Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 07-4566 · 30Day-07-07AD · FR Doc. E7-18231 Filed 9-14-07; 8:45 am

Summary

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Dates

Fax written comments on the collection of information by October 17, 2007.

Supplementary Information

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance: Premarket Approval of Medical Devices—21 CFR Part 814 and Food and Drug Administration Modernization Act Sections 201, 202, 205, 208, and 209 (OMB Control Number 0910-0231)—Extension Section 515 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e) sets forth the requirements for premarket approval of certain class III medical devices. Class III devices are either preamendments devices that have been classified into class III, or postamendments devices which are not substantially equivalent to a preamendments device, or transitional devices. Class III devices are devices such as implants, life sustaining or life supporting devices, devices that are of substantial importance in preventing impairment of human health, and devices that otherwise present a potentially unreasonable risk of illness or injury. Most premarket approval application (PMAs) are for postamendments class III devices. Under section 515 of the act, an application must contain certain specific information, including full reports of all information concerning investigations showing whether the device is reasonably safe and effective. The application should also include a statement of components, ingredients, and properties of the principles of operation for such a device. In addition, the application should also include a full description of the methods used in, and the facilities and controls used for, the manufacture and processing of the device and labeling specimens. The implementing regulations, contained in part 814 (21 CFR part 814), further specify the contents of a PMA for a class III medical device and the criteria FDA sets forth in approving, denying, or withdrawing approval of a PMA as well as supplements to PMAs. The purpose of these regulations is to establish an efficient and thorough procedure for FDA's review of PMAs and supplements to PMAs for certain class III (premarket approval), medical devices. The regulations under part 814 facilitate the approval of PMAs and supplements to PMAs for devices that have been shown to be reasonably safe and effective and otherwise meet the statutory criteria for approval. The regulations also ensure the disapproval of PMAs and supplements to PMAs for devices that have not been shown to be reasonably safe and effective and that do not otherwise meet the statutory criteria for approval. The Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) was enacted on November 21, 1997, to implement revisions to the act by streamlining the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market. Several FDAMA provisions affect the PMA process, such as section 515(d)(6) of the act. This section provided that PMA supplements were required for all device changes that affect safety and effectiveness of a device unless such changes are modifications to manufacturing procedures or method of manufacture. This type of manufacturing change now requires a 30-day notice, or where FDA finds such notice inadequate, a 135-day PMA supplement. To make the PMA process more efficient, in the past several years FDA has done the following: (1) Made changes to the PMA program based on comments received, (2) complied with changes to the program mandated by FDAMA and Medical Device User Fee Modernization Act (Public Law 107-250), and (3) worked toward completion of its PMA reinvention efforts. Respondents to this information collection are persons filing a PMA application or a PMA supplement with FDA for approval of certain class III medical devices. Part 814 defines a person as any individual, partnership, corporation, association, scientific or academic establishment, Government agency or organizational unit, or other legal entity. These respondents include entities meeting the definition of manufacturers, such as manufacturers of commercial medical devices in distribution prior to May 28, 1976 (the enactment date of the Medical Device Amendments). In addition, hospitals that reuse single use devices (SUDs) are also included in the definition of manufacturers. It is expected that FDA will receive four PMA applications from hospitals that remanufacture SUDs annually. This figure has been included in table 1 of this document, as part of the reporting burden in § 814.15. In the Federal Register of June 28, 2007 (72 FR 35494), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1.—Estimated Annual Reporting Burden 1 Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 21 CFR 814.15(b) 10 1 10 2 20 814.20(a) through (c) and (e) 48 1 48 668 32,064 814.37 48 1 48 167 8,016 814.39(a) 460 1 460 60 27,600 814.39(d) 70 1 70 6 420 814.39(f) 254 1 254 16 4,064 814.82(a)(9) 34 1 34 135 4,590 814.84(b) 34 1 34 10 340 FDAMA 201—Agreement Meeting 3 1 3 50 150 202—Expedited Reviews 7 1 7 10 70 205—Determination Meeting 5 1 5 50 250 208—Classification Panel Meetings 19 1 19 30 570 209—100-day Meeting 36 1 36 10 360 Total 1,028 13 1,028 1,214 78,514 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2.—Estimated Annual Recordkeeping Burden 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 814(a)(5) and (a)(6) 1,128 1 1,128 17 19,176 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The industry-wide burden estimate for PMAs is based on an FDA actual average fiscal year (FY) annual rate of receipt of 48 PMA original applications, 530 PMA supplements, and 254 30-day notices using FY 2002 through FY 2006 data. The burden data for PMAs is based on data provided by manufacturers by device type and cost element in an earlier study. The specific burden elements for which FDA has data are as follows: • Clinical investigations: 67 percent of total burden estimate; • Submission of additional data or information to FDA during a PMA review: 12 percent; • Additional device development cost (e.g., testing): 10 percent; and • PMA and PMA supplement preparation and submissions, and development of manufacturing and controls data: 11 percent. Reporting Burden The reporting burden can be broken out by certain sections of the PMA regulation as follows: § 814.15—Research Conducted Outside the United States Approximately 20 percent of the