Department of Health and Human Services July 2012 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 247
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Administration on Intellectual and Developmental Disabilities; Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Status Reporting Form for State Councils on Developmental Disabilities
For the program of the State Councils on Developmental Disabilities, funds are awarded to State agencies contingent on fiscal requirements in subtitle B of the Developmental Disabilities Assistance and Bill of rights Act. The SF-425, ordinarily mandated in the revised OMB Circular A-102, provides no accounting breakouts necessary for proper stewardship. Consequently, the proposed streamlined form will substitute for the SF-425 and will allow compliance monitoring and proactive compliance maintenance and technical assistance.
Drugs for Human Use; Drug Efficacy Study Implementation; Certain Prescription Drugs Offered for Various Indications; Opportunity To Affirm Outstanding Hearing Request
The Food and Drug Administration (FDA) is offering an opportunity to affirm outstanding hearing requests pertaining to several dockets. FDA will assume that companies with outstanding hearing requests that do not respond to this notice are no longer interested in pursuing their requests, and will deem the requests withdrawn.
Notice Regarding Section 340B of the Public Health Service Act Registration Period
The Health Resources and Services Administration (HRSA) is issuing this notice to inform stakeholders of the revised deadlines for registration of new covered entities and for adding outpatient facilities and contract pharmacy arrangements to the 340B Drug Pricing Program (340B Program).
Medicaid Program; Disproportionate Share Hospital Allotments and Institutions for Mental Diseases Disproportionate Share Hospital Limits for FYs 2010, 2011, and Preliminary FY 2012 Disproportionate Share Hospital Allotments and Limits
This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal FY (FY) 2010, 2011 and the preliminary Federal share DSH allotments for FY 2012. This notice also announces the final FY 2010, 2011 and the preliminary FY 2012 limits on aggregate DSH payments that States may make to institutions for mental diseases (IMD) and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments.
Children's Health Insurance Program (CHIP); Final Allotments to States, the District of Columbia, and U.S. Territories and Commonwealths for Fiscal Year 2012
This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2012 (with the qualification that potential increases in such allotments may be available for certain States). Title XXI of the Social Security Act (the Act) authorizes payment of Federal matching funds to States, the District of Columbia, and the U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the Children's Health Insurance Program (CHIP). The fiscal year allotments contained in this notice were determined in accordance with the funding provisions and final regulations published in the February 17, 2011 Federal Register.
Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals (QIs) for FY 2012
This notice sets forth the States' final allotments available to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the Federal fiscal year (FY) 2011 and the preliminary QI allotments for FY 2012. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations and reflect funding for the QI program made available under recent legislation as described in this notice.
Public Comment Period Extension for the Final Supplementary Risk Assessment for the Boston University (BU) National Emerging Infectious Diseases Laboratories (NEIDL)
A Notice of Availability for the Final Supplementary Risk Assessment for the Boston University (BU) National Emerging Infectious Diseases Laboratories (NEIDL) was published in the Federal Register on July 6, 2012. Upon the publication of the Notice of Availability, a required comment period of at least 30 day began in which the National Institutes of Health would accept and consider comments from the public on the final supplementary risk assessment. This comment period was set to end on August, 6, 2012. In order to provide the public with additional time to review and comment on the final supplementary risk assessment, the National Institutes of Health (NIH) has decided to extend the public comment period for the final supplementary risk assessment until August 24, 2012.
Solicitation of Written Comments on Draft Phase 3 Long-Term Care Facilities Strategy/Module for Inclusion in the National Action Plan To Prevent Healthcare-Associated Infections: Roadmap to Elimination
The Office of Healthcare Quality is soliciting public comment on a new long-term care facilities strategy/module of the National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination. To further the HHS mission to protect the health and well- being of the nation, the HHS Steering Committee for the Prevention of Healthcare-Associated Infections has developed a draft comprehensive strategy for preventing and reducing healthcare-associated infections in long-term care facilities. This Phase 3 Long-Term Care Facilities module builds upon and is to be included in the existing National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination that focuses on reducing healthcare-associated infections (HAIs) in acute care hospitals, ambulatory surgical centers, and end stage renal disease facilities and presents strategies for increasing healthcare personnel influenza vaccination coverage (Phases 1 & 2).
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on August 16, 2012, from 9:30 to 11:30 a.m. at 31 Center Drive on the NIH campus, Building 31C, Conference Room 6. The meeting is open to the public.
Nomination of an In Vitro Test Method for the Identification of Contact Allergens: Request for Comments and Data
On behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests public comment on an ICCVAM test method nomination for validation studies. The validation studies are proposed to determine the usefulness and limitations of an in vitro test method to identify electrophilic substances that have the potential to produce allergic contact dermatitis (ACD). NICEATM also requests data generated using in vivo and in vitro test methods for assessing ACD hazard potential, including but not limited to guinea pig methods, the murine local lymph node assay, the direct protein reactivity assay, the human cell line activation test, and the KeratinoSens\TM\ assay. Data will be used to develop integrated testing and decision strategies that will also consider incorporation of the nominated test method following adequate validation studies.
Evaluation of an Up-and-Down Procedure for Acute Dermal Systemic Toxicity Testing: Request for Nominations for an Independent Expert Panel and Submission of Relevant Data
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), is planning to convene an independent scientific peer review panel (Panel) to assess the validation status of an up-and-down procedure (UDP) for acute dermal systemic toxicity testing. NICEATM requests nominations of scientific experts who can be considered for the Panel and submission of data for substances tested in in vivo acute dermal and oral systemic toxicity tests.
Agency Information Collection Activities; Proposed Collection; Comment Request; Chronic Disease Self-Management Education Program Standardized Data Collection
The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information. 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 information collection requirements relating to the Chronic Disease Self-Management Education Program.
Patient Protection and Affordable Care Act; Data Collection To Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans
This final rule establishes data collection standards necessary to implement aspects of section 1302 of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. This final rule also establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans.
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