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Code · REGISTER · 2007-03-05 · Food and Drug Administration, HHS · Notices

Notices. Notice

15,246 words·~69 min read·/register/2007/03/05/07-983

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

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005P-0237] Determination That LAMICTAL (Lamotrigine) Tablets, 50 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined that LAMICTAL (lamotrigine) tablets, 50 milligrams
(mg)and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for lamotrigine tablets, 50 mg and 250 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is typically a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, are the subject of approved NDA 20-241 held by GlaxoSmithKline (GSK). LAMICTAL (lamotrigine) is an antiepileptic drug indicated as adjunctive therapy for partial seizures in adults and pediatric patients. It is also approved for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug or valproate. In addition, LAMICTAL (lamotrigine) is indicated for the maintenance treatment of Bipolar I Disorder in certain patients. FDA approved the NDA for LAMICTAL (lamotrigine) tablets, including the 50 mg and 250 mg strengths, on December 27, 1994. GSK has never marketed the 50 mg and 250 mg strengths of LAMICTAL (lamotrigine) tablets. In a citizen petition dated June 9, 2005 (Docket No. 2005P-0237/CP1), submitted under 21 CFR 10.30, J. Mark Pohl of Pharmaceutical Patent Attorneys, LLC, requested that the agency determine whether LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA has determined that LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. To date, GSK has not marketed LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg. In previous instances (see, e.g., 67 FR 79640, December 30, 2002 (addressing a relisting request for Diazepam Autoinjector)), the agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. The petitioner identified no data or other information suggesting that LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were withdrawn from sale as a result of safety or effectiveness concerns. GSK has marketed other strengths of LAMICTAL (lamotrigine) tablets: 25 mg, 100 mg, 150 mg, and 200 mg. FDA has reviewed its files for records concerning the withdrawal of LAMICTAL (Lamotrigine) tablets, 50 mg and 250 mg. There is no indication that GSK's decision not to market LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, commercially is a function of safety or effectiveness concerns, and no information has been submitted to the docket concerning the reason for which LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were withdrawn from sale. FDA's independent evaluation of relevant information has uncovered nothing that would indicate that LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were withdrawn from sale for reasons of safety or effectiveness. For the reasons outlined in this document, FDA has determined that LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety and effectiveness. ANDAs that refer to LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, may be approved by the agency, as long as they meet all relevant legal and regulatory requirements for approval of ANDAs. Dated: February 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-3713 Filed 3-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committees* : Anti-Infective Drugs Advisory Committee and the Pediatric Advisory Committee. *General Function of the Committees* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on April 12, 2007, from 8:30 a.m. to 5 p.m. *Location* : Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. *Contact Person* : Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *sohail.mosaddegh@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), codes 3014512530 or 8732310001. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will discuss clinical trial designs for products that seek indications for the prevention and/or treatment of disease caused by Shiga toxin-producing bacteria. FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 29, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 21, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 22, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Sohail Mosaddegh at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 26, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-3720 Filed 3-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0055] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Arthritis Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on April 12, 2007, from 8:30 a.m. to 5 p.m. *Addresses* : Electronic comments should be submitted to *http://www.fda.gov/dockets/ecomments.* Select “2007N-0055—Arcoxia—Arthritis Advisory Committee Meeting, April 12, 2007” and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on March 29, 2007. All comments will be posted without change, including any personal information provided. Comments received on or before March 29, 2007, will be provided to the committee before the meeting. *Location* : Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Johanna Clifford, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *Johanna.Clifford@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512532. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will discuss new drug application
(NDA)21-389/21-772, ARCOXIA (etoricoxib), Merck & Co., Inc., proposed treatment for the relief of signs and symptoms of osteoarthritis. FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 29, 2007. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 21, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 22, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Johanna Clifford at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 26, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-3722 Filed 3-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Cardiovascular and Renal Drugs Advisory Committee *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on April 18, 2007, from 8 a.m. to 5 p.m. *Location* : Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. *Contact Person* : Cathy A. Groupe, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *Cathy.Groupe@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512533. Please call the information line for up-to-date information on this meeting. *Agenda* : The committee will discuss supplemental new drug application
(sNDA)20-758/S-037, AVALIDE (irbesartan plus hydrochlorothiazide), Bristol-Myers Squibb Co. The sponsor is seeking approval for first-line use in hypertensive patients unlikely to achieve blood pressure goals on one drug. The committee will be asked to consider what constitutes adequate data to support such a claim and how the information can be most usefully displayed in labeling. FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 3, 2007. Oral presentations from the public will be scheduled between approximately 8:30 a.m. to 9:30 a.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants and an indication of the approximate time requested to make their presentation on or before March 26, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 27, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cathy Groupe at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 26, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-3721 Filed 3-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0061] Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. *Name of Committee* : Cellular, Tissue, and Gene Therapies Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on March 29, 2007, from 8 a.m. to approximately 6:30 p.m. and on March 30, 2007 from 8 a.m. to approximately 3 p.m. *Address* : Electronic comments should be submitted to *http://www.fda.gov/dockets/ecomments* . Select Docket No. 2007N-0061, “Sipuleucel-T Dendreon,” and follow prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on March 22, 2007. All comments received will be posted without change, including any personal information provided. Comments received on or before March 22, 2007, will be provided to the committee before or at the meeting. *Location* : Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD, Grand Ballroom. *Contact Person* : Gail Dapolito or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-1289, FAX: 301-827-0294, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512389. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On March 29, 2007, in open session, the committee will discuss Sipuleucel-T, Dendreon (BLA-STN 125197) indicated for the treatment of men with asymptomatic metastatic hormone refractory prostate cancer. The committee will also hear overviews of research programs in the Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research. On March 30, 2007, in open session, the committee will discuss the draft document entitled “Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies.” For a copy of the draft guidance visit *http://www.fda.gov/cber/gdlns/cordbld.pdf* . The committee will also discuss scientific issues regarding minimally manipulated, unrelated allogeneic peripheral blood stem cells. FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : On March 29, 2007, from 8 a.m. to approximately 5:30 p.m., and on March 30, 2007, from 8 a.m. to approximately 3 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 15, 2007. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. on March 29, 2007, and between 10 a.m. and 11 a.m. on March 30, 2007. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 7, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 8, 2007. *Closed Committee Deliberations* : On March 29, 2007, at approximately 5:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss a report of intramural research programs in the Division of Cellular and Gene Therapies. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 26, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-3712 Filed 3-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (Formerly Advisory Committee for Pharmaceutical Science); Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (formerly Advisory Committee for Pharmaceutical Science). *General Function of the Subcommittee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on April 30, 2007, from 8:30 a.m. to 5 p.m. *Location* : Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. *Contact Person* : Victoria Ferretti-Aceto, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *Victoria.FerrettiAceto@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The subcommittee will do the following:
(1)As an awareness topic, discuss issues pertaining to the stability of tablets split for patient use;
(2)receive a general update and discuss current strategies on quality by design and the Office of Generic Drugs' question-based review; and