clinical studies submitted in support of a PMA application are conducted outside the United States. Each study should be performed in accordance with the “Declaration of Helsinki” or the laws and regulations of the country in which the study was conducted. If the study was conducted in accordance with the laws of the country, the PMA applicant is required to explain to FDA in detail the differences between the laws of the country and the “Declaration of Helsinki.” Based on the number of PMAs received that contained studies from overseas, FDA estimates that the burden estimate necessary to meet this requirement is 20 hours. § 814.20(a) through (c) and (e)—Application The majority of the 32,064 hourly burden estimate is due in part to this requirement. Included in this requirement are the conduct of laboratory and clinical trials as well as the analysis, review, and physical preparation of the PMA application. FDA estimates that 48 manufacturers, including hospital re-manufacturers of single use devices (SUDs), will be affected by these requirements which are based on the actual average of FDA receipt of new PMA applications in FY 2002 through 2006. FDA's estimate of the hours per response (668), was derived through FDA's experience and consultation with industry and trade associations. In addition, FDA also based its estimate on the results of an earlier study which accounts for the bulk of the hourly burden for this requirement, identified by manufacturers. § 814.37—PMA Amendments and Resubmitted PMAs As part of the review process, FDA often requests PMA applicant to submit additional information regarding the device necessary for FDA to file the PMA or to complete its review and make a final decision. The PMA applicant may, also on their own initiative, submit additional information to FDA during the review process. These amendments contain information ranging from additional test results, re-analysis of the original data set to revised device labeling. Almost all PMAs received by the Agency have amendments submitted during the review process. FDA estimates that 8016 burden hours are necessary to satisfy this requirement. § 814.39(a)—PMA Supplements FDA believes that the amendments mandated by FDAMA for § 814.39(f), permitting the submission of the 30-day notices in lieu of regular PMA supplements, will result in an approximate 20 percent reduction in the total number of hours as compared to regular PMA supplements. As a result, FDA estimates that 27,600 hours of burden are needed to complete the requirements for regular PMA supplements. § 814.39(d)—Special PMA Supplements—Changes Being Effected This type of supplements is intended to enhance the safety of the device or the safe use of the device. The number of PMA supplements received that fit this category averaged 70 per year based on the numbers received from FY 2002 through FY 2006. Because of the minimal data required to be included in this type of supplement, FDA estimates that the burden hours necessary to satisfy this requirement are 420 hours. § 814.39(f)—30-day Notice Under section 515(d) of the act, modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement under § 814.39(a) and are eligible to be the subject of a 30-day notice. A 30-day notice shall describe in detail the change, summarize the data or information supporting the change, and state that the change has been made in accordance with the requirements of part 820 (21 CFR part 820). The manufacturer may distribute the device 30 days after the date on which FDA receives the 30-day notice, unless FDA notifies the applicant within 30 days from receipt of the notice that it is not adequate. FDA estimates the burden to satisfy this requirement is 4,064 hours. § 814.82(a)(9)—Postapproval Requirements Postapproval requirements concern approved PMAs that were not reclassified and require a periodic report. After approval, all PMAs require a submission of an annual report. On average, approximately half of the submitted PMAs (34), require associated postapproval studies, i.e., followup of patients used in clinical trials to support the PMA or additional preclinical information, that is labor-intensive to compile and complete; the remaining PMAs require minimal information. Based on experience and consultation with industry, FDA has estimated that preparation of reports and information required by this section requires 4,590 hours. § 814.84(b)—Reports Postapproval requirements described in § 814.82(a)(7) require submission of an annual report for each approved PMA. FDA estimates that respondents will average about 10 hours in preparing their reports to meet this requirement. This estimate is based on FDA's experience and consultation with industry. Thus, FDA estimates that the periodic reporting burden required by this section will take 340 hours. Statutory Reporting Burden Estimate (FDAMA) The total statutory reporting burden under the requirements of FDAMA sections 201, 202, 205, 208, and 209 is estimated to be 1,400 hours. This burden estimate was based on actual real FDA data tracked from January 1, 1998, to the present, and an estimate was also derived to forecast future expectations with regard to this statutory data. § 814.82(a)(5) and (a)(6)—Recordkeeping The recordkeeping burden under this section requires the maintenance of records, used to trace patients, and the organization and indexing of records into identifiable files to ensure the device's continued safety and effectiveness. These records are required only of those manufacturers who have an approved PMA and who had original clinical research in support of that PMA. For a typical year's submissions, 70 percent of the PMAs are eventually approved with 75 percent of these having original clinical trial data. Therefore, approximately 34 PMAs a year (48 annual submissions x 70 percent), would be subject to these requirements. Also, because the requirements apply to all active PMAs, all holders of an active PMA applications must maintain these records. PMAs have been required since 1976, and there are 1,128 active PMAs that could be subject to these requirements, based on actual FDA data. Each study has approximately 200 subjects, and at an average of 5 minutes per subject, there is a total burden per study of 1,000 minutes, or 17 hours. The aggregate burden for all 1,128 holders of approved original PMAs, therefore, is 19,176 hours (1,127 approved PMAs with clinical