Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

Code · REGISTER · 2008-02-14 · Department of Health and Human Services, Office of Public Health and Science, The President's Council on Bioethics · Notices

Notices. Notice

7,808 words·~35 min read·/register/2008/02/14/08-678

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

BILLING CODE 1610-02-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Meeting of the President's Council on Bioethics AGENCY: Department of Health and Human Services, Office of Public Health and Science, The President's Council on Bioethics. ACTION: Notice. SUMMARY: The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-second meeting, at which it will discuss and hear presentations on
(1)newborn screening and
(2)the problems of cost, access, and quality in American health care. The Council will also unveil its most recent publication, *Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics.* Subjects discussed at past Council meetings (although not on the agenda for the March 2008 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, and lifespan-extension. Publications issued by the Council to date include: *Human Cloning and Human Dignity: An Ethical Inquiry* (July 2002); *Beyond Therapy: Biotechnology and the Pursuit of Happiness* (October 2003); *Being Human: Readings from the President's Council on Bioethics* (December 2003); *Monitoring Stem Cell Research* (January 2004), *Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004)* , *Alternative Sources of Human Pluripotent Stem Cells: A White Paper* (May 2005), *Taking Care: Ethical Caregiving in Our Aging Society* (September 2005), and *Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics* (March 2008). Reports on
(a)controversies in the determination of death, and
(b)organ procurement, transplantation, and allocation are forthcoming. DATES: The meeting will take place Thursday, March 6, 2008, from 9 a.m. to 5 p.m., ET; and Friday, March 7, 2008, from 8:30 a.m. to 12 noon, ET. ADDRESSES: Hotel Palomar Arlington, 1121 North 19th Street, Arlington, VA 22209. Phone 703-351-9170. FOR FURTHER INFORMATION CONTACT: Ms. Diane M. Gianelli, Director of Communications, The President's Council on Bioethics, 1425 New York Avenue, NW., Suite C100, Washington, DC 20005. *Telephone:* 202/296-4669. E-mail: *info@bioethics.gov.* Web site: *http://www.bioethics.gov.* SUPPLEMENTARY INFORMATION: The meeting agenda will be posted at *http://www.bioethics.gov.* The Council encourages public input, either in person or in writing. At this meeting, interested members of the public may address the Council, beginning at 11:45 am, on Friday, March 7. Comments are limited to no more than five minutes per speaker or organization. As a courtesy, please inform Ms. Diane M. Gianelli, Director of Communications, in advance of your intention to make a public statement, and give your name and affiliation. To submit a written statement, mail or e-mail it to Ms. Gianelli at one of her contact addresses given above. Dated: February 1, 2008. F. Daniel Davis, Executive Director, The President's Council on Bioethics. [FR Doc. E8-2779 Filed 2-13-08; 8:45 am] BILLING CODE 4154-06-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Council for the Elimination of Tuberculosis
(ACET)In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned committee: *Times and Dates:* 8:30 a.m.-5 p.m., March 26, 2008; 8:30 a.m.-2 p.m., March 27, 2008. *Place:* Corporate Square, Building 8, 1st Floor Conference Room, Atlanta, Georgia 30333, Telephone:
(404)639-8317. *Status:* Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. *Purpose:* This council advises and makes recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis. Specifically, the Council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating tuberculosis. *Matters To Be Discussed:* Agenda items include issues pertaining to Lessons Learned: Potential for Transmission of Tuberculosis during Air Travel; Tuberculosis as a Cause of Death; and Update on Nucleic Acid Amplification Testing and Second Line Drug Susceptibility Guidelines and other related tuberculosis issues. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Margie Scott-Cseh, Coordinating Center for Infectious Diseases, Strategic Business Unit, 1600 Clifton Road, NE., M/S E-07, Atlanta, Georgia 30333, Telephone:
(404)639-8317. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** Notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: February 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. E8-2796 Filed 2-13-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC) In accordance with section 10(a)(2)of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned committee: *Times and Dates:* 8:30 a.m.-5p.m., March 4, 2008. 8:30 a.m.-1p.m., March 5, 2008. *Place:* Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Tom Harkin Global Community Center, Building 19, Atlanta, Georgia 30333, Telephone:
(404)639-1717. *Status:* Open to the public, limited only by the space available. *Purpose:* The committee is charged with advising the Secretary, Department of Health and Human Services, and the Director, CDC, regarding the early detection and control of breast and cervical cancer. The committee makes recommendations regarding national program goals and objectives; implementation strategies; and program priorities including surveillance, epidemiologic investigations, education and training, information dissemination, professional interactions and collaborations, and policy. *Matters To Be Discussed:* The agenda will include a review and discussion of the National Breast and Cervical Cancer Early Detection Program components; and related policies and emerging issues. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Debra Younginer, Executive Secretary, BCCEDCAC, Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop K-57, Chamblee, Georgia 30316, Telephone:
