Frozen Concentrate for Lemonade Deviating From Identity Standard; Temporary Permit for Market Testing; Correction, 16024 [E8-6056]

Download as PDF 16024 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 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 Donald W. Jehn or Pearline K. Muckelvene 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 http://www.fda.gov/oc/advisory/ default.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 20, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–6208 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S 1. On page 11095, in the second column, in the SUPPLEMENTARY INFORMATION section, line twenty-two, the number ‘‘56°’’ is corrected to read ‘‘37.6°’’. Dated: March 18, 2008. Barbara Schneeman, Director, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition. [FR Doc. E8–6056 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0178] International Conference on Harmonisation; Draft Guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0158] (formerly Docket No. FDA–2008–N–0131) Frozen Concentrate for Lemonade Deviating From Identity Standard; Temporary Permit for Market Testing; Correction AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the Federal Register of February 29, 2008 (73 FR 11095). The document announced that a temporary permit has been issued to Florida’s Natural Growers, to market test a product designated as ‘‘Frozen Concentrate for Lemonade 3+1 Ratio.’’ The document was published with an incorrect value for the Brix (measure of concentration of sugars in juice). This document corrects the error. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2371. SUPPLEMENTARY INFORMATION: In FR Doc. E8–3912, appearing on page 11095 in the Federal Register of Friday, February 29, 2008, the following correction is made: VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines information from two ICH guidances, ‘‘S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals’’ and ‘‘S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.’’ The draft guidance is intended to help facilitate drug development programs, ensure patient safety, and reduce animal usage. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by May 12, 2008. ADDRESSES: Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. Submit written requests for single copies of the draft PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 guidance to the Division of Drug Information (HFD–240), Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; or the Office of Communication, Training and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send two self-addressed adhesive labels to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: David Jacobson-Kram, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6488, Silver Spring, MD 20993–0002, 301– 796–0175. Regarding the ICH: Michelle Limoli, Office of International Programs (HFG– 1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Page 16024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0158] (formerly Docket No. FDA-2008-N-0131)


Frozen Concentrate for Lemonade Deviating From Identity Standard; 
Temporary Permit for Market Testing; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice that 
appeared in the Federal Register of February 29, 2008 (73 FR 11095). 
The document announced that a temporary permit has been issued to 
Florida's Natural Growers, to market test a product designated as 
``Frozen Concentrate for Lemonade 3+1 Ratio.'' The document was 
published with an incorrect value for the Brix (measure of 
concentration of sugars in juice). This document corrects the error.

FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-3912, appearing on page 11095 
in the Federal Register of Friday, February 29, 2008, the following 
correction is made:
    1. On page 11095, in the second column, in the SUPPLEMENTARY 
INFORMATION section, line twenty-two, the number ``56[deg]'' is 
corrected to read ``37.6[deg]''.

    Dated: March 18, 2008.
Barbara Schneeman,
Director, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. E8-6056 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S