Notices. Notice

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention

(CDC)Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Non-Pharmaceutical Interventions for Pandemic Influenza, Request for Applications

(RFA)CI06-010 *Correction:* This notice was published in the **Federal Register** on July 13, 2006, Volume 71, Number 134, page 39683. The date has been changed due to reviewer's conflict with the original date. The meeting will be held on August 28, 2006. *Title:* Non-Pharmaceutical Interventions for Pandemic Influenza, RFA CI06-010. *Contact Person for more Information:* Felix Rogers, Ph.D., Scientific Review Administrator, National Immunization Program, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS E-05, Atlanta, GA 30333, Telephone 404.639.6101. 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: July 27, 2006. Alvin Hall, Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E6-12542 Filed 8-2-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0189] Determination of Regulatory Review Period for Purposes of Patent Extension; IPLEX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for IPLEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions 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.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product IPLEX (mecasermin rinfabate [rDNA origin]). IPLEX is indicated for treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone

(GH)gene depletion who have developed neutralizing antibodies to GH. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for IPLEX (U.S. Patent No. 5,681,818) from Insmed Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 19, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of IPLEX represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for IPLEX is 3,527 days. Of this time, 3,183 days occurred during the testing phase of the regulatory review period, while 344 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : April 18, 1996. The applicant claims April 24, 1996, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was April 18, 1996, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : January 3, 2005. FDA has verified the applicant's claim that the new drug application

(NDA)for IPLEX (NDA 21-884) was initially submitted on January 3, 2005. 3. *The date the application was approved* : December 12, 2005. FDA has verified the applicant's claim that NDA 21-884 was approved on December 12, 2005. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,657 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by October 2, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 30, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 21, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-12571 Filed 8-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999E-5113] Determination of Regulatory Review Period for Purposes of Patent Extension; CLINACOX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for CLINACOX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product. ADDRESSES: Submit written comments and petitions 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.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B). FDA approved for marketing the animal drug product CLINACOX (diclazuril). CLINACOX is indicated for use in broiler chickens, for the prevention of coccidicosis caused by *Eimeria tenella* , *E. necatrix* , *E. acervulina* , *E. brunette* , *E. mitis* ( *mivati* ), and *E. maxima* . Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for CLINACOX (U.S. Patent No. 4,631,278) from Janssen Pharmaceutica N.V., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 4, 2000, FDA advised the Patent and Trademark Office that this animal drug product had undergone a regulatory review period and that the approval of CLINACOX represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for CLINACOX is 5,111 days. Of this time, 1,749 days occurred during the testing phase of the regulatory review period, 3,362 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(j)), involving this animal drug product, became effective* : April 25, 1985. FDA has verified the applicant's claim that the date the investigational new animal drug application became effective was on April 25, 1985. 2. *The date the application was initially submitted with respect to the animal drug product under section 512(b) of the act* : February 6, 1990. The applicant claims January 31, 1990, as the date the new animal drug application

(NADA)for CLINACOX (NADA 140-951) was initially submitted. However, FDA records indicate that NADA 140-951 was officially acknowledged and assigned the NADA number on February 6, 1990, which is considered to be the NADA initially submitted date. 3. *The date the application was approved* : April 21, 1999. FDA has verified the applicant's claim that NADA 140-951 was approved on April 21, 1999. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,096 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by October 2, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 30, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 20, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-12572 Filed 8-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003E-0418] Determination of Regulatory Review Period for Purposes of Patent Extension; EMEND AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for EMEND and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions 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.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product EMEND (aprepitant). EMEND, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for EMEND (U.S. Patent No. 5,719,147) from Merck & Co., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 18, 2003, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of EMEND represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for EMEND is 2,513 days. Of this time, 2,332 days occurred during the testing phase of the regulatory review period, while 181 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : May 10, 1996. The applicant claims May 9, 1996, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was May 10, 1996, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : September 27, 2002. FDA has verified the applicant's claim that the new drug application

(NDA)for EMEND (NDA 21-549) was initially submitted on September 27, 2002. 3. *The date the application was approved* : March 26, 2003. FDA has verified the applicant's claim that NDA 21-549 was approved on March 26, 2003. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,022 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by October 2, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 30, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 20, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-12573 Filed 8-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0004] Determination of Regulatory Review Period for Purposes of Patent Extension; CYMBALTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for CYMBALTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions 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.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product CYMBALTA (duloxetine hydrochloride). CYMBALTA is indicated for the treatment of major depressive disorder. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for CYMBALTA (U.S. Patent No. 5,023,269) from Eli Lilly and Company, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 24, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of CYMBALTA represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for CYMBALTA is 4,781 days. Of this time, 3,786 days occurred during the testing phase of the regulatory review period, while 995 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : July 4, 1991. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on July 4, 1991. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : November 13, 2001. FDA has verified the applicant's claim that the new drug application

