Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents

This notice contains fiscal year (FY) 2009 revised final wage indices and hospital reclassifications for 27 hospitals. These revised final wage indices and hospital reclassifications were made according to special procedural rules set forth in the FY 2009 hospital inpatient prospective payment systems final rule (73 FR 48588-9).

This final rule will implement provisions of section 6044 of the Deficit Reduction Act of 2005, which amends the Social Security Act by adding a new section 1937 related to the coverage of medical assistance under approved State plans. It also provides States increased flexibility under an approved State plan to define the scope of covered medical assistance by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaid recipients. In addition, this final rule responds to public comments on the February 22, 2008, proposed rule that pertain to the State Medicaid benefit package provisions.

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 notice announces the list of proposed substances that will be evaluated for CERCLA Set 23 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for use of ractopamine hydrochloride Type A medicated articles to make Type B and Type C medicated feeds used for increased rate of weight gain and improved feed efficiency in finishing turkeys.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Colorado Regional Health Information Exchange (CORHIO) Point of Care Exchange System Evaluation: Point of Care Questionnaires and Focus Groups.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The U.S. Department of Health and Human Services (HHS) announces the seventh and eighth meetings of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (Committee). These meetings will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will address issues regarding the development and implementation of the nation's health promotion and disease prevention objectives for 2020 and activities to improve the health status of and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.

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 for the United Nuclear Corp., Hematite, Missouri, 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: United Nuclear Corp. Location: Hematite, Missouri. Job Titles and/or Job Duties: All site employees. Period of Employment: January 1, 1958 through December 31, 1969, and from January 1, 1970 through July 31, 2006 (residual radiation period).

This notice announces the Rechartering of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) by the Secretary, DHHS (the Secretary) for a 2-year period with the new charter effective through November 21, 2010.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 195, entitled ``Draft Guidance for Industry: Small Entities Compliance Guide for RenderersSubstances Prohibited From Use in Animal Food or Feed.'' This small entities compliance guide aids renderers in complying with the requirements of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720). FDA's goal is to strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle and to reduce the risk of human exposure to the BSE agent.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA).'' Public Meeting Time and Date: 10 a.m.-4 p.m. EST, January 22, 2009. Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000, Washington, DC 20201. Purpose of Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the Sector Councils on their progress, priorities, and implementation plans to date, including the Agriculture, Forestry and Fishing Sector; Healthcare and Social Assistance Sector; Mining Sector; MiningOil and Gas Extraction Sub- Sector; and Transportation, Warehousing and Utilities Sector. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation by Web meeting (requirements include: computer, internet connection, and telephone, preferably with ``mute'' capability) or in person. An e-mail confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the Web meeting. Non-US citizens registering to attend in person after January 8 will not have time to comply with security procedures. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Eight sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008, most of these Councils have posted draft strategic plans for public comment. One has posted its finalized National Sector Agenda after considering comments on its draft. For more information, see the link above and choose ``Sector-based Approach,'' ``NORA Sector Councils,'' ``Sector Agendas'' and ``Comment on Draft Sector Agendas'' from the right-side menu. Contact Person for Technical Information: Sidney C. Soderholm, Ph.D., NORA Coordinator, e-mail noracoordinator@cdc.gov, telephone (202) 245-0665.

The Food and Drug Administration (FDA) is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. FDA received many substantive comments on the order of prohibition. The agency is taking this action so that it may fully consider these comments.

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 U.S. Department of Health and Human Services is hereby giving notice that the Trans-Federal Task Force on Biosafety and Biocontainment Oversight will be holding a public consultation meeting. The meeting is open to the public.

This final rule implements and interprets the provisions of sections 6041, 6042, and 6043 of the Deficit Reduction Act of 2005 (DRA), and section 405(a)(1) of the Tax Relief and Health Care Act of 2006 (TRHCA). The DRA was amended by the TRHCA which revised sections 6041, 6042, and 6043 of the DRA including limitations on cost sharing for individuals with family incomes at or below 100 percent of the federal poverty line. These sections amended the Social Security Act (the Act) by adding a new section 1916A to provide State Medicaid agencies with increased flexibility to impose premium and cost sharing requirements on certain Medicaid recipients. This flexibility supplements the existing authority States have to impose premiums and cost sharing under section 1916 of the Act. The DRA provisions also specifically address cost sharing for non-preferred drugs and non- emergency care furnished in a hospital emergency department.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Contents of a Complete Submission for the Evaluation of Proprietary Names.'' This draft guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary drug and biological product names and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names.

