Department of Health and Human Services September 20, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.'' This guidance document describes a means by which oral rinse to reduce the adhesion of dental plaque may comply with the requirements of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify oral rinse to reduce the adhesion of dental plaque into class II (special controls). This guidance document is immediately in effect as the special control for the oral rinse to reduce the adhesion of dental plaque, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). General comments on agency guidance documents are welcomed at any time.

The Indian Health Service (IHS) announces a supplement to the single-source cooperative agreement award to the National Indian Health Board (NIHB) for costs in providing advice and technical assistance to the IHS on behalf of federally recognized Tribes in the area of health care policy analysis and program development. The NIHB is a non-profit organization as described in section 501(c)(3) of the Internal Revenue Code. The mission of the IHS is to work in partnership with American Indian and Alaska Native people to raise their health to the highest level. Under the original cooperative agreement published in the Federal Register, 69 FR 11447, on March 10, 2004, the NIHB assists the IHS in carrying out its mission through access to a broad based consumer network involving the Areas Health Boards or Health Board representatives from each of the 12 IHS Areas. The NIHB communicates with these boards and with Tribes and Tribal organizations in order to raise health of AI/AN people to the highest level. NIHB also disseminates health care information which serves to improve and expand access for American Indians and Alaska Natives (AI/ AN) Tribal Governments to all available health programs in the Department of Health and Human Services (HHS). The NIHB assists in the coordination of the Tribal consultation activities associated with formulating the IHS annual budget request. The program supplement to the single-source cooperative agreement is for $321,800 of non-recurring funding for use during the current budget period in effect from 01/01/2005 to 12/31/2005. The annual funding level of this single-source cooperative agreement is approximately $230,000, subject to the availability of appropriations.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``PET Drug ProductsCurrent Good Manufacturing Practice (CGMP).'' Elsewhere in this issue of the Federal Register, we are issuing proposed regulations on CGMPs for positron emission tomography (PET) drug products. We are making the draft guidance available so that producers of PET drugs can better understand FDA's thinking on CGMP compliance if the proposed regulations become final after notice-and-comment rulemaking.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Anti-Cancer Chemotherapy for Colorectal Cancer (CRC) System, System No. 09-70- 0554.'' National Coverage Determinations (NCD) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act (the Act) section 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be ``reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member'' (section 1862(a)(1)(A). Under authority of section 1861(t)(2) of the statute, Medicare provides coverage for Food and Drug Administration (FDA) approved indications for anticancer chemotherapeutic agents and for other indications that are in the specific approved compendia listed below. Increased understanding of the biology of cancer and emerging technologies is making possible new approaches in treating cancer. To ensure that beneficiaries have access to the most appropriate cancer treatments, it is imperative that adequate clinical trial data for off- label uses be made available to patients and providers for clinical decision-making and to policy-making. CMS has determined that Medicare will cover the use of oxaliplatin (Eloxatin[reg]), irinotecan (Camptosar[reg]), cetuximab (ErbituxTM), or bevacizumab (AvastinTM), in clinical trials identified by CMS and sponsored by the National Cancer Institute (NCI). The purpose of this system is to provide reimbursement for CRCs and assist in the collection of data on patients receiving CRC as a new or emerging cancer treatment regimen to a data collection process to assure patient safety and protection and to determine that the CRC is reasonable and necessary. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) 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; (3) to 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 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.