Notices. Notice

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

BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities. Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility;

(b)the accuracy of the Agency's estimate of the burden of the proposed collection of information;

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

(d)ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Proposed Project: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Regulations and Forms (OMB No. 0915-0126)—Extension The National Practitioner Data Bank

(NPDB)was established through Title IV of Public Law (P.L.) 99-660, the Health Care Quality Improvement Act of 1986, as amended. Final regulations governing the NPDB are codified at 45 CFR part 60. Responsibility for NPDB implementation and operation resides in the Bureau of Health Professions, Health Resources and Services Administration, Department of Health and Human Services (HHS). The NPDB began operation on September 1, 1990. The intent of Title IV of P.L. 99-660 is to improve the quality of health care by encouraging hospitals, State licensing boards, professional societies, and other entities providing health care services, to identify and discipline those who engage in unprofessional behavior; and to restrict the ability of incompetent physicians, dentists, and other health care practitioners to move from State to State without disclosure of the practitioner's previous damaging or incompetent performance. The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information on medical malpractice payments, adverse licensure actions, adverse clinical privileging actions, adverse professional society actions, and Medicare/Medicaid exclusions is collected from, and disseminated to, eligible entities. It is intended that NPDB information should be considered with other relevant information in evaluating a practitioner's credentials. The reporting forms and the request for information forms (query forms) are accessed, completed, and submitted to the NPDB electronically through the NPDB Web site at *http://www.npdb-hipdb.hrsa.gov* . All reporting and querying is performed through this secure Web site. Due to overlap in requirements for the Healthcare Integrity and Protection Data Bank (HIPDB), some of the NPDB's burden has been subsumed under the HIPDB. Estimates of Annualized Burden are as Follows: Regulation citation Number of respondents Frequency of responses Hours per response (minutes) Total burden hours 60.6(a) Errors & Omissions 303 5 15 385 60.6(b) Revisions to Actions 115 1.1 30 64 60.7(b) Medical Malpractice Payment Report 485 39 45 14,236 60.8(b) Adverse Action Reports—State Boards 0 0 0 0 60.9(a)3 Adverse Action Clinical Privileges & Professional Society 686 1.5 45 785 Requests for Hearings by Entities 1 1 480 8 60.10(a)(1) Queries by Hospital—Practitioner Applications 6,000 37.3 5 18,615 60.10(a)(2) Queries by Hospitals—Two Yr. Cycle 6,000 149 5 74,461 60.11(a)(1) Disclosure to Hospitals 0 0 0 0 60.11(a)(2) Disclosure to Practitioners (Self-Query) 0 0 0 0 60.11(a)(3) Disclosure to Licensure Boards 80 225 5 1,499 60.11(a)(4) Queries by Non-Hospital Health Care Entities 4,938 437 5 179,673 60.11(a)(5) Queries by Plaintiffs' Attorneys 5 5 30 3.0 60.11(a)(6) Queries by Non-Hospital Health Care Entities—Peer Review 0 0 0 0 60.11(a)(7) Requests by Researchers for Aggregated Data 100 1 30 50 60.14(b) Practitioner Places a Report in Disputed Status 666 1 5 55 60.14(b) Practitioner Statement 2,563 1 45 1,922 60.14(b) Practitioner Requests for Secretarial Review 117 1 480 936 60.3 Entity Registration—Initial 500 1 60 500 60.3 Entity Registration—Update 643 1 5 54 60.11(a) Authorized Agent Designation—Initial 500 1 15 125 60.11(a) Authorized Agent-Update 86 1 5 7 60.12(c) Account Discrepancy Report 300 1 15 75 60.12(c) Electronic Funds Transfer Authorization 363 1 15 91 60.3 Entity Reactivation 100 1 60 100 Total 293,644 Numbers in the table may not add up exactly due to rounding. Send comments to Susan Queen, PhD, HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received within 60 days of this notice. Dated: February 22, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-3446 Filed 2-27-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Commission on Childhood Vaccines (ACCV). *Date and Time:* March 7, 2007, 1 p.m.-5 p.m., EST. March 8, 2007, 9 a.m.-3:30 p.m., EST. *Place:* Audio Conference Call and Parklawn Building, Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857. The ACCV will meet on Wednesday, March 7, from 1 p.m. to 5 p.m., and on Thursday, March 8, from 9 a.m. to 3:30 p.m. The public can join the meeting in person at the address listed above or by audio conference call by dialing 1-888-947-9967 on March 7 and 8 and providing the following information: *Leader's Name:* Dr. Geoffrey Evans. *Password:* ACCV. *Agenda:* The agenda items for the March meeting will include, but are not limited to: A discussion of VICP outreach activities; an overview of the Vaccine Adverse Event Reporting System, including the requirements for the reporting of adverse events; a report from the ACCV Futures Workgroup; and updates from the Division of Vaccine Injury Compensation (DVIC), Department of Justice, National Vaccine Program Office, Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health), and Center for Biologics and Evaluation Research (Food and Drug Administration). Agenda items are subject to change as priorities dictate. *Public Comments:* Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation, to: Ms. Cheryl Lee, Principal Staff Liaison, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857 or e-mail: *clee@hrsa.gov* . Requests should contain the name, address, telephone number, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by mail or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the comment period. These persons will be allocated time as it permits. *For Further Information Contact:* Anyone requiring information regarding the ACCV should contact Ms. Cheryl Lee, Principal Staff Liaison, DVIC, HSB, HRSA, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857; telephone

(301)443-2124 or e-mail: *clee@hrsa.gov* . *Notification:* Due to inclement weather, the requirement that the public be notified of this meeting at least 15 calendar days in advance was not met. Dated: February 22, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-3559 Filed 2-27-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Request for Genetic Studies in a Cohort of U.S. Radiologic Technologists SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health

(NIH)has submitted to the Office of Management and Budget

(OMB)a request to review and approve the information collection listed below. This proposed information collection was previously published in the **Federal Register** on December 29, 2006, pages 78445-78446 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection *Title:* Genetic Studies in a Cohort of U.S. Radiologic Technologists (formerly known as “Generic Clearance to Collect Medical Outcome and Risk Factor Data from a Cohort of U.S. Radiologic Technologists”). *Type of Information Collection Request:* Renewal with change of a previously approved collection (OMB No. 0925-0405, expiration 02/28/2007). *Need and Use of Information Collection:* The primary aim of this collection is to substantially increase knowledge about the possible modifying role of genetic variation on the long-term health effects associated with protracted low-to moderate-dose radiation exposures. With this submission, the NIH, Office of Communications and Public Liaison, seeks to obtain OMB's approval to collect biospecimens and risk factor data in this ongoing cohort study of U.S. radiologic technologists to assess genetic and molecular risk factors for cancer, and to evaluate possible modifying effects of genetic variation on radiation-cancer relationships. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 18,400 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. Overall study objectives are:

(1)To quantify radiation dose-response for cancers of the breast, thyroid, and other radiogenic sites, and selected benign conditions related to cancer (e.g. thyroid nodules);

(2)to assess cancer risk associated with genotypic, phenotypic, or other biologically measurable factors (e.g. serum levels of C-reactive protein, insulin growth factors or binding proteins); and

(3)to determine if genetic variation modifies the radiation-related cancer risk. A third follow-up of this cohort was completed during the past three years. During 2003-2005, the “Third Survey” questionnaire was mailed or administered by telephone to 101,694 living cohort members who had completed at least one prior survey; 73,838 technologists (73% response) completed the survey. The questionnaire elicited information on: Medical outcomes to assess radiation-related risks; detailed employment data to refine the occupational radiation dose estimates; and behavioral and residential histories for estimating lifetime ultraviolet