(770)488-1074. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: February 6, 2008. Elaine L. Baker, Director, Management Analysis and Service Office, Centers for Disease Control and Prevention (CDC). [FR Doc. E8-2795 Filed 2-13-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Monitoring and Evaluation of Malaria Activities in the Greater Mekong Sub-Region, Request for Applications
(RFA)CK08-003 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the aforementioned meeting. *Time and Date:* 12 p.m.-2 p.m., March 13, 2008 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)
(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “Monitoring and Evaluation of Malaria Activities in the Greater Mekong Sub-Region, RFA CK08-003.” *Contact Person For More Information:* Christine Morrison, PhD, Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone:
(404)639-3098. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: February 7, 2008. Elaine L. Baker Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-2793 Filed 2-13-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Natural History and Prevention of Viral Hepatitis Among Alaska Natives, Request for Applications
(RFA)PS08-004 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the aforementioned meeting. *Time and Date:* 12 p.m.-4 p.m., March 24, 2008 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)
(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “Natural History and Prevention of Viral Hepatitis Among Alaska Natives, RFA PS08-004.” *Contact Person for More Information:* Shree Marshall Williams, PhD, M.Sc., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone:
(404)639-4896. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: February 8, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-2799 Filed 2-13-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Office of the Director, Office of Strategy and Innovation, Office of Minority Health and Health Disparities In accordance with Presidential Executive Order No. 13175, November 6, 2000, and the Presidential Memorandum of September 23, 2004, Consultation and Coordination with Indian Tribal Governments, the CDC announces the following meeting: *Name:* Tribal Consultation Advisory Committee
(TCAC)Meeting, An Overview and Orientation to CDC, and the Biannual Tribal Consultation Session. *Times and Dates:* 8 a.m.-5:30 p.m., February 26, 2008; TCAC Meeting. 8 a.m.-5:30 p.m., February 27, 2008; An Overview and Orientation to CDC. 8 a.m.-5:30 p.m., February 28, 2008; Biannual Tribal Consultation Session. *Place* : Centers for Disease Control (CDC), 1600 Clifton Road NE, Atlanta, GA 30333, Telephone: 404-498-2343. Roybal Campus—Building 19, Room 206 Auditorium A. *Status:* Open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. *Purpose:* CDC established the Tribal Consultation Policy in October of 2005 with the primary purpose of providing guidance across the agency to work effectively with American Indian/Alaska Native (AI/AN) communities and organizations to enhance AI/AN access to CDC programs. In October of 2005, an Agency Advisory Committee (CDC/ATSDR Tribal Consultation Advisory Committee—TCAC) was established to provide a complementary venue wherein tribal representatives and CDC staff will exchange information about public health issues in Indian Country, identifying urgent public health issues in Indian country, and discuss collaborative approaches to these issues. Within the CDC Consultation Policy, it is stated that CDC will conduct Government-to-government consultation with elected tribal officials or their designated representatives and also confer with tribal and Alaska Native organizations and AI/AN urban and rural communities before taking actions and/or making decisions that affect them. Consultation is an enhanced form of communication that emphasizes trust, respect, and shared responsibility. It is an open and free exchange of information and opinion among parties that leads to mutual understanding and comprehension. CDC believes that consultation is integral to a deliberative process that results in effective collaboration and informed decision making with the ultimate goal of reaching consensus on issues. Although formal responsibility for the agency's overall Government-to-government consultation activities rests within the Office of the Director, Coordinating Centers and Coordinating Offices, and center leadership shall actively participate in TCAC meetings and HHS-sponsored regional and national tribal consultation sessions as frequently as possible. *Matters To Be Discussed:* The TCAC will convene their quarterly committee meeting with discussions and presentations from various CDC senior leadership on activities and areas identified by tribal leaders as priority public health issues. The Tribal Leaders Orientation Agenda has been established in response to tribal leaders' request to learn more about the CDC and its potential resources available. The Biannual Tribal Consultation Session will engage CDC Senior leadership from the Office of the Director and various CDC Offices and National Centers including the Financial Management Office, National Center for Environmental Health and the Agency for Toxic Substances, Coordinating Office for Terrorism and Preparedness and Emergency Response, National Center for Health Marketing, the Office of Chief of Public Health Practice, and the Office of Enterprise Communications. Opportunities will be provided during the Consultation Session for tribal testimony. Tribal Leaders are encouraged to submit written testimony by COB on February 8, 2008 to the contact person below. Depending on the time available it may be necessary to limit the time of each presenter. Please reference this web link *http://www.cdc.gov/omhd/TCAC/AAC.html* to review information about the TCAC and CDC's tribal Consultation Policy. *For Further Information Contact:* CAPT Pelagie
