Proposed Data Collection; Comment Request; National Physician Survey of Practices on Diet, Physical Activity, and Weight Control, 35499-35500 [E7-12535]
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Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices
Drug Evaluation and Research, by the
Commissioner.
Dated: June 11, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–12494 Filed 6–27–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dermatologic and Ophthalmic Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Dermatologic
and Ophthalmic Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on August 1, 2007, from 8 a.m. to
12:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy, Gaithersburg, MD.
Contact Person: Sohail Mosaddegh,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, fax: 301–827–6776, e-mail:
Sohail.Mosaddegh@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), codes
3014512534 or 3014512535. Please call
the Information Line for up-to-date
information on this meeting. A notice in
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modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
agency’s Web site and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
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18:23 Jun 27, 2007
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Agenda: The committees will meet in
joint session to be briefed on iPLEDGE,
the risk management program for
isotretinoin products. Presentations will
provide updates on risk management
activities for isotretinoin since the full
implementation of iPLEDGE on March
1, 2006.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 11, 2007. Oral
presentations from the public will be
scheduled between approximately 10:15
a.m. and 11:15 a.m. Those desiring to
make formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 2, 2007. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 3, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact John
Lauttman, 301-827-7001, at least 7 days
in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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35499
Dated: June 21, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–12501 Filed 6–27–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment
Request; National Physician Survey of
Practices on Diet, Physical Activity,
and Weight Control
SUMMARY: In compliance with the
provisions of Section 3506 (c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comments on
proposed data collection projects, the
National Institutes of Health (NIH),
National Cancer Institute (NCI) 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: Physician
Survey of Practices on Diet, Physical
Activity, and Weight Control. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
This study will obtain current, national
data on primary care physicians’
knowledge, attitudes, and practices
related to diet, physical activity, and
weight control. Obesity, poor diet, and
lack of physical activity are becoming
recognized as major public health
problems in the United States, and have
been linked to increased risk, adverse
prognosis, and poor quality of life for
cancer and many other chronic diseases.
The data collected in this study will
support and further NCI work in
monitoring and evaluating providers’
cancer prevention knowledge, attitudes,
and practices and their impact on
population health, as well as enable
monitoring of progress toward major
cancer control goals. Data from the
survey will be used to profile existing
physician practice, understand barriers
to counseling and referral, and to inform
methods for improving the utilization of
these services for adults and children.
Two questionnaires, one sent to
physicians and one sent to their practice
administrators, will be administered by
mail or telephone to a randomlyselected national sample of 2,000
physicians belonging to primary care
specialties. Study participants will be
2,000 practicing physicians who are
family practitioners, general internists,
pediatricians, and obstetrician/
gynecologists and 2,000 practice
administrators.
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35500
Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices
The annual reporting burden is as
follows: Estimated Number of
Respondents: 4,000; Estimated Number
of Responses per Respondent: 1;
Average Burden Hours Per Response:
.333; and Estimated Total Annual
Burden Hours Requested: 1,332. The
annualized cost to respondents is
estimated at: $65,048. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Estimated number
of respondents
Estimated number
of responses per
respondent
Physician ..................................................................................
Medical Practice Administrator ................................................
2000
2000
1
1
0.333
0.333
666
666
Total ..................................................................................
4000
1
..............................
1,332
Type of respondent
Average burden
hours per
response
Estimated total
annual burden
hours
*Hourly earnings data are taken from the National Compensation Survey: Occupational Wages in the United States, June 2005, U.S. Department of Labor, U.S. Bureau of Labor Statistics.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(a) Whether the proposed collection of
information is necessary for the
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT:
Send comments to Ashley Wilder
Smith, PhD, M.P.H., Health Sciences
Specialist, National Cancer Institute,
6130 Executive Blvd., MSC 7344,
Executive Plaza North, Room 4090,
Bethesda, MD 20892–7344. Telephone:
301–451–1843; E-mail:
smithas@mail.nih.gov.
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 should be received by
August 27, 2007.
Dated: June 20, 2007.
Ashley Wilder Smith,
National Cancer Institute Task Order Monitor,
National Institutes of Health.
[FR Doc. E7–12535 Filed 6–27–07; 8:45 am]
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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:
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18:23 Jun 27, 2007
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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
be required to receive copies of the
patent applications.
Orally Active Derivatives of 1,3,5(10)estratriene
Description of Technology: The utility
of estrogenic substances in the practice
of medicine is well documented.
Estrogens may be used for the
replacement of the natural hormone
estradiol in hypogonadism, and
following the removal of the ovaries or
cessation of ovarian activity during
menopause. They are also widely
employed as a component of oral
contraceptives. However, orally-active
synthetic estrogens are associated with
a number of side effects, such as:
Enhanced risk of endometrial
carcinoma; induction of malignant
carcinoma, especially in the cervix,
breast, vagina and liver; promotion of
gallbladder disease, thromboembolic
and thrombotic diseases, myocardial
infarction, hepatic adenoma, elevated
blood pressure, and hypercalcemia; and
reduced glucose tolerance.
