Statement of Delegation of Authority, 72713 [2011-30411]
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72713
Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Respondents
Activity
Number of
Responses per
Respondent
Total annual
responses
235
1
235
Request for reduction of fees collected under section 743 of the FD&C Act .......................................
1 There
Total hours
2
470
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 510 facilities will
be subject to the reinspection and the
recall fees under section 743 of the
FD&C Act. Of these facilities, we
estimate that 46 percent will be small
businesses with annual gross sales
under $250,000. Therefore, 46 percent
of 510 equals to 235 respondents. Each
respondent will submit 1 request for
reduction of fees. Total annual
responses are 235. The average burden
is 2 hours, giving a total of 470 hours
annual burden.
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30411 Filed 11–23–11; 8:45 am]
BILLING CODE 4165–15–P
Government-Owned Inventions;
Availability for Licensing
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
Health Resources and Services
Administration
Statement of Delegation of Authority
I hereby delegate to the
Administrator, Health Resources and
Services Administration (HRSA), and
the Director, Centers for Disease Control
and Prevention (CDC), with authority to
redelegate, the authority vested in the
Secretary under Title III, Part P, Section
399T (42 U.S.C. 280g–8), titled ‘‘Support
for Patients Receiving a Positive
Diagnosis of Down Syndrome or Other
Prenatally or Postnatally Diagnosed
Conditions,’’ of the Public Health
Service Act, as amended, insofar as such
authority pertains to the functions of
HRSA and CDC, respectively. HRSA and
CDC will coordinate and collaborate
with each other and with the National
Institutes of Health, as appropriate, in
implementing this authority.
This delegation excludes the authority
to issue regulations, to establish
advisory committees and councils, and
appoint their members, and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines.
Jkt 226001
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.
SUMMARY:
Centers for Disease Control and
Prevention
14:31 Nov 23, 2011
Dated: November 14, 2011.
Kathleen Sebelius,
Secretary.
National Institutes of Health
BILLING CODE 4160–01–P
VerDate Mar<15>2010
I hereby affirm and ratify any actions
taken by the Administrator, HRSA, the
Director, CDC, or other HRSA and CDC
officials, which involve the exercise of
these authorities prior to the effective
date of this delegation.
This delegation is effective upon date
of signature.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–30471 Filed 11–22–11; 11:15 am]
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Average
burden per
response
Genetically Engineered Mouse Model
for Use as an Alternative Screening
Method for Evaluating P-glycoprotein
(P-gp) Substrate Toxicity in
Avermectin-sensitive Dogs
Description of Technology: A pitfall to
avermectins is central nervous system
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
(CNS) toxicities in herding dogs. As a
result, all new avermectins must be
tested in a ‘‘Collie Safety Study’’ to
determine the degree of CNS toxicity.
The toxicity is due to a 4 base pair
mutation in the ATP-binding cassette,
sub-family B member 1 (ABCB1) gene.
This gene encodes for the Pglycoprotein (P-gp) that affects
absorption, distribution and elimination
of certain drugs. Researchers at FDA
have developed an alternate animal
model that includes two transgenic
mouse models, one containing the
mutant form of the canine ABCB1 gene
(Yancy 1 line) and the other containing
the canine wild-type gene (Yancy 2
line). The paired mouse system can be
utilized to assess the safety of
avermectins and other canine drugs by
determining the toxicity to canines with
the mutated form of the ABCB1 gene.
Ivermectin, a derivative of the
avermectin family of heartworm drugs
used to treat and control parasitic
infections, was used to verify this
mouse model. This technology will
enhance the population predictions
derived from clinical safety data and
serve to reduce the use of dogs in
avermectin derivative safety studies that
are part of the Investigational New
Animal Drug (INAD) approval process.
Potential Commercial Applications:
Drug screening technology to assess the
toxicity of canine drugs to canines with
the mutated form of the ABCB1 gene.
Competitive Advantages: Use as an
alternative in vivo model to canines for
assessment of drug safety in the
presence of the ABCB1 mutation.
Development Stage: In vivo data
available (animal).
Inventor: Haile F. Yancy (FDA).
Publication: Orzechowski K, et al., in
press Am J Vet Res.
Intellectual Property: HHS Reference
No. E–292–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Jaime Greene; (301)
435–5559; greenejaime@mail.nih.gov.
Collaborative Research Opportunity:
The FDA Center for Veterinary
Medicine is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
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25NON1
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[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Page 72713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30411]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Centers for Disease Control and Prevention
Statement of Delegation of Authority
I hereby delegate to the Administrator, Health Resources and
Services Administration (HRSA), and the Director, Centers for Disease
Control and Prevention (CDC), with authority to redelegate, the
authority vested in the Secretary under Title III, Part P, Section 399T
(42 U.S.C. 280g-8), titled ``Support for Patients Receiving a Positive
Diagnosis of Down Syndrome or Other Prenatally or Postnatally Diagnosed
Conditions,'' of the Public Health Service Act, as amended, insofar as
such authority pertains to the functions of HRSA and CDC, respectively.
HRSA and CDC will coordinate and collaborate with each other and with
the National Institutes of Health, as appropriate, in implementing this
authority.
This delegation excludes the authority to issue regulations, to
establish advisory committees and councils, and appoint their members,
and shall be exercised in accordance with the Department's applicable
policies, procedures, and guidelines.
I hereby affirm and ratify any actions taken by the Administrator,
HRSA, the Director, CDC, or other HRSA and CDC officials, which involve
the exercise of these authorities prior to the effective date of this
delegation.
This delegation is effective upon date of signature.
Dated: November 14, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-30411 Filed 11-23-11; 8:45 am]
BILLING CODE 4165-15-P