(Mike)Snesrud, Senior Tribal Liaison for Policy and Evaluation, Office of Minority Health and Health Disparities, 1600 Clifton Road NE., MS E-67, Atlanta, Georgia 30333, telephone
(404)498-2343, fax
(404)498-2355, e-mail: *pws8@cdc.gov.* The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both the CDC and Agency for Toxic Substances and Disease Registry. Dated: February 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-2789 Filed 2-13-08; 8:45 am] BILLING CODE 4160-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; comment request; The REDS-II Donor Iron Status Evaluation
(RISE)Study SUMMARY: In compliance with the requirement of Section 3506(c)
(A)of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget
(OMB)for review and approval. PROPOSED COLLECTION: *Title:* The REDS-II Donor Iron Status Evaluation
(RISE)Study. *Type of Information Collection Request:* Revisions due to program adjustments. *Need and Use of Information Collection:* Although the overall health significance of iron depletion in blood donors is uncertain, iron depletion leading to iron deficient erythropoiesis and lowered hemoglobin levels results in donor deferral and, occasionally, in mild iron deficiency anemia. Hemoglobin deferrals represent more than half of all donor deferral, deferring 16% of women. Several cross sectional studies of blood donors, using older measures of iron status in blood donors have indicated that female sex, frequent donation and not taking iron supplements are predictors of iron depletion. However, none of these studies have included racial/ethnic, anthropomorphic, or behavioral factors and none have evaluated the impact of newly discovered iron protein polymorphisms. The RISE Study is a longitudinal study of iron status in two cohorts of blood donors: A first time/reactivated donor cohort in which baseline iron and hemoglobin status can be assessed without the influence of previous donations, and a frequent donor cohort, where the cumulative effect of additional frequent blood donations can be assessed. Each cohort's donors will donate blood and provide evaluation samples during the study period. The primary goal of the study is to evaluate the effects of blood donation intensity on iron and hemoglobin status and assess how these are modified as a function of baseline iron/hemoglobin measures, demographic factors, and reproductive and behavioral factors. Hemoglobin levels, a panel of iron protein, red cell and reticulocyte indices will be measured at baseline and at a final follow-up visit 15-24 months after the baseline visit. A DNA sample will be obtained once at the baseline visit to assess three key iron protein polymorphisms. Donors will also complete a self-administered survey assessing past blood donation, smoking history, use of vitamin/mineral supplements, iron supplements, aspirin, frequency of heme rich food intake, and, for females, menstrual status and pregnancy history at these two time points. This study aims to identify the optimal laboratory measures that would predict the development of iron depletion, hemoglobin deferral, and/or iron deficient hemoglobin deferral in active whole blood and double red cell donors at subsequent blood donations. The data collected will help evaluate hemoglobin distributions in the blood donor population (eligible and deferred donors) and compare them with NHANES data. Other secondary objectives include elucidating key genetic influences on hemoglobin levels and iron status in a donor population as a function of donation history; and establishing a serum and DNA archive to evaluate the potential utility of future iron studies and genetic polymorphisms. This study will develop better predictive models for iron depletion and hemoglobin deferral (with or without iron deficiency) in blood donors; allow for the development of improved donor screening strategies and open the possibility for customized donation frequency guidelines for individuals or classes of donors; provide important baseline information for the design of targeted iron supplementation strategies in blood donors, and improved counseling messages to blood donors regarding diet or supplements; and by elucidating the effect of genetic iron protein polymorphisms on the development of iron depletion, enhance the understanding of the role of these proteins in states of iron stress, using frequent blood donation as a model. *Frequency of Response:* Twice. *Affected Public:* Individuals. *Type of Respondents:* Adult Blood Donors. The annual reporting burden is a follows: *Estimated Number of Respondents:* Baseline visit: 2,340, Follow up Visit: 1,530; *Estimated Number of Responses per Respondent:* 1; *Average Burden of Hours per Response:* Baseline Visit: 0.37, Follow up Visit: 0.17; and *Estimated Total Annual Burden Hours Requested:* Baseline visit: 866, Follow up Visit: 260. The annualized cost to respondents is estimated at: Baseline Visit: $15,588, Follow up Visit: $4,680 (based on $18 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Blood donors at Baseline Visit 2,340 1 0.37 866 Blood donors at Follow-up Visit 1,530 1 0.17 260 Total 1,126 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address one or more of the following points:
(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, 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 the assumptions used;