(UV)radiation exposure. Analyses of these data are currently underway and findings will address an important gap in the scientific understanding of radiation dose-rate effects, i.e., whether cumulative exposures of the same magnitude have the same health effects when received in a single or a few doses over a very short period of time (as in the atomic bomb or therapeutic exposures) or in many small doses over a protracted period of time (as in medical or nuclear occupational settings). There are few, if any, other study populations in which both quantified breast radiation doses and blood samples are available for individuals with protracted low-dose radiation exposures. The current petition is for renewal with change of the previous clearance to administer a Genetic Studies Questionnaire and collect biospecimens from 10,000 cohort members who completed at least one prior survey. These individuals would serve as a comparison group for case-cohort studies of gene main effects and gene-radiation interactions. To improve statistical power to detect such associations, we plan to select the comparison sample based on dose; this is to ensure inclusion of sufficient numbers of high-dose individuals. The Genetic Studies Questionnaire will collect information on: Family history of cancer; reproductive history in women (e.g. pregnancy outcomes, menopause); personal medical radiation exposures (e.g. diagnostic x-rays, therapeutic irradiation); and personal history of chemotherapy. The survey will be in optical-read format for computerized data capture. A blood collection kit will be mailed to technologists along with the Genetic Studies Questionnaire; they will be asked to take the kit to a phlebotomist to have a single tube of blood drawn and returned to the study laboratory by pre-paid Federal Express overnight delivery. Ongoing efforts to medically validate self-reported cancers and other medical outcomes will continue. The annual reporting burden is as follows: *Frequency of Response:* On occasion. *Affected Public:* U.S. radiologic technologists who willingly participated in earlier investigations to quantify the carcinogenic risks of protracted low-to moderate-dose occupational radiation exposures. *Estimated Number of Respondents:* 4,233. *Estimated Number of Responses per Respondent:* 1. *Average Burden Hours per Response:* 1.3. Annual Burden Hours Requested: 5,630. Total cost to respondents is estimated at $157,471. There are no capital costs, operating costs and/or maintenance costs to report. Respondent and Burden Estimate—OMB No. 0925-0405 Type of respondent Number of respondents (3 yr) Frequency of response Total respondents (3 yr) Average hours per response Total hours (3 yr) Annual hour burden Genetic Studies/Risk Factor Survey and Blood Collection Sub-Cohort 10,000 1 10,000 1.66666 16,666 5,555 Medical Validation Hospitals/ Physicians 2,700 1 2,700 0.08333 225 75 Total: 12,700 12,700 16,891 5,630 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:

(1)Whether the proposed collection of information is necessary for the proper performance of the functioning of the National Cancer Institute, including whether the information will have practical utility;

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

(4)ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Direct Comments to OMB:* Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Michele M. Doody, Radiation Epidemiology Branch, National Cancer Institute, Executive Plaza South, Room 7040, Bethesda, MD 20892-7238, or call non-toll-free at 301-594-7203 or e-mail your request, including your address to: *doodym@mail.nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: February 16, 2007. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E7-3435 Filed 2-27-07; 8:45 am] BILLING CODE 4104-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Methods of Determining the Prognosis of Hepatocellular Carcinoma *Description of Technology:* Hepatocellular carcinoma

(HCC)represents an extremely poor prognostic cancer that remains one of the most common and aggressive malignancies worldwide. A major hallmark of HCC is intrahepatic metastasis and post-surgical reoccurrence. With current diagnostic methods, HCC patients are often diagnosed with end-stage cancer and have poor survival. Thus, there is a need for an accurate method to identify HCC and its proclivity for metastases/relapse, particularly at early stages of this disease. The inventors have discovered a unique set of microRNA (miRNA) biomarkers that are associated with HCC metastasis/recurrence. This miRNA signature was validated in an independent cohort of 110 HCC samples as an independent predictor of HCC prognosis and likelihood of metastasis and relapse. In particular, the inventors provide evidence that these miRNA markers can predict HCC metastasis in the early stages of cancer. This methodology may enable clinicians to effectively stratify patients for appropriate cancer treatment and prioritize liver transplantation candidates. *Applications:*

(1)Method to prognose HCC, patient survival and likelihood of HCC metastasis/relapse;

(2)Diagnostic tool to aid clinicians in determining appropriate cancer treatment;

(3)Compositions that inhibit miRNA HCC biomarkers such as siRNA;

(4)Method to treatment HCC patients with inhibitory miRNA compositions. *Market:*

(1)Primary liver cancer accounts for about 2% of cancers in the U.S., but up to half of all cancers in some undeveloped countries;

(2)Post-operative five year survival rate of HCC patients is 30-40%. *Development Status:* This technology is currently in the pre-clinical stage of development. *Inventors: Xin Wei Wang et al.* (NCI). *Publication:* Budhu *et al.* A Unique Metastasis-related MicroRNA Expression Signature Predicts Survival and Recurrence in Hepatocellular Carcinoma, manuscript in preparation. *Patent Status:* U.S. Provisional Application No. 60/884,052 filed 09 Jan 2007 (HHS Reference No. E-050-2007/0-US-01). *Licensing Availability:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Jennifer Wong; 301/435-4633; *wongje@mail.nih.gov.* A Varicella-Zoster Virus Mutant that is Markedly Impaired for Latent Infection Available for the Development of Shingles Vaccines and Diagnostics *Description of Technology:* Reactivation of latent Varicella-Zoster virus

(VZV)infection is the cause of shingles, which is prominent in adults over the age of 60 and individuals who have compromised immune systems, due to HIV infection, cancer treatment and/or transplant. Shingles is a worldwide health concern that affects approximately 600,000 Americans each year. The incidence of shingles is also high in Europe, South America, and India; the latter having an estimated two million individuals affected, yearly. Recent research studies show that VZV vaccines have a significant effect on decreasing the incidence of shingles in elderly. The current technology describes compositions, cells and methods related to the production and use of a mutant VZV and the development of vaccines against the infectious agent. Latent VZV expresses a limited repertoire of viral genes including the following six open reading frames (ORFs): 4, 21, 29, 62, 63, and 66. The present invention describes an ORF29 mutant VZV that demonstrates a weakened ability to establish latency in animal studies. The current technology provides methods for using the mutant in the development of live vaccines and diagnostic tools. A related invention is described in PCT/US05/021788 (publication number WO2006012092). *Applications:* Development of vaccines and diagnostics for prevention of shingles. *Development Status:* Pre-clinical studies have been performed to demonstrate the reduced latency of the ORF29 mutant VZV in animals. *Inventors:* Jeffrey Cohen (NIAID) and Lesley Pesnicak (NIAID). *Patent Status:* U.S. Provisional Application No. 60/857,766 filed 09 Nov 2006 (HHS Reference No. E-029-2007/0-US-01). *Licensing Availability:* Available for licensing and commercial development. *Licensing Contact:* Chekesha Clingman, Ph.D.; 301/435-5018; *clingmac@mail.nih.gov.* *Collaborative Research Opportunity:* The NIAID Laboratory of Clinical Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize vaccine strains of VZV vaccine with impaired latency. Please contact Kelly Murphy, J.D., M.S., at 301/451-3523 or *murphykt@niaid.nih.gov* for more information. Highly Soluble Pyrimido-Dione-Quinoline Compounds: Small Molecules That Stabilize and Activate p53 in Transformed Cells *Description of Technology:* The tumor-suppressor p53 protein plays a major role in tumor development. Most human cancers ail to normally activate p53, which is at least partly responsible for the unregulated growth of cancer cells and their failure to undergo apoptosis. While many chemotherapeutics enhance p53 levels, their non-specific DNA damage (genotoxicity) causes unfavorable side effects. This invention reports the composition and function of a pyrimido-dione-quinoline that was found to inhibit HDM2's ubiquitin ligase

