Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 35499 [E7-12501]

Download as PDF 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] BILLING CODE 4160–01–S 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. mstockstill on PROD1PC66 with NOTICES 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 the Federal Register about last minute 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. VerDate Aug<31>2005 18:23 Jun 27, 2007 Jkt 211001 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). PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 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. E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Page 35499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12501]


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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.

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 the Federal Register about last minute 
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.
    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).

    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

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