(3)Ways to enhance the quality, utility, and clarity of the information 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. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two Rockledge Center, Suite 10042, 6701 Rockledge Drive, Bethesda, MD 20892-7950, or call 301-435-0075, or E-mail your request to *nemog@nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: February 4, 2008. George Nemo, NHLBI Project Officer, NHLBI, National Institutes of Health. [FR Doc. E8-2748 Filed 2-13-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Cooperative Research and Development Agreement (CRADA) Opportunity With the National Heart Lung and Blood Institute and Licensing Opportunity for Development of Multi-Domain Amphipathic Helical Peptides for the Treatment of Cardiovascular Disease AGENCY: National Institutes of Health, PHS, HHS. ACTION: Notice. SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended, and in accordance with 35 U.S.C. 207 and 37 CFR Part 404, the National Institutes of Health
(NIH)of the Public Health Service
(PHS)of the Department of Health and Human Services
(HHS)seeks a Cooperative Research and Development Agreement (CRADA) and/or license(s) with a pharmaceutical or biotechnology company to develop and commercialize amphipathic helical peptides potentially useful for the treatment and prevention of cardiovascular disease. The CRADA would have an expected duration of one
(1)to five
(5)years. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, methods of treatment or prevention that may result from the research. The CRADA Collaborator will have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA defined by the CRADA Research Plan, subject to any pre-existing licenses already issued for other fields of use, and can apply for background licenses to the existing patent applications encompassed within HHS Reference Nos. E-114-2004/0-US-01 (United States Patent Application Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and Methods of Their Use. DATES: Inquiries regarding CRADA proposals and scientific matters may be forwarded at any time. Confidential preliminary CRADA proposals, preferably two pages or less, must be submitted to the NHLBI on or before April 14, 2008. Guidelines for preparing final CRADA proposals will be communicated shortly thereafter to all respondents with whom initial confidential discussions will have established sufficient mutual interest. There is no deadline by which license applications must be received by the Office Technology Transfer however applicants are encouraged to respond on or before April 14, 2008. This notice replaces that published in the **Federal Register** on May 11, 2005 (70 FR 24832). ADDRESSES: Proposals and questions about this CRADA opportunity may be addressed to Dr. Denise Crooks, Office of Technology Transfer and Development, NHLBI 6705 Rockledge Drive, MSC 7992, Bethesda, MD 20892 (phone: 301-402-5579, Fax: 391-594-3080, E-mail: *Crooksd@nhlbi.nih.gov* ). Scientific Inquiries should be directed to Dr. Alan T. Remaley, NHLBI, 10 Center Drive, Building 10, Room 2C-433, MSC 1508, Bethesda, MD 20892 (phone: 301-402-9796; fax: 301-402-1885; E-mail: *aremaley1@cc.nih.gov* ). Licensing inquiries and requests for license application should be directed to Ms. Fatima Sayyid, Technology Licensing Specialist, Office of Technology Transfer, NIH, 6011 Executive Blvd., Suite 325, Rockville, MD, 20852 (phone: 301-435-4521, Fax: 301-402-0220, E-mail: *Fatima.Sayyid@nih.hhs.gov* ). SUPPLEMENTARY INFORMATION: Technology Available HHS scientists within the Lipoprotein Metabolism Section (LMS), NHLBI, have discovered a novel class of non-hemolytic amphipathic synthetic peptides that are specific for effluxing excess cellular cholesterol by the ABCA1 transporter. These agents have been shown to significantly inhibit the progression of atherosclerosis in a mouse model of cardiovascular disease. Details are noted in HHS Reference #s E-114-2004/0-US-01 (United States Patent Application Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and Methods of Their Use. They are available for review under an appropriate Confidential Disclosure Agreement. Technology Sought Accordingly, HHS now seeks collaborative arrangements to provide more extensive biological and pharmacological evaluation of both current and any new amphipathic peptides that are being developed within the Lipoprotein Metabolism Section of NHLBI. The ultimate purpose of the collaboration would be to advance the most promising agents into clinical trials for the prevention and regression of cardiovascular disease. For collaboration with the private sector, a Cooperative Research and Development Agreement (CRADA) will be established to provide for equitable distribution of intellectual property rights developed under the collaboration. CRADA aims will include rapid publication of research results as well as full and timely exploitation of commercial opportunities. NHLBI and Collaborator Responsibilities The role of LMS, NHLBI in this CRADA may include, but not be limited to: 1. Providing intellectual, scientific, and technical expertise and experience to the research project. 2. Perform in conjunction with Collaborator *in vitro* studies to identify novel peptides. 3. Perform in conjunction with Collaborator animal studies on peptides with anti-atherosclerotic properties. 4. Provide the Collaborator with sequences of any novel peptides for future pharmaceutical development. 5. Planning and conducting research and clinical studies and interpreting research results. 6. Publishing research results. The role of the CRADA Collaborator may include, but not be limited to: 1. Providing significant intellectual, scientific, and technical expertise or experience to the research project. 