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 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0435] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending OMB approval on the existing reporting requirements for the information collection activity entitled “How to Use E-mail to Submit a Notice of Intent to Slaughter For Human Food Purposes.” DATES: Submit written or electronic comments on the collection of information by January 8, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry on “How to Use E-mail to Submit a Notice of Intent to Slaughter for Human Food Purposes,” Section 512j, Federal Food, Drug, and Cosmetic Act; (OMB Control Number 0910-0450)—Extension Section 512(j) of the Federal Food, Drug, and Cosmetic Act (the act), gives FDA the authority to set conditions under which animals treated with investigational new animal drugs may be marketed for food use. Under this authority, the Center for Veterinary Medicine (CVM), issues to a new animal drug sponsor (sponsors) a slaughter authorization letter that sets the terms under which investigational animals may be slaughtered. The United States Department of Agriculture (USDA), also monitors the slaughter of animals treated with investigational new animal drugs under the authority of the Meat Inspection Act (21 U.S.C. 601-95). Sponsors must submit slaughter notices each time investigational animals are presented for slaughter, unless this requirement is waived by an authorization letter ((21 CFR 511.1(b)(5)), (9 CFR 309.17)). These notifications assist CVM and USDA in monitoring the safety of the food supply. Slaughter notices were previously submitted to CVM and USDA on paper. (OMB No. 0910-0450). CVM's guidance on “How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes” provides sponsors with the option to submit a slaughter notice as an e-mail attachment to CVM and USDA by the internet. The electronic submission of slaughter notices is part of CVM's ongoing initiative to provide a method for paperless submissions. The likely respondents are new animal drug sponsors. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Form No. No. of Respondents Annual Frequency per Response Total Annual Responses 2 Hours per Response Total Hours FDA Form #3488 25 .08 2 0.41 .82 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Electronic submissions received between July 1, 2005 and June 30, 2006. The number of respondents in table 1 of this document is the number of sponsors registered to make electronic submissions (25). The number of total annual responses are based on a review of the actual number of submissions made between July 1, 2005, and June 30, 2006. 2 x hours per response (.41) = .82 total hours. Submitting a slaughter notice electronically represents an alternative to submitting a notice of intent to slaughter on paper. The reporting burden for compilation and submission of this information on paper is included in OMB clearance of the information collection provisions of 21 CFR 511.1 (OMB No. 0910-0450). The estimates in Table 1 of this document reflect the burden associated with putting the same information on FDA Form #3488 and resulted from previous discussions with sponsors about the time necessary to complete this form. Dated: November 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18896 Filed 11-7-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0432] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(OMB)approval on the existing reporting requirements relating to how one may submit information electronically to the Center for Veterinary Medicine (CVM), using e-mail. DATES: Submit written or electronic comments on the collection of information by January 8, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine—21 CFR 11.2 (OMB Control Number 0910-0454—Extension) CVM accepts certain types of submissions electronically with no requirement for a paper copy. These types of documents are listed in public docket 97S-0251 as required by 21 CFR 11.2. CVM's ability to receive and process information submitted electronically is limited by its current information technology capabilities and the requirements of the Electronic Records; Electronic Signatures final regulation. CVM's guidance entitled “Guidance for Industry #108: “How to Submit Information in Electronic Format by E-Mail” outlines general standards to be used for the submission of any information by e-mail. The likely respondents are sponsors for new animal drug applications. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses 2 Hours per Respondent Total Hours 11.2 25 5.62 140 .08 11.2 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Electronic submissions received between July 1, 2005, and June 30, 2006. The number of respondents in table 1 of this document is the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 3006. (140 x hours per response (.08) =11.2 total hours.) Dated: November 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18901 Filed 11-7-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0436] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Use E-Mail To Submit A Study Protocol AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending OMB approval of existing reporting requirements for the information collection activity on guidance for industry on “How to Use E-Mail to Submit a Study Protocol.” DATES: Submit written or electronic comments on the collection of information by January 8, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry on “How to Use E-Mail to Submit a Study Protocol—21 CFR 58.120; 21 CFR 514.117(b); (OMB Control Number 0910-0524)—Extension Protocols for nonclinical laboratory studies (safety studies), are required under 21 CFR 58.120 for approval of new animal drugs. Protocols for adequate and well-controlled effectiveness studies are required under 21 CFR 514.117(b). Upon request by the animal drug sponsors, the Center for Veterinary Medicine (CVM), reviews protocols for safety and effectiveness studies that CVM and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application. Establishing a process for acceptance of the electronic submission of protocols for studies conducted by sponsors in support of new animal drug applications, is part of CVM's ongoing initiative to provide a method for paperless submissions. Sponsors may submit protocols to CVM in paper format. CVM's guidance on how to submit a study protocol permits sponsors to submit a protocol without data as an e-mail attachment via the Internet. CVM's guidance on how to submit a study protocol electronically implements provisions of the Government Paperwork Elimination Act (GPEA). The GPEA requires Federal agencies, by October 21, 2003, to provide for the following:

(1)The option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitution for paper; and

