Notices. Notice

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BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0369] Guidance for Industry; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a final guidance for industry entitled “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.” The guidance provides recommendations to developers of new plant varieties, including bioengineered plant varieties, on the early food safety evaluation of new non-pesticidal proteins. The guidance describes procedures for submitting an early food safety evaluation of such proteins to the agency. DATES: This guidance document is final upon the date of publication. Submit written or electronic comments concerning the guidance at any time. ADDRESSES: Submit written requests for single copies of the guidance entitled “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” to the Office of Food Additive Safety (HFS-255), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Include a self-addressed adhesive label to assist that office in processing your request. Submit written comments concerning 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* . To ensure a timelier processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Mary D. Ditto, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740- 3835, 301-436-1165, FAX 301-436-2965, or e-mail: *mary.ditto@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of August 2, 2002 (67 FR 50578), the U.S. Office of Science and Technology Policy

(OSTP)proposed Federal actions to update field test requirements and to establish early voluntary food safety evaluations for new proteins produced by bioengineered plants. Rapid developments in genomics are resulting in dramatic changes in the way new plant varieties are developed and commercialized. Scientific advances are expected to accelerate over the next decade, leading to the development and commercialization of a greater number and diversity of bioengineered crops. As the number and diversity of field tests for bioengineered plants increase, the likelihood that cross-pollination due to pollen drift from field tests to commercial fields and commingling of seeds produced during field tests with commercial seeds or grain may also increase. This could result in the inadvertent, intermittent, low-level presence in the food supply of proteins that have not been evaluated through FDA's voluntary consultation procedures for foods derived from new plant varieties (referred to as “biotechnology consultation” in the case of bioengineered plants). 1 FDA is issuing this guidance document to address this possibility. 1 “Guidance on Consultation Procedures: Foods Derived from New Plant Varieties” can be found at *http://www.cfsan.fda.gov/~lrd/consulpr.html* . In the **Federal Register** of November 24, 2004 (69 FR 68381), FDA made available a draft guidance for industry entitled “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” and gave interested parties an opportunity to submit comments by January 24, 2005. The agency considered received comments as it finalized this guidance. This guidance describes the procedure for early food safety evaluation of new proteins produced by new plant varieties that are under development for food use, including, for example, such proteins produced in bioengineered plants. This guidance also provides information to sponsors and developers about submitting their evaluation to FDA. FDA is issuing this guidance document as a level 1 guidance consistent with FDA's good guidance practices regulation § 10.115 (21 CFR 10.115). This guidance represents FDA's current thinking on the early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT ). If you cannot identify the appropriate FDA staff, call the telephone number listed in the title page of the guidance. II. Paperwork Reduction Act of 1995 This 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 collection of information in the guidance was approved under OMB Control No. 0910-0583. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this 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 document and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the guidance document at either *http://www.cfsan.fda.gov/guidance.html* or *http://www.fda.gov/cvm/Guidance/published.htm* . Dated: June 14, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-9688 Filed 6-20-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Agency Information Collection Activities: Petroleum Refineries in Foreign Trade Subzones AGENCY: Customs and Border Protection, Department of Homeland Security. ACTION: Proposed collection; comments requested. SUMMARY: Customs and Border Protection

(CBP)of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget

(OMB)for review and approval in accordance with the Paperwork Reduction Act of 1995: Petroleum Refineries in Foreign Trade. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with a change to the burden hours. This document is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the **Federal Register** (71 FR 12383-12384) on March 10, 2006, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10. DATES: Written comments should be received on or before July 21, 2006. ADDRESSES: Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to the Office of Management and Budget Desk Officer at *Nathan.Lesser@omb.eop.gov* . SUPPLEMENTARY INFORMATION: The Bureau of Customs and Border Protection

(CBP)encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Your comments should address one of the following four points:

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

(2)Evaluate the accuracy of the agencies/components estimate of the burden of The proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. *Title:* Petroleum Refineries in Foreign Trade Subzones *OMB Number:* 1651-0063. *Form Number:* None. *Abstract:* The Petroleum Refineries in Foreign Trade Subzones is a rule that amended the regulations by adding special procedures and requirements governing the operations of crude petroleum and refineries approved as foreign trade zones. *Current Actions:* This submission is to extend the expiration date with a change to the burden hours. *Type of Review:* Extension (with change). *Affected Public:* Business or other for-profit. *Estimated Number of Respondents:* 81. *Estimated Time Per Respondent:* 1000 hours. *Estimated Total Annual Burden Hours:* 81,000. *Estimated Total Annualized Cost on the Public:* N/A. If additional information is required contact: Tracey Denning, Bureau of Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Room 3.2.C, Washington, DC 20229, at 202-344-1429. Dated: June 15, 2006. Tracey Denning, Agency Clearance Officer, Information Services Branch. [FR Doc. E6-9759 Filed 6-20-06; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Information Collection Renewal To Be Sent to the Office of Management and Budget