2. Planning scientific and clinical research studies and interpreting research results. 3. Providing some financial support for CRADA-related research as outlined in the CRADA Research Plan. 4. Publishing research results. Selection criteria for choosing the CRADA Collaborator may include, but not be limited to: 1. The ability to collaborate with NHLBI on further research and development of this technology. This ability can be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to on-going research and development. 2. Expertise and experience in the following areas: Peptide design and synthesis, performance of preclinical studies including animal model studies of atherosclerosis, animal toxicology studies, knowledge of GMP grade production and scale up and lipid reconstitution of synthetic peptides, and design, U.S. Food and Drug Administration regulatory filings, and performance of clinical trials. The demonstration of adequate resources to perform the research, development and commercialization of this technology (e.g. facilities, personnel, expertise and funds) and accomplish objectives according to an appropriate timetable to be outlined in the CRADA Collaborators proposal. 3. The willingness to commit best efforts and demonstrated resources to the research, development and commercialization of this technology. 4. The demonstration of expertise in the commercial development, production, marketing and sales of products related to this area of technology. 5. The willingness to cooperate with the National Heart Lung and Blood Institute in the timely publication of research results. 6. The willingness to accept the legal provisions and language of the CRADA with only minor modifications, if any. These provisions govern the equitable distribution of patent rights to CRADA inventions. Generally, the rights of ownership are retained by the organization that is the employer of the inventor, with
(1)the grant of a license for research and other Government purposes to the Government when the CRADA Collaborator's employee is the sole inventor, or
(2)the grant of an option to elect an exclusive or non-exclusive license to the CRADA Collaborator when the Government employee is the sole or joint inventor. Dated: February 7, 2008. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-2750 Filed 2-13-08; 8:45 am] BILLING CODE 4140-01-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. Use of Amyloid Proteins as Vaccine Scaffolds *Description of Technology:* Amyloid proteins are composed of peptides whose chemical properties are such that they spontaneously aggregate *in vitro* or *in vivo* , assuming parallel or antiparallel beta sheet configurations. Amyloid proteins can arise from peptides which, though differing in primary amino acid sequences, assume the same tertiary and quaternary structures. The amyloid structure presents a regular array of accessible N-termini of the peptide molecules. Claimed in this application are compositions and methods for use of amyloid proteins as vaccine scaffolds, on which peptide determinants from microorganisms or tumors may be presented to more efficiently generate and produce a sustained neutralizing antibody response to prevent infectious diseases or treat tumors. The inventors have arrayed peptides to be optimally immunogenic on the amyloid protein scaffold by presenting antigen using three different approaches. First, the N-terminal ends of the amyloid forming peptides can be directly modified with the peptide antigen of interest; second, the N-termini of the amyloid forming peptides are modified with a linker to which the peptide antigens of interest are linked; and third, the scaffold amyloid may be modified to create a chimeric molecule. Aside from stability and enhanced immunogenicity, the major advantages of this approach are the synthetic nature of the vaccine and its low cost. Thus, concerns regarding contamination of vaccines produced from cellular substrates, as are currently employed for some vaccines, are eliminated; the robust stability allows the amyloid based vaccine to be stored at room temperature for prolonged periods of time; and the inexpensive synthetic amino acid starting materials, and their rapid spontaneous aggregation *in vitro* should provide substantial cost savings over the resource and labor-intensive current vaccine production platforms. *Application:* Immunization to prevent infectious diseases or treat chronic conditions or cancer. *Developmental Status:* Vaccine candidates have been synthesized and preclinical studies have been performed. *Inventors:* Amy Rosenberg (CDER/FDA), James E. Keller (CBER/FDA), Robert Tycko (NIDDK). *Patent Status:* U.S. Provisional Application No. 60/922,131 filed 06 Apr 2007 (HHS Reference No. E-106-2007/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, JD; 301-435-4646; *soukasp@mail.nih.gov* . *Collaborative Research Opportunity:* The FDA, Division of Therapeutic Proteins
(CDER)and Office of Vaccines, Division of Bacterial Products
(CBER)is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize amyloid based vaccines for prevention of infectious disease or treatment of malignant states. Please contact Amy Rosenberg at *amy.rosenberg@fda.hhs.gov* or
