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

This notice announces the availability of the final toxicological profile for perchlorates, which completes the nineteenth set prepared by ATSDR. The announcement of seven toxicological profiles for the nineteenth set was published in the Federal Register on October 25, 2005 (70 FR 61622).

AHRQ and OCR are announcing the availability of the guidance entitled ``Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization.'' The Interim Guidance document explains how the Department of Health and Human Services (HHS) will begin implementing the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), how an entity can become a Patient Safety Organization (PSO), and how information may be protected as Patient Safety Work Product (PSWP) in the interim period prior to the promulgation of a final regulation. To access the Interim Guidance, visit AHRQ's PSO Web site at https://www.pso.ahrq.gov.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its seventeenth meeting. The meeting will be open to the public.

The NTP announces the availability of the draft background document for cobalt-tungsten carbide powders and hard metals by October 10, 2008 on the RoC Web site (https://ntp.niehs.nih.gov/go/29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for cobalt-tungsten carbide powders and hard metals. The expert panel will meet on December 9-10, 2008, at the Sheraton Chapel Hill Hotel, One Europa Drive, Chapel Hill, NC 27514 to peer review the draft background document for cobalt-tungsten carbide powders and hard metals and, once completed, make a recommendation regarding the listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for cobalt-tungsten carbide powders and hard metals in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final background document and the expert-panel peer review report on the RoC Web site.

The National Institutes of Health (NIH) is issuing standards to implement provisions of the Chimpanzee Health Improvement, Maintenance, and Protection Act (CHIMP Act) authorizing the Secretary of the Department of Health and Human Services (HHS) to develop and publish standards of care for chimpanzees held in the sanctuary system supported by federal funds authorized under the CHIMP Act. This regulation applies to only those facilities receiving federal funds as a part of the federally funded chimpanzee sanctuary system.

Through this interim final rule, the Secretary removes the category of vaccines containing live, oral, rhesus-based rotavirus, Category XII, from the Vaccine Injury Table (Table). The Table includes a list of covered vaccines under the National Vaccine Injury Compensation Program (VICP). The VICP provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This interim final rule is technical in nature. Even prior to the publication of this final rule, Category XII, the category that is being removed from the Table, only applied to vaccines that were administered on or before August 26, 2002. Given the applicable statute of limitations and the fact that Category XII limited its application to vaccines administered on or before August 26, 2002, the Secretary believes that no persons have claims that could be pursued under that category. Petitioners may still be able to file petitions relating to rotavirus vaccines under Category XI of the Table, the category of ``rotavirus vaccines,'' which does not include any associated injuries. Although the Secretary believes that the changes made in this interim final rule are noncontroversial as they do not affect the rights of any potential petitioners with the VICP, the Department is seeking public comment on this interim final rule. Written comments must be submitted on or before November 10, 2008. The Department will consider the comments received and will decide whether to amend the Table based on such comments.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 15, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

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 Intervet Inc. The supplemental NADA provides for use of a fenbendazole free choice, liquid Type C medicated feed in dairy and beef cattle for the removal and control of various internal parasites.