(E3)activity without the accompanying genotoxicity of current therapeutic drugs. Like the HLI98 family of compounds reported previously (see reference below), the subject of the current invention stabilizes p53 in cells, inhibiting its ubiquitin-mediated proteasomal degradation. Unlike the HLI98 compound, the pyrimido-dione-quinoline reported here induces a robust p53 response, and is highly water-soluble. Thus, these pyrimido-dione-quinoline compounds have the potential to stabilize p53 and activate a p53 response in tumors. *Applications and Modality:* Water-soluble with improved potency in stabilizing p53 and activating a p53 response; Inhibits unregulated growth of cancer cells; Reduced genotoxicity compared to many chemotherapeutics. *Market:* Small molecule-based cancer therapeutics for tumors expressing wild type p53, which comprises approximately 50% of cancers. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* Allan M. Weissman and Yili Yang (NCI). *Related Publication:* Y Yang et al. Small molecule inhibitors of HDM2 ubiquitin ligase activity stabilize and activate p53 in cells. Cancer Cell 2005 Jun;7(6):547-559. *Patent Status:* U.S. Provisional Application No. 60/813,946 filed 14 Jun 2006 (HHS Reference No. E-138-2006/0-US-01). *Availability:* Available for exclusive and non-exclusive licensing. *Licensing Contact:* Thomas P. Clouse, J.D.; 301/435-4076; clousetp *@mail.nih.gov.* *Collaborative Research Opportunity:* The Laboratory of Protein Dynamics and Signaling

(LPDS)at the National Cancer Institute, NIH, is seeking a collaborative partner under a Cooperative Research and Development Agreement (CRADA) to develop therapeutics approaches utilizing inhibitors of the ubiquitin system such as described in this invention. Please contact John D. Hewes, Ph.D. at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Human Cancer Therapy Using Engineered Anthrax Lethal Toxin *Description of Technology:* Anthrax lethal toxin

(LeTx)consists of two components: The protective antigen

(PrAg)and the lethal factor (LF). PrAg binds to the cell surface where it is activated by furin protease, followed by the formation of a PrAg heptamer. LF is then translocated into the cytosol of a cell via this heptamer, where it acts as a metalloprotease on all but one mitogen-activated protein kinase kinase (MAPKK). Approximately 70% of human melanomas contain a mutation (B-RAF V600E) that constitutively activates a MAPKK pathway, and LeTx has been shown to have significant toxicity towards cells which have this mutation. This suggested a potential use for LeTx in cancer therapy. Unfortunately, native LeTx is toxic to normal cells, detracting from its *in vivo* applicability. PrAg has been engineered to be activated by a matrix metalloprotease (MMP), instead of by furin protease. Because MMPs are highly expressed in tumor cells, this modification increases selectivity towards cancer cells. Surprisingly, mouse data shows that the modified LeTx (denoted PrAg-L1/LF) is less cytotoxic to “normal” cells in vivo, when compared to wild-type LeTx. Significantly, PrAg-L1/LF maintained its high toxicity toward human tumors in mouse xenograft models of human tumors, including melanomas. However, this toxicity applied not only to tumors having mutations that constitutively activate MAPKKs, but also to other tumor types such as lung and colon carcinomas. The absence of toxicity to “normal” cells coupled to its effectiveness on a wide range of cancer cell types suggests that PrAg-L1/LF may represent a novel cancer therapeutic. *Applications:* PrAg-L1/LF has applications as a human cancer therapeutic; Applicability extends beyond melanomas, including lung and colon carcinomas. *Market:* The worldwide market for melanoma therapeutics is approximately $437M, and is predicted to reach $680M by the year 2009. Approximately 2.4 million people are afflicted with melanoma, with around 150,000 new cases each year. Demonstration of effectiveness *in vivo* for lung and colon carcinomas will increase the market for this technology. *Development Status:* The technology is at the preclinical stage. *Inventors:* Stephen H. Leppla (NIAID), Shi-hui Liu (NIAID), Thomas H. Bugge (NIDCR), John R. Basile (NIDCR), Brooke Currie (NIDCR). *Related Publications:* 1. S Liu *et al.* Intermolecular complementation achieves high-specificity tumor targeting by anthrax toxin. Nat Biotechnol. 2005 Jun;23(6):725-730. 2. RJ Abi-Habib *et al.* A urokinase-activated recombinant anthrax toxin is selectively cytotoxic to many human tumor cell types. Mol Cancer Ther. 2006 Oct;5(10):2556-2562. *Patent Status:* U.S. Provisional Application No. 60/870,050 filed 14 Dec 2006 (HHS Reference E-070-2007/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* David A. Lambertson, Ph.D.; 301/435-4632; *lambertsond@od.nih.gov.* *Collaborative Research Opportunity:* The NIAID Laboratory of Bacterial Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize PrAg-L1/LF as a novel cancer therapeutic. Please contact Stephen H. Leppla, Ph.D. at 301/594-2865 and/or *sleppla@niaid.nih.gov* for more information. This abstract was originally published in the **Federal Register** on Wednesday, February 7, 2007, 72 FR 5726, with an incorrect title of “Extended Transgene Expression for a Non-Integrating Adenoviral Vector Containing Retroviral Elements.” Dated: February 20, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-3436 Filed 2-27-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on

(240)276-1243. Comments are invited on:

(a)Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Underage Drinking Prevention: Town Hall Meeting Feedback Form—New The Substance Abuse and Mental Health Services Administration's (SAMHSA), Center for Substance Abuse Prevention

(CSAP)is proposing the project the 2008 Underage Drinking Prevention: Town Hall Meetings

(THM)Initiative. In 2006, approximately 1,510 THMs were held in 1,262 community-based organizations

(CBO)throughout the Nation. Each of the THMs strived to increase the understanding and awareness of underage alcohol use and its consequences by encouraging individuals, families, and communities to address the problem. The local THMs gave communities the opportunity to come together to learn more about the new research on underage alcohol use and its impact on both the individuals and the community. They also discussed how their communities can best prevent underage alcohol use. To help guide decision making and planning for future THMs, SAMHSA/CSAP plans to conduct a process assessment of the THMs to be held in 2008. CBOs who agree to participate in this initiative will be asked to provide feedback about the implementation and results of the THMs in their community. This information collection is being implemented under the authority of Section 501(d)

(4)of the Public Health Service Act (42 U.S.C. 290aa). The contractor conducting this information collection will distribute a brief feedback form to all participating organizations. The form includes 14 items about the THM, including where, when, and who conducted the meeting, number of attendees, format of meeting, participants in the presentations, actions planned, media coverage of the meeting, composition of the audience, responses of the attendees, materials provided in the town hall meetings, and indications of increased awareness and increased involvement. In addition to distributing the feedback form, the contractor will be responsible for collecting, compiling, analyzing, and reporting on information requested through this feedback form. The feedback form will be completed by an estimated 1,200 employees from CBOs. The paper form will take an average of 10 minutes (.167 hours) to review instructions, complete the form, and mail it in a self-addressed, stamped envelope. This burden estimate is based on comments from several potential respondents who reviewed the form and provided comments on how long it would take them to complete it. Form name Number of respondents Responses per respondent Hours per response Total hour burden Feedback Form 1,200 1 .167 120 Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 7-1044, One Choke Cherry Road, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: February 22, 2007. Elaine Parry, Acting Director, Office of Program Services. [FR Doc. E7-3468 Filed 2-27-07; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Notice of Issuance of Final Determination Concerning Digital Color Multifunctional Systems AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of final determination. SUMMARY: This document provides notice that the Bureau of Customs and Border Protection

