Department of Health and Human Services February 17, 2012 – Federal Register Recent Federal Regulation Documents

In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing this information collection by March 5, 2012. NCI is requesting emergency processing of this information collection, pursuant to 5 CFR 1320.13, because NCI cannot reasonably comply with the normal clearance procedures which would cause a delay and likely prevent or substantially disrupt the collection of information. A delay in starting the information collection would hinder the agency in accomplishing its mission to the detriment of the public good. Public harm could result through the loss of critically needed information to understand and reduce the cancer burden from lymphoid malignancies in the Asian population. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: A Multi-Center International Hospital- Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI). Type of Information Collection Request: Emergency. Need and Use of Information Collection: Incidence rates of certain lymphomas have increased in several centers in Asia thereby increasing the cancer burden in these populations, but the causes remain unknown. AsiaLymph is a multi- disciplinary case-control study that will confirm and extend previous findings and yield novel insights into the causes of lymphoma in both Asia and the West. The major postulated risk factors for evaluation in this study are chemical exposures (i.e., organochlorines, trichloroethylene, and benzene) and genetic susceptibility. Other factors potentially related to lymphoma, such as viral infections, ultraviolet radiation exposure, medical conditions, and other lifestyle factors will also be studied. Patterns of key risk factors, including range of exposures, prevalence of exposures, correlations between exposures, and variation in gene regions are of particular interest. Patients from 19 participating hospitals will be screened and enrolled. There will be a one-time computer-administered interview, and patients will also be asked to provide a one-time blood and buccal cell mouth wash sample and lymphoma cases will be asked to make available a portion of their pathology sample. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Newly diagnosed patients with lymphoma or patients undergoing surgery or other treatment for non-cancer related medical issues who live in Hong Kong, Taiwan, and Chengdu and Tianjin, China will be enrolled at treating hospitals. The annual reporting burden is estimated at 3,377 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in US patent application 13/180,111, filed July 11, 2011 (HHS Reference E-205-2010/0-US-02), originated from provisional application 61/363,079 filed July 09, 2010, and entitled ``Photosensitizing Antibody Fluorophore Conjugates for Photo- Immunotherapy'' to Aspyrian Therapeutics, Inc., a company incorporated under the laws of the State of Delaware, having its headquarters in San Diego, California. The United States of America is the assignee of the rights of the above inventions. The field of use may be limited to ``use of photosensitizing antibody-fluorophore conjugate for imaging and photo-immunotherapy of cancer'' and may be further limited to certain types of cancer and/or specific platforms. Upon the expiration or termination of the exclusive evaluation option license, Aspyrian Therapeutics, Inc. will have the right to execute an exclusive worldwide patent commercialization license which will supersede and replace the exclusive evaluation option license with the same field of use.

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 Food and Drug Administration (FDA) is proposing to reclassify the sorbent hemoperfusion system, a preamendments class III device, into class II (special controls) for the treatment of poisoning and drug overdose, and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the treatment of hepatic coma and metabolic disturbances. FDA is identifying the proposed special controls that the Agency believes will reasonably ensure the safety and effectiveness of the device for the treatment of poisoning and drug overdose. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.

The Health Resources and Services Administration (HRSA) will be issuing a non-competitive one-year extension with funds for the Leadership Training in Pediatric Dentistry awards to Columbia University, The Regents of the University of California and the University of Washington. Up to $196,506 per grantee will be awarded over a one-year extended project period. The Leadership Training in Pediatric Dentistry program supports a national focus on leadership training in pediatric dentistry through the support of: (1) The postdoctoral training of dentists in the primary care specialty of pediatric dentistry for leadership roles in education, research, public health, advocacy, and public service related to oral health programs for populations of mothers and children (infants through adolescents), particularly children with special health care needs; (2) the development and dissemination of curricula, teaching models, and other educational resources to enhance maternal and child health (MCH) oral health programs; and (3) the continuing education, consultation, and technical assistance in pediatric oral health which address the needs of the MCH community. This extension with funds will allow HRSA's Maternal and Child Health Bureau (MCHB) to align its leadership training initiatives in oral health with HRSA's other oral health training investments.

The Food and Drug Administration (FDA) is announcing that the American Chemistry Council (ACC) has filed a petition proposing that the food additive regulations be amended to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles and spill- proof cups designed to help train babies to drink from cups because these uses have been abandoned. PC resins are formed by the condensation of 4,4'-isopropylenediphenol (i.e., Bisphenol A (BPA)), and carbonyl chloride or diphenyl carbonate.