Department of Health and Human Services November 2005 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 283
New Animal Drugs; Florfenicol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the use of florfenicol by veterinary feed directive in catfish feed for the control of mortality due to enteric septicemia of catfish.
Medicare Program; Exclusion of Vendor Purchases Made Under the Competitive Acquisition Program (CAP) for Outpatient Drugs and Biologicals Under Part B for the Purpose of Calculating the Average Sales Price (ASP)
This interim final rule with comment period provides clarification and solicits comments on the relationship between drugs supplied under the Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals and the calculation of Average Sales Price (ASP). (For purposes of this interim final rule, the term ``drug'' refers to drugs and biologicals.) This interim final rule with comment period also will exclude units of drugs supplied under the CAP from ASP calculations for a period of up to 3 years, at which time the policy will be re-evaluated. In addition, this rule revises the definition of unit to reflect the exclusion of units of CAP drugs administered to beneficiaries by participating CAP physicians.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 and Certain Provisions Related to the Competitive Acquisition Program of Outpatient Drugs and Biologicals Under Part B
This rule addresses Medicare Part B payment policy, including the physician fee schedule that are applicable for calendar year (CY) 2006; and finalizes certain provisions of the interim final rule to implement the Competitive Acquisition Program (CAP) for Part B Drugs. It also revises Medicare Part B payment and related policies regarding: Physician work; practice expense (PE) and malpractice relative value units (RVUs); Medicare telehealth services; multiple diagnostic imaging procedures; covered outpatient drugs and biologicals; supplemental payments to Federally Qualified Health Centers (FQHCs); renal dialysis services; coverage for glaucoma screening services; National Coverage Decision (NCD) timeframes; and physician referrals for nuclear medicine services and supplies to health care entities with which they have financial relationships. In addition, the rule finalizes the interim RVUs for CY 2005 and issues interim RVUs for new and revised procedure codes for CY 2006. This rule also updates the codes subject to the physician self-referral prohibition and discusses payment policies relating to teaching anesthesia services, therapy caps, private contracts and opt-out, and chiropractic and oncology demonstrations. As required by the statute, it also announces that the physician fee schedule update for CY 2006 is -4.4 percent, the initial estimate for the sustainable growth rate for CY 2006 is 1.7 percent and the conversion factor for CY 2006 is $36.1770.
Request for Comment on the Status of Pyridoxamine
The Food and Drug Administration (FDA) is announcing that comments related to the status of pyridoxamine may be submitted until December 19, 2005. FDA is requesting comments in response to the submission of a citizen petition requesting, among other things, that the agency determine the status of pyridoxamine. All comments postmarked on or before December 19, 2005 will be accepted as part of the official record for this matter.
Implementation Plan on the Sharing of Confidential Information Between the European Commission's Health and Consumer Protection Directorate General and the United States Food and Drug Administration of the Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of an Implementation Plan on the sharing of confidential information between the European Commission's Health and Consumer Protection Directorate General and the United States Food and Drug Administration of the Department of Health and Human Services. The purpose is for both participants to cooperate to facilitate the sharing of documents and/or information related to food safety.
Notice and Solicitation for Written Comments on the Draft CDC Health Protection Research Guide, 2006-2015
The U.S. Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (hereto referred to as CDC) announces the availability for public comment of the draft CDC Health Protection Research Guide, 2006-2015. CDC is requesting input on this Research Guide because maximizing the health impact of public health research can only be achieved through the collective efforts of CDC, other Federal agencies, State and local partners, academic partners, business partners, non-profit organizations, professional societies, and the public. Please provide input on any aspect of the Research Guide, including but not limited to: Scope and use of the Research Guide (including whether it has identified the areas of health protection research that most need to be addressed within the next decade); Relevance and level of specificity of the proposed research topics; Additions, deletions or modifications to the proposed research topics; Research Guide development process; and Other improvements to the Research Guide.
2005 White House Conference on Aging
Pursuant to section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging (WHCoA) will have a conference call to finalize the resolutions and other items related to the 2005 WHCoA. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.