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 Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of tulathromycin injectable solution for the treatment of bovine foot rot (interdigital necrobacillosis) in beef and non-lactating dairy cattle.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Kirk Sperber, M.D., Mount Sinai School of Medicine: Based on the report of an investigation conducted by the Mount Sinai School of Medicine (MSSM) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, the U.S. Public Health Service (PHS) found that Dr. Kirk Sperber, former Associate Professor, Department of Medicine, Division of Clinical Immunology, MSSM, engaged in scientific misconduct while supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI45343 and P01 AI44236, and National Cancer Institute, NIH, grant R29 CA256990. PHS finds the Respondent engaged in scientific misconduct by falsifying and fabricating data that were included in NIAID, NIH, grant applications R01 AI45343-01A1, R01 AI45343-04A2, and P01 AI44236-05. Respondent's scientific misconduct occurred while he was a faculty member at MSSM. Respondent is no longer employed at MSSM. Specifically, PHS found that Respondent engaged in scientific misconduct by falsifying and fabricating data in the following publications: 1. In multiple figures reported in Sperber, K., Beuria, P., Singha, N., Gelman, I., Cortes, P., Chen, H., & Kraus, T. ``Induction of apoptosis by HIV-1-infected monocytic cells.'' Journal of Immunology 170:1566-1578, 2003 (``2003 J. Immunol. paper'') (Retracted in December 2005); by duplicating and reusing panels of FACS data in Figures 1A, 2, 4A, 4B, and 7; by duplicating and reusing lanes of polyacrylamide gels in Figure 3, of Western blot analyses in Figures 5A, 5C, 6C, and 9, and of agarose gels in PCR analyses in Figure 5B; and by duplicating and reusing laser confocal micrographs in Figures 10 and 11. Respondent's claims that Figures 1A, 2, 4A, and 7 were representative of experiments repeated five times and that Figures 3, 4B, 5A, 6C, and 9 were representative of experiments repeated three times constitute additional falsifications. The effect of these misrepresentations was to falsely demonstrate the proapoptotic activity of a protein from a novel cDNA clone isolated from an HIV-infected human macrophage cell line and to falsify its presence in brain and lymphoid tissue from patients with HIV-associated dementia. 2. In Figure 10 reported in Rakoff-Nahoum, S., Chen, H., Kraus, T., George, I., Oei, E., Tyorlin, M., Salik, E., Beuria, P., & Sperber, K. ``Regulation of Class II Expression in Monocytic Cells after HIV-1 Infection.'' J. Immunol. 167:2331-2342, 2001 (Retracted in November 2006), by duplicating and reusing four confocal micrographs to misrepresent different panels for the Cath D, 43pol and CD-63, 43neve data; for the Cath D, 43gag and Cath D, 43nef data; for the DAMP, 43 nef and M6PR, 43nef data; and for the M6PR, 43gag and the CD-63, 43gag data. Respondent's reported claim that the results were representative of an experiment repeated five times constitutes an additional falsification. 3. In Figures 3B, 4B, and 6B reporting flow cytometry analyses (FACS) in Chen, H., Yip, Y.K., George, I., Tyorkin, M., Salik, E., & Sperber, K. ``Chronically HIV-1-Infected Monocytic Cells Induce Apoptosis in Cocultured T Cells.'' J. Immunol. 161:4257-4267, 1998 (Retracted in November 2006); by reusing two FACS histograms, each to represent 2 different experiments in Figure 3B; by reusing the same FACS histogram as the negative control for CD-4 cells and for the CD-8 cells in Figure 4B; and by duplications of the top two panels, the middle two panels, and the bottom two panels of data as graded dilutions of different fractions in Figure 6B to falsely show that a soluble factor from 43HIV cells induced apoptosis. Figure 6B was also presented in grant application AI45343-01A1 as Figure 5B. Respondent's reported claims that the results in Figures 3B, 4B, and 6B were each representative of experiments that were repeated three times constitute additional falsifications. PHS also finds that Respondent engaged in scientific misconduct by falsifying and fabricating the following data in NIAID, NIH, research applications R01 AI45343-04A2 and P01 AI44236-05: 4. The results of Figures 1, 6C, 7, 9, 10 and 11 from the 2003 J. Immunology paper were reported in NIAID, NIH, grant application R01 AI45343-04A2; nearly all of the figures in the paper were falsified, so that the claims in the grant application derived from those figures were also false. 5. Two figures in NIAID, NIH, grant application P01 AI44236-05 contained falsified data: In Figure 1b, panels of confocal microscopy images of intestinal biopsies from four patients were falsified by duplication; and in Figure 3, one panel of PCR data was duplicated and similarly misrepresented as data from the same four biopsy specimens. Dr. Sperber has entered into a Voluntary Exclusion Agreement in which he neither admitted or denied HHS' findings of scientific misconduct. However, he recognized that if this matter were to proceed to an administrative hearing, there is sufficient evidence upon which an Administrative Law Judge could make findings of scientific misconduct against him. Dr. Sperber agreed not to contest or appeal the jurisdiction of the PHS or HHS findings of scientific misconduct as set forth above and in the MSSM Report. Dr. Sperber has voluntarily agreed, for a period of four (4) years, beginning on September 12, 2008: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States pursuant to HHS' Implementation (2 CFR Part 376 et seq.) of OMB Guidelines to Agencies on Government wide Debarment and Suspension (2 C.F.R., Part 180); and (2) To exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant or contractor to PHS.

