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

The Food and Drug Administration (FDA) is amending the animal drug regulations to correct the indications for use for the 200 milligram (mg)/milliliter (mL) strength of oxytetracycline injectable solution used in beef cattle for the treatment and control of various bacterial diseases. This action is being taken to improve the accuracy of the regulations.

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, is contemplating the grant of a co-exclusive license to practice the inventions embodied in: 1. U.S. Provisional Patent Application Serial No. S/N 60/378,406, PCT/US03/14905, NIH (DHHS) Ref. No. E-144-2002/1-PCT-02 converted into 03733940.5 (E-144-2002/1-EP-04) filed in Europe on November 25, 2004, and 2003239356 (E-144-2002/1-AU-05) filed in Australia October 29, 2004, 10/512,966 (E-144-2002/1-US-03) filed in USA October 28, 2004, as well as 2485120 (E-144-2002/1-CA-06) filed in Canada May 6, 2003, entitled: ``Identification of Novel Broadly Cross-Reactive Neutralizing Human Monoclonal Antibodies''. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC). 2. U.S. Patent Application, S/N 60/506,946 (E-316-2003/0-US-01), PCT/US2004/31878 (E-316-2003/0-PCT-02) entered the national stage filing on March 29, 2006 in USA (E-316-2003/0-US-03), in Canada (E-316- 2003/0-CA-04), in Europe (E-316-2003/0-EP-05), and in Australia (E-316- 2003/0-AU-06), entitled: ``Immunoglobulins With Potent and Broad Antiviral Activity''. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei- Yun Zhang (SAIC) to Virosys Pharmaceuticals Inc. (hereafter Virosys) having a place of business in Los Altos Hills, California, and Profectus Biosciences, Inc. (hereafter Profectus) having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.

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, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Patent Application Number 10/485,140 filed January 27, 2004, entitled ``GLP-1 Exendrin-4 Peptide Analogs and Uses Thereof,'' to Amylin Pharmaceuticals, Inc., having a place of business in San Diego, CA 92121. The contemplated exclusive license may be limited to use to human therapeutics for diabetes, obesity and cardiovascular disease, as well as neurological and neurodegenerative diseases, disorders and injuries. The United States of America is the assignee of the patent rights in this invention.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to Provide Input on a proposed Web based document:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency.'' The purpose of this guidance is to assist sponsors in developing and submitting nonclinical and clinical virology data, which are important to support clinical trials of antiviral products. Nonclinical and clinical virology reports are essential components in the review of investigational antiviral products. The information in this guidance will facilitate the development of antiviral products.

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 announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Chronic Cutaneous Ulcer and Burn WoundsDeveloping Products for Treatment.'' This document provides recommendations on developing products for the treatment of chronic cutaneous ulcer and burn wounds. It includes general guidance on clinical trial design as well as preclinical and manufacturing considerations. This guidance finalizes the draft guidance published on June 28, 2000.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Investigational New Drug Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary survey of health care professional on the food safety and nutrition information that they provide to pregnant women.

The public comment period for the First Generation Guidelines for NCI-Supported Biorepositories (Federal Register, Vol. 71, Number 82, Page 25814, April 28, 2006) will be extended an additional 30 days beyond publication of this notice.

This announcement seeks applications from public and nonprofit private entities for one cooperative agreement grant to establish and operate one family planning clinical training project to serve Title X service delivery projects nationally. The project will include two components: (1) Training of clinical preceptors to work in Title X family planning service projects; and (2) conducting a national clinical training meeting every other year of the project. In close collaboration with the Office of Family Planning (OFP) project officer, the successful applicant will be responsible for the development and overall management of all components of the clinical training program. The successful applicant should anticipate substantial involvement of the OFP project officer in the conduct of this cooperative agreement.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, ractopamine, monensin, and tylosin to make four-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review.