(2)the use and acceptance of electronic signatures, where applicable. FDA is also seeking an extension of an existing paperwork clearance for form FDA 3536 to facilitate the use of electronic submission of protocols. This collection of information is for the benefit of animal drug sponsors, giving them the flexibility to submit data for review via the Internet. The likely respondents are sponsors of new animal drug applications. FDA estimates the burden for this collection of information as follows 1 : 21 CFR Section/FDA Form No. No. of Respondents Annual Frequency per Response Total Annual Responses 2 Hours per Response Total Hours 514.117(b), 58.120/Form 3536 25 4.2 103 .20 20.6 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Electronic submissions received between July 1, 2005, and June 30, 2006. The number of respondents in Table 1 of this document is the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 2006. 103 x hours per response (.20) = 20.6 total hours. Dated: November 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18908 Filed 11-7-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0434] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance For Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(OMB)approval of existing reporting requirements on electronic submission of requests for meetings, in person or via teleconference, to discuss with animal drug sponsors studies to be conducted and how to meet the statutory requirements for drug approval under the Federal Food, Drug, and Cosmetic Act. Requests for meetings about new animal drug submissions were previously submitted on paper copy to the Center for Veterinary Medicine (CVM). DATES: Submit written or electronic comments on the collection of information by January 8, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation—21 CFR 10.65 (OMB Control Number—(0910-0452)—Extension CVM holds meetings and/or teleconferences when a sponsor requests a presubmission conference under 21 CFR 514.5, or requests a meeting to discuss general questions. Generally, meeting requests are submitted to CVM on paper. However, CVM now allows registered sponsors to submit information electronically, and to request meetings electronically, if they determine this is more efficient and time saving for them. CVM's guidance entitled “How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation” provides sponsors with the option to submit a request for a meeting or teleconference as an e-mail attachment by the Internet. The likely respondents are sponsors for new animal drug applications. CVM estimates the burden for this information collection activity as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section/FDA Form # No. of Respondents Annual Frequency per Response Total Annual Responses 2 Hours per Respondent Total Hours 10.65/FDA Form 3489 25 6.24 156 .08 12.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Electronic submissions received between July 1, 2005, and June 30, 2006. The number of respondents in table 1 of this document is the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 2006. (156 x hours per response (.08) = 12.5 total hours). Dated: November 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18911 Filed 11-7-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Mice Lacking Expression of Chemokine Receptor CCR9 Generated by Gene Targeting (CCR9 KO Mice) *Description of Technology:* Chemokines and their receptors are key regulators of thymocytes migration and maturation in normal and inflammation conditions. The chemokine CCL25 is highly expressed in the thymus and small intestine. CCR9, the receptor for CCL25, is expressed on the majority of thymocytes, indicating that CCR9 and its ligand may play an important role in thymocyte development. To investigate the role of CCR9 during lymphocyte development, CCR9 knockout mice were developed. Knockout mice had increased numbers of peripheral γδ-T cells but reduced numbers of αβ-T cells. In competitive transplantation experiments bone marrow from CCR9 knockout mice was much less efficient at repopulating the thymus than control (wild type) bone marrow. Thus, CCR9 KO mice are a model for studying thymocyte development and trafficking in the body. Additionally, as the ligand for CCR9 is highly expressed in the small intestine, CCR9 potentially plays a role in the specialization of immune responses in the gastrointestinal tract. *Applications:*

(1)Evaluate drugs aimed at blocking or augmenting lymphocyte trafficking;

(2)A model for studying T cell development;

(3)A model for studying immunological based gastrointestinal disorders. *Inventors:* Paul E. Love (NICHD), Joshua M. Farber (NIAID), Shoji Uehara (NICHD). *Publications:* 1. S Uehara *et al.* A role for CCR9 in T lymphocyte development and migration. J Immunol. 2002 Mar 15;168(6):2812-2819. 2. S Uehara *et al.* Characterization of CCR9 expression and CCL25/thymus-expressed chemokine responsiveness during T cell development: CD3 high CD69+ thymocytes and γδ TCR+ thymocytes preferentially respond to CCL25. J Immunol. 2002 Jan 1;168(1):134-142. *Patent Status:* HHS Reference No. E-328-2006/0—Research Tool. *Licensing Status:* This technology is available as a research tool under a Biological Materials License. *Licensing Contact:* Jennifer Wong; 301/435-4633; *wongje@mail.nih.gov. * mFPR2 Transgenic and Knockout Mouse Models for Alzheimer's and Other Inflammatory Diseases *Description of Technology:* Human Formyl Peptide-Like Receptor 1 (hFPLR1) has been implicated in host defense for disease processes including Alzheimer's disease, infection, and other inflammatory diseases. hFPLR1 and its mouse homologue Formyl Peptide Receptor 2 (mFPR2) are G-protein coupled receptors that are expressed at high levels on phagocytic leukocytes, mediating leukocyte chemotaxis and activation in response to a number of pathogen- and host-derived peptides. Activation of hFPRL1/mFPR2 by lipoxin A4 may play a role in preventing and resolving inflammation. Also, hFPRL1/mFPR2 has been shown to mediate the chemotactic activity of amyloid β 1-42, a key pathogenic peptide in Alzheimer's disease. Available for licensing are mice expressing the mFPR2 transgene on either the FVB or C58BL background, as well as mFPR2 knockout mice on the C57BL background. These mice are anticipated to be highly useful in the study of a wide variety of inflammatory, infectious, immunologic and neurodegenerative diseases. *Applications:*

(1)Drug development model for Alzheimer's disease and other inflammatory diseases;