Drug and Biological Product Consolidation; Investigational New Drug Application Number Conversion
The Food and Drug Administration (FDA) is announcing that the Center for Drug Evaluation and Research (CDER) will assign new numbers to a group of investigational new drug applications (INDs). In 2003, FDA transferred certain product oversight responsibilities from the Center for Biologics Evaluation and Research (CBER) to CDER. The consolidation of INDs transferred from CBER with CDER INDs resulted in INDs with duplicate numbers. To resolve this issue, CDER is renumbering some INDs that were submitted to CDER before the consolidation. This Federal Register notice serves to notify sponsors in lieu of sending letters to them.
Office of Community Services; Program Announcement for Assets for Independence Demonstration Program Grants
On February 9, 2005, the Office of Community Services, Administration for Children and Families, U.S. Department of Health and Human Services published an announcement seeking applications for the Assets for Independence Demonstration Program. The announcement appeared in Volume 70, pages 6879-6888 of the Federal Register. This document announces a change in the application receipt requirements. To be considered timely for all application due dates, applications now must be received at the OCS Operations Center no later than the due dates. The Program Announcement for Assets for Independence Demonstration Program is a standing announcement. It is effective until canceled or changed by the Office of Community Services (OCS). Applicants may submit applications at any time throughout the year. OCS will review and make funding decisions about applications submitted by any of three due dates: March 15, June 15, and November 1. (If a date falls on a weekend, the due date will be the following Monday.) For example, starting in mid-March annually, OCS will review all applications submitted November 2 through March 15. Starting in early June, OCS will review all applications submitted March 16 through June 15. And, starting in early November, OCS will review all applications submitted June 16 through November 1. Unsuccessful applicants may submit a new application in any succeeding application period. (1) Under Section IV.3. Submission Dates and Times Please Delete the following: Explanation of Due Dates The closing time and date for receipt of applications is referenced above. Mailed applications postmarked after the closing date will be classified as late. Deadline: Mailed applications shall be considered as meeting an announced deadline if they are either received on or before the deadline date or sent on or before the deadline date and received by ACF in time for the independent review referenced in Section IV.6. Applicants must ensure that a legibly dated U.S. Postal Service postmark or a legibly dated, machine produced postmark of a commercial service is affixed to the envelope/package containing the application(s). To be acceptable of proof of timely mailing, a postmark from a commercial mail service must include the logo/emblem of the commercial mail service company from the applicant. Private Metered postmarks shall not be acceptable as proof of timely mailing. (Applicants are cautioned that express/overnight mail services do not always deliver as agreed.) Please Replace the deleted paragraphs under Section IV.3. Submission Dates and Times with the following: Explanation of Due Dates The closing time and date for receipt of applications is referenced above. Applications received after 4:30 p.m., eastern time, on the closing date will be classified as late and will not be considered in the current competition. Applicants are responsible for ensuring that applications are mailed or submitted electronically well in advance of the application due date. (Applicants are cautioned that express/overnight mail services do not always deliver as agreed.) All information in this Notice of amendment is accurate and replaces information specified in the February 9, 2005 Notice. Announcement Availability: The Assets for Independence Demonstration Program announcement and all application materials are available at https://www.Grants.gov. Standard forms and certifications may also be found at https://www.acf.hhs.gov/programs/ofs/forms.htm. Finally, the OCS Asset Building Web site at https://www.acf.hhs.gov/ assetbuilding provides much information about the Assets for Independence Demonstration Program and the application process. The page includes links to all required forms as well as to a guidebook for developing an AFI Project and applying for an AFI grant.