(OMB)for Approval Under the Paperwork Reduction Act; OMB Control Number 1018-0124; Migratory Bird Subsistence Harvest Household Survey AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (Fish and Wildlife Service) will ask OMB to renew approval for the information collection associated with our migratory bird subsistence harvest household survey. The current OMB control number for this information collection is 1018-0124, which expires on October 31, 2006. We will request that OMB renew approval of this information collection for a 3-year term. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this information collection. DATES: You must submit comments on or before August 21, 2006. ADDRESSES: Send your comments on the information collection to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail); *hope_grey@fws.gov* (e-mail); or

(703)358-2269 (fax). FOR FURTHER INFORMATION CONTACT: To request additional information about this information collection request, contact Hope Grey at one of the addresses above or by telephone at

(703)358-2482. SUPPLEMENTARY INFORMATION: OMB regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). Federal agencies 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. The Migratory Bird Treaty Act (16 U.S.C. 703-712) and the Fish and Wildlife Act of 1956 (16 U.S.C. 742d) designate the Department of the Interior as the key agency responsible for managing migratory bird populations that frequent the United States and for setting harvest regulations that allow for the conservation of those populations. These responsibilities include gathering accurate geographical and temporal data on various characteristics of migratory bird harvest. We use those data to promulgate harvest regulations. Annually, we adjust harvest regulations as needed to provide a maximum of subsistence harvest opportunity while keeping migratory bird populations at desired levels. The Migratory Bird Treaty Act Protocol Amendment

(1995)(Amendment) provides for the customary and traditional use of migratory birds and their eggs for subsistence use by indigenous inhabitants of Alaska. The Amendment, however, states that its intent is not to cause significant increases in the take of species of migratory birds relative to their continental population sizes. A May 20, 1996, submittal letter from the Department of State to the White House accompanied the Amendment and specified the need for harvest monitoring. The letter stated that the Fish and Wildlife Service, the Alaska Department of Fish and Game, and Native organizations cooperatively would collect harvest estimates within the subsistence eligible areas. Harvest survey data help ensure that customary and traditional use of migratory birds and their eggs for subsistence use by indigenous inhabitants of Alaska does not significantly increase the take of species of migratory birds relative to their continental population sizes. From 1989 to 2004, we monitored subsistence harvest in Alaska through the use of annual household surveys in the most heavily used subsistence harvest areas; *e.g.* , Yukon-Kuskokwim Delta. In 2004, we began monitoring subsistence harvest in subsistence eligible areas Statewide. We presently rotate survey areas due to budget constraints. This monitoring enables us to track significant changes or trends in levels of harvest and user participation. We gather information on the annual subsistence harvest of 54 species of birds (including geese, ducks, swans, cranes, loons, seabirds, shorebirds, and upland game birds) through surveys of households in the subsistence eligible areas of Alaska. Annually, local village resident surveyors produce lists of all households in each village and provide survey forms to randomly selected households. We combine the estimates of harvest per household with the complete list of households in the subsistence eligible areas to obtain estimates of the total annual harvest. We use four forms to collect the harvest information. We will aggregate all information collected and use it only for statistical purposes. We do not arrange or retrieve forms by a personal identifier. *Title:* List of Occupied Households—Village Harvest Survey Household Enrollment Form. *OMB Control Number:* 1018-0124. *Form Number:* 7-FW-100. *Frequency of Collection:* Once per year. *Description of Respondents:* Local village surveyors. This form contains information on the village name and number, surveyor's name, year of survey, total houses, house number and household name, and harvest activity level. The local village surveyor maintains this form. *Title:* Households Separated by Hunting Category—Village Harvest Survey Household Selection by Activity Level. *OMB Control Number:* 1018-0124. *Form Number:* 7-FW-101. *Frequency of Collection:* Once per year. *Description of Respondents:* Local village surveyors. This form provides information on the village name and number, surveyor's name, year, total houses, and activity level. The local surveyor takes each household listed on form 7-FW-100 and categorizes it on this form according to activity level. The local village surveyor provides this form to the Service. *Title:* Household Permission Slip. *OMB Control Number:* 1018-0124. *Form Number:* 7-FW-102. *Frequency of Collection:* Once per year. *Description of Respondents:* Households within the subsistence eligible areas of Alaska (Alaska Peninsula, Kodiak Archipelago, the Aleutian Islands, or in areas north and west of the Alaska Range (50 CFR 92.5)). The local village surveyor