(3)receive an update on and discuss the status of the Office of New Drug Quality Assessment Chemistry, Manufacturing, and Controls Pilot Program. FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person on or before April 16, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 6, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 9, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Victoria Ferretti-Aceto at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 26, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-3717 Filed 3-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on
(240)276-1243. *Project:* School Climate Survey for the National Cross-Site Evaluation of Safe School/Healthy Student (SS/HS) Initiative Grants-NEW. The SS/HS Initiative is a collaborative grant program supported by three Federal departments—the U.S. Departments of Health and Human Services, Education, and Justice. The program is authorized under the Elementary and Secondary Education Act of 1965, as amended, and the Higher Education Act of 1965, Title IV, Part A, Subpart 2 (National Programs), Section 4121 (Federal Activities). It is also authorized under Section 581 of the Public Health Service Act. This initiative, instituted by Congress following the murderous assaults at Columbine High School in Colorado, is designed to provide Local Educational Agencies (LEAs), including school districts and multi-district regional consortia, with 3 years of funding to simultaneously improve school safety, student access to mental health services, the reduction of violence and substance abuse, school relationships with the larger community, and early childhood preparation for learning. Collectively, Congress expects these changes to be reflected in improved school climate. Local Education Agencies
(LEAs)serve as the primary applicants for SS/HS grants, but the LEAs are required to establish formal partnerships with the local mental health system, the local law enforcement agency, and the local juvenile justice agency. Other partners often include public and private social services agencies, businesses, civic organizations, the faith community, and private citizens. As a result of these partnerships, comprehensive plans are developed, implemented, evaluated, and sustained with the goals of promoting the healthy development of children and youth, fostering their resilience in the face of adversity, and preventing violence. From FY 1999 through FY 2004, grants of $1 million to $3 million annually for 3 years were awarded to 190 LEAs, for a total of $916 million. Approximately 40 new SS/HS grants were awarded in FY 2005. These grants are providing support for rural, tribal, suburban, and urban communities that include diverse racial and ethnic groups across the country. In compliance with the Government Performance and Results Act
(GPRA)of 1993, grantees are required to collect and report data that measure the results of the programs implemented with this grant. Specifically, grantees are required to collect and report information on the following GPRA indicators: 1. The percentage of SS/HS grant sites that experience a decrease in the number of violent incidents at schools. 2. The percentage of SS/HS grant sites that experience a decrease in substance abuse. 3. The percentage of SS/HS grant sites that improve school attendance. 4. The percentage of SS/HS grant sites that increase mental health services to students and families. In addition to GPRA measures, the Federal Evaluation Work Group of the Safe School/Healthy Students (SS/HS) Initiative national evaluation, comprised of Federal officials representing the U.S. Departments of Education, Health and Human Services, and Justice, determined that information on changes in school climate is also required to provide a direct basis of comparison for performance with subsequent cohorts of grantees. Although GPRA measures monitor changes in individual outcomes among students, GPRA measures have been found to provide an incomplete metric of performance in terms of observed in changes in overall “school climate.” The SS/HS National Evaluation Team proposes to adopt the staff version of the California Healthy Kids Survey for this purpose. This instrument contains 43 multiple choice questions that are used to obtain school staff perceptions of student behavior and attitudes, school programs and policies, and the overall school climate as they relate to student well-being and learning. It deals with such issues as truancy, safety, harassment, substance abuse, school connectedness and learning supports. The instrument, modified slightly to form the SS/HS School Climate Survey, will track changes in school climate in schools targeted for program services under the SS/HS Initiative. In the absence of the School Climate Survey, there would be no common, cross-site measure of performance across SS/HS initiative grantees. In practice, the School Climate Survey will be administered electronically among approximately 67,500 local educational system employees. These employees will be encouraged to log onto a Web site during each year that their school benefits from the grant to answer questions concerning their perception of student behavior and safety at the school. *The burden estimate for the annual survey is as follows:* Number of respondents Responses per respondent Burden/ response (hours) Total annual burden (hours) 70,875 1 0.117 8,269 Written comments and recommendations concerning the proposed information collection should be sent by April 4, 2007 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974. Dated: February 27, 2007. Patricia S. Bransford, Acting Director, Office of Program Services. [FR Doc. E7-3764 Filed 3-2-07; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Revision of an Existing Information Collection; Comment Request ACTION: 60-day notice of information collection under review; Form I-824, Application for Action on an Approved Application or Petition; OMB Control No. 1615-0044. The Department of Homeland Security, U.S. Citizenship and Immigrations Services (USCIS) has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until May 4, 2007. Written comments and suggestions regarding items contained in this notice, and especially with regard to the estimated public burden and associated response time should be directed to the Department of Homeland Security (DHS), USCIS, Chief, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, NW., 3rd Floor, Suite 3008, 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 add the OMB Control No. 1615-0044 in the subject box. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information 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 Action on an Approved Application or Petition.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-824. 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 or Households. The Form I-824 facilitates a request from a petitioner or applicant for further action on a previously approved petition or application, or it can be used by a U.S. citizen to notify the Department of State of his or her U.S. citizenship status.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 43,772 responses at 25 minutes (.416 hours) per response.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 18,209 annual burden hours. If you have additional comments, suggestions, or need a copy of the information collection instrument, please contact Richard A. Sloan, Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, 111 Massachusetts Avenue, NW., 3rd Floor, Suite 3008, Washington, DC 20529; Telephone Number 202-272-8377. Dated: February 28, 2007. Richard A. Sloan, Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E7-3779 Filed 3-2-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Extension of a Currently Approved Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Form I-777, Application for Issuance or Replacement of Northern Mariana Card; OMB Control No. 1615-0042. 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 May 4, 2007. Written comments and suggestions regarding items contained in this notice, and especially with regard to the estimated public burden and associated response time should be directed to the Department of Homeland Security (DHS), USCIS, Chief, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, NW., 3rd Floor, Suite 3008, 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 add the OMB Control No. 1615-0042 in the subject box. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more 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, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agencies 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 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:* Extension of a currently approved information collection.
(2)*Title of the Form/Collection:* Application for Issuance or Replacement of Northern Mariana Card.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-777. 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 or Households. This information collection is used by applicants to applying for a Northern Mariana identification card if they received United States citizenship pursuant to Public Law 94-241 (Covenant to Establish a Commonwealth of the Northern Mariana Islands).
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 100 responses at 30 minutes (.50 hours) per response.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 50 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument, please contact Richard A. Sloan, Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, 111 Massachusetts Avenue, NW., 3rd Floor, Suite 3008, Washington, DC 20529; Telephone No. 202-272-8377. Dated: February 28, 2007. Richard A. Sloan, Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E7-3780 Filed 3-2-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Extension of an Approved Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Form I-102, Application for Replacement/Initial Nonimmigrant Arrival-Departure Document; OMB Control No.1615-0079. 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 May 4, 2007. Written comments and suggestions regarding items contained in this notice, and especially with regard to the estimated public burden and associated response time should be directed to the Department of Homeland Security (DHS), USCIS, Chief, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, NW., 3rd Floor, Suite 3008, 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 add the OMB Control No. 1615-0079 in the subject box. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information 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 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 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:* Extension of a currently approved information collection.
