Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents

On September 21, 2011, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published a notice in the Federal Register requesting public comment on the draft ``Public Health Service (PHS) Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ Transplantation'' (76 FR 58517). Written and electronic comments were to be received on or before November 21, 2011. However, HHS/CDC has received requests for a 30 day extension of the comment period. In consideration of those requests, HHS/CDC is extending the comment period by 30 days to December 23, 2011. CDC also published a supporting document for reference, the Evidence Report. The Evidence Report includes primary evidence, studies, and data tables that were used by the Guideline authors in developing the recommendations in the Guideline. The draft Guideline is for use by organ procurement organizations (OPOs); transplant centers, including physicians, nurses, administrators, and clinical coordinators; laboratory personnel responsible for testing and storing donor and recipient specimens; and persons responsible for developing, implementing, and evaluating infection prevention and control programs for OPOs and transplant centers. This Guideline provides evidence-based recommendations for reducing unexpected transmission of HIV, HBV and HCV from deceased and living organ donors.

Statement of Organization, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of the Assistant Secretary (OAS) and the Administration on Developmental Disabilities (ADD). This reorganization realigns the President's Committee for People with Intellectual Disabilities Staff within the OAS and moves the function to ADD as a result of the Charter Amendment for PCPID governed by Public Law 92-463 signed by the Secretary, HHS, on May 9, 2011.

The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies, and describes criteria that the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of anticoccidial drugs intended for use in poultry and other food-producing animals. The draft guidance also suggests times during the evaluation of effectiveness when sponsors may wish to consult with CVM.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Monday, November 7, 2011 (76 FR 68769). The document announced a public workshop entitled ``Bridging the Idea Development Evaluation Assessment and Long-Term Initiative and Total Product Life Cycle Approaches for Evidence Development for Surgical Medical Devices and Procedures.'' The document was published with an incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA) is reopening the comment period for the notice announcing a public meeting for the ``Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8, 2011 (76 FR 48169). In the notice, FDA requested public comments regarding matters to be discussed at the October 13, 2011, meeting, including the performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public health/clinical needs, and quality criteria for establishing the accuracy of reference databases. FDA is reopening the comment period to receive comment updates or any new information on the concept paper entitled ''Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices,'' for FDA's proposed evaluation approach for assessing the performance of highly multiplexed microbiology/MCM devices.

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).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Notification for a New Dietary Ingredient'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces a town hall meeting in accordance with to discuss fiscal year (FY) 2013 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2013 new medical services and technologies applications meet the substantial clinical improvement criterion.

This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS for ``reasonable and necessary'' determinations under Medicare. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.

The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Committee is the responsibility of the NVPO. Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.