data x 17 hours per PMA). The applicant determines which records should be maintained during product development to document and/or substantiate the device's safety and effectiveness. Records required by the current good manufacturing practices for medical devices regulation (part 820) may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device's continuing safety and effectiveness. Dated: September 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-18222 Filed 9-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0347] Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening until October 17, 2007, the comment period for “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays” published in the Federal Register of July 26, 2007 (72 FR 41081). That guidance was a revised version of the original draft, which was published on September 7, 2006, with a 90-day comment period that was extended to 180 days. In addition, FDA held a public meeting on the draft guidance in February 2006. FDA is reopening the comment period on the revised draft to allow sufficient time for stakeholder comment. DATES: Submit written or electronic comments by October 17, 2007. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Draft Guidance for industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments or http://www.regulations.gov . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0694. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 26, 2007 (72 FR 41081), FDA published a notice of availability of a revised draft guidance, “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays” with a 30-day comment period. The In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) guidance document has been the subject of attention, comment, and public discussion for almost a year. The original draft was published on September 7, 2006, with a 90-day comment period. In response to requests for further opportunity to comment, FDA extended the comment period to 180 days and held a public meeting on the guidance document. The second draft, which was published July 26, 2007, incorporated many of the suggested comments on the first draft. Among other things, the second draft simplified the definition of IVDMIAs, and provided a variety of specific examples to assist sponsors in understanding the definition. In light of the opportunities for comment on the first draft, we had originally set a 30-day period for comments on the second draft. The initial comment period closed on August 27, 2007. However, at the request of in vitro diagnostic device stakeholders, the agency has decided to reopen the comment period for an additional 30 days on the “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.” This draft guidance is intended to provide clarification on FDA's approach to regulation of IVDMIAs. II. Request for Comments Following publication of the July 26, 2007, “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays,” FDA received requests to allow interested persons additional time to comment. The requesters asserted that the time period of 30 days was insufficient to respond fully to FDA's specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues. III. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the agency's current thinking on IVDMIAs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. IV. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To received “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays,” you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1610 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh . A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html . Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets . V. How to Submit Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-18221 Filed 9-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Data System for Organ Procurement and Transplantation Network (42 CFR Part 121, OMB No. 0915-0184): Extension The operation of the Organ Procurement and Transplantation Network (OPTN) necessitates certain recordkeeping and reporting requirements in order to perform the functions related to organ transplantation under contract to HHS. This is a request for an extension of the current recordkeeping and reporting requirements associated with the OPTN. These data will be used by HRSA in monitoring the contracts for the OPTN and the Scientific Registry of Transplant Recipients (SRTR) and in carrying out other statutory responsibilities. Information is needed to match donor organs with recipients, to monitor compliance of member organizations with OPTN rules and requirements, to ensure that all qualified entities are accepted for membership in the OPTN, and to ensure patient safety. Estimated Annual Reporting and Record Keeping Burden Section and activity Number of respondents Responses per respondents Total responses Hours per response Total burden hours 121.3(b)(2)—OPTN membership and application requirements for OPOs, hospitals, and histocompatibility laboratories 40 3 120 15 1, 800 121.3(b)(4)—Appeal for OPTN membership 2 1 2 3 6 121.6(c) (Reporting)—Submitting criteria for organ acceptance 900 1 900 0.5 450 121.6(c) (Disclosure)—Sending criteria to OPOs 900 1 900 0.5 450 121.7(b)(4)—Reasons for Refusal 900 38 34,200 0.5 17,100 121.7(e) —Transplant to prevent organ wastage 260 1.5 390 0.5 195 121.9(b)—Designated Transplant Program Requirements 10 1 10 5.0 50 121.9(d)—Appeal for designation 2 1 2 6 12 Total 954 36,524 20,063 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: September 10, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-18220 Filed 9-14-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443-1129. The following request has been submitted to the OMB for review under the Paperwork Reduction Act of 1995: Proposed Project: The Nurse Faculty Loan Program (NFLP): Annual Operating Report (AOR) Form—NEW The Annual Operating Report (AOR) provides information on the Nurse Faculty Loan Program (NFLP) funded loan activities. Under Title VIII of the Public Health Service Act, as amended by Public Law 107-205, Section 846A, the Secretary of Health and Human Services (HHS) enters into an agreement with a school of nursing to establish and operate the NFLP fund. HHS makes an award to the school in the form of a Federal Capital Contribution (FCC). The award is used to establish a distinct account for the NFLP loan fund at the school or is deposited into an existing