Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications, 54393-54394 [05-18223]
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Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
54393
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
860.123
1There
6
1
Hours per
Response
6
Total Hours
500
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on current trends and actual
reclassification petitions received, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff that are familiar with
the requirements for submission of a
reclassification petition, have consulted
and advised manufacturers on these
requirements, and have reviewed the
documentation submitted.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18221 Filed 9–13–05; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
Food and Drug Administration
[Docket No. 2004D–0251]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Requests for Inspection by an
Accredited Person Under the
Inspection by Accredited Persons
Program
AGENCY:
Food and Drug Administration,
HHS.
Notice.
16:17 Sep 13, 2005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0186]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Enforcement
Notifications
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Requests for Inspection by an
Accredited Person Under the Inspection
by Accredited Persons Program’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
VerDate Aug<18>2005
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 7, 2005 (70 FR
33179), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0569. The
approval expires on August 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18222 Filed 9–13–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Total Annual
Responses
Jkt 205001
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 14,
2005.
PO 00000
Frm 00044
Fmt 4703
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OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
State Enforcement Notifications—21
CFR 100.2(d) (OMB Control Number
0910–0275)—Extension
Section 310(b) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 337(b)) authorizes States to
enforce certain sections of the act in
their own names, but provides that
States must notify FDA before doing so.
Section 100.2(d) (21 CFR 100.2(d)) sets
forth the information that a State must
provide to FDA in a letter of notification
when it intends to take enforcement
action under the act against a particular
food located in the State. The
information required under § 100.2(d)
will enable FDA to identify the food
against which the State intends to take
action and advise the State whether
Federal action has been taken against it.
With certain narrow exceptions, Federal
enforcement action precludes State
action under the act.
In the Federal Register of June 20,
2005 (70 FR 35446), FDA published a
60-day notice requesting public
comment on the information collection
provisions. FDA received no comments.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\14SEN1.SGM
14SEN1
54394
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
100.2(d)
1 There
Annual
Frequency per
Response
1
Total Annual
Responses
1
1
Hours per
Response
Total Hours
10
10
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.2(d) is
insignificant because enforcement
notifications are seldom used by States.
During the last 3 years, FDA has not
received any enforcement notifications.
Since the enactment of section 403A(b)
of the act (21 U.S.C. 343–1(b)) as part of
the Nutrition Labeling and Education
Act of 1990, FDA has received only a
few enforcement notifications. Although
FDA believes that the burden will be
insignificant, it believes these
information collection provisions
should be extended to provide for the
potential future need of a State
government to submit enforcement
notifications informing FDA when it
intends to take enforcement action
under the act against a particular food
located in the State.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18223 Filed 9–13–05; 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, DHHS.
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/
VerDate Aug<18>2005
16:17 Sep 13, 2005
Jkt 205001
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Soluble Fragments of the IGF1R
Ectodomain
Dimiter S. Dimitrov et al. (NCI)
HHS Reference No. E–144–2005/0—
Research Tool
Licensing Contact: Michelle A. Booden;
301/451–7337;
boodenm@mail.nih.gov.
The type 1 insulin-like growth factor
(IGF) receptor (IGF1R) is over-expressed
by many tumors and mediates
proliferation, motility, and protection
from apoptosis. Agents that inhibit
IGF1R expression or function can
potentially block tumor growth and
metastasis.
The present invention relates to the
identification of soluble fragments of the
IGF1R ectodomain, where these
fragments bind IGF-I, IGF-II, or the
various other ligands of IFG1R. The
identified fragment may be useful for
identifying agents that block IGF1R and
may act as a strong dominant negative
inhibitor of tumor growth by blocking
the IGF1R pathway. The invention also
encompasses other IGF1R fragments or
derivatives of the original fragments,
methods of identifying IGF1R fragments
or other similar fragments in the IGF1R
ectodomain, methods of using said
fragments to block binding of ligands,
and methods of producing antibodies
against the IGF1R fragments.