Privacy Act of 1974; Report of New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing a new SOR titled, ``Medicare Premium Withhold System (PWS), No. 09-70-0552.'' On December 8, 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173). Among other provisions, MMA allows Medicare payment to health plans for coverage of outpatient prescription drugs under the Medicare Part D benefit. The Social Security Act (the Act) provides for four summary payment mechanisms: Risk adjusted, federal reinsurance subsidies, risk corridor payments, and subsidized coverage for qualified low-income individuals. In addition, there is a premium payable by each beneficiary for Part D coverage, as well as the pre-existing premium for Part C (now known as Medicare Advantage (MA)), created under Title II legislation. Beginning January 2006, MMA will provide enrollees in MA, and Medicare Advantage Prescription Drug (MAPD) plans an option to have Part C and Part D premiums withheld from their monthly retirement annuities provided by the Social Security Administration (SSA), Railroad Retirement Board (RRB), or Office of Personnel Management (OPM). The Medicare Premium Withhold System is the system of record (SOR) for maintaining and managing Part C and Part D beneficiary premium payment amounts. For 2006, two external agencies, the SSA and the RRB, provide this monthly premium withholding through the PWS. The Medicare Advantage Prescription Drug System (MARx) notifies SSA and RRB of premium amounts to be withheld and applicable periods on a daily basis. PWS uses interfaces from MARx to track these premium withholding amounts as ``expected.'' PWS also uses interfaces with SSA and RRB to record the withheld premium amounts and periods they apply to as ``actual.'' The PWS notifies the appropriate MA and MAPD of all beneficiary withholdings and facilitates the payment of withheld premiums via the automated plan payment system (APPS) and the Financial Accounting System (FACS) for ultimate payment by the United States Treasury. The primary purpose of the SOR is to process a monthly premium withhold file from SSA and RRB, capture expected premium withholding amounts from MARx and compare them to actual withholding amounts, produce a reconciliation of the reported withholding amounts with amounts transferred via Governmental Payment and Collection (IPAC) files from SSA and RRB, and generate plan payment requests to APPS. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by a contractor or consultant contracted by the Agency; (2) support Medicare Prescription Drug Plans (PDP) and Medicare Advantage Prescription Drug Plans (MAPD) directly or through a CMS contractor for the administration of Title XVIII of the Act; (3) support another Federal or State agency, agency of a state government, an agency established by state law, or its fiscal agent; (4) support constituent requests made to a congressional representative; (5) support litigation involving the Agency, and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified 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.
Notice of Public Input Opportunity
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to Provide Input on two proposed documents: ``Recommendations for Applying the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses in Medical Diagnosis, Research and Population Surveillance, Worker Health Monitoring, Government Program Eligibility, and Compensation Settings,'' and ``Ethical Considerations for B Readers.'' The National Institute for Occupational Safety and Health (NIOSH), acting on behalf of the Secretary of Health and Human Services (HHS), is responsible for prescribing the manner in which radiographs are read and classified for the chest x-ray program available to coal miners under the Federal Mine Safety and Health Act, 30 U.S.C. 843; 42 CFR part 37. In carrying out this responsibility, NIOSH issues B Reader certifications to physicians who demonstrate proficiency in the classification of chest radiographs for the pneumoconioses using the International Labour Office (ILO) Classification System. NIOSH uses these B Readers in its Coal Workers Health Surveillance Program. B Readers are also employed in a variety of other clinical, research and compensation settings. NIOSH is using the issuance of the new International Labour Office (ILO) Classification of Radiographs as an opportunity to expand its Web site on the B Reader Program and use of the ILO system. NIOSH-certified B Readers use the internationally- recognized ILO system to classify chest radiographs for the presence and severity of pulmonary parenchymal and pleural changes potentially caused by exposure to dusts such as asbestos, silica, and coal mine dust. The revised program Web site provides more information about radiographic reading and the ILO system including recommendations or ``best practices'' for use of the ILO system in different settings. We are specifically seeking public comment for the draft Document: ``Recommendations for Applying the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses in Medical Diagnosis, Research and Population Surveillance, Worker Health Monitoring, Government Program Eligibility, and Compensation Settings.'' This document can be found at https://www.cdc.gov/ niosh/ topics/ chestradiography/ recommendations.html. At this same time, NIOSH is also seeking comment on its proposed [l x dquo]Ethical Considerations for B Readers'' which can be found at this same Web site. In a recent decision in the In Re Silica Products Litigation, 2005 WL 1593936 (S.D. Tex June 30, 2005), Federal District Court Judge Janis Jack raised questions regarding the ethical conduct of certain physicians, some of whom were B Readers, in reading x-rays in litigation. NIOSH is proposing ``Ethical Considerations for B Readers'' which includes a code of ethics modeled after those of the American College of Radiology and the American Medical Association. We welcome comments on this proposed code of ethics. Please review and submit your comments on either or both of these documents to CWHSP@cdc.gov. If you would prefer to have a hard copy rather than electronic, please contact NIOSH at this same e-mail address, and we will be happy to fax or mail copies of the documents to you. The documents will remain available for comment until January 17, 2006. After that date, NIOSH will consider all the comments submitted and make appropriate revisions to the document before posting a final version on its Web site.