(301)827-1794 for more information. Inhibiting HIV Infection Using Integrin Antagonists *Description of Technology:* Infection with HIV depletes and impairs CD4 cells, a key component of the immune system. Effective therapies such as highly active antiretroviral therapy (HAART) have focused on preserving CD4 cells. However, long term HAART has significant toxicity associated with it. The current technology describes the use of integrin antagonists as an alternative to treating or preventing HIV infection and replication. Specifically, α4 integrin plays a role in directing lymphocytes to the primary site of HIV replication. Inhibition of the interaction of α4β1 or α4β7 with gp120 can therefore be important in the development of effective HIV treatments. *Applications:* Inhibiting HIV infection; Inhibiting HIV replication. *Development Status:* *In vitro* data. *Inventors:* James Arthos, Diana Goode, Claudia Cicala, and Anthony Fauci (NIAID). *Patent Status:* U.S. Patent Application No. 60/873,884 filed 07 Dec 2006 (HHS Reference No. E-055-2007/0-US-01) U.S. Patent Application No. 60/920,880 filed 03 Mar 2007 (HHS Reference No. E-055-2007/1-US-01) U.S. Patent Application No. 60/957,140 filed 21 Aug 2007 (HHS Reference No. E-055-2007/2-US-01) PCT Patent Application No. PCT/US2007/086663 filed 06 Dec 2007 (HHS Reference No. E-055-2007/3-PCT-01) *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Susan Ano, PhD; 301-435-5515; *anos@mail.nih.gov* . *Collaborative Research Opportunity:* The NIAID Laboratory of Immunoregulation is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Dr. James Arthos at 301-435-2374 for more information. Coacervate Microparticles Useful for the Sustained Release Administration of Therapeutics Agents *Description of Technology:* The described technology is a biodegradable microbead or microparticle, useful for the sustained localized delivery of biologically active proteins or other molecules of pharmaceutical interest. The microbeads are produced from several USP grade materials, a cationic polymer, an anionic polymer and a binding component (e.g., gelatin, chondroitin sulfate and avidin), in predetermined ratios. Biologically active proteins are incorporated into preformed microbeads via an introduced binding moiety under nondenaturing conditions. Proteins or other biologically active molecules are easily denatured, and once introduced into the body, rapidly cleared. These problems are circumvented by first incorporating the protein into the microbead. Microbeads with protein payloads are then introduced into the tissue of interest, where the microbeads remain while degrading into biologically innocuous materials while delivering the protein/drug payload for adjustable periods of time ranging from hours to weeks. This technology is an improvement of the microbead technology described in U.S. Patent No. 5,759,582. *Applications:* This technology has two commercial applications. The first is a pharmaceutical drug delivery application. The bead allows the incorporated protein or drug to be delivered locally at high concentration, ensuring that therapeutic levels are reached at the target site while reducing side effects by keeping systemic concentration low. The microbead accomplishes this while protecting the biologically active protein from harsh conditions traditionally encountered during microbead formation/drug formulation. The microbeads are inert, biodegradable, and allow a sustained release or multiple-release profile of treatment with various active agents without major side effects. In addition, the bead maintains functionality under physiological conditions. Second, the microbeads and microparticles can be used in various research assays, such as isolation and separation assays, to bind target proteins from biological samples. A disadvantage of the conventional methods is that the proteins become denatured. The denaturation results in incorrect binding studies or inappropriate binding complexes being formed. The instant technology corrects this disadvantage by using a bead created in a more neutral pH environment. It is this same environment that is used for the binding of the protein of interest as well. *Inventor:* Phillip F. Heller (NIA). *Patent Status:* U.S. Provisional Application No. 60/602,651 filed 19 Aug 2004 (HHS Reference No. E-116-2004/0-US-01) PCT Application No. PCT/US2005/026257 filed 25 Jul 2005, which published as WO 2006/023207 on 02 Mar 2006 (HHS Reference No. E-116-2004/0-PCT-02) U.S. Patent Application No. 11/659,976 filed 12 Feb 2007 (HHS Reference No. E-116-2004/0-US-03) *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan O. Ano, PhD; 301/435-5515; *anos@mail.nih.gov* . Dated: February 7, 2008. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-2749 Filed 2-13-08; 8:45 am] BILLING CODE 4140-01-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. New Inhibitors of Multidrug Resistant Proteins Such as ABCG2 *Description of Technology:* Drug resistance plays a significant role in the failure of cancer chemotherapy. Some proteins such as ABCG2, Pgp and MRP1 that belong to the superfamily of ATP-binding cassette transporters contribute to this process. Two categories of ABCG2 protein inhibitors—botryllamides, isolated from a marine sponge, and naphthopyrones, isolated from marine sea stars—have been obtained by high-throughput screening of 89,000 natural product extracts from the Natural Products Repository at NCI. These new compounds serve as potential therapeutic agents for cancer chemotherapy either exclusively or in combination with conventional regimens. The study of structure-activity relationships will help delineate features that would enhance activity and specificity to multiple drug resistant proteins. *Advantages:* Increase bioavailability of orally administered drugs; Enhance drug delivery to certain tissues. *Applications:* Cancer therapeutics; Cancer stem cell research; Study of structure, function and relevance of MDR in cancer. *Market:* Cancer is the second leading cause of death in America, after heart disease. Multiple drug resistance is a significant impediment in the treatment of cancers resulting in poor prognosis. Some cancers with demonstrated high levels of MDR are leukemia, colon, renal, liver, adrenocortical, and pancreatic. Breast, ovarian, sarcoma and small-cell lung cancer show increased MDR on treatment. This new technology has the potential to increase the effectiveness of conventional chemotherapy and prognosis of cancer. *Developmental Status:* Early stage. *Inventors:* Curtis J. Henrich *et al.* (NCI). *Patent Status:* U.S. Provisional Application No. 60/018,758 filed 03 Jan 2008 (HHS Reference No. E-315-2007/0-US-01). *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* John Stansberry, PhD; 301/435-5236; *stansbej@mail.nih.gov* . TGF- **β** Gene Expression Signature in Cancer Prognosis *Description of Technology:* Hepatocellular carcinoma