(2)Tool to probe the role of hFPRL1/mFPR2 in host responses in a variety of disease processes, including inflammatory, infectious, immunologic, and neurodegenerative disease. *Inventors:* Ji Ming Wang *et al.* (NCI). *Related Publications:* 1. K Chen, P Iribarren, J Hu, J Chen, W Gong, EH Cho, S Lockett, NM Dunlop, and JM Wang. Activation of Toll-like receptor 2 on microglia promotes cell uptake of Alzheimer disease-associated amyloid beta peptide. J Biol Chem. 2006 Feb 10;281(6):3651-3659. 2. H Yazawa, ZX Yu, Takeda, Y Le, W Gong, VJ Ferrans, JJ Oppenheim, CC Li, and JM Wang. Beta amyloid peptide (Abeta42) is internalized via the G-protein-coupled receptor FPRL1 and forms fibrillar aggregates in macrophages. FASEB J. 2001 Nov;15(13):2454-2462. 3. YH Cui, Y Le, W Gong, P Proost, J Van Damme, WJ Murphy, and JM Wang. Bacterial lipopolysaccharide selectively up-regulates the function of the chemotactic peptide receptor formyl peptide receptor 2 in murine microglial cells. J Immunol. 2002 Jan 1;168(1):434-442. *Patent Status:* HHS Reference No. E-303-2006/0—Research Tool. *Licensing Status:* This technology is available as a research tool under a Biological Materials License. *Licensing Contact:* Tara L. Kirby, Ph.D.; 301/435-4426; *tarak@mail.nih.gov.* *Collaborative Research Opportunity:* The National Cancer Institute—Frederick, Laboratory of Molecular Immunoregulation, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize mFPR2 Transgenic and Knockout Mouse Models for Alzheimer's and Other Inflammatory Diseases. Please contact Betty Tong, Ph.D. at 301-594-4263 or *tongb@mail.nih.gov* for more information. Vaccine Production Strain for Acellular Pertussis Vaccine *Description of Technology:* Available for licensing from the NIH is a vaccine production strain of Bordetella bronchiseptica that produces Bordetella pertussis toxin in high yield. The Bordetella bronchiseptica strain has been modified to eliminate expression of filamentous hemagglutinin, which typically has to be removed in purification of the toxin, thereby reducing the yield of the active vaccine component. Immediately available for licensing is a strain that encodes a mutated pertussis toxin, which does not have to be chemically detoxified. *Application:* Production of Bordatella pertussis toxin for acellular vaccine use. *Inventors:* Tod Merkel, Jerry Keith, and Xiaoming Yang (NIDCR). *Patent Status:* U.S. Patent No. 7,101,558 issued 05 Sep 2006 (HHS Reference No. E-159-1999/0-US-03). *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov* . HSV-2 Diagnostic *Description of Technology:* The present invention relates to novel diagnostic methods for Herpes Simplex Virus Type 2 (HSV-2). HSV-2 infects approximately one fifth of adults in the United States and is the most common cause of genital ulceration. The invention relates to the detection of HSV-2 based on a transforming nucleic acid sequence and its protein product. This DNA sequence harbors the potential to induce the tumorigenic transformation of normal cells in *in vitro* and *in vivo* assays and thus will be useful as a means of prognostic evaluation in predicting the development of genital or cervical cancer. Current HSV-2 diagnostic tests relying on tedious viral culture and/or immunoassays that do not have the sensitivity and the specificity essential for diagnosis. Using PCR, the current invention will provide a superior method for viral detection and subtyping. *Application:* HSV-2 diagnostic. *Inventors:* Joseph A. DiPaolo (NCI-) *Publication:* JA DiPaolo *et al.* Relationship of stable integration of herpes simplex virus-2 Bg/II N subfragment Xho2 to malignant transformation of human papillomavirus-immortalized cervical keratinocytes. Int J Cancer 1998 Jun 10;76(6):865-871. *Patent Status:* U.S. Patent 6,617,103 issued 09 Sep 2003 (HHS Reference No. E-091-1999/0-US-03); CA Application 2,259,657 filed 30 Jun 1997 (HHS Reference No. E-091-1999/0-CA-04). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov* . *Collaborative Research Opportunity:* The NCI Division of Basic Science is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize HSV-2 Diagnostic. Please contact Betty Tong, Ph.D. at 301-594-4263 or *tongb@mail.nih.gov* for more information. Dated: October 24, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-18885 Filed 11-7-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Briefs on Genistein and Soy Formula; Request for Public Comments AGENCY: National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH). ACTION: Request for comments. SUMMARY: CERHR invites the submission of public comments on the draft NTP Briefs on Genistein and Soy Formula. The draft NTP Briefs are available from the CERHR Web site ( *http://cerhr.niehs.nih.gov* see “CERHR Reports & Monographs”) or in hardcopy from CERHR (see ADDRESSES below). Public comments will be considered during peer review and finalization of the NTP Briefs. DATES: Written comments on the draft NTP Briefs on Genistein and Soy Formula should be received by December 8, 2006. ADDRESSES: Public comments and any other correspondence should be addressed to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709 (mail),

(919)541-3455 (phone),

(919)316-4511 (fax), or *shelby@niehs.nih.gov* (e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709. SUPPLEMENTARY INFORMATION: Background Genistein (CAS RN: 446-72-0) is a phytoestrogen found in some legumes, especially soybeans. Genistein is found in many food products, especially soy-based foods such as tofu, soy milk, and soy infant formula, and in some over-the-counter dietary supplements. Soy formula is fed to infants as a supplement or replacement for human milk or cow milk. On March 15-17, 2006, CERHR convened an expert panel to conduct evaluations of the potential reproductive and developmental toxicities of genistein and soy formula. The expert panel reports were released for public comment on May 5, 2006 ( **Federal Register** Vol. 71, No. 94, pp. 28368, May 16, 2006). Following this public comment period, CERHR staff prepared draft NTP Briefs on Genistein and Soy Formula that provides in plain language: • Background information on the substance(s). • Findings of the expert panel. • Discussion of any relevant data available after the expert panel meeting. • NTP's conclusions on the potential for the substance to cause adverse reproductive and/or developmental effects in exposed humans. Upon finalization, the NTP Briefs on Genistein and Soy Formula will be included in the CERHR Monographs on Genistein and Soy Formula. The draft NTP Briefs on Genistein and Soy Formula and related background materials, including the genistein expert panel report, soy formula expert panel report, and previously received public comments, are available on the CERHR Web site ( *http://cerhr.niehs.nih.gov* see Genistein and Soy Formula under “CERHR Reports & Monographs”). Request for Comments The NTP invites written public comments on the draft NTP Briefs on Genistein and Soy Formula. Any comments received will be posted on the CERHR Web site and considered during the peer reviews and finalization of the NTP Brief on Genistein and the NTP Brief on Soy Formula. Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone and facsimile numbers, e-mail, and sponsoring organization, if any) and submit comments to Dr. Shelby (see ADDRESSES above) for receipt by December 8, 2006. Background Information on CERHR The NTP established CERHR in June 1998 [ **Federal Register** , December 14, 1998 (Volume 63, Number 239, page 68782)]. CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. CERHR invites the nomination of agents for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its homepage ( *http://cerhr.niehs.nih.gov* ) or by contacting Dr. Michael Shelby, CERHR Director (see ADDRESSES ). CERHR selects chemicals for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent of public concern, and extent of data from reproductive and developmental toxicity studies. Expert panels conduct scientific evaluations of agents selected by CERHR in public forums. Following these evaluations, CERHR prepares the NTP-CERHR monograph on the agent evaluated. The monograph is transmitted to appropriate Federal and State agencies and made available to the public. Dated: October 31, 2006. David A. Schwartz, Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6-18796 Filed 11-7-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice and request for comments. SUMMARY: The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the Hazard Mitigation Grant Program reporting requirements. SUPPLEMENTARY INFORMATION: Section 404 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 44 U.S.C. 5170c, establishes the Hazard Mitigation Grant Program. Grant requirements, and grants management procedures of the program are outlined in 44 CFR Part 13. Collection of Information *Title:* Hazard Mitigation Grant Program Application and Reporting. *Type of Information Collection:* Revision of a currently approved collection. *OMB Number:* 1660-0076. *Form Numbers:* None. *Abstract:* Grantees administer the Hazard Mitigation Grant Program, which is a post-disaster program that contributes funds toward the cost of hazard mitigation activities in order to reduce the risk of future damage hardship, loss or suffering in any area affected by a major disaster. FEMA uses applications to provide financial assistance in the form of grant awards and, through grantee quarterly reporting, monitors grantee project activities and expenditure of funds. *Affected Public:* State, local or tribal government. *Estimated Total Annual Burden Hours:* Annual Burden Hours Data collection activities/instruments Number of respondents

