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Code · REGISTER · 2006-01-04 · Food and Drug Administration, HHS · Notices

Notices. Notice of public workshop

6,076 words·~28 min read·/register/2006/01/04/06-48·

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 University of Arkansas/Food and Drug Administration Food Labeling; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas (UA), is announcing a public workshop entitled “UA/FDA Food Labeling Workshop.
” This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. *Date and Time* : This public workshop will be held on April 5, 2006, from 8 a.m. to 5 p.m., and on April 6, 2006, from 8 a.m. to 3 p.m. *Location* : The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). *Contact* : Steven C.
Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575-4221, FAX: 479-575-2165, or e-mail: *seideman@uark.edu* . For information on accommodation options, contact Steven C. Seideman (see *Contact* ). *Registration* : You are encouraged to register by March 21, 2006. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Seats are limited, please submit your registration as soon as possible.
Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $200 payable to: “The University of Arkansas.” If you need special accommodations due to a disability, please contact Steven C.
Seideman (see *Contact* ) at least 7 days in advance. *Registration Form Instructions* : To register, please complete the following form and submit along with a check or money order for $150 payable to the “The University of Arkansas.” Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. Name: ______________________ Affiliation: ____________________ Mailing Address: ____________________ City: ____________________ State:_____ Zip Code: ________ Phone:
( ) ________________ FAX: ( ) ________________ E-mail: ( ) _________________ Special Accommodations Required: ____________________________________ *Transcripts* : Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested at cost through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The FDA SWR SBR previously presented this workshop in Fayetteville, AR, on April 5 and 6, 2005 (70 FR 6450, February 7, 2005). This public workshop is being held in response to the large volume of food labeling inquiries from small food manufacturers and startups originating from the area covered by the FDA Denver District Office. The SWR SBR presents these workshops to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public.
This is consistent with the purposes of the SBR Program, which are in part to respond to industry inquiries, develop educational materials, sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA's requirements and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach activities by government agencies to small businesses.
The goal of this public workshop is to present information that will enable manufacturers and regulated industry to better comply with labeling requirements, especially in light of growing concerns about obesity and food allergens. Information presented will be based on agency position as articulated through regulation, compliance policy guides, and information previously made available to the public. Topics to be discussed at the workshop include:
(1)Mandatory label elements,
(2)nutrition labeling requirements,
(3)health and nutrition claims,
(4)the Food Allergen Labeling and Consumer Protection Act of 2004, and
(5)special labeling issues such as exemptions. FDA expects that participation in this public workshop will provide regulated industry with greater understanding of the regulatory and policy perspectives on food labeling and increase voluntary compliance. Dated: December 27, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-8225 Filed 1-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0468] Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a guidance for industry (#123) entitled “Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals.” This guidance provides recommendations regarding the development of target animal safety and effectiveness data to support approval of veterinary non-steroidal anti-inflammatory drugs (NSAIDs), specifically cyclooxygenase
(COX)inhibitors. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, 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 guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Linda Wilmot, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0135, e-mail: *lwilmot@cvm.fda.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of November 10, 2004 (69 FR 65202), FDA published a notice of availability for a draft guidance entitled “Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals” giving interested persons until January 24, 2005, to comment on the draft guidance. This final guidance reflects changes in response to comments received on the draft guidance. In addition, FDA provided further clarification regarding recommendations on the generation of pharmacokinetic
(PK)data. In particular, FDA included several examples of the type of PK information that would be recommended for certain types of products including those involving repeated administration or multiple dosage forms. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 addressed in this guidance have been approved under OMB control number 0910-0032. III. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the agency's current thinking on the development of target animal safety and effectiveness data to support approval of non-steroidal anti-inflammatory drugs for use in animals. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. IV. Comments As with all FDA guidances, the public is encouraged to submit written or electronic comments with new data or other new information pertinent to this guidance. FDA periodically will review the comments in the docket, and where appropriate, will amend the guidance. The agency will notify the public of any such amendments through a notice in the **Federal Register** . Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this 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 should be identified with the docket number found in brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Persons with access to the Internet may obtain the guidance at either *http://www.fda.gov/cvm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: December 21, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-8223 Filed 1-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0493] Guidance for Industry and Review Staff on Recommended Approaches to Integration of Genetic Toxicology Study Results; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a guidance for industry and review staff entitled “Recommended Approaches to Integration of Genetic Toxicology Study Results.” This guidance is intended to inform industry and the review staff in the Center for Drug Evaluation and Research