(NDA)for CYMBALTA (NDA 21-427) was initially submitted on November 13, 2001. 3. *The date the application was approved* : August 3, 2004. FDA has verified the applicant's claim that NDA 21-427 was approved on August 3, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by October 2, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 30, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 20, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-12574 Filed 8-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration National Mammography Quality Assurance 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* : National Mammography Quality Assurance 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 September 28, 2006, from 10 a.m. to 6 p.m., and on September 29, 2006, from 8 a.m. to 1 p.m. *Location* : Atrium Court Hotel, Remington 1 and 2, Three Research Ct., Rockville, MD. *Contact Person* : Nancy Wynne, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3284, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512397. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will discuss:

(1)Amendments to the current regulations, and

(2)all guidance documents issued since the last meeting. The committee will also receive updates on recently approved alternative standards and the radiological health program. MQSA regulations and guidance documents are available to the public on the Internet at *http://www.fda.gov/cdrh/mammography* . *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 August 29, 2006. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. on September 28, 2006, and between approximately 8:30 a.m. and 9:30 a.m. on September 29, 2006. Time allotted for each presentation may be limited. 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 August 29, 2006. 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 Shirley Meeks, Conference Management Staff, at 301-827-7292, 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: July 27, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-12569 Filed 8-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies 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* : Transmissible Spongiform Encephalopathies 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 September 18, 2006, from 8 a.m. to 4:30 p.m. and September 19, 2006, from 8 a.m. to 1 p.m. *Location* : Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD. *Contact Person* : William Freas or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On September 18, 2006, the committee will hear updates on the following topics: United States and worldwide bovine spongiform encephalopathies (BSE); variant Creutzfeldt-Jakob disease

(vCJD)epidemiology and transfusion-transmission; blood and plasma donor deferral for transfusion in France since 1980 guidance; FDA's current assessment and plans regarding the potential exposure to vCJD from an investigational product, FXI, that was manufactured from UK donor plasma; and a summary of World Heath Organization Consultation on distribution of infectivity in tissues of animals and humans with transmissible spongiform encephalopathies. The committee will then discuss experimental clearance of transmissible spongiform encephalopathy infectivity in plasma-derived Factor VIII products. In the afternoon, the committee will discuss FDA's risk assessment for potential exposure to vCJD from human plasma-derived antihemophilic factor (FVIII) products and potential responses. On September 19, 2006, the committee will discuss possible criteria for approval of donor screening tests for vCJD. *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 September 6, 2006. Oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:15 a.m. and 2:30 p.m. and 3 p.m. on September 18, 2006, and between approximately 10:15 a.m. and 11:45 a.m. on September 19, 2006. Time allotted for each presentation may be limited. 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 September 11, 2006. 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 William Freas or Rosanna Harvey 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: July 27, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-12567 Filed 8-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard [CGD17-06-001] Implementation of Sector Anchorage AGENCY: Coast Guard, DHS. ACTION: Notice of organizational change. SUMMARY: The Coast Guard announces the stand-up of Sector Anchorage. The creation of Sector Anchorage is an internal reorganization that combines Marine Safety Office Anchorage with all prior subordinate units in addition to USCGC LONG ISLAND, USCGC MUSTANG, USCGC ROANOKE ISLAND, and Station Valdez into a single command. In addition, a Sector Field Office has been created to provide remote logistics support at Valdez, Alaska named Sector Field Office Valdez, which will be subordinate to Sector Anchorage. The Coast Guard has established a continuity of operations whereby all previous practices and procedures will remain in effect until superseded by an authorized Coast Guard official or document. DATES: This notice is effective August 3, 2006. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD17 and are available for inspection or copying at Commander (dr), Seventeenth Coast Guard District, 709 West 9th Street, Room 771, Juneau, Alaska, 99802 between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: LCDR Carl Hinshaw, Assistant Branch Chief for Enforcement, Seventeenth District Response Division at 907-463-2284. SUPPLEMENTARY INFORMATION: Discussion of Notice Sector Anchorage is located at 510 L Street, Suite 100, Anchorage, Alaska 99501-1946. A Sector Field Office

(SFO)will be created to provide remote logistics support at Valdez, AK named SFO Valdez. MSO Anchorage OPFAC 17-33280 will be cancelled. A Command Center supporting Sector Anchorage will be located at Anchorage, AK. Sector Anchorage will be composed of a Response Department, Prevention Department and a Logistics Department. The Sector Command Center, Intelligence staff and Contingency Planning and Force Readiness staff will report directly to the Sector Commander and serve the Response, Prevention, and Logistics components. The Western Alaska Marine Inspection Zone and Captain of the Port Office are located in Anchorage, Alaska. MSO Valdez will be renamed Marine Safety Unit