The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill two positions on the Committee membership that will be vacated in June of 2009.

This interim final rule with comment period makes technical changes to the existing methodology and process used to compute and issue each State's preliminary and final allotments available to pay the Medicare Part B premiums for qualifying individuals (QIs). The technical revisions conform the existing regulations to reflect continued funding of this program. Additionally, this rule contains charts providing the States' final QI allotments for the Federal fiscal year (FY) 2008 and preliminary QI allotments for FY 2009, determined in accordance with the methodology set forth in the October 2006 final rule, and reflecting funding for the QI program made available under recent legislation.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. George Kindness from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Mr. Kindness was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Kindness failed to request a hearing. Mr. Kindness's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approval of the information listed below. The proposed information collection was previously published in the Federal Register on September 8, 2008, pages 52052-52053 and allowed 60 days for public comment. The National Institutes of Health received one comment that was determined to be not relevant to the specific questions stated in the notice. 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, the collection of information that has been extended, revised, or implemented unless it displays a currently valid OMB control number. Proposed Collection: Title: The National Diabetes Educations Program Comprehensive Evaluation Plan. Type of Information Collection Request: Extension of a currently approved collection (0925- 0552). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goals of the NDEP are to improve the treatment and health outcomes of people with diabetes, to promote early diagnosis, and, ultimately, to prevent the onset of diabetes. The NDEP objectives are: (1) To increase awareness of the seriousness of diabetes, its risk factors, and strategies for preventing diabetes and its complications among people at risk for diabetes; (2) to improve understanding about diabetes and its control and to promote better self-management behaviors among people with diabetes; (3) to improve health care providers' understanding of diabetes and its control and to promote an integrated approach to care; (4) to promote health care policies that improve the quality of and access to diabetes care. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Creating partnerships with other organizations concerned about diabetes; (2) developing and implementing awareness and education activities with special emphasis on reaching the racial and ethnic populations disproportionately affected by diabetes; (3) identifying, developing, and disseminating educational tools and resources for the program's diverse audiences; (4) promoting policies and activities to improve the quality of and access to diabetes care. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This generic clearance request is for the collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Approval is requested for a survey of audiences targeted by the National Diabetes Education Program including people at risk for diabetes, people with diabetes and their families and the public. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 3759, Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .153; and Estimated Total Annual Burden Hours Requested: 575. There are no Capital Costs, Operating or Maintenance Costs to report.

The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has initiated a strategic planning process that will culminate in the ODS Strategic Plan for 2010-2014. To assist with this process, the ODS requests input from research communities academic, government, and industryand from other interested parties. The overall purpose of the strategic planning effort is to identify both new opportunities and emerging needs for incorporation in the programmatic efforts of the Office. A background paper has been prepared, A Report to the Public, that summarizes progress in four key areas of ODS activity. The background paper and related information are available on the ODS Web site at https://ods.od.nih.gov/strategicplan. Public comment can be sent directly to ODS or through the public Webinars ODS will hold on January 29, 2009, February 3, 2009, February 11, 2009, and February 19, 2009. The section on Public Participation (below) gives details for the Webinars.

The Food and Drug Administration (FDA) is announcing its determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 milligrams/milliliter (mg/ml), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nalbuphine hydrochloride injection, 10 and 20 mg/ml, if all other legal and regulatory requirements are met.

In the September 18, 2008 issue of the Federal Register (73 FR 54226), we published an interim final rule with comment period that revises the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans. The interim final rule makes conforming changes to the MA regulations to reflect new statutory requirements regarding special needs plans (SNP), private-fee-for-service plans (PFFS), regional preferred provider organizations (RPPO) plans, Medicare medical savings accounts (MSA) plans, and new statutory provisions governing cost- sharing for dual-eligible enrollees in the MA program prescription drug pricing, coverage, and payment processes in the Part D program. In addition, the interim final rule sets forth new requirements governing the marketing of Part C and Part D plans which by statute must be in place at a date specified by the Secretary, but no later than November 15, 2008. Both the conforming changes to the regulations to reflect new statutory provisions and the new marketing requirements are based on provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008. This correcting amendment corrects technical and typographical errors identified in the September 18, 2008 interim final rule.