(CDER)on how CDER views positive findings in genetic toxicology assays during drug development. The guidance provides recommendations on how to proceed with clinical studies while ensuring the safety of study participants when results in genotoxicity studies suggest a potential cancer or genetic hazard. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: David Jacobson-Kram, Center for Drug Evaluation and Research (6411), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6488, Silver Spring, MD 20993, 301-796-0175. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and review staff entitled “Recommended Approaches to Integration of Genetic Toxicology Study Results.” Pharmaceuticals administered through oral, intravenous, topical, and other routes, as appropriate, are subject to this guidance. In the **Federal Register** of December 2, 2004 (69 FR 70153), FDA announced the availability of a draft version of the guidance entitled “Recommended Approaches to Integration of Genetic Toxicology Study Results.” When the draft guidance was published, FDA requested comments on the document. Some changes were made to the draft document based on comments submitted to the docket including the following changes:
(1)The guidance now suggests that for a compound giving positive results in a genetic toxicology assay, an alternative to demonstrating “mechanism of action” would be ruling out mechanisms involving direct interaction with dexoyribonucleic acid
(DNA)and
(2)alkaline elution is included as an example of an assay for measuring DNA damage. Other editorial changes were also made. A number of comments to the docket suggested that the fourth test in the International Conference on Harmonisation
(ICH)battery should be an option for compounds giving a positive response in one of the initial assays. This change was not included. Positive responses are primarily seen in the in vitro chromosomal aberration assay and/or the mouse lymphoma assay. Because these two tests measure common genetic lesions and have similar drug exposure protocols, the data from the two assays can be used to corroborate results. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on recommended approaches to integration of genetic toxicology study results. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the guidance at any time. 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. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: December 21, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-8224 Filed 1-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D-2215] (formerly 99D-2215) International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); 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 (#92) entitled “Impurities in New Veterinary Drug Substances (Revision)” VICH GL10(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). The draft revised document is intended to provide guidance for registration applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously registered in a country, region, or member state. DATES: Submit written or electronic comments by February 3, 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 request. 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, rm. 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: 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 Drug Substances In May 2005, the VICH steering committee agreed that a draft revised guidance entitled “Impurities in New Veterinary Drug Substances (Revision)” VICH GL10(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 42020). The draft revised guidance clarifies the 2000 guidance, adds information, and provides consistency with more recently published VICH guidances. The draft revised guidance is the 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 registration 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 revised guidance includes revised text on recommended threshold limits and revised text on recommended specification limits for impurities. Additions to the glossary include definitions for the terms “identification threshold” and “qualification threshold.” References to validated limits of quantitation were removed. In addition, 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 provisions 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,” “required,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement. The draft revised VICH guidance represents the agency's current thinking on impurities in new veterinary drug substances. 