(2)*Title of the Form/Collection:* Application for Replacement/Initial Nonimmigrant Arrival-Departure Document.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-102. 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 or Households. This information collection will be used by an alien temporarily residing in the United States to request a replacement of his or her arrival evidence. The information provided can be used to verify status and for determination as to the eligibility of the applicant.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 12,195 responses at 25 minutes (.416 hours) per response.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 5,073 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument, please contact Richard A. Sloan, Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, 111 Massachusetts Avenue, NW., 3rd Floor, Suite 3008, Washington, DC 20529; Telephone No. 202-272-8377. Dated: February 28, 2007. Richard A. Sloan, Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E7-3781 Filed 3-2-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Receipt of Applications for Permit AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of applications for permit. SUMMARY: The public is invited to comment on the following applications to conduct certain activities with endangered species. DATES: Written data, comments or requests must be received by April 4, 2007. ADDRESSES: Documents and other information submitted with these applications 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: U.S. Fish and Wildlife Service, Division of Management Authority, 4401 North Fairfax Drive, Room 700, Arlington, Virginia 22203; fax 703/358-2281. FOR FURTHER INFORMATION CONTACT: Division of Management Authority, telephone 703/358-2104. SUPPLEMENTARY INFORMATION: Endangered Species The public is invited to comment on the following applications for a permit to conduct certain activities with endangered species. This notice is provided pursuant to section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ). Written data, comments, or requests for copies of these complete applications should be submitted to the Director (address above). *Applicant:* Sierra Endangered Cat Haven, Dunlap, CA, PRT-135919. The applicant requests a permit to import two captive-born male cheetahs ( *Acinonyx jubatus* ) from the DeWildt Cheetah and Wildlife Trust, South Africa for the purpose of enhancement of the survival of the species. *Applicant:* Nashville Zoo, Nashville, TN, PRT-145446. The applicant requests a permit to import two males and two female captive-born clouded leopards ( *Neofelis nebulosa* ) from Khao Kheow Open Zoo, Chonburi, Thailand for the purpose of enhancement of the species through captive breeding. *Applicant:* Panther Ridge Sanctuary, Wellington, FL, PRT-128590. The applicant requests a permit to import two captive-born male cheetahs ( *Acinonyx jubatus* ) from the Savannah Cheetah Foundation, South Africa for the purpose of enhancement of the survival of the species. *Applicant:* U.S. Geological Survey, National Wildlife Health Center, Madison, WI, PRT-048370. The applicant requests a permit to import multiple shipments of biological samples from wild or captive-held, or captive-born specimens of any endangered species for the purpose of scientific research. No animals can be intentionally killed for the purpose of collecting specimens. Any invasively collected sample can only be collected by trained personnel. This notification covers activities conducted by the applicant over a period of 5 years. *Applicant:* Wildlife Conservation Society, Field Veterinary Program, Bronx, NY, PRT-033594. The applicant requests a permit to import multiple shipments of biological samples from wild or captive-held or captive-born specimens of any endangered species for the purpose of scientific research. No animals can be intentionally killed for the purpose of collecting specimens. Any invasively collected sample can only be collected by trained personnel. This notification covers activities conducted by the applicant over a period of 5 years. *Applicant:* University of Florida, Museum of Natural History, Gainesville, FL, PRT-146577. The applicant requests a permit to import biological samples from Nile Crocodile ( *Crocodylus niloticus* ), slender-snouted crocodile ( *Crocodylus cataphractus* ) and dwarf crocodile ( *Osteolaemus tetraspis* ) collected from both wild and captive animals in Cote D' Ivoire and Ghana, for the purpose of scientific research. *Applicant:* Memphis Zoo, Memphis, TN, PRT-146704. The applicant requests a permit to import one captive-born male Sumatran orangutan ( *Pongo pygmaeus abelii* ) from the Toronto Zoo, Ontario, Canada, for the purpose of enhancement of the survival of the species and captive propagation. *Applicant:* Robert H. Clark, Spring Lake, MI, PRT-146530. The applicant requests a permit to import the sport-hunted trophy of one male bontebok ( *Damaliscus pygargus pygargus* ) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species. *Applicant:* Nicholas H. Altman, Houston, TX, PRT-143415. The applicant requests a permit to import the sport-hunted trophy of one male bontebok ( *Damaliscus pygargus pygargus* ) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species. *Applicant:* Mark D. Crowther, Lilburn, GA, PRT-144846. The applicant requests a permit to import the sport-hunted trophy of one male bontebok ( *Damaliscus pygargus pygargus* ) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species. *Applicant:* New York State Museum, Albany, NY, PRT-140174. The applicant requests a permit to export and re-import non-living museum specimens of endangered and threatened species previously accessioned into the applicant's collection for scientific research. This notification covers activities to be conducted by the applicant over a five-year period. Dated: February 9, 2007. Michael L. Carpenter, Senior Permit Biologist, Branch of Permits, Division of Management Authority. [FR Doc. E7-3736 Filed 3-2-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Draft Environmental Assessment/Habitat Conservation Plan; Issuance of a Section 10(a)(1)(B) Permit for Incidental Take of the Golden-Cheeked Warbler in Williamson County, TX (CA 1100, LTD.) AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability; receipt of application. SUMMARY: CA 1100, LTD. (Applicant) has applied to the U.S. Fish and Wildlife Service (Service) for an incidental take permit (TE-139553-0) pursuant to Section 10(a)(1)(B) of the Endangered Species Act
(Act)of 1973, as amended. The requested permit, which is for a period of 30 years, would authorize incidental take of the golden-cheeked warbler ( *Dendroica chrysoparia* ). The proposed take would occur as a result of the construction and occupation of a residential development on 176 acres of the Shadow Canyon property, Williamson County, Texas. We invite public comment. DATES: To ensure consideration, written comments must be received on or before May 4, 2007. ADDRESSES: Persons wishing to review the application may obtain a copy by writing to the Regional Director, U.S. Fish and Wildlife Service, P.O. Box 1306, Room 4102, Albuquerque, New Mexico 87103. Persons wishing to review the draft Environmental Assessment/Habitat Conservation Plan (EA/HCP) may obtain a copy by contacting William Amy, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512-490-0057). Documents will be available for public inspection by written request, by appointment only, during normal business hours (8 a.m. to 4:30 p.m.) at the Service's Austin office. Written data or comments concerning the application and draft EA/HCP should be submitted to the Supervisor, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758. Please refer to permit number TE-139553-0 when submitting comments. All comments received, including names and addresses, will become a part of the official administrative record and may be made available to the public. FOR FURTHER INFORMATION CONTACT: William Amy at U.S. Fish and Wildlife Service Austin office, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512-490-0057) or by e-mail, *William_Amy@fws.gov* . SUPPLEMENTARY INFORMATION: The Applicant has applied to the Service for a Section 10(a)(1)(B) incidental take permit for a period of 30 years in order to authorize incidental take of the golden-cheeked warbler. Section 9 of the Act prohibits the “taking” of endangered species such as the golden-cheeked warbler. However, the Service, under limited circumstances, may issue permits to take endangered wildlife species incidental to, and not the purpose of, otherwise lawful activities. We provide this notice under section 10(c) of the Act (16 U.S.C. 1531 *et seq.* ) and its implementing regulations (50 CFR 17.22), and the National Environmental Policy Act (42 U.S.C. 4371 *et seq.* ) and its implementing regulations (40 CFR 1506.6). *Applicant:* The Applicant plans to construct a residential and commercial development on the 176-acre property located on Shadow Canyon property, Williamson County, Texas. This action will adversely affect 70.1 acres of oak-juniper woodland resulting in take of three pairs of golden-cheeked warblers. The Applicant proposes to mitigate for incidental take of the golden-cheeked warbler by purchasing 97 mitigation credits from a conservation bank approved by the Service to preserve 97 acres of golden-cheeked warbler habitat in perpetuity within the acquisition area of the Balcones Canyonlands National Wildlife Refuge. Christopher T. Jones, Acting Regional Director, Region 2, Albuquerque, New Mexico. [FR Doc. E7-3766 Filed 3-2-07; 8:45 am] BILLING CODE 4510-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Draft Environmental Assessment/Habitat Conservation Plan; Receipt of Application for Incidental Take of the Houston Toad in Bastrop County, TX (Combs Lot 3) AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability; receipt of application. SUMMARY: Lee Combs (Applicant) has applied to the U.S. Fish and Wildlife Service (Service) for an incidental take permit (TE-141969-0) pursuant to Section 10(a)(1)(B) of the Endangered Species Act
