Federal Register / Vol. 74, No. 125 / Wednesday, July 1, 2009 / Notices 31457

Name of Committee: Center for Scientific and/or exclusively licensed to the of the license would not be consistent Review Special Emphasis Panel, Fellowships Government of the United States of with the requirements of 35 U.S.C. 209 in Language and Communication. America. and 37 CFR Part 404.7. Date: July 6, 2009. The prospective exclusive license Applications for a license in the field Time: 3 p.m. to 5 p.m. territory may be worldwide, and the of use filed in response to this notice Agenda: To review and evaluate grant applications. field of use may be limited to: will be treated as objections to the grant Place: Hyatt Regency Chicago, 151 East All fields of use, both human and of the contemplated exclusive license. Wacker Drive, Chicago, IL 60601. veterinary, covered under the above listed Comments and objections submitted to Contact Person: Dana Jeffrey Plude, PhD, patents, for the life of these patents; the this notice will not be made available Scientific Review Officer, Center for selective ablation of pain-sensing neurons for public inspection and, to the extent Scientific Review, National Institutes of using vanilloid receptor agonists including permitted by law, will not be released Health, 6701 Rockledge Drive, Room 3176, resiniferatoxin and capsaicin using localized under the Freedom of Information Act, MSC 7848, Bethesda, MD 20892. 301–435– delivery, including intrathecal and 5 U.S.C. 552. 2309. [email protected]. intraganglionic injection. This notice is being published less than 15 Dated: June 19, 2009. days prior to the meeting due to the timing DATES: Only written comments and/or Richard U. Rodriguez, limitations imposed by the review and applications for a license which are Director, Division of Technology Development funding cycle. received by the NIH Office of and Transfer, Office of Technology Transfer, (Catalogue of Federal Domestic Assistance Technology Transfer on or before National Institutes of Health. Program Nos. 93.306, Comparative Medicine; August 31, 2009 will be considered. [FR Doc. E9–15576 Filed 6–30–09; 8:45 am] 93.333, Clinical Research, 93.306, 93.333, ADDRESSES: Requests for copies of the BILLING CODE 4140–01–P 93.337, 93.393–93.396, 93.837–93.844, patent application, inquiries, comments, 93.846–93.878, 93.892, 93.893, National and other materials relating to the Institutes of Health, HHS) contemplated exclusive license should DEPARTMENT OF HEALTH AND Dated: June 22, 2009. be directed to: Norbert Pontzer, Senior HUMAN SERVICES Anna Snouffer, Licensing and Patenting Manager, Office Deputy Director, Office of Federal Advisory of Technology Transfer, National Food and Drug Administration Committee Policy. Institutes of Health, 6011 Executive [Docket No. FDA–2009–N–0294] [FR Doc. E9–15584 Filed 6–30–09; 8:45 am] Boulevard, Suite 325, Rockville, MD BILLING CODE 4140–01–M 20852–3804; Telephone: (301) 435– Regulation of Tobacco Products; 5502; Facsimile: (301) 402–0220; E-mail: Request for Comments [email protected]. AGENCY: DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Pain Food and Drug Administration, HUMAN SERVICES pathways, including those mediating HHS. severe pain associated with chronic and ACTION: Notice; request for comments. National Institutes of Health terminal diseases, have unique receptors SUMMARY: The Food and Drug (termed vanilloid or more recently Prospective Grant of Exclusive Administration (FDA) is establishing a TRPV1) that mediate the transmission of License: Pain Control by Selective public docket to obtain information on nociceptive sensory signals from the Ablation of Pain-Sensing Neurons by the implementation of the Family periphery through the spinal cord to the Administration of Resiniferatoxin Smoking Prevention and Tobacco brain. Compounds such as capsaicin Control Act. FDA is establishing this AGENCY: from hot peppers activate pain neurons National Institutes of Health, docket in order to provide an by opening cation channels linked to Public Health Service, HHS. opportunity for all interested parties to TRPV1 receptors on nerve terminals and ACTION: Notice. provide information and share views on cell bodies. NIH inventors discovered the implementation of the new law. SUMMARY: This is notice, in accordance that resiniferatoxin (RTX) is an with 35 U.S.C. 209(c)(l) and 37 CFR Part