Department of Health and Human Services August 14, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to `Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products,''' dated August 2006. The draft guidance document, when finalized, is intended to amend FDA's ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated January 2002. This draft guidance, which is a level I guidance document, would add to the January 2002 guidance a donor deferral recommendation for donors who have received a transfusion of blood or blood components in France since 1980. After we review comments received on this draft guidance, we intend to incorporate this donor deferral recommendation and reissue the revised January 2002 guidance as a level II guidance document for immediate implementation.

In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act), the National Institutes of Health (NIH) hereby publishes a notice of a proposal to alter System of Records, No. 09-25-0168, ``Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.'' NIH proposes a new legal authority for the maintenance of the System to read: 15 U.S.C. 3710, 3710a, 3710c & 3710d and 35 U.S.C. 200 et seq. provide authority to maintain the records; 37 CFR part 401 ``Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements;'' 37 CFR part 404 ``Licensing of Government Owned Inventions;'' and 45 CFR part 7 ``Employee Inventions.'' NIH is also proposing new routine uses for this System. These records will be maintained by the Office of Technology Transfer (OTT), OIR/OD; Office of Financial Management (OFM), OD; Office of Reports and Analysis (ORA), OER/OD; Health and Human Services Technology Development Coordinators and HHS Contract Attorneys who retain files supplemental to the records maintained by the Office of Technology Transfer; and the Extramural Inventions and Technology Resources Branch, OPERA/OER/OD.

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.

This is notice, in accordance with 35 U.S.C. Sec. 209(c)(1) and 37 CFR Sec. (a)(1)(I), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in: PCT patent application PCT/US2004/041256 filed December 9, 2004, entitled: ``Methods for Suppressing an Immune Response or Treating a Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], to Sahajanand Medical Technologies Pvt. Ltd., registered as a private limited company in accordance with the Companies Act of India, having a principle place of business in Surat, India and U.S. headquarters in Gaithersburg, Maryland. The field of use may be limited to the use of 2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the treatment and prevention of stenosis and restenois and/or other proliferative disorders. The United States of America is an assignee of the patent rights in these inventions.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH), is giving public notice that the agency proposes to request reinstatement of an information collection activity for which approval has expired. Proposed Collection: Title: NIDDK Information Clearinghouses Customer Satisfaction Survey. Type of Information Requested: Reinstatement, with change, of a previously approved collection for which approval has expired. The OMB control number 0925-0480 expired on July 31, 2003. Need and Use of Information Collection: NIDDK is conducting a survey to access the efficiency and effectiveness of services provided by NIDDK's three clearinghouses: the National Diabetes Information Clearinghouse (NDIC); the National Digestive Diseases Information Clearinghouse (NDDIC); and the National Kidney and Urologic Diseases Information Clearinghouse (NKUDRIC). The survey responds to Executive Order 12821, ``Setting Customer Service Standards,'' which requires agencies and departments to identify and survey their ``customers to determine the kind and quality of service they want and their level of satisfaction with existing services.'' Frequency of Response: On occasion. Affected Public: Individuals or households; business and for profit organizations; not-for-profit agencies, Type of Respondents: Physicians, healthcare professionals, patients, family and friends of patients. The annual reporting burden is as follows: estimated number of respondents: 5,112; estimated number of responses per respondent: 1; estimated average burden hours per response: 0.025; and estimated total annual burden hours requested: 128. The annualized costs to respondents are estimated at $6,400. There are no capital costs to report. There are no operating or maintenance costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of the information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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.

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.