(CBP)has issued a final determination concerning the country of origin of certain digital color multifunctional systems to be offered to the United States Government under an undesignated government procurement contract. Based on the facts presented, the final determination found that Japan is the country of origin of the subject digital color multifunctional systems for purposes of U.S. government procurement. DATES: The final determination was issued on February 8, 2007. A copy of the final determination is attached. Any party-at-interest as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within 30 days of February 28, 2007. FOR FURTHER INFORMATION CONTACT: Daniel Cornette, Valuation and Special Programs Branch, Office of International Trade; telephone

(202)572-8731. SUPPLEMENTARY INFORMATION: Notice is hereby given that on February 8, 2007, pursuant to subpart B of part 177, Customs Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of certain digital color multifunctional systems to be offered to the United States Government under an undesignated government procurement contract. The CBP ruling number is HQ 563491. This final determination was issued at the request of Sharp Electronics Corporation under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). The final determination concluded that, based upon the facts presented, the assembly in Japan of Japanese and foreign components to create the subject digital color multifunctional systems substantially transformed the foreign components into a product of Japan. Section 177.29, CBP Regulations (19 CFR 177.29), provides that notice of final determinations shall be published in the **Federal Register** within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), states that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the **Federal Register** . Dated: February 21, 2007. Sandra L. Bell, Executive Director, Office of Regulations and Rulings, Office of International Trade. HQ 563491 February 8, 2007. MAR-2-05 RR:CTF:VS 563491 DCC *Category:* Marking. Ms. Fusae Nara, Pillsbury Winthrop Shaw Pittman, 1540 Broadway, New York, NY 10036-4039. *Reference:* U.S. Government Procurement; Final Determination; country of origin of digital color multifunctional systems; substantial transformation; 19 CFR Part 177. Dear Ms. Nara: This is in response to your letter dated April 24, 2006, requesting a final determination on behalf of Sharp Electronics Corporation (“Sharp”) pursuant to subpart B of Part 177, Customs and Border Protection (“CBP”) Regulations (19 CFR 177.21 *et seq.* ). Under these regulations, which implement Title III of the Trade Agreements Act of 1979, as amended (codified at 19 U.S.C. 2411 *et seq.* ), CBP issues country of origin advisory rulings and final determinations on whether an article is or would be a product of a designated foreign country or instrumentality for the purpose of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government. This final determination concerns the country of origin of certain digital color multifunctional systems that Sharp may sell to the U.S. Government. We note that Sharp is a party-at-interest within the meaning of 19 CFR 177.22(d)(1) and is entitled to request this final determination. *Facts:* The products subject to this ruling are digital color multifunctional systems manufactured by Sharp, Model Nos. MX-2300NJ and MX-2700NJ (hereinafter the “J-Models”), imported from Japan for the purpose of sales to U.S. government agencies. The J-Models have photocopying, printing, faxing, and scanning functions. The primary difference between the two models is the speed at which they are able to process images. The MX-2300NJ prints 23 pages per minute compared to 27 pages per minute for the MX-2700NJ. Sharp's parent company (“Sharp Japan”) developed the J-Model in Japan, and performs the entire engineering, development, design, and art work processes for both models in Japan. According to your submission, the production process may be broken down into four stages. In the first stage, the following key subassemblies are assembled: laser scanner unit (“LSU”) (assembled in China); first transfer unit subassembly (assembly begins in China and is finished in Japan); process unit subassembly (assembled in China); and controller unit subassembly (assembled in Japan). In addition, four minor subassemblies are assembled in China: first transfer cleaner unit; cabinet subassembly; auto document feeder subassembly, and fuser unit. The finished systems have one unit each of five different kinds of application-specific integrated circuits (“ASIC”), all of which are made in Japan. The second stage is the final physical assembly of the J-Models. In the third stage, Sharp Japan makes adjustments and conducts testing of the J-Models. In the fourth stage, the J-Models undergo final inspection and packaging for shipment to the United States. 1. Subassembly Preparation

(a)Laser Scanner Unit Subassembly The LSU writes the image data of the documents or graphics onto the drum unit. While the components comprising the LSU are assembled in China, the charge coupled device (“CCD”) and the ASIC, which are mounted on the cabinet as well as the laser diodes (“LDs”), are made in Japan. Color images are created by exposing the laser lights of the LDs to four color-specific drums (black, cyan, magenta, and yellow). The ASIC is designed to control the exposure of the laser lights following the scanned data with speed and precision.

(b)First Transfer Unit Subassembly The first transfer unit is where the four color images, which are created by the four color drums, are transformed into an integrated color image that is then transferred onto paper. The image is transferred to the paper by a wide belt known as a transfer belt. The transfer belt rotates around the first transfer unit generating print images, while a cleaner cartridge continuously cleans the surface of the belt. The unfinished first transfer unit is manufactured in China and completed in Japan where the transfer belt is manufactured and installed.

(c)Process Unit Subassembly The process unit is a combination of the drum, developer, and toner cartridges. Because the J-Models are color multifunctional systems, they require four sets of the process units, which includes a drum, developer and toner for each of the four colors, *i.e.* , black, yellow, cyan, and magenta. The developer and toner materials, as well as the drums, are produced in Japan. The process unit subassembly is assembled by attaching each of the four drums to the four drum cartridges. The toner and developer cartridges are filled with toner and developer and installed on the subassembly for testing purposes.

(d)Control Box Unit Subassembly The control box unit is the “brain” of the J-Model machines. The control printed wiring board (“PWB”) and the mother PWB are populated in China with diodes, resisters, and condensers. In Japan, Sharp forms a harness for the hard disk (either from Malaysia or China) that is then fastened to the harness board of the control box unit with screws. The hard disk is affixed to the harness and then to the PWB. Cushioning is installed around the hard disk and flash memory chips ( *i.e.* , the boot flash ROM, and the program flash ROM) are inserted into designated slots on the control box. 2. Final Assembly The final Japanese assembly process begins with the cabinet that houses the middle section of the finished product. The cabinet is fabricated in China and contains certain components, such as Japanese ASICs, that are installed in China. The major subassemblies described above are assembled into the cabinet as follows: a. The side panel of the cabinet is opened and the LSU subassembly is inserted and fastened to the cabinet with screws. b. The front panel of the cabinet is opened and the first transfer unit assembly is inserted into a slot and fastened to the cabinet with screws. c. Four drum cartridges, four developer cartridges, and four toner cartridges—one for each of the four colors ( *i.e.* , black, yellow, cyan, and magenta)—are installed. d. A small panel on the back of the cabinet is removed and the control box unit is inserted into a slot in the cabinet assembly and secured with screws. e. The automatic document feeder is fastened to the hinge on top of the cabinet assembly with screws. 3. Testing In Japan, extensive tests are conducted and adjustments are made to all functions, including scanning, image placement, color and darkness. a. Adjustments. The following adjustments are made to each unit: • Confirm data input circuitry by connecting the printer/scanner unit to a computer based on the destination of the finished unit. • Inspect the card reader by running a test card with a simulation program. • Apply high voltage to the printer unit and adjust it to be within the permitted range for each color. • Measure the bias voltage to confirm that the voltage used to remove excess toner is proper. • Confirm the rotation of the toner motor. • Confirm the functioning of the hard disk and the hard disk output on the LCD display panel of the operation unit. • Measure the distance between the drum “sleep” position and the toner cartridge magnet roller to ensure even print quality. • Adjust the amount of developer by connecting the developer unit for each color. • Attach the toner cartridge and adjust the darkness sensor. b. Test Copying. After the assembly adjustments are complete, the unit undergoes alignments by running test copies to confirm the following functions: Paper placement; print darkness; optical images; print placement; color balance for printer engine and print output; color pattern chart; manual copy; print and image output; two-sided copying; feeder functions; intermediate tone process control for various printing modes ( *i.e.* , letter, photograph, and combination); print output from an attached computer; USB cable connection; and memory. After testing is complete, each unit is reset to the default position to prepare for final inspection and packaging for shipment. 4. Final Inspection and Packaging The finished assembly is prepared for shipment by removing the drum cartridges, toner cartridges, and developer cartridges used for testing purposes and by cleaning the color toner pipes, printing mechanism, scanner surface, and exterior. New drum and developer cartridges are inserted and secured to the unit. An operator conducts a final inspection that includes testing the power supply, the LCD display panel, sensors, and proper operation of the unit. After final inspection, the finished unit is packaged for shipping. *Issue:* Whether the multifunctional systems manufactured by Sharp (Model Nos. MX-2300NJ and MX-2700NJ) are products of Japan for purposes of U.S. Government procurement. *Law and Analysis:* Pursuant to Subpart B of Part 177, 19 CFR 177.21 *et seq.* , which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511 *et seq.* ), CBP issues country of origin advisory rulings and final determinations on whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government. Under the rule of origin set forth under 19 U.S.C. 2518(4)(B): An article is a product of a country or instrumentality only if

