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have been made to the guidance. The
guidance announced in this notice
finalizes the draft guidance dated
October 2005.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
§ 601.12(d) and (f)(2) have been
approved under OMB control number
0910–0338.
III. Comments
Interested persons may, at any time,
submit written or electronic comments
to the Division of Dockets Management
(see ADDRESSES) regarding this
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either http://
www.fda.gov/cber/guidelines.htm or
http://www.fda.gov/ohrms/dockets/
default.htm.
Dated: August 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–13233 Filed 8–11–06; 8:45 am]

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection: Comment
Request; National Institute of Diabetes
and Digestive and Kidney Diseases
Information Clearinghouses Customer
Satisfaction Survey
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 to
provide opportunity for public comment
on proposed data collection projects, the
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
the National Institutes of Health (NIH),
is giving public notice that the agency
proposes to request reinstatement of an
information collection activity for
which approval has expired.
Proposed Collection: Title: NIDDK
Information Clearinghouses Customer
Satisfaction Survey. Type of Information
Requested: Reinstatement, with change,
of a previously approved collection for
which approval has expired. The OMB
control number 0925–0480 expired on
July 31, 2003. Need and Use of
Information Collection: NIDDK is
conducting a survey to access the
efficiency and effectiveness of services
provided by NIDDK’s three
clearinghouses: the National Diabetes
Information Clearinghouse (NDIC); the
National Digestive Diseases Information
Clearinghouse (NDDIC); and the
National Kidney and Urologic Diseases
Information Clearinghouse (NKUDRIC).
The survey responds to Executive Order
12821, ‘‘Setting Customer Service
Standards,’’ which requires agencies
and departments to identify and survey
their ‘‘customers to determine the kind
and quality of service they want and
their level of satisfaction with existing
services.’’ Frequency of Response: On
occasion. Affected Public: Individuals or
households; business and for profit
organizations; not-for-profit agencies,
Type of Respondents: Physicians,
healthcare professionals, patients,
family and friends of patients.
The annual reporting burden is as
follows: estimated number of
respondents: 5,112; estimated number of
responses per respondent: 1; estimated
average burden hours per response:
0.025; and estimated total annual
burden hours requested: 128. The
annualized costs to respondents are
estimated at $6,400. There are no capital
costs to report. There are no operating
or maintenance costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited

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on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’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 the
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection reports and
instrument, contact Kathy Kranzfelder,
Project Officer, NIDDK Information
Clearinghouses, NIH, Building 31, Room
9A06, MSC2560, Behtesda, MD 20892.
You may also submit comment and data
by electronic mail (e-mail) at
[email protected].
Dated: July 11, 2006.
Barbara Merchant,
NIDDK Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 06–6878 Filed 8–11–06; 8:45am]
BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Pre-Testing of NCI
Communication Messages
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Pretesting
of NCI Communication Messages. Type
of Information Collection Request:
EXTENSION (OMB# 0925–0046, expires
10/31/06). Need and Use of Information
Collection: In order to carry out NCI’s
legislative mandate to educate and
disseminate information about cancer
prevention, detection, diagnosis, and
treatment to a wide variety of audiences

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Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
and organizations (e.g. cancer patients,
their families, the general public, health
providers, the media, voluntary groups,
scientific and medical organizations), it
is beneficial for NCI to pretest their
communications strategies, concepts,
and messages while they are under
development. The primary purpose of
this pretesting, or formative evaluation,
is to ensure that the messages,
communication materials, and
information services created by NCI
have the greatest capacity of being
received, understood, and accepted by
their target audiences. By utilizing
appropriate qualitative and quantitative

methodologies, NCI is able to (1)
understand characteristics of the
intended target audience—their
attitudes, beliefs, and behaviors—and
use this information in the development
of effective communication tools and
strategies; (2) produce or refine
messages that have the greatest potential
to influence target audience attitudes
and behavior in a positive manner; and
(3) expend limited program resource
dollars wisely and effectively.
Frequency of Response: On occasion.
Affected Public: Individuals or
households; Businesses or other for
profit; Not-for-profit institutions;

Federal Government; State, Local, or
Tribal Government. Type of
Respondents: Adult cancer patients;
members of the public; health care
professionals; organizational
representatives. The annual reporting
burden is as follows: Estimated Number
of Respondents: 13,780; Estimated
Number of Responses per Respondent:
1; Average Burden Hours Per Response:
.1458; and Estimated Total Annual
Burden Hours Requested: 2,010. The
annualized cost to respondents is
estimated at: $34,155. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.

ESTIMATE HOURS OF BURDEN
No. of respondents

Type of respondents

Average time
per response

Annual hour
burden

Adults 18+ ........................................................................................................

13,780

1

.1458

2009.12

Total ..........................................................................................................

13,780

........................

........................

2009.12

Request For Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Nina Goodman,
Senior Analyst, Operations Research
Office, OESI, NCI, NIH, 6116 Executive
Blvd., Suite 400, Rockville, MD 20892,
call non-toll-free number 301–435–7789
or e-mail your request, including your
address to: [email protected].
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.

FOR FURTHER INFORMATION CONTACT:

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Dated: August 2, 2006.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E6–13190 Filed 8–11–06; 8:45 am]
BILLING CODE 4101–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.

AGENCY:
ACTION:

Notice.

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

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be required to receive copies of the
patent applications.
Real-Time Correction of Magnetic Field
Fluctuations in MIR
Description of Technology: Available
for licensing is a new MRI technique
that will markedly improve the
diagnostic potential of the rendered
images. This is a method for applying
real-time corrections to prevent image
distortions caused by field variations
that are due to the patient’s respiratory
cycle or instrument instability. These
field variations reduce the B0
homogeneity in a non-uniform and
spatially-dependent manner. They may
lead to a variety of image artifacts such
as ghosting and blurring. This method
provides a way of calculating the correct
electrical currents that must be applied
to a set of gradients and shims, smaller
magnets that are used to make fine-tune
adjustments to the magnetic field in a
spatially-dependent manner. As the MRI
subject breathes, changes in the B0 field
occur. During a brief training session,
the amplitude of these changes as a
function of chest motion is recorded in
a phase map. Similarly, changes in B0 as
a function of chest motion is recorded
in a phase map. Similarly, changes in B0
as a function of current intensity is
available from calibration data
containing B0 as a function of coil
current. As the subject undergoes a
scan, compensatory currents are applied
to the x, y, or z axis of the gradients and
the shims coils in order to correct for
the effect of respiration on the B0
homogeneity. The shim values can be
updated every 10 to 80 milliseconds

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