(A)Frequency of responses

(B)Burden hours per respondent

(C)Annual responses (D=A×B) Total annual burden hours (E=C×D) Project Narrative section 209.8(b) 56 18 12 1008 12,096 Benefit-Cost Determination 56 18 5 1008 5,040 Environmental Review 56 18 7.5 1008 7,560 FEMA 345, HMGP Desk Reference 56 1 4 56 224 Annual Audit & Audit Trail Requirements 56 1 40 56 2,240 Total Burden for HMGP 56 56 3136 27,160 *Estimated Cost:* The State Hazard Mitigation Office staff is usually comprised of urban and regional planners. Wage rates for urban and regional planners were determined using data from the U.S. Department of Labor, Bureau of Labor Statistics (BLS). Currently, BLS data indicate that the median hourly earnings of urban and regional planners for 2004 were $26.75 for an annualized cost of $726,530. *Comments:* Written comments are solicited to

(a)evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility;

(b)evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c)enhance the quality, utility, and clarity of the information to be collected; and

(d)minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submission of responses. Comments must be submitted on or before January 8, 2007. ADDRESSES: Interested persons should submit written comments to Chief, Records Management and Privacy, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, 500 C Street, SW., Room 316, Washington, DC 20472. FOR FURTHER INFORMATION CONTACT: Contact Cecelia Rosenberg, Chief, Grants Policy Section, Mitigation Division,

(202)646-3321 for additional information. You may contact the Records Management Branch for copies of the proposed collection of information at facsimile number

(202)646-3347 or e-mail address: *FEMA-Information-Collections@dhs.gov* . Dated: November 2, 2006. John A. Sharetts-Sullivan, Chief, Records Management and Privacy Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-18834 Filed 11-7-06; 8:45 am] BILLING CODE 9110-41-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1666-DR] Alaska; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Alaska (FEMA-1666-DR), dated October 27, 2006, and related determinations. DATES: *Effective Date:* October 27, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated October 27, 2006, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Alaska resulting from a fire during the period of August 3-4, 2006, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Alaska. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Public Assistance in the designated area, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs. If Other Needs Assistance under Section 408 of the Stafford Act is later warranted, Federal funding under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The Federal Emergency Management Agency

(FEMA)hereby gives notice that pursuant to the authority vested in the Director, under Executive Order 12148, as amended, William M. Lokey, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Alaska to have been affected adversely by this declared major disaster: The City of Hooper Bay within the Lower Yukon Regional Educational Attendance Area for Public Assistance. All boroughs and Regional Educational Attendance Areas in the State of Alaska are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers

(202)646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Indiana is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of October 6, 2006: Warrick County for Individual Assistance. (The following Catalog of Federal Domestic Assistance Numbers

(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident period for this emergency is closed effective October 25, 2006. (The following Catalog of Federal Domestic Assistance Numbers

