Department of Health and Human Services July 18, 2008 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Refugee Resettlement's Division of Unaccompanied Children's Services (ORR/DUCS) will award a noncompetitive urgent single-source award to the Latin American Health Institute (LHI) to provide urgent care for unaccompanied alien children (UAC) in response to an unsolicited application. ORR/DUCS-funded facilities currently have very limited capacity to help UAC cope with potentially devastating consequences of trauma. Such limited trauma-informed services within the ORR/DUCS network of care puts UAC and the ORR/DUCS program at tremendous risk. A great number of UAC have been subjected to severe trauma, including sexual abuse and sexual assault in their home countries or on their journey to the U.S.; gang violence; domestic violence; traumatic loss of a parent; and physical abuse and neglect. In addition, UAC experience the increased probability of ongoing trauma as a result of their uncertain legal status and return to difficult life circumstances. ORR/DUCS-funded facilities currently have very limited specifically targeted capacity to help UAC cope with the potentially devastating consequences of trauma. Trauma affects children in very complex ways, including behavioral problems and potential involvement with the juvenile justice system; suicidal ideation and attempts; serious depression; and lasting delays in reaching emotional, cognitive, and interpersonal developmental milestones. ORR/DUCS-funded care providers are in a unique position to assist and intervene in these cases in order to minimize the harmful effects of past and possible ongoing trauma. The lack of expertise in addressing trauma leaves the ORR/DUCS- funded care provider facilities staff particularly vulnerable to the occupational hazards of working with traumatized children, such as vicarious trauma, boundary violations with children, job burnout, and high staff turnover. The youth workers in the ORR/DUCS-funded facilities do not have specific knowledge of childhood trauma and more importantly, they lack effective responses such that they are left ill-prepared to handle the complex needs of the UAC in their care. Without this type of expertise, staff in the facilities may in certain situations indirectly or unknowingly foster an environment that perpetuates trauma for the children. Trauma training will prepare care provider facility staff to better help UAC and to convey accurate information to their sponsors, thus creating safer outcomes for the youth and the communities where they are released. The LHI Unaccompanied Alien Children Trauma Initiative will provide specialized training in delivery of trauma- informed services, and identification of ways that promote mastery and resilience in trauma victims, based on proven expertise in child trauma and immigrant and refugee experience.

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 Hanford Nuclear Reservation in Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 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 Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at Horizons, Inc., Cleveland, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 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 announcing the withdrawal of Compliance Policy Guide Sec. 540.575 FishFresh and FrozenAdulteration Involving Decomposition (CPG 7108.05) (CPG Sec. 540.575). This action is being taken because the guidance in CPG Sec. 540.575 relating to decomposition in fresh and frozen fish is not current.

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of September 23, 1997, entitled ``Food Labeling; Nutrient Content Claims; Definition for ``High Potency'' and Definition of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods.'' This SECG is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

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: J. Keith Hampton, St. Luke's Hospital: Based on the report of an investigation conducted by St. Luke's Hospital (SLH) in Chesterfield, MO, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that J. Keith Hampton, MSN, APRN, former Clinical Research Associate, SLH, engaged in scientific misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), awards U10 CA69651, U10 CA12027, and U10 CA33601. PHS found that Mr. Hampton engaged in scientific misconduct by falsifying and fabricating data that were reported to the National Surgical Adjuvant Breast & Bowel Project (NSABP) and Cancer and Leukemia Group B (CALGB) cooperative research groups. Specifically, PHS found that: 1. For protocol CALGB 90206, Respondent: (a) Falsified a patient's CT scan reports and registration forms and reported the falsified CT scan reports and registration worksheet to CALGB, (b) Falsified a patient's performance status records (giving 80% performance status) and registration forms and reported the falsified performance status report and registration form to CALGB. 2. For protocol NSABP B-35, Respondent: (a) Falsified eligibility data related to hematology and chemistry assays and to the performance of a pelvic exam on one patient's registration form and reported the falsified registration forms to the National Cancer Institute Cancer Trial Support Unit (CTSU), (b) Falsified pelvic exam eligibility on a second patient's registration form and reported the falsified registration form to the CTSU, (c) Falsified hematology and chemistry assay eligibility on a third patient's registration form and reported the falsified registration form to the CTSU. 3. For protocol NSABP B-36, Respondent falsified a patient's multigated acquisition test (MUGAa test of heart function) records, cardiac function, and registration forms, certified the patient's eligibility, and reported the falsified MUGA test, cardiac function, and registration forms to the CTSU. 4. For protocol NSABP B-38, Respondent falsified hematology, chemistry, and MUGA eligibility for a patient on the registration form and reported the falsified registration form to the CTSU. 5. For protocol NSABP C-08, Respondent: (a) Falsified urine protein/creatinine ratio eligibility for one patient on the registration form and reported the falsified registration form to the CTSU, (b) Falsified urine protein/creatinine ratio eligibility for a second patient on the registration form and reported the falsified registration form to the CTSU, (c) Falsified claims of the urine protein/creatinine ratio and PT(INR) eligibility for a third patient on the registration form and reported the falsified registration form to the CTSU. 6. For protocol NSABP R-04, Respondent falsified a patient's colonoscopy report and eligibility at registration and reported the falsified colonoscopy report and registration form to the CTSU. Mr. Hampton has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed for a period of three (3) years, beginning on June 17, 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 Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq.) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (2 CFR 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.