NFLP fund. The school of nursing makes loans from the NFLP fund to eligible students enrolled full-time in a master's or doctoral nursing education program that will prepare them to become qualified nursing faculty. Following graduation from the NFLP lending school, loan recipients may receive up to 85 percent NFLP loan cancellation over a consecutive four-year period in exchange for service as full-time faculty at a school of nursing. The NFLP lending school collects any portion of the loan that is not cancelled. The lending school deposits monies from loan collection and repayment into the NFLP loan fund to make additional NFLP loans. The school of nursing must keep records of all NFLP loan fund transactions. The NFLP Annual Operating Report is used to collect information relating to the NFLP loan fund operations and financial activities for a specified reporting period (July 1 through June 30 of the academic year). Participating schools will complete and submit an electronic copy of the AOR annually to provide the Federal Government with current and cumulative information on: (1) The number and amount of loans made, (2) the number of NFLP recipients and graduates, (3) the number and amount of loans collected, (4) the number and amount of loans in repayment, (5) the number of NFLP graduates employed as nurse faculty, and (6) NFLP loan fund receipts, disbursements and other related costs. The NFLP loan fund balance is used with other criteria to determine the annual award to the school. Once the AOR is completed by the participating school, the AOR will be submitted electronically through the HRSA Electronic Handbook. The estimate of burden for this form is as follows: Form Number of respondents Responses per respondent Total responses Hours per responses Total burden hours Nurse Faculty Loan Program Annual Operating Report (AOR) 150 1 150 8 1200 Total Burden 150 1 150 8 1200 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: September 10, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-18223 Filed 9-14-07; 8:45 am] BILLING CODE 4165-15-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. Suppression of Allergic Asthma by Ascaris Antigens Description of Technology: Available for licensing and commercial development are compositions and methods for suppressing allergic reactions, as well as Th-1 and Th-2 associated immunological diseases, by administering any of the two identified Ascaris polypeptide antigens, or active fragments or variants thereof, to the affected subject. Allergic asthma is characterized by antigen-specific IgE production, reversible airway hyper-reactivity and eosinophilic infiltration of the airways. There is a dramatic increase in the prevalence of allergic disorders in emerging and industrialized countries and studies suggest that the hygienic environment in those countries may not provide allergy-protective mechanisms associated with some forms of infection. Recent studies have found that helminth infection may suppress the development of allergic disease. Helminth infections currently affect over 2 billion people worldwide, causing significant morbidity. The most successful geohelminths are members of the Ascaris species, including A. lumbricoides and A. suum, which are known to infect 1.5 billion people. The inventors studied the modulation of allergic disease mediated by a chronic A. suum infection in their murine model of ragweed-induced allergic conjunctivitis and allergic asthma, and demonstrated that the infection prevents allergic inflammation in sites distal from larval migration. This protection was due, in part, to the induction of immunoregulatory cytokines such as IL-10. In further studies, they demonstrated that a cocktail of antigens from the pseudocoelomic fluid (PCF) of A. suum, administered during ragweed sensitization, significantly reduced the eosinophil migration into the conjunctiva, pulmonary eosinophilic inflammation, and total lung pathology induced by the ragweed. PCF exposure also reduced the secretion of the pro-allergic cytokines IL-5 and IL-13 in the broncho-alveolar lavage fluid after ragweed exposure. All findings suggest PCF is capable of suppressing the allergic response to a traditional allergen and at multiple tissue sites. In further studies, the inventors determined that the protection conferred by PCF to allergic inflammation was through a specific first antigenic protein isolated from PCF, results that were confirmed by using the recombinant form of the first antigen. Furthermore, it is known that Toll-like receptors (TLRs) on dendritic cells (DCs) and other antigen presenting cells recognize specific molecular patterns on invading pathogens, leading to the development of host immunity. A number of pathogens, including helminths, have used pattern recognition by TLRs to modulate host immunity and inflammation to establish a chronic infection. In further studies, the inventors identified a second specific antigenic protein, also isolated from PCF, which can modulate activation of bone marrow derived DCs in response to stimuli with bacterial lipopolysaccharide (LPS); and to stimulate DCs to produce significant increases in IL-10 but not IL-12 upon co-stimulation with LPS. Studies in various genetically deficient mice suggested that this second antigen augments the IL-10 production dependent on one of the TLRs, TLR4. In further studies with the cloned and expressed form of the second antigen, as well as its two domains, the inventors showed that the activity is dependent on domain 2 but not domain 1. The purified second antigen exhibits different properties than unfractionated PCF. PCF administration prevents an initial response from occurring, as it inhibits the initiation of the inflammatory cascade. By contrast, the second antigen can activate DCs and alter cells such that they ultimately suppress responses through the production of IL-10 and can therefore act on the effector phase of the inflammatory response (i.e., modulate a response that is already occurring). Applications: Suppression of allergic responses to traditional allergens by administering the identified Ascaris polypeptide antigens, or active fragments or variants thereof, to the affected subjects. The inventions provide different ways to treat allergic diseases or prevent allergic reactions, rather than merely ameliorating the symptoms. The inventions are also applicable to other Th-1 and Th-2 associated