Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 15866 [05-6087]

Download as PDF 15866 Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices manufacturer, and indications to be studied under the referrals (21 U.S.C. 355a(d)(4)(B)(ii)). In accordance with section 4 of the BPCA, FDA is announcing that it has referred to the Foundation the written requests for pediatric studies for KEMSTRO (baclofen) and DROXIA (hydroxyurea). On April 30, 2004, FDA issued a written request for pediatric studies to Schwarz Pharma, Inc., the holder of approved applications for KEMSTRO (baclofen) that have market exclusivity. The studies described in the written request were for the treatment of spasticity in the pediatric population. Schwarz Pharma, Inc., declined to conduct the requested studies. FDA has determined that there is a continuing need for information relating to the use of KEMSTRO (baclofen) in the pediatric population. On March 29, 2004, FDA issued a written request for pediatric studies to Bristol-Myers Squibb Co., the holder of approved applications for DROXIA (hydroxyurea) that have market exclusivity. The studies described in the written request were for the treatment of sickle cell disease in the pediatric population. Bristol-Myers Squibb Co. declined to conduct the requested studies. FDA has determined that there is a continuing need for information relating to the use of DROXIA (hydroxyruea) in the pediatric population. Consistent with the provisions of the BPCA, FDA referred to the Foundation the written requests for the conduct of the pediatric studies for KEMSTRO (baclofen) on September 1, 2004, and DROXIA (hydroxyurea) on October 20, 2004. Dated: March 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–6158 Filed 3–28–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy 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. VerDate jul<14>2003 17:01 Mar 28, 2005 Jkt 205001 Name of Committee: PulmonaryAllergy 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 June 6, 2005, from 8 a.m. to 5:30 p.m. Location: Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Teresa A. Watkins, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5630 Fishers Lane, rm. 1093, Rockville, MD 20857, 301–827– 7001, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512545. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will consider the safety and efficacy of new drug application (NDA) 50–799, proposed trade name PULMINIQ (cyclosporine, inhalation solution) Chiron Corp., for use in combination with standard immunosuppressive therapy to increase survival and prevent chronic rejection in patients receiving allogenic lung transplants. 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 by May 26, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 26, 2005, 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. 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 La’Nise Giles at 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 00050 Fmt 4703 Sfmt 4703 Dated: March 21, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–6087 Filed 3–28–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2004D–0187, 2004D–0188, and 2004D–0189] Guidances for Industry on Premarketing Risk Assessment; Development and Use of Risk Minimization Action Plans; and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of three guidances for industry entitled ‘‘Premarketing Risk Assessment,’’ ‘‘Development and Use of Risk Minimization Action Plans,’’ and ‘‘Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.’’ These guidances provide guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidances address, respectively, premarket risk assessment; the development, implementation, and evaluation of risk minimization action plans for drug products; and good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data. DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the guidances to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. These guidances may also be obtained by mail by calling CBER at 1–800–4709 or 301– 827–1800. Send three self-addressed ADDRESSES: E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Page 15866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Pulmonary-Allergy 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 June 6, 2005, from 8 
a.m. to 5:30 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Teresa A. Watkins, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane, rm. 
1093, Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512545. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will consider the safety and efficacy of new 
drug application (NDA) 50-799, proposed trade name PULMINIQ 
(cyclosporine, inhalation solution) Chiron Corp., for use in 
combination with standard immunosuppressive therapy to increase 
survival and prevent chronic rejection in patients receiving allogenic 
lung transplants.
    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 by May 26, 2005. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before May 26, 2005, 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.
    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 La'Nise Giles at 
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: March 21, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-6087 Filed 3-28-05; 8:45 am]
BILLING CODE 4160-01-S