October 8, 2008 – Federal Register Recent Federal Regulation Documents

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 collection of information concerning the establishment and operation of clinical trial data monitoring committees.

We propose to adopt a new airworthiness directive (AD) for all Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. For all airplanes, this proposed AD would require repetitive overhaul of the retract actuator beam of the main landing gear (MLG). For certain airplanes, this proposed AD would require repetitive inspections for damage of the retract actuator beam, and related investigative and corrective actions if necessary. This proposed AD results from reports of broken retract actuator beams of the MLG and the subsequent failure of the MLG to fully retract. We are proposing this AD to detect and correct broken retract actuator beams of the MLG, which could cause damage to the beam arm, hydraulic tubing, and flight control cables. Damage to the flight control cables could result in loss of control of the airplane.

This document affirms as final, with changes, an interim final rule that amended regulations regarding grants to States for the construction or acquisition of State homes for furnishing domiciliary and nursing home care to veterans, or for the expansion, remodeling, or alteration of existing State homes for furnishing domiciliary, nursing home, or adult day health care to veterans. This rule is necessary to update the regulations and to implement statutory provisions, including provisions of the Veterans Millennium Health Care and Benefits Act. This document also incorporates some non-substantive changes to the regulations in the interim final rule and recognizes a change made to 38 CFR 59.50(b) on February 14, 2007.

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.

The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

The purpose of this notice is to inform the public that the Forest Service intends to prepare an environmental impact statement for amending the Dakota Prairie Grasslands Land and Resource Management Plan (DPG Plan) pursuant to 16 U.S.C. 1604(f)(5) and 36 CFR 219.12. This includes approving certain site specific projects associated with the same lands. The National Environmental Policy Act (NEPA), the Forest and Rangeland Renewable Resources Planning Act (RPA) and the National Forest Management Act (NFMA) are among the laws that set forth the requirements for Forest Service planning. This DPG Plan amendment will determine management direction including land-use determinations, management area prescriptions, and standards and guidelines. The need for the DPG Plan amendment results from the recent acquisition of 5,200 acres of private land, the majority of which lie in a solid block east of the Little Missouri River in Billings County, North Dakota. Site specific project proposals relate to: (1) Restoring ecological functions and wildlife habitat, (2) improving livestock grazing opportunities, (3) enhancing heritage and recreation opportunities, and 4) promoting conservation activities. Respondents are encouraged to review grassland planning documents and the final response to the Scientific Review Team Report for more information on woody and riparian communities' restoration, prescribed burning, grazing management issues, and drought management strategies. Documents are available at: https://www.fs.fed.us/r1/dakotaprairie/ and https://www.fs.fed.us/ngp. The Forest Service will be soliciting comments from individuals, state and local governments, American Indians, federal agencies, and organizations on the scope of the analysis specific to this DPG Plan amendment and the site-specific projects proposed.

The Bureau of Reclamation (Reclamation) will begin charging a recreation user fee to take the guided tour of Glen Canyon Dam and Powerplant. Reclamation has determined that the new fee is reasonable and appropriate to specifically offset at least, in part, increased costs associated with public visitation to the Carl Hayden Visitor Center. The Visitor Center, located 700 feet above the Colorado River overlooking Glen Canyon Dam and Bridge, accommodates about one million visitors each year. The Visitor Center is jointly operated by Reclamation and the National Park Service. The new fee will initially be $5.00 per adult with a reduced fee schedule for certain groups as follows: seniors (age 62 and over) will be $4.00, children ages 7-16 will be $2.50, members of the U.S. military will be $4.00, and school groups will be $0.50 per person. There will be no fee charged for children six years of age and under. These fees will be reviewed and adjusted, as appropriate, in subsequent years.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), 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: Information Program on Clinical Trials: Maintaining a Registry and Results Databank; Type of Information Collection Request: Revision of currently approved collection [OMB No. 0925-0586, expiration date 01/31/2009], Form Number: NA; Need and Use of Information Collection: The National Institutes of Health is modifying the clinical trial registry databank established under previous law [FDAMA, Section 113] to comply with provisions of Title VIII of Public Law 110-85 (Food and Drug Administration Amendments Act of 2007). The databank collects specified registration and results information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials, to the benefit of public health. The databank is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research studies. Public Law 110-85 expands the scope of clinical trials that must be registered in ClinicalTrials.gov, increases the clinical trial information that must be submitted as part of each registration, and requires the submission of basic results information for registered trials of approved drugs, biologics and devices. Frequency of Response: Responsible parties must submit the required registration information not later than 21 days after enrolling the first subject. Results information is to be reported not later than 12 months after the completion date (as defined in the law), but can be delayed under certain circumstances. Updates to submitted information are required at least once a year, unless there are no changes to report. Changes in recruitment status and completion of a trial must be reported not later than 30 days after such events. Description of Respondents: Respondents are referred to in the law as ``responsible parties,'' and are defined as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3) or (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, provided that ``the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements'' for submitting information under the law. Estimate of Burden: The burden associated with this information collection consists of two parts: the burden associated with registration of clinical trials; and the burden associated with the reporting of results information. In both cases, the burden includes the time necessary to extract information from the study protocol or results record, reformat it, enter it into the databank, and provide necessary updating over the course of the study. It is estimated that registration information will be required for 3,000 trials of drugs and biologics and 445 trials of medical devices each year. Each initial registration is estimated to take 7 hours and each of the subsequent 8 updates to the record are estimated to take 2 hours, resulting in an annual burden of 79,235 hours. It is estimated that there will be voluntary submissions of registration information for 6,000 trials of drugs and biologics, 545 trials of devices, and 5,280 trials of other types of medical interventions. Using the same hour estimates as for mandatory registration, the burden associated with voluntary registrations is estimated at 271,975 hours, bringing the total registration burden to 351,210 hours. In the first year of operation, it is estimated that there will be an additional burden of 84,150 hours associated with the updating of information for 7,000 trials of drugs and biologics and 650 trials of medical devices that were previously registered in the databank and ongoing as of December 26, 2007 (90 days after enactment). It is estimated that such trials will require one update of 3 hours to bring them into compliance with the new law (FDAAA) and 4 subsequent updates of 2 hrs each. Results reporting is required only for those applicable clinical trials of drugs, biologics, and devices that are subject to the mandatory registration requirements of FDAAA and for which the product(s) under study have been approved or cleared by the FDA. It is estimated that results reporting will be required for 1,645 trials of drugs and biologics and 375 trials of medical devices each year. Initial submission of results information is estimated to require 10 hours, and each result submission is expected to require two updates that take 5 hours each. The total burden for results reporting is therefore estimated at 40,400 hours per year. There are no capital costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

This action confirms the effective date of the direct final rule that established Class E airspace at Muldrow Army Heliport, Lexington, OK, published in the Federal Register August 6, 2008 (73 FR 45607) Docket No. FAA-2008-0003.

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 National Offshore Safety Advisory Committee (NOSAC) will meet, in New Orleans, LA, to discuss various issues relating to offshore safety and security. The meeting will be open to the public.

This action confirms the effective date of the direct final rule that amended Class E airspace at Black River Falls, WI, published in the Federal Register August 6, 2008 (73 FR 45606) Docket No. FAA- 2008-0024.