The Centers for Disease Control and Prevention (CDC) invites individuals and organizations to nominate public health topic areas or related population-oriented interventions (i.e., interventions delivered to groups of people in communities or healthcare systems) for the Task Force on Community Preventive Services (Task Force) to consider for review. Topics that have been recently reviewed by the Task Force or are currently under review are listed below in the SUPPLEMENTARY INFORMATION section. The Task Force is an independent panel of experts that makes evidence-based recommendations regarding use of population-based interventions, which are selected from broad topic areas. Recommendations are based on the evidence gathered in rigorous and systematic scientific reviews of published studies conducted by Guide to Community Preventive Services (Community Guide) scientific teams. The findings from reviews are published in peer-reviewed journals and made available through the Community Guide Web site (https:// thecommunityguide.org). Community Guide topics coordinate with Healthy People 2010 objectives; address topics related to the large preventable burden of disease; provide guidance on ways to reduce disease, injury, and impairment; and address social challenges. Topics can be nominated by individuals or organizations. The Task Force will consider nominations and prioritize topics for review using the following criteria: Public health importance (burden of disease, injury, impairment, or exposure); preventability (amount of burden that could realistically be reduced given adequate resources); relationship to other public health initiatives; and usefulness of the package of topics selected and level of current research and intervention activity in the public and private sectors. The Task Force will also prioritize topics for which there are gaps in the evidence and the potential to significantly improve public health decisionmaking. Nominations can be for new topics or topics previously reviewed by the Task Force. Basic Topic Nomination Requirements: Nominations must be no more than 250 words long and must include the following information. (A separate appendix, not included in the word count, can contain references and supporting documents.) 1. Name of topic or intervention. 2. Rationale for consideration by the Task Force, to include as appropriate: a. Justification that topic area addresses risk behaviors related to the largest burden of disease; provides guidance on ways to reduce disease, injury, and impairment; or addresses environmental and social challenges. b. Description of public health importance (burden of disease, injury, impairment, or exposure). Citations and supporting documents are recommended. c. Public health relevance (amount of burden that could realistically be reduced given adequate resources). d. Summary of new evidence, if any, that has potential to affect the Task Force's recommendation on a previously reviewed topic. Please refer to https://thecommunityguide.org for current Task Force recommendations. Citations and supporting documents are recommended. e. In topic areas that have already been addressed or identified as high priority by the Task Force, important interventions that have not yet been addressed or where additional new information may lead to updated conclusions can be identified. Please refer to https:// thecommunityguide.org for existing Task Force recommendations. Citations and supporting documents are recommended.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine injectable suspension, administered to horses as a systemic antibacterial.

For more than a quarter century, the NTP testing program has provided extensive and useful scientific information for predicting human health hazards and protecting public health. The NTP periodically conducts reviews of models used in its testing program to critically analyze their predictive power and determine whether study protocols should be altered. As part of this effort, the NTP is convening a workshop titled ``Biomarkers for Toxicology Studies.'' The meeting will be held on September 20-21, 2006, at the NIEHS in Research Triangle Park, NC. The workshop will include plenary sessions and three simultaneous breakout group sessions for in-depth discussion. The workshop's overall goal is to identify biomarkers for carbohydrate/lipid metabolism and lung and cardiac function and then evaluate their utility for inclusion in rodent toxicology studies to better characterize endpoints of environmentally induced diseases or biological processes related to disease etiology. This meeting is open to the public with time set aside for public comments during the plenary session on the first day. The public is invited to attend the breakout groups as observers. A copy of the agenda and any additional information about the workshop, including background materials, public comments, and invited participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Calendar of Upcoming Events'').

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 announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Investigational Device Exemptions Reports and Records.

We are proposing to set forth changes to the fee schedule for payment of ambulance services by adopting revised geographic designations for urban and rural areas as set forth in Office of Management and Budget's (OMB) Core-Based Statistical Areas (CBSAs) standard. We propose to remove the definition of Goldsmith modification and reference the most recent version of Goldsmith modification in the definition of rural area. In addition, we propose to add the definition of urban area as defined by OMB and revise our definitions of emergency response, rural area, and specialty care transport (SCT). We also propose to discontinue the annual review of the conversion factor (CF) and of air ambulance rates. We would continue to monitor payment and billing data on an ongoing basis and make adjustments to the CF and to air ambulance rates as appropriate to reflect any significant changes in these data.