immunological diseases. Development Status: The technologies are currently in the pre-clinical stage of development. Inventors: Andrea Keane-Myers et al. (NIAID). Relevant Publications: Manuscripts describing the above technologies will be available as soon as they are accepted for publication. Patent Status: U.S. Provisional Application No. 60/902,506 filed 22 February 2007 (HHS Reference No. E-126-2007/0-US-01). U.S. Provisional Application No. 60/924,537 filed 18 May 2007 (HHS Reference No. E-174-2007/0-US-01). Licensing Status: Available for non-exclusive or exclusive licensing. Licensing Contact: Cristina Thalhammer-Reyero, Ph.D, MBA; 301/435-4507; thalhamc@mail.nih.gov. Citrobacter freundii WR7011 as a Vaccine Strain or Source of Vi Capsular Antigen for Protection Against Typhoid Fever Description of Invention: According to the WHO, typhoid fever remains a serious public health problem throughout the world, with an estimated 16-33 million cases and 500,000 to 600,000 deaths annually. The Vi capsule of S. typhi , the causative agent of typhoid fever, is a surface-bound carbohydrate polymer to which antibodies have been shown to protect against typhoid fever. Purification of this polymer from virulent S. typhi strains poses a danger to those handling the live organisms. However, an unusual strain of Citrobacter freundii , WR7004 was mutated by the inventors to create a strain (WR7011) that makes Vi polysaccharide on its surface. Specifically, the strain was mutated using nitrosoguanidine. C. freundii WR7011 makes several times as much Vi polysaccharide as strains of S. typhi , is nonpathogenic, and is much safer to work with for Vi production or use as a vaccine strain. The inventors anticipate that this strain of C. freundii will reduce costs of purifying the Vi polysaccharide and also provide an increased level of safety during manufacture of the polysaccharide. Applications and Modality: Synthesis of S. typhi Vi polysaccharide. Market: Research tool useful for vaccine studies and/or vaccine production. Development Status: The technology is a research tool. Inventors: Dennis Kopecko and DeQi Xu (CBER/FDA). Pertinent References: 1. NJ Snellings et al. Genetic regulation of variable Vi antigen expression in a strain of Citrobacter freundii . J Bacteriol. 1981 Feb;145(2):1010-1017. 2. H-S Houng et al. Expression of Vi antigen in Escherichia coli K-12: characterization of ViaB from Citrobacter freundii and identity of ViaA with RcsB. J Bacteriol. 1992 Sep;174(18):5910-5915. 3. JT Ou et al. Specific insertion and deletion of insertion sequence 1-like DNA element causes the reversible expression of the virulent capsular antigen Vi of Citrobacter freundii in Escherichia coli. Proc Natl Sci USA. 1988 June;85(12):4402-4405. 4. SC Szu et al. Vi capsular polysaccharide-protein conjugates for prevention of typhoid fever. J Exp Med. 1987 Nov 1;166(5):1510-24. Patent Status: HHS Reference No. E-004-2007/0—Research Tool. Licensing Status: This technology is not patented. The mouse model will be transferred through a Biological Materials License. Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The FDA-CBER Laboratory of Enteric and Sexually Transmitted Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Vi polysaccharide from Citrobacter freundii . Please contact Dr. Dennis J. Kopecko at 301-496-1893 or ( dennis.kopecko@fda.hhs.gov ) for more information. Catalytic Domains of beta [blocked]-galactosyltransferase I Having Altered Donor and Acceptor Specificities, Domains That Promote In Vitro Protein Folding, and Methods for Their Use Description of Technology: beta [blocked]-galactosyltransferase I catalyzes the transfer of galactose from the donor, UDP-galactose, to an acceptor, N-acetylglucosamine, to form a galactose-beta [blocked]-N-acetylglucosamine bond. This reaction allows galactose to be linked to an N-acetylglucosamine that may itself be linked to a variety of other molecules. The reaction can be used to make many types of molecules having great biological significance. For example, galactose-beta [blocked]-N-acetylglucosamine linkages are very important for cellular recognition and binding events as well as cellular interactions with pathogens, such as viruses. Therefore, methods to synthesize these types of bonds have many applications in research and medicine to develop pharmaceutical agents and improved vaccines that can be used to treat disease. The present invention is based on the surprising discovery that the enzymatic activity of beta [blocked]-galactosyltransferase can be altered such that the enzyme can make chemical bonds that are very difficult to make by other methods. These alterations involve mutating the enzyme such that the mutated enzyme can transfer many different types of sugars from sugar nucleotide donors to many different types of acceptors. Therefore, the mutated beta [blocked]- galactosyltransferases of the invention can be used to synthesize a variety of products that, until now, have been very difficult and expensive to produce. The invention also provides amino acid segments that promote the proper folding of a galactosyltransferase catalytic domain and mutations in the catalytic domain that enhance folding efficiency and make the enzyme stable at room temperature. The amino acid segments may be used to properly fold the galactosyltransferase catalytic domains of the invention and thereby increase their activity. The amino acid segments may also be used to increase the activity of galactosyltransferases that are produced recombinantly. Accordingly, use of the amino acid segments according to the invention allows for production of beta [blocked]-galactosyltransferases having increased enzymatic activity relative to beta [blocked]-galactosyltransferases produced in the absence of the amino acid segments. Applications: Synthesis of polysaccharide antigens for conjugate vaccines, glycosylation of monoclonal antibodies, and as research tools. Development Stage: The enzymes have been synthesized and preclinical studies have been performed. Inventors: Pradman K. Qasba, Boopathy Ramakrishnan, Elizabeth Boeggeman (NCI). Patent Status: U.S. and Foreign Rights Available (HHS Reference No. E-230-2002/2). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute's Nanobiology Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of galactose and modified galactose to be linked to an N-acetylglucosamine that may itself be linked to a variety of other molecules. Please contact John D. Hewes, PhD. at 301-435-3121 or hewesj@mail.nih.gov for more information. Rapid Motion Perception MRI Navigator Method Description of Technology: Available for licensing and commercial development is a non-breathhold flow sensitive navigator technique for reducing respiratory motion artifacts in magnetic resonance (MR) images. The method, called Rapid Motion Perception (RaMP), tracks bulk translational motion of the heart in real-time. The position of the blood volume is a direct representation of the heart position. RaMP tracks fast-moving blood volume during systole as a marker for the heart position, while suppressing stationary or slow moving spins. This approach allows cardiac navigation in two orthogonal directions simultaneously, eliminates the need to obtain empirical correlations between the diaphragm and the heart, and increases tracking reliability among individual patients. The method uses a spoiled-Fast Low Angle Shot (FLASH) navigator and incorporates an alternating pair of bipolar velocity-encoding gradients. Data at 1.5T indicate that RaMP is capable of correcting bulk motion of the heart over multiple cardiac cycles to within +/−1.43 mm in the superior-inferior direction and +/−0.84 mm in the anterior-posterior direction. Applications: Reduction of MR image artifacts due to respiration motion. Real-time tracking of cardiac motion. Market: Magnetic Resonance Imaging. Development Status: Late-stage technology. Inventors: Vinay M. Pai and Han Wen (NHLBI). Patent Status: U.S. Patent Application No. 10/244,903 filed 16 Sep 2002 (HHS Reference No. E-164-2002/0-US-01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Chekesha S. Clingman, Ph.D.; 301/435-5018; clingmac@mail.nih.gov. Collaborative Research Opportunity: The NHLBI is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Lili Portilla at 301-594-4273 or via e-mail at Lilip@nih.gov for more information. Dated: September 7, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-18189 Filed 9-14-07; 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 and Improved Chemotherapy Adjuvants: Folate Based Inactivators of O 6 -alkylguanine-DNA alkyltransferase (alkyltransferase) Description of Technology: O 6 -Benzylguanine derivatives, some O 6 -benzylpyrimidines, and related compounds are known to be inactivators of the human DNA repair protein O 6 -alkylguanine-DNA alkyltransferase (alkyltransferase). This repair protein is the primary source of resistance many tumor cells develop when exposed to chemotherapeutic agents that modify the O 6 -position of DNA guanine residues. Therefore, inactivation of this protein can bring about a significant improvement in the therapeutic effectiveness of these chemotherapy drugs. The prototype inactivator O 6 -benzylguanine is currently in clinical trials in the United States as an adjuvant in combination with the chloroethylating agent 1, 3-bis (2-chloroethyl)-1-nitrosourea (BCNU) and the methylating agent temozolomide. A similar alkyltransferase inactivator, O 6 -(4-bromothenyl) guanine is in clinical trials in the UK. This technology is directed to the discovery of a new class of potent alkyltransferase inactivators, based on folate ester derivatives of O 6 -benzyl-2′-deoxyguanosine and of O 6 -[4-(hydroxymethyl)benzyl] guanine. All the folate ester derivatives of O 6 -benzyl-2′-deoxyguanosine were able to sensitize human tumor cells to killing by 1, 3-bis (2-chloroethyl)-1-nitrosourea with O 6 -benzyl-3′-O-[γ-folyl]-2′-deoxyguanosine being the most active. The 3′ ester was found to be more potent than the 5′ ester and was more than an order of magnitude more active than O 6 - benzylguanine, which is currently in clinical trials. Applications Promising candidates as chemotherapy adjuvants for the treatment of cancer. Therapeutic application for drug resistant tumors where acquired resistance is caused by O 6 -alkylguanine-DNA alkyltransferase. Advantages The folate ester derivatives are highly water soluble. Conjugation of folic acid to an alkyltransferase inactivating compound should allow targeting of delivery to cells that express folate receptor as many tumor cells are known to do. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Drs. Gary Pauly (NCI), Robert C. Moschel (NCI), Sahar Javanmard (NCI), et al. Patent Status: This technology consists of U.S. Provisional Application No. 60/915,510 foreign equivalents, entitled “Inactivators of O 6 -Alkylguanine-DNA Alkyltransferase” (HHS Reference No. E-200-2007/0). Related Technology: HHS Reference No. E-274-2003/0, entitled “2-Amino-O 4 -Substituted Pteridines and Their Use as Inactivators of O 6 -Alkylguanine-DNA Alkyltransferase”. Licensing Status: Available for exclusive and non-exclusive licensing. Licensing Contact: Adaku Nwachukwu, J.D.; 301/435-5560; madua@mail.nih.gov. Papilloma Pseudovirus for Detection and Therapy of Tumors Description of Technology: There is extensive literature on the use of viral vectors, particularly those based on the adenovirus and AAV, to increase the potency of anti-tumor gene therapy. However, these approaches have had limited success because of limited anti-tumor effects and unacceptable toxicity. This invention describes the use of papillomavirus pseudoviruses (PsV) as a gene transfer technology and a tumor diagnostic method. Preliminary studies showed that PsV bind to cells that were transplanted with human ovarian tumor (Shin-3) while normal tissues were not affected. PsV does not infect several other normal intact tissues but continues to selectively infect additional cell types that are damaged. Additionally, the inventors have constructed oligoT PsV vectors that can be engineered to express certain cytotoxic genes to induce tumor regression and simultaneous increase human papilloma virus' immunogenicity. This technology could be an effective anti-tumor therapy because it has shown increased infection of compromised cells with an inability to infect normal cells thereby reducing potential toxicity to patients. In addition to a potential anti-cancer therapeutic, this technology could also be used as a diagnostic tool in the detection of tumor masses. Detection can be achieved through the use of fluorescent dye coupled particles of PsV that have preferential binding to tumor tissues and not normal tissues. Applications Method to treat and selectively target cancer with limited toxicity. Method to accurately diagnose cancer. Anti-tumor therapeutic vaccines. Anti-tumor cytoxic gene therapy constructs. Market An estimated 1,444,920 new cancer cases in 2007. 