(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program—Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-18838 Filed 11-7-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF THE INTERIOR Office of the Secretary Natural Resource Damage Assessment and Restoration Program Office; Notice of Natural Resource Damage Assessment and Restoration Advisory Committee Meeting ACTION: Notice; FACA Committee meeting announcement. SUMMARY: As required by the Federal Advisory Committee Act, Public Law 92-463, the Department of the Interior, Natural Resource Damage Assessment and Restoration Program Office gives notice of the fourth meeting of the Department's Natural Resource Damage Assessment and Restoration Advisory Committee. The Advisory Committee will meet at the U.S. Department of the Interior, South Building Auditorium, 1951 Constitution Avenue, NW., Washington, DC 20240 from 8:30 a.m. to 5 p.m. on November 29 and November 30, 2006. Members of the public are invited to attend the Committee Meeting to listen to the committee proceedings and to provide public input. *Public Input:* Any member of the public interested in providing public input at the Committee Meeting should contact Mr. Steve Glomb, whose contact information is listed under the FOR FURTHER INFORMATION CONTACT section of this notice. Each individual providing oral input is requested to limit those comments to three minutes. This time frame may be adjusted to accommodate all those who would like to speak. Requests to be added to the public speaker list must be received in writing (letter, e-mail, or fax) by noon eastern standard time on November 20, 2006. Anyone wishing to submit written comments should provide a copy of those comments to Mr. Glomb in the following formats: One hard copy with original signature, and one electronic copy via e-mail (acceptable file formats are: Adobe Acrobat, WordPerfect, Word, or Rich Text files) by noon eastern standard time on November 20, 2006. *Document Availability:* Interested individuals may view the draft agenda for the meeting online at *http://restoration.doi.gov/faca* or may request the draft agenda from Mr. Glomb. In preparation for this meeting of the Advisory Committee, the Committee and the public can find helpful background information at the Restoration Program Web site *http://restoration.doi.gov.* The site provides a good introduction to the program for those who are relatively new to the damage assessment and restoration arena and a useful reference for seasoned practitioners and policy leaders. Links to the statutory and regulatory framework for the program are found at *http://restoration.doi.gov/laws.htm.* DOI Program policies are found at *http://restoration.doi.gov/policy.htm.* Agenda for Meeting The agenda will cover the following principal subjects: —Presentation and discussion on cultural services provided by natural resources. —Discussion of subcommittee reports. —Formal public input (if any). —Committee agreement on each subcommittee scope and plan. —Develop schedule for next Committee meeting. We estimate that each subcommittee report, discussion, and associated public input will take approximately three to four hours. However, the timeframes will remain flexible. If a subcommittee report and discussion requires less time, the committee will move directly on to the next topic. *Meeting Access:* Individuals requiring special accommodation at this meeting must contact Mr. Steve Glomb (see contact information below) by noon eastern standard time on November 15, 2006, so that appropriate arrangements can be made. DATES: November 29, 2006, from 8:30 a.m. to 5 p.m. (open to the public). November 30, 2006, from 8:30 a.m. to 5 p.m. (open to the public). ADDRESSES: Auditorium, U.S Department of the Interior, South Building, 1951 Constitution Avenue, NW., Washington, DC 20240. All individuals attending the Committee Meeting will be required to present photo identification to security officers to gain access to the South Interior Building. FOR FURTHER INFORMATION CONTACT: Steve Glomb, U.S. Department of the Interior, Natural Resource Damage Assessment and Restoration Program, Mail Stop MIB 4449, 1849 C Street, NW., Washington, DC 20240; phone 202-208-4863; fax 202-208-2681; or *steve_glomb@ios.doi.gov* . Dated: November 3, 2006. Frank M. DeLuise, Designated Federal Officer, DOI Natural Resource Damage Assessment and Restoration Advisory Committee. [FR Doc. E6-18871 Filed 11-7-06; 8:45 am] BILLING CODE 6820-PE-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Construction of a Commercial Park, Brevard County, FL AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice: receipt of application for an incidental take permit; request for comments. SUMMARY: We, the Fish and Wildlife Service (Service), announce the availability of one ITP and Habitat Conservation Plan (HCP)/Application for one incidental take permit. Marsol Development Corporation (Applicant) requests an incidental take permit

(ITP)for a duration of 2 years pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (Act). The Applicant anticipates taking about 7.5 acres of Florida scrub-jay ( *Aphelocoma coerulescens* ) (scrub-jay) foraging, sheltering, and possibly nesting habitat incidental to lot preparation for the construction of a commercial park and supporting infrastructure in Brevard County, Florida (Project). The destruction of 7.5 acres of foraging, sheltering, and possibly nesting habitat is expected to result in the take of one family of scrub-jays. The Applicant's Habitat Conservation Plan

(HCP)describes the mitigation and minimization measures proposed to address the effects of the Project to the Florida scrub-jay. DATES: We must receive any written comments on the ITP application and HCP at the Jacksonville Field Office (see ADDRESSES ) on or before December 8, 2006. ADDRESSES: Persons wishing to review the application and HCP may obtain a copy by writing the Service's Jacksonville Field Office. Please reference permit number TE126179-0 in such requests. Documents will also be available for public inspection by appointment during normal business hours at the Jacksonville Field Office, 6620 Southpoint Drive South, Suite 310, Jacksonville, Florida 32216-0912. FOR FURTHER INFORMATION CONTACT: Ms. Erin Gawera, Fish and Wildlife Biologist, Jacksonville Field Office (see ADDRESSES ), telephone: 904/232-2580, ext. 121. SUPPLEMENTARY INFORMATION: If you wish to comment, you may submit comments by any one of several methods. Please reference permit number TE126179-0 in all requests or comments. You may mail comments to the Service's Jacksonville Field Office (see ADDRESSES ). You may also comment via the internet to *erin_gawera@fws.gov* . Please include your name and return address in your internet message. If you do not receive a confirmation from us that we have received your internet message, contact us directly at the telephone number listed above ( FOR FURTHER INFORMATION CONTACT ). Finally, you may hand deliver comments to the Service office listed under ADDRESSES . Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address from the administrative record. We will honor such requests to the extent allowable by law. There may also be other circumstances in which we would withhold from the administrative record a respondent's identity, as allowable by law. If you wish us to withhold your name and address, you must state this prominently at the beginning of your comments. We will not, however, consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. Commercial construction for Marsol Development Corporation will take place within Section 31, Township 26 South, Range 37 East, Port St. Johns, Brevard County, Florida, on the southeast corner of Wickham Road and Summer Brook Drive. This parcel is within locations where scrub-jays were sighted during surveys for this species during the period 1999-2003. The project encompasses about 9.0 acres, of which there is 7.5 acres of scrub-jay foraging, sheltering, and possibly nesting habitat. The footprint of the commercial park, infrastructure, and landscaping preclude retention of scrub-jay habitat. In order to minimize take on site, the Applicant agrees to avoid construction during the nesting season if active nests are found on site, but no other on-site minimization measures are proposed to reduce take of scrub-jays. The Applicant proposes to mitigate for the loss of 7.5 acres of scrub-jay habitat by purchasing a minimum of 15 acres of occupied scrub-jay habitat within property in holdings mapped within the Valkaria portion of the Brevard County Environmentally Endangered Lands Program

(EEL)Coastal Scrub Ecosystem. In addition, $1,200 per acre will be provided for management of this land. The Service has determined that the Applicant's proposal, including the proposed mitigation and minimization measures, will have a minor or negligible effect on the species covered in the HCP. Therefore, the ITP is a “low-effect” project and qualifies as a categorical exclusion under the National Environmental Policy Act (NEPA), as provided by the Department of the Interior Manual (516 DM 2 Appendix 1 and 516 DM 6 Appendix 1). This preliminary information may be revised based on our review of public comments that we receive in response to this notice. Low-effect HCPs are those involving