The technology is available for
licensing under a biological material
license. In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Polymer-Linked Pseudomonas Exotoxin
Immunotoxin
Ira Pastan (NCI) et al.
U.S. Provisional Application No. 60/
636,007 filed 12 Dec 2004 (HHS
Reference No. E–121–2005/0-US–01)
Licensing Contact: Jesse Kindra; 301/
435–5559; kindraj@mail.nih.gov.
Molecules based on monoclonal
antibodies hold the promise of highly
selective therapeutics. However, their
efficacy can be limited by poor tissue
PO 00000
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Fmt 4703
Sfmt 4703
penetration, rapid renal clearance and
an immune response to the antibody.
The present technology provides an
immunotoxin that is modified to
overcome such limitations.
The technology relates to polymerconjugated immunotoxins targeted to
the mesothelin tumor cell antigen.
These polymer-immunotoxin conjugates
possess an enhanced therapeutic index
and may provide improved methods of
treating tumors and cancers expressing
the mesothelin antigen.
Tumor Suppressor Gene Caliban
Mark A. Mortin et al. (NICHD)
U.S. Provisional Application filed 06
Jun 2005 (DHHS Reference No. E–
118–2005/0-US–01)
Licensing Contact: Jesse S. Kindra; 301/
435–5559; kindraj@mail.nih.gov.
This invention relates to the
identification of a tumor suppressor
gene named Caliban from Drosophila
melanogaster. The inventors have
demonstrated that Caliban is very
similar to the corresponding human
gene and they have shown that the
human gene is inactive in human lung
cancer cells but active in normal lung
cells. For the first time, it has been
shown that when full length Caliban is
expressed in human lung cancer cells
they lose many of their tumorigenic
properties. Hence, using gene therapy to
replace the inactive gene with full
length Caliban may treat cancer. Details
of this were published in Bi et al.,
‘‘Drosophila caliban, a nuclear export
mediator, can function as a tumor
suppressor in human lung cancer cells,’’
Oncogene advance online publication,
August 15, 2005; doi:10.1038/
sj.onc.1208962.
This invention also provides a
biomarker assay that can be used to
determine if the fly or human tumor
suppressor Caliban gene product is
functioning in cells. This assay uses a
peptide from the fly gene Prospero,
named HDA, which when fused to a
reporter such as green fluorescent
protein, is exported from the nucleus
when Caliban is working.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Notices]
[Pages 54393-54394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18223]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0186]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Enforcement
Notifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
14, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
State Enforcement Notifications--21 CFR 100.2(d) (OMB Control Number
0910-0275)--Extension
Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections
of the act in their own names, but provides that States must notify FDA
before doing so. Section 100.2(d) (21 CFR 100.2(d)) sets forth the
information that a State must provide to FDA in a letter of
notification when it intends to take enforcement action under the act
against a particular food located in the State. The information
required under Sec. 100.2(d) will enable FDA to identify the food
against which the State intends to take action and advise the State
whether Federal action has been taken against it. With certain narrow
exceptions, Federal enforcement action precludes State action under the
act.
In the Federal Register of June 20, 2005 (70 FR 35446), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received no comments.
FDA estimates the burden of this collection of information as
follows:
[[Page 54394]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
100.2(d) 1 1 1 10 10
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The reporting burden for Sec. 100.2(d) is insignificant because
enforcement notifications are seldom used by States. During the last 3
years, FDA has not received any enforcement notifications. Since the
enactment of section 403A(b) of the act (21 U.S.C. 343-1(b)) as part of
the Nutrition Labeling and Education Act of 1990, FDA has received only
a few enforcement notifications. Although FDA believes that the burden
will be insignificant, it believes these information collection
provisions should be extended to provide for the potential future need
of a State government to submit enforcement notifications informing FDA
when it intends to take enforcement action under the act against a
particular food located in the State.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18223 Filed 9-13-05; 8:45 am]
BILLING CODE 4160-01-S