(1)asks each household if that household will participate in the subsistence harvest survey and notes a “yes” or “no” on a permission slip;

(2)provides a survey form (described below) to each household with a “yes” permission slip; and

(3)provides the completed permission slip to the Service. *Title:* Subsistence Household Survey. *OMB Control Number:* 1018-0124. *Form Numbers:* 7-FW-103, 7-FW-103a (Interior Alaska), and 7-FW-103b (Southern Coastal Alaska). *Frequency of Collection:* Three times per year. *Description of Respondents:* Households within the subsistence eligible areas of Alaska (Alaska Peninsula, Kodiak Archipelago, the Aleutian Islands, or in areas north and west of the Alaska Range (50 CFR 92.5)). There are three survey forms. The form that a household receives depends on the household's location. Each survey form consists of three pages, one page each for spring, summer, and fall (fall/winter for the Southern Coastal Alaska form). Each page contains bird illustrations, with spaces beside each illustration to mark down numbers of birds and eggs taken. The household number is on each page of the survey form, along with a village number. The local village surveyor provides completed survey forms to the Fish and Wildlife Service. Form Number of respondents Annual number of responses Avg. time/response (in minutes) Total annual burden hours 7-FW-100 182 23,000 1 383 7-FW-101 182 182 30 91 7-FW-102 14,000 14,000 5 1,167 7-FW-103, a, b 11,500 34,500 5 2,875 We invite comments concerning this information collection on:

(1)Whether or not the collection of information is necessary, including whether or not the information will have practical utility;

(2)the accuracy of our estimate of the burden for this collection of information;

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

(4)ways to minimize the burden of the collection of information on respondents. Comments submitted in response to this notice are a matter of public record. We will include and/or summarize each comment in our request to OMB to renew approval for this information collection. Dated: June 8, 2006. Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service. [FR Doc. E6-9734 Filed 6-20-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Availability of the Draft Comprehensive Conservation Plan and Environmental Assessment for the Alligator River National Wildlife Refuge in Dare and Hyde Counties, NC; Extension of Comment Period AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of extension of comment period. SUMMARY: The availability of the Draft Comprehensive Conservation Plan and Environmental Assessment (Draft CCP/EA) was announced in the **Federal Register** on May 30, 2006 (71 FR 30687) for a 30-day public review and comment period ending June 29, 2006. The purpose of this notice is to extend the public review and comment period an additional 15 days. DATES: Comments on the Draft CCP/EA received by July 14, 2006, will be considered in the preparation of the Final CCP. ADDRESSES: All comments should be addressed to Bonnie Strawser, CCP, Alligator River National Wildlife Refuge, P.O. Box 1969, Manteo, North Carolina 27954, or direct e-mail to; *bonnie_strawser@fws.gov.* FOR FURTHER INFORMATION CONTACT: Bonnie Strawser at telephone: 252/473-1131, extension 230. SUPPLEMENTARY INFORMATION: Alligator River National Wildlife Refuge, in northeast North Carolina, consists of 152,260 acres in fee simple ownership. On the refuge, 38,533 acres are pond pine shrub pocosin; 30,400 acres are pond pine cane pocosin; 25,204 acres are brackish march; 12,236 acres are non-alluvial hardwood forest; 11,380 acres are mixed pine hardwood forest, and 8,468 acres are Atlantic white cedar swamp. These habitats support a variety of wildlife species, including red wolves, red-cockaded woodpeckers, waterfowl, shorebirds, wading birds, march birds, and netropical migratory songbirds. The Draft CCP/EA was prepared pursuant to the National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, and the National Environmental Policy Act of 1969. The CCP/EA describes how the Service proposes to manage the refuge over the next 15 years. To fully ensure that the public has sufficient time to comment after the public meeting is held, an extension of 15 days is needed. Authority: This notice is published under the authority of the National Wildlife Refuge System Improvement Act of 1997, Public Law 105-57. Dated: June 5, 2006. Sam D. Hamilton, Regional Director. [FR Doc. 06-5544 Filed 6-20-06; 8:45 am]

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