Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 13559-13560 [2010-6169]

Download as PDF Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Cancellation of Meeting Notice is hereby given of the cancellation of the National Cancer Institute Special Emphasis Panel, April 8, 2010, 8 a.m. to April 9, 2010, 5 p.m., Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Maryland, Rockville, MD 20852 which was published in the Federal Register on March 5, 2010, 75FR10295. This FRN is cancelling the meeting notification due to an administrative adjustment. A new FRN will be published to provide notification of this meeting. Dated: March 12, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Long Term Outcomes of Infants Identified With Congenital Cytomegalovirus (CMV) Infection, Funding Opportunity Announcement (FOA) IP10–006, Initial Review In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: pwalker on DSK8KYBLC1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Time and Date: 12 p.m.–2 p.m., June 8, 2010 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Long Term Outcomes of Infants Identified with Congenital CMV Infection, FOA IP10–006.’’ For More Information Contact: Gregory Anderson, M.S., M.P.H., Scientific Review Officer, CDC, 1600 Clifton Road, NE., Mailstop E60, Atlanta, GA 30333, Telephone: (404) 498–2293. The Director, Management Analysis and Services Office, has been delegated the Jkt 220001 BILLING CODE 4163–18–P AGENCY: BILLING CODE 4140–01–P 16:41 Mar 19, 2010 [FR Doc. 2010–6217 Filed 3–19–10; 8:45 am] Food and Drug Administration, HHS. [FR Doc. 2010–6128 Filed 3–19–10; 8:45 am] VerDate Nov<24>2008 Dated: March 15, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. 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 Committee: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 27, 2010, from 8 a.m. to 5 p.m. Location: The Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd. East, Adelphi, MD. The hotel telephone number is 301–985– 7300. Contact Person: Paul Tran, 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: paul.tran@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512536. 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 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 13559 committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On May 27, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22–505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease). 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/ AdvisoryCommittees/Calendar/ default.htm. 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 May 13, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.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 May 5, 2010. 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 May 6, 2010. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. E:\FR\FM\22MRN1.SGM 22MRN1 13560 Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices 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 Paul Tran at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). pertaining to announcements of meetings and other committee management activities, for both the CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 16, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Surveillance, Natural History, Quality of Care and Outcomes of Diabetes Mellitus With Onset in Childhood and Adolescence, RFA DP 10–001, Initial Review [FR Doc. 2010–6169 Filed 3–19–10; 8:45 am] BILLING CODE 4160–01–S Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Knowledge Synthesis Center for Evaluating Genomic Application in Practice and Prevention, GD 10–001, Initial Review pwalker on DSK8KYBLC1PROD with NOTICES In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 10 a.m.–5 p.m., May 25, 2010 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Knowledge Synthesis Center for Evaluating Genomic Application in Practice and Prevention, GD 10–001.’’ Contact Person for More Information: Donald Blackman, PhD, Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, Office of the Director, Extramural Research Program Office, 4770 Buford Highway, NE., Mailstop K–92, Atlanta, GA 30341, Telephone: (770) 488–3023, E-mail: DBY7@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices 16:41 Mar 19, 2010 Jkt 220001 [FR Doc. 2010–6194 Filed 3–19–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): RFA DD 10–002 Public Health Research on Spina Bifida, RFA DD 10–003 Public Health Research on Children and Adults Living With Spina Bifida, RFA DD 10– 004 Developing a Prospective Assessment of the Development, Health, and Condition Progression in Young Children With Spina Bifida,and RFA DP 10–006 Epidemiologic Study of Inflammatory Bowel Disease, Initial Review In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 10 a.m.–5 p.m., May 27, 2010 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of ‘‘Surveillance, Natural History, Quality of Care and Outcomes of Diabetes Mellitus With Onset in Childhood and Adolescence, RFA DP 10–001.’’ For More Information Contact: Donald Blackman, PhD, Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, Office of the Director, Extramural Research Program Office, 4770 Buford Highway, NE., Mailstop K–92, Atlanta, GA 30341, Telephone: (770) 488–3023, E-mail: DBY7@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the CDC and the Agency for Toxic Substances and Disease Registry. Time and Date: 9 a.m.–4 p.m., April 15, 2010 (Closed) Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of ‘‘RFA DD 10–002 Public Health Research on Spina Bifida, RFA DD 10–003 Public Health Research on Children and Adults Living with Spina Bifida, RFA DD 10– 004 Developing a Prospective Assessment of the Development, Health, and Condition Progression in Young Children with Spina Bifida, and RFA DP 10–006 Epidemiologic Study of Inflammatory Bowel Disease.’’ Contact Person for More Information: Donald Blackman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, Office of the Director, Extramural Research Program Office, 4770 Buford Highway, NE., Mailstop K–92, Atlanta, GA 30341, Telephone: (770) 488–3023, Email: DBY7@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 12, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. Dated: March 12, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–6180 Filed 3–19–10; 8:45 am] [FR Doc. 2010–6178 Filed 3–23–10; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4163–18–P In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Nov<24>2008 Dated: March 12, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00078 Fmt 4703 Sfmt 9990 E:\FR\FM\22MRN1.SGM 22MRN1

Agencies

[Federal Register Volume 75, Number 54 (Monday, March 22, 2010)]
[Notices]
[Pages 13559-13560]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6169]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Endocrinologic and Metabolic Drugs 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 Committee: Endocrinologic and Metabolic Drugs Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 27, 2010, from 8 
a.m. to 5 p.m.
    Location: The Inn and Conference Center, University of Maryland 
University College (UMUC), 3501 University Blvd. East, Adelphi, MD. The 
hotel telephone number is 301-985-7300.
    Contact Person: Paul Tran, 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: paul.tran@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512536. 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: On May 27, 2010, the committee will discuss the safety and 
efficacy of new drug application (NDA) 22-505, EGRIFTA (tesamorelin 
acetate), sterile lyophilized powder for injection, by 
Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound 
that resembles another compound in structure) of growth hormone 
releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in 
this application is to induce and maintain a reduction of excess 
visceral abdominal fat in human immunodeficiency virus (HIV)-infected 
patients with lipodystrophy (a condition in which abnormal deposits of 
fat are seen partly as a result of using certain drugs to treat HIV 
disease).
    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/AdvisoryCommittees/Calendar/default.htm. 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 May 
13, 2010. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.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 May 5, 2010. 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 May 6, 
2010.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.

[[Page 13560]]

    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 Paul Tran at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 16, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-6169 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S

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