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Code · REGISTER · 2006-01-10 · Food and Drug Administration, HHS · Notices

Notices. Notice

9,705 words·~44 min read·/register/2006/01/10/06-178·

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

BILLING CODE 6750-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0209] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Contact Substances Notification AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a collection of information entitled “Food Contact Substances Notification” has been approved by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of October 24, 2005 (70 FR 61452), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0495. The approval expires on December 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at “ *http://www.fda.gov/ohrms/dockets* ”. Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-91 Filed 1-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0120] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Carbohydrate Content Claims on Food Labels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a collection of information entitled “Experimental Study of Carbohydrate Content Claims on Food Labels” has been approved by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of August 17, 2005 (70 FR 48423), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0570. The approval expires on December 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-94 Filed 1-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D-2145] (formerly 99D-2145) International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revised); Request for Comments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability for comments of a draft revised guidance for industry (#93) entitled “Impurities in New Veterinary Medicinal Products (Revised)” VICH GL11(R). This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the **Federal Register** of July 7, 2000 (the 2000 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products. DATES: Submit written or electronic comments by February 9, 2006, to ensure their adequate consideration in preparation of the final guidance document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft revised guidance document. Submit written comments on the draft revised guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Comments should be identified with the full title of the draft revised guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6956, e-mail: *dbensley@cvm.fda.gov* . SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonization of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. VICH is a parallel initiative for veterinary medicinal products. VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and Includes input from both regulatory and industry representatives. The VICH steering committee is composed of member representatives from the European Commission; European Medicines Evaluation Agency; European Federation of Animal Health; Committee on Veterinary Medicinal Products; FDA; the U.S. Department of Agriculture; the Animal Health Institute; the Japanese Veterinary Pharmaceutical Association; the Japanese Association of Veterinary Biologics; and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Four observers are eligible to participate in the VICH steering committee as follows: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH steering committee meetings. II. Draft Revised Guidance on Impurities in New Veterinary Medicinal Products In May 2005, the VICH steering committee agreed that a draft revised guidance entitled “Impurities in New Veterinary Medicinal Products (Revised)” VICH GL11(R) should be made available for public comment. The draft revised guidance is a revision of a final guidance on the same topic for which a notice of availability was published in the **Federal Register** of July 7, 2000 (65 FR 42019). The draft revised guidance clarifies the 2000 guidance, adds information, and provides consistency with more recently published VICH guidances. The draft revised guidance is a product of the Quality Expert Working Group of VICH. Comments about this draft will be considered by FDA and the Quality Expert Working Group. This draft revised document is intended to provide guidance for new animal drug applications on the content and qualification of impurities in new veterinary drug substances intended to be used for new veterinary medicinal products, produced by chemical syntheses and not previously registered in a country, region, or member state. The draft guidance has been revised to add information to certain sections and to provide clarification to other sections of the previous guidance. The revisions include changes in the following ways:
(1)The text on the recommended reporting, identification, and qualification thresholds;
(2)the recommended deletion of the exception to conventional rounding practice;
(3)modification of the decision tree in Attachment 2, which sets out a recommended approach to identifying and qualifying degradation products; and
(4)additions and revisions to the previous glossary including definitions for the terms “unspecified degradation product,” “reporting threshold,” and “identification threshold.” In addition, the guidance was updated to reference, where appropriate, other more recently published VICH guidances relevant to this topic. Finally, minor editorial changes were made to improve the clarity and consistency of the document. III. Paperwork Reduction Act of 1995 This draft revised guidance contains information collection previsions that are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this draft revised guidance have been approved under OMB control number 0910-0032. IV. Significance of Guidance This draft revised document, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement. The draft revised VICH guidance (#93) represents the agency's current thinking on impurities in new veterinary drug medicinal products. This draft revised guidance does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative method may be used as long as it satisfies the requirements of applicable statutes and regulations. V. Comments This draft revised guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this draft revised guidance document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the draft revised guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VI. Electronic Access Electronic comments may also be submitted on the Internet at *http://www.fda.gov/dockets/ecomments* . Once on this Internet site, select Docket No. 1999D-2245, entitled “Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revised)” (VICH GL11(R)) and follow the directions. Copies of the draft guidance document entitled “Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revised)” VICH GL11(R) may be obtained on the Internet from the CVM home page at *http://www.fda.gov/cvm* . Dated: December 30, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-90 Filed 1-9-06; 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. Polysaccharide Derived Nitric Oxide Releasing Carbon Bound Diazeniumdiolates Joseph A. Hrabie et al.
