Department of Health and Human Services November 17, 2005 – Federal Register Recent Federal Regulation Documents
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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.
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