This rule adopts as final the provisions in the interim final regulation that published June 1, 2000, which explain the terms and conditions that apply to State grants for counseling and assistance to Medicare beneficiaries, and makes several minor technical clarifications.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-fifth meeting, at which, among other things, it will hear presentations on and discuss issues in two broad areas (1) organ transplantation and procurement and (2) newborn screening for genetic disorders. The discussions in both areas are continuations of previous Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the June 2006 meeting) include: human dignity, therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Filing Objections and Requests for a Hearing on a Regulation or Order'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Financial Disclosure by Clinical Investigators'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 (the PRA).

This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term ``child'' survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.

Under the provisions of Section 3507(a)(1)(D) 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 review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 23, 2006, page 3312 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. 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: Actigraph Accelerometer Validation Study Type of Information Collection Request: New. Need and Use of Information Collection: The NCI is collaborating with other NIH Institutes on a proposed longitudinal study of Hispanic subpopulations in the United States referred to as the Hispanic Community Health Study. The Hispanic population is now the largest minority population in the U.S. with a projected three-fold growth by 2050. Hispanic subgroups are influenced by a number of chronic disease risk factors associated with immigration from different cultural settings and environments. These factors include diet, physical activity, community support, working conditions, and access to health care. Hispanic groups have higher rates of obesity and diabetes than non-Hispanic groups, but have lower coronary disease and cancer (all sites) mortality. There are also observed differences in health outcomes between Hispanic subgroups. For example, Puerto Ricans have a four-fold higher asthma prevalence than Mexican-Americans. Hispanic populations are understudied with respect to many diseases and risk factors. Their projected population growth underscores the need for accurate evaluation of their disease burden and risk. A vast amount of research suggests that the level of physical activity influences many of the chronic diseases and conditions of interest, including obesity, diabetes, cardiovascular disease, and cancer. To better understand the relationship between physical activity and chronic disease, and to make specific activity prescriptions, it is necessary to be able to accurately assess levels and types of activity. In particular, better methods are needed to improve the validity and reliability of physical activity assessment instruments to better assess the frequency, duration, and intensity of physical activity. For that reason, NCI plans to evaluate the use of a new type of accelerometer, a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time. This new accelerometer will be used in the Hispanic Community Health Study and will allow examination of levels as well as patterns of activity. Physical activity was measured with accelerometers in the nationally representative 2003-2006 National Health and Nutrition Examination Survey (NHANES) (OMB: 0920- 0237, October 15, 2004, Vol 69, pp. 61253-61254). NHANES provides estimates for Mexican-American, but not other Hispanic subgroups. Between the time of the NHANES and the Hispanic Community Health Study, there has been a change in the technology of the accelerometer used in NHANES. To allow comparison of the physical activity data that will be collected from the four Hispanic subgroups in the Hispanic Community Study to the data collected with the previous technology used in NHANES, a cross-validation study is needed. The proposed study, the ActiGraph Accelerometer Validation Study, will serve this purpose. It is a cross-validation study comparing the two ActiGraph accelerometer models under different circumstances of walking or jogging in differing age groups and for both genders. Frequency of response: One-time study. Affected Public: Individuals. Type of Respondents: Healthy adults between the ages of 18-74 years. The annual reporting burden is as follows: Estimated Number of Respondents: 144; Estimated Number of Responses per Respondent: 1.14; Average Burden Hours Per Response: 0.66; and Estimated Total Annual Burden Hours Requested: 62. The annualized cost to respondents is estimated at: $1116.