(NCI)U.S. Provisional Application No. 60/731,946 filed 31 Oct 2005 (HHS Reference No. E-279-20050-US-01) Licensing Contact: John Stansberry; 301/435-5236; *stansbej@mail.nih.gov* The invention discloses a method for producing nitric oxide(NO)-releasing derivatives of any material containing a reducing sugar component. It may be used to produce NO-releasing cotton bandages or surgical fabrics, cellulose filters or dialysis membranes, and drug formulating/compounding agents to prevent stomach irritation. The method involves incorporation of a diazeniumdiolate (-N <sup>2</sup> O <sup>2</sup> ) group at one or more carbons via the base-catalyzed replacement of acidic hydrogens and is thus compatible with traditional polysaccharide processing techniques. Monosaccharides such as glucose may also be derivatized. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Hydropneumatic Fluid Control for a Cell Culturing System Alexandr Chanturiya, Svetlana Glushakova, and Joshua Zimmerberg (NICHD) U.S. Provisional Application No. 60/725,327 filed 12 Oct 2005 (HHS Reference No. E-166-2005/0-US-01) Licensing Contact: Michael Shmilovich; 301/435-5019; *shmilovm@mail.nih.gov* Available for licensing and commercial development is a hydropneumatic fluid control system in which cell culture media is perfused through a bioreactor by gas pressure where the direction of the gas directs the direction of perfusion. The gas can also act to regulate the pH of the cell culture media. Containers holding the cell culture media are situated on either side of an axis of rotation of a platform. The weight of the container as it fills with media forces the platform to oscillate. The oscillation actuates a piston—also coupled to the platform—which regulates a valve that switches the flow of gas to the other container. This system does not use electricity and, with an appropriate gas mixture, saturates cell culture media with gas. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. A Knockout Mouse for Transcription Factor Nurr1 Dr. Vera Nikodem (NIDDK) HHS Reference No. E-024-1999/0—Research Tool Licensing Contact: Marlene Shinn-Astor; 301/435-4426; *shinnm@mail.nih.gov* Transcriptional factor Nurr1 is an obligatory factor for neurotransmitter dopamine biosynthesis only in ventral midbrain as demonstrated by the Nurr1 genomic locus inactivation using homologous recombination. From a neurological and clinical perspective, it suggests an entirely new mechanism for dopamine depletion in a region where dopamine is known to be involved in Parkinson's disease. Clinically, our findings indicate that activation of Nurr1 may be therapeutically useful for Parkinson's disease patients; therefore, the mice would be useful in Parkinson's disease research. Dated: January 3, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-86 Filed 1-9-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Anthrax Lethal Factor Is a MAPK Kinase Protease AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Nos. 6,485,925 B1, issued November 26, 2002, 6,893,835 B2, issued May 17, 2005, and 6,911,203 B1, issued June 28, 2005, and U.S. Patent App. No. 11/112,137, filed April 22, 2005 and published on September 8, 2005 as U.S. Pat. Pub. No. 2005/0196822 A1, all titled “Lethal Factor is a MAPK Kinase Protease” (HHS Ref. Nos. E-066-1998/0-US-06, -07, -08, and -10) to Van Andel Research Institute, of Grand Rapids, Michigan. The patent rights in these inventions have been assigned to the Government of the United States. The prospective exclusive license territory will be worldwide. The field of use may be limited to the development and sale of Anthrax lethal factor, a MAPK kinase protease, as a therapeutic agent for the treatment of cancer. DATES: Only license applications which are received by the National Institutes of Health on or before March 13, 2006 will be considered. ADDRESSES: Requests for information, inquiries, comments, and other materials relating to the contemplated co-exclusive license should be directed to: Thomas P. Clouse, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-4076; Facsimile: 301-402-0220; E-mail: *clouset@mail.nih.gov.* Copies of the U.S. patent publications can be obtained from *http://www.uspto.gov.* SUPPLEMENTARY INFORMATION: The above-identified patents relates to the discovery that Mitogen Activated Protein Kinase
(MAPK)signal transduction pathway is an evolutionarily conserved pathway for effecting gene regulation that controls cell proliferation and differentiation in response to extracellular signals and also plays a crucial role in regulating oocyte meiotic maturation. The above-identified patent discloses in vitro and in vivo methods of screening for modulators, homologues, and mimetics of LF mitogen activated protein kinase kinase (MAPKK) protease activity. Mos (i.e., an oncogene first identified as the transforming determinant of Moloney Murine Sarcoma Virus) is a serine/threonine kinase which phosphorylates and activates MAPK1 kinase which in turn phosphorylates and activates MAPK. The patent also discloses that LF prevents activation of MAPK in oocytes of Xenopus laevis and tumor derived NIH3T3
(490)cells expressing an effector domain mutant form of the human V12HaRas oncogene. The tumor derived NIH3T3 cells reverted to a more normal morphology after LF treatment. Therefore, LF directly inhibits the Mos/MAPK pathway. Tumor cells utilize MAPK kinases in a different way than normal cells as in tumor cells there is a constitutive MAPK kinase activity. Additionally, MAPKK1 was found to be a proteolytic substrate for the metalloprotease LF. By analysis of MAPKK2, a consensus sequence for LF activity was found. The disclosure is claimed in the above-identified patent and other patents in the same patent family. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless within sixty
(60)days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: January 3, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-89 Filed 1-9-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on
(240)276-1243. Comments are invited on:
(a)Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Strategic Prevention Framework State Incentive Grant (SPF SIG) Program—NEW The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention
(CSAP)is responsible for the Evaluation of the Strategic Prevention Framework State Incentive Grant (SPF SIG) Program. The program is a major national initiative designed to:
(1)Prevent the onset and reduce the progression of substance abuse, including childhood and underage drinking;