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-2215, entitled “Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision)” VICH GL10(R), and follow the directions. Copies of the draft guidance document entitled “Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision)” VICH GL10(R), may be obtained on the Internet from the CVM home page at *http://www.fda.gov/cvm* . Dated: December 21, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-8222 Filed 1-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-4665-N-27] Conference Call Meeting of the Manufactured Housing Consensus Committee AGENCY: Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD. ACTION: Notice of Three Upcoming Meetings Via Conference Call. SUMMARY: This notice sets forth the schedule and proposed agenda of three upcoming meetings of the Manufactured Housing Consensus Committee (the Committee) to be held via telephone conference. The meetings are a continuation of the Committee's meeting held by telephone conference on December 19, 2005, and recessed until the next meeting. These meetings are open to the general public, which may participate by following the instructions below. DATES: The conference call meetings will be held on Wednesday, January 11; Thursday, January 12; and Monday, January 23, 2006, each meeting from 11 a.m. to 3 p.m. Eastern Standard Time. ADDRESSES: Information concerning the conference call can be obtained from the Department's Consensus Committee Administering Organization, the National Fire Protection Association (NFPA). Interested parties can link onto NFPA's Web site for instructions concerning how to participate, and for contact information for the conference call from a HUD Web site, in the section marked “Business” “Manufactured Housing Consensus Committee Information”. The link can be found at: *http://www.hud.gov/offices/hsg/sfh/mhs/mhshome.cfm* . Alternately, interested parties may contact Valaree Crawford of NFPA by phone at
(617)984-7507 (this is not a toll-free number) for conference call information. FOR FURTHER INFORMATION CONTACT: William W. Matchneer III, Associate Deputy Assistant Secretary, Office of Regulatory Affairs and Manufactured Housing, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410, telephone
(202)708-6409 (this is not a toll-free number). Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Information Relay Service at
(800)877-8339. SUPPLEMENTARY INFORMATION: Notice of this meeting is provided in accordance with Sections 10(a) and
(b)of the Federal Advisory Committee Act (5 U.S.C. App. 2) and 41 CFR 102-3.150. The Manufactured Housing Consensus Committee was established under Section 604(a)(3) of the National Manufactured Housing Construction and Safety Standards Act of 1974, as amended, 42 U.S.C. 5403(a)(3). The Committee is charged with providing recommendations to the Secretary to adopt, revise, and interpret manufactured home construction and safety standards and procedural and enforcement regulations, and with developing and recommending proposed model installation standards to the Secretary. The purpose of these conference call meetings is to permit the Committee, at its request, to review and make further recommendations to the Secretary regarding proposed changes to the proposed Model Manufactured Home Installation Standards, and when that discussion is complete, to proposed changes to Title 24, *Code of Federal Regulations* , Part 3282 401 through 418 (Subpart I—Consumer Complaint Handling and Remedial Actions). The exceptional circumstances providing less than 15 calendar days notice of the meeting are that it is necessary to have this meeting on this date, which is a continuation of its December 19, 2005 meeting called to discuss these matters, to permit the Committee to continue its consideration and take action regarding the foregoing matters in a timely manner. Tentative Agenda A. Roll Call. B. Welcome and Opening remarks. C. Full Committee meeting and take actions on proposed changes to the proposed Model Manufactured Home Installation Standards. D. Full Committee meeting to take actions on proposed changes to 24 CFR Part 3282, Subpart I. E. Adjournment. Dated: December 28, 2005. Brian D. Montomery, Assistant Secretary for Housing—Federal Housing Commissioner [FR Doc. E5-8254 Filed 1-3-06; 8:45 am] BILLING CODE 4210-27-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Availability of the Draft Comprehensive Conservation Plans and Environmental Assessments for Chickasaw National Wildlife Refuge in Lauderdale County, TN; Hatchie National Wildlife Refuge in Haywood County, TN; Lower Hatchie National Wildlife Refuge in Lauderdale and Tipton Counties, TN; and Reelfoot and Lake Isom National Wildlife Refuges in Obion and Lake Counties, TN; and Fulton County, KY AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability. SUMMARY: The Fish and Wildlife Service announces that Draft Comprehensive Conservation Plans and Environmental Assessments for the above referenced refuges are available for review and comment. The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, requires the Service to develop a comprehensive conservation plan for each national wildlife refuge. The purpose in developing a comprehensive conservation plan is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and Service policies. In addition to outlining broad management direction on conserving wildlife and their habitats, plans identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation, wildlife photography, and environmental education and interpretation. DATES: A meeting will be held to present the plans to the public. Mailings, newspaper articles, and posters will be the avenues to inform the public of the date and time for the meeting. Individuals wishing to comment on these draft plans and environmental assessments should do so no later than February 21, 2005. ADDRESSES: Requests for copies of each of these plans and environmental assessments should be addressed to West Tennessee Refuges, 301 No. Church, Room 201, Dyersburg, Tennessee 38024; Telephone 731/287-0650. The plans may also be accessed and downloaded from the Service's Internet Web site * http:// southeast.fws.gov/planning/ * . Comments on the draft plans may be submitted to the above address or via electronic mail to *Randy_Cook@fws.gov* . Please include your name and return address in your Internet message. 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 addresses from the record, which we will honor to the extent allowable by law. SUPPLEMENTARY INFORMATION: Significant issues addressed in the draft plans include: threatened and endangered species; waterfowl management; neotropical migratory birds; bottomland hardwood forest restoration; agriculture; visitor services; funding and staffing; cultural resources; and land acquisition. Alternatives The Service developed the following alternatives for managing the refuges and selected Alternative D as the preferred alternative. *Alternative A.* Existing refuge management and public outreach practices would be favored under this alternative. Refuge management actions would be directed toward achieving established refuge purposes including
