Submission for OMB Review; 30-Day Comment Request: Customer and Other Partners Satisfaction Surveys, 3833-3834 [2014-01343]
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: May 14, 2010.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
GADAVIST (NDA 201–277) was
initially submitted on May 14, 2010.
3. The date the application was
approved: March 14, 2011. FDA has
verified the applicant’s claim that NDA
201–277 was approved on March 14,
2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,470 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by March 24,
2014. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by July 22, 2014. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, you must submit two copies of
the written petition. A petition
submitted electronically must be
submitted to https://
www.regulations.gov, Docket No. FDA
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01307 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Customer and
Other Partners Satisfaction Surveys
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health Clinical Center (CC)
has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 6, 2013, pp.
66750–66751, and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health Clinical Center (CC),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact Dr. David K. Henderson, Deputy
Director for Clinical Care, National
SUMMARY:
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3833
Institutes of Health Clinical Center,
Building 10, Room 6–1480, 10 Center
Drive, Bethesda, Maryland 20892, or
call non-toll free: 301–496–3515, or
email your request or comments,
including your address to: < dkh@
nih.gov >. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Title: Generic
Clearance for Surveys of Customers and
Other Partners, 0925–0458, Expiration
Date 12/31/2013, Type of Submission:
REINSTATEMENT WITHOUT
CHANGE, National Institutes of Health
Clinical Center (CC), National Institutes
of Health (NIH).
Need and Use of Information
Collection: The information collected in
these surveys will be used by Clinical
Center personnel: (1) To evaluate the
perceptions of various Clinical Center
customers and other partners of Clinical
Center services; (2) to assist with the
design of modifications of these
services, based on customer input; (3) to
develop new services, based on
customer need; (4) to evaluate the
perceptions of various Clinical Center
customers and other partners of
implemented service modifications, and
(5) for hospital accreditation. These
surveys are voluntary and necessary for
the proper performance of Clinical
Center functions and will almost
certainly lead to quality improvement
activities that will enhance and/or
streamline the Clinical Center’s
operations. The major mechanisms by
which the Clinical Center will request
customer input is through surveys and
focus groups. The surveys will be
tailored specifically to each class of
customer and to that class of customer’s
needs. Surveys will either be collected
as written documents, as faxed
documents, mailed electronically or
collected via the web or by telephone
from customers. Information gathered
from these surveys of Clinical Center
customers and other partners will be
presented to, and used directly by,
Clinical Center management to enhance
the services and operations of our
organization.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4,900.
E:\FR\FM\23JAN1.SGM
23JAN1
3834
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
FY 2014
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
FY 2015
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
FY 2016
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
Dated: January 14, 2014.
David K. Henderson,
Deputy Director for Clinical Care, CC,
National Institutes of Health.
FOR FURTHER INFORMATION CONTACT:
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.
[FR Doc. 2014–01343 Filed 1–22–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
Improved Therapeutic Immunotoxins
National Institutes of Health,
HHS.
ACTION:
Notice.
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. 209 and 37 CFR part 404 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.
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
Description of Technology:
Immunotoxins kill cancer cells while
allowing healthy, essential cells to
survive. As a result, patients receiving
immunotoxins are less likely to
experience the deleterious side-effects
associated with non-discriminate
therapies, such as chemotherapy or
radiation therapy. Unfortunately, the
continued administration of
immunotoxins often leads to a reduced
patient response due to the formation of
neutralizing antibodies against
immunogenic epitopes contained within
the toxin. One such toxin is
Pseudomonas exotoxin A (PE). To
improve the therapeutic effectiveness of
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
PE-based immunotoxins through
multiple rounds of drug administration,
NIH inventors previously reduced the
immunogenicity of PE through the
removal of B-cell and T-cell epitopes by
mutation or deletion. Although this
resulted in immunotoxins with
improved therapeutic activity, the
modifications to reduce
immunogenicity decreased the activity
of PE. Through further specific
modification, the inventors have now
created a PE that has reduced
immunogenicity with limited loss of
activity. The resulting PE-based
immunotoxins have increased resistance
to the formation of neutralizing
antibodies, while retaining greater
activity, and are expected to have
improved therapeutic efficacy.