(MSU)Valdez and retain the authorities of Captain of the Port (COTP), Officer in Charge Marine Inspection (OCMI), Federal on Scene Coordinator (FOSC), and Federal Maritime Security Coordinator (FMSC). MSU Valdez will report directly to the Sector Commander. Vessel Traffic Service

(VTS)Prince William Sound, a subunit of MSU Valdez, will be renamed VTS Valdez. SFO Valdez will report directly to the Sector Logistics Department. All existing missions and functions performed by MSO Anchorage will be realigned under this new organizational structure. The new Sector's area of responsibility for search and rescue

(MSU)Valdez is responsible for the Coast Guard missions of Officer in Charge of Marine Inspection (OCMI), Federal Maritime Security Coordinator (FMSC), Federal On Scene Coordinator (FOSC), and COTP duties in the Prince William Sound Marine Inspection ‘sub-zone’ and COTP ‘sub-zone’ described as follows: The Prince William Sound Marine Inspection sub-zone and Captain of the Port sub-zone comprise the area within the boundary, which starts at Cape Puget at 148°26′ W. longitude, 59°56.06′ N. latitude, and proceeds northerly to 61°30′ N. latitude; thence easterly to the United States-Canadian boundary; thence southerly along the United States-Canadian boundary to 60°18.7′ N. latitude; thence southwesterly to the sea at 60°01.3′ N. latitude, 142°00′ W. longitude; thence southerly along 142°00′ W. longitude to the outermost boundary of the EEZ; thence along the outermost boundary of the EEZ to 148°26′ N. longitude; thence northerly along 148°26′ W. longitude to the place of origin at Cape Puget at 59°56.06′ N. latitude. The Sector Anchorage Commander is vested with all the rights, responsibilities, duties, and authority of a Group Commander and Commanding Officer, Marine Safety Office, as provided for in Coast Guard regulations, and is the successor in command to the Commanding Officer of Marine Safety Office Anchorage. Under Operating Facility Change Order

(OFCO)No. 028-06, the Sector Anchorage Commander is designated: • Captain of the Port

(COTP)for the Western Alaska COTP zone; • Federal Maritime Security Coordinator (FMSC); • Federal On Scene Coordinator

(FOSC)for the Western Alaska COTP zone, consistent with the National Contingency Plan; • Officer in Charge of Marine Inspection

(OCMI)for the Southeast Alaska Marine Inspection Zone; and • Search and Rescue Mission Coordinator (SMC). The Deputy Sector Commander is designated alternate COTP, FMSC, FOSC, SMC, and Acting OCMI. A continuity order was issued ensuring that all previous Marine Safety Office Anchorage practices and procedures will remain in effect until superseded by Commander, Sector Anchorage. This continuity of operations order addressed existing COTP regulations, orders, directives, and policies. The following information is updated address and point of contact to facilitate requests from the public and assist with entry into security or safety zones: *Name:* Sector Anchorage. *Address:* Commander, U.S. Coast Guard Sector Anchorage, 510 L Street, Suite 100, Anchorage, Alaska 99501-1946 *Telephone:* General Number,

(907)271-6700 Dated: July 21, 2006. Arthur E. Brooks, Rear Admiral, U.S. Coast Guard, Commander, Seventeenth Coast Guard District. [FR Doc. E6-12531 Filed 8-2-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard [CGD17-06-002] Implementation of Sector Juneau AGENCY: Coast Guard, DHS. ACTION: Notice of organizational change. SUMMARY: The Coast Guard announces the stand-up of Sector Juneau. The creation of Sector Juneau is an internal reorganization that combines Marine Safety Office Juneau with all prior subordinate units in addition to USCGC LIBERTY, USCGC ANACAPA, USCGC NAUSHON, USCGC ELDERBERRY, Station Juneau, Station Ketchikan, and Aids to Navigation Team Sitka into a single command. In addition, a Sector Field Office has been created to provide remote logistics support at Ketchikan, Alaska, named Sector Field Office Ketchikan, which will be subordinate to Sector Juneau. The Coast Guard has established a continuity of operations whereby all previous practices and procedures will remain in effect until superseded by an authorized Coast Guard official or document. DATES: This notice is effective the date of publication in the **Federal Register** . ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD17-06-002 and are available for inspection or copying at Commander (dr), Seventeenth Coast Guard District, 709 West 9th Street, Room 771, Juneau, Alaska, 99802 between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: LCDR Carl Hinshaw, Assistant Branch Chief for Enforcement, Seventeenth District Response Division at 907-463-2284. SUPPLEMENTARY INFORMATION: Discussion of Notice The Command Center for Sector Juneau is located at 2760 Sherwood Lane, Suite 2A, Juneau, Alaska 99801-8545. This Command Center will be collocated with the District Seventeen Command Center. A Sector Field Office has been created to provide remote logistics support at Ketchikan, Alaska. Sector Field Office Ketchikan is subordinate to Sector Juneau. Sector Juneau is composed of a Response Department, Prevention Department, and Logistics Department. The new Sector's area of responsibility for search and rescue