In Fiscal Year 2005, in an effort to assist local school systems that were being strained by the arrivals of large numbers of refugee children, The Office of Refugee Resettlement (ORR) awarded, through competition, a Refugee School Impact grant to the Tennessee Department of Human Services, Nashville, TN, for a project period of August 15, 2005 through August 14, 2010. The Tennessee Department of Human Services served as the fiscal sponsor and legal entity for the project. As of June 30, 2008, the Tennessee Department of Human Services relinquished the grant. Catholic Charities of Tennessee, Inc., Nashville, TN, is now awarded a non-competitive replacement grant to continue to provide services under the Refugee School Impact project. Services provided under the grant to Catholic Charities of Tennessee, Inc., are within the scope and operation of the original award. Under the award, Catholic Charities of Tennessee, Inc., is eligible apply for a non-competitive continuation award for the period of August 15, 2009 through August 14, 2010.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 23, 2007 (72 FR 8184). The notice announced that FDA was withdrawing approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (PREA). FDA has determined that approval of the suitability petition submitted by Roxane Laboratories, Inc. (Roxane), for lorazepam oral solution, 1 milligram (mg)/10 milliliters (mL) (Docket No. FDA- 1994-P-0017),\1\ should not have been withdrawn and therefore retroactively reinstates its approval of that petition. This document also corrects errors in the petition numbers for two of the suitability petitions listed in the notice.

The Food and Drug Administration (FDA) is announcing the availability of a concept paper entitled ``PDUFA Pilot Project Proprietary Name Review.'' The concept paper provides information to pharmaceutical firms about how to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review under an anticipated pilot program. FDA plans to begin enrollment in the pilot program in fiscal year (FY) 2009.

Pursuant to Section 814 of the Native American Programs Act of 1974, as amended by 42 U.S.C. 2992b-1, the Administration for Native Americans (ANA) herein describes its proposed interpretive rules, general statements of policy and rules of agency procedure or practice in relation to the following Program Announcements: Social and Economic Development Strategies (hereinafter referred to as SEDS), Social and Economic Development Strategies for Alaska (hereinafter referred to as SEDS-AK), Native Language Preservation and Maintenance Assessment (hereinafter referred to as Native Language Assessment), Native Language Preservation and Maintenance Planning (hereinafter referred to as Native Language Planning), Native Language Preservation and Maintenance Implementation (hereinafter referred to as Native Language Implementation), Native Language Preservation and Maintenance Immersion (hereinafter referred to as Native Language Immersion), Family PreservationImproving the Well-Being of Children Project Planning (hereinafter referred to as Family Preservation Planning), Family PreservationImproving the Well-Being of Children Project Implementation (hereinafter referred to as Family Preservation Implementation) and Environmental Regulatory Enhancement (hereinafter referred to as ERE). Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, general statements of policy and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. This notice also provides additional information about ANA's plan for administering the programs.

The Secretary of the Department of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4), to justify the emergency use of doxycycline hyclate tablets accompanied by emergency use information, contained in emergency kits for eligible United States Postal Service (USPS) Cities Readiness Initiative (CRI) participants and their household members in advance of a potential attack involving Bacillus anthracis. Bacillus anthracis is a biological agent known to cause anthrax. The Secretary, HHS, provides notice of the determination of the Secretary of Homeland Security on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis, although there is no current domestic emergency involving anthrax, no current heightened risk of an anthrax attack, and no credible information indicating an imminent threat of an attack involving Bacillus anthracis. The Secretary also provides notice that, on the basis of such determination, he has declared an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a).

