Department of Health and Human Services July 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2008. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority- setting process.

The Food and Drug Administration (FDA) is denying the petition submitted by Scientific Laboratory Products LTD., to reclassify electroencephalogram (EEG) electrodes from class II to class I. The agency is denying the petition because the Scientific Laboratory Products LTD., failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. This document also summarizes the basis for the agency's decision.

This notice announces the intent of ATSDR to develop two interaction profiles.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2008. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.'' This draft guidance document describes a means by which the tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify tissue adhesive for the topical approximation of skin from class III into class II (special controls). This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies.'' This guidance document describes a means by which filtering facepiece respirators for use by the general public in public health medical emergencies may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). This guidance document is immediately in effect as a special control for the filtering facepiece respirator for use by the general public in public health medical emergencies, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is proposing to establish a new system of records (SOR), 09-20-0170, ``National Select Agent Registry (NSAR)/Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER.'' The purpose of the system is to limit access to those biological agents and toxins listed in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331, to those individuals who have a legitimate need to handle or use such agents or toxins, and who are not identified as restricted persons by the U.S. Attorney General. NSAR is a single web-based information management system shared by CDC and the U.S. Department of Agriculture (USDA)/ Animal and Plant Health Inspection Service (APHIS) that tracks the possession, use and transfer of select agents and toxins that could pose a severe threat to public health and safety, to the health and safety of animals, and to the safety of plants or animal and plant products. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Supplemental Medical Insurance (SMI) and Hospital Insurance (HI) Premium Accounting Collection and Enrollment (SPACE) System,'' System No. 09-70-0505, last published at 67 Federal Register 40933 (June 14, 2002). The third party premium collection system bills and collects Part A and/or Part B Medicare premiums paid by third party payers on behalf of beneficiaries represented by that entity. In September, 2003, the third party premium collection system known as ``SPACE'' was replaced by a redesigned system referred to as the ``Third Party System (TPS).'' The new system was designed to: (1) Integrate beneficiary third party data onto the EDB with Direct Billing and Enrollment/Entitlement data; (2) eliminate redundant and discrepant data; (3) reduce the number of exception cases requiring processing; (4) provide daily update of third party data at CMS and Social Security Administration; (5) implement several legislative provisions affecting premium collection; and (6) provide integrated online access to Medicare enrollment data. To more accurately reflect the changes proposed for this system, we will modify the name of this system to read: ``Third Party System (TPS).'' TPS will retain its current system identification number: CMS No. 09-70-0505. We propose to modify existing routine use number 3 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of published routine uses number 7 and 8, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all federally-funded health benefit programs. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to process beneficiary premium billing accretions and deletions to third party premium payer accounts (state Medicaid agencies, Office of Personnel Management (OPM), and formal third party groups and surcharge only group payers (latter as defined in 42 Code of Federal Regulations (CFR) 408.80 through 408.92 and 408.200 through 408.210)) for the payment of Part B (SMI) and/or Part A (HI) premiums on behalf of Medicare beneficiaries, the payment of the surcharge portion of the Part B premium on behalf of Medicare beneficiaries by a State or local government entity, and for enrolling individuals for Part A or Part B coverage under state buy-in agreements. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal or State agency, agency of a State government, an agency established by State law, or its fiscal agent; (3) support formal third party groups and surcharge only group payers pursuant to an agreement with CMS; (4) assist an individual or research organization to support research evaluation of epidemiological projects; (5) support litigation involving the agency; and (6) combat fraud, waste, and abuse in certain Federally-funded health care 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Indian Health Service published a document Federal Register on June 20, 2007, concerning rates for inpatient and outpatient medical care provided by Indian Health Service facilities for Calendar Year 2007 for Medicare and Medicaid beneficiaries of other Federal Programs. The document contained five incorrect rates.