(SAR)will be maintained in accordance with the District SAR plan. We projected that by 2007, all existing administrative and operational missions and functions performed by Marine Safety Office Juneau and prior subordinate units will be performed by Sector Juneau. Administrative missions and functions performed by USCGC LIBERTY, USCGC ANACAPA, USCGC NAUSHON, USCGC ELDERBERRY, Station Juneau, Station Ketchikan, and Aids to Navigation Team Sitka will be performed by Sector Juneau. All operational missions and functions performed by USCGC LIBERTY, USCGC ANACAPA, USCGC NAUSHON, USCGC ELDERBERRY, Station Juneau, Station Ketchikan, and Aids to Navigation Team Sitka will be assumed by Sector Juneau upon stand up of a single Command Center at Sector Juneau. Sector Juneau is responsible for all Coast Guard Missions in the following zone: The Southeast Alaska Marine Inspection Zone and Captain of the Port Zone comprising the area within the boundary, which starts at 60°01.3′ N. latitude, 142°00′ W. longitude; thence proceeds northeasterly to the Canadian border at 60°18.7′ N. latitude, 141°00′ W. longitude; thence southerly and easterly along the United States-Canadian shore side boundary to 54°40′ N. latitude; thence westerly along the United States-Canadian maritime boundary to the outermost extent of the EEZ; thence northerly along the outer boundary of the EEZ to 142°00′ W. longitude; thence due north to the point of origin. There are no changes to the Southeast Alaska Marine Inspection Zone and Southeast Alaska Captain of the Port Zone, which are delineated in 33 CFR 3.85-10. Sector Juneau will retain Captain of the Port, Federal Maritime Security Coordinator, Officer in Charge of Marine Inspection and Federal On-Scene Coordinator authorities and responsibilities in the Southeast Alaska Marine Inspection Zone and Captain of the Port Zone. The Sector Juneau Commander is vested with all the rights, responsibilities, duties, and authority of a Group Commander and Commanding Officer, Marine Safety Office, as provided for in Coast Guard regulations, and is the successor in command to the Commanding Officer of Marine Safety Office Juneau. Under Operating Facility Change Order

(OFCO)No. 027-06, the Sector Juneau Commander is designated: • Captain of the Port

(COTP)for the Southeast Alaska COTP zone; • Federal Maritime Security Coordinator (FMSC); • Federal On Scene Coordinator

(FOSC)for the Southeast Alaska COTP zone, consistent with the National Contingency Plan; • Officer in Charge of Marine Inspection

(OCMI)for the Southeast Alaska Marine Inspection Zone; and • Search and Rescue Mission Coordinator (SMC). The Deputy Sector Commander is designated by Alternate COTP, FMSC, FOSC, SMC, and Acting OCMI. A continuity order was issued on the May 8, 2006, ensuring that all previous Marine Safety Office Juneau practices and procedures will remain in effect until superseded by Commander, Sector Juneau. This continuity order addresses existing COTP regulations, orders, directives, and policies. The following information is an updated address and point of contact to facilitate requests from the public and assist with entry into security or safety zones: *Name:* Sector Juneau. *Address:* Commander, U.S. Coast Guard Sector Juneau, 2760 Sherwood Lane, Suite 2A, Juneau, Alaska 99801-8545. *Telephone:* General Number,

(907)463-2450. Dated: July 20, 2006. Arthur E. Brooks, Rear Admiral, U.S. Coast Guard Commander, Seventeenth Coast Guard District. [FR Doc. E6-12562 Filed 8-2-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5041-N-21] Notice of Proposed Information Collection: Comment Request; Utility Allowance Adjustments AGENCY: Office of the Assistant Secretary for Housing, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below will be submitted to the Office of Management and Budget

(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: *Comments Due Date:* October 2, 2006. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Lillian Deitzer, Reports Management Officer, Department of Housing and Urban Development, 451 7th Street, SW., L'Enfant Building, Room 8202, Washington, DC 20410, telephone

(202)708-5221 (this is not a toll-free number) for copies of the proposed forms and other available information. FOR FURTHER INFORMATION CONTACT: Kimberly R. Munson, Office of Asset Management, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410, telephone number

(202)708-1320 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to:

(1)Evaluate whether the proposed collection is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond; including the use of appropriate automated collection techniques or other forms of information technology, *e.g.* , permitting electronic submission of responses. This Notice also lists the following information: *Title of Proposal:* Utility Allowance Adjustments. *OMB Control Number, if applicable:* 2502-0352. *Description of the need for the information and proposed use:* HUD requires an analysis of the project's utility allowances to be included in the owner's request for rent increase. HUD's review and approval is required for utility allowance increases of 10 percent or higher. *Agency form numbers, if applicable:* None. *Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response:* The estimated number of respondents is 1,200; the frequency of responses is 1; estimated time to gather and prepare the necessary documents is .50 per hour per submission, and the estimated total annual burden hours are 600. *Status of the proposed information collection:* Extension of a currently approved collection. Authority: The Paperwork Reduction Act of 1995, 44 U.S.C., Chapter 35, as amended. Dated: July 28, 2006. Frank L. Davis, General Deputy Assistant Secretary for Housing-Federal Housing Commissioner. [FR Doc. E6-12495 Filed 8-2-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5030-C-21A, 22A] Notice of HUD's Fiscal Year

(FY)2006 Notice of Funding Availability, Policy Requirements and General Section to SuperNOFA for HUD's Discretionary Grant Programs; Correction AGENCY: Office of the Secretary, HUD. ACTION: Super Notice of Funding Availability (SuperNOFA) for HUD Discretionary Grant Programs; Correction. SUMMARY: On March 8, 2006, HUD published its Fiscal Year

(FY)2006 SuperNOFA (SuperNOFA), for HUD's Discretionary Grant Programs. This document makes corrections to the notices of funding availability

(NOFA)for the Section 202 Supportive Housing for the Elderly Program (Section 202) and the Section 811 Supportive Housing for Persons with Disabilities Program (Section 811). Through this notice, HUD is announcing that it has amended its requirement for the preparation of Phase I Environmental Site Assessments

(ESA)to permit HUD to accept as an acceptable Phase I ESA, either one that had been prepared based on the current American Society for Testing and Material

(ASTM)Standard E 1527-05 or the previous Standard E 1527-00. Because the requirement to submit a Phase I ESA is a threshold issue that does not affect an applicant's scoring, HUD is not reopening either the Section 202 or Section 811 competitions and will not accept additional applications. DATES: The application submission dates for the Section 202 and Section 811 programs of the FY2006 SuperNOFA remain as published in the **Federal Register** on March 8, 2006. FOR FURTHER INFORMATION CONTACT: For the programs listed in this notice, please contact the office or individual listed under Section VII of the individual program sections of the SuperNOFA, published on March 8, 2006. SUPPLEMENTARY INFORMATION: On March 8, 2006 (71 FR 11712), HUD published its Notice of HUD's Fiscal Year

(FY)2006, SuperNOFA for HUD's Discretionary Grant Programs. The FY2006 SuperNOFA announced the availability of approximately $2.2 billion in HUD assistance. On April 28, 2006, HUD published (71 FR 25208), a notice that further clarified the Section 202 and Section 811 NOFAs. This notice published in today's **Federal Register** corrects the Section 202 and Section 811 NOFAs. As described in further detail below, this notice announces that for both the Section 202 and Section 811 programs, HUD will accept as a Phase I ESA, either one that had been prepared based on the current ASTM E 1527-05 or the previous E 1527-00. Since the requirement to submit a Phase I ESA is a threshold issue that does not affect an applicant's scoring, HUD is not reopening either the Section 202 or Section 811 competitions and will not accept additional applications. I. Changes to the Section 202 and Section 811 NOFAs HUD is amending its Section 202 and Section 811 NOFAs to permit HUD to accept Phase I ESAs that were prepared in accordance with either the current ASTM E 1527-05 or the previous E 1527-00. This amendment recognizes that the Environmental Protection Agency (EPA), in its final rule entitled, “Standards and Practices for All Appropriate Inquires” (70 FR 66070, November 1, 2005) provided, that until the rule's effective date, November 1, 2006, either ASTM Standard E 1527-00 or 1527-05 could be used to comply with 40 CFR 312.23 through 312.31, its rules implementing the “all appropriate inquiry”

