Department of Health and Human Services January 2007 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 238
Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the Food and Drug Administration Food Code by Local, State, and Tribal Governments
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 FDA's collection of information from local, State, and tribal governmental agencies concerning their adoption of, or plans to adopt, all or portions of the FDA Food Code or its equivalent by regulation, law, or ordinance.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form Food and Drug Administration 3356; Eligibility Determination for Donors; and Current Good Tissue Practice
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 the information collection requirements for FDA regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP).
Medicare Program; Notification of Hospital Discharge Appeal Rights
This document corrects a technical error that appeared in the final rule published in the Federal Register on November 27, 2006 entitled ``Medicare Program; Notification of Hospital Discharge Appeal Rights.'' This document is a supplement to the November 27, 2006 final rule.
Medicare Program; Renewal and Renaming of the Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence Development Coverage Advisory Committee (MedCAC) and a Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
This notice announces the renewal and name change of the Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence Development Coverage Advisory Committee (MedCAC). It also requests nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MedCAC).
Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 5, 2007
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Medicare Program; Hospice Wage Index for Fiscal Year 2007; Correction
This document corrects a technical error that appeared in the wage index table in the September 1, 2006 Federal Register, entitled ``Hospice Wage Index for Fiscal Year 2007.''
Proposed Implementation of Section 6053(b) of the Deficit Reduction Act for Fiscal Year 2008 FMAP
This notice with comment period describes the procedure for implementing Section 6053(b) of the Deficit Reduction Act of 2005, Public Law 109-171 for fiscal year 2008. Section 6053(b) of the Deficit Reduction Act provides for a modification of the Federal Medical Assistance Percentages for any state which has a significant number of evacuees from Hurricane Katrina.
National Institute for Occupational Safety and Health; Report on Residual Radioactive and Beryllium Contamination at Atomic Weapons Employer Facilities and Beryllium Vendor Facilities
The Department of Health and Human Services (HHS) gives notice as required by the National Defense Authorization Act for Fiscal Year 2005 (Pub. L. 108-375) of the release of a report on residual contamination of facilities under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384 et seq. The report is below. The report and appendices are also available at: https://www.cdc.gov/niosh/ocas.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is included with this notice.
Request for Information (RFI): Guidance for Prioritization of Pre-pandemic and Pandemic Influenza Vaccine-Extension of Comment Period
On December 14, 2006, the Department of Health and Human Services (HHS) issued a notice in the Federal Register (FR Doc. Vol. 71, No. 240, Pages 75252-75253) to request input from the public on considerations in developing guidance for prioritization of the distribution and administration of both pre-pandemic and pandemic influenza vaccines based on various pandemic severity and vaccine supply scenarios. Specifically, HHS is seeking input on pandemic influenza vaccine prioritization considerations from all interested and affected parties, including but not limited to public health and health care individuals and organizations, as well as those from other sectors of the economy including, for example, travel and transportation, commerce and trade, law enforcement, emergency management and responders, other critical infrastructure sectors and the general public. Previous reports relating to pandemic influenza vaccine prioritization issues are available at https://www.pandemicflu.gov. The purpose of this notice is to inform all interested parties that the comment period originally identified in the December 14, 2006 Federal Register is now being extended to February 5, 2007.
Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests'' dated January 2007. The guidance document provides establishments that make HCT/P donor eligibility determinations with recommendations concerning the donor eligibility requirements contained in 21 CFR part 1271, subpart C, which became effective on May 25, 2005. The guidance applies only to certain HCT/Ps that were not regulated as HCT/Ps before May 25, 2005, and that were recovered from donors beginning on or after the May 25, 2005, and within 30 days of the date of publication of this document in the Federal Register. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate. In certain cases, donor retesting needs to be initiated quickly, and the availability of certain HCT/Ps may be critical to their intended recipients.
Child Support Enforcement Program
These proposed regulations implement provisions of title IV-D of the Social Security Act (the Act) as amended by the Deficit Reduction Act of 2005, Pub. L. 109-171 (DRA of 2005). The proposed regulations address use of the tax refund intercept program to collect past-due child support on behalf of children who are not minors, mandatory review and adjustment of child support orders for families receiving Temporary Assistance to Needy Families (TANF), reduction of Federal matching rate for laboratory costs incurred in determining paternity, States' option to pay more child support collections to former assistance families, and the mandatory annual $25 fee in certain child support (IV-D) cases in which the State has collected and disbursed at least $500 of support. The regulations also make other conforming changes necessary to implement changes to the distribution and disbursement requirements.
