Department of Health and Human Services April 2007 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 311
American Indians Into Psychology; Notice of Competitive Grant Applications for American Indians Into Psychology Program
The Indian Health Service published a document in the Federal Register on March 28, 2007. The document contained three errors. For further information Contact: Martha Redhouse, Grants Management Branch, Indian Health Service, Reyes Building, 801 Thompson Avenue, Rockville, MD 20852, Telephone (301) 443-5204. (This is not a toll-free number). Correction
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Improving Quality of Care in Long Term Care.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 16, 2007 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 8th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, and Security Workgroup Meeting
This notice announces the 10th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92- 463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 16th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the fifth meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 15th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 16th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Nevada Test Site, Mercury, NV, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nevada Test Site, Mercury, Nevada, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Nevada Test Site. Location: Mercury, Nevada. Job Titles and/or Job Duties: All employees of the Department of Energy (DOE), DOE contractors, and subcontractors in all areas. Period of Employment: September 1, 1963 through September 30, 1992.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition to Designate a Class of Employees at the Nevada Test Site, Mercury, NV, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nevada Test Site, Mercury, Nevada, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Nevada Test Site. Location: Mercury, Nevada. Job Titles and/or Job Duties: All workers at the Rainier Mesa, including areas 12, 16, and 20. Period of Employment: March 1, 1966 through December 31, 1990.
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Public Notice of Revocation of Certification
The Substance Abuse and Mental Health Services Administration has revoked the certification to provide opioid assisted treatment for the three opioid treatment programs listed below.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting by conference call. The meeting is open to the public.
Office of the Assistant Secretary for Preparedness and Response; HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats
The United States faces serious public health threats from the deliberate use of weapons of mass destruction (WMD)chemical, biological, radiological, or nuclear (CBRN)by hostile States or terrorists, and from naturally emerging infectious diseases that have a potential to cause illness on a scale that could adversely impact national security. Effective strategies to prevent, mitigate, and treat the consequences of CBRN threats is an integral component of our national security strategy. To that end, the United States must be able to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the American people. The HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has taken a holistic, end-to-end approach that considers multiple aspects of the medical countermeasures mission including research, development, acquisition, storage, maintenance, deployment, and guidance for utilization. Phase one of this approach established the HHS PHEMCE Strategy for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Strategy). The HHS PHEMCE Strategy, published in the Federal Register on March 20, 2007, described a framework of strategic policy goals and objectives for identifying medical countermeasure requirements and establishing priorities for medical countermeasure evaluation, development and acquisition. These strategic policy goals and objectives were used to establish the Four Pillars upon which this HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan (HHS PHEMCE Implementation Plan) is based. The HHS PHEMCE Implementation Plan considers the full spectrum of medical countermeasures-related activities, including research, development, acquisition, storage/maintenance, deployment, and utilization. The HHS PHEMCE Implementation Plan is consistent with the President's Biodefense for the 21st Century and is aligned with the National Strategy for Medical Countermeasures against Weapons of Mass Destruction.
Oral Dosage Form New Animal Drugs; Dexmedetomidine; Technical Amendment
The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of January 4, 2007 (72 FR 263), revising the animal drug regulations to reflect approval of an original new animal drug application (NADA). The document incorrectly listed the amount of drug per milliliter of dexmedetomidine hydrochloride injectable solution. This action is being taken to improve the accuracy of the regulations.
National Vaccine Injury Compensation Program: Addition of Meningococcal and Human Papillomavirus (HPV) Vaccines to the Vaccine Injury Table
Through this notice, the Secretary announces that meningococcal (conjugate and polysaccharide) and human papillomavirus (HPV) vaccines are covered vaccines under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This notice serves to include meningococcal and HPV vaccines as covered vaccines under Category XIV (new vaccines) of the Vaccine Injury Table (Table), which lists the vaccines covered under the VICP. This notice ensures that petitioners may file petitions relating to meningococcal and HPV vaccines with the VICP even before such vaccines are added as separate and distinct categories to the Table through rulemaking.
New Animal Drugs; Florfenicol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the use of florfenicol by veterinary feed directive (VFD) for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.
Oral Dosage Form New Animal Drugs; Clindamycin 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 ANADA provides for the veterinary prescription use of clindamycin hydrochloride oral solution in dogs and cats for the treatment of various infections due to susceptible bacterial pathogens.
Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Brussels, Belgium'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Brussels, Belgium. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Brussels, Belgium, May 5 through 10, 2007, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Thursday, May 3, 2007, from 11:30 a.m. to 1 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Conference Room D, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 11:20 a.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room D. Contact Person: All participants must register with Tammie Bell, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, e-mail: Tammie.Bell2@fda.hhs.gov or fax: 301-827-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by April 20, 2007. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.
Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for intermediate premixes used to manufacture Type C medicated feeds. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs.
New Animal Drugs For Use in Animal Feed; Withdrawal of Approval of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for intermediate premixes used to manufacture Type C medicated feeds. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs.
Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of NADAs; Estradiol Benzoate
The Food and Drug Administration (FDA) is amending the animal drug regulations that reflect approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, and in suckling beef calves for increased rate of weight gain. In a notice published elsewhere in this issue of the Federal Register, FDA has withdrawn approval of the NADAs.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Post-Acute Care Payment Reform / Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC-CARE), System No. 09-70-0569.'' The program is authorized under Section 5008 of the Deficit Reduction Act of 2005, which allows for the establishment of a demonstration program for purposes of understanding costs and outcomes across different post- acute care sites. The PAC-CARE will collect information that will enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post-acute care related costs in the Medicare program. Anticipated results of the PAC- CARE include a standardized assessment instrument for post-acute care patients and a proposal for site-neutral payment for post-acute care services. The purpose of this system is to collect and maintain demographic, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support the functions of Quality Improvement Organizations; (5) support the functions of national accrediting organizations; (6) support litigation involving the agency; and (7) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI),'' System No. 09-70- 0591. This notice serves as the Master system for all demonstrations, evaluation, and research studies administered by ORDI. Fifteen existing ORDI demonstration, evaluation, and research studies will be included under this notice and the separate, existing systems of records notices for those studies will be deleted upon the effective date of this notice. DERS will become effective 30 days from the publication of the notice in the Federal Register, or 40 days from the date submitted to OMB and the Congress, whichever is later. With the publication of this master system, ORDI will only be deleting the systems of records listed below as separate stand alone notices to the public. Retention and destruction of the data contained in these systems will follow the schedules listed in this DERS system notice. The existing ORDI systems of records to be included under DERS and which will be deleted by this notice are as follows: ``Municipal Health Services Program System No. 09-70- 0022,'' 65 Federal Register (FR) 37792 (June 16, 2000); ``Monitoring of the Home Health Agency Prospective Payment Demonstration,'' System No. 09-70-0048, 65 FR 37792 (June 16, 2000); ``Person-Level Medicaid Data System, System No. 09-70- 0507'' last published at 71 FR 60726 (October 16, 2006); ``Medicare Cancer Registry Record System,'' System No. 09- 70-0509, last published at 71 FR 67133 (November 20, 2006); ``Evaluations of the Medicaid Reform Demonstrations,'' System No. 09-70-0523, last published at 71 FR 60540 (October 13, 2006); ``MMA Section 641 Prescription Drug Benefit Demonstration,'' System No. 09-70-0545, last published at 69 FR 32587 (June 10, 2004); ``Medicare Physician Group Practice Demonstration,'' System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005); ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities,'' System No. 09-70-0560, last published at 70 FR 57602 (October 3, 2005); ``Medicare Care Management Performance Demonstration,'' System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005); ``Rural Hospice Demonstration,'' System No. 09-70-0563, last published at 71 FR 57968 (October 2, 2006); ``Medicare Chiropractic Coverage Demonstration and Evaluation,'' System No. 09-70-0577, last published at 71 FR 41450 (July 21, 2006); ``Low Vision Rehabilitation Demonstration,'' System No. 09-70-0582, last published at 71 FR 58621 (October 4, 2006); ``Medicare Lifestyle Modification Program Demonstration,'' System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006); ``Competitive Bidding for Clinical Laboratory Services,'' System No. 09-70-0589, last published at 71 FR 60713 (October 16, 2006); and ``Senior Risk Reduction Demonstration and Evaluation,'' System No. 09-70-0592, last published at 71 FR 60718 (October 16, 2006). The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or CMS grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Date'' section for comment period.
Privacy Act of 1974; Retraction of a New System of Records
The Centers for Medicare & Medicaid Services CMS inadvertently published a new system of records titled ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI)'' System No. 09-70-0591 in the Federal Register (FR) on Tuesday, April 10, 2007 (72 FR 17918). CMS is withdrawing the Tuesday, April 10, 2007 notification due to the inadvertent inclusion of an existing system of records that should not be deleted from the existing inventory, ``End Stage Renal Disease Program Management and Medical Information System,'' System No. 09-70- 0520, last published at 67 FR 41244 (June 17, 2002). The notice of a new system of records will be republished.
Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate
The Food and Drug Administration (FDA) has withdrawn approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, and in suckling beef calves for increased rate of weight gain. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs.
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