Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents
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Webinar Overview of the National Vaccine Advisory Committee Healthcare Personnel Influenza Vaccination Subgroup's Draft Report and Draft Recommendations for Achieving the Healthy People 2020 Annual Coverage Goals for Influenza Vaccination in Healthcare Personnel
The National Vaccine Program Office (NVPO), on behalf of the National Vaccine Advisory Committee (NVAC), Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS), will host an informational webinar to introduce the committee's draft report and draft recommendations for annually achieving 90% influenza vaccination coverage among healthcare personnel, as stated in the Healthy People 2020 goals. The informational webinar provides an opportunity for the public to listen to an overview of the findings and processes used by the HCPIVS members to derive their recommendations. Pre-registration for the webinar is required. The co-chairs of the HCPIVS working group will also provide information to the public on how to submit written comments on the draft report and draft recommendations through the Federal Register process. Registrants for the webinar will be provided an opportunity to submit questions about the report at the time of registration. Public and Stakeholder comments on the draft report and the draft recommendations should be directed to https://www.hhs.gov/ nvpo/nvac/subgroups/healthcare_personnel_influenza_vacc_ subgroup.html.
Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Healthcare Personnel Influenza Vaccination Subgroup for Consideration by the National Vaccine Advisory Committee on Achieving the Healthy People 2020 Annual Coverage Goals for Influenza Vaccination in Healthcare Personnel
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. The ASH has charged the NVAC with developing recommended strategies for annually achieving 90% influenza vaccination coverage among healthcare personnel, as stated in the Healthy People 2020 goals. The Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS), a subgroup of the NVAC Adult Immunization Working Group (AWIG), was established to address this charge on behalf of the NVAC. A draft report and draft recommendations have been developed by the HCPIVS for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the Healthcare Personnel Influenza Vaccination Subgroup draft report and draft recommendations for increasing vaccination of healthcare personnel to meet the Healthy People 2020 goals. Individuals and organizations are encouraged to submit their comments on the draft report and draft recommendations. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented in February 2012 to the NVAC for deliberation and decision on their final recommendations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Examination of Online Direct-to-Consumer Prescription Drug Promotion
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.
Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests
This proposed rule would require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (``covered recipients''). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public Web site.
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Proposed Rule
On October 3, 2011, the Centers for Disease Control (CDC), located within the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (76 FR 61206) requesting public comment on the appropriateness of the current HHS and Overlap list of select agents and toxins including whether there are other agents or toxins that should be added to the HHS or Overlap list or whether agents or toxins currently on the HHS or Overlap list should be deleted from the list; the appropriateness of the proposed tiering of the select agents and toxins list; whether minimum standards for personnel reliability, physical and cyber security should be prescribed for identified Tier 1 agents; and any other aspect of the proposed amendments to the select agent regulations. The comment period closed on December 2, 2011. Since we would like to allow interested persons additional time to prepare and submit comments, we are reopening the comment period for the NPRM.
Medicare Program; First Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP-Formerly Known as the Advisory Panel on Ambulatory Payment Classification Groups-APC Panel)-February 27, 28, and 29, 2012
This notice announces the first semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP), formerly known as the Advisory Panel on Ambulatory Payment Classification Groups (the APC Panel) for 2012. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the APC groups and their associated weights, and hospital outpatient supervision issues.
Ophthalmic and Topical Dosage Form New Animal Drugs; Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate Otic Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Virbac AH, Inc. The NADA provides for the veterinary prescription use of a hydrocortisone aceponate, miconazole nitrate, and gentamicin sulfate suspension for the treatment of otitis externa in dogs.
Oral Dosage Form New Animal Drugs; Estriol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
Organ Procurement and Transplantation Network
This notice of proposed rulemaking sets forth the Secretary's proposal to include vascularized composite allografts, described below, within the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network. The Secretary further proposes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2011
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Announcing the Award of a Single-Source Grant to Support Services for Haitian Medical Evacuees to the Florida Department of Children and Families in St. Petersburg, FL
Notice is hereby given that a single-source grant of $220,000 was awarded to Florida Department of Children and Families, located in St. Petersburg, FL, by the Administration for Children and Families, Office of Refugee Resettlement. Award funds will provide medical and supportive social services to Haitian medical evacuees affected by the earthquake in 2010. The Haitian medical evacuees were brought to the United States (U.S.) in the aftermath of the earthquake in Haiti on January 12, 2010. This is a population that arrived in the U.S. with significant medical issues and no available system for ongoing medical and supportive social services. They had sustained a wide range of injuries, including burns, crush injuries, and head and spine injuries. During Fiscal Year 2010, the refugees' medical costs for their first 8 months in Florida totaled $6.2 million. The single-source award will provide urgently needed support to this group, which are currently residing in a tent complex in St. Petersburg, FL.
Availability of Draft NTP Technical Reports; Request for Comments; Announcement of a Public Meeting To Peer Review Draft NTP Technical Reports
The NTP announces the availability of seven draft NTP Technical Reports (TRs) tentatively scheduled for peer review by an NTP Technical Reports Peer-Review Panel at a meeting on February 8-9, 2012. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ``Request for Comments'' below). Information about this meeting, including draft reports and preliminary agenda, will be available on the NTP Web site (https://ntp.niehs.nih.gov/go/36051). Summary minutes from the peer review will be posted on the NTP Web site following the meeting.
Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of intravascular diagnostic and imaging medical devices, including: Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR), Intravascular Ultrasound (IVUS), Intravascular Ultrasound (VH-IVUS) with Virtual Histology, Optical Coherent Tomography (OCT), Near- Infrared Spectroscopy (NIR), Angioscopy, Intravascular Magnetic Resonance Imaging (MRI), Elastrography, and Thermography. Scientific information is being solicited to inform our Comparative Effectiveness Review of Intravascular Diagnostic Procedures and Imaging Techniques versus Angiography Alone, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Scientific Information Request on CYP2C19 Variants and Platelet Reactivity Tests
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of CYP2C19 variants and platelet reactivity tests. Scientific information is being solicited to inform our Comparative Effectiveness Review of Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on the Public Display of Lists of Harmful and Potentially Harmful Tobacco Constituents
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 a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study on the Public Display of the List of Harmful and Potentially Harmful Tobacco Constituents. This study is being conducted in support of the provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) that requires FDA to publish in a format that is understandable and not misleading to a lay person and to place on public display the list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
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.
Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review
The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled ``Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review'' (literature review report). A literature review was conducted to address a requirement of the Patient Protection and Affordable Care Act (Affordable Care Act). FDA is publishing the literature review report to allow the public to provide comment on the report as it relates to the Affordable Care Act.
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