The Office on Women's Health (OWH) within the Department of Health and Human Services (DHHS) is the government's champion and focal point for women's health issues, and works to redress inequities in research, health care services, and education that have historically placed the health of women at risk. The OWH coordinates women's health efforts within DHHS to eliminate disparities in health status and supports culturally sensitive educational programs that encourage women to take personal responsibility for their own health and wellness. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide, namely mentoring partnerships (prot[eacute]g[eacute] and mentor) meant to strengthen the capacity of non-profit organizations that provide HIV/AIDS prevention services to women at risk and/or living with HIV/AIDS. Women of color represent over 80 percent of the reported AIDS cases. Younger women are increasingly at higher risk for HIV/AIDS. Thus, the Mentoring Partnership ProgramProt[eacute]g[eacute] intends to demonstrate how small, non-profit, community-based, faith-based, and women's service organizations will be strengthened, programs/service effectiveness increased, and gender-focused and culturally competent practices instituted so that efforts to reach women most at risk and/or living with HIV/AIDS are increased. The non-profit community-based, faith- based, and women's service organizations receive training to increase their competencies in operating a sound organization. Moreover, mentors prepare prot[eacute]g[eacute]s to compete for additional public and private funding. During the funding period, prot[eacute]g[eacute] organizations will demonstrate a gain in knowledge and skills by reaching more women with HIV/AIDS prevention education and support services. In order to improve HIV/AIDS program services to women, prot[eacute]g[eacute] grantees are also required to receive additional training by attending two HIV/AIDS prevention conferences (regional and national) and establish collaborative partnerships with the local health and social service departments for referral resources in areas such as primary health care, housing, education, job and/or trade training, to name a few.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Automated Survey Processing Environment (ASPEN) Complaints/Incidents Tracking System (ACTS),'' System No. 09-70-1519, last published at 68 FR 50795 (August 22, 2003). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0565. We propose to delete published routine uses number 5 authorizing disclosures to the agency of a state government, number 8 authorizing disclosure to researchers, and number 12 authorizing disclosure to another agency or instrumentality of any governmental jurisdiction. Disclosures permitted under routine uses number 5 and 12 will be made a part of proposed routine use number 2. The scope of routine use number 2 will be broadened to allow for release of information to ``another Federal and/or state agency, an agency established by state law, or its fiscal agent.'' Routine use number 8 is being deleted because disclosure of ACTS data for research and evaluation purposes will be restricted to the release of aggregate data rather than individual- specific data. CMS proposes to exempt this system from the notification, access, correction and amendment provisions of the Privacy Act of 1974 (5 U.S.C. 552a (k) (2)) due to investigatory and law enforcement activities. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or MMA provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to track and process complaints and incidents reported against Medicare and/or Medicaid certified providers and suppliers, and CLIA-certified laboratories, these include: skilled nursing facilities, nursing facilities, hospitals, home health agencies, end-stage renal disease facilities, hospices, rural health clinics, comprehensive outpatient rehabilitation facilities, outpatient physical therapy services, community mental health centers, ambulatory surgical centers, suppliers of portable X-Ray services, and intermediate care facilities for persons with mental retardation. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or state agency, an agency established by state law, or its fiscal agent; (3) assist Quality Improvement Organizations; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; (6) assist a national accreditation organization that has been granted deeming authority by CMS; (7) assist a state- mandated Protection and Advocacy System that provides legal representation and other advocacy services to beneficiaries; and (8) combat fraud and abuse in certain Federally-funded health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Monsanto Chemical Company, Dayton, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Monsanto Chemical Company. Location: Dayton, Ohio. Job Titles and/or Job Duties: Directors and subordinates, physicists, chemists, technicians, and workers. Period of Employment: 1943-1949.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q8 Pharmaceutical Development.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on guidance on reagents for detection of specific novel influenza A viruses.

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 (the PRA).

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on the relationship between beta-glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD) by adding barley as an additional source of beta-glucan soluble fiber eligible for the health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.

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 announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition'' (the guidance). This guidance provides information to industry on how to prepare a claim of categorical exclusion or an environmental assessment (EA) for submission to the Center for Food Safety and Applied Nutrition (CFSAN) in notifications for food contact substances, food additive petitions, color additive petitions, requests for exemption from regulation as a food additive, generally recognized as safe (GRAS) petitions, and petitions for certain food labeling regulations.

This notice announces those sites for which ATSDR has completed public health assessments during the period from January 2006 through March 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

This proposed rule would revise the methodology for calculating the occupational mix adjustment announced in the Fiscal Year (FY) 2007 Hospital Inpatient Prospective Payment System (IPPS) proposed rule by applying the occupational mix adjustment to 100 percent of the wage index using the new occupational mix data collected from hospitals. This proposed rule also proposes to modify hospitals' procedures for withdrawing requests to reclassify for the FY 2007 wage index and for supplementing the FY 2008 reclassification application with official data used to develop the FY 2007 wage index. In addition, we are proposing to replace in full the descriptions of the data and methodology that would be used in calculating the occupational mix adjustment discussed in the FY 2007 IPPS proposed rule.