Department of Health and Human Services September 2007 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 206
``Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms''; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms'' dated September 2007. The guidance document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The guidance document provides recommendations to industry in response to changes made to the requirements for spore-forming microorganisms to allow greater flexibility in manufacturing. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms'' dated February 2005.
Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative and analgesic in cats.
Implantation or Injectable Dosage Form New Animal Drugs; Etodolac
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of etodolac injectable solution in dogs for the control of pain and inflammation associated with osteoarthritis.
Office of Child Support Enforcement (OCSE); Privacy Act of 1974; Amended System of Records
In accordance with the requirement of the Privacy Act of 1974 (5 U.S.C. 552a), the Office of Child Support Enforcement (OCSE) is publishing notice of its amendment of its system of records entitled ``The Location and Collection System,'' No. 09-90-0074.
Memorandum of Understanding Between the Food and Drug Administration and the University System of Maryland
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the University System of Maryland to establish terms of collaboration to support shared interests that can proceed through a variety of programs including collaborative research, public outreach, cooperative international initiatives, interdisciplinary training, and exchange of scientists and staff through sabbaticals, postdoctoral fellowships, and student internships.
Medicaid Program; Elimination of Reimbursement Under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School
Under the Medicaid program, Federal payment is available for the costs of administrative activities ``as found necessary by the Secretary for the proper and efficient administration of the State plan.'' The proposed rule would eliminate reimbursement under the Medicaid program for the costs of certain activities based on a Secretarial finding that these activities are not necessary for the proper and efficient administration of the State plan, nor do they meet the definition of an optional transportation benefit. Based on these determinations, under the proposed rule, Federal Medicaid payments would no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and transportation from home to school and back for school-aged children with an Individualized Education Program (IEP) or an Individualized Family Services Plan (IFSP) established pursuant to the Individuals with Disabilities Education Act (IDEA).
Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a determination concerning a petition to add a class of employees at the Rocky Flats Plant, Golden, Colorado, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On August 6, 2007, the Secretary of HHS determined that the following employees do not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Rocky Flats Plant, Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 6, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Rocky Flats Plant, Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 6, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Determination That MILTOWN (Meprobamate) Tablets and Five Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the six drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program)
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.
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). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity
The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research. This request for information and comments stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission (NBAC) entitled ``Research Involving Persons With Mental Disorders That May Affect Decision-making Capacity'' (December 1998), and from subsequent recommendations by the National Human Research Protections Advisory Committee (NHRPAC).\a\
Child Care and Development Fund Error Rate Reporting
This final rule revises the Child Care and Development Fund (CCDF) regulations to provide for the reporting of error rates in the expenditure of CCDF grant funds by the fifty States, the District of Columbia and Puerto Rico. The error rate reports will serve to implement provisions of the Improper Payments Information Act of 2002 (IPIA) and the President's Management Agenda (PMA)'s goal of ``Eliminating Improper Payments.''
Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III)
This final rule is the third phase (Phase III) of a final rulemaking amending our regulations regarding the physician self- referral prohibition in section 1877 of the Social Security Act (the Act). Specifically, this rule finalizes, and responds to public comments regarding, the Phase II interim final rule with comment period published on March 26, 2004, which set forth the self-referral prohibition and applicable definitions, interpreted various statutory exceptions to the prohibition, and created additional regulatory exceptions for arrangements that do not pose a risk of program or patient abuse (69 FR 16054). In general, in response to public comments, in this Phase III final rule, we have reduced the regulatory burden on the health care industry through the interpretation of statutory exceptions and modification of the exceptions that were created using the Secretary's discretionary authority under section 1877(b)(4) of the Act to promulgate exceptions for financial relationships that pose no risk of program or patient abuse.
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