(2)reduce substance abuse-related problems in communities; and,
(3)build prevention capacity and infrastructure at the State/territory and community levels. Five steps comprise the SPF: • Step 1: Profile population needs, resources, and readiness to address needs and gaps. • Step 2: Mobilize and/or build capacity to address needs. • Step 3: Develop a comprehensive strategic plan. • Step 4: Implement evidence-based prevention programs, policies, and practices. • Step 5: Monitor, evaluate, sustain, and improve or replace those that fail. Under a contract with CSAP, an evaluation team will implement a multi-method quasi-experimental evaluation at national, State, and community levels. Evaluation data will be collected from 26 states receiving grants in 2004 and 2005 and as many as 32 non-grantee states that will serve as a comparison group. The primary evaluation objective is to determine the impact of SPF SIG on the SAMHSA National Outcome Measures (NOMs). This notice invites comment on state-level and community-level data collection instruments. The instruments for assessing state-level change will be included in an OMB review package submitted immediately after the expiration of the comment period and are the main focus of this announcement. These instruments will be reviewed first by OMB to ensure that state-level data collection occurs as specified in the evaluation plan (on or before June 30, 2006). Because the states have not awarded community-level funding, the evaluators will not initiate community-level data collection until late in 2006. Thus, the community-level survey will be submitted as an addendum approximately one month after the comment period expires. However, the instrument is described in this notice and comments on the instrument are invited. State-Level Data Collection Two instruments were developed for assessing state-level effects. Both instruments are guides for telephone interviews that will be conducted by trained interviewers three to four times over the life of the SPF SIG award. The *Strategic Prevention Framework Index* will be used to assess the relationship between SPF implementation and change in the national outcome measures. The *State Infrastructure Index* will capture data to assess infrastructure change and to test the relationship of this change to outcomes. Prevention infrastructure refers to the organizational features of the system that delivers prevention services, including all procedures related to planning, data management systems, workforce development, intervention implementation, evaluation and monitoring, financial management, and sustainability. The estimated annual burden for state-level data collection is displayed below in the table. State Level Burden Estimate Interview guide Content description Number of respondents Number of responses Hourly burden per response Total hourly burden Year 1 SPF Implementation Index SEW activities, indicators for each SPF step, including cultural competence throughout all five steps 26 1 3 78 State Infrastructure Index Assessment of a state's progress over time toward the implementation of these best practices 26 1 6 156 Total State Level Year 1 Burden 2 9 234 Year 2 SPF Implementation Index SEW activities, indicators for each SPF step, including cultural competence throughout all five steps 26 1 3 78 State Infrastructure Index Assessment of a state's progress over time toward the implementation of these best practices 26 1 6 156 Total State Level Year 2 Burden 2 9 234 Year 3 SPF Implementation Index SEW activities, indicators for each SPF step, including cultural competence throughout all five steps 26 1 3 78 State Infrastructure Index Assessment of a state's progress over time toward the implementation of these best practices 26 1 6 156 Total State Level Year 3 Burden 2 9 234 Average Annual State Burden 2 9 234 Community-level Data Collection The Community Level Index is a two-part, web-based survey for capturing information about SPF SIG implementation at the community level. Part 1 of the survey focuses on the five SPF SIG steps and efforts to ensure cultural competency throughout the SPF SIG process. Part 2 will capture data on the specific intervention(s) implemented at the community level including both individual-focused and environmental prevention strategies. Community partners receiving SPF SIG awards will be required to complete the survey every six months, using a secure password system. The survey data will be analyzed in conjunction with state and community outcome data to determine the relationship, if any, between the SPF process and substance use outcomes. This survey will be submitted as an addendum to the forthcoming OMB package approximately one month after the expiration of the comment period. The estimated annual burden for community-level data collection is displayed below. Note that the total burden assumes an average of 15 community-level sub-grantees per state (a total of 390 respondents) and two survey administrations per year. Note also that some questions will be addressed only once and the responses will be used to pre-fill subsequent surveys. In addition, as community partners work through the SPF steps, they will report only on step-related activities. For example, needs assessment activities will likely precede monitoring and evaluation activities. Thus, respondents will answer questions related to needs assessment in the first few reports but will not need to address monitoring and evaluation items until later in the implementation process. Community Level Survey Burden Estimate Survey section Content description Number of respondents Number of responses Hourly burden/response Total hourly burden Year 1 Part I, 1-10 Contact Information and Reporting Period 390 1 0.2 78 11-19 Organization Type and Funding 390 1 0.2 78 20-26 Cultural Competence, Sustainability and Framework Progress 390 2 0.1 78 27-47 Needs and Resources Assessments 390 1 0.5 195 48-137 Capacity Building Activities 390 2 1.7 1,326 138-155 Strategic Plan Development 390 1 1.0 390 172-178 Contextual Factors and Closing Questions 390 2 1.0 780 Sub-form 179-191 Coalition Organizational Information 390 1 1.0 390 Part II 1-52 Intervention Specific Information and Adaptations 390 3 2.0 2,340 Review of past responses 390 2 1.0 780 Total Community Level Year 1 Burden 16 8.6 6,435 Year 2 Part I, 20-26 Cultural Competence, Sustainability and Framework Progress 390 2 0.1 78 48-137 Capacity Building