Notices. Notice

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0006] Determination of Regulatory Review Period for Purposes of Patent Extension; LYRICA (New Drug Application 21-446) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for LYRICA (new drug application

(NDA)21-446) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product LYRICA (NDA 21-446) (pregabalin). LYRICA (NDA 21-446) is indicated for management of neuropathic pain associated with diabetic peripheral neuropathy. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for LYRICA (NDA 21-446) (U.S. Patent No. 6,197,819) from Warner-Lambert Company LLC, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 24, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of LYRICA (NDA 21-446) represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for LYRICA (NDA 21-446) is 3,279 days. Of this time, 2,852 days occurred during the testing phase of the regulatory review period, while 427 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : January 10, 1996. The applicant claims August 24, 1997, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was January 10, 1996, which was 30 days after FDA receipt of the initial IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : October 31, 2003. The applicant claims October 30, 2003, as the date the new drug application

(NDA)for LYRICA (NDA 21-446) was initially submitted. However, FDA records indicate that NDA 21-446 was initially submitted on October 31, 2003. 3. *The date the application was approved* : December 30, 2004. FDA has verified the applicant's claim that NDA 21-446 was approved on December 30, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 299 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by November 27, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 26, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 15, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-15908 Filed 9-26-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS-2006-0054] Notice of Meeting of National Infrastructure Advisory Council

(NIAC)AGENCY: Directorate for Preparedness, DHS. ACTION: Notice of meeting. SUMMARY: The National Infrastructure Advisory Council

(NIAC)will meet in open session. DATES: Tuesday, October 10, 2006, from 1:30 p.m. to 4:30 p.m. ADDRESSES: National Press Club, 529 14th Street, NW., Washington, DC 20045. You may submit comments, identified by DHS-2006-0054, by *one* of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • E-mail: *william.corcoran@associates.dhs.gov* . When submitting comments electronically, please include by DHS-2006-0054, in the subject line of the message. • Mail: Jenny Menna, Department of Homeland Security, Directorate for Preparedness, Washington, DC 20528. To ensure proper handling, please reference by DHS-2006-0054, on your correspondence. This mailing address may be used for paper, disk or CD-ROM submissions. • Hand Delivery/Courier: Jenny Menna, Department of Homeland Security, Directorate for Preparedness, Washington, DC 20528. Contact Telephone Number 703-235-5316. *Instructions:* All submissions received must include the words “Department of Homeland Security” and DHS-2006-0054, the docket number for this action. Comments received will be posted without alteration at *http://www.regulations.gov* , including any personal information provided. *Docket:* For access to the docket to read background documents or comments received, go to *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Jenny Menna, NIAC Designated Federal Officer, Department of Homeland Security, Washington, DC 20528; telephone 703-235-5316. SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. App.1 *et seq.* ). At this meeting, the NIAC will be briefed on the status of several Working Group activities in which the Council is currently engaged. This meeting is open to the public on a first-come, first-served basis. Please note that the meeting may close early if all business is finished. A tentative agenda for the meeting is set forth below, but may be updated. Please consult the NIAC Web site, *http://www.dhs.gov/niac* , for the most current agenda. *Information on Services for Individuals with Disabilities:* For information on facilities or services for individuals with disabilities, or to request special assistance at the meeting, telephone the Designated Federal Officer as soon as possible. Dated: September 18, 2006. Jenny Menna, Designated Federal Officer for the NIAC. Draft Agenda of October 10, 2006 Meeting I. Opening of Meeting: *Jenny Menna,* Designated Federal Officer, NIAC, Department of Homeland Security. II. Roll Call of Members: *Jenny Menna* . III. Opening Remarks and Introductions: NIAC Chairman, *Erle A. Nye,* Chairman Emeritus, TXU Corp, NIAC Vice Chairman, *John T. Chambers,* President and CEO, Cisco Systems, Inc, * Michael Chertoff, * Secretary, Department of Homeland Security

