal and inflammation
conditions. The chemokine CCL25 is
highly expressed in the thymus and
small intestine. CCR9, the receptor for
CCL25, is expressed on the majority of
thymocytes, indicating that CCR9 and
its ligand may play an important role in
thymocyte development. To investigate
the role of CCR9 during lymphocyte
development, CCR9 knockout mice were
developed. Knockout mice had
increased numbers of peripheral gd-T
cells but reduced numbers of ab-T cells.
In competitive transplantation
experiments bone marrow from CCR9
knockout mice was much less efficient
at repopulating the thymus than control
(wild type) bone marrow. Thus, CCR9
KO mice are a model for studying
VerDate Aug<31>2005
15:11 Nov 07, 2006
Jkt 211001
thymocyte development and trafficking
in the body. Additionally, as the ligand
for CCR9 is highly expressed in the
small intestine, CCR9 potentially plays
a role in the specialization of immune
responses in the gastrointestinal tract.
Applications: (1) Evaluate drugs
aimed at blocking or augmenting
lymphocyte trafficking; (2) A model for
studying T cell development; (3) A
model for studying immunological
based gastrointestinal disorders.
Inventors: Paul E. Love (NICHD),
Joshua M. Farber (NIAID), Shoji Uehara
(NICHD).
Publications:
1. S Uehara et al. A role for CCR9 in
T lymphocyte development and
migration. J Immunol. 2002 Mar
15;168(6):2812–2819.
2. S Uehara et al. Characterization of
CCR9 expression and CCL25/thymusexpressed chemokine responsiveness
during T cell development:
CD3highCD69+ thymocytes and gd TCR+
thymocytes preferentially respond to
CCL25. J Immunol. 2002 Jan
1;168(1):134–142.
Patent Status: HHS Reference No. E–
328–2006/0—Research Tool.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Jennifer Wong;
301/435–4633; wongje@mail.nih.gov.
mFPR2 Transgenic and Knockout
Mouse Models for Alzheimer’s and
Other Inflammatory Diseases
Description of Technology: Human
Formyl Peptide-Like Receptor 1
(hFPLR1) has been implicated in host
defense for disease processes including
Alzheimer’s disease, infection, and
other inflammatory diseases. hFPLR1
and its mouse homologue Formyl
Peptide Receptor 2 (mFPR2) are Gprotein coupled receptors that are
expressed at high levels on phagocytic
leukocytes, mediating leukocyte
chemotaxis and activation in response
to a number of pathogen- and hostderived peptides. Activation of hFPRL1/
mFPR2 by lipoxin A4 may play a role
in preventing and resolving
inflammation. Also, hFPRL1/mFPR2 has
been shown to mediate the chemotactic
activity of amyloid b 1–42, a key
pathogenic peptide in Alzheimer’s
disease.
Available for licensing are mice
expressing the mFPR2 transgene on
either the FVB or C58BL background, as
well as mFPR2 knockout mice on the
C57BL background. These mice are
anticipated to be highly useful in the
study of a wide variety of inflammatory,
infectious, immunologic and
neurodegenerative diseases.
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
Applications: (1) Drug development
model for Alzheimer’s disease and other
inflammatory diseases; (2) Tool to probe
the role of hFPRL1/mFPR2 in host
responses in a variety of disease
processes, including inflammatory,
infectious, immunologic, and
neurodegenerative disease.
Inventors: Ji Ming Wang et al. (NCI).
Related Publications:
1. K Chen, P Iribarren, J Hu, J Chen,
W Gong, EH Cho, S Lockett, NM
Dunlop, and JM Wang. Activation of
Toll-like receptor 2 on microglia
promotes cell uptake of Alzheimer
disease-associated amyloid beta peptide.
J Biol Chem. 2006 Feb 10;281(6):3651–
3659.
2. H Yazawa, ZX Yu, Takeda, Y Le, W
Gong, VJ Ferrans, JJ Oppenheim, CC Li,
and JM Wang. Beta amyloid peptide
(Abeta42) is internalized via the Gprotein-coupled receptor FPRL1 and
forms fibrillar aggregates in
macrophages. FASEB J. 2001
Nov;15(13):2454–2462.
3. YH Cui, Y Le, W Gong, P Proost,
J Van Damme, WJ Murphy, and JM
Wang. Bacterial lipopolysaccharide
selectively up-regulates the function of
the chemotactic peptide receptor formyl
peptide receptor 2 in murine microglial
cells. J Immunol. 2002 Jan 1;168(1):434–
442.
Patent Status: HHS Reference No. E–
303–2006/0—Research Tool.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Tara L. Kirby,
Ph.D.; 301/435–4426;
tarak@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute—
Frederick, Laboratory of Molecular
Immunoregulation, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize mFPR2 Transgenic and
Knockout Mouse Models for
Alzheimer’s and Other Inflammatory
Diseases. Please contact Betty Tong,
Ph.D. at 301–594–4263 or
tongb@mail.nih.gov for more
information.
Vaccine Production Strain for Acellular
Pertussis Vaccine
Description of Technology: Available
for licensing from the NIH is a vaccine
production strain of Bordetella
bronchiseptica that produces Bordetella
pertussis toxin in high yield. The
Bordetella bronchiseptica strain has
been modified to eliminate expression
of filamentous hemagglutinin, which
typically has to be removed in
purification of the toxin, thereby
E:\FR\FM\08NON1.SGM
08NON1
]]>Agencies
[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65535-65536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18911]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0434]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance For Industry on How to Use E-Mail to Submit a
Request for a Meeting or Teleconference to the Office Of New Animal
Drug Evaluation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on extending Office of Management
and Budget (OMB) approval of existing reporting requirements on
electronic submission of requests for meetings, in person or via
teleconference, to discuss with animal drug sponsors studies to be
conducted and how to meet the statutory requirements for drug approval
under the Federal Food, Drug, and Cosmetic Act. Requests for meetings
about new animal drug submissions were previously submitted on paper
copy to the Center for Veterinary Medicine (CVM).
DATES: Submit written or electronic comments on the collection of
information by January 8, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from OMB for each collection of
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
How to Use E-Mail to Submit a Request for a Meeting or Teleconference
to the Office Of New Animal Drug Evaluation--21 CFR 10.65 (OMB Control
Number--(0910-0452)--Extension
CVM holds meetings and/or teleconferences when a sponsor requests a
presubmission conference under 21 CFR 514.5, or requests a meeting to
discuss general questions. Generally, meeting requests are submitted to
CVM on paper. However, CVM now allows registered sponsors to submit
information electronically, and to request meetings electronically, if
they determine this is more efficient and time saving for them. CVM's
guidance entitled ``How to Use E-Mail to Submit a Request for a Meeting
or Teleconference to the Office of New Animal Drug Evaluation''
provides sponsors with the option to submit a request for a meeting or
teleconference as an e-mail attachment by the Internet.
The likely respondents are sponsors for new animal drug
applications.
CVM estimates the burden for this information collection activity
as follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Hours per
21 CFR Section/FDA Form No. of Respondents per Response Total Annual Responses\2\ Respondent Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.65/FDA Form 3489 25 6.24 156 .08 12.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Electronic submissions received between July 1, 2005, and June 30, 2006.
The number of respondents in table 1 of this document is the number
of sponsors registered to make electronic submissions (25). The number
of total annual responses is based on a review of the actual number of
such submissions made between July 1, 2005, and June 30, 2006. (156 x
hours per response (.08) = 12.5 total hours).
[[Page 65536]]
Dated: November 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18911 Filed 11-7-06; 8:45 am]
BILLING CODE 4160-01-S