(Act)of 1973, as amended. The requested permit, which is for a period of five years, would authorize incidental take of the Houston toad (Bufo houstonensis). The proposed take would occur as a result of the construction and occupation of commercial development on Lot 3, a 1.15-acre property located on Highway 71 in the Tahitian Village Subdivision, Bastrop County, Texas. We invite public comment. DATES: To ensure consideration, written comments must be received on or before April 4, 2007. ADDRESSES: Persons wishing to review the application may obtain a copy by writing to the Regional Director, U.S. Fish and Wildlife Service, P.O. Box 1306, Room 4102, Albuquerque, New Mexico 87103. Persons wishing to review the draft EA/HCP may obtain a copy by contacting Clayton Napier, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512/490-0057). Documents will be available for public inspection by written request, by appointment only, during normal business hours (8 a.m. to 4:30 p.m.) at the Service's Austin office. Written data or comments concerning the application and draft EA/HCP should be submitted to the Supervisor, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758. Please refer to permit number TE-141969-0 when submitting comments. All comments received, including names and addresses, will become a part of the official administrative record and may be made available to the public. FOR FURTHER INFORMATION CONTACT: Clayton Napier at U.S. Fish and Wildlife Service Austin office, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512/490-0057) or by e-mail, *Clayton_Napier@fws.gov* . SUPPLEMENTARY INFORMATION: The Applicant has applied to the Service for a Section 10(a)(1)(B) incidental take permit for a period of five years in order to authorize incidental take of the Houston toad. Section 9 of the Act prohibits the “taking” of endangered species such as the Houston toad. However, the Service, under limited circumstances, may issue permits to take endangered wildlife species incidental to, and not the purpose of, otherwise lawful activities. We provide this notice under section 10(c) of the Act (16 U.S.C. 1531 *et seq.* ) and its implementing regulations (50 CFR 17.22), and the National Environmental Policy Act (42 U.S.C. 4371 *et seq.* ), and its implementing regulations (40 CFR 1506.6). *Applicant:* The Applicant is proposing general commercial development and construction activities on Lot 3, a 1.15-acre property located on Highway 71 in the Tahitian Village Subdivision, Bastrop County, Texas. This action will eliminate up to 1.15 acres of Houston toad habitat and result in indirect impacts within the lot. The Applicant proposes to compensate for incidental take of the Houston toad by providing $3,450.00 to the Houston Toad Conservation Fund at the National Fish and Wildlife Foundation for the specific purpose of land acquisition and management within Houston toad habitat. Christopher T. Jones, Acting Regional Director, Region 2, Albuquerque, New Mexico. [FR Doc. E7-3767 Filed 3-2-07; 8:45 am] BILLING CODE 4510-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Draft Environmental Assessment/Habitat Conservation Plan; Receipt of Application for Incidental Take of the Houston Toad in Bastrop County, TX (Combs Lot 2) AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability; receipt of application. SUMMARY: Lee Combs (Applicant) has applied to the U.S. Fish and Wildlife Service (Service) for an incidental take permit (TE-141705-0) pursuant to Section 10(a)(1)(B) of the Endangered Species Act
(Act)of 1973, as amended. The requested permit, which is for a period of five years, would authorize incidental take of the Houston toad ( *Bufo houstonensis* ). The proposed take would occur as a result of the construction and occupation of commercial development on Lot 2, a 0.75-acre property located on Highway 71 in the Tahitian Village Subdivision, Bastrop County, Texas. We invite public comment. DATES: To ensure consideration, written comments must be received on or before April 4, 2007. ADDRESSES: Persons wishing to review the application may obtain a copy by writing to the Regional Director, U.S. Fish and Wildlife Service, P.O. Box 1306, Room 4102, Albuquerque, New Mexico 87103. Persons wishing to review the draft EA/HCP may obtain a copy by contacting Clayton Napier, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512/490-0057). Documents will be available for public inspection by written request, by appointment only, during normal business hours (8 a.m. to 4:30 p.m.) at the Service's Austin office. Written data or comments concerning the application and draft EA/HCP should be submitted to the Supervisor, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758. Please refer to permit number TE-141705-0 when submitting comments. All comments received, including names and addresses, will become a part of the official administrative record and may be made available to the public. FOR FURTHER INFORMATION CONTACT: Clayton Napier at U.S. Fish and Wildlife Service Austin office, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512/490-0057) or by e-mail, *Clayton_Napier@fws.gov* . SUPPLEMENTARY INFORMATION: The Applicant has applied to the Service for a Section 10(a)(1)(B) incidental take permit for a period of five years in order to authorize incidental take of the Houston toad. Section 9 of the Act prohibits the “taking” of endangered species such as the Houston toad. However, the Service, under limited circumstances, may issue permits to take endangered wildlife species incidental to, and not the purpose of, otherwise lawful activities. We provide this notice under section 10(c) of the Act (16 U.S.C. 1531 *et seq.* ) and its implementing regulations (50 CFR 17.22), and the National Environmental Policy Act (42 U.S.C. 4371 *et seq.* ), and its implementing regulations (40 CFR 1506.6). *Applicant:* The Applicant is proposing general commercial development and construction activities on Lot 2, a 0.75-acre property located on Highway 71 in the Tahitian Village Subdivision, Bastrop County, Texas. This action will eliminate up to 0.75 acres of Houston toad habitat and result in indirect impacts within the lot. The Applicant proposes to compensate for incidental take of the Houston toad by providing $2,250.00 to the Houston Toad Conservation Fund at the National Fish and Wildlife Foundation for the specific purpose of land acquisition and management within Houston toad habitat. Christopher T. Jones, Acting Regional Director, Region 2, Albuquerque, New Mexico. [FR Doc. E7-3768 Filed 3-2-07; 8:45 am] BILLING CODE 4510-55-P DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Land Acquisitions; Cherokee Nation of Oklahoma AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice of final agency determination to take land into trust under 25 CFR part 151. SUMMARY: The Associate Deputy Secretary made a final agency determination to acquire approximately 3.519 acres of land into trust for the Cherokee Nation of Oklahoma on February 9, 2007. This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Principal Deputy Assistant Secretary—Indian Affairs by 209 Departmental Manual 8. FOR FURTHER INFORMATION CONTACT: George Skibine, Office of Indian Gaming, 1849 C Street, NW., Mail Stop 3657-MIB, Washington, DC 20240; Telephone