(AAI)requirements of the Comprehensive Environmental Response Compensation and Liability Act (CERCLA) (42 U.S.C. 9601 *et seq.* ). As a result, HUD decided to be proactive by requiring, in its FY2006 Section 202 and Section 811 NOFAs, that the Phase I ESA be prepared in accordance with ASTM Standard E 1527-05 instead of ASTM Standard E 1527-00. Unfortunately, many Section 202 and 811 applicants and the environmental professionals employed by the applicants misread, misinterpreted or were confused by HUD's revised Phase I requirements and did not perform the Phase I ESAs in accordance with ASTM Standard E 1527-05. HUD has determined, therefore, that it would be in the public's best interest to amend the FY2006 Section 202 and Section 811 NOFAs to permit HUD to accept the Phase I ESA prepared in accordance with either ASTM Standard E 1527-00 or ASTM Standard E 1527-05. II. Summary of Corrections *Section 202 Program.* On page 12014, section III.C.2.b.(3)(c)(i), Phase I Environmental Site Assessment (ESA), third column, the requirement that the Phase I ESA be prepared in accordance with the ASTM Standard E 1527-05, as amended, is revised to require, and to permit HUD to accept, Phase I ESAs that have been prepared in accordance with either ASTM Standard E 1527-00 or E 1527-05. On page 12020, section IV.B.2.c.(1)(d)(vii), A Phase I Environmental Site Assessment (ESA), third column, the requirement that applicants must undertake and complete a Phase I ESA that has been prepared in accordance with ASTM Standard E 1527-05, as amended, and submit it with their Section 202 applications is amended to require, and to permit HUD to accept, Phase I ESAs that have been prepared in accordance with either ASTM Standard E 1527-00 or E 1527-05. *Section 811 Program.* On page 12035, section III.C.2.b.(3)(d)(i), Phase I Environmental Site Assessment (ESA), third column, the requirement that the Phase I ESA be prepared in accordance with the ASTM Standard E 1527-05, as amended, is revised to require, and to permit HUD to accept, Phase I ESAs that have been prepared in accordance with either ASTM Standard E 1527-00 or Standard E 1527-05. On page 12043, section IV.B.2.c.(1)(d)(vii), A Phase I Environmental Site Assessment (ESA), third column, the requirement that applicants must undertake and complete a Phase I ESA that has been prepared in accordance with ASTM Standard E 1527-05, as amended, and submit it with their Section 811 applications is amended to require, and to permit HUD to accept, Phase I ESAs that have been prepared in accordance with either ASTM Standard E 1527-00 or E 1527-05. Accordingly, in the Notice of HUD's Fiscal Year

(FY)2006, Notice of Funding Availability (NOFA), Policy Requirements and General Section to the SuperNOFA for HUD's Discretionary Grant Programs, beginning at 71 FR 11712, in the issue of March 8, 2006, the following corrections are made. 1. *Section 202 Supportive Housing for the Elderly Program.* On page 12014, third column, revise section III.C.2.b.(3)(c)(i) to read as follows:

(i)*Phase I Environmental Site Assessment (ESA).* You must undertake and submit a Phase I ESA, prepared in accordance with ASTM Standard E 1527-05, as amended, or ASTM Standard E 1527-00, as amended, completed or updated no earlier than six months prior to the application deadline date. The Phase I ESA must be completed and submitted with the application. Therefore, it is important that you start the Phase I ESA process as soon after publication of the SuperNOFA as possible. To help you choose an environmentally safe site, HUD invites you to review the documents “Choosing an Environmentally Safe Site” and “Supplemental Guidance, Environmental Information,” which are available on the HUD Web site at *http://www.hud.gov/offices/adm/grants/fundsavail.cfm* . On page 12020, third column, revise section IV.B.2.c.(1)(d)(vii) to read as follows:

(vii)A Phase I Environmental Site Assessment (ESA), in accordance with ASTM Standards E 1527-05, as amended, or ASTM Standard E 1527-00, as amended, must be undertaken and completed by you and submitted with the application. In order for the Phase I ESA to be acceptable, it must have been completed or updated no earlier than six months prior to the application deadline date. Therefore, it is important to start the site assessment process as soon after the publication of the NOFA as possible. 2. *Section 811 Supportive Housing for Persons with Disabilities Program.* On page 12035, third column, revise section III.C.2.b.(3)(d)(i) to read as follows:

(i)Phase I Environmental Site Assessment (ESA). You must submit a Phase I ESA, prepared in accordance with ASTM Standard E 1527-05, as amended, or ASTM Standard E 1527-00, as amended, completed or updated no earlier than six months prior to the application deadline date in order for the application to be considered as an application with site control. The Phase I ESA must be completed and in your application. Therefore, it is important that you start the Phase I ESA process as soon after publication of the SuperNOFA as possible. To help you choose an environmentally safe site, HUD invites you to review the documents “Choosing an Environmentally Safe Site” and “Supplemental Guidance, Environmental Information,” which are available on the HUD Web site at *http://www.hud.gov/offices/adm/grants/fundsavail.cfm* . On page 12043, first column, revise section IV.B.2.c.(1)(d)(vii) to read as follows:

