Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents
Results 501 - 550 of 3,846
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of “Health Care Providers' Responses to Medical Device Labeling”
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on this proposed information collection ``Health Care Providers' Responses to Medical Device Labeling.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
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.
Preventive Controls for Registered Human Food and Animal Food/Feed Facilities; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the notice, published in the Federal Register of May 23, 2011 (76 FR 29767), entitled ``Preventive Controls for Registered Human Food and Animal Food/Feed Facilities; Request for Comments.'' In that document, FDA opened a docket and requested information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Cosmetic Microbiological Safety Issues; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Cosmetic Microbiological Safety Issues.'' The purpose of the public meeting is to provide stakeholders an opportunity to present information regarding cosmetic microbiological safety and to suggest areas for the possible development of FDA guidance documents. FDA is seeking information regarding microbiological testing of cosmetics; types of preservative systems and how to test their efficacy; the identity and prevalence of microorganisms, including antibiotic-resistant strains, that pose specific health risks in finished products; routes of exposure to microorganisms and the corresponding infective doses; product and packaging characteristics that affect microbial growth and risk of infection; particular subpopulations that may be at greater risk of infection when using different cosmetic products; the occurrence of adverse events associated with microbial contamination of cosmetics; and any other issues relevant to the microbiological safety of cosmetics.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Panels
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain device panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the National Mammography Quality Assurance Advisory Committees
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Medicare Program; Part A Premiums for CY 2012 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2012. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2012, for these individuals will be $451. The reduced premium for certain other individuals as described in this notice will be $248.
Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2012
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2012 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2012, the inpatient hospital deductible will be $1,156. The daily coinsurance amounts for CY 2012 will be(1) $289 for the 61st through 90th day of hospitalization in a benefit period; (2) $578 for lifetime reserve days; and (3) $144.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2012
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2012. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2012 are $199.80 for aged enrollees and $192.50 for disabled enrollees. The standard monthly Part B premium rate for 2012 is $99.90, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2011 standard premium rate was $115.40) The Part B deductible for 2012 is $140.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage.
Common Formats for Patient Safety Data Collection and Event Reporting
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow health care providers to voluntarily collect and submit standardized information regarding patient safety events. The purpose of this notice is to announce the availability of a new beta version Common Format for Venous Thromboembolism (VTE) for public review and comment.
Announcing the Award of a Single-Source Program Expansion Supplement Grant to the Johns Hopkins University, Bloomberg School of Public Health in Baltimore, MD, To Support the Development of a Human Services National Interoperable Architecture (HSNIA)
The Administration for Children and Families (ACF), Office of Administration (OA), Office of Information Services (OIS) announces the award of $1,000,000 as a single-source expansion supplement grant to extend an award made to the Johns Hopkins University (JHU), Greenberg School of Public Health in Baltimore, MD. The grant will allow JHU, and its partner, JHU Applied Physics Laboratory, to continue the development of a Human Services National Interoperable Architecture (HSNIA). Under the supplement award, JHU and its partners will develop Phase III of an architectural framework that will be used as a model to facilitate State and local agencies in information exchanges among eligibility and verification services that are developed by the HHS/ Centers for Medicare and Medicaid Services (CMS) under the requirements of the Patient Protection and Affordable Care Act (ACA). To address issues related to implementation of the ACA and the Improper Payments Elimination and Recovery Act of 2010, the Administration has directed Federal Agencies to begin to design and execute plans related to the legislation. JHU and its partners will create the development of a conceptual information technology architecture with ACF/Office of Information Services. The project will produce a solution that supports information exchanges and interoperability that will lead to reductions in improper payments as a preventative step in the program integrity process.
Announcing the Award of a Single-Source Expansion Supplement Grant to the National Association of Councils on Developmental Disabilities in Washington, DC
The Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD), Office of Program Support (OPS) announces the award of a single-source program expansion supplement grant of $388,640 to the National Association of Councils on Developmental Disabilities (NACDD), Washington, DC, to support implementation of 3 to 4 self-advocacy summit meetings. The self-advocacy summits will be interactive meetings requiring a high degree of participation from the attending self-advocates who will act as the primary presenters. The meetings are intended to educate both the network of ADD grantees on the ADD Program's four goals and, as such, every participant will be required to communicate their expertise related to:
Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the University of Massachusetts, Institute for Community Inclusion in Boston, MA, To Support the Think College Project
This notice announces that the Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD) has awarded a single-source program expansion supplement grant of $159,679 for post-secondary education opportunities. The Institute for Community Inclusion at the University of Massachusetts in collaboration with seven ACF-ADD supported University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs) in Delaware, Minnesota, Hawaii, South Carolina, Tennessee [Vanderbilt], Ohio, and California along with the Association of University Centers on Disabilities (AUCD) has established a consortium that will conduct research, provide training and technical assistance, and disseminate information on promising practices that support individuals with developmental disabilities to increase their independence, productivity, and inclusion through access to post-secondary education. Think College's goals are to improve long- term independent living and employment outcomes for individuals with developmental disabilities. The consortium is acting as a national resource for knowledge, training, materials, and dissemination of information on participation in post-secondary education of individuals with developmental disabilities.
Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the University of Massachusetts, Institute for Community Inclusion, in Boston, MA
This notice announces that the Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD) has awarded a single-source expansion supplement grant of $150,000 for data collection analyses, and reporting. The following project will be funded: The University of Massachusetts, Institute for Community Inclusion will collect data, analyze, and report on the employment and economic status of youth and young adults, ages 16 to 30, with intellectual and developmental disabilities. The project will also develop a rigorous, yet practical, ethical, and affordable research design for this evaluation. The data will originate from various existing data sources and will be analyzed using appropriate data analysis techniques. The data will be simplified and categories will be formed that reflect the activities and outcomes of youth and young adults with intellectual and developmental disabilities. A report will be written, highlighting a profile of education, employment, and economic outcomes for youth and young adults with intellectual and developmental disabilities. This information will be provided to ADD and its partners, and will be made available to the public.
Announcement of a Single-Source Grant Award to the National Association of Councils on Developmental Disabilities in Washington, DC
The Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD), Office of Program Support (OPS) announces the award of a single-source grant of $620,000 to the National Association of Councils on Developmental Disabilities (NACDD), located in Washington, DC. The award will support a project to provide training and technical assistance (T/TA) to the designated State Councils on Developmental Disabilities (State Councils). The primary focus of the T/TA is to improve program performance, statutory compliance, and program outcomes across the network of State Councils. Toward this end, NACDD shall provide T/TA to the entities designated by ADD as State Councils. Under this project, it is expected that initiatives shall be identified and undertaken to support the improvement of State Council operations and performance.
Proposed National Toxicology Program (NTP) Review Process for the Report on Carcinogens: Request for Public Comment and Listening Session
The NTP invites written public comment on the proposed Report on Carcinogens (RoC) review process and announces a public listening session to receive oral comments on the proposed process.
Prospective Grant of Exclusive License: Electron Paramagnetic Resonance Devices and Systems for Oximetry
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-175-1995/0 and/1;
Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and AdvertisementsSmall Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628). The notice published with an incorrect docket number. This document corrects that error.
Administration on Children, Youth and Families Announces the Award of Five Single-Source Expansion Supplement Grants To Support Expanded Technical Assistance Activities in the Field of Child Welfare
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of five single-source program expansion supplement grants to the following organizations:
Administration on Children, Youth and Families Announces the Award of a Single-Source Program Expansion Supplement Grant to the National Runaway Switchboard (NRS) in Chicago, IL
The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), announces the award of a single-source program expansion supplement grant of $311,997 to the National Runaway Switchboard (NRS) in Chicago, IL, for initiatives in the areas of quality assurance, comprehensive outreach and increased capacity through technology improvements. Through these initiatives, NRS will improve its outreach to youth through Web site enhancements such as, increased access to the ``Live Chat'' function; recruitment of additional Spanish-English bilingual volunteers; increased outreach and partnerships with local, regional and national organizations to enhance NRS' national impact in crisis intervention for youth and families. In terms of evidence-based programming, this funding will also enable NRS to conduct a study and evaluate efforts in the area of reconnecting runaway youth with their families.
Administration on Children, Youth and Families Announces the Award of a Single-Source Program Expansion Supplement Grant To Support Expanded Training and Technical Assistance to the Pennsylvania Coalition Against Domestic Violence in Harrisburg, PA
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) is announcing the award of a single-source program expansion supplement of $250,000 to the Pennsylvania Coalition Against Domestic Violence in Harrisburg, PA. The supplemental funds will support the grantee in providing training and technical assistance to domestic violence service providers including ACF grantees, State and local social service agencies; so that they better serve victims of domestic violence and their children who are experiencing the mental health and traumatic effects of intimate partner violence. These efforts will increase domestic violence programs awareness and access to effective interventions that are trauma informed.
Approaches to Reducing Sodium Consumption; Establishment of Dockets; Request for Comments, Data, and Information; Correction
The Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) are correcting a notice that appeared in the Federal Register of September 15, 2011 (76 FR 57050). In that notice, FDA and FSIS established dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium, as well as current and emerging approaches designed to promote sodium reduction. The document published with two typographical errors in the References section. This document corrects those errors.
