Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Carbohydrate Content Claims on Food Labels, 1542-1543 [E6-94]

Download as PDF 1542 Federal Register / Vol. 71, No. 6 / Tuesday, January 10, 2006 / Notices Trans No. Acquiring Acquired Entities 20060338 ......................... MarineMax, Inc. ................................. Cecil Van Tuyl ................................... Lake Port Marine, Inc., Port Arrowhead, Inc., Port Arrowhead Marine, Inc. Transactions Granted Early Termination—12/21/2005 20060327 ......................... OCM/GFI Power Opportunities Fund II, L.P.. GT Equipment Technologies, Inc. ..... GT Equipment Technologies, Inc. Transactions Granted Early Termination—12/22/2005 20060565 ......................... 20060263 ......................... 20060346 ......................... Sierra Pacific Resources ................... Wyeth ................................................ Embridge Inc. .................................... Pinnacle West Capital Corporation ... Trubion Pharmaceuticals, Inc. ........... BP P.L.C. ........................................... GenWest, LLC. Trubion Pharmaceuticals, Inc. Olympic Pipe Line Company. Transactions Granted Early Termination—12/23/2005 20060335 20060345 20060347 20060349 ......................... ......................... ......................... ......................... Richard L. Scott ................................. Danaher Corporation ......................... Yell Group PLC ................................. PMC-Sierra, Inc. ................................ Secure Computing Corporations ....... Visual Networks, Inc. ......................... James W. Clarke, Sr. ........................ Bali Investments S.a.r.l. .................... 20060356 20060359 20060361 20060363 ......................... ......................... ......................... ......................... Brown & Brown, Inc. ......................... Sprint Nextel Corporation .................. The Related Company, L.P. .............. OCM/GFA Power Opportunities Fund II, L.P.. Steel Dynamics, Inc. ......................... Silver Lake Partners II, L.P. .............. Horace M. Johnson, Jr. ..................... Velocita Holdings, LLC ...................... Equinox Holdings, L.P. ...................... Equitable Resources Inc. .................. Secure Computing Corporations. Visual Networks, Inc. Clarke Directory Publications, Inc. Avago Technologies Storage (U.S.A.) Inc. Axion Intermediaries, LLC. Velocita Wireless Holding Corp. Equinox Holdings, L.P. Noresco Holdings, Inc. Roanoke Electric Steel Corporation .. Serena Software, Inc. ........................ Roanoke Electric Steel Corporation. Serena Software, Inc. 20060366 ......................... 20060377 ......................... FOR FURTHER INFORMATION CONTACT: FOR FURTHER INFORMATION CONTACT: Sandra M. Peay, Contact Representative or Renee Hallman, Contact Representative, Federal Trade Commission, Premerger Notification Office, Bureau of Competition, Room H– 303, Washington, DC 20580, (202) 326– 3100. Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. By Direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 06–176 Filed 1–09–06; 8:45 am] BILLING CODE 6750–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0209] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Contact Substances Notification AGENCY: Food and Drug Administration, HHS. wwhite on PROD1PC65 with NOTICES ACTION: Notice. In the Federal Register of October 24, 2005 (70 FR 61452), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0495. The approval expires on December 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at ‘‘https://www.fda.gov/ ohrms/dockets’’. SUPPLEMENTARY INFORMATION: Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–91 Filed 1–9–06; 8:45 am] BILLING CODE 4160–01–S SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food Contact Substances Notification’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. VerDate Aug<31>2005 17:14 Jan 09, 2006 Jkt 208001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0120] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Carbohydrate Content Claims on Food Labels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Experimental Study of Carbohydrate Content Claims on Food Labels’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. SUPPLEMENTARY INFORMATION: In the Federal Register of August 17, 2005 (70 FR 48423), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it E:\FR\FM\10JAN1.SGM 10JAN1 Federal Register / Vol. 71, No. 6 / Tuesday, January 10, 2006 / Notices displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0570. The approval expires on December 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–94 Filed 1–9–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D–2145] (formerly 99D– 2145) International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revised); Request for Comments; Availability AGENCY: Food and Drug Administration, HHS. wwhite on PROD1PC65 with NOTICES ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (#93) entitled ‘‘Impurities in New Veterinary Medicinal Products (Revised)’’ VICH GL11(R). This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the Federal Register of July 7, 2000 (the 2000 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products. DATES: Submit written or electronic comments by February 9, 2006, to ensure their adequate consideration in preparation of the final guidance document. General comments on agency VerDate Aug<31>2005 16:09 Jan 09, 2006 Jkt 208001 guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft revised guidance document. Submit written comments on the draft revised guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Comments should be identified with the full title of the draft revised guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary Medicine (HFV–143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6956, email: dbensley@cvm.fda.gov. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonization of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. VICH is a parallel initiative for veterinary medicinal products. VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 1543 States, and Includes input from both regulatory and industry representatives. The VICH steering committee is composed of member representatives from the European Commission; European Medicines Evaluation Agency; European Federation of Animal Health; Committee on Veterinary Medicinal Products; FDA; the U.S. Department of Agriculture; the Animal Health Institute; the Japanese Veterinary Pharmaceutical Association; the Japanese Association of Veterinary Biologics; and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Four observers are eligible to participate in the VICH steering committee as follows: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH steering committee meetings. II. Draft Revised Guidance on Impurities in New Veterinary Medicinal Products In May 2005, the VICH steering committee agreed that a draft revised guidance entitled ‘‘Impurities in New Veterinary Medicinal Products (Revised)’’ VICH GL11(R) should be made available for public comment. The draft revised guidance is a revision of a final guidance on the same topic for which a notice of availability was published in the Federal Register of July 7, 2000 (65 FR 42019). The draft revised guidance clarifies the 2000 guidance, adds information, and provides consistency with more recently published VICH guidances. The draft revised guidance is a product of the Quality Expert Working Group of VICH. Comments about this draft will be considered by FDA and the Quality Expert Working Group. This draft revised document is intended to provide guidance for new animal drug applications on the content and qualification of impurities in new veterinary drug substances intended to be used for new veterinary medicinal products, produced by chemical syntheses and not previously registered in a country, region, or member state. The draft guidance has been revised to add information to certain sections and to provide clarification to other sections of the previous guidance. The E:\FR\FM\10JAN1.SGM 10JAN1

Agencies

[Federal Register Volume 71, Number 6 (Tuesday, January 10, 2006)]
[Notices]
[Pages 1542-1543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-94]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0120]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Experimental Study of Carbohydrate 
Content Claims on Food Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Experimental Study of Carbohydrate 
Content Claims on Food Labels'' has been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 17, 2005 
(70 FR 48423), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it

[[Page 1543]]

displays a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0570. 
The approval expires on December 31, 2008. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.fda.gov/ohrms/dockets.

    Dated: January 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-94 Filed 1-9-06; 8:45 am]
BILLING CODE 4160-01-S

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