(202)219-4066. SUPPLEMENTARY INFORMATION: This notice is published to comply with the requirement of 25 CFR part 151.12(b) that notice be given to the public of the Secretary's decision to acquire land in trust at least 30 days prior to signatory acceptance of the land into trust. The purpose of the 30-day waiting period in 25 CFR part 151.12(b) is to afford interested parties the opportunity to seek judicial review of final administrative decisions to take land in trust for Indian tribes and individual Indians before transfer of title to the property occurs. On February 9, 2007, the Associate Deputy Secretary decided to accept approximately 3.519 acres of land into trust for the Cherokee Nation of Oklahoma under the authority of the Indian Reorganization Act of 1934, 25 U.S.C. 465. The 3.519 parcel is located within the former reservation boundaries of the Cherokee Nation near the City of Roland, Sequoyah County, Oklahoma. The parcel will be used as additional parking for the Cherokee Casino facility. The 3.519 acre parcel is located near the City of Roland, Sequoyah County, Oklahoma is described as follows: Part of the SW 1/4 SW 1/4 of Section 23, Township 11 North, Range 26 East, Sequoyah County, Oklahoma, being more particularly described as follows: Commencing at the Southwest corner of the N 1/2 SW 1/4 SW 1/4 of said Section 23; thence East along the South line of N 1/2 SW 1/4 SW 1/4 of, 660.00 feet; thence North 00°52′00″ East 454.22 feet to the North line of the SW 1/4 SW 1/4 ; thence South 89°45′59″ East along said North line, 334.64 feet; thence South 452.78 feet; thence South 89°59′47″ West 341.52 feet to the Point of Beginning, containing 3.519 acres, more or less, Less and Except minerals. Dated: February 9, 2007. Michael D. Olsen, Principal Deputy Assistant Secretary—Indian Affairs. [FR Doc. E7-3715 Filed 3-2-07; 8:45 am] BILLING CODE 4310-4N-P DEPARTMENT OF THE INTERIOR National Park Service Draft General Management Plan and Environmental Impact Statement for Pipestone National Monument, Minnesota; Notice of Availability AGENCY: National Park Service, Department of the Interior. ACTION: Notice. SUMMARY: Pursuant to section 102(2)(C) of the National Environmental Policy Act of 1969, the National Park Service announces the availability of the draft General Management Plan and Environmental Impact Statement (GMP/EIS) for Pipestone National Monument. DATES: The GMP/EIS will remain available for public review for 60 days following the publishing of the notice of availability in the **Federal Register** by the Environmental Protection Agency. Public meetings will be held in the cities of Pierre and Yankton, South Dakota, and Marshall and Pipestone, Minnesota. Meeting places and times will be announced through the local media and on the park Web site at: *http://www.nps.gov.gov/pipe.* ADDRESSES: Copies of the GMP/EIS are available by request by writing to the Superintendent at Pipestone National Monument, 36 Reservation Avenue, Pipestone, MN 56164. The document is also available to be reviewed in person at the park. Finally, the document can be found at the following Web site: *http://parkplanning.nps.gov/.* This Web site allows the public to review and comment directly on this document. FOR FURTHER INFORMATION CONTACT: Superintendent, Pipestone National Monument, 36 Reservation Avenue, Pipestone, MN 56164. SUPPLEMENTARY INFORMATION: Pipestone National Monument offers an opportunity to explore American Indian culture and the natural resources of the tallgrass prairie. Established by Congress in 1937 to protect the historic pipestone quarries, the site is considered sacred by many American Indians. Spanning centuries of use, American Indians continue to quarry pipestone, which they carve into sacred pipes. The GMP/EIS analyzes the impacts of a no-action and three action alternatives. The no-action alternative describes the existing conditions and trends of park management and serves as a basis for comparison in evaluating the other alternatives. The focus of alternative one is the removal of development from the heart of the national monument. Alternative two focuses on updating the existing facilities and increasing the interpretive emphasis on quarrying. Alternative three was developed to meld the most advantageous features of the other two action alternatives by removing some park operations from the national monument and updating existing facilities. Persons wishing to comment may do so by any one of several methods. They may attend the public hearing or open houses noted above. They may mail comments directly to Pipestone National Monument. They also may comment via the Web site at *http://parkplanning.nps.gov/.* Finally, they may hand-deliver comments to the Pipestone National Monument in Pipestone, Minnesota. Before including your address, telephone number, e-mail address, or other personal identifying information in your comments please be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comments to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. We will make all submissions from organizations or businesses and from individuals identifying themselves as representatives or officials or organizations or businesses available for public inspection in their entirety. The responsible official is Ernest Quintana, Regional Director, Midwest Region. Dated: November 29, 2006. David N. Given, Acting Regional Director, Midwest Region. [FR Doc. E7-3769 Filed 3-2-07; 8:45 am] BILLING CODE 4312-AA-P DEPARTMENT OF THE INTERIOR National Park Service National Register of Historic Places; Notification of Pending Nominations and Related Actions Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before February 17, 2007. Pursuant to section 60.13 of 36 CFR Part 60 written comments concerning the significance of these properties under the National Register criteria for evaluation may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St. NW., 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service,1201 Eye St. NW., 8th Floor, Washington, DC 20005; or by fax, 202-371-6447. Written or faxed comments should be submitted by March 20, 2007. Patrick W. Andrus, Acting Chief, National Register of Historic Places/National, Historic Landmarks Program. ARKANSAS Garland County CCC Company 3767 Powder Magazine Historic District, (Facilities Constructed by the CCC in Arkansas MPS), K59P Rd. N of Forest Service Rd. 11 (Gladstone Rd., Jessieville, 07000200 Montgomery County CCC Company 741 Powder Magazine Historic District, (Facilities Constructed by the CCC in Arkansas MPS), Forest Service Rd. 177M NE of Norman, Norman, 07000201 Newton County Archeological Site 3NW79, (Rock Art Sites in Arkansas TR), Address Restricted, Cowell, 07000202 Polk County Buckeye Vista Overlook, (Facilities Constructed by the CCC in Arkansas MPS), Forest Service Rd. 38, Athens, 07000204 Sugar Creek Vista Overlook, (Facilities Constructed by the CCC in Arkansas MPS), Forest Service Rd. 38, Athens, 07000205 Pope County Archeological Site 3PP614, (Rock Art Sites in Arkansas TR), Address Restricted, Sand Gap, 07000203 Yell County CCC Company 749 Powder Magazine, (Facilities Constructed by the CCC in Arkansas MPS), N of Forest Service Rd. 4128 and S of Briggsville, Briggsville, 07000199 INDIANA Allen County Forest Park Boulevard Historic District, Roughly bounded by Dodge Ave., the alley bet. Forest Park Blvd. and Anthony Blvd, Lake Ave. and the alley, Fort Wayne, 07000212 Clark County Spring Street Freight House, 1030 Spring St., Jeffersonville, 07000209 Greene County Linton Commercial Historic District, Roughly bounded by B St. N, 1st St. E, A St. S, 1st St. W, Linton, 07000214 Lake County Crown Point Courthouse Square Historic District (Boundary Increase II), 208 Main St, Crown Point, 07000210 Porter County Young, Martin, House, 324 Second St., Chesterton, 07000208 Randolph County Fudge Site, Address Restricted, Winchester, 07000213 St. Joseph County North Liberty Park, (New Deal Resources in Indiana State Parks MPS), 309 N. Jefferson St., North Liberty, 07000211 IOWA Marion County First Christian Church, 824 Franklin St., Pella, 07000206 Woodbury County Overseen, Julius and Anine House, 2037 S. Lemon St., Sioux City, 07000207 NORTH CAROLINA Vance County Machpelah, 12079 NC 39, approx. 