Draft Guidance for Industry on Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-Recommended Prescribing Information for Health Care Providers and Patient Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy SymptomsRecommended Prescribing Information for Health Care Providers and Patient Labeling.'' The draft guidance is intended to assist applicants in developing labeling for new drug applications (NDAs) for such drug products. This is the fifth draft of the guidance, which FDA initially published for comment in October 1998.
Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order
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 requirements for filing objections and requests for a hearing on a regulation or order.
Oral Dosage Form New Animal Drugs; Tylosin
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 Elanco Animal Health. The supplemental NADA provides for use of tylosin soluble powder in honey bees for the control of American foulbrood (Paenibacillus larvae).
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Di-(2-Ethylhexyl)Phthalate (DEHP) Update Expert Panel Report; Request for Public Comment
The CERHR announces the availability of the DEHP update expert panel report on November 21, 2005 from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from the CERHR (see ADDRESSES below). The expert panel report is an updated evaluation of the reproductive and developmental toxicity of DEHP conducted by an 11-member expert panel composed of scientists from the Federal government, universities, and private organizations. The expert panel met in public on October 10-12, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to DEHP is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. The CERHR invites the submission of public comments on this expert panel report (see SUPPLEMENTARY INFORMATION below). The CERHR previously solicited public comment on the draft version of this expert panel report (70 FR 43870-43871, July 29, 2005).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importer's Entry Notice
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.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in cheese and cheese products at a level above that currently allowed by the regulations. This action is in response to a petition filed by Kraft Foods Global, Inc. (Kraft).
Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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 reporting requirements contained in existing FDA regulations regarding the general administrative procedures for a person to take the following actions: Petition the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; file a petition for an administrative reconsideration or an administrative stay of action; and request an advisory opinion from the Commissioner.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we propose to create a new system of records titled, ``Medicare True Out-of-Pocket (TrOOP) Expenditures System,'' HHS/CMS/OIS, System No. 09-70-0557. The TrOOP facilitation process is mandated by the Medicare Prescription Drug Benefit Program enacted into law December 8, 2003 under provisions of Section 101 of Title 1 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). MMA amends Title XVIII, Section 1860D of the Social Security Act (the Act). Section 1860D-2 of the Act requires the tracking of beneficiaries' TrOOP expenditures. TrOOP costs are treated as ``incurred'' only if they were paid by the individual (or by another person, such as a family member, on behalf of the individual), paid on behalf of a low-income subsidy-eligible individual under the Sec. 1860D-14 provisions, or paid under a State Pharmaceutical Assistance Program (SPAP) as defined in Sec. 1860D-23. Section 1860D- 2(b)(4)(D)(i) of the MMA authorizes CMS to establish procedures for determining whether costs for Part D enrollees are being reimbursed by excluded payers and alerting Part D plans about the existence of such payers. The purpose of this system is to collect and maintain a master file to establish a ``TrOOP'' facilitation process, maintain information on individuals and entities that make payments on covered drugs under the Medicare Part D Program, and coordinate TrOOP relevant data from State Pharmaceutical Programs (SPAPs) and other health insurers. 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) support Medicare Prescription Drug Plans (PDP) and Medicare Advantage Prescription Drug Plans (MAPD) directly or through a CMS contractor for the administration of Title XVIII of the Act; (3) assist another Federal or state agency with information to 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; (4) assist Quality Improvement Organization (QIO) in connection with review of claims; (5) assist insurance companies and other groups providing protection against medical expenses of their enrollees; (6) assist an individual or organization engaged in the performance activities of the demonstration or in 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; (7) support constituent requests made to a congressional representative; (8) support litigation involving the agency; and (9) combat fraud and abuse in certain 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Program Funding
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey on Program Funding'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