(1)minor or negligible effects on federally listed or candidate species and their habitats, and

(2)minor or negligible effects on other environmental values or resources. The Service will evaluate the HCP and comments submitted thereon to determine whether the application meets the requirements of section 10(a) of the Act (16 U.S.C. 1531 *et seq.* ). If it is determined that those requirements are met, the ITP will be issued for the incidental take of the Florida scrub-jay. The Service will also evaluate whether issuance of the section 10(a)(1)(B) ITP complies with section 7 of the Act by conducting an intra-Service section 7 consultation. The results of this consultation, in combination with the above findings, will be used in the final analysis to determine whether or not to issue the ITP. Authority: This notice is provided pursuant to Section 10 of the Endangered Species Act and NEPA regulations (40 CFR 1506.6). Dated: October 17, 2006. David L. Hankla, Field Supervisor, Jacksonville Field Office. [FR Doc. E6-18822 Filed 11-7-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Proposed Holland Properties Safe Harbor Agreement, Orange County, FL AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice. This notice advises the public that Holland Properties Inc. (Applicant), has applied to the Fish and Wildlife Service (Service) for an enhancement of survival permit (permit) pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1539 *et seq.* ). The permit application includes a proposed Safe Harbor Agreement (Agreement) for the endangered red-cockaded woodpecker ( *Picoides borealis* ) (Woodpecker) for a period of 30 years. We (the Service) announce the opening of a 30-day comment period and request comments from the public on the Applicant's enhancement of survival permit application and the accompanying proposed Agreement. All comments we receive, including names and addresses, will become part of the administrative record and may be released to the public. For further information and instructions on reviewing and commenting on this application, see the ADDRESSES section, below. DATES: Written comments should be received on or before December 8, 2006. ADDRESSES: You may obtain a copy of the information available by contacting the Service's Regional Safe Harbor Coordinator, U.S. Fish and Wildlife Service, 1875 Century Boulevard, Suite 200, Atlanta, Georgia 30345, or Field Supervisor, U.S. Fish and Wildlife Service, 6620 Southpoint Drive S., Suite 310, Jacksonville, Florida 32216. Alternatively, you may set up an appointment to view these documents at either location during normal business hours. Written data or comments should be submitted to the Atlanta, Georgia, Regional Office. Requests for the documentation must be in writing to be processed, and comments must be written to be considered. FOR FURTHER INFORMATION CONTACT: Mr. Rick Gooch (telephone: 404/679-7124; facsimile: 404/679-7081), or Ms. Annie Dziergowski (telephone: 904/232-2580; facsimile: 904/232-2404). SUPPLEMENTARY INFORMATION: Under a safe harbor agreement, a participating property owner voluntarily undertakes management activities on its property to enhance, restore, or maintain habitat benefiting species listed under the Endangered Species Act. Agreements encourage private and other non-Federal property owners to implement conservation efforts for listed species by assuring them they will not be subjected to increased property use restrictions if their efforts attract listed species to their property or increase the numbers of listed species already on their property. Application requirements and issuance criteria for enhancement of survival permits through safe harbor agreements are found in 50 CFR 17.22 and 17.32. We have worked with the Applicant to design conservation measures intended to benefit the Woodpecker on about 3,863 acres of pine-dominated forest in southern Orange County. Under the Agreement, the Applicant will undertake the following actions:

(1)Implement a prescribed fire program designed to maintain and enhance pine stand characteristics suitable for the Woodpecker;

(2)implement forest management actions to enhance existing pine stocking densities and reduce hardwood canopies;

(3)enhance future pine stocking densities by planting;

(4)enhance existing Woodpecker clusters through construction of artificial cavities;

(5)create potential new cluster sites using artificial cavity inserts; and

(6)translocate individual Woodpeckers within the enrolled property to enhance pair-bond formation and establish new groups. The Applicant's property currently supports seven clusters of Woodpeckers. Conservation measures proposed by the Applicant will enhance existing habitat conditions and contribute to the continued survival of the seven Woodpecker clusters currently residing on the property. In addition, the Applicant intends to similarly manage unoccupied habitat in a similar manner that will create suitable habitat for Woodpeckers. The Applicant anticipates that the proposed conservation measures will lead to additional groups of Woodpeckers inhabiting the enrolled property. Without the proposed Agreement, it would not be possible for the Applicant to undertake the proposed conservation measures and receive regulatory assurances from the Service through the Endangered Species Act. Consistent with the Service's Safe Harbor policy and implementing regulations, we propose to issue a permit to the Applicant authorizing the incidental take of Woodpeckers, that occur on the enrolled lands through lawful activities on the enrolled land, as long as baseline conditions are maintained and terms of the Agreement are implemented. Future activities of the Applicant could result in a return to the baseline condition, but the Applicant has indicated that a return to baseline condition is not anticipated. This Notice also advises the public that the Service has made a preliminary determination that issuance of the enhancement of survival permit will not result in significant impacts to the human environment and is, therefore, categorically excluded from review under the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4331 *et seq.* ) (NEPA), pursuant to 516 Departmental Manual 2, Appendix 1 and 516 Departmental Manual 6, Appendix 1. This Notice is provided pursuant to Section 10 of the Endangered Species Act. The Service specifically requests information, views, and opinions from the public. We will evaluate the proposed Agreement, associated documents, and comments submitted by the public to determine whether the requirements of Section 10(a) of the Endangered Species Act and NEPA regulations have been met. If we determine that the requirements are met, we will issue an enhancement of survival permit under Section 10(a)(1)(A) of the Endangered Species Act to the Applicant in accordance with the terms of the Agreement and specific terms and conditions of the authorizing permit. We will not make our final decision until the end of the 30-day comment period and will fully consider all comments received during the comment period. Dated: October 18, 2006. Jeffrey M. Fleming, Southeast Region, Acting Regional Director. [FR Doc. E6-18827 Filed 11-7-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Meeting Announcement: Sporting Conservation Council AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of meeting. SUMMARY: This notice announces a meeting of the Sporting Conservation Council (Council). This meeting is designed to review wildlife conservation endeavors that benefit recreational hunting and wildlife resources and that encourage partnerships among the public, the sporting conservation community, wildlife conservation groups, and State and Federal governments. This meeting is open to the public, and will include a session for the public to comment. DATES: We will hold the meeting on November 28, 2006, from 10 a.m. to 4:30 p.m. and on November 29, 2006, from 9 a.m. to 4:30 p.m. From 9 a.m. to 10 a.m. on November 29, we will host a public comment session. ADDRESSES: The meeting will be held in the Riviera Room at the Omni Corpus Christi Hotel Marina, 707 North Shoreline Blvd., Corpus Christi, Texas 78401. FOR FURTHER INFORMATION CONTACT: Phyllis T. Seitts, 9828 North 31st Avenue, Phoenix, Arizona 85051-2517; 602-906-5603 (phone); or *Twinkle_Thompson-Seitts@blm.gov* (e-mail). SUPPLEMENTARY INFORMATION: The Secretary of the Interior established the Council in February 2006 (71 FR 11220, March 6, 2006). The Council's mission is to provide advice and guidance to the Federal Government through the Department of the Interior on how to increase public awareness of:

(1)The importance of wildlife resources,

(2)the social and economic benefits of recreational hunting, and

(3)wildlife conservation efforts that benefit recreational hunting and wildlife resources. The Secretary of the Interior and the Secretary of Agriculture signed an amended charter for the Council in June 2006 and July 2006, respectively. The revised charter states that the Council will provide advice and guidance to the Federal Government through the Department of the Interior and the Department of Agriculture. The Council will hold a meeting on the dates shown in the DATES section at the address shown in the ADDRESSES section. The meeting will include a session for the public to comment. Dated: November 2, 2006. Phyllis T. Seitts, Designated Federal Officer, Sporting Conservation Council. [FR Doc. E6-18913 Filed 11-7-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [AK-910-1310PP-ARAC] Notice of Public Meeting, Alaska Resource Advisory Council AGENCY: Bureau of Land Management, Alaska State Office, 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)Alaska Resource Advisory Council will meet as indicated below. DATES: The meeting will be held December 13-14, 2006, at the University of Alaska—Anchorage campus, Library Building, Third Floor, Anchorage, Alaska. The December 13 meeting starts at 1 p.m. in Room 302A. The December 14 meeting begins at 8 a.m. in Room 307 with a public comment period starting at 1 p.m. FOR FURTHER INFORMATION CONTACT: Danielle Allen, Alaska State Office, 222 W. 7th Avenue #13, Anchorage, AK 99513. Telephone

(907)271-3335 or e-mail *Danielle_Allen@ak.blm.gov* . 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 Alaska. At this meeting, topics planned for discussion include: • National Petroleum Reserve—Alaska • Community Based Planning • Lands Transfer Program • Other topics the Council may raise All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allotted for hearing public comments. Depending on the number of people 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, transportation, or other reasonable accommodations, should contact BLM. Dated: November 1, 2006. Julia Dougan, Acting State Director. [FR Doc. E6-18836 Filed 11-7-06; 8:45 am] BILLING CODE 4310-JA-P DEPARTMENT OF THE INTERIOR National Park Service Boston Harbor Islands Advisory Council; Notice of Meeting Notice is hereby given in accordance with the Federal Advisory Committee Act (Pub. L. 92-463) that the Boston Harbor Islands Advisory Council will meet on Wednesday, December 6, 2006. The meeting will convene at 4 p.m. at Northeastern University, Shillman Hall, Room 220, Boston, MA. The Advisory Council was appointed by the Director of National Park Service pursuant to Public Law 104-333. The 28 members represent business, educational/cultural, community and environmental entities; municipalities surrounding Boston Harbor; Boston Harbor advocates; and Native American interests. The purpose of the Council is to advise and make recommendations to the Boston Harbor Islands Partnership with respect to the development and implementation of a management plan and the operations of the Boston Harbor Islands national park area. The Agenda for this meeting is as follows: 1. Call to Order, Introductions of Advisory Council members present. 2. Review and approval of minutes of the September meeting. 3. Preparation for the Annual Meeting in March. 4. Park Update. 5. New Business. 6. Public Comment. 7. Adjourn. The meeting is open to the public. Further information concerning Council meetings may be obtained from the Superintendent, Boston Harbor Islands. Interested persons may make oral/written presentations to the Council or file written statements. Such requests should be made at least seven days prior to the meeting to: Superintendent, Boston Harbor Islands NRA, 408 Atlantic Avenue, Boston, MA 02110, telephone

(617)223-8667. Dated: October 24, 2006. Bruce Jacobson, Superintendent, Boston Harbor Islands NRA. [FR Doc. E6-18898 Filed 11-7-06; 8:45 am] BILLING CODE 4310-8G-P INTERNATIONAL TRADE COMMISSION [Investigation No. 332-478] U.S.-China Trade: Implications of U.S.-Asia-Pacific Trade and Investment Trends AGENCY: United States International Trade Commission. ACTION: Institution of investigation and scheduling of hearing. DATES: *Effective Date:* November 1, 2006. SUMMARY: Following receipt of a request letter on October 2, 2006, from the Committee on Ways and Means of the U.S. House of Representatives (Committee) under section 332(g) of the Tariff Act of 1930 (19 U.S.C. (332(g)), the U.S. International Trade Commission (Commission) instituted investigation No. 332-478, *U.S.-China Trade: Implications of U.S.-Asia-Pacific Trade and Investment Trends* . *Background:* In its October 2, 2006 letter, the Committee requested that the Commission prepare three reports with respect to U.S.-China trade, with the first report to be delivered 12 months after receipt of the letter and the second and third reports, 18 and 24 months after receipt of the letter, respectively. This notice announces institution of the first of three investigations for the purpose of preparing the requested reports. The Commission will issue separate notices relating to the second and third reports at a later date (see below). As requested by the Committee, in its first report the Commission will analyze the principal trends and patterns in trade and foreign direct investment