(DHS)*(Invited)* , *Frances Fragos Townsend,* Assistant to the President for Homeland Security and Counterterrorism *(Invited)* . IV. Approval of July Minutes: NIAC Chairman, *Erle A. Nye* . V. Final Reports and Deliberations: NIAC Chairman, *Erle A. Nye* Presiding. A. The Prioritization of Critical Infrastructures for a Pandemic Outbreak in the United States: *Chief Rebecca F. Denlinger* , Fire Chief, Cobb County, Georgia Fire and Emergency Services, NIAC Member, *Martha H. Marsh,* Chairman and CEO, Stanford Hospital and Clinics, NIAC Member and *Bruce Rohde,* Chairman and CEO Emeritus, ConAgra Foods, Inc. B. Deliberation and Approval of Recommendations of Final Report: *NIAC Members* . VI. Status Report on Current Working Group Initiatives: NIAC Chairman, *Erle A. Nye* Presiding. A. Convergence of Physical and Cyber Technologies and Related Security Management Challenges: *George Conrades,* Executive Chairman, Akamai Technologies, NIAC Member, *Margaret Grayson,* President, AEP Government Solutions Group, NIAC Member, and *Gregory A. Peters,* Former President and CEO, Internap Network Services Corporation, NIAC Member. VII. New Business: NIAC Chairman, *Erle A. Nye,* NIAC Members TBD. A. Discussion of Potential New Working Group Topics: *NIAC Members* . B. Recommendations Follow-up: *Nancy Wong,* Designated Federal Officer, DHS. VIII. Adjournment: NIAC Chairman, *Erle A. Nye* . [FR Doc. E6-15864 Filed 9-26-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Revision of a Currently Approved Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Application for T Nonimmigrant Status; Application for Immediate Family Member of T-1 Recipient; and Declaration of Law Enforcement Officer for Victim of Trafficking in Persons; Form I-914 and Supplements A and B; OMB Control No. 1615-0099. The Department of Homeland Security, U.S. Citizenship and Immigration Services has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until November 27, 2006. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), USCIS, Director, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, 3rd floor, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov.* When submitting comments by e-mail please make sure to add OMB Control Number 1615-0099 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

(2)Evaluate the accuracy of the agencies estimate of the burden of the 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 collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. *Overview of this information collection:*

(1)*Type of Information Collection:* Revision of an existing information collection.

(2)*Title of the Form/Collection:* Application for T Nonimmigrant Status; Application for Immediate Family Member of T-1 Recipient; and Declaration of Law Enforcement Officer for Victim of Trafficking in Persons.

(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-914 and Supplements A and B. U.S. Citizenship and Immigration Services.

(4)*Affected public who will be asked or required to respond, as well as a brief abstract:* *Primary:* Individuals and households. This application permits victims of severe forms of trafficking and their immediate family members to demonstrate that they qualify for temporary nonimmigrant status pursuant to the Victims of Trafficking and Violence Protection Act of 2000 (VTVPA), and to receive temporary immigration benefits.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* Form I-914 (500 responses at 2.25 hours per response); Supplement A (500 responses at 1 hour per response); Supplement B (200 responses at .5 hours per response);

(6)*An estimate of the total public burden (in hours) associated with the collection:* 1,725 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please visit the USCIS Web site at: *http://uscis.gov/graphics/formsfee/forms/pra/index.htm.* If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, 3rd Floor, Washington, DC 20529,

(202)272-8377. Dated: September 22, 2006. Stephen Tarragon, Acting Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. E6-15785 Filed 9-26-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Information Collection Sent to the Office of Management and Budget

(OMB)for Approval; OMB Control Number 1018-0014; Special Use Permit Applications for National Wildlife Refuges in Alaska AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (Fish and Wildlife Service) have sent an Information Collection Request

(ICR)to OMB for review and approval. The ICR, which is summarized below, describes the nature of the collection and the estimated burden and cost. This ICR is scheduled to expire on September 30, 2006. We 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. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB. DATES: You must submit comments on or before October 27, 2006. ADDRESSES: Send your comments and suggestions on this ICR to the Desk Officer for the Department of the Interior at OMB-OIRA at

(202)395-6566

(fax)or *OIRA_DOCKET@OMB.eop.gov* (e-mail). Please provide a copy of your comments to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail);

(703)358-2269 (fax); or *hope_grey@fws.gov* (e-mail). FOR FURTHER INFORMATION CONTACT: To request additional information about this ICR, contact Hope Grey at one of the addresses above or by telephone at