600,000 cancer deaths in the U.S. in 2006. It is estimated that market for cancer drugs would double to $50 billion a year in 2010 from $25 billion in 2006. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Jeffrey Roberts, John T. Schiller, Douglas R. Lowy (NCI). Publications 1. CB Buck, et al. Generation of HPV pseudovirions using transfection and their use in neutralization assays. Methods Mol Med. 2005;119:445-462. 2. CB Buck, et al. Efficient intracellular assembly of papillomaviral vectors. J Virol. 2004 Jan;78(2):751-757. Patent Status: U.S. Provisional Application No. 60/928,495 filed 08 May 2007 (HHS Reference No. E-186-2007/0-US-01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Jennifer Wong; 301/435-4633; wongje@mail.nih.gov. New Synthetic Variants of 2-(4-isothiocyanatobenzyl)-6-methyldiethylenetriamine Pentaacetic Acid (1B4M-DTPA): Novel Macromolecular MRI Contrast Agents Description of Technology: The present invention describes the synthesis and use of two protected variants of the 2-(4-isothiocyanatobenzyl)-6-methyldiethylenetriamine pentaacetic acid (1B4M-DTPA) (also known as the commercial bifunctional chelator, tiuxetan), bearing either an isothiocyanate or a succinimidyl ester moiety, respectively. These molecules were synthesized for the following uses: (1) Use in the introduction of the chelator to the N-terminus of peptides, aptamers, PNA, etc. wherein deprotection or cleavage from resin or solid phase support of the product is possible and (2) introduction of the chelator to macromolecular structures such as dendrimer wherein this is accomplished in organic solvents eliminating the gross inefficiency of the prior aqueous methods. In both uses, the elimination or delay of any aqueous chemistry steps in the synthesis process obviates the possibilities of contamination by spurious metals. Metal contaminations could compromise latter radiolabeling or can also hinder the introduction of paramagnetic ions such as Gd(II1) for MRI applications. The chemistry used in this synthetic process is very flexible and provides the basis for an extensive list of conjugation functional groups to be introduced. Comparative MR imaging with these dendrimer based molecules revealed equivalent enhancement of the vessels and organs such as the kidney and liver. Applications Useful in the conjugation of nearly all peptides for targeting antigens/peptides associated with cancers. Useful for modification of macromolecules such as dendrimer, carbon tubes, etc., for labeling with radioactive metal ions suitable for imaging and/or therapy and paramagnetics for MRI. Advantages The chemistry is very flexible and provides the basis for an extensive list of conjugation functional groups to be introduced. The elimination of aqueous chemistry steps obviates the possibilities of contamination by spurious metals that could compromise subsequent radiolabeling. The elimination of aqueous steps aids in the introduction of paramagnetic ions such as Gd(III) for MRI applications. The general synthesis process provides a procedure for preparing dendrimer-based MR agents with higher yields and efficiency while enhancing versatility. Benefits: In spite of advances in cancer therapeutics and diagnostics, more than 600,000 cancer deaths are estimated to occur in 2007. Early and accurate detection is a key component of successful clinical management of cancer. This technology can contribute to the development of better MRI agents for diagnosing cancer and thus improve overall survival and quality of life of patients suffering from cancer. Inventors: Drs. Martin Brechbiel and Heng Xu (NCI). Development Status: Synthesis process and data available. Patent Status: U.S. Provisional Application No. 60/864,503 filed 06 Nov 2006 (HHS Reference No. E-226-2006/0-US-01). Publication: H Xu, CA Regino, M Bernardo, Y Koyama, H Kobayashi, PL Choyke, MW Brechbiel. Toward improved syntheses of dendrimer-based magnetic resonance imaging contrast agents: New bifunctional diethylenetriaminepentaacetic acid ligands and nonaqueous conjugation chemistry. J Med Chem. 2007 Jul 12;50(14):3185-3193. Epub 2007 Jun 7. Licensing Contact: Mojdeh Bahar; 301/435-2950; baharm@mail.nih.gov. Methods and Compositions for Treating FUS1 Related Disorders Description of Technology: The FUS1 gene residing in the 3p21.3 chromosome region may function as a tumor suppressor gene. In animal models, disruption of FUS1 is associated with an increased frequency of spontaneous vascular tumors and signs of autoimmune disease. The investigators have in vivo data that demonstrate that FUS1 null mutants show a consistent defect in NK cell maturation that correlate with changes in the expression of IL-15. Injection of IL-15 into FUS1 knockout mice completely rescued the NK cell maturation defect suggesting that FUS1 plays an important role in the development and activation of the mammalian immune system. Applications Method to treat cancer, autoimmune diseases, and immune disorders such as HIV. Method to boost immunity in conjunction with cancer and immune disorder therapies. Method to diagnose FUS1 related disorders. Animal model to study anti-tumor response and autoimmunity. Market An estimated 1,444,920 new cancer diagnoses in the U.S. in 2007. 600,000 deaths caused by cancer in the U.S. in 2006. Cancer is the second leading cause of death in United States. It is estimated that market for cancer drugs would double to $50 billion a year in 2010 from $25 billion in 2006. An estimated 8.5 million Americans are afflicted with autoimmune diseases. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Michael I. Lerman, et al. (NCI). Publication: AV Ivanova, et al. Autoimmunity, spontaneous tumourigenesis, and IL-15 insufficiency in mice with a targeted disruption of the tumour suppressor gene Fus1. J Path. 2007 Apr;211(5):591-601. Patent Status: PCT Patent Application No. PCT/US2006/026533 (HHS Reference No. E-137-2005/0-PCT-02). 