(i)it is wholly the growth, product, or manufacture of that country or instrumentality, or

(ii)in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed. See also, 19 CFR 177.22(a). A substantial transformation “results in an article having a name, character, or use differing from that of the imported article.” *Uniroyal, Inc.* v. *United States* , 542 F. Supp. 1026, 1029 (Ct. Int'l Trade 1982), aff'd, 702 F.2d 1022 (Fed. Cir. 1983). In determining whether the combining of parts or materials constitutes a substantial transformation, the determinative issue is the extent of operations performed and whether the parts lose their identity and become an integral part of the new article. See *Belcrest Linens* v. *United States* , 573 F. Supp. 1149 (Ct. Int'l Trade 1983), *aff'd,* 741 F.2d 1368 (Fed. Cir. 1984). Assembly operations that are minimal or simple, as opposed to complex or meaningful, will generally not result in a substantial transformation. See C.S.D. 80-111, C.S.D. 85-25, C.S.D. 89-110, C.S.D. 89-118, C.S.D. 90-51, and C.S.D. 90-97. In C.S.D. 85-25, 19 Cust. Bull. 844 (1985), CBP held that for purposes of the Generalized System of Preferences (“GSP”), the assembly of a large number of fabricated components onto a printed circuit board in a process involving a considerable amount of time and skill resulted in a substantial transformation. In that case, in excess of 50 discrete fabricated components (such as resistors, capacitors, diodes, integrated circuits, sockets, and connectors) were assembled. CBP has held in a number of cases involving similar merchandise that complex and meaningful assembly operations involving a large number of components will generally result in a substantial transformation. In Headquarters Ruling Letter (“HRL”) 562936, 69 FR 13577 (March 23, 2004), we addressed the country of origin of certain multifunction printers assembled in Japan of various Japanese- and Chinese-origin parts. In that ruling, we determined that the multifunction printer was a product of Japan based on the fact that a “substantial portion of the printer's individual components and subassemblies [were] of Japanese origin.” Furthermore, we noted that some of the Japanese components and subassemblies were essential parts of the finished article, and other Japanese parts, including the reader scanner unit and the control panel unit, were critical to the production of the printer. Finally, HRL 562936 noted that the Japanese processing operations were complex and meaningful, that required “the assembly of a large number of components, and render[ed] a new and distinct article of commerce that possesse[d] a new name, character, and use.” In HRL 562495, dated November 13, 2002, color ink jet printers were assembled in Singapore of components imported from a number of other countries. In that ruling, we determined that the imported components were substantially transformed during assembly such that the country of origin of the assembled ink jet printers was Singapore. In support of this determination, we considered the processing occurring within Singapore to be complex and extensive, requiring the integration of 13 major subassemblies to the chassis, and that the resulting product was a new and distinct article of commerce that possessed a new name, character, and use. In HRL 561734, dated March 22, 2001, published in the **Federal Register** on March 29, 2001 (66 FR 17222), we held that certain multifunctional machines (consisting of printer, copier, and fax machines) assembled in Japan were a product of that country for purposes of U.S. Government procurement. The multifunctional machines were assembled from 227 parts (108 parts obtained from Japan, 92 from Thailand, 3 from China, and 24 from other countries) and eight subassemblies, each of which was assembled in Japan. One of the subassemblies produced in Japan, referred to as the scanner unit, was described as the “heart of the machine.” In finding that the imported parts were substantially transformed in Japan, we stated that the individual parts and components lost their separate identities when they became part of the multifunctional machine. See also HRL 561568, dated March 22, 2001, published in the **Federal Register** on March 29, 2001 (66 FR 17222). By contrast, assembly operations that are minimal or simple will generally not result in a substantial transformation. For example, in HRL 734050, dated June 17, 1991, we determined that Japanese-origin components were not substantially transformed in China when assembled in that country to form finished printers. The printers consisted of five main components identified as the “head,” “mechanism,” “circuit,” “power source,” and “outer case.” The circuit, power source and outer case units were entirely assembled or molded in Japan. The head and mechanical units were made in Japan but exported to China in an unassembled state. All five units were exported to China where the head and mechanical units were assembled with screws and screwdrivers. Thereafter, the head, mechanism, circuit, and power source units were mounted onto the outer case with screws. In holding that the country of origin for marking purposes was Japan, CBP recognized that the vast majority of the printer's parts were of Japanese origin and that the operations performed in China were relatively simple assembly operations. In order to determine whether a substantial transformation occurs when components of various origins are assembled to form multifunctional machines, CBP considers the totality of the circumstances and makes such decisions on a case-by-case basis. The primary considerations in such cases are the country of origin of the machine's components and subassemblies, extent of processing that occurs within a given country, and whether such processing renders a product with a new name, character, and use. In addition, facts such as resources expended on product design and development, extent and nature of post-assembly inspection procedures, and worker skills required during the actual manufacturing process will be considered when analyzing whether a substantial transformation has occurred; however, no single factor is determinative. Based on the facts and law of this case, we find that the assembled J-Model multifunctional systems are products of Japan for purposes of U.S. Government procurement. Although several of the subassemblies are assembled in China, we find that enough of the Japanese subassemblies and individual components serve major functions and are high in value, in particular, the transfer belt, control box unit, application-specific integrated circuits, charged couple device, and laser diodes. The process unit subassembly is also crucial in the performance of the multifunctional systems. While it is assembled in China, its key components, the developer and toner materials, and drums are produced in Japan. Furthermore, it is significant that although the PWB is of Chinese origin, the firmware for the control box unit subassembly is developed in Japan. This firmware programming controls the print engine, readout mechanism, processes images for the copier, printer, fax, and scanner, and controls the operation panel display. We further note that the testing and adjustments performed in Japan are technical and complex. Finally, the assembly operations that occur in Japan are sufficiently complex and meaningful. Through the product assembly and testing and adjustment operations, the individual components and subassemblies of Japanese and foreign-origin are subsumed into a new and distinct article of commerce that has a new name, character, and use. Therefore, we find that the country of origin of the J-Models digital color multifunctional systems for purposes of U.S. Government procurement is Japan. *Holding:* Based on the facts of this case, we find that the processing in Japan substantially transforms the non-Japanese components. Therefore, the country of origin of the Sharp digital color multifunctional systems (Model Nos. MX-2300NJ and MX-2700NJ) is Japan for purposes of U.S. Government procurement. Notice of this final determination will be given in the **Federal Register** as required by 19 CFR 177.29. Any party-at-interest other than the party that requested this final determination may request, pursuant to 19 CFR 177.31, that CBP reexamine the matter anew and issue a new final determination. Any party-at-interest may, within 30 days after publication of the **Federal Register** notice reference above, seek judicial review of this final determination before the U.S. Court of International Trade. Sincerely, Sandra L. Bell, *Executive Director, Office of Regulations and Rulings, Office of International Trade.* [FR Doc. E7-3482 Filed 2-27-07; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [CIS No. 2394-06; DHS Docket No. USCIS-2006-0051] RIN 1615-ZA40 Special FOIA Processing Track for Individuals Appearing Before an Immigration Judge AGENCY: U.S. Citizenship and Immigration Services, DHS. ACTION: Notice. SUMMARY: U.S. Citizenship and Immigration Services (USCIS) is improving its processing of Freedom of Information Act