0.5 mi. S of Townsville, Townsville, 07000215 PENNSYLVANIA Berks County Rhoads—Lorah House and Barn, 1832 Old Swede Rd., Amity Township, 07000216 SOUTH CAROLINA Calhoun County Fort Motte (38CL1), 0.75 mi. from N. end of Lang Syne Rd., St. Matthews, 07000221 Clarendon County James Building, 124-126 Main St., Summerton, 07000222 TEXAS Parker County Byron Farmstead, 905 Meadowview Rd., Weatherford, 07000217 VIRGINIA Albemarle County Mechum River Farm, 1207 Burchs Creek Rd., Charlottesville, 07000235 Amherst County Forest Hill, 713 Indian Creek Rd., Amherst, 07000218 Carroll County Buffalo Mountain Presbyterian Church and Cemetery, (Reverend Robert Childress Presbyterian Churches MPS), 2102 Childress Rd., Willis, 07000229 Dinwiddie Presbyterian Church and Cemetery, (Reverend Robert Childress Presbyterian Churches MPS), 2698 Homestead Rd., Hillsville, 07000228 Fairfax County Holmes Run Acres Historic District, Area generally bounded by Gallows Rd., Surrey Ln, and Holmes Run Dr., Falls Church, 07000230 Floyd County Slate Mountain Presbyterian Church and Cemetery, (Reverend Robert Childress Presbyterian Churches MPS), 2121 Lonesome Dove Dr., Christiansburg, 07000227 Willis Presbyterian Church and Cemetery, (Reverend Robert Childress Presbyterian Churches MPS), 5733 Floyd Hwy S, Willis, 07000226 Henry County Edgewood, 150 Old Stage Rd., Stanleytown, 07000231 James City County White Hall, 3200 Rochambeau Rd., Toano, 07000234 Lunenburg County Eubank Hall, 319 Eubank Rd., Fort Mitchell, 07000233 Nelson County Elk Hill, 511 Rockfish Valley Hwy, Nellysford, 07000220 Norton Independent City Roanoke Downtown Historic District (Boundary Increase), 310-324 Salem Ave. SW, Roanoke (Independent City), 07000232 Patrick County Bluemont Presbyterian Church and Cemetery, (Reverend Robert Childress Presbyterian Churches MPS), Blue Ridge Pkwy, Mile Post #192, Fancy Gap, 07000224 Mayberry Presbyterian Church, (Reverend Robert Childress Presbyterian Churches MPS), 1127 Mayberry Church Rd., Meadows of Dan, 07000225 Richmond Independent City Broad Street Commercial Historic District (Boundary Increase II), 100 Blk of E. Marshall St., S side. 300 Blks 1st and 2nd Sts. bet. Broad and Marshall Sts., Richmond (Independent City), 07000219 Rockbridge County Poague, Margaret E., House, 4907 S. Lee Hwy (US 11), Lexington, 07000236 WEST VIRGINIA Cabell County Downtown Huntington Historic District, Portions of Third Ave. to the alley bet. Sixth and Seventh Aves. and from Twelth St. to Seventh St., Huntington, 07000240 Jackson County Ravenswood “Old Town” Historic District, Bounded by Sandy Creek, the Ohio R, Sycamore St. and adjoining properties and the city limits to the east, Ravenswood, 07000243 Jefferson County Barleywood, Ambler Rd., Approx. 1 mi. N of WV 51, Charles Town, 07000241 Cool Spring Farm, 1735 Lloyd Rd., Charles Town, 07000239 Ritchie County Pennsboro B&O Depot, Corner of Broadway St. and Collins Ave., Pennsboro, 07000242 Roane County Chrystal Water and Power Company—Spencer Water and Ice Company, Church St., Spencer, 07000238 WISCONSIN Clark County Dickinson, Decatur and Kate, House, 411 State St., Neillsville, 07000223 Fond Du Lac County Baptist Church, 133 East Fond Du Lac St., Ripon, 07000237 Jackson County Black Hawk Powwow Grounds, W8426 WI 54E, Komensky, 07000244 A request for *removal* has been made for the following resource: IOWA Pottawattamie County Ogden House, 169 W. Broadway, Council Bluffs, 76000803 [FR Doc. E7-3726 Filed 3-2-07; 8:45 am] BILLING CODE 4312-51-P DEPARTMENT OF THE INTERIOR Bureau of Reclamation Information Collection Activities; Proposed Information Collection; Comment Request AGENCY: Bureau of Reclamation, Interior. ACTION: Notice and request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ), this notice announces that the Bureau of Reclamation (we, our, or us) intends to seek approval of the following proposed new information collection: Recreation Visitor Use Surveys. We will use several distinct forms to collect different types of recreation information. Before submitting the information collection request to the Office of Management and Budget
(OMB)for approval, we are soliciting comments on specific aspects of the information collection. DATES: Comments on this notice must be received by May 4, 2007. ADDRESSES: Address all comments concerning this notice to Bureau of Reclamation, Office of Program and Policy Services, Attention: Darrell Welch (84-53000), PO Box 25007, Denver CO 80225-0007 or via e-mail at *dwelch@do.usbr.gov.* FOR FURTHER INFORMATION CONTACT: For further information or a copy of the proposed collection of information forms, contact Darrell Welch at 303-445-2711. SUPPLEMENTARY INFORMATION: We are requesting approval for the collection of data from recreational users of our lands, rivers, and reservoirs. To meet our needs for the collection of visitor use data, we will be requesting OMB to authorize a two-part request. The first part of the request provides us with a set of 11 pre-approved questionnaires to be administered as approved by OMB. The second part of the request consists of OMB and the Bureau of Reclamation agreeing upon a process whereby we custom design a survey instrument to fit a specific situation or area. The custom designed survey would be created by extracting questions from the approved questionnaires as applicable to the area and issue being evaluated. Only questions included in the pre-approved questionnaires will be used. We will then submit the new survey form to OMB for expedited approval. *Title:* Recreation Visitor Use Surveys. *Abstract:* The Bureau of Reclamation is responsible for recreation development at all of its reservoirs. Presently there are 300 designated recreation areas on our lands within the 17 Western States hosting almost 90 million visitors annually. Visitation to our reservoirs is increasing at an average rate of 1.2 million visitors per year, and more than 100 million people are projected to visit our reservoirs by the early twenty-first century. We must be able to respond to emerging trends, changes in the demographic profile of users, changing values, needs, wants, and desires, and conflicts between user groups. Statistically valid and up-to-date data derived from the user is essential to developing and providing recreation programs relevant to today's visitor. *Respondents:* Respondents to the surveys will be members of the public engaged in recreational activities on our lands. Several surveys target people engaged in specific activities such as boating on a specific lake, or people camping at a developed campground. Visitors will primarily consist of local residents, people from large metropolitan areas in the vicinity of the lake/reservoir, and visitors from out of state. *Frequency:* Varies by survey. *Estimated Total Number of Respondents:* 7,350. *Estimated Number of Responses per Respondent:* 1.0. *Estimated Total of Annual Responses:* 7,350. *Estimated Total Annual Burden Hours on Respondents:* 2,013. Estimate of Burden for Each Form Survey instrument Burden estimate per survey (in minutes) Number of surveys (times/yr.) Number of respondents per survey Total estimated number of respondents Total annual hour burden Marina Survey 10 2 278 556 93 Campground Survey 25 2 278 556 232 River Instream Flow Survey 20 2 278 556 185 Reservoir Preferred Water Level Survey 15 2 278 556 139 Lake/River Visit Expenditure Survey 15 2 278 556 139 Recreation Activities Survey 15 2 278 556 139 Recreation Management Survey 15 2 278 556 139 Recreation Fee Survey 10 1 400 400 67 Recreation Development Survey 15 2 278 556 139 Water Level Impacts on Recreation Boating Use 10 2 278 556 93 River Recreation Quality Survey 20 2 278 556 185 Customized Surveys 20 5 278 556 463 Totals 7,350 2,013 Comments *Comments are invited on:*
(a)Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical use;
(b)The accuracy of our estimated time and cost burdens of the proposed new collection of information, including the validity of the methodology and assumptions used;
(c)Ways to enhance the quality, use, and clarity of the information to be collected; and
(d)Ways to minimize the burden of the collection of information on respondents, including increased use of automated collection techniques or other forms of information technology. We will summarize all comments received regarding this notice. We will publish that summary in the **Federal Register** when the information collection is submitted to OMB for review and approval. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: January 26, 2007. Roseann Gonzales, Director, Office of Program and Policy Services. [FR Doc. E7-3765 Filed 3-2-07; 8:45 am] BILLING CODE 4310-MN-P DEPARTMENT OF JUSTICE Office on Violence Against Women [OMB Number 1122-0003] Agency Information Collection Activities: Extension of a Currently Approved Collection; Comments Requested ACTION: 30-Day Notice of Information Collection Under Review: Annual Progress Report for the STOP Formula Grants Program The Department of Justice, Office on Violence Against Women
(OVW)will be submitting 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. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the **Federal Register** Volume 71, Number 247, page 77412-77413, on December 26, 2007, allowing for a 60-day comment period. The purpose of this notice is to allow for an additional 30 days for public comment until April 4, 2007. This process is conducted in accordance with 5 CFR 1320.10. 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, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB via facsimile to
(202)395-5806. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more 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, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(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:* Extension of a currently approved collection.