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the third meeting of the Secretary's Advisory Committee on Re-designation of Head Start Grantees, Department of Health and Human Services (HHS). The meeting will be held on Tuesday, October 21, 2008, from 9 a.m. to 5:30 p.m., and on Wednesday, October 22, 2008, from 9 a.m. to 1 p.m. at the Hotel Palomar Arlington, 1121 North 19th Street, in Arlington, Virginia. The meeting will be open to the public; however, seating is limited and preregistration is encouraged (see below).

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), herein announces the awarding of a Mentoring Children of Prisoners (MCP) replacement grant to Mother Seton House, Inc., in Virginia Beach, VA. A prior grantee recently relinquished their MCP grant. With the funds provided, Mother Seton House, Inc., will continue the provision of mentoring services for children of incarcerated parents in Hampton Roads, VA.

The purpose of the ORR award is to assist California in providing medical screenings in accordance with ORR guidance in State Letter 95-37, 11/21/95, and follow-up activities to newly arriving refugees for conditions of public health concern. California Senate Bill 162 established a new California Department of Public Health to take the place of the California Department of Health Services which ceased to exist. California requests that the funds be awarded to the new California Department of Public Health to carry out the remaining years of the project.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Hispanic Community Health Study (HCHS)/Study of Latinos (SOL). Type of Information Collection Request: Revision. OMB 0925-0584, exp. 2/28/2011. Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the US, are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six-and-a-half year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will also examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 30,320; Estimated Number of Responses per Respondent: 2.238; Average Burden Hours Per Response: 0.7161; and Estimated Total Annual Burden Hours Requested: 48,583. The annualized cost to respondents is estimated at $753,285, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 contains tables listing the final wage indices, hospital reclassifications, payment rates, impacts, and other related tables effective for fiscal year (FY) 2009. The tables and impacts included in this notice reflect the extension of the expiration date for certain geographic reclassifications and special exception wage indices as required by section 124 of the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA), Public Law 110-275. These geographic reclassifications and special exception wage indices were previously set to expire on September 30, 2008 and are now extended through September 30, 2009. (Additionally, the final rates, wage indices, budget neutrality factors and tables included in this notice also reflect a correction made to the wage data for one hospital, as discussed in the correction notice for the FY 2009 IPPS final rule published elsewhere within this Federal Register.)

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: ``National Study of the Hospital Adverse Event Reporting Follow-Up Survey.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506()(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 July 24th, 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. Changes were made to this 30 day notice to account for the electronic patient records review which were not accounted for in the 60 day notice.

The CERHR plans to convene an expert panel to conduct updated evaluations of the scientific evidence regarding the potential reproductive and/or developmental toxicity associated with exposure to genistein and soy formula begun in 2006. The expert panel will consist of approximately 10-12 scientists selected for their scientific expertise in various aspects of reproductive and developmental toxicology and other relevant areas of science. CERHR invites the submission of information about ongoing studies or upcoming publications on these substances that might be considered for inclusion in the evaluations and the nomination of scientists to serve on the expert panel (see SUPPLEMENTARY INFORMATION below). This meeting is tentatively scheduled for spring or summer 2009, although the exact date and location are not yet set. As plans are finalized, they will be announced in the Federal Register and posted on the CERHR Web site (https://cerhr.niehs.nih.gov). CERHR expert panel meetings are open to the public with time scheduled for oral public comment.

This notice solicits nominations for individuals to serve on the Program Advisory and Oversight Committee (PAOC) that will advise the Secretary of Health and Human Services on the competitive acquisition of durable medical equipment and certain other items and services under the Medicare program. Section 1847(c) of the Social Security Act requires the Secretary of the Department of Health and Human Services (Secretary) to establish the PAOC. In addition, section 1847(c)(4) exempts the PAOC from the Federal Advisory Committee Act, 5 U.S.C., appendix 2.

This document corrects technical errors that appeared in the August 8, 2008 Federal Register entitled, ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2009.''

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a computer matching agreement between CMS and the Department of Defense (DoD). We have provided background information about the proposed matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.