extremely potent TRPV1 receptor DATES: Submit written or electronic 404.7(a)(l)(i), that the National Institutes agonist that produces a calcium comments by September 29, 2009. of Health, Department of Health and overload and selectively degeneration of ADDRESSES: Submit electronic Human Services, is contemplating the pain neurons when cell body TRPV1 comments to http:// grant of an exclusive patent license to receptors are activated by RTX. www.regulations.gov. practice the inventions embodied in Intrathecal or intraganglionic Submit written comments to the PCT Patent Application PCT/US2001/ administration of RTX can thus cause Division of Dockets Management (HFA– 09425 [HHS Ref. E–109–2000/0–PCT– the permanent and selective destruction 305), Food and Drug Administration, 01], US Patent Application 10/472,874 of the pain neurons in the CNS 5630 Fishers Lane, rm. 1061, Rockville, [HHS Ref. E–109–2000/0–US–02], both displaying TRPV1 receptors. This MD 20852. entitled ‘‘Molecular Neurochirurgerie invention allows pain control in human FOR FURTHER INFORMATION CONTACT: Erik for Pain Control Administering Locally and other animals with intractable pain Mettler, Office of Policy, Food and Drug Capsaicin or Resiniferatoxin’’, and through selective ablation of pain Administration, 10903 New Hampshire Canadian Patent Application 2442049 pathway neurons. Ave., WO1, rm. 4300, Silver Spring, MD [HHS Ref. E–109–2000/0–CA–03] The prospective exclusive license will 20993, 301–796–4830, FAX: 301–847– entitled ‘‘Selective Ablation of Pain- be royalty bearing and will comply with 3541, [email protected]. Sensing Neurons by Administration of a the terms and conditions of 35 U.S.C. SUPPLEMENTARY INFORMATION: Vanilloid Receptor Agonist’’, and all 209 and 37 CFR Part 404.7. The continuing applications and foreign prospective exclusive license may be I. Background counterparts, to Sherrington granted unless within sixty (60) days Tobacco products are responsible for Pharmaceuticals, which has offices in from the date of this published notice, more than 430,000 deaths each year. New York, N.Y. The patent rights in the NIH receives written evidence and The Centers for Disease Control and these inventions have been assigned to argument that establishes that the grant Prevention (CDC) report an estimated 60

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million adults smoke cigarettes in the in response to this notice using these ACTION: 60-Day Notice and request for United States, even though this behavior general categories: comments: New information collection will result in death or disability for half Federal, State, and local government request 1670–NEW. of all regular users. Paralleling this collaboration; enormous health burden is the New product submission and SUMMARY: The Department of Homeland economic burden of tobacco use, which approval; Security, National Protection and is estimated to total $193 billion Product ingredient disclosure; Programs Directorate, Office of annually in medical expenditures and Prevention; Infrastructure Protection, Infrastructure lost productivity. Curbing the Tobacco use by specific groups Security Compliance Division (ISCD) significant adverse consequences of including minors, women, and will be submitting the following tobacco use is one of the most important racial and ethnic minority information collection request (ICR) to public health goals of our time. populations; the Office of Management and Budget On June 22, 2009, the President Tobacco addiction; (OMB) for review and clearance in signed H.R. 1256, the Family Smoking Smoking cessation; accordance with the Paperwork Prevention and Tobacco Control Act, Data collection; Reduction Act of 1995. The information into law. The Family Smoking Products with ‘‘reduced harm/risk’’ collection is a new information Prevention and Tobacco Control Act claims; collection. The purpose of this notice is grants FDA important new authority to Enforcement; to solicit comments during a 60-day regulate the manufacture, marketing, Research and testing; public comment period prior to the and distribution of tobacco products to Advertising and marketing of tobacco submission of this collection to OMB. protect the public health generally and products; The submission describes the nature of to reduce tobacco use by minors. The Label statements and warnings the information collection, the