(2)*Title of the Form/Collection:* Annual Progress Report for the STOP Violence Against Women Formula Grants Program.
(3)*Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:* Form Number: 1122-0003. U.S. Department of Justice, Office on Violence Against Women.
(4)*Affected public who will be asked or required to respond, as well as a brief abstract:* The affected public includes the 56 STOP state administrators (from 50 states, the District of Columbia and five territories and commonwealths (Guam, Puerto Rico, American Samoa, Virgin Islands, Northern Mariana Islands)) and their subgrantees. The STOP Violence Against Women Formula Grant Program was authorized through the Violence Against Women Act of 1994
(VAWA)and reauthorized and amended by the Violence Against Women Act of 2000 (VAWA 2000) and by the Violence Against Women Act of 2005 (VAWA 2005). Its purpose is to promote a coordinated, multi-disciplinary approach to improving the criminal justice system's response to violence against women. The STOP Formula Grant Program envisions a partnership among law enforcement, prosecution, courts, and victim advocacy organizations to enhance victim safety and hold offenders accountable for their crimes of violence against women. The Department of Justice's Office on Violence Against Women administers the STOP Formula Grant Program. The grant funds must be distributed by STOP state administrators to subgrantees according to a statutory formula (as amended by VAWA 2000 and by VAWA 2005).
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply:* It is estimated that it will take the 56 respondents (STOP administrators) approximately one hour to complete an annual progress report. It is estimated that it will take approximately one hour for roughly 2500 subgrantees 1 to complete the relevant portion of the annual progress report. The Annual Progress Report for the STOP Formula Grant Program is divided into sections that pertain to the different types of activities that subgrantees may engage in and the different types of subgrantees that receive funds, i.e. law enforcement agencies, prosecutors' offices, courts, victim services agencies, etc. 1 Each year the number of STOP subgrantees changes. The number 2,500 is based on the number of reports that OVW has received in the past from STOP subgrantees.
(6)*An estimate of the total public burden (in hours) associated with the collection:* The total annual hour burden to complete the annual progress report is 2556 hours. If additional information is required contact: Lynn Bryant, Deputy Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Suite 1600, Patrick Henry Building, 601 D Street NW., Washington, DC 20530. Dated: February 27, 2007. Lynn Bryant, Department Clearance Officer, United States Department of Justice. (1( (5( [FR Doc. E7-3723 Filed 3-2-07; 8:45 am] BILLING CODE 4410-FX-P DEPARTMENT OF JUSTICE [AAG/A Order No. 005-2007] Privacy Act of 1974; System of Records AGENCY: United States Marshals Service, DOJ. ACTION: Modified System of Records. SUMMARY: Pursuant to the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, notice is given that the Department of Justices
(DOJ)proposes to modify a United States Marshals Service
(USMS)system of records entitled “Warrant Information Network (WIN), USM-007.” Changes have been made to the “Categories of Individuals Covered by the System” to include individuals suspected in a state's case that has been adopted by a USMS-sponsored task force; individuals for whom the USMS is conducting a criminal investigation or aiding in a criminal investigation by another law enforcement agency; missing persons, including children, for whom the USMS is conducting an investigation or aiding in a criminal investigation by another law enforcement agency; individuals, and their associates, who are the subject of, and who may provide information, assistance or leads in USMS fugitive, criminal, or missing persons investigations. Other changes are made consistent with the new categories of individuals covered, necessary updates are made, and routine uses have been revised to conform with DOJ model routine use language. DATES: In accordance with the requirements of 5 U.S.C. 552a (e)(4) and (11), the public is given a 30 day period in which to comment. The Office of Management and Budget (OMB), which has oversight responsibility under the Act, has 40 days in which to conclude its review of the system. Therefore, please submit any comments by April 16, 2007 ADDRESSES: The public, OMB and the Congress are invited to submit any comments to Mary E. Cahill, Management and Planning Staff, Justice Management Division, Department of Justice, Washington, DC 20530 (Room 1400 National Place Building), Facsimile Number 202-307-1853. FOR FURTHER INFORMATION CONTACT: Ed Bordley on 202-307-8571. SUPPLEMENTARY INFORMATION: The notice for USM-007 was last published on November 8, 1999 at 64 FR 60832, 39. In accordance with 5 U.S.C. 552a (r), the Department has provided a report to OMB and appropriate members of Congress. Dated: February 22, 2007. Lee J. Lofthus, Assistant Attorney General for Administration. JUSTICE/USM-007 System name: Warrant Information Network (WIN). Security classification: Limited Official Use. System location: *Primary System:* Investigative Services Division, U.S. Marshals Service (USMS), CS-4, Washington, DC 20530-1000. *Decentralized Segments:* Each district office of the USMS maintains their own files. The addresses of USMS district offices are available on the Internet at *http://www.usdoj.gov/marshals/usmsofc.html.* Categories of individuals covered by the system: Individuals for whom federal warrants have been issued; individuals for whom State or local warrants have been issued when the warrant is part of a USMS sponsored multi-agency task force; individuals suspected in a state's case that has been adopted by a USMS-sponsored task force; individuals for whom the USMS is conducting a criminal investigation or aiding in a criminal investigation by another law enforcement agency; missing persons, including children, for whom the USMS is conducting an investigation or aiding in a criminal investigation by another law enforcement agency; individuals, and their associates, who are the subject of, and who may provide information, assistance or leads in USMS fugitive, criminal, or missing persons investigations. Categories of records in the system: Computerized records in this system consist of information pertaining to a warrant such as dates, issuing federal district, nature of the offense, investigative notes, information related to subjects, including biographical data, physical description, and criminal history, and a subject's association with other individuals, dangerous gangs, extremist groups, or other organizations; information concerning criminal and/or missing persons investigations, such as the evidence collected in support of criminal and/or missing persons investigations, the nature of the crime, investigative reports, investigative notes, biographical data relating to the investigation's subject and the subject's associates. Information on associates includes physical description, photographs, numerical identifiers, addresses, driver's license information and investigative information furnished by other federal, state or local law enforcement or other government agencies and non-government sources. In addition to the abbreviated data described above, the complete file contains the warrant and other court records and internal correspondence relating to the warrant; photographs; wanted flyers/posters; and investigative reports reflecting patterns of activity, leads, witnesses' and other persons' statements. Investigative reports and criminal record information from other federal, state, local, and foreign law enforcement agencies participating in or cooperating with USMS fugitive, criminal, or missing person investigations and apprehension efforts are also included in this system. Authority for maintenance of the system: 28 U.S.C. 509, 510, and 561 *et seq.* ; 28 CFR 0.111(a) and (q). Purpose(s): The USMS is responsible for ensuring the judicial system's effective operation through the execution of federal arrest warrants, parole violator warrants, federal custodial and extradition warrants, and by investigating fugitive, criminal, and missing person matters. The WIN system facilitates the efficient management and administration of warrant executions and USMS fugitive, criminal and missing person investigations through the collection, flow, analysis, dissemination and maintenance of records and information necessary to accomplish these missions. Routine uses of records maintained in the system, including categories of users and the purposes of such uses: Records or information may be disclosed:
(a)To public and private organizations, individuals, and federal, state, territorial, local and foreign agencies to the extent necessary to obtain information or cooperation in USMS investigations and apprehension efforts;
(b)To any criminal, civil, or regulatory law enforcement authority (whether federal, state, territorial, local, tribal, or foreign) where the information is relevant to the recipient entity's law enforcement responsibilities;
(c)To contractors, grantees, experts, consultants, students, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for the Federal Government, when necessary to accomplish an agency function related to this system of records;
(d)In an appropriate proceeding before a court, or administrative or adjudicative body, when the Department of Justice determines that the records are arguably relevant to the proceeding; or in an appropriate proceeding before an administrative or adjudicative body when the adjudicator determines the records to be relevant to the proceeding;
(e)To the news media and the public, including disclosures pursuant to 28 CFR 50.2, unless it is determined that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy;
(f)To a Member of Congress or staff acting upon the Member's behalf when the Member or staff requests the information on behalf of, and at the request of, the individual who is the subject of the record;
(g)To the National Archives and Records Administration for purposes of records management inspections conducted under the authority of 44 U.S.C. 2904 and 2906;
(h)To an actual or potential party to litigation or the party's authorized representative for the purpose of negotiation or discussion of such matters as settlement, plea bargaining, or in informal discovery proceedings;
(i)To federal, state, territorial, local, tribal, foreign, or international licensing agencies or associations which require information concerning the suitability or eligibility of an individual for a license or permit;
(j)A record may be disclosed to designated officers and employees of state, territorial, local (including the District of Columbia), or tribal law enforcement or detention agencies in connection with the hiring or continued employment of an employee or contractor, where the employee or contractor would occupy or occupies a position of public trust as a law enforcement officer or detention officer having direct contact with the public or with prisoners or detainees, to the extent that the information is relevant and necessary to the recipient agency's decision;
(k)To a former employee of the Department for purposes of: Responding to an official inquiry by a federal, state, or local government entity or professional licensing authority, in accordance with applicable Department regulations; or facilitating communications with a former employee that may be necessary for personnel-related or other official purposes where the Department requires information and/or consultation assistance from the former employee regarding a matter within that person's former area of responsibility.