Activities 390 2 1.7 1,326 172-178 Contextual Factors and Closing Questions 390 2 1.0 780 Part II 1-52 Intervention Specific Information and Adaptations 390 3 2.0 2,340 53-60 Intervention Outcomes 390 6 1.0 2,340 Sub-forms Intervention Component Information 390 6 1.0 2,340 Review of past responses 390 2 1.0 780 Total Community Level Year 2 Burden 23 7.8 9,984 Year 3 Part I, 20-26 Cultural Competence, Sustainability and Framework Progress 390 2 0.1 78 48-137 Capacity Building Activities 390 1 1.7 1,326 156-160 Intervention Implementation 390 2 0.1 78 172-178 Contextual Factors and Closing Questions 390 2 1.0 780 Part II, 1-52 Intervention Specific Information and Adaptations 390 3 2.0 2,340 53-60 Intervention Outcomes 390 6 1.0 2,340 Sub-forms Intervention Component Information 390 6 1.0 2,340 Review of past responses 390 2 1.0 780 Total Community Level Year 3 Burden 24 7.9 10,062 Average Annual Community Burden 21 8.1 8,827 Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 71-1044, One Choke Cherry Road, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: December 30, 2005. Anna Marsh, Director, Office of Program Services. [FR Doc. E6-95 Filed 1-9-06; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. SUMMARY: The Department of Health and Human Services
(HHS)notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the **Federal Register** on April 11, 1988 (53 FR 11970), and subsequently revised in the **Federal Register** on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the **Federal Register** during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program
(NLCP)during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at *http://workplace.samhsa.gov* and *http://www.drugfreeworkplace.gov.* FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh or Dr. Walter Vogl, Division of Workplace Programs, SAMHSA/CSAP, Room 2-1035, 1 Choke Cherry Road, Rockville, Maryland 20857; 240-276-2600 (voice), 240-276-2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. Subpart C of the Mandatory Guidelines, “Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,” sets strict standards that laboratories must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A laboratory must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards. In accordance with Subpart C of the Mandatory Guidelines dated April 13, 2004 (69 FR 19644), the following laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens: ACL Laboratories, 8901 W. Lincoln Ave., West Allis, WI 53227. 414-328-7840/800-877-7016. (Formerly: Bayshore Clinical Laboratory). ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624. 585-429-2264. Advanced Toxicology Network, 3560 Air Center Cove, Suite 101, Memphis, TN 38118. 901-794-5770/888-290-1150. Aegis Analytical Laboratories, Inc., 345 Hill Ave., Nashville, TN 37210. 615-255-2400. Baptist Medical Center-Toxicology Laboratory, 9601 I-630, Exit 7, Little Rock, AR 72205-7299. 501-202-2783. (Formerly: Forensic Toxicology Laboratory Baptist Medical Center). Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215-2802. 800-445-6917. Diagnostic Services, Inc., dba DSI, 12700 Westlinks Drive, Fort Myers, FL 33913. 239-561-8200/800-735-5416. Doctors Laboratory, Inc., 2906 Julia Drive, Valdosta, GA 31602. 229-671-2281. DrugScan, Inc., P.O. Box 2969, 1119 Mearns Road, Warminster, PA 18974. 215-674-9310. Dynacare Kasper Medical Laboratories,* 10150-102 St., Suite 200, Edmonton, Alberta, Canada T5J 5E2. 780-451-3702/800-661-9876. ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655. 662-236-2609. Express Analytical Labs, 3405 7th Ave., Suite 106, Marion, IA 52302. 319-377-0500. Gamma-Dynacare Medical Laboratories,* A Division of the Gamma-Dynacare, Laboratory Partnership, 245 Pall Mall Street, London, ONT, Canada N6A 1P4. 519-679-1630. General Medical Laboratories, 36 South Brooks St., Madison, WI 53715. 608-267-6225. Kroll Scientific Testing Laboratories, Inc., 450 Southlake Blvd., Richmond, VA 23236. 804-378-9130. (Formerly: Scientific Testing Laboratories, Inc.) Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040. 713-856-8288/800-800-2387. Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869. 908-526-2400/800-437-4986. (Formerly: Roche Biomedical Laboratories, Inc.) Laboratory Corporation of America Holdings, 1904 Alexander Drive, Research Triangle Park, NC 27709. 919-572-6900/800-833-3984. (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group.) Laboratory Corporation of America Holdings, 10788 Roselle St., San Diego, CA 92121. 800-882-7272. (Formerly: Poisonlab, Inc.) Laboratory Corporation of America Holdings, 550 17th Ave., Suite 300, Seattle, WA 98122. 206-923-7020/800-898-0180. (Formerly: DrugProof, Division of Dynacare/Laboratory of Pathology, LLC; Laboratory of Pathology of Seattle, Inc.; DrugProof, Division of Laboratory of Pathology of Seattle, Inc.) Laboratory Corporation of America Holdings, 1120 Main Street, Southaven, MS 38671. 866-827-8042/800-233-6339. (Formerly: LabCorp Occupational Testing Services, Inc.; MedExpress/National Laboratory Center.) Marshfield Laboratories, Forensic Toxicology Laboratory, 1000 North Oak Ave., Marshfield, WI 54449. 715-389-3734/800-331-3734. MAXXAM Analytics Inc.,* 6740 Campobello Road, Mississauga, ONT, Canada L5N 2L8. 905-817-5700. (Formerly: NOVAMANN (Ontario), Inc.) MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112 651-636-7466/800-832-3244. MetroLab-Legacy Laboratory Services, 1225 NE 2nd Ave., Portland, OR 97232. 503-413-5295/800-950-5295. Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417. 612-725-2088. National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304. 661-322-4250/800-350-3515. One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504. 888-747-3774. (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory.) Oregon Medical Laboratories, P.O. Box 972, 722 East 11th Ave., Eugene, OR 97440-0972. 541-687-2134. Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311. 800-328-6942. (Formerly: Centinela Hospital Airport Toxicology Laboratory.) Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204. 509-755-8991/800-541-7897x7. Physicians Reference Laboratory, 7800 West 110th St., Overland Park, KS 66210. 913-339-0372/800-821-3627. Quest Diagnostics Incorporated, 3175 Presidential Dr., Atlanta, GA 30340. 770-452-1590/800-729-6432. (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories). Quest Diagnostics Incorporated, 4770 Regent Blvd., Irving, TX 75063. 