(vii)A Phase I Environmental Site Assessment (ESA), in accordance with ASTM Standard E 1527-05, as amended, or ASTM Standard E 1527-00, as amended, must be completed and submitted with the application. In order for the Phase I ESA to be acceptable, it must have been completed or updated no earlier than six months prior to the application deadline date. Therefore, it is important to start the site assessment process as soon after the publication of the NOFA as possible. Dated: July 28, 2006. Brian D. Montgomery, Assistant Secretary for Housing—Federal Housing Commissioner. [FR Doc. E6-12498 Filed 8-2-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [UT-910-06-1210-PH-24-1A] Call for Nominations for Utah's Resource Advisory Council Vacancy AGENCY: Bureau of Land Management, Department of the Interior. ACTION: Notice of Call for Nominations for the Utah Resource Advisory Council. SUMMARY: The Federal Land Policy and Management Act (FLPMA) (43 U.S.C. 1730) directs the Secretary of the Interior to involve the public in planning and issues related to management of lands administered by Bureau of Land Management (BLM). Section 309 of FLPMA authorizes the Secretary to establish 10 to 15 member citizen-based advisory councils, whose operation shall be consistent with the requirements of the Federal Advisory Committee Act (FACA). As required by FACA, Resource Advisory Council

(RAC)membership must be balanced and representative of the various interests concerned with the management of the public lands. The BLM regulations governing RACs are found at 43 CFR part 1784. The BLM Utah State Office is hosting a call for nominations for a Transportation/Rights-of-Way position on the Utah RAC. Upon appointment, the individual selected to this position will fill the seat until September 20, 2008, the remainder of this position's term. DATES: BLM will accept public nominations until September 5, 2006. Applicants are requested to submit a completed nomination form and reference letters to the address listed below. FOR FURTHER INFORMATION CONTACT: Sherry Foot, Special Programs Coordinator, Utah State Office, Bureau of Land Management, 440 West 200 South, Suite 500, Salt Lake City, Utah, 84101; telephone

(801)539-4195. SUPPLEMENTARY INFORMATION: Individuals may nominate themselves or others. Nominees must be residents of Utah. BLM will evaluate nominees based on their education, training, experience, and their knowledge of the geographical area of the RAC. Nominees should demonstrate a commitment to collaborative resource decision making. The following must accompany nominations: • Letters of reference from represented interests or organizations; • A completed background information nomination form (contact Sherry Foot at

(801)539-4195 to obtain a nomination form); and • Any other information that highlights the nominee's qualifications. Dated: May 16, 2006. John Mehlhoff, Acting Associate State Director. [FR Doc. E6-12559 Filed 8-2-06; 8:45 am] BILLING CODE 4310-$$-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [ID-300-1020-PH] Notice of Public Meetings, Idaho Falls District Resource Advisory Council Meeting and Challis OHV Subgroup Meeting AGENCY: Bureau of Land Management, Interior. ACTION: Notice of public meetings. SUMMARY: In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management

(BLM)Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below. DATES: Two meetings have been scheduled in September 2006. The first will be a meeting of the Off-Highway Vehicle Subgroup of the RAC, which will be an open house at Challis High School, September 6, 2006 from 7 p.m. to 9 p.m. The purpose of the meeting is for the RAC Subgroup to begin gathering public input that will be given to the BLM Challis Field Office as part of its comprehensive Travel Management Plan. The public is encouraged to attend. The second meeting in September is the RAC's regularly-scheduled quarterly meeting. This will be held September 19-20, 2006 at the BLM Challis Field Office, 801 Blue Mountain Road in Challis, Idaho. The meeting will begin September 19 at 10 a.m. and will conclude before 5 p.m. the following day. Among the scheduled agenda items are a discussion of the proposed BLM/USFS Recreation RACs in Idaho, a review of the OHV Subgroup's September 6 public meeting, a review of the Upper Snake Field Office's interactions with the Idaho National Laboratory on noxious weeds, and field tours of the Bayhorse Townsite and the Thompson Creek Mine. Transportation for the field tours will be provided for RAC members and BLM staff; other individuals wishing to attend should provide their own transportation. SUPPLEMENTARY INFORMATION: The 15-member Council advises the Secretary of the Interior, through the Bureau of Land Management, on a variety of planning and management issues associated with public land management in the BLM Idaho Falls District (IFD), which covers eastern Idaho. All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance, such as sign language interpretation, tour transportation or other reasonable accommodations, should contact the BLM as provided below. FOR FURTHER INFORMATION CONTACT: David Howell, RAC Coordinator, Idaho Falls District, 1405 Hollipark Dr., Idaho Falls, ID 83401. Telephone

(208)524-7559. E-mail: *David_Howell@blm.gov.* Dated: July 28, 2006. David Howell, RAC Coordinator, Public Affairs Specialist. [FR Doc. E6-12538 Filed 8-2-06; 8:45 am] BILLING CODE 4310-GG-P DEPARTMENT OF THE INTERIOR Bureau of Land Management Notice of Public Meeting: Resource Advisory Council to the Boise District, Bureau of Land Management, U. S. Department of the Interior AGENCY: Bureau of Land Management, U.S. Department of the Interior. ACTION: Notice of Public Meeting. SUMMARY: In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management