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0001, ``Medical, Health and Billing Records.'' The amended and altered system of records makes only administrative edits and revisions as necessary.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Conducting Measurement Activities in Support of the AHRQ Health IT Initiative.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on September 19th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Secretary of Health and Human Services is adopting rules to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005, Pub. L. 109-41, 42 U.S.C. 299b-21b-26 (Patient Safety Act). The final rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The final rule outlines the requirements that entities must meet to become PSOs and the processes by which the Secretary will review and accept certifications and list PSOs. It also describes the privilege and confidentiality protections for the information that is assembled and developed by providers and PSOs, the exceptions to these privilege and confidentiality protections, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.

The Food and Drug Administration (FDA) is announcing the availability of proposed and final documents that have been prepared by Study Group 1 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Group that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Process Validation: General Principles and Practices.'' FDA is revising its guidance for industry entitled ``Guideline on General Principles of Process Validation,'' which issued in May 1987 (the 1987 guidance). The revised draft guidance promotes a ``lifecycle'' approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. When finalized, this draft guidance will replace the 1987 guidance.

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 Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently removed. This action is being taken to correct the regulations.

The Food and Drug Administration (FDA) has determined the regulatory review period for SOMATULINE DEPOT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

Section 103(d) of the Americans with Disabilities Act of 1990, Public Law 101-336, requires the Secretary to publish a list of infectious and communicable diseases that are transmitted through handling the food supply and to review and update the list annually. The Centers for Disease Control and Prevention (CDC) published a final list on August 16, 1991 (56 FR 40897) and updates on September 8, 1992 (57 FR 40917); January 13, 1994 (59 FR 1949); August 15, 1996 (61 FR 42426); September 22, 1997 (62 FR 49518-9); September 15, 1998 (63 FR 49359), September 21, 1999 (64 FR 51127); September 27, 2000 (65 FR 58088), September 10, 2001 (66 FR 47030), and September 27, 2002 (67 FR 61109). The final list has been reviewed in light of new information and has been revised as set forth below.

This notice announces our decision to approve the Joint Commission for continued recognition as a national accreditation program for ambulatory surgical centers (ASCs) seeking to participate in the Medicare or Medicaid programs.

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 contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.

This notice announces an administrative hearing to be held on January 6, 2009, at the CMS Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, Chicago, Illinois 60601 to reconsider CMS' decision to disapprove Michigan SPA 07-21.

The Administration for Children and Families (ACF) hereby gives notice to the public that certain programs within the Agency will administratively impose a matching requirement on grants awarded under the following program titles and funding opportunity announcements for Fiscal Year 2009:

The Food and Drug Administration (FDA) is issuing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust their civil money penalties at least once every 4 years. This rule does not adjust the civil money provisions enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment.

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 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.

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), a federal agency under the Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in HHS Ref. Nos. E-091-1998 ``Method For Non- Invasive Identification Of Individuals At Risk For Diabetes;'' U.S. Patent No. 6,721,583; and HHS Ref. No. E-079-1998 ``Optical Fiber Probe and Methods for Measuring Optical Properties;'' U.S. Patent No. 6,678,541; to Eyelight Diagnostics, Inc., a corporation formed under the laws of the state of Connecticut and having a principle place of business therein. The United States of America is the assignee of the patent rights in the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices and integrated systems for non-invasive ocular clinical diagnostics for diabetes.

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 amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.

The Food and Drug Administration (FDA) has determined the regulatory review period for TYKERB and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

Outpatient hospital services are a mandatory part of the standard Medicaid benefit package. This final rule aligns the Medicaid definition of outpatient hospital services more closely to the Medicare definition in order to: Improve the functionality of the applicable upper payment limits (which are based on a comparison to Medicare payments for the same services), provide more transparency in determining available hospital coverage in any State, and generally clarify the scope of services for which Federal financial participation (FFP) is available under the outpatient hospital services benefit category.

The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.''

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on adding additional diseases to the list of tropical diseases recognized under the Food and Drug Administration Amendments Act (FDAAA), which adds a new section to the Federal Food, Drug, and Cosmetic Act (the act). The new section authorizes FDA to award priority review vouchers to sponsors of certain tropical disease product applications that meet the criteria specified by the act. The new section lists diseases considered to be ``tropical diseases'' for the purposes of this legislation, and provides for expansion of the list to include diseases meeting certain criteria. This public meeting is being held to obtain comments from the public on the criteria that should be used to determine whether an infectious disease should be added to the list, and to elicit suggestions for adding specific diseases.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)], directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 22nd set of toxicological profiles, which consists of four updated drafts prepared by ATSDR for review and comment. The toxicological profiles for formaldehyde and perfluoroalkyls are on a modified schedule pending additional review.