(FDI)between Asia-Pacific countries and the United States and their implications for the U.S.-China trade relationship. The report will include:

(1)A discussion of the main factors influencing these trends;

(2)an in-depth examination of the industries that have had a major effect on trade and investment patterns in recent years; and (3), if required, formal quantitative analyses that may help explain these trends and provide an assessment of the reliability of the data used in each analysis. The report will also review the relationship between international trade and FDI, the trade and investment policies in the major countries of the region, and their effect on economic activity both on a global scale and within the Asian and Pacific region. The Commission will provide its first report to the Committee by October 2, 2007. The Committee also directed that the Commission provide two other reports on U.S.-China trade. For the second report, the Committee asked the Commission to investigate the driving factors behind the rapid growth in U.S.-China trade. The Commission expects to initiate the investigation relating to this report in April 2007 and to provide its report to the Committee by April 2, 2008. For the third report, the Committee asked the Commission to provide an in-depth examination of China's integration with the global economy through processing trade and FDI, and its implications for U.S.-China trade and investment. The Commission expects to initiate the investigation relating to this report in October 2007 and to provide its report to the Committee by October 2, 2008. FOR FURTHER INFORMATION CONTACT: Project leaders Nannette Christ (202-205-3263 or *nannette.christ@usitc.gov* ) or Dennis Fravel (202-205-3404 or *dennis.fravel@usitc.gov* ) for information specific to this investigation (the first report). For information on the legal aspects of these investigations, contact William Gearhart of the Commission's Office of the General Counsel (202-205-3091 or *william.gearhart@usitc.gov* ). The media should contact Margaret O'Laughlin, Office of External Relations (202-205-1819 or *margaret.olaughlin@usitc.gov* ). *Public Hearing:* A public hearing in connection with this first investigation and report will be held at the U.S. International Trade Commission Building, 500 E Street, SW., Washington, DC beginning at 9:30 a.m. on March 8, 2007. Requests to appear at the public hearing should be filed with the Secretary, no later than 5:15 p.m., February 22, 2007, in accordance with the requirements in the “Submissions” section below. *Written Submissions:* In lieu of or in addition to participating in the hearing, interested parties are invited to submit written statements or briefs concerning this investigation. All written submissions, including requests to appear at the hearing, statements, and briefs, should be addressed to the Secretary, United States International Trade Commission, 500 E Street, SW., Washington, DC 20436. Any pre-hearing briefs or statements should be filed not later than 5:15 p.m., February 22, 2007; the deadline for filing post-hearing briefs or statements is 5:15 p.m., March 22, 2007. All written submissions must conform with the provisions of section 201.8 of the Commission's *Rules of Practice and Procedure* (19 CFR 201.8). Section 201.8 requires that a signed original (or a copy so designated) and fourteen

(14)copies of each document be filed. In the event that confidential treatment of a document is requested, at least four

(4)additional copies must be filed, in which the confidential information must be deleted (see the following paragraph for further information regarding confidential business information). The Commission's rules do not authorize filing submissions with the Secretary by facsimile or electronic means, except to the extent permitted by rule section 201.8 (19 CFR 201.8) (see Handbook for Electronic Filing Procedures, *ftp://ftp.usitc.gov/pub/reports/electronic_filing_handbook.pdf* ). Persons with questions regarding electronic filing should contact the Secretary (202-205-2000 or *edis@usitc.gov* ). Any submissions that contain confidential business information must also conform with the requirements of section 201.6 of the *Commission's Rules of Practice and Procedure* (19 CFR 201.6). Section 201.6 of the rules require that the cover of the document and the individual pages be clearly marked as to whether they are the “confidential” or “non-confidential” version, and that the confidential business information be clearly identified by means of brackets. All written submissions, except for confidential business information, will be made available for inspection by interested parties. In its request letter, the Committee stated that it intends to make the Commission's report available to the public in its entirety, and asked that the Commission not include any confidential business information or national security classified information in the reports that the Commission sends to the Committee. Any confidential business information received by the Commission in this investigation and used in preparing this report will not be published in a manner that would reveal the operations of the firm supplying the information. General information concerning the Commission may also be obtained at *http://www.usitc.gov* . The public record for this investigation may be viewed on the Commission's electronic docket

(EDIS)at *http://www.usitc.gov/secretary/edis.htm* . Hearing-impaired individuals are advised that information on this matter can be obtained by contacting our TDD terminal on

(202)205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. Issued: November 2, 2006. By order of the Commission. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E6-18846 Filed 11-7-06; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on August 21, 2006 and August 24, 2006, Johnson Matthey, Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066, made application by letter to the Drug Enforcement Administration

(DEA)to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Nabilone

(7379)II Noroxymorphone

(9668)II The company plans to manufacture the listed controlled substances in bulk for sales to its customers. Any other such applicant and any person who is presently registered with DEA to manufacture such substances may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA **Federal Register** Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA **Federal Register** Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than January 8, 2007. Dated: November 2, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-18844 Filed 11-7-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Foreign Claims Settlement Commission [F.C.S.C. Meeting Notice No. 9-06] Sunshine Act Meeting Notice The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR Part 504) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of meetings for the transaction of Commission business and other matters specified, as follows: Date and Time: Thursday, November 16, 2006, at 10 a.m. Subject Matter: Issuance of Amended Proposed Decisions and Amended Final Decisions in claims against Albania. Status: Open. All meetings are held at the Foreign claims Settlement Commission, 600 E Street, NW., Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Administrative Officer, Foreign Claims Settlement Commission, 600 E Street, NW., Room 6002, Washington, DC 20579. Telephone:

(202)616-6988. Mauricio J. Tamargo, Chairman. [FR Doc. 06-9160 Filed 11-6-06; 3:48 pm]

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