Healthy Tomorrows Partnership for Children Program (HTPC)
This Final Rule sets forth the Secretary's proposal to require HTPC grant recipients to contribute non-Federal matching funds in years 2 through 5 of the project period equal to two times the amount of the Federal Grant Award or such lesser amount determined by the Secretary for good cause shown.
Annual Update of the HHS Poverty Guidelines
This notice provides an update of the HHS poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Hydrogen Peroxide Solution for Control of Various Fungal and Bacterial Diseases in Fish; Availability of Data
The Food and Drug Administration (FDA) is announcing the availability of effectiveness, target animal safety, and environmental data that may be used in support of a new animal drug application (NADA) or supplemental NADA for use of a 35 percent solution of hydrogen peroxide by immersion for control of mortality in several life stages of certain freshwater-reared finfish species due to various fungal and bacterial diseases. The data, contained in Public Master File (PMF) 5639, were compiled by the United States Geological Survey, Biological Resources Section, Upper Midwest Environmental Sciences Center.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
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.
Establishment of Advisory Council on Blood Stem Cell Transplantation and Solicitation of Nominations for Membership
Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended) and the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Administrator, HRSA, announces the establishment of the Advisory Council on Blood Stem Cell Transplantation by the Secretary, HHS. The Council will advise the Secretary on proposed C.W. Bill Young Cell Transplantation Program policies and other such matters as the Secretary determines. Duration of this Council is for two years unless renewed by the Secretary, HHS. This notice also requests nominations for membership on the Council.
Food Labeling; Gluten-Free Labeling of Foods
The Food and Drug Administration (FDA) is proposing to define the term ``gluten-free'' for voluntary use in the labeling of foods, to mean that the food does not contain any of the following: An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (all noted grains are collectively referred to as ``prohibited grains''); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten. A food that bears the claim ``gluten-free'' or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of ``gluten-free'' would be deemed misbranded. FDA also is proposing to deem misbranded a food bearing a gluten-free claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of that same type (e.g., ``milk, a gluten-free food'' or ``all milk is gluten-free''). In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed misbranded if the claim suggests that all such foods are gluten-free or if 20 ppm or more gluten is present in the food. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. This proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
The Data Measures, Data Composites, and National Standards To Be Used in the Child and Family Services Reviews; Corrections
The Administration for Children and Families (ACF) published a notice in the Federal Register of June 7, 2006 (Vol. 71, No. 109), pages 32969-32987, presenting the data measures, data composites, and national standards to be used in the Child and Family Services Review (CFSR). This notice provides corrections to this notice. A consolidated version of the June 7 Federal Register Announcement incorporating these corrections is provided on the Children's Bureau's Web site (address). The following are the key changes in the document and the reasons for the changes: There are new specifications for each of the individual measures included in each composite. After publication of the June 7, Federal Register Announcement, ACF conducted trainings on the CFSR data indicators at each of the 10 ACF Regional Offices. The trainings were provided to key administrators and staff of State child welfare agencies. During these trainings, issues were identified and questions were raised regarding the individual measures included in the composite. After reviewing these issues and questions, ACF determined that more specific information about the measures was needed and that some measures required revision in order to better target the outcome being assessed. The increased specification includes using the precise terminology that is used in the Adoption and Foster Care Analysis and Reporting System (AFCARS) and describing in greater detail the children who are in the denominator and numerator of each measure. The revisions to some of the measures required changes in the syntax used to calculate the measures. There is a new definition of foster parent used by the National Child Abuse and Neglect Data System (NCANDS). The change was made in this definition because the definition of a foster parent used by NCANDS was recently revised. There is a new version of the table of ranges, percentiles, and national standards for the data indicators and measures to be used in the second round of the Child and Family Services Review. This table replaces the Table 1 provided in the June 7, 2006 Federal Register. It was revised to reflect new data and new national standards for all of the CFSR data indicators. The data in the table and the national standards for all of the data indicators and measures are different than those presented in the June 7 Federal Register notice. This difference is due to one or both of the following reasons: (1) A change in the syntax for calculating some of the measures, and (2) a change in the process for calculating the national standards. The reason for the change in the procedures for calculating the national standards is provided in the following bullet. There are revisions and corrections to Attachment B: Methodology for Developing the Composites. The revisions in Attachment B were made to (1) correct an error in the original attachment B, (2) provide the new coefficients (weights) for the composite measures that resulted from the changes in the syntax, and (3) explain the new procedure for calculating the national standards. The error in the original attachment B occurred in Step 10 of the process of calculating the composite scores. The new coefficients (weights) for each of the measures included in the composites are presented in Table 1 of the attachmentCoefficients (Weights) for the Measures Included in the Permanency Related Data Composites. The coefficients/weights changed due to changes in the syntax used to calculate some of the individual measures. The new procedure for calculating the national standards involved changes in the statistical requirements for fitting the data to a normal curve and to changes in the parameters used in calculating the sampling error.