(l)To appropriate agencies, entities, and persons when
(1)the Department suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;
(2)the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and
(3)the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. *Disclosure to Consumer Reporting Agencies:* Not Applicable. Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage: Records are stored in standard file folders. Duplicate copies of paper records are stored on magnetic discs. Retrievability: Records are retrieved by individual names or identifying numbers. Safeguards: Except as otherwise noted in paragraph
(b)under “Routine uses,” access is restricted to personnel in the Investigative Services Division and in each USMS district office. Access to computerized records is safeguarded by user identification and password restrictions. Paper records are maintained in filing cabinets within supervised areas of the U.S. Marshals' offices. District and headquarters offices are locked during working and non-duty hours and entry is restricted to employees with official identification. Retention and disposal: Records are kept in an operating file until warrant is executed and then transferred to a closed file. Closed files are retained for one year after file is closed, then transferred to the Federal Records Center and destroyed after 55 years. Computerized records are retained indefinitely as an operating file or as a closed case file. System manager(s) and address: Assistant Director, Investigative Services Division, U.S. Marshals Service, CS-4, Washington, DC 20530-1000. Notification procedure: Same as “Record access procedures.” Record access procedures: Make all requests for access in writing and clearly mark the letter and envelope “Freedom of Information/Privacy Act Request.” Clearly indicate the name of the requester, nature of the record sought, approximate date of the record, and provide the required verification of identity (28 CFR 16.41(d)). Direct all requests to the system manager identified above, Attention: FOI/PA Officer, and provide a return address for transmitting the information. Contesting record procedures: Direct all requests to contest or amend information to the system manager identified above. State clearly and concisely the information being contested, the reason for contesting it, and the proposed amendment to the information sought. Clearly mark the envelope “Freedom of Information/Privacy Act Request.” Record source categories: Information is obtained from the courts, federal, state, local and foreign law enforcement agencies, public and private organizations, commercial information resellers, witnesses, informants, and other persons interviewed during the course of the fugitive, criminal, or missing person investigations. Exemptions claimed for the system: The Attorney General has exempted this system from subsections (c)(3) and (4), (d), (e)(1),
(2)and (3), (e)(4)(G) and (H), (e)(5), (e)(8),
(f)and
(g)of the Privacy Act pursuant to 5 U.S.C. 552a(j)(2). Rules have been promulgated in accordance with the requirements of 5 U.S.C. 553(b), (c), and
(e)and have been published in the **Federal Register** . See 28 CFR 16.101. [FR Doc. E7-3757 Filed 3-2-07; 8:45 am] BILLING CODE 4410-04-P DEPARTMENT OF JUSTICE Office of Justice Programs [OJP
(OJP)Docket No. 1467] Meeting of the Department of Justice's Global Justice Information Sharing Initiative Federal Advisory Committee AGENCY: Office of Justice Programs, Justice. ACTION: Notice of meeting. SUMMARY: This is an announcement for a meeting of the Department of Justice's Global Justice Information Sharing Initiative (Global) Federal Advisory Committee
(GAC)to discuss the Global Initiative, as described at *http://www.it.ojp.gov/global.* DATES: The meeting will take place on Wednesday, April 18, 2007, from 8:30 a.m. to 4 p.m. ET. ADDRESSES: The meeting will take place at the Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, Virginia 22202; Phone:
(703)486-1111. FOR FURTHER INFORMATION CONTACT: J. Patrick McCreary, Global Designated Federal Employee (DFE), Bureau of Justice Assistance, Office of Justice Programs, 810 7th Street, Washington, DC 20531; Phone:
(202)616-0532 [note: this is not a toll-free number]; E-mail: *James.P.McCreary@usdoj.gov.* SUPPLEMENTARY INFORMATION: Purpose The GAC acts as the focal point for justice information systems integration activities in order to facilitate the coordination of technical, funding, and legislative strategies in support of the Administration's justice priorities. In addition, the GAC guides and monitors the development of the Global information sharing concept. It advises the Attorney General, the President (through the Attorney General), the Assistant Attorney General, Office of Justice Programs, and local, state, tribal, and federal policymakers in the executive, legislative, and judicial branches. The GAC also advocates for strategies for accomplishing a Global information sharing capability. Meeting Registration and Accommodation This meeting is open to the public. Due to security measures, however, members of the public who wish to attend this meeting must register with Mr. J. Patrick McCreary at the above address at least
(7)days in advance of the meeting. Registrations will be accepted on a space available basis. No persons will be allowed access to the meeting without registering. All attendees will be required to sign in at the meeting registration desk. Please bring photo identification and allow extra time prior to the meeting. Interested persons whose registrations have been accepted may be permitted to participate in the discussions at the discretion of the meeting chairman and with approval of the DFE. Anyone requiring special accommodations should notify Mr. McCreary at least seven
(7)days in advance of the meeting. J. Patrick McCreary, Global DFE, Bureau of Justice Assistance, Office of Justice Programs. [FR Doc. 07-983 Filed 3-2-07; 8:45 am]
Connectionstraces to 18
Traces to 18 documents
7 references not yet in our index
  • Pub. L. 98-417
  • Pub. L. 94-241
  • 50 CFR 17.22
  • 40 CFR 1506.6
  • 25 CFR 151
  • 36 CFR 60
  • 5 CFR 1320.10
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cites case law
Notices
Notice
U.S.C.§ 355
C.F.R.§ 314.162
C.F.R.§ 314.161
C.F.R.§ 10.30
U.S.C.§ 552b
U.S.C.§ 1531
U.S.C.§ 4371
C.F.R.§ 151.12
U.S.C.§ 465
Pub. L.Pub. L. 98-417
Pub. L.Pub. L. 94-241
Cite50 CFR 17.22
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