(FOIA)requests from the general public by establishing a third processing track for individuals appearing before an immigration court. Currently, a large portion of FOIA requests are submitted by individuals who have received a Notice To Appear for a hearing before an immigration judge or by such individuals' attorneys or representatives. By creating an additional processing track, USCIS will be able to provide the public with more expeditious service and to thereby improve customer satisfaction. DATES: This notice is effective March 30, 2007. FOR FURTHER INFORMATION CONTACT: Brian J. Welsh, Chief, Freedom of Information Act and Privacy Act, U.S. Citizenship and Immigration Services, Department of Homeland Security, P.O. Box 648010, Lee's Summit, Missouri 64064, *Phone:* 816-350-5785, *E-Mail:* *uscis.foia@dhs.gov .* SUPPLEMENTARY INFORMATION: Background: Under the Freedom of Information Act, 5 U.S.C. 552 (“FOIA”), the Privacy Act, 5 U.S.C. 552a, and the Department of Homeland Security's implementing regulations located at 6 CFR 5.5(b), the Secretary of Homeland Security may use two or more processing tracks for responding to FOIA requests. *Currently, USCIS has two tracks:* Track 1 is for less complex requests that can be processed in 20 working days or less. Track 2 is for complex requests that may require more than 20 working days to process and that include searching and line-by-line review of numerous pages of information. With this notice, USCIS will establish a third processing track, the “Notice To Appear” track, which will allow for accelerated access to the Alien-File (A-File) for those individuals who have been served with a charging document and have been scheduled for a hearing before an immigration judge as a result. The creation of this track is consistent with Executive Order 13392, “Improving Agency Disclosure of Information” (December 14, 2005), which requires Federal agencies to improve their FOIA processing. “Notice To Appear” track cases do not include cases in which the immigration judge has issued a final order or cases in which an appeal of an immigration judge's decision has been filed with the Board of Immigration Appeals (BIA). “Notice To Appear” track cases do not include cases in which the subject's date of scheduled hearing before the immigration judge has passed and current records indicate that the subject failed to appear for his/her scheduled hearing, resulting in closure of the removal/deportation proceedings by the immigration judge. An Alien-File or A-File is the series of records USCIS maintains on immigrants, certain non-immigrants, applicants for citizenship, certain individuals who have relinquished their United States citizenship, applicants for permanent residence or other immigration benefits, and individuals who have become subjects of immigration enforcement proceedings. The A-File documents the history of such people's interaction with USCIS or other components of the Department of Homeland Security

(DHS)in actions prescribed by the Immigration and Nationality Act

(INA)and related regulations. USCIS uses the information in an A-File to adjudicate requests for immigration-related benefits and to enforce U.S. immigration laws. Individuals may request access to their A-files by filing a FOIA request with Form G-639, Freedom of Information/Privacy Act Request, or by having their attorney or representative submit such a request along with a Form G-28, Notice of Entry of Appearance as Attorney or Representative, on their behalf. These forms can be found at *http://www.uscis.gov.* *A requester (including individuals, attorneys, or representatives) seeking to be placed in the queue must provide a copy of one of the following documents:* 1. Form I-862, Notice To Appear, documenting the scheduled date of the subject's hearing before the immigration judge; 2. Form I-122, Order To Show Cause, documenting the scheduled date of the subject's hearing before the immigration judge; 3. A written notice of continuation of a scheduled hearing before the immigration judge; or 4. Form I-863, Notice of Referral to Immigration Judge. After USCIS receives the request and validates it as a proper request, USCIS will place it in a queue of previously received requests of a similar nature. USCIS will take the requests in the order of receipt, as mandated by the FOIA and the applicable implementing DHS regulations at 6 CFR 5. USCIS will only accept requests for expedited processing for this queue if the requester has satisfied the requirements outlined in 6 CFR 5.5(d). All other FOIA requirements, as described in 6 CFR part 5, Disclosure of Records and Information, will apply. This notice does not affect those requests that do not fall in the above-described category. Dated: February 21, 2007. Emilio T. Gonzalez, Director, U.S. Citizenship and Immigration Services. [FR Doc. E7-3357 Filed 2-27-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Availability of Draft Comprehensive Conservation Plan and Environmental Impact Statement for Vieques National Wildlife Refuge AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability. SUMMARY: The Fish and Wildlife Service announces that a Draft Comprehensive Conservation Plan and Environmental Impact Statement (Draft CCP/EIS) for the Vieques National Wildlife Refuge is available for review and comment. This Draft CCP/EIS was prepared pursuant to the National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, and the National Environmental Policy Act of 1969. The Draft CCP/EIS describes how the Service intends to manage the refuge over the next 15 years. DATES: Written comments must be received at the postal address listed below no later than April 30, 2007. ADDRESSES: To provide written comments or to obtain a copy of the Draft CCP/EIS, please write to: Oscar Diaz, Refuge Manager, Vieques National Wildlife Refuge, P.O. Box 1527, Vieques, Puerto Rico 00765. A copy of the Draft CCP/EIS is also available on compact diskette. It can be accessed and downloaded at the following Internet address: *http://www.fws.gov/southeast/planning/* . A public meeting will be held at the Multiple Use Center (Centro de Usos Multiples) in Isabel Segunda, Vieques, Puerto Rico, to present the plan to the public. Special mailings, news media outlets, and posters will be avenues to inform the public of the date and time of the meeting. SUPPLEMENTARY INFORMATION: The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd-668ee) requires the Service to develop a comprehensive conservation plan for each refuge. The purpose in developing a plan is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife science, conservation, legal mandates, and Service policies. In addition to outlining broad management direction on conserving wildlife and their habitats, plans identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation and photography, and environmental education and interpretation. The Vieques National Wildlife Refuge was created from former Navy managed lands by congressional actions in 2001 and 2003. It consists of approximately 17,771 acres—3,100 acres on western Vieques and 14,671 acres on eastern Vieques. The transferred lands are to be managed in accordance with the Refuge Administration Act (as amended). The refuge lands were historically used for agricultural purposes and more recently for military training activities. As a result, the wildlife habitats and communities are significantly altered and non-native invasive species are common along with remnants of native habitats. As a result of the military training, portions of the refuge contain unexploded ordnance and other contaminants. These areas have been classified as a “superfund site” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Cleanup of these portions of the refuge is being conducted by the Navy in accordance with CERCLA. In addition, a Federal Facilities Agreement between the Navy, Environmental Protection Agency, Fish and Wildlife Service, and Commonwealth of Puerto Rico will help to guide the cleanup process. Although the short-term use and management of areas contaminated with unexploded ordnance would be restricted, the alternatives presented in this Draft Plan were developed with the assumption that these lands would be cleaned of any contaminants that would pose a threat to either wildlife or humans. Before the Service began the development of the Draft Plan, it hosted a series of public scoping meetings to solicit public opinion and identify issues that should be addressed. To address the existing habitat conditions, the ongoing cleanup activities, the issues identified by the public, and the mission and purpose of the refuge, the planning team developed a series of goals for the plan. The goals are:

(1)Conserve, enhance, and restore native plant communities and wetland habitats and their associated fish, wildlife, and plants, representative of the native biological diversity that would have been found on Vieques Refuge lands prior to major agricultural and military use of the lands;

(2)monitor, protect, and recover special status animals, plants, and species of management interest;