800-824-6152. (Moved from the Dallas location on 03/31/01; Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories). Quest Diagnostics Incorporated, 4230 South Burnham Ave., Suite 250, Las Vegas, NV 89119-5412. 702-733-7866/800-433-2750. (Formerly: Associated Pathologists Laboratories, Inc.) Quest Diagnostics Incorporated, 10101 Renner Blvd., Lenexa, KS 66219. 913-888-3927/800-873-8845. (Formerly: LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.) Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403. 610-631-4600/877-642-2216. (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories). Quest Diagnostics Incorporated, 506 E. State Pkwy., Schaumburg, IL 60173. 800-669-6995/847-885-2010. (Formerly: SmithKline Beecham Clinical Laboratories; International Toxicology Laboratories). Quest Diagnostics Incorporated, 7600 Tyrone Ave., Van Nuys, CA 91405. 818-989-2520/800-877-2520. (Formerly: SmithKline Beecham Clinical Laboratories). Quest Diagnostics Incorporated, 2282 South Presidents Drive, Suite C, West Valley City, UT 84120. 801-606-6301/800-322-3361. (Formerly: Northwest Toxicology, a LabOne Company; LabOne, Inc., dba Northwest Toxicology; NWT Drug Testing, NorthWest Toxicology, Inc.; Northwest Drug Testing, a division of NWT Inc.) S.E.D. Medical Laboratories, 5601 Office Blvd., Albuquerque, NM 87109, 505-727-6300/800-999-5227. South Bend Medical Foundation, Inc., 530 N. Lafayette Blvd., South Bend, IN 46601. 574-234-4176 x276. Southwest Laboratories. 4645 E. Cotton Center Boulevard, Suite 177, Phoenix, AZ 85040. 602-438-8507/800-279-0027. Sparrow Health System, Toxicology Testing Center, St. Lawrence Campus, 1210 W. Saginaw, Lansing, MI 48915. 517-364-7400. (Formerly: St. Lawrence Hospital & Healthcare System). St. Anthony Hospital Toxicology Laboratory, 1000 N. Lee St., Oklahoma City, OK 73101. 405-272-7052. Toxicology & Drug Monitoring Laboratory, University of Missouri Hospital & Clinics, 301 Business Loop 70 West, Suite 208, Columbia, MO 65203. 573-882-1273. Toxicology Testing Service, Inc., 5426 N.W. 79th Ave., Miami, FL 33166. 305-593-2260. US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755-5235. 301-677-7085. *The Standards Council of Canada
(SCC)voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation
(DOT)regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS' NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do. Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory ( **Federal Register** , July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the **Federal Register** on April 13, 2004 (69 FR 19644). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program. Anna Marsh, Director, Office Program Services, SAMHSA. [FR Doc. E6-96 Filed 1-9-06; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Endangered Species Recovery Permit Application AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of a permit application. SUMMARY: The following applicant has applied for an enhancement of propagation or survival permit to conduct certain activities with endangered species pursuant to section 10(a)(1)(A) of the Endangered Species Act. The U.S. Fish and Wildlife Service (“we”) solicits review and comment from local, State and Federal agencies, and the public on the following permit request. DATES: Comments on this permit application must be received on or before February 9, 2006. ADDRESSES: Written data or comments should be submitted to the U.S. Fish and Wildlife Service, Chief, Endangered Species, Ecological Services, 911 NE. 11th Avenue, Portland, Oregon 97232-4181 (fax: 503-231-6243). Please refer to the permit number when submitting comments. All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public. FOR FURTHER INFORMATION CONTACT: Documents and other information submitted with this application are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents within 30 days of the date of publication of this notice to the address above (telephone: 503-231-2063). Please refer to the permit number when requesting copies of documents. SUPPLEMENTARY INFORMATION: Permit No. TE-114934 *Applicant:* Idaho Department of Fish and Game, Boise, Idaho. The applicant requests a permit to take (harass by survey, capture, handle, collar, take blood samples, relocate, sacrifice, and release) the gray wolf ( *Canis lupus* ) in conjunction with wolf management activities in the State of Idaho north of Interstate 90, for the purpose of enhancing its survival. The applicant proposes to:
(a)Conduct monitoring of wolf populations; and
(b)coordinate non-lethal and lethal control actions to reduce wolf conflicts with livestock and dogs. These actions are currently coordinated by the U.S. Fish and Wildlife Service (Service). If the permit is issued, the applicant would take on responsibility for managing wolves in northern Idaho. Wolf management activities would be in accordance with the requirements of the State of Idaho Wolf Conservation and Management Plan (March 2002) and the Service's Interim Wolf Control Plan for Northwestern Montana and the Panhandle of Northern Idaho (Control Plan) (September 1999). If issued, the permit would not affect ongoing wolf management in the remainder of the State of Idaho conducted in accordance with the non-essential experimental population regulations found at 50 CFR 17.84(n). We have determined that a practical, responsive management program is essential to enhancing survival of the wolf in the wild (Service 1987; Service 1994; Service 1999). The program must respond to wolf-livestock conflicts, while promoting wolf recovery objectives. The Control Plan provides guidelines for:
(a)Determining problem wolf status (including investigative procedures and criteria),
(b)conducting wolf control actions, and
