Department of Health and Human Services May 2010 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 311
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference in Electronic Format to the Center for Veterinary Medicine
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.
Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory.'' This guidance is intended to advise food manufacturers that once a boil-water advisory has been issued they should stop using the water subject to the advisory until the water again meets the applicable Federal and State drinking water quality standards. Further, this guidance is intended to assist food manufacturers in evaluating food that already was produced with water subject to the advisory. The guidance is in response to the recent major water pipe break in Massachusetts that interrupted service to 30 Massachusetts Water Resources Authority (MWRA) customer communities (serving approximately 2 million residents).
Notice of Public Comment on Tribal Consultation Sessions
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic 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 (the PRA).
Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Dependent Coverage of Children to Age 26 Under the Patient Protection and Affordable Care Act
This document contains interim final regulations implementing the requirements for group health plans and health insurance issuers in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding dependent coverage of children who have not attained age 26.
Health Care Integrity and Protection Data Bank (HIPDB) and National Practitioner Data Bank (NPDB): Public Posting of Non-Compliant Government Agencies
``Government agencies,'' as defined in section 1128E(g)(3) of the Social Security Act (42 U.S.C. 1320a-7e(g)(3)), that are not in compliance with the reporting requirements of the HIPDB will have their names published in a report on the HRSA and Data Bank Web sites (http:/ /www.hrsa.gov and https://www.npdb-hipdb.hrsa.gov) by July 1, 2010. This listing of non-compliant Government agencies will be reviewed and updated on a periodic basis.
Public Readiness and Emergency Preparedness Act Countermeasures Injury Compensation Program, Procedures for Submitting a Letter of Intent To File Requests for Benefits
The Secretary of Health and Human Services (HHS) announces procedures for submitting a Letter of Intent to File a Request for Benefits under the Countermeasures Injury Compensation Program (CICP). The CICP administers the compensation program authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act provides compensation to individuals for serious physical injuries or deaths from pandemic, epidemic, or security countermeasures identified in declarations issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act, as amended (42 U.S.C. 247d-6d, 247d- 6e). A PREP Act declaration by the Secretary of the Department of Health and Human Services specifies the countermeasures and the categories of health threats or conditions for which the countermeasures are recommended, the period liability protections are in effect, the population of individuals protected, and the geographic areas for which the protections are in effect.
Notice of Re-Designation of the Service Delivery Area for the Cowlitz Indian Tribe
This Notice advises the public that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Service Delivery Area (SDA) for the Cowlitz Indian Tribe. The Cowlitz SDA currently is comprised of Clark, Cowlitz, King, Lewis, Pierce, Skamania, and Thurston in the State of Washington. These counties were designated as the Tribe's SDA in 67 FR 46329. Under this final decision, Columbia County, Oregon, and Kittitas and Wahkiakum Counties, Washington will be added to the existing Cowlitz SDA.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of SACATM on June 17-18, 2010, at the U.S. Environmental Protection Agency, 109 T.W. Alexander Drive, Research Triangle Park, NC 27711. The meeting is open to the public with attendance limited only by the space available. The meeting will be videocast through a link at (https://www.niehs.nih.gov/news/video/live). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.
Request for Comment: National Center for Complementary and Alternative Medicine Announcement of Strategic Planning White Papers
The National Center for Complementary and Alternative Medicine (NCCAM) is developing its third strategic plan and invites the public to provide comments on two white papers which will support the development of this plan. The papers will cover two topics of particular research interest to NCCAM: natural products research and back pain research. They will be publicly available through the NCCAM Web site at https://nccam.nih.gov from on or about May 10 through May 24, 2010. The public is invited to provide comments through the NCCAM Web site.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
State Median Income Estimate for a Four-Person Family: Notice of the Federal Fiscal Year (FFY) 2011 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) (Catalog of Federal Domestic Assistance Number 93.568) Administered by the U.S. Department of Health and Human Services (HHS), Administration for Children and Families, Office of Community Services, Division of Energy Assistance
This notice announces to LIHEAP grantees the estimated median income of four-person families in each State and the District of Columbia for FFY 2011 (October 1, 2010, to September 30, 2011). LIHEAP grantees that choose to base their income eligibility criteria on these State median income estimates may adopt these estimates (up to 60 percent) on the estimates' date of publication in the Federal Register or on a later date as discussed below. This enables these grantees to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2010, or the beginning of the grantees' fiscal years, whichever is later, these grantees must adjust their income eligibility criteria so that such criteria are in accord with the FFY 2011 State median income estimates.
Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for use of an ivermectin injectable solution in cattle and swine for treatment and control of various internal and external parasites.
Oral Dosage Form New Animal Drugs; Orbifloxacin Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of an oral suspension containing orbifloxacin for the treatment of various bacterial infections in dogs and cats.
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Survey of Older Americans Act Title III Service Recipients
The Administration on Aging (AoA) 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 relating to the information collection requirements contained in consumer assessment surveys that are used by AoA to measure program performance for programs funded under Title III of the Older Americans Act.
Designation of Medically Underserved Populations and Health Professions Shortage Areas; Intent To Form Negotiated Rulemaking Committee
As required by Section 5602 of Public Law 111-148, the Patient Protection and Affordable Care Act of 2010, HRSA plans to establish a comprehensive methodology and criteria for Designation of Medically Underserved Populations (MUPs) and Primary Care Health Professions Shortage Areas (HPSAs) [under sections 330(b)(3) and 332 of the Public Health Service (PHS) Act, respectively], using a Negotiated Rulemaking process. To do this, HRSA intends to establish a Negotiated Rulemaking Committee under the Federal Advisory Committee Act (FACA).
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