(BLM)Boise District Resource Advisory Council (RAC), will meet as indicated below. DATES: The meeting will be held August 29, 2006, beginning at 9 a.m. and adjourning at 5 p.m. at the Boise Foothills Environmental Learning Center, Boise, ID. A field trip is scheduled for the morning hours. Public comment periods will be held after topics on the agenda. FOR FURTHER INFORMATION CONTACT: MJ Byrne, Public Affairs Officer and RAC Coordinator, BLM Boise District, 3948 Development Ave., Boise, ID 83705, Telephone

(208)384-3393. SUPPLEMENTARY INFORMATION: The 15-member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in southwestern Idaho. The agenda and meeting topics will include the following: • Field Trip to public lands affected by development in the Four Rivers Field Office located around the Boise Valley; • Review of Action Items from previous RAC meeting; • Hot Topics; • Review and discussion of issue papers sent to RAC of planned activities in the District and three Field Offices; • Subcommittee Reports: ○ OHV & Transportation Management; ○ Sage Grouse Habitat Management; ○ Resource Management Plans

(RMPs)—Bruneau Field Office' Draft RMP-EIS Alternatives —Update on Draft EIS for the NCA-RMP ○ River and Recreation Management —Proposed Geographic Footprint for Idaho Recreation RAC's and Structure for Subgroups Agenda items and location may change due to changing circumstances, including wildfire emergencies. All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance, such as sign language interpretation, tour transportation or other reasonable accommodations, should contact the BLM Coordinator as provided above. Expedited publication is requested to give the public adequate notice. Dated: July 28, 2006. Jim Johansen, Acting District Manager. [FR Doc. E6-12550 Filed 8-2-06; 8:45 am] BILLING CODE 4310-GG-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [MT-922-06-1310-FI-P; MTM 93186, MTM 93187] Notice of Proposed Reinstatement of Terminated Oil and Gas Leases MTM 93186 and MTM 93187 AGENCY: Bureau of Land Management, Interior. ACTION: Notice. SUMMARY: Per 30 U.S.C. 188(d), Coastal Petroleum Company timely filed petitions for reinstatement of oil and gas leases MTM 93186 and MTM 93187, Valley County, Montana. The lessee paid the required rentals accruing from the date of termination. No leases were issued that affect these lands. The lessee agrees to new lease terms for rentals and royalties of $5 per acre and 16 2/3 percent or 4 percentages above the existing competitive royalty rate. The lessee paid the $500 administration fee for the reinstatement of each lease and $163 cost for publishing this Notice. The lessee met the requirements for reinstatement of the leases per Sec. 31

(d)and

(e)of the Mineral Leasing Act of 1920 (30 U.S.C. 188). We are proposing to reinstate the leases, effective the date of termination subject to: • The original terms and conditions of the leases; • The increased rental of $5 per acre for each lease; • The increased royalty of 16 2/3 percent or 4 percentages above the existing competitive royalty rate for each lease; and • The $163 cost of publishing this Notice. FOR FURTHER INFORMATION CONTACT: Karen L. Johnson, Chief, Fluids Adjudication Section, BLM Montana State Office, 5001 Southgate Drive, Billings, Montana 59101-4669, 406-896-5098. Dated: July 27, 2006. Karen L. Johnson, Chief, Fluids Adjudication Section. [FR Doc. E6-12557 Filed 8-2-06; 8:45 am] BILLING CODE 4310-$$-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [MT-922-06-1310-FI-P; NDM 94462] Notice of Proposed Reinstatement of Terminated Oil and Gas Lease NDM 94462 AGENCY: Bureau of Land Management, Interior. ACTION: Notice. SUMMARY: Per 30 U.S.C. 188(d), Whiting Oil and Gas Corporation timely filed a petition for reinstatement of oil and gas lease. NDM 94462, Mountrail County, North Dakota. The lessee paid the required rental accruing from the date of termination. No leases were issued that affect these lands. The lessee agrees to new lease terms for rental and royalty of $10 per acre and 16 2/3 percent or 4 percentages above the existing competitive royalty rate. The lessee paid the $500 administration fee for the reinstatement of the lease and $163 cost for publishing this Notice. The lessee met the requirements for reinstatement of the lease per Sec. 31(d) and

(e)of the Mineral Leasing Act of 1920 (30 U.S.C. 188). We are proposing to reinstate the lease, effective the date of termination subject to: • The original terms and conditions of the lease; • The increased rental of $10 per acre for the lease; • The increased royalty 16 2/3 percent or 4 percentage above the existing competitive royalty rate for the lease; and • The $163 cost of publishing this Notice. FOR FURTHER INFORMATION CONTACT: Karen L. Johnson, Chief, Fluids Adjudication Section, BLM Montana State Office, 5001 Southgate Drive, Billings, Montana 59101-4669, 406-896-5098. Date: July 27, 2006. Karen L. Johnson, Chief, Fluids Adjudication section. [FR Doc. 06-6663 Filed 8-2-06; 8:45 am]

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