(c)disposition of problem wolves. We have made a preliminary determination that issuance of this permit would be categorically excluded from further consideration under the National Environmental Policy Act of 1969 (NEPA). If issued, the permit would authorize Idaho Department of Fish and Game to manage wolves in the same manner that the Service has in the 6 years since the Control Plan was adopted for northern Idaho. No additional environmental impacts would be expected beyond those analyzed in the Service's 1988 Environmental Assessment, the Service's 1999 Environmental Action Memorandum, and the Control Plan. The effect of the permit would be to allow continuation of previously analyzed and authorized activities; therefore, its issuance would be an administrative action. Our preliminary NEPA categorical exclusion determination, the two wolf plans noted above, and the Idaho Department of Fish and Game permit application, can be found at: *http://www.fws.gov/pacific/ecoservices/endangered/recovery/default.htm.* Additional information about wolf recovery and conservation in the northwestern United States, including control of problem wolves, can be found in various reports at: *http://westerngraywolf.fws.gov/.* All comments received from individuals become part of the official public record. Requests for such comments will be handled in accordance with the Freedom of Information Act and the Council on Environmental Quality's National Environmental Protection Act regulations [40 CFR 1506.6(f)]. Our practice is to make comments, including names and addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address from the record, but this must be stated prominently at the beginning of their comments. We will honor these requests to the extent allowable by law. We solicit public review and comment on this recovery permit application. Authority: This document is published under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ). Dated: December 13, 2005. David J. Wesley, Acting Regional Director, Region 1, U.S. Fish and Wildlife Service. [FR Doc. E6-93 Filed 1-9-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [NV-030-1610-DU] Notice of Intent To Prepare an Amendment to the Carson City Field Office Consolidated Resource Management Plan AGENCY: Bureau of Land Management, Interior. ACTION: Notice of intent. SUMMARY: This document provides notice that the Bureau of Land Management
(BLM)intends to prepare a Resource Management Plan
(RMP)amendment to address Lands and Land Tenure Issues, and Recreation and Travel Management. The appropriate state, tribal and local governments will be invited to participate as cooperating agencies. DATES: All relevant public meetings will be announced through the local news media, newsletters, and the BLM Web site at *http://www.nv.blm.gov/carson/* at least 15 days prior to the event. The minutes and list of attendees from each meeting will be available to the public and open for 30 days to any participant who wishes to clarify the views they expressed. ADDRESSES: Comments should be addressed to Donald T. Hicks, Manager, Carson City Field Office, Bureau of Land Management, 5665 Morgan Mill Road, Carson City, NV 89701. FOR FURTHER INFORMATION CONTACT: For further information and/or to have your name added to our mailing list, contact Desna Young, Environmental Planner at the Carson City Field Office, 775-885-6000. Documents pertinent to this proposal may be examined at the Carson City Field Office. SUPPLEMENTARY INFORMATION: The proposed RMP amendment involves approximately 19,000 acres of public land in Alpine County, California. As part of the RMP amendment, an EA will be prepared to analyze designation of public lands suitable for retention, disposal by sale or exchange, or conveyance for community expansion purposes. Public lands needing access will be identified as well as lands with existing access that could be improved to permit easier access to the public. The EA will also analyze travel and management by designating road and trail routes on public land. Comments will be accepted throughout the RMP amendment and EA process. The plan amendment will fulfill the needs and obligations set forth by the National Environmental Policy Act (NEPA), the Federal Land Policy and Management Act (FLPMA), and BLM management policies. Comments, including names and street addresses of respondents, will be available for public review at the Carson City Field Office during regular business hours 7:30 a.m. to 5 p.m. Monday through Friday, except holidays, and may be published as part of the EA. Individual respondents may request confidentiality. If you wish to withhold your name or street address from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your written comment. Such requests will be honored to the extent allowed by law. All submissions from organizations and businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be available for public inspection in their entirety. Dated: November 21, 2005. Donald T. Hicks, Manager, Carson City Field Office. [FR Doc. E6-88 Filed 1-9-06; 8:45 am] BILLING CODE 4310-HC-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [ID-200-1610-DO-081D] Notice of Intent To Prepare a Resource Management Plan for the Jarbidge Field Office, Idaho and Associated Environmental Impact Statement AGENCY: Bureau of Land Management, Interior. ACTION: Notice of intent. SUMMARY: The Bureau of Land Management
(BLM)Jarbidge Field Office, Twin Falls, Idaho intends to prepare a Resource Management Plan
(RMP)with an associated Environmental Impact Statement
(EIS)for the Jarbidge Field Office and by this notice is announcing public scoping meetings. The RMP will replace the existing 1987 Jarbidge RMP. DATES: The BLM will announce public scoping meetings to identify relevant issues through local news media, newsletters, and the BLM Web site *http://www.blm.gov/rmp/id/jarbidge* at least 15 days prior to the first meeting. We will provide formal opportunities for public participation upon publication of the Draft RMP/EIS. ADDRESSES: You may submit comments by any of the following methods: • Web site: *http://www.blm.gov/rmp/id/jarbidge* (subject to change). • E-mail: *ID_Jarbidge_RMP@blm.gov.* • Fax:
(208)736-2375 or
(208)735-2076. • Mail: Project Manager, Jarbidge Field Office, 2536 Kimberly Road, Twin Falls, Idaho 83301. Documents pertinent to this proposal may be examined at the Jarbidge Field Office. FOR FURTHER INFORMATION CONTACT: For further information and/or to have your name added to our mailing list, contact Rick Vandervoet, Acting Field Manager, Jarbidge Field Office, Telephone 208-735-2060; e-mail *richard_vandervoet@blm.gov* or Howard Hedrick, District Manager, Twin Falls District, Telephone 208-735-2060; e-mail *howard_hedrick@blm.gov.