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

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.