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

Results 101 - 150 of 261
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-16407
Type: Notice
Date: 2008-07-21
Agency: Department of Health and Human Services, National Institutes of Health
Child Support Enforcement Program; Medical Support
Document Number: E8-15771
Type: Rule
Date: 2008-07-21
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This regulation revises Federal requirements for establishing and enforcing medical support obligations in Child Support Enforcement (CSE) program cases receiving services under title IV-D of the Social Security Act (the Act). The changes: require that all support orders in the IV-D program address medical support; redefine reasonable-cost health insurance; require health insurance to be accessible, as defined by the State; and make conforming changes to the Federal interstate, substantial-compliance audit, and State self-assessment requirements.
Noncompetitive Urgent Single Source Unaccompanied Alien Children Trauma Initiative
Document Number: E8-16573
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services, Office of Refugee Resettlement
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.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-16468
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services
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 Nuclear Materials and Equipment Corporation (NUMEC) facility in Parks Township, Pennsylvania, 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:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-16467
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services
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:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-16466
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services
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 SAM (Special Alloyed or Substitute Alloy Materials) Laboratories of Columbia University in New York City, New York, 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:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-16465
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services
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:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for the Linde Ceramics Plant, Tonawanda, NY, To Be Included in the Special Exposure Cohort
Document Number: E8-16464
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Linde Ceramics Plant, Tonawanda, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Linde Ceramics Plant. Location: Tonawanda, New York. Job Titles and/or Job Duties: All employees. Period of Employment: During the applicable covered residual radiation period from January 1, 1954 through July 31, 2006.
Animal Models for the Treatment of Acute Radiation Syndrome; Public Workshop
Document Number: E8-16461
Type: Notice
Date: 2008-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
Compliance Policy Guide Sec. 540.575 Fish-Fresh and Frozen-Adulteration Involving Decomposition (CPG 7108.05); Withdrawal
Document Number: E8-16456
Type: Notice
Date: 2008-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products - Decomposition; Availability
Document Number: E8-16453
Type: Notice
Date: 2008-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products Decomposition (the draft CPG). The draft CPG, when final, will provide FDA staff with current regulatory action guidance relating to decomposition in fish and fishery products.
Safety and Occupational Health Study Section: Notice of Charter Renewal
Document Number: E8-16450
Type: Notice
Date: 2008-07-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors for the National Center for Public Health Informatics
Document Number: E8-16449
Type: Notice
Date: 2008-07-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Small Entity Compliance Guide: 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; Availability
Document Number: E8-16448
Type: Notice
Date: 2008-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
Document Number: E8-16447
Type: Notice
Date: 2008-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 reporting requirements contained in existing FDA regulations governing State enforcement notifications.
Findings of Scientific Misconduct
Document Number: E8-16357
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services, Office of the Secretary
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.
Submission for OMB Review; Comment Request
Document Number: E8-15898
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: E8-15897
Type: Notice
Date: 2008-07-18
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2009 Payment Rates
Document Number: E8-15539
Type: Proposed Rule
Date: 2008-07-18
Agency: Department of Health and Human Services, Part II, Centers for Medicare & Medicaid Services
This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2009. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we propose the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other pertinent ratesetting information for the CY 2009 ASC payment system. These changes would be applicable to services furnished on or after January 1, 2009.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-16406
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: E8-16405
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-16399
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Small Entity Compliance Guide: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Availability
Document Number: E8-16396
Type: Notice
Date: 2008-07-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing theavailability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of February 11, 2004 (69 FR 6788), entitled ``Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk.'' This SECG is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.
[Docket No. FDA-2005-D-0208] (formerly Docket No. 2005D-0438)
Document Number: E8-16395
Type: Notice
Date: 2008-07-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency,'' dated June 2008. The guidance document provides recommendations for the design of clinical trials to assess the safety, efficacy, and pharmacokinetics of immune globulin intravenous (human) (IGIV) products as replacement therapy in primary humoral immunodeficiency. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2005.
Small Entity Compliance Guide: Standard of Identity for White Chocolate; Availability
Document Number: E8-16394
Type: Notice
Date: 2008-07-17
Agency: Food and Drug Administration, Department of Health and Human Services
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 October 4, 2002 (67 FR 62171). This SECG entitled ``Standard of Identity for White Chocolate'' is intended to set forth, in plain language, the requirements of the regulation and to help small businesses understand the regulation.
Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children (ACHDGDNC); Notice of Meeting
Document Number: E8-16360
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-16358
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
Document Number: E8-16354
Type: Rule
Date: 2008-07-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers'' that will serve as the special control for these devices.
Organization, Functions, and Delegations of Authority, Part G, Indian Health Service, Proposed Functional Statement
Document Number: E8-16353
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, Indian Health Service
National Institute on Aging; Notice of Closed Meeting
Document Number: E8-16336
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-16333
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: E8-16197
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-16183
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-16180
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-16147
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: E8-16146
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: E8-16144
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-16143
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-16142
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Meeting
Document Number: E8-16141
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Guidance for Industry and Food and Drug Administration Staff
Document Number: E8-16094
Type: Notice
Date: 2008-07-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.'' The guidance document describes a means by which bone sonometers may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III (premarket approval) into class II (special controls).
Notice of Correction-Assessing the Impact of the Patient Safety Improvement Corps (PSIC) Training Program
Document Number: E8-16062
Type: Notice
Date: 2008-07-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Office of Urban Indian Health Programs
Document Number: E8-16051
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, Indian Health Service
National Institute on Aging; Notice of Closed Meeting
Document Number: E8-15825
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: E8-15824
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: E8-15823
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-15821
Type: Notice
Date: 2008-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Office of Inspector General; Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG
Document Number: E8-15777
Type: Rule
Date: 2008-07-17
Agency: Department of Health and Human Services, Office of the Secretary, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.
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