* SUPPLEMENTARY INFORMATION: This document provides notice that the BLM Jarbidge Field Office, Twin Falls, Idaho, intends to prepare a RMP with an associated EIS for the Jarbidge Field Office and announces public scoping meetings. The planning area is located in Twin Falls, Owyhee and Elmore Counties, Idaho and Elko County, Nevada. This planning activity encompasses approximately 1,366,000 acres of public land. The plan will fulfill the needs and obligations set forth by the National Environmental Policy Act (NEPA), the Federal Land Policy and Management Act (FLPMA), and BLM management policies. Preparation of an RMP for the Jarbidge Field Office is necessary to respond to a Stipulated Settlement Agreement under the jurisdiction of the District Court, for the District of Idaho; respond to changing resource conditions; respond to new issues; and prepare a comprehensive framework for managing public lands administered by the field office into the future. The BLM will work collaboratively with interested parties to identify the management decisions that are best suited to local, regional, and national needs and concerns. The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis and EIS alternatives. These issues will also guide the planning process. You may submit comments on issues and planning criteria in writing to the BLM at any public scoping meeting, or you may submit them to the BLM using one of the methods listed in the ADDRESSES section above. Individual respondents may request confidentiality. If you wish to withhold your name and/or address from public review or disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your written comment. The BLM will honor such requests to the extent allowed by law. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, are available for public inspection in their entirety. To be most helpful, scoping comments should be received within 60 days following the publication of this notice in the **Federal Register;** however, coordination with the public will continue throughout the planning process. Preliminary issues and management concerns have been identified by BLM personnel, other agencies, and in meetings with individuals and user groups. They represent the BLM's knowledge to date regarding the existing issues and concerns with current land management. The major issues that will be addressed in this planning effort include: Tribal treaty rights and trust responsibilities; availability and management of public lands for commercial uses (e.g., livestock grazing, minerals development); vegetation management (including invasive species, noxious weeds, riparian areas and wetlands); fire and fuels management; management of habitat for wildlife and special status species; management of transportation, public access, and recreational opportunities; land tenure adjustments, rights of way including wind energy and utility corridors; wild horses; and management of areas with special values. After gathering public comments as to what issues the plan should address, they will be placed in one of three categories: 1. Issues to be resolved in the plan; 2. Issues to be resolved through policy or administrative action; or 3. Issues beyond the scope of this plan. The BLM will provide an explanation in the plan for placing an issue in either category two or three. In addition to these major issues, the plan will address a number of management questions and concerns. BLM encourages the public to help identify these questions and concerns during the scoping phase. Preliminary planning criteria include the following: 1. The plan will comply with all applicable laws, regulations, and current policies. This includes local, state, Tribal, and Federal air quality standards; as well as water quality standards from the Idaho Non-Point Source Management Program Plans. 2. The RMP planning effort will be collaborative in nature. The BLM will strive to ensure that its management decisions are complementary to other planning jurisdictions and adjoining properties, within the limits described by law and Federal Regulations. 3. The BLM will continue to manage all previously established Wilderness Study Areas for wilderness values and character until Congress either designates them as wilderness areas or releases them for other types of multiple use management. 4. The RMP will recognize all valid existing rights. 5. As part of this RMP process, BLM will analyze areas for potential designation as Areas of Critical Environmental Concern
(ACEC)in accordance with 43 CFR 1610.7-2, and river corridors for designation under the Wild and Scenic Rivers Act. The BLM will use an interdisciplinary approach to develop the plan in order to consider the variety of resource issues and concerns identified. Specialists with expertise in the following disciplines will be involved in the planning process: Rangeland management, botany, noxious weeds, minerals and geology, fire use, outdoor recreation and wilderness, archaeology, paleontology, wildlife and fisheries, lands and realty, hydrology, soils, sociology and economics, public affairs, and geographic information. Dated: November 23, 2005. K Lynn Bennett, Idaho State Director, Bureau of Land Management. [FR Doc. E6-85 Filed 1-9-06; 8:45 am] BILLING CODE 4310-GG-P \ DEPARTMENT OF THE INTERIOR Minerals Management Service Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Minerals Management Service (MMS), Interior. ACTION: Notice of extension of an information collection (1010-0128). SUMMARY: To comply with the Paperwork Reduction Act of 1995 (PRA), MMS is inviting comments on a collection of information that we will submit to the Office of Management and Budget
(OMB)for review and approval. The information collection request
(ICR)concerns the paperwork requirements in the regulations under 30 CFR 250, Subpart O, “Well Control & Production Safety Training.” DATES: Submit written comments by March 13, 2006. ADDRESSES: You may submit comments by any of the following methods listed below. Please use the Information Collection Number 1010-0128 as an identifier in your message. • Public Connect on-line commenting system, *https://ocsconnect.mms.gov.* Follow the instructions on the Web site for submitting comments. • E-mail MMS at *rules.comments@mms.gov.* Identify with Information Collection Number 1010-0128 in the subject line. • Fax: 703-787-1093. Identify with Information Collection Number 1010-0128. • Mail or hand-carry comments to the Department of the Interior; Minerals Management Service; Attention: Rules Process Team (RPT); 381 Elden Street, MS-4024; Herndon, Virginia 20170-4817. Please reference “Information Collection 1010-0128” in your comments. FOR FURTHER INFORMATION CONTACT: Cheryl Blundon, Rules Processing Team at
(703)787-1600. You may also contact Cheryl Blundon to obtain a copy, at no cost, of the regulations that require the subject collection of information. SUPPLEMENTARY INFORMATION: *Title:* 30 CFR Part 250, Subpart O, Well Control & Production Safety Training. *OMB Control Number:* 1010-0128. *Abstract:* The Outer Continental Shelf