Announcement of Establishment of the Physical Activity Guidelines Advisory Committee and Solicitation of Nominations for Appointment to the Committee
The Department of Health and Human Services (HHS) announces the establishment of a Physical Activity Guidelines Advisory Committee and is seeking nominations of qualified candidates to be considered for appointment as a member of the Committee.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Review of Diagnostic Tests Available for the Detection of Tuberculosis in Imported Nonhuman Primates Undergoing Federal Quarantine
This notice announces a public meeting on the subject of tuberculosis detection in imported nonhuman primates. The purpose of the meeting is to review current Institute of Laboratory Animal Research recommendations and compare newer diagnostic tests available for tuberculosis testing in nonhuman primates.
Public Meeting of the President's Council on Bioethics on February 15-16, 2007
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-eighth meeting, at which it will (1) Consider and discuss policy proposals in organ procurement, allocation, and transplantation; (2) hear presentations on and discuss issues in clinical applications of advancements in genetics, as well as genetics policy and ethics; and (3) discuss contributions to a pending Council report and volume on the bioethical significance of the concept of human dignity. All agenda items are continuations of previous Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the February 2007 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).
Prospective Grant of Exclusive License: Devices for Countercurrent Chromatography
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, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-274-1998 ``Chromatographic Separation Apparatus and Method,'' U.S. Patent No. 6,379,973; HHS Ref. No. E-044-1993 ``Variable-Position Cross-Axis Synchronous Coil Plant Centrifuge for Countercurrent Chromatography;'' U.S. Patent 5,380,429; HHS Ref. No. E- 148-2001 ``Method and Apparatus for Countercurrent Chromatography;'' U.S. Patent Application No. 10/509,697 filed April 5, 2002; to CC Biotech LLC, a company incorporated under the laws of the State of Maryland having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to instrumentation for countercurrent chromatographic purification of proteins and peptides.
Proposed Collection; Comment Request; Evaluation of User Satisfaction With NIH Internet Sites
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Evaluation of User Satisfaction with NIH Internet Sites. Type of Information Collection Request: Renewal. Need and Use of Information Collection: Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the NIH Office of Communications and Public Liaison seeks to obtain OMB's generic approval to conduct online customer satisfaction surveys. Since the late 1980's, the NIH has seized the opportunity to disseminate information and materials via the Internet. Today, rapid technological changes of the World Wide Web warrant on- going constitute nt and resource analysis. With survey data, the NIH is enabled to serve, and respond to, the ever-changing demand by the public. The `public' includes individuals (such as patients, health professionals, educators, and scientists), interested communities (such as national or local organizations/institutions) and businesses. Survey information will augment current Web content, delivery, and design research that is used to understand the needs of the Web user, and more specifically, the NIH user community. Primary objectives are to: (1) Classify NIH Internet users; (2) summarize and better understand customer needs; and (3) quantify the effectiveness/efficiency of current tools and delivery. Overall, the Institutes, Centers, and Offices of the NIH will use the survey results to identify strengths and weaknesses in current Internet strategies. Findings will help to: (1) Understand the user community and how to better serve Internet users; (2) discover areas requiring improvement in either content or delivery; (3) realize how to align Web offerings with identified user need(s); and (4) explore methods to offer and deliver information with efficacy and equity. Frequency of Response: On occasion [As needed on an on-going and potentially concurrent basis (by Institute, Center, or Office)]. Affected Public: Users of the Internet. Primarily, this is an individual at their place(s) of access including, but not limited to, home and/or work environments. Type of Respondents: Public users of the NIH Internet site, www.nih.gov, which may include organizations; medical researchers; physicians and other health care provides; librarians; students; and the general public. Estimated Number of Respondents: 104,000. Number of Responses Per Respondent: 1. Average Burden Hours Per Response: 0.0835. Burden Hours Request: 8684. Total annualized cost to respondents is estimated at $130,260. There are no capital costs, operating costs and/or maintenance costs to report.
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