Medicare Program: Notice of Two Membership Appointments to the Advisory Panel on Ambulatory Payment Classification Groups
This notice announces two new membership appointments to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The two appointments are for 4-year periods through January 31, 2016. The purpose of the Panel is to review the APC groups and their associated weights, and to advise the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (the Administrator) concerning the clinical integrity of the APC groups and their weights. The advice provided by the Panel will be considered as CMS prepares its annual updates of the hospital outpatient prospective payment system (OPPS).
Medicare and Medicaid Programs; The American Association for Accreditation of Ambulatory Surgery Facilities for Approval of Deeming Authority for Rural Health Clinics
This proposed notice with comment period acknowledges the receipt of a deeming application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Accountable Care Organization Accelerated Development Learning Sessions; Center for Medicare and Medicaid Innovation
This notice announces the date and location of the third and last in a series of public educational sessions hosted by the Centers for Medicare & Medicaid Services (CMS). This two-day training session is the third and final Accelerated Development Learning Session (ADLS) hosted by CMS to help Accountable Care Organizations (ACOs) deliver better care and reduce costs. We invite all new or existing ACO entities to register a team of senior executives to attend the in- person ADLS. The ADLS will provide executives with the opportunity to learn about core functions of an ACO and ways to build their organization's capacity to succeed as an ACO.
The National Cancer Institute (NCI) Announces the Initiation of a Public Private Industry Partnership on Translation of Nanotechnology in Cancer (TONIC) To Promote Translational Research and Development Opportunities of Nanotechnology-Based Cancer Solutions
The Alliance for Nanotechnology in Cancer of the National Cancer Institute (NCI) is initiating a public private industry partnership called TONIC (Translation Of Nanotechnology In Cancer) to promote translational research and development opportunities of nanotechnology-based cancer solutions. An immediate consequence of this effort will be the formation of a consortium involving government and pharmaceutical, and biotechnology companies. This consortium will evaluate promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients. The purpose of this notice is to inform the community about the Alliance for Nanotechnology in Cancer of NCI's intention to form the consortium and to invite eligible companies (as defined in last paragraph) to participate.
New Policies and Procedural Requirements for the Electronic Submission of Discretionary Grant Applications
The Administration for Children and Families (ACF), an Operating Division of HHS, announces the opportunity for public comment on its initial transition plan to implement required electronic submission of Federal discretionary grant applications and official grant file documents. In accordance with e-Government initiatives mandated by the Federal Financial Assistance Management Improvement Act of 1999, Public Law 106-107, ACF officially acknowledges that electronically generated and/or stored documents are recognized equivalents of an official paper grant file. Recognizing the equivalency of such documents eliminates duplicative effort and administrative burden for Federal grant applicants, recipients, and the awarding agency, by facilitating the submission and storage of official grant files. The ACF transition plan will begin with the required electronic submission of discretionary grant applications. ACF has previously afforded applicants and recipients the option of submitting Federal discretionary grant applications in both electronic and paper formats. This notice announces that during the initial transition phase and thereafter, discretionary grant applicants and recipients are now required to submit competing, and non-competing continuation, grant applications electronically. The electronic portals used to support this effort are https://www.Grants.gov and https:// www.GrantSolutions.gov.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues will conduct its seventh meeting in November. At this meeting, the Commission will continue discussing the current Federal standards regarding human subjects protection in scientific studies supported by the Federal government. The Commission will also develop and finalize recommendations regarding actions the Federal government should take to ensure that the health and well-being of participants in scientific studies supported by the Federal government are protected.
Announcement of Requirements and Registration for the NIBIB DEsign by Biomedical Undergraduate Teams (DEBUT) Challenge
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) DEBUT Challenge is open to teams of undergraduate students working on projects that develop innovative solutions to unmet health and clinical problems. NIBIB's mission is to improve health by leading the development and accelerating the application of biomedical technologies. The goals of the DEBUT Challenge are (1) to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building, and debugging solutions for such open-ended problems; (2) to generate novel, innovative tools to improve health care, consistent with NIBIB's purpose to support research, training, dissemination of health information, and other programs with respect to biomedical imaging and engineering and associated technologies and modalities with biomedical applications; and (3) to highlight and acknowledge the contributions and accomplishments of undergraduate students.
Government-Owned Inventions; Licensing and Collaborative Research Opportunity for PANVAC-Cancer Vaccine for the Prevention and Treatment of Colorectal Cancer
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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