(3)provide opportunities for wildlife-dependent recreation and education to enhance public appreciation, understanding, and enjoyment of refuge wildlife, habitats, and cultural history;

(4)ensure, through the cooperative efforts of partners, that the refuge is cleaned of all classes of contaminants that could pose a threat to the health and safety of the wildlife, residents, staff, and visitors;

(5)provide the resources needed to implement the selected management alternative and ensure the other goals and objectives identified in the plan can be achieved; and

(6)develop effective and open communication with the community to raise public awareness of refuge programs, management decisions, the missions of the Fish and Wildlife Service and the National Wildlife Refuge System by working closely with Vieques citizens and interested groups and organizations. Based on these goals and information obtained during the scoping process, the plan offers three alternatives to help address the issues identified and achieve the vision of the Vieques National Wildlife Refuge. Alternative A (Current Management or No Action) The current management alternative provides for a continuation of the existing level of management. Staffing would remain at the current levels and ongoing programs and activities would continue with only minor changes and no new programs. Alternative B (Resource Emphasis) This alternative focuses on wildlife and habitat management but maintains the existing visitor programs and public uses. Habitat management and monitoring would be expanded and agreements with research, governmental, and non-governmental organizations would be developed to provide information needed for the management of forests, grasslands, coastal wetlands, beaches, and listed species and their habitats. In partnership with others, programs would be developed for management of nesting sea turtle populations on Vieques Refuge beaches. Alternative C (Habitat Management and Public Use Emphasis) (Proposed Alternative) This alternative directs the refuge toward a realistic and achievable level of both habitat management and public use and provides a management program that addresses the needs of the resources and, where appropriate and compatible with the refuge purposes, the needs of the community. This alternative provides for an increase in management efforts to restore the refuge habitats without diminishing the wildlife values associated with the current conditions. There is also a focus on management activities to benefit threatened and endangered species. This includes the possible reintroduction of species extirpated from Vieques and expansion of populations of species already found on the refuge. Priority public uses, as identified in the National Wildlife Refuge System Improvement Act of 1997, would be expanded and other uses that are determined to be compatible with the refuge mission may be permitted. Historic and archaeological resources would be stabilized and, where possible, interpretation of their significance and role in the evolution of Vieques Refuge would be provided. After the review and comment period for the Draft Plan and Environmental Impact Statement, all comments will be analyzed and considered by the Service. All comments become part of the official public record. Requests for such comments will be handled in accordance with the Freedom of Information Act and other Service and Departmental policies and procedures. FOR FURTHER INFORMATION CONTACT: Gisella Burgos; Telephone: 787/741-2138. Authority: This notice is published under the authority of the National Wildlife Refuge System Improvement Act of 1997, Public Law 105-57. Dated: November 21, 2006. Cynthia K. Dohner, Acting Regional Director. [FR Doc. E7-3478 Filed 2-27-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service National Wildlife Refuges, North Dakota AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent to prepare a comprehensive conservation plan and environmental assessment; request for comments. SUMMARY: We, the U.S. Fish and Wildlife Service (Service, we) intend to gather information necessary to prepare a comprehensive conservation plan

(CCP)and associated environmental documents for twelve

(12)National Wildlife Refuges

(NWRs)located in the State of North Dakota. The twelve

(12)NWRs are Stump Lake, Lake Alice, Kellys Slough, Audubon, Chase Lake, Lake Nettie, McLean, Lake Zahl, Shell Lake, White Lake, Lake Ilo, and Stewart Lake. We furnish this notice in compliance with our CCP policy to advise other agencies and the public of our intentions, and to obtain suggestions and information on the scope of issues to be considered in the planning process. DATES: To ensure consideration, we must receive your written comments by March 30, 2007. ADDRESSES: Send your comments or requests for more information to John Esperance, Planning Team Leader, Division of Refuge Planning, P.O. Box 25486, Denver Federal Center, Denver, CO 80225. FOR FURTHER INFORMATION CONTACT: John Esperance, 303-236-4369, or Michael Spratt, 303-236-4366. SUPPLEMENTARY INFORMATION: With this notice, the Service initiates a CCP for twelve

(12)NWRs in various locations throughout the State of North Dakota. Background The CCP Process The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd-668ee), requires the Service to develop a CCP for each NWR. The purpose in developing a CCP is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and Service policies. In addition to outlining broad management direction on conserving wildlife and their habitats, plans identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation, wildlife photography, and environmental education and interpretation. The Service established each unit of the National Wildlife Refuge System, including these twelve

(12)NWRs, with specific purposes. We use these purposes to develop and prioritize management goals and objectives within the National Wildlife Refuge System mission, and to guide which public uses will occur on these NWRs. The planning process is a way for the Service and the public to evaluate management goals and objectives for the best possible conservation efforts of this important wildlife habitat, while providing for wildlife-dependent recreation opportunities that are compatible with each NWR and the mission of the National Wildlife Refuge System. The Service will conduct a comprehensive conservation planning process that will provide opportunity for Tribal, State, and local governments; agencies; organizations; and the public to participate in issue scoping and public comment. We request input for issues, concerns, ideas, and suggestions for the future management of these NWRs in North Dakota. We invite anyone interested to respond to the following two questions.

(1)What problems or issues do you want to see addressed in the CCP?

(2)What improvements would you recommend for these twelve

(12)NWRs? We have provided the above questions for your optional use; you are not required to provide information to us. The planning team developed these questions to gather information about individual issues and ideas concerning these NWRs. Our planning team will use the comments it receives as part of the planning process; however, we will not reference individual comments in our reports or directly respond to them. We will also give the public an opportunity to provide input at an open house to scope issues and concerns. You can obtain the schedule from the Planning Team Leaders (see ADDRESSES ). You may also submit comments anytime during the planning process by writing to the above addresses. All information provided voluntarily by mail, phone, or at public meetings becomes part of our official public record (i.e., names, addresses, letters of comment, input recorded during meetings). If a private citizen or organization requests this information under the Freedom of Information Act, we may provide informational copies. The Service will conduct the environmental review of this project in accordance with the requirements of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 *et seq.* ); NEPA Regulations (40 CFR parts 1500-1508); other appropriate Federal laws and regulations; and our policies and procedures for compliance with those regulations. All comments we receive from individuals on our environmental assessments and environmental impact statements become part of the official public record. We will handle requests for such comments in accordance with the Freedom of Information Act, NEPA (40 CFR 1506.6(f)), and other Departmental and Service policies and procedures. When we receive a request, we generally will provide comment letters with the names and addresses of the individuals who wrote the comments. However, to the extent permissible by law, we will not provide the telephone number of the commenting individual in response to such requests. North Dakota NWRs These twelve

(12)NWRs were established for the protection of critical migratory waterfowl habitat within the State of North Dakota. Through these NWRs, the Service manages a complex of wetlands in 34 counties within North Dakota. The wetlands range from seasonal shallow basins to deeper, more permanent ponds that provide resting and feeding areas for millions of birds during Spring and Fall migration. Dated: January 30, 2007. James J. Slack, Deputy Regional Director, Region 6, Denver, Colorado. [FR Doc. E7-3463 Filed 2-27-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Wetland Management Districts, North Dakota AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent to prepare a comprehensive conservation plan and environmental assessment; request for comments. SUMMARY: We, the U.S. Fish and Wildlife Service (Service, we) intend to gather information necessary to prepare a comprehensive conservation plan

