Notices. Notice

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2005P-0300 and 2005P-0319] Determination That PHENERGAN (Promethazine Hydrochloride) Tablets, 12.5 Milligrams and 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined that PHENERGAN (promethazine hydrochloride (HCl)) tablets, 12.5 milligrams

(mg)and 50 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for promethazine HCl tablets, 12.5 mg and 50 mg. FOR FURTHER INFORMATION CONTACT: Quynh Nguyen, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (the 1984 amendments) (Public Law 98-417), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, are the subject of approved NDA 7-935 held by Wyeth Pharmaceuticals, Inc. (Wyeth). PHENERGAN (promethazine HCl) tablets are indicated for, among other things, certain types of allergic reactions and sedation. Wyeth's NDA 7-935 was originally approved in 1951. In 1971, under the Drug Efficacy Study Implementation (DESI), FDA concluded that promethazine HCl tablets were effective or probably effective for the indications described in the **Federal Register** notice published on June 18, 1971 (DESI 6290, 36 FR 11758). Wyeth discontinued sale of the 12.5 mg and 50 mg tablets in 2004. Amide Pharmaceutical, Inc., and Peter S. Reichertz submitted citizen petitions dated July 28, 2005 (Docket No. 2005P-0300/CP1), and August 10, 2005 (Docket No. 2005P-0319/CP1), respectively, under 21 CFR 10.30, requesting that the agency determine, as described in § 314.161, whether PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, were withdrawn from sale for reasons of safety or effectiveness. The agency has determined that Wyeth's PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, were not withdrawn from sale for reasons of safety or effectiveness. In support of this finding, we note that promethazine HCl is a widely used product that has been marketed for many decades in many dosage forms. FDA has independently evaluated relevant literature and data for adverse event reports and has found no information that would indicate that PHENERGAN tablets, 12.5 mg and 50 mg, were withdrawn for reasons of safety or effectiveness. After considering the citizen petitions (including comments submitted) and reviewing agency records, FDA determines that for the reasons outlined previously, Wyeth's PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to PHENERGAN (promethazine HCl) tablets, 12.5 mg and 50 mg, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for the approval of ANDAs. Dated: June 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11072 Filed 7-13-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0266] Medical Devices; Anesthesiology Devices; Neurological Devices; Denial of Request for Change in Classification of Breathing Frequency Monitor and Electroencephalograph AGENCY: Food and Drug Administration, HHS. ACTION: Notice; denial of petition. SUMMARY: The Food and Drug Administration

(FDA)is denying the petitions submitted by IM Systems to reclassify the SleepCheck, the ActiTrac, and PAM-RL devices from class II (special controls) to class I (general controls). The agency is denying the petitions because the petitioner failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190. SUPPLEMENTARY INFORMATION: I. Classification and Reclassification of Devices Under the Medical Devices Amendments of 1976 (the 1976 Amendments) The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 *et* *seq* .), as amended by the 1976 amendments (Public Law 94-295), the Safe Medical Devices Act of 1990

(SMDA)(Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices under the 1976 amendments are class I (general controls), class II (special controls), and class III (premarket approval). Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the amendments), generally referred to as preamendments devices, are classified after FDA has:

(1)Received a recommendation from a device classification panel (an FDA advisory committee);

(2)published the panel's recommendation for comment, along with a proposed regulation classifying the device; and

(3)published a final regulation classifying the device. FDA has classified most preamendment devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Postamendments devices remain in class III and require premarket approval, unless:

(1)The device is reclassified into class I or II;

