Prospective Granting of an Exclusive License, 23819 [2011-10257]
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Federal Register / Vol. 76, No. 82 / Thursday, April 28, 2011 / Notices
Dated: April 21, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–10256 Filed 4–27–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Prospective Granting of an Exclusive
License
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
This is a notice in accordance
with 35 U.S.C. 209(e) and 37 CFR
404.7(a)(1)(i) that the Technology
Transfer Office of the Centers for
Disease Control and Prevention (CDC),
located within the Department of Health
and Human Services (HHS), is
contemplating granting a worldwide
exclusive license to AES Raptor, LLC,
located in North Kansas City, Missouri.
Under this exclusive license, only AES
Raptor, LLC would be permitted to
commercialize the technology described
in the patent applications listed below.
CDC intends to grant rights to
commercialize this invention to no
other licensees. The patent rights in this
invention have been assigned to the
government of the United States of
America. The invention to be licensed
is:
Title: Barricade System and Barricade
Bracket for Use Therein, CDC Ref. #: I–
016–04, a safety rail system that
provides protection to individuals
working on inclined structures. The
system is designed to prevent
individuals from falls to a lower level.
U.S. Patent No.: 7,509,702.
U.S. Application No.: 11/257,472.
Filing date: 10/24/2005.
Canadian Application No.: 2,565,354.
Filing date: October 23, 2006.
The prospective exclusive license will
be royalty-bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7.
ADDRESSES: Requests for a copy of this
patent application, inquiries, comments,
and other materials relating to the
contemplated licenses should be
directed to Andrew Watkins, Director,
Technology Transfer Office, Centers for
Disease Control and Prevention (CDC),
4770 Buford Highway, Mailstop K–79,
Atlanta, GA 30341, telephone: (770)
488–8610; facsimile: (770) 488–8615.
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SUMMARY:
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Jkt 223001
Applications for an exclusive license
filed in response to this notice will be
treated as objections to the grant of the
contemplated exclusive license. Only
written comments and/or applications
for a license which are received by CDC
within thirty days of this notice will be
considered. Comments and objections
submitted in response to this notice will
not be made available for public
inspection, and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–10257 Filed 4–27–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0588]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exceptions or
Alternatives to Labeling Requirements
for Products Held by the Strategic
National Stockpile
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 May 31,
2011.
SUMMARY:
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: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0614. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
23819
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile; Interim
Final Rule—(OMB Control Number
0910–0614)—Extension
Under the Public Health Service Act
(PHS Act), the Department of Health
and Human Services stockpiles medical
products that are essential to the health
security of the nation (see PHS Act,
section 319F–2, 42 U.S.C. 247d–6b).
This collection of medical products for
use during national health emergencies,
known as the Strategic National
Stockpile (SNS), is to ‘‘provide for the
emergency health security of the United
States, including the emergency health
security of children and other
vulnerable populations, in the event of
a bioterrorist attack or other public
health emergency.’’
It may be appropriate for certain
medical products that are or will be
held in the SNS to be labeled in a
manner that would not comply with
certain FDA labeling regulations given
their anticipated circumstances of use in
an emergency. However, noncompliance
with these labeling requirements could
render such products misbranded under
section 502 of the Federal Food, Drug,
and Cosmetic Act (the FD& C Act) (21
U.S.C. 352).
In the Federal Register of December
28, 2007 (72 FR 73589), FDA published
an interim final rule entitled
‘‘Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile.’’ In the
interim final rule, FDA issued
regulations under §§ 201.26, 610.68,
801.128, and 809.11 (21 CFR 201.26,
610.68, 801.128, and 809.11), which
allow the appropriate FDA Center
Director to grant a request for an
exception or alternative to certain
regulatory provisions pertaining to the
labeling of human drugs, biological
products, medical devices, and in vitro
diagnostics that currently are or will be
included in the SNS if certain criteria
are met. The appropriate FDA Center
Director may grant an exception or
alternative to certain FDA labeling
requirements if compliance with these
labeling requirements could adversely
affect the safety, effectiveness, or
availability of products that are or will
be included in the SNS. An exception
or alternative granted under the
E:\FR\FM\28APN1.SGM
28APN1
Agencies
[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Page 23819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10257]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Prospective Granting of an Exclusive License
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is a notice in accordance with 35 U.S.C. 209(e) and 37
CFR 404.7(a)(1)(i) that the Technology Transfer Office of the Centers
for Disease Control and Prevention (CDC), located within the Department
of Health and Human Services (HHS), is contemplating granting a
worldwide exclusive license to AES Raptor, LLC, located in North Kansas
City, Missouri. Under this exclusive license, only AES Raptor, LLC
would be permitted to commercialize the technology described in the
patent applications listed below. CDC intends to grant rights to
commercialize this invention to no other licensees. The patent rights
in this invention have been assigned to the government of the United
States of America. The invention to be licensed is:
Title: Barricade System and Barricade Bracket for Use Therein, CDC
Ref. : I-016-04, a safety rail system that provides protection
to individuals working on inclined structures. The system is designed
to prevent individuals from falls to a lower level.
U.S. Patent No.: 7,509,702.
U.S. Application No.: 11/257,472.
Filing date: 10/24/2005.
Canadian Application No.: 2,565,354.
Filing date: October 23, 2006.
The prospective exclusive license will be royalty-bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
ADDRESSES: Requests for a copy of this patent application, inquiries,
comments, and other materials relating to the contemplated licenses
should be directed to Andrew Watkins, Director, Technology Transfer
Office, Centers for Disease Control and Prevention (CDC), 4770 Buford
Highway, Mailstop K-79, Atlanta, GA 30341, telephone: (770) 488-8610;
facsimile: (770) 488-8615. Applications for an exclusive license filed
in response to this notice will be treated as objections to the grant
of the contemplated exclusive license. Only written comments and/or
applications for a license which are received by CDC within thirty days
of this notice will be considered. Comments and objections submitted in
response to this notice will not be made available for public
inspection, and, to the extent permitted by law, will not be released
under the Freedom of Information Act, 5 U.S.C. 552.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2011-10257 Filed 4-27-11; 8:45 am]
BILLING CODE 4163-18-P