Department of Health and Human Services January 2012 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of section 333A(b)(1) of the Public Health Service (PHS) Act, as amended by the Health Care Safety Net Amendments of 2002, 42 U.S.C. 254f-1(b)(1), the Secretary of HHS shall establish the criteria which she will use to make determinations under section 333A(a)(1)(A) of the health professional shortage areas (HPSAs) with the greatest shortages. This notice sets forth revised criteria for determining correctional facility HPSA scores.

This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.

The Food and Drug Administration (FDA) is announcing an alteration to an existing System of Records (System) titled ``Bioresearch Monitoring Information System, HHS/FDA'' (System No. 09- 10-0010). Among other updates, this alteration adds new routine uses for disclosures of certain relevant information to Agencies, authorities, and organizations with responsibilities related to clinical investigations and/or clinical investigators; persons who require access to records to perform services for FDA; and individual research subjects.

The Food and Drug Administration (FDA, the Agency) is issuing an order prohibiting certain extralabel uses of cephalosporin antimicrobial drugs in certain food-producing animals. We are issuing this order based on evidence that certain extralabel uses of these drugs in these animals will likely cause an adverse event in humans and, therefore, present a risk to the public health.

The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.

Title IV-E rules provide Federal Financial Participation (FFP) through a beneficial cost allocation methodology if a State or Tribe implements a comprehensive Statewide Automated Child Welfare Information System (SACWIS) to track and manage child protection, foster care and adoption assistance activities. With the continuing implementation of the Fostering Connections to Success and Increasing Adoptions Act of 2008 (Pub. L. 110-351) we wish to analyze the impact of the State-centric SACWIS rules on Tribes and Tribal child welfare agencies, to determine if Tribes have sufficient flexibility and latitude to build information systems that will meet their business needs. The Children's Bureau's (CB) Division of State Systems (DSS) has been assigned responsibility to undertake consultation with Tribes in this area. To offer Tribes the opportunity for informed comment on the implications that the State-centric rules have on their ability to build and operate information systems that will support their title IV- E programs, we will provide an education session on the SACWIS regulations. This will be followed by a consultation to listen to the concerns and ideas from Tribal leaders and their representatives about the existing SACWIS rules and how CB can support title IV-E Tribal agencies in building information systems that will meet their business needs. We propose two such combined meetings via teleconferences to reach a broad audience of interested parties. The teleconference on February 15, 2012, is intended for consultation with Tribal leaders; the teleconference on February 16, 2012, is intended to engage in consultation with their representatives.

This document corrects technical errors and typographical errors in the final rule with comment period entitled ``Medicare Program; Payment Policies under the Physician Fee Schedule, Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee Schedule: Signature on Requisition, and Other Revisions to Part B for CY 2012'' which appeared in the November 28, 2011 Federal Register.

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 30, 2011, entitled ``Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Patient Notification Requirements in Provider Agreements.''

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the guidance document is to educate regulated industry and FDA Staff on how, when, and why to use classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). This document describes how classification product codes are used in a variety of FDA program areas to regulate and track medical devices. This draft guidance is not final nor is it in effect at this time.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Jennifer Jamieson, State University of New York, Upstate Medical University: Based on the report of an investigation conducted by the State University of New York, Upstate Medical University (SUNY US) and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Jennifer Jamieson, former graduate student, Department of Cell and Developmental Biology, SUNY US, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM047607-18A1, and National Heart, Lung, and Blood Institute (NHLBI), NIH, grants R01 HL70244-05. ORI found that Respondent engaged in research misconduct by falsifying data that were included in grant application R01 GM047607- 18A1, in a manuscript submitted for publication to the Journal of Cell Biology, and in several interdepartmental data presentations. Specifically, ORI found that: Respondent falsified Figure 1A in a manuscript submitted for publication to the Journal of Cell Biology, by altering immunoprecipitation Western blot data to make this experiment appear that no Vav2 SH2 was associated with PKL 3YF, when in fact it did. In addition, the Respondent falsified five figures depicting Western blots of similar experiments in four laboratory meeting presentations. The purpose of the falsifications was to show that the experimental results were as described when they were not, or to show that the results were of greater significance than they actually were. Respondent falsified Figure 3I in a manuscript submitted for publication to the Journal of Cell Biology by falsely labeling a Western blot to indicate levels of expression for various Vav2 mutants, when the experimental data were taken from a completely unrelated experiment. Respondent falsified Figure 6A in an interdepartmental laboratory presentation by falsifying Western blot data to falsely depict Paxillin and Hic-5 expression and phosphorylation levels after siRNA treatment. Respondent falsified Figure 5 from NIGMS, NIH, grant application GM047607-18A1, by falsifying Western blot data to support the hypothesis that co-transfection of PKL plus RhoA GEF Vav2 induces RhoA activation and signaling upon plating on fibronectin. Ms. Jamieson has entered into a Voluntary Settlement Agreement (Agreement). Ms Jamieson neither admits nor denies ORI's finding of scientific misconduct nor any particular finding of fact asserted in support of that finding. The settlement is not an admission of liability on the part of the Respondent. Ms. Jamieson has voluntarily agreed for a period of three (3) years, beginning on December 20, 2011: (1) To have her research supervised if employed by an institution that receives or applies for U.S. Public Health Service (PHS) funding; Respondent agrees that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agrees that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology were accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself 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.

The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.