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 Basic Research Laboratory is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize cancer and immune disorder therapies Please contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information. Tumor Suppressor Genes Description of Technology: Members of the inhibitor of growth (ING) family of tumor suppressor genes are involved in the regulation of diverse processes including cell cycle progression, apoptosis, and DNA repair as important cofactors of p53. ING members contain a highly evolutionary conserved sequence common in chromatin-regulating proteins, and there are overlapping functions between ING family members in negative regulation of cell growth as well as a dependent regulation between various ING members and p53. Available for licensing are compositions for new tumor suppressor designated p28ING5, p33ING2, and p47ING3 (pING). Overexpression of these proteins has been shown to inhibit cell proliferation in human cancer cells lines, and these characteristics suggest that they may have important implications in cancer diagnosis and therapy. These compositions include nucleic acids, polypeptides, and antibodies that specifically bind to their respective ING members. Also claimed are cancer diagnostic and treatment methods. Applications Methods to treat and diagnose cancer with pING compositions. Methods to identify pING modulating agents. Research tool to study cell cycle regulation and p53 pathways. pING compositions. Market Cancer is the second leading cause of death in United States. An estimated 600,000 deaths caused by cancer in 2006. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Curtis C. Harris (NCI), et al. Publications 1. T Okano, et al. Alterations in novel candidate tumor suppressor genes, ING1 and ING2 in human lung cancer. Oncol Rep. 2006 Mar;15(3):545-549. 2. H Kataoka, et al. ING1 represses transcription by direct DNA binding and through effects on p53. Cancer Res. 2003 Sep 15;63(18):5785-5792. 3. M Nagashima, et al. A novel PHD-finger motif protein, p47ING3, modulates p53-mediated transcription, cell cycle control, and apoptosis. Oncogene. 2003 Jan 23;22(3):343-350. 4. M Nagashima, et al. DNA damage-inducible gene p33ING2 negatively regulates cell proliferation through acetylation of p53. Proc Natl Acad Sci USA. 2001 Aug 14;98(17):9671-9676. Patent Status U.S. Patent No. 6,790,948 issued 14 Sep 2004 (HHS Reference No. E-272-1998/0-US-02) U.S. Patent Application No. 10/868,270 filed 14 Jun 2004 (HHS Reference No. E-272-1998/0-US-03) PCT Patent Application No. PCT/US2001/04425 filed 09 Feb 2001 (HHS Reference No. E-254-1999/0-PCT-02) U.S. Patent Application No. 10/203,532 filed 02 Aug 2002 (HHS Reference No. E-254-1999/0-US-03) PCT Patent Application No. PCT/US2003/02174 filed 23 Jul 2003 (HHS Reference No. E-300-2001/0-PCT-02) U.S. Patent Application No. 10/502,431 filed 22 Jul 2004 (HHS Reference No. E-300-2001/0-US-03) Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Jennifer Wong; 301/435-4633; wongje@mail.nih.gov. Peptide Inhibitor of Cyclin Dependent Kinase 4 (CDK4) Derived From MyoD Description of Technology: This invention pertains to cell cycle regulation and the activity of the G1 cyclin-dependent kinase 4 (CDK4). The invention describes a 15 amino acid peptide and variants thereof derived from muscle determination factor, MyoD, which is an inhibitor of the CDK4. CDK4 is one of a number of cyclin-dependent kinases which control progression through the cell cycle through their ability to phosphorylate particular substrates at the correct phase of the cell cycle. CDK4 has been shown to be involved in cell cycle control through its ability to regulate the activity of the retinoblastoma protein, pRb, an activator of genes essential for cell division. Inhibitors of the cyclin-dependent kinases, such as the peptides described in this invention, prevent cell cycle progression and induce cells to exit the cell cycle into the Go state. The peptides described in this invention prevent the phosphorylation of pRb by CDK4, an obligate step for entry into the cell cycle. Osteosarcomas and habdosarcomas are two types of tumors known to over-express pRb. The inhibitor described in this invention may be useful in treating these cancers or other diseases which have been specifically linked to over-expression of active pRb. Applications Method to treat proliferative disorders, including cancer. Anti-proliferative therapeutics. Research tool to study the cell cycle. Advantages: Expression of this peptide either as a fusion protein with GST or GFP results in the cessation of cell growth. Market An estimated 1,444,920 new cancer diagnoses in the U.S. in 2007. 600,000 deaths caused by cancer in the U.S. in 2006. Cancer is the second leading cause of death in the United States. It is estimated that market for cancer drugs would double to $50 billion a year in 2010 from $25 billion in 2006. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Bruce M. Paterson and Jian-min Zhang (NCI). Publication: JM Zhang, et al. Coupling of the cell cycle and myogenesis through the cyclin D1-dependent interaction of MyoD with cdk4. EMBO J. 1999 Feb 15;18(4):926-933. Patent Status: U.S. Patent Application No. 10/018,964 filed 11 Apr 2002, claiming priority to 18 Jun 1999 (HHS Reference No. E-153-1998/0-US-03). 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's Laboratory of Biochemistry and Molecular Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the described cdk4 inhibitory peptides or equivalent peptide mimetics. Please contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information. Dated: September 6, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-18192 Filed 9-14-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders And Stroke; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Neurological Disorders And Stroke, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. Date: September 30-October 2, 2007. Time: September 30, 2007, 7 p.m. to 10 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Susquehanna/Severn Room, Bethesda, MD 20814. Time: October 1, 2007, 8:30 a.m. to 6:30 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Conference Room A, Rockville, MD 20852. Time: October 2, 2007, 8:30 a.m. to 12 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Susquehanna/Severn Room, Bethesda, MD 20814. Contact Person: Alan P. Koretsky, PhD, Scientific Director, Division of Intramural Research. National Institute Of Neurological Disorders & Stroke, NIH, 35 Convent Drive, Room 6A 908, Bethesda, MD 20892, 301-435-2232, koretskya@ninds.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS). Dated: September 6, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-4566 Filed 9-14-07; 8:45 am]