(HCC)is the third leading cause of cancer death worldwide, and it is very heterogeneous in terms of its clinical presentation as well as genomic and transcriptomic patterns. This heterogeneity and the lack of appropriate biomarkers have hampered patient prognosis and treatment stratification. Available for licensing is a novel temporal TGF-β gene expression signature that predicts HCC patient clinical outcomes. Patients with tumors expressing late TGF-β responsive genes had a malignant prognosis and an invasive tumor phenotype as evaluated by decreased survival time, increased tumor recurrence, and vascular invasion rate. Additionally, this signature may also be able to prognose other cancers, including lung cancer. *Applications:* Method to diagnose cancer; Method to monitor cancer progression and aid clinicians to choose appropriate therapies; Commercial kits to prognose cancer. *Advantages:* Early diagnostic tool to stratify HCC patients to chose more effective treatment. *Development Status:* The technology is currently in the pre-clinical stage of development. *Market:* An estimated 1,444,920 new cancer diagnoses in the U.S. in 2007. Cancer is the second leading cause of death in United States. It is estimated that the cancer therapeutic market would double to $50 billion a year in 2010 from $25 billion in 2006. *Inventors:* Snorri Thorgeirsson
(NCI)and Cedric Coulouaran (NCI). *Relevant Publication:* Manuscript in press Hepatology 2008. *Patent Status:* U.S. Provisional Application No. 60/981,661 filed 22 Oct 2007 (HHS Reference No. E-282-2007/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Jennifer Wong; 301-435-4633; *wongje@mail.nih.gov* . *Collaborative Research Opportunity:* The National Cancer Institute, Center for Cancer Research, Laboratory of Experimental Carcinogenesis is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a novel temporal TGF-β gene expression signature that predicts HCC patient clinical outcomes. Please contact John D. Hewes, PhD at 301-435-3121 or *hewesj@mail.nih.gov* for more information. A Fold-Back Diabody Format for Diphtheria Toxin-Based Immunotoxins That Can Increase Binding and Potency *Description of Technology:* NIH inventors, in collaboration with Scott and White Memorial Hospital inventors, have developed new immunotoxins comprising a mutant diphtheria toxin linked to an anti-prostate specific membrane antigen
(PSMA)fold-back diabody. The fold-back diabody construct has a shortened linker region between the heavy and light chains of the antibody variable domain. This construct allows interactions between the longer-linked variable domains while preventing interactions between the shorter-linked variable domains. This results in increased efficiency of epitope recognition and delivery to the appropriate target cells. These immunotoxins can be used for the treatment of cancers that overexpress PMSA, with specific application against prostate cancer. *Applications:* Treatment of primary prostate tumors. Treatment of metastatic prostate tumors, for which no currently effective treatment exists. Application against other tumors expressing the PSMA epitope on the tumor neovasculature such as breast cancer. *Advantages:* Increased potency of 10-40-fold resulting from the use of the fold-back diabody construct. First treatment with applications to metastatic prostate cancer. *Pichia pastoris* production process of the fold-back immunotoxin can be used to scale up for GMP production. *Benefits:* Significant social benefit for successfully treating the second leading cause of cancer-related deaths among males in the United States. Approximately 8 billion USD per year are spent on prostate cancer treatment; a new treatment could procure a significant financial position. Opportunity to occupy a strong market position through the development of the first treatment of metastatic prostate cancer. *Inventors:* David Neville
(NIMH)*et al.* *Patent Status:* U.S. Patent Application No. 60/953,416 filed 01 Aug 2007 (HHS Reference No. E-268-2007/0-US-01). *Licensing Status:* Available for licensing. *Licensing Contact:* David A. Lambertson, PhD; 301-435-4632; *lambertsond@mail.nih.gov* . *Collaborative Research Opportunity:* The National Institute of Mental Health, Laboratory of Molecular Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize anti-PSMA fold-back immunotoxins. Please contact David Neville by phone at 301-496-6807 or e-mail *davidn@mail.nih.gov* for more information. Ribosomal Protein S3 (RPS3), an Essential Component of NF-kB is a Novel and Selective Drug Target *Description of Technology:* NF-kB, represented by the p50-p65 heterodimer, is a DNA binding protein complex that has well documented functions in inflammatory or autoimmune diseases. Its potential as a drug target is currently being explored by the pharmaceutical industry. The present invention describes that ribosomal protein S3