Potential Commercial Applications:
• Essential payload component of
immunotoxins
• Treatment of any disease associated
with increased or preferential
expression of a specific cell surface
receptor
• Specific diseases include
hematological cancers, lung cancer,
ovarian cancer, breast cancer, and head
and neck cancers
Competitive Advantages:
E:\FR\FM\23JAN1.SGM
23JAN1
Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3833-3834]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01343]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: Customer and
Other Partners Satisfaction Surveys
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health Clinical
Center (CC) has submitted to the Office of Management and Budget (OMB)
a request for review and approval of the information collection listed
below. This proposed information collection was previously published in
the Federal Register on November 6, 2013, pp. 66750-66751, and allowed
60-days for public comment. No public comments were received. The
purpose of this notice is to allow an additional 30 days for public
comment. The National Institutes of Health Clinical Center (CC),
National Institutes of Health, may not conduct or sponsor, and the
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, or request more information on the
proposed project, contact Dr. David K. Henderson, Deputy Director for
Clinical Care, National Institutes of Health Clinical Center, Building
10, Room 6-1480, 10 Center Drive, Bethesda, Maryland 20892, or call
non-toll free: 301-496-3515, or email your request or comments,
including your address to: < dkh@nih.gov >. Formal requests for
additional plans and instruments must be requested in writing.
Proposed Collection: Title: Generic Clearance for Surveys of
Customers and Other Partners, 0925-0458, Expiration Date 12/31/2013,
Type of Submission: REINSTATEMENT WITHOUT CHANGE, National Institutes
of Health Clinical Center (CC), National Institutes of Health (NIH).
Need and Use of Information Collection: The information collected
in these surveys will be used by Clinical Center personnel: (1) To
evaluate the perceptions of various Clinical Center customers and other
partners of Clinical Center services; (2) to assist with the design of
modifications of these services, based on customer input; (3) to
develop new services, based on customer need; (4) to evaluate the
perceptions of various Clinical Center customers and other partners of
implemented service modifications, and (5) for hospital accreditation.
These surveys are voluntary and necessary for the proper performance of
Clinical Center functions and will almost certainly lead to quality
improvement activities that will enhance and/or streamline the Clinical
Center's operations. The major mechanisms by which the Clinical Center
will request customer input is through surveys and focus groups. The
surveys will be tailored specifically to each class of customer and to
that class of customer's needs. Surveys will either be collected as
written documents, as faxed documents, mailed electronically or
collected via the web or by telephone from customers. Information
gathered from these surveys of Clinical Center customers and other
partners will be presented to, and used directly by, Clinical Center
management to enhance the services and operations of our organization.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 4,900.
[[Page 3834]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) hour burden
----------------------------------------------------------------------------------------------------------------
FY 2014
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients........................ 5000 1 30/60 2500
Family Members of Patients...................... 2000 1 30/60 1000
Visitors to the Clinical Center................. 500 1 10/60 84
NIH Intramural Collaborators.................... 2000 1 10/60 334
Vendors and Collaborating Commercial Enterprises 500 1 20/60 167
Professionals and Organizations Referring 2000 1 20/60 667
Patients.......................................
Regulators...................................... 30 1 20/60 10
Volunteers...................................... 275 1 30/60 138
----------------------------------------------------------------------------------------------------------------
FY 2015
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients........................ 5000 1 30/60 2500
Family Members of Patients...................... 2000 1 30/60 1000
Visitors to the Clinical Center................. 500 1 10/60 84
NIH Intramural Collaborators.................... 2000 1 10/60 334
Vendors and Collaborating Commercial Enterprises 500 1 20/60 167
Professionals and Organizations Referring 2000 1 20/60 667
Patients.......................................
Regulators...................................... 30 1 20/60 10
Volunteers...................................... 275 1 30/60 138
----------------------------------------------------------------------------------------------------------------
FY 2016
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients........................ 5000 1 30/60 2500
Family Members of Patients...................... 2000 1 30/60 1000
Visitors to the Clinical Center................. 500 1 10/60 84
NIH Intramural Collaborators.................... 2000 1 10/60 334
Vendors and Collaborating Commercial Enterprises 500 1 20/60 167
Professionals and Organizations Referring 2000 1 20/60 667
Patients.......................................
Regulators...................................... 30 1 20/60 10
Volunteers...................................... 275 1 30/60 138
----------------------------------------------------------------------------------------------------------------
Dated: January 14, 2014.
David K. Henderson,
Deputy Director for Clinical Care, CC, National Institutes of Health.
[FR Doc. 2014-01343 Filed 1-22-14; 8:45 am]
BILLING CODE 4140-01-P