(2)FDA issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the act; or

(3)FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807, subpart E of the regulations. Reclassification of classified preamendments devices is governed by section 513(e) of the act. This section of the act provides that FDA may, by rulemaking, reclassify a device based on “new information.” The reclassification can be initiated by FDA or by the petition of an interested person. The term “new information,” as used in section 513(e) of the act includes information developed as a result of a reevaluation of the data before the agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., *Holland Rantos* v. *United States Department of Health, Education, and Welfare* , 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); *Upjohn* v. *Finch* , 422 F.2d 944 (6th Cir. 1970); *Bell* v. *Goddard* , 366 F.2d 177 (7th Cir. 1966).) Reevaluation of the data previously before the agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see *Bell* v. *Goddard* , supra, 366 F.2d at 181; *Ethicon, Inc. v. FDA* , 762 F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in “medical science.” (See *Upjohn* v. *Finch* , supra, 422 F.2d at 951.). Regardless of whether data before the agency are past or new data, the “new information” upon which reclassification under section 513(e) of the act is based must consist of “valid scientific evidence,” as defined in section 513(a)(3) of the act and § 860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., *General Medical Co.* v. * FDA* , 770 F.2d 214 (D.C. Cir. 1985); *Contact Lens Assoc.* v. *FDA* , 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)). In addition, § 860.123(a)(6) (21 CFR 860.123(a)(6)) provides that a reclassification petition must include a “full statement of the reasons, together with supporting data satisfying the requirements of § 860.7, why the device should not be classified into its present classification and how the proposed classification will provide reasonable assurance of the safety and effectiveness of the device.” (§ 860.123(a)(6).) The “supporting data satisfying the requirements of § 860.7” referred to is “valid scientific evidence.” For the purpose of reclassification, the valid scientific evidence upon which the agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA. (See section 520(c) of the act (21 U.S.C. 360j(c).) II. Reclassification Under the SMDA SMDA further amended the act to change the definition of a class II device. Under the SMDA, class II devices are those devices that cannot be classified into class I because general controls by themselves are not sufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the agency deems necessary (Section 513(a)(1)(B) of the act). Thus, the definition of a class II device was changed from “performance standards” to “special controls.” In order for a device to be reclassified from class II to class I, the agency must determine that special controls are not necessary to provide reasonable assurance of its safety and effectiveness. III. Background In the **Federal Register** of July 16, 1982 (47 FR 31130), FDA issued a final rule classifying the breathing frequency monitor into class II (§ 868.2375). The preamble to the proposal to classify the device included the recommendation of the Anesthesiology Device Panel. The Panel identified the following risks to health associated with the use of the devices:

(1)Failure of the device or alarm may cause abnormal conditions to go undiscovered and result in serious patient injury or death and

(2)if the device does not monitor the patient's breathing frequency accurately he/she may receive incorrect therapy. In the **Federal Register** of September 4, 1979 (44 FR 51726), FDA issued a final rule classifying the electroencephalograph into class II (§ 882.1400 (21 CFR 882.1400)). The preamble to the proposal to classify the device included the recommendation of the Neurological Device Panel. The Panel's recommendation identified the following risks to health associated with use of the device:

(1)Misuse of the device as a result of using untrained persons may result in improper diagnosis and treatment;

(2)misdiagnosis of the physiological symptoms could cause a misdiagnosis and lead to improper treatment of the patient's neurological condition; and

(3)electrical shock could be associated with current leakage of the device, making it hazardous because the device makes a low resistance contact with the patient. On August 18, 2004, IM Systems submitted three petitions requesting FDA to reclassify the SleepCheck device, the ActiTrac, and PAM-RL devices from class II to class I (Ref. 1). Under 21 CFR 860.120(b) the reclassification of any device within a generic type of device causes the reclassification of all substantially equivalent devices within that generic type of device. IV. Device Description The SleepCheck device is classified within the generic type of device called the breathing frequency monitor (§ 868.2375). FDA identifies the breathing frequency monitor as a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. The ActiTrac and PAM-RL devices are classified within the generic type of device called the electroencephalograph (§ 882.1400). FDA identifies the electroencephalograph as a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. V. FDA's Decision After reviewing both the reclassification petitions and the petitioner's responses to our subsequent requests for information, FDA has found that the petitions do not contain any valid scientific evidence to support a conclusion that general controls would provide reasonable assurance of the devices' safety and effectiveness for their intended uses or that special controls are not necessary to provide reasonable assurance of the safety and effectiveness of the devices. Therefore, FDA is denying the petitions for reclassification of these device types. VI. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Petitions from IM Systems for the reclassification of the SleepCheck device, PAM-RL device, and the ActiTrac device, dated August 18, 2004. Dated: July 5, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-11115 Filed 7-13-06; 8:45 am] BILLING CODE 4160-01-S 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. Method for Expanding Allodepleted Antigen Specific T Cells *Description of Technology:* Available for licensing and commercial development are methods of producing a population of purified non-alloreactive antigen-specific T cells that recognize an antigen of interest. Thus, the population of donor T cells can be used to produce immune response against the antigen of interest (e.g., cytomegalovirus) in a recipient without producing an immune response to the recipient. Currently available methods for isolating and expanding antigen-specific T cells can be inefficient and produce populations of cells that include donor-reactive T cells. The present method enables rapid production of populations of T cells that recognize an antigen of interest but are depleted for alloreactive T cells: A population of donor T cells is contacted with a population of irradiated recipient antigen presenting cells (T-APCs) to produce a population of alloreactive T cells. The alleractive T cells are removed by purification with an antibody that specifically binds a cell surface marker (e.g., CD25, CD69, CD38 or CD71). The population of allo-depleted donor cells is then contacted with donor T antigen presenting cells (T-APCs) expressing an antigen of interest and produces a population of donor allo-depleted activated CD4 and CD8 T cells. *Applications:* Immune response to opportunistic infectious in immuno-compromised transplant or graft recipients. *Market:*