(RPS3)is a novel component of the p65 homodimer and p65-p50 heterodimer DNA binding complex. Experiments confirmed that RPS3 is essential for normal expression of specific NF-kB target genes, including key physiological events that require p65. *Advantages and Applications:* A novel and selective target for drug candidates targeting the NF-kB pathway. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* Michael J. Lenardo and Fengyi Wan (NIAID). *Patent Status:* U.S. Provisional Application No. 60/913,336 filed 23 Apr 2007 (HHS Reference No. E-162-2007/0-US-01). *Licensing Status:* Available for exclusive and non-exclusive licensing. *Licensing Contact:* Mojdeh Bahar, J.D.; 301-435-2950; *baharm@mail.nih.gov* . *Collaborative Research Opportunity:* The NIAID Laboratory of Immunology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Dr. Michael Lenardo at 301-496-6754 for more information. A New Technology for Identification of Genes Expressed in Hypoxia Conditions *Description of Technology:* Low concentrations of oxygen (hypoxia) are a major pathophysiological condition conducive for angiogenesis, necessary for tumor growth and metastasis of cancer cells. A new technology comprising of a vector DNA (pGL2-TK-HRE) that expresses the luciferase gene under the influence of a hypoxia inducible promoter sequence from the nitric oxide synthase gene has been used to transform various human tumor cell lines such as U251-HRE and PC3-HRE. These cells express little to no luciferase under normal oxygen levels, but stably express significantly higher levels under low oxygen levels. The transformed cell lines can be used to screen and develop drugs and small molecules that inhibit angiogenesis, an attractive target for cancer therapy. The technology can also be used in gene therapy where the therapeutic gene is being expressed under a hypoxia inducible promoter. *Advantages:* Quantitative; Robust, stably express luciferase; Can be used in vivo. *Applications:* Early detection of angiogenesis; Cancer therapeutics; Gene therapy. *Market:* Cancer is the second leading cause of death in America, after heart disease. Every year, more than a million people are diagnosed with cancer. Over 50% of the cases reported in the U.S. affect the lung, breast, prostate and colorectal. Although the number of deaths reported is declining 553,888 cancer deaths in 2004 compared to 556,902 in 2003, the total number of all cancer deaths among women is rising. With the help of the new technology early detection, therapy and monitoring of cancer combating efforts would be possible. *Development Status:* Developed. *Inventor:* Giovanni Melillo
(NCI)*Patent Status:* HHS Reference No. E-220-2003/0—Research Tool. Patent protection is not being sought for this technology. *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* John Stansberry, PhD; 301/435-5236; *stansbej@mail.nih.gov* . Date: February 6, 2008. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-2752 Filed 2-13-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Prevention; Notice of Meeting Pursuant to Public Law 92-463, notice is hereby given of the meeting of the Center for Substance Abuse Prevention
(CSAP)National Advisory Council on March 6, 2008. The meeting is open and will include discussion of the Center's policy issues, and current administrative, legislative and program developments. Attendance by the public will be limited to space available. Public comments are welcome. Please communicate with the CSAP Council's Designated Federal Official, Ms. Tia Haynes (see contact information below), to make arrangements to attend, comment or to request special accommodations for persons with disabilities. Substantive program information, a summary of the meeting, and a roster of Council members may be obtained as soon as possible after the meeting, either by accessing the SAMHSA Committee Web site, *http://www.samhsa.gov/council/csap/csapnac.aspx,* or by contacting Ms. Haynes. The transcript for the open session will also be available on the SAMHSA Council Web site within three weeks after the meeting. *Committee Name:* Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention National Advisory Council. *Date/Time/Type:* March 6, 2008. From 9 a.m.-4:30 p.m.: Open. *Place:* 1 Choke Cherry Road, Sugarloaf and Seneca Conference Rooms, Rockville, Maryland 20857. *Contact:* Tia Haynes, Designated Federal Official, SAMHSA/CSAP National Advisory Council, 1 Choke Cherry Road, Room 4-1066, Rockville, MD 20857, Telephone:
(240)276-2436, Fax:
(240)276-2430, E-mail: *tia.haynes@samhsa.hhs.gov.* Toian Vaughn, Committee Management Officer, Substance Abuse and Mental Health Services Administration. [FR Doc. E8-2715 Filed 2-13-08; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of accreditation and approval of Amspec Services LLC, as a commercial gauger and laboratory. SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.12 and 19 CFR 151.13, Amspec Services LLC, 1818 A Federal Road, Galena Park, TX 77015, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling
(202)344-1060. The inquiry may also be sent to *cbp.labhq@dhs.gov* . Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories. *http://cbp.gov/xp/cgov/import/operations_support/labs_scientific_svcs/commercial_gaugers/* . DATES: The accreditation and approval of Amspec Services LLC, as commercial gauger and laboratory became effective on April 10, 2007. The next triennial inspection date will be scheduled for April 2010. FOR FURTHER INFORMATION CONTACT: Commercial Gauger Laboratory Program Manager, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Suite 1500N, Washington, DC 20229, 202-344-1060. Dated: January 31, 2008. Ira S. Reese, Executive Director, Laboratories and Scientific Services. [FR Doc. 08-678 Filed 2-13-08; 8:45 am]
Connectionstraces to 6
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.