Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting, 8104 [05-3055]

Download as PDF 8104 Federal Register / Vol. 70, No. 32 / Thursday, February 17, 2005 / Notices [FR Doc. 05–3088 Filed 2–16–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting Food and Drug Administration AGENCY: [Docket No. 1983G–0318] Kerry, Inc.; Withdrawal of Generally Recognized as Safe Affirmation Petition AGENCY: ACTION: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a generally recognized as safe (GRAS) affirmation petition (GRASP 3G0287) proposing that the use of gum acacia (arabic) in alcoholic beverages up to a maximum level of 20 percent in the finished preparation (liqueur) is GRAS. FOR FURTHER INFORMATION CONTACT: Mical Honigfort, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1278. In a notice published in the Federal Register of October 13, 1983 (48 FR 46626), FDA announced that a petition (GRASP 3G0287) had been filed by Beatrice Foods Co., c/o 135 South LaSalle, Chicago, IL 60603 (now Kerry, Inc., c/ o Bell, Boyd, and Lloyd, LLC, Three First National Plaza, 70 West Madison St., suite 3300, Chicago, IL 60602). This petition proposed to amend § 184.1330 Acacia (gum arabic) (21 CFR 184.1330) to affirm the use of gum acacia (arabic) in alcoholic beverages up to a maximum level of 20 percent in the finished preparation (liqueur) as GRAS. Kerry, Inc. has now withdrawn the petition without prejudice to a future filing (21 CFR 171.7). SUPPLEMENTARY INFORMATION: Dated: January 28, 2005. Leslye M. Fraser, Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition. [FR Doc. 05–3024 Filed 2–16–05; 8:45 am] BILLING CODE 4160–01–S VerDate jul<14>2003 14:41 Feb 16, 2005 Jkt 205001 Food and Drug Administration, HHS. 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 Nonprescription Drugs 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 March 24, 2005, from 8 a.m. to 5:30 p.m. Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Teresa A. Watkins, 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: 301–827–6801, or email: watkinst@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512534 or 3014512541. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss what should be the necessary and sufficient safety database in order to evaluate the prescription (Rx) to overthe-counter (OTC) switch of topical corticosteroids, especially the database to evaluate the potential for hypothalamic, pituitary, adrenal (HPA) and growth suppression and other systemic and local adverse events. 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 March 17, 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 person before March 17, 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 LaNise 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: February 10, 2005. Sheila Dearybury Walcoff, Assistant Commissioner for External Relations. [FR Doc. 05–3055 Filed 2–16–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper 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 E:\FR\FM\17FEN1.SGM 17FEN1

Agencies

[Federal Register Volume 70, Number 32 (Thursday, February 17, 2005)]
[Notices]
[Page 8104]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3055]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory 
Committee and the Nonprescription 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 Committees: Dermatologic and Ophthalmic Drugs Advisory 
Committee and the Nonprescription Drugs 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 March 24, 2005, from 8 
a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Teresa A. Watkins, 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: 301-827-6801, or email: watkinst@cder.fda.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512534 or 3014512541. Please call 
the Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss what should be the necessary and 
sufficient safety database in order to evaluate the prescription (Rx) 
to over-the-counter (OTC) switch of topical corticosteroids, especially 
the database to evaluate the potential for hypothalamic, pituitary, 
adrenal (HPA) and growth suppression and other systemic and local 
adverse events.
    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 March 17, 
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 March 17, 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 LaNise 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: February 10, 2005.
Sheila Dearybury Walcoff,
Assistant Commissioner for External Relations.
[FR Doc. 05-3055 Filed 2-16-05; 8:45 am]
BILLING CODE 4160-01-S

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