(1)Cytomegalovirus;

(2)General post-transplant opportunistic infections. *Inventors:* J. Joseph Melenhorst and A. John Barrett (NHLBI). *Publications:* 1. JJ Melenhorst, TH Brummendorf, M Kirby, PM Lansdorp, AJ Barrett. “CD8+T cells in large granular lymphocyte leukemia are not defective in activation- and replication-related apoptosis.” Leuk Res. 2001 Aug;25(8):699-708. 2. H Fujiwara, JJ Melenhorst, F El Ouriaghli, et al.“In vitro induction of myeloid leukemia-specified CD4 and CD8 T cells by CD40 ligand-activated B cells gene modified to express primary granule proteins.” Clin Cancer Res. 2005 Jun 15;11(12):4495-4503. *Patent Status:* U.S. Provisional Application No. 60/804,404 filed 09 Jun 2006 (HHS Reference No. E-136-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Michael A. Shmilovich, Esq.; 301/435-5019; *shmilovm@mail.nih.gov* . *Collaborative Research Opportunity:* The NHLBI Hematology Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a Method for Expanding Allodepleted Antigen Specific T Cells. Please contact Dr. A.J. Barrett at 301/402-4170 or *barrettjj@mail.nih.gov* for more information. A Newly Discovered Bacterium in the Family Acetobacteraceae *Description of Technology:* Available for licensing and commercial development is a newly discovered bacterium in the Acetobacteraceae family. This bacterium was isolated, characterized and grown from lymph nodes of a patient with chronic granulomatous disease (CGD), a rare genetic disorder that impairs the immune system. This Gram-negative bacterium is an aerobic, faculatitive methylotroph that produces yellow pigmented colonies. The closest nucleic acid sequence match was to Gluconacetobacter sacchari (95.7% similarity) of the acetic acid bacteria. The newly descibed bacterium belongs to a new genus and species in the Acetobacteraceae family and was named Granulibacter bethesdenis. Acetobacteraceae are characterized by their ability to convert alcohol (ethanol) to acetic acid in the presence of air. Members of this family are used industrially in the production of vinegar, and are encountered during fermentation of wine. G. bethesdenis can breakdown methanol, formaldehyde, ethanol and their intermediate breakdown products into non-toxic end-products. Examples of non-toxic end-products include carbon dioxide, water, and acetic acid. The invention provides the complete genome sequence from the bacterium. Also included are permission to purify and utilize unique enzymes that the bacteriuum uses to degrade organic materials, for example methanol dehydrogenase, formaldehyde-activating enzyme, and methylenetetrahydrofolate dehydrogenase (NAPD+). *Applications:*

(1)Biodegradation of organic waste;

(2)Microbial fuel cell;