(OCS)Lands Act, as amended (43 U.S.C. 1331 *et seq.* and 43 U.S.C. 1801 *et seq.* ), authorizes the Secretary of the Interior (Secretary) to prescribe rules and regulations to administer leasing of the OCS. Such rules and regulations will apply to all operations conducted under a lease. Operations on the OCS must preserve, protect, and develop oil and natural gas resources in a manner that is consistent with the need to make such resources available to meet the Nation's energy needs as rapidly as possible; to balance orderly energy resource development with protection of human, marine, and coastal environments; to ensure the public a fair and equitable return on the resources of the OCS; and to preserve and maintain free enterprise competition. Section 1332(6) of the OCS Lands Act (43 U.S.C. 1332) requires that “operations in the [O]uter Continental Shelf should be conducted in a safe manner by well trained personnel using technology, precautions, and other techniques sufficient to prevent or minimize the likelihood of blowouts, loss of well control, fires, spillages, physical obstructions to other users of the waters or subsoil and seabed, or other occurrences which may cause damage to the environment or to property or endanger life or health.” This authority and responsibility are among those delegated to the Minerals Management Service (MMS). To carry out these responsibilities, MMS issues regulations governing oil and gas or sulphur operations in the OCS. Regulations at 30 CFR part 250, subpart O, implement these safe operation requirements. The MMS uses the information collected under subpart O to ensure that workers in the OCS are properly trained with the necessary skills to perform their jobs in a safe and pollution-free manner. In some instances, MMS will conduct oral interviews of offshore employees to evaluate the effectiveness of a company's training program. The information collected is necessary to verify personnel training compliance with the requirements. We will protect information from respondents considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR part 2) and under regulations at 30 CFR parts 250, 251, and 252. No items of a sensitive nature are collected. Responses are mandatory or required to obtain or retain a benefit. *Frequency:* Primarily on occasion or annual. *Estimated Number and Description of Respondents:* Approximately 130 Federal oil and gas OCS lessees. *Estimated Reporting and Recordkeeping “Hour” Burden:* The currently approved annual reporting burden for this collection is 2,067 hours. The following chart details the individual components and respective hour burden estimates of this ICR. In calculating the burdens, we assumed that respondents perform certain requirements in the normal course of their activities. We consider these to be usual and customary and took that into account in estimating the burden. Citation 30 CFR 250 subpart O Reporting and recordkeeping requirement Hour burden 1503(b),
(c)Develop training plans 60. 1503(c) Maintain copies of training plan and employee training documentation for 5 years plan = 15 min.; employee record = 5 min. 1503(c) Upon request, provide MMS copies of employee training documentation or provide copy of training plan 5. 1507(b) Employee oral interview conducted by MMS 10 min. 1507(c), (d); 1508; 1509 Written testing conducted by MMS or authorized representative. [Exempt under 5 CFR 1320.3(h)(7).] 1510(b) Revise training plan and submit to MMS 4. 1500-1510 General departure or alternative compliance requests not specifically covered elsewhere in subpart O 2. *Estimated Reporting and Recordkeeping “Non-Hour Cost” Burden:* We have identified no cost burdens for this collection. *Public Disclosure Statement:* The PRA (44 U.S.C. 3501, *et seq.* ) provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. *Comments:* Before submitting an ICR to OMB, PRA section 3506(c)(2)(A) requires each agency “* * * to provide notice * * * and otherwise consult with members of the public and affected agencies concerning each proposed collection of information * * *”. Agencies must specifically solicit comments to:
(a)Evaluate whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful;
(b)evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)enhance the quality, usefulness, and clarity of the information to be collected; and
(d)minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology. Agencies must also estimate the “non-hour cost” burdens to respondents or recordkeepers resulting from the collection of information. Therefore, if you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information, monitoring, and record storage facilities. You should not include estimates for equipment or services purchased:
(i)Before October 1, 1995;
(ii)to comply with requirements not associated with the information collection;
(iii)for reasons other than to provide information or keep records for the Government; or
(iv)as part of customary and usual business or private practices. We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB. *Public Comment Procedures:* MMS's practice is to make comments, including names and addresses of respondents, available for public review. If you wish your name and/or address to be withheld, you must state this prominently at the beginning of your comment. MMS will honor this request to the extent allowable by law; however, anonymous comments will not be considered. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public inspection in their entirety. *MMS Information Collection Clearance Officer:* Arlene Bajusz,
(202)208-7744. Dated: December 20, 2005. E.P. Danenberger, Chief, Office of Offshore Regulatory Programs. [FR Doc. E6-107 Filed 1-9-06; 8:45 am] BILLING CODE 4310-MR-P DEPARTMENT OF JUSTICE National Institute of Corrections Advisory Board Meeting *Time and Date:* 8:30 a.m. to 4:30 p.m. on Monday, January 23, 2006. 8:30 a.m. to 4:30 p.m. on Tuesday, January 24, 2006. *Place:* The Holiday Inn, 625 First Street, Alexandria, Virginia 22314. *Status:* Open. *Matters To Be Considered:* Reports; Gangs; NIC Balance Scored Card update; Faith-based Recommendations; PREA Regional Workshops; Mental Health Hearing; Quarterly Report by Office of Justice Programs. *Contact for Further Information:* Larry Solomon, Deputy Director, 202-307-3106, ext. 44254. Morris L. Thigpen, Director. [FR Doc. 06-178 Filed 1-9-06; 8:45 am]
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