Family Smoking Prevention and (including graphic warnings); categories of respondents, the estimated Tobacco Control Act authorizes FDA to Tobacco product standards (including burden and cost. require disclosure of tobacco product flavors, ingredients, etc.); ingredients and additives; regulate Sale and distribution of tobacco DATES: Comments are encouraged and ‘‘modified risk’’ tobacco products; create products; will be accepted until August 31, 2009. standards for tobacco products, Manufacturing restrictions and This process is conducted in accordance including standards for the reduction or facilities controls; and with 5 CFR 1320.8. elimination of certain constituents; Other. ADDRESSES: Interested persons are restrict sales, distribution, advertising, III. Comments invited to submit comments on the and promotion of tobacco products; and proposed information collection require stronger health warnings on Interested persons may submit to the through Federal Rulemaking Portal at packaging. The Family Smoking Division of Dockets Management (see http://www.regulations.gov. Follow the Prevention and Tobacco Control Act ADDRESSES) written or electronic instructions for submitting comments. also requires FDA to issue its 1996 final comments regarding this document. Comments must be identified by docket regulation restricting the sale and Submit a single copy of electronic number DHS–2009–0035. distribution of nicotine-containing comments or two paper copies of any cigarettes and smokeless tobacco mailed comments, except that FOR FURTHER INFORMATION CONTACT: A products. The rule contains provisions individuals may submit one paper copy. copy of this ICR, with applicable designed to limit young people’s access Comments are to be identified with the supporting documentation, may be to tobacco products, as well as docket number found in brackets in the obtained through Federal Rulemaking restrictions on marketing to curb the heading of this document. Received Portal at http://www.regulations.gov. appeal of these products to minors. comments may be seen in the Division SUPPLEMENTARY INFORMATION: We are requesting comments that will of Dockets Management between 9 a.m. inform strategies to protect the public and 4 p.m., Monday through Friday. Program Description health as we implement this new authority. A copy of the Family Dated: June 25, 2009. The Chemical Facility Anti-Terrorism Smoking Prevention and Tobacco Jeffrey Shuren, Standards (CFATS), 6 CFR Part 27, are Control Act is available on the agency’s Associate Commissioner for Policy and the Department’s regulations under Web site at http://www.fda.gov/tobacco. Planning. Section 550 governing security at high- [FR Doc. E9–15549 Filed 6–30–09; 8:45 am] risk chemical facilities. CFATS II. Request for Comments and BILLING CODE 4160–01–S represents a national-level effort to Information minimize terrorism risk to such We are particularly interested in facilities. Its design and implementation comments on the approaches and DEPARTMENT OF HOMELAND balance maintaining economic vitality actions the agency should consider SECURITY with securing facilities and their initially to increase the likelihood of surrounding communities. The reducing the incidence and prevalence [Docket No. DHS–2009–0035] regulations were designed, in collaboration with the private sector and of tobacco product use and protecting National Protection and Programs the public health. Although the agency other stakeholders, to take advantage of Directorate, Office of Infrastructure protective measures already in place will not respond to specific suggestions, Protection; Submission for Chemical we will consider them in establishing and to allow facilities to employ a wide Facility Anti-Terrorism Standards range of tailored measures to satisfy the the new Center for Tobacco Products Information Collection 1670–NEW. and in implementing the Family regulations’ Risk-Based Performance Smoking Prevention and Tobacco AGENCY: National Protection and Standards (RBPS). Control Act. In the future, we intend to Programs Directorate, Office of The instruments within this solicit public input on specific issues. Infrastructure Protection, Infrastructure collection will be used to manage the Please organize any comments you have Security Compliance Division, DHS. CFATS program.

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