(CCP)and associated environmental documents for nine

(9)Wetland Management Districts

(WMDs)located in the State of North Dakota. The nine

(9)WMDs are Devils Lake, Arrowwood, Valley City, Chase Lake, Kulm, Audubon, J. Clark Salyer, Lostwood and Crosby. We furnish this notice in compliance with our CCP policy to advise other agencies and the public of our intentions, and to obtain suggestions and information on the scope of issues to be considered in the planning process. DATES: To ensure consideration, we must receive your written comments by March 30, 2007. ADDRESSES: Send your comments or requests for more information to John Esperance, Planning Team Leader, Division of Refuge Planning, P.O. Box 25486, Denver Federal Center, Denver, CO 80225. FOR FURTHER INFORMATION CONTACT: John Esperance, 303-236-4369, or Michael Spratt, 303-236-4366. SUPPLEMENTARY INFORMATION: With this notice, the Service initiates a CCP for nine

(9)WMDs in various locations throughout the State of North Dakota. Background The CCP Process The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd-668ee), requires the Service to develop a CCP for each national wildlife refuge. The purpose in developing a CCP is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and Service policies. In addition to outlining broad management direction on conserving wildlife and their habitats, plans identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation, wildlife photography, and environmental education and interpretation. The Service established each unit of the National Wildlife Refuge System, including these nine

(9)WMDs, with specific purposes. We use these purposes to develop and prioritize management goals and objectives within the National Wildlife Refuge System mission, and to guide which public uses will occur on these WMDs. The planning process is a way for the Service and the public to evaluate management goals and objectives for the best possible conservation efforts of this important wildlife habitat, while providing for wildlife-dependent recreation opportunities that are compatible with each WMD and the mission of the National Wildlife Refuge System. The Service will conduct a comprehensive conservation planning process that will provide opportunity for Tribal, State, and local governments; agencies; organizations; and the public to participate in issue scoping and public comment. We request input for issues, concerns, ideas, and suggestions for the future management of these WMDs in North Dakota. We invite anyone interested to respond to the following two questions.

(1)What problems or issues do you want to see addressed in the CCP?

(2)What improvements would you recommend for these nine

(9)WMDs? We have provided the above questions for your optional use; you are not required to provide information to us. The planning team developed these questions to gather information about individual issues and ideas concerning these WMDs. Our planning team will use the comments it receives as part of the planning process; however, we will not reference individual comments in our reports or directly respond to them. We will also give the public an opportunity to provide input at an open house to scope issues and concerns. You can obtain the schedule from the Planning Team Leaders (see ADDRESSES ). You may also submit comments anytime during the planning process by writing to the above addresses. All information provided voluntarily by mail, phone, or at public meetings becomes part of our official public record (i.e., names, addresses, letters of comment, input recorded during meetings). If a private citizen or organization requests this information under the Freedom of Information Act, we may provide informational copies. The Service will conduct the environmental review of this project in accordance with the requirements of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 *et seq.* ); NEPA Regulations (40 CFR parts 1500-1508); other appropriate Federal laws and regulations; and our policies and procedures for compliance with those regulations. All comments we receive from individuals on our environmental assessments and environmental impact statements become part of the official public record. We will handle requests for such comments in accordance with the Freedom of Information Act, NEPA (40 CFR 1506.6(f)), and other Departmental and Service policies and procedures. When we receive a request, we generally will provide comment letters with the names and addresses of the individuals who wrote the comments. However, to the extent permissible by law, we will not provide the telephone number of the commenting individual in response to such requests. North Dakota WMDs These nine

(9)WMDs were established for the protection of critical migratory waterfowl habitat within the State of North Dakota. Through these WMDs, the Service manages a complex of wetlands in 34 counties within North Dakota. The wetlands range from seasonal shallow basins to deeper, more permanent ponds that provide resting and feeding areas for millions of birds during Spring and Fall migration. Dated: January 30, 2007. James J. Slack, Deputy Regional Director, Region 6, Denver, Colorado. [FR Doc. E7-3466 Filed 2-27-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Loan Guaranty, Insurance and Interest Subsidy Program AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice of Submission of Information Collection to the Office of Management and Budget. SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs

(BIA)is submitting the information collection, titled 25 CFR 103, Loan Guaranty, Insurance, and Interest Subsidy Program, OMB Control Number 1076-0020 for renewal. DATES: Submit comments on or before March 30, 2007. ADDRESSES: You may submit comments on the information collection to the Desk Officer for Department of the Interior, by facsimile at

(202)395-6566 or you may send an e-mail to: *OIRA_DOCKET@ omb.eop.gov.* Please send a copy of your comments to David Johnson, Acting Director, Division of Capital Investment, Office of Indian Energy and Economic Development, Department of the Interior, 1951 Constitution Avenue, NW., Mail Stop 20-SIB, Washington, DC 20240. FOR FURTHER INFORMATION CONTACT: You may request further information or obtain copies of the information collection request submission from Woodrow B. Sneed, Financial Analyst, Division of Capital Investment, 1951 Constitution Avenue, NW., Mail Stop 20-SIB, Washington, DC 20240 or by telefacsimile at

(202)208-6512. SUPPLEMENTARY INFORMATION: The purpose of the Loan Guaranty, Insurance, and Interest Subsidy Program, 25 U.S.C. 1481 *et seq.* and 25 U.S.C. 1511 *et seq.* , is to encourage private lending to individual Indians and organizations of Indians, by providing lenders with loan guaranties or loan insurance to reduce their potential risk. Lenders, borrowers, and the loan purpose all must qualify under Program terms. In addition, the Secretary of the Interior must be satisfied that there is a reasonable prospect that the loan will be repaid. BIA collects information under the regulations, 25 CFR 103, to assure compliance with Program requirements. BIA forms concerned with this regulation include: 5-4753 Loan Guaranty Agreement, 5-4754 Loan Insurance Agreement, 5-4754a Notice of Insured Loan, 5-4755 Request to BIA for Loan Guaranty, Loan Insurance, and/or Interest Subsidy, 5-4749 BIA Interest Subsidy Report, 5-4759 Assignment of Loan Documents and Related Rights, 5-4760a Notice of Default, and 5-4760b Claim for Loss. A request for comments on this information collection request appeared in the **Federal Register** on November 24, 2006 (71 FR 67895). No comments were received. Request for Comments The Office of Indian Energy and Economic Development requests you to send your comments on this collection to the two locations listed in the ADDRESSES section. Your comments should address:

(a)The necessity of this information collection for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b)the accuracy of the agency's estimate of the burden (hours and cost) of the collection of information, including the validity of the methodology and assumptions used;

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

(d)ways we could minimize the burden of the collection of the information on the respondents, such as through the use of automated collection techniques or other forms of information technology. Please note that an agency may not sponsor or request, and an individual need not respond to, a collection of information unless it displays a valid OMB Control Number. Once this notice is published in the **Federal Register** , OMB has up to 60 days to make a decision on approving this collection but may decide after 30 days; therefore, your comments will receive maximum attention if sent within the 30 day period. *OMB Approval Number:* 1076-0020. *Title:* 25 CFR 103, Loan Guaranty, Insurance, and Interest Subsidy Program. *Brief Description of Collection:* The Loan Guaranty, Insurance, and Interest Subsidy Program (Program) was established by the Act of April 12, 1974, as amended, 88 Stat. 79, 25 U.S.C. 1481 *et seq.* and 25 U.S.C. 1511 *et seq.* The Program has existed since 1974 and the regulations implementing it have existed since 1975, with significant revision in 2001. It is necessary to collect information from users of this program in order to determine eligibility and credit worthiness of Indian applicants for loans. Submission of this information is mandatory for respondent to receive or maintain a benefit. *Type of Review:* Renewal. *Respondents:* Commercial banks. *Number of Respondents:* 612. *Number of Responses:* 1,527. *Estimated Time per Response:* 2 hours. *Frequency of Response:* As needed. *Total Annual Burden to Respondents:* 3,054. Dated: February 23, 2007. Debbie L. Clark, Deputy Assistant Secretary—Indian Affairs (Management). [FR Doc. 07-920 Filed 2-26-07; 12:05 pm]

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