The NIH announces a new family of
novel, active estrogens that are nitrate
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esters of estradiol. These nitrate esters
possess enhanced estrogenic activity
following oral administration and lack a
17-ethynyl alcohol, which has been
implicated in many side effects
attributed to other synthetic estrogens. It
is anticipated that these esters could be
used in all instances where estrogen is
prescribed as a treatment.
Applications: Hormone replacement
therapies; Oral contraceptives.
Market: The hormone replacement
market exceeds one billion dollars per
year, and the oral contraceptive market
is more than three billion dollars per
year.
Development Status: Early stage.
Inventors: Hyun K. Kim et al.
(NICHD).
Patent Status: U.S. Patent 5,554,603
issued 10 Sep 1996 (HHS Reference No.
E–137–1993/0–US–01); Foreign
counterparts in Australia, Canada,
Japan, and Europe.
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Tara L. Kirby, PhD;
301/435–4426; tarak@mail.nih.gov.
Methods of Inducing Immune
Tolerance Using Immunotoxins
Description of Invention: The
invention concerns immunotoxins and
methods of using the immunotoxins for
the treatment of rejection response in a
patient, including graft-versus-host
disease and transplantation of organs,
tissues and cells into a host. In a
specific embodiment of the invention,
the transplant involves pancreatic islet
cells. The immunotoxins are targeted
via an antibody that is specific to T
cells. This allows the specific ablation
of resting T cells, resulting in an
accentuation of immune tolerizing
responses and an increased tolerance to
transplants and grafts. The toxin portion
of the immunotoxin is genetically
engineered to maintain bioactivity when
recombinantly produced in Pichia
pastoris. Data are available in transgenic
animals expressing human CD3e which
E:\FR\FM\28JNN1.SGM
28JNN1
Agencies
[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35499-35500]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12535]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment Request; National Physician
Survey of Practices on Diet, Physical Activity, and Weight Control
SUMMARY: In compliance with the provisions of Section 3506 (c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public
comments on proposed data collection projects, the National Institutes
of Health (NIH), National Cancer Institute (NCI) 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: Physician Survey of Practices on Diet,
Physical Activity, and Weight Control. Type of Information Collection
Request: NEW. Need and Use of Information Collection: This study will
obtain current, national data on primary care physicians' knowledge,
attitudes, and practices related to diet, physical activity, and weight
control. Obesity, poor diet, and lack of physical activity are becoming
recognized as major public health problems in the United States, and
have been linked to increased risk, adverse prognosis, and poor quality
of life for cancer and many other chronic diseases. The data collected
in this study will support and further NCI work in monitoring and
evaluating providers' cancer prevention knowledge, attitudes, and
practices and their impact on population health, as well as enable
monitoring of progress toward major cancer control goals. Data from the
survey will be used to profile existing physician practice, understand
barriers to counseling and referral, and to inform methods for
improving the utilization of these services for adults and children.
Two questionnaires, one sent to physicians and one sent to their
practice administrators, will be administered by mail or telephone to a
randomly-selected national sample of 2,000 physicians belonging to
primary care specialties. Study participants will be 2,000 practicing
physicians who are family practitioners, general internists,
pediatricians, and obstetrician/gynecologists and 2,000 practice
administrators.
[[Page 35500]]
The annual reporting burden is as follows: Estimated Number of
Respondents: 4,000; Estimated Number of Responses per Respondent: 1;
Average Burden Hours Per Response: .333; and Estimated Total Annual
Burden Hours Requested: 1,332. The annualized cost to respondents is
estimated at: $65,048. There are no Capital Costs to report. There are
no Operating or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated number Average burden Estimated total
Type of respondent Estimated number of responses per hours per annual burden
of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Physician........................... 2000 1 0.333 666
Medical Practice Administrator...... 2000 1 0.333 666
---------------------------------------------------------------------------
Total........................... 4000 1 ................. 1,332
----------------------------------------------------------------------------------------------------------------
*Hourly earnings data are taken from the National Compensation Survey: Occupational Wages in the United States,
June 2005, U.S. Department of Labor, U.S. Bureau of Labor Statistics.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (a) Whether the proposed collection of information is
necessary for the performance of the functions of the agency, including
whether the information shall have practical utility; (b) the accuracy
of the agency's estimate of the burden of the proposed collection of
information; (c) ways to enhance the quality, utility, and clarity of
the information to be collected; and (d) ways to minimize the burden of
the collection of information on respondents, including through the use
of automated collection techniques or other forms of information
technology.
FOR FURTHER INFORMATION CONTACT: Send comments to Ashley Wilder Smith,
PhD, M.P.H., Health Sciences Specialist, National Cancer Institute,
6130 Executive Blvd., MSC 7344, Executive Plaza North, Room 4090,
Bethesda, MD 20892-7344. Telephone: 301-451-1843; E-mail:
smithas@mail.nih.gov.
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 should be received by August 27, 2007.
Dated: June 20, 2007.
Ashley Wilder Smith,
National Cancer Institute Task Order Monitor, National Institutes of
Health.
[FR Doc. E7-12535 Filed 6-27-07; 8:45 am]
BILLING CODE 4140-01-P