(1)preserving wintering waterfowl habitat (e.g., croplands, moist-soil management units), and
(2)meeting the habitat conservation goals of the North American Waterfowl Management Plan. Additionally, these actions would contribute to other national, regional, and state goals to protect and restore habitat for shorebirds, wading birds, neotropical breeding birds, and threatened and endangered species. Refuge management programs would continue to be developed and implemented with little baseline biological information. Active habitat management would continue to be implemented through water level manipulations, moist-soil and cropland management, and forest management designed to provide a diverse complex of habitats that meet the foraging, resting, and breeding requirements for a variety of species. However, no additional moist-soil units would be developed and no new lands would be acquired. Control of exotic plants or nuisance wildlife populations, including beaver, would be kept to a reactive level. Hunting and fishing would continue to be the major focus for the public use program, with no expansion of current opportunities. Current restrictions or prohibitions would remain, including the seasonal closure of the waterfowl sanctuary. No new visitor education facilities would be built and only limited improvements would occur for existing environmental education exhibits and interpretive materials. *Alternative B.* This alternative would emphasize recreational uses and environmental education while maintaining a low maintenance approach to managing habitats. Additional staff and resources would be dedicated to allow for more public use activities in all areas of the refuges. Bottomland hardwood forests and moist-soil habitats would be maintained on existing lands but no additional moist-soil units would be developed. Cropland acres would be reduced to accommodate increased public use programs. If opportunities and funding become available, new refuge lands could be acquired up to the completion of the current approved acquisition boundaries. Additional lands would be managed for public use rather than habitat management under this alternative. Control of exotic plants or nuisance wildlife populations would be kept to a minimal and reactive level. Beaver control would be conducted only where necessary to protect property of adjoining landowners. However, the deer herd would be controlled through public hunting and opportunity would be expanded under this alternative. Hunting and fishing seasons and regulations would be examined to provide more opportunities. Outreach opportunities would be designed to increase public understanding and enjoyment of fish and wildlife and their habitats. Efforts would include increased participation in the local civic organizations and in meeting with city, county, and State officials. Secondary recreational uses would be considered for compatibility on refuge lands. The environmental education program could see a visitor education facility, exhibits, and interpretive materials. Additional staff and/or volunteers would be added in an effort to increase on-site public contacts, including enhanced environmental education and interpretation programs on and off the refuges. *Alternative C.* Under this alternative, the emphasis would be the active and intensive management of existing fish, wildlife, and plant habitats. Primary management efforts would focus on restoring and enhancing habitats and associated plant communities for the benefit of migratory birds, threatened and endangered species, and other federal trust species. Forest habitat would be managed to increase and enhance the red oak component for migratory waterfowl by manipulating existing timber stands through both commercial and non-commercial harvest methods, and by incorporating native tree species in any future reforestation efforts. Additional staff and resources would be dedicated to allow for more habitat management activities in all areas of the refuges, such as tree planting in converted bottomland hardwood forests and a prescribed burning program. Integrated biological controls and harvest methods would be used to control exotic plant or nuisance wildlife species. The biological research and monitoring program would also receive more attention. Refuge staff would continue to restore, enhance, and maintain existing bottomland hardwood forests and moist-soil units, and additional moist-soil units would be developed on existing and newly acquired lands. Cropland habitats would be managed by cooperative and force account farming and additional units would be developed on newly acquired lands. As opportunities and funding become available, new refuge lands could be acquired to complete the current approved acquisition boundaries. Newly acquired lands would be managed with an emphasis on habitat management rather than public use under this alternative. In contrast to the expansion of habitat work, new recreational opportunities for visitors would not be pursued and environmental education and outreach programs would remain at present levels. Hunting and fishing seasons and access would continue, but with the possibility of more seasonal closures to protect sensitive wildlife resources. The environmental education program could see a new visitor facility but only minimal improvements in existing exhibits and interpretive materials. A slight increase in public awareness of the refuges would be expected due to land protection efforts. *Alternative D.