The Food and Drug Administration (FDA) has determined that the 11 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

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 information collection requirements for Humanitarian Use Devices.

The Food and Drug Administration (FDA) is announcing the Web location where the agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development in fiscal year (FY) 2009. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Application 60/891,856 filed February 27, 2007 (E-084-2007/0-US-01) and International Application PCT/US2008/055149 filed February 27, 2008 (E-084-2007/0- PCT-02), entitled ``Use of Histone Deacetylase Inhibitors for the Treatment of Central Nervous System Metastases,'' to Waypharm S.A.S. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be the United States and Europe, and the field of use may be limited to therapeutics based on CNS metastases of extra-CNS origin cancers.

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 Federal Register notice sets forth the supplemental compliance program guidance (CPG) for nursing facilities developed by the Office of Inspector General (OIG). OIG is supplementing its prior CPG for nursing facilities issued in 2000. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas. The supplemental CPG takes into account Medicare and Medicaid nursing facility payment systems and regulations, evolving industry practices, current enforcement priorities (including the Government's heightened focus on quality of care), and lessons learned in the area of nursing facility compliance. The supplemental CPG provides voluntary guidelines to assist nursing facilities in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our regulations to require that the holder of a new drug application (NDA) submit certain information in an annual report regarding authorized generic drugs. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.

The Food and Drug Administration (FDA) is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis; eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and allow reference for the need of physical activity in either of the health claims to be optional rather then required. This final rule is, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness, LLC.

This notice announces our decision to approve Det Norske Veritas Healthcare, Inc. (DNVHC) for recognition as a national accreditation program for hospitals seeking to participate in the Medicare or Medicaid programs.

Section 1936 of the Social Security Act (the Act) (as added by section 6034 of the Deficit Reduction Act of 2005 (DRA) established the Medicaid Integrity Program to promote the integrity of the Medicaid program by requiring CMS to enter into contracts with eligible entities to: (1) Review the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of such plan approved under section 1115 of the Act; (2) audit claims for payment of items or services furnished, or administrative services rendered, under a State plan; (3) identify overpayments to individuals or entities receiving Federal funds; and (4) educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide requirements for an eligible entity to enter into a contract under the Medicaid integrity audit program. The final rule will also establish the contracting requirements for eligible entities. The requirements will include procedures for identifying, evaluating, and resolving organizational conflicts of interest that are generally applicable to Federal acquisition and procurement; competitive procedures to be used; and procedures under which a contract may be renewed.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``End-of-Phase 2A Meetings.'' This draft guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs) who seek guidance on employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo) to design trials for better dose response estimation, dose selection, and other appropriate issues. This draft guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and to improve the quality of drug applications through early meetings with sponsors.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/689,746, filed June 10, 2005, now abandoned [HHS Ref. No. E-089-2005/0-US-01]; PCT Patent Application No. PCT/ US2006/22401, filed June 7, 2006, now abandoned [HHS Ref. No. E-089- 2005/0-US-02]; U.S. Patent Application No. 11/917,036, filed December 10, 2007 [HHS Ref. No. E-089-2005/0-US-03]; European Patent Application No. 06772641.4, filed December 7, 2007, which published as 1888064 on February 20, 2008 [HHS Ref. No. E-089-2005/0-EP-04]; Australian Patent Application No. 2006258035, filed November 30, 2007 [HHS Ref. No. E- 089-2005/0-AU-05]; Japanese Patent Application No. 2008-515947, filed December 7, 2007 [HHS Ref. No. E-089-2005/0-JP-06]; and Canadian Patent Application No. 2609577, filed November 23, 2007 [HHS Ref. No. E-089- 2005/0-CA-07], all of which are entitled ``Benztropinamine Analogs as Dopamine Uptake Inhibitors'' (Inventors: Amy Newman and Jonathan Katz, NIDA) to Shire LLC, having an office in at least Basingstoke, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of benztropinamine analogs, specifically, compounds derived from Formula I, wherein B is NR \4\ and wherein R \4\ is not CH3 (methyl group) to treat psychiatric and neurological disorders.

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.