(703)358-2482. SUPPLEMENTARY INFORMATION: *OMB Control Number:* 1018-0014. *Title:* Special Use Permit Application for National Wildlife Refuges in Alaska (50 CFR 25.61, 26.22(b), 26.25, 36.33, 36.37, 36.39, and 36.41). *Service Form Number(s):* 3-2001. *Type of Request:* Revision of a currently approved collection. *Affected Public:* Individuals; businesses and other for-profit institutions; not-for-profit institutions; State, local, or tribal governments; and the Federal Government. *Respondent's Obligation:* Required to obtain or retain benefits. *Frequency of Collection:* On occasion. Type of permit application Number of annual respondents Number of annual responses Completion time per response Annual burden hours Noncompetitive—Kodiak 240 240 20 minutes 80 Noncompetitive—Other 120 170 90 minutes 255 Competitive 80 180 30 hours 5,400 Totals 440 590 5,735 *Abstract:* We collect information from individuals or organizations that apply for a special use permit required to conduct economic or other privileged or specialized uses on National Wildlife Refuge System lands in Alaska. We use the information to:

(1)Determine if the applicant is qualified or eligible for a permit.

(2)Evaluate the impacts of the proposed activity on refuge resources and other users.

(3)Determine if the proposed activity is compatible with refuge purposes and the mission of the refuge system. *Comments:* On May 26, 2006, we published in the **Federal Register** (71 FR 30439) a notice of our intent to request that OMB renew approval for this information collection. In that notice, we solicited comments for 60 days, ending on July 25, 2006. We received two comments from the same individual. The comments did not address issues surrounding the proposed collection of information or the cost and hour burden estimates, but instead objected to our issuing permits for guided hunting. The commenter also questioned who verified the information submitted in the application, and suggested requesting additional information for two of the application items. If we include the suggested additional information on our application, we would collect information in excess of the minimum necessary to fulfill our statutory and regulatory requirements and responsibilities. Therefore, we have not made any changes to FWS Form 3-2001 as a result of these comments. We again 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. Dated: August 10, 2006. Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service. [FR Doc. E6-15788 Filed 9-26-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Cedar Island National Wildlife Refuge AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability of the Final Comprehensive Conservation Plan and Finding of No Significant Impact for Cedar Island National Wildlife Refuge on Cedar Island National Wildlife Refuge in Carteret County, North Carolina. SUMMARY: The Fish and Wildlife Service announces that a Final Comprehensive Conservation Plan and Finding of No Significant Impact for Cedar Island National Wildlife Refuge are available for distribution. The plan was prepared pursuant to the National Wildlife Refuge System Improvement Act of 1997 and in accordance with the National Environmental Policy Act of 1969. The compatibility determinations for hunting, fishing, wildlife observation, wildlife photography, environmental education and interpretation, trapping of selected furbearers, forest management, and resource research studies are also available within the plan. ADDRESSES: A copy of the plan may be obtained by writing to: Mattamuskeet National Wildlife Refuge, 38 Mattamuskeet Road, Swan Quarter, North Carolina 27885. The plan may also be accessed and downloaded from the Service's Web site: *http://southeast.fws.gov/planning/.* SUPPLEMENTARY INFORMATION: The availability of the Draft Comprehensive Conservation Plan and Environmental Assessment for a 30-day public review and comment period was announced in the **Federal Register** on February 14, 2006 (71 FR 7794). The draft plan and environmental assessment identified and evaluated three alternatives for managing the refuge over the next 15 years. Based on the environmental assessment and the comments received, the Service adopted alternative 2 as its preferred alternative. Alternative 2 emphasizes management of the refuge's priority wildlife species. The staff will survey waterfowl from the air on a routine basis. The refuge will continue to allow the six priority public use activities, but will have the capacity to increase the number of opportunities. The staff will conduct environmental education programs and establish an interpretive and observation trail with a brochure and a photo blind. The staff will control dominant pest plants and animals. There will be four staff members stationed at Cedar Island National Wildlife Refuge. Cedar Island National Wildlife Refuge covers a total of 14,480 acres within a 16,887-acre acquisition boundary on Cedar Island in Pamlico Sound. The refuge is comprised of 11,000 acres of brackish marsh, 1,500 acres of longleaf pine savanna, 150 acres of brackish shrub, 125 acres of pond pine woodland, 100 acres of bay forest, 100 acres of low pocosin, and 50 acres of cypress-gum swamp. These habitats support a variety of wildlife species, including waterfowl, shorebirds, wading birds, marsh birds, and neotropical migratory songbirds. Authority: This action is published under the authority of the National Wildlife Refuge System Improvement Act of 1997, Public Law 105-57. Dated: June 21, 2006. Cynthia K. Dohner, Acting Regional Director. [FR Doc. 06-8279 Filed 9-26-06; 8:45 am]

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