* The Service planning team has identified Alternative D as the preferred alternative. This alternative was developed based on public input and the best professional judgment of the planning team. Strategies presented in the draft plans were developed as a direct result of the selection of Alternative D. Alternative D represents a combination and/or compromise between Alternative B (Habitat Management Emphasis) and Alternative C (Public Use Emphasis). Whereas these two alternatives seek to maximize either expanded wildlife habitat management or expanded public use opportunities, Alternate D seeks to optimize the benefits of the refuges to wildlife and people, recognizing that tradeoffs may preclude maximizing the benefits of each alternative. By seeking the “best of both” Alternatives B and C, Alternative D would promote better management and protection of fish, wildlife, and their habitats and higher quality recreational and educational programs for visitors. Under Alternative D, refuge lands would be more intensely managed than at present to provide high quality habitat for wildlife, which would work toward fulfilling the habitat objectives outlined for the Mississippi Alluvial Valley Migratory Bird Initiative, and would include significant benefits for waterfowl, shorebirds, and neotropical migratory birds. With the implementation of this alternative, there would be significant habitat benefits to migratory bird species by increasing and enhancing breeding, wintering, and migration habitat for wetland-dependent migratory species. This alternative contributes directly to the objectives of the Lower Mississippi Joint Venture of the North American Waterfowl Management Plan, the Partners in Flight—Mississippi Alluvial Valley Habitat Conservation Plan, the United States Shorebird Conservation Plan—Lower Mississippi Valley/West Gulf Coastal Plain, West Tennessee Wildlife Resources Conservation Plan, and the North American Woodcock Plan, and provides integrated migratory bird management objectives in a landscape-level, biologically driven framework particularly for migratory birds. This would include creating and maintaining additional moist-soil units and restoring bottomland hardwood forest habitats. Fisheries management would be emphasized and, where appropriate, restored for native diversity within the floodplain. Refuge habitats would be managed and restored for natural diversity in support of national and regional plans. Forest management would address the need to restore and enhance the red oak component for migratory waterfowl and develop vertical structure to provide habitat for a diversity of species, particularly priority migratory birds. Any future reforestation efforts would incorporate greater native tree species diversity. This alternative would encourage more public recreational and educational uses, where feasible, while intensifying current habitat management. Hunting and fishing would continue with greater emphasis on the quality of the experience and with more diverse opportunities, including those for youth and disabled hunters/anglers. Education and interpretation would be promoted while providing programs and partnerships with local schools. Wildlife observation and photography opportunities would be expanded. Information guides and signage that highlight refuge management programs, as well as unique wildlife habitats, would also be developed. Efforts would also be undertaken to improve road maintenance in order to provide better visitor access. A visitor center and headquarters office would be constructed on the refuges, with space for interpretation, environmental education, and staff. Research studies would continue to be fostered and partnerships developed with universities and other agencies, with the refuges providing needed resources and study sites. Research would also provide benefits to conservation efforts throughout the Lower Mississippi River Valley to preserve, enhance, restore, and manage bottomland hardwood habitat. Inventorying and monitoring of birds, freshwater mussels, reptiles, and amphibians would be continued and expanded in order to assess population trends, correlate with environmental pressures, and provide baseline data to be used in development of appropriate management strategies. Additional staff would include biological, law enforcement, outreach, and maintenance personnel. Providing a wildlife biologist, outdoor recreation planner, maintenance workers, and an additional full-time law enforcement officer would enable the Service to fully develop and manage fish and wildlife resources and habitats, provide opportunities and facilities for wildlife observation and photography, provide environmental educational programs that promote a greater understanding of natural resources, and protect natural and cultural resources, as well as refuge visitors. Under this alternative, the refuges would continue to acquire lands within the present acquisition boundaries for the use of compatible wildlife-dependent public recreation and environmental education opportunities. Tracts that provide better-quality habitat and connectivity to existing refuge lands would receive higher priority for acquisition. The refuges would also use other important acquisition tools, including partnerships with conservation organizations, conservation easements with adjacent landowners, and leases/cooperative agreements. Authority: This notice is published under the authority of the National Wildlife Refuge System Improvement Act of 1997, Public Law 105-57. Dated: October 7, 2005. Cynthia K. Dohner, Acting Regional Director. [FR Doc. 06-48 Filed 1-3-06; 8:45 am]
Connectionstraces to 3
5 references not yet in our index
  • Pub. L. 104-121
  • 44 USC 3501-3520
  • 41 CFR 102
  • 24 CFR 3282
  • Pub. L. 105-57
Citation graph
cites case law
Notices
Notice of public workshop
Pub. L.Pub. L. 104-121
Cite44 USC 3501-3520
Cite41 CFR 102
Cite24 CFR 3282
Pub. L.Pub. L. 105-57
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