(3)Production of purified polypeptide enzymes for industrial use. *Inventors:* Steven M. Holland (NIAID), Patrick Murray (CC), Adrian M. Zelazny (CC), David E. Greenberg (NIAID). *Publication:* DE Greenberg, L Ding, AM Zelazny, F Stock, A Wong, et al. “A novel bacterium associated with lymphadenitis in a patient with chronic granulomatous disease.” PLoS Pathog 2006 Apr;2(4):e28. Epub 2006 Apr 14, doi: 10.1371/journal.ppat.0020028. (PubMed abstract = *http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16617373&query_hl=1&itool=pubmed_docsum* ). *Patent Status:* U.S. Provisional Application No. 60/788,521 filed 31 Mar 2006 (HHS Reference No. E-083-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Chekesha Clingman, PhD.; 301/435-5018; *clingmac@mail.nih.gov* *Collaborative Research Opportunity:* The NIAID Laboratory of Host Defenses is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Kelly Murphy at 301-451-3523 or *murphykt@niaid.nih.gov* for more information. Fluorescent Imaging and Photodynamic Treatment of Tumors *Description of Technology:* Available for licensing and commercial development are methods and compositions for optically detecting tumors, in particular disseminated intraperitoneal cancers. Unlike exiting detection methods using avidin and/or galactosyl serum albumin (GSA), the current invention allows tumors to be visualized *in situ* , with high sensitivity and without hazardous radioactive probes. The invention also provides methods of treating tumors. The invention describes the labeling of avidin and GSA with fluorophores. The fluorescently labeled agents selectively bind to cells expressing asialoglycoprotein receptors on the surface of tumor cells, such as in tumors of the ovary, stomach, colon or pancreas. Metastatic tumor cells can then be detected endoscopically, laparoscopically, or during surgery with an appropriate imaging system. The fluorescently labeled avidin and GSA can be used diagnostically, but also have an application for treating cancer. Using photoactivatable fluorophores linked to avidin or GSA, free radicals can be produced which results in localized death of tumor cells upon exposure to excitation with the appropriate wavelength. *Applications:*

(1)Optical detection of tumor cells and metastatic nodules;

(2)Photodynamic treatment of tumors. *Inventors:* Hisataka Kobayashi and Peter Choyke (NCI). *Patent Status:* U.S. Provisional Application No. 60/751,429 filed 16 Dec 2005 (HHS Reference No. E-335-2005/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Chekesha Clingman, PhD; 301/435-5018; *clingmac@mail.nih.gov* . *Collaborative Research Opportunity:* The National Cancer Institute *Molecular Imaging Program* is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize tumor specific imaging agents. Please contact Laurie Zipper, Ph.D., at 301-594-4650 or *zipperl@mail.nih.gov* 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. This 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 microbead 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 the same environment that is used for the finding 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-PCF-02). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan O. Ano, Ph.D.; 301-435-5515; *anos@mail.nih.gov.* Methods and Compositions Related to GHS-R Antagonist *Description of Technology:* This invention describes that additional functional role for D-Lys3 GHRP-6 (a known GHS-R antagonist, peptide) as a blocker of two well-known chemokine receptors, namely CCR5 and CXCR4. These receptors are major HIV co-receptors and are critical for HIV binding, fusion and entry into human T cells, monocytes, dendritic cells, and various other cells within the body. Moreover, these receptors and their ligands play a major role in inflammation and a variety of acute and chronic disease states. Overall, these two mammalian chemokine receptors are currently major drug targets for treatment of AIDS, cancer and many immunoregulatory disorders. Many identified antogonists block one or the other receptor. Since D-Lys3 GHRP-6 actually binds and blocks both these chemokines receptors at the same time hindering their activity and HIV infectivity, D-Lys3 GHRP-6 may be a good therapeutic candidate for treatment of AIDS and inflammatory diseases. *Inventors:* Vishwa D. Dixit and Dennis D. Taub (NIA). *Patent Status:* U.S. Provisional application No. 60/773,076 filed 13 Feb 2006 (HHS Reference No. E-017-2004/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Sally Hu, Ph.D., M.B.A.; 301-435-5605; *hus@od.nih.gov.* *Collaborative Research Opportunity:* The National Institute on Aging's 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 Nicole D. Guyton at 301-435-3101 or *darackn@mail.nih.gov* for more information. Dated: July 3, 2006 David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 06-6211 Filed 7-13-06; 8:45 am]

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