2005 – Federal Register Recent Federal Regulation Documents

The Bureau of the Census (Census Bureau) is proposing to expand the 2005 Annual Trade Survey (ATS) to include agents, brokers, and electronic markets (AGBR). The Census Bureau proposes this expansion at the request of the Bureau of Economic Analysis (BEA). The BEA considers this information vital to its accurate measurement of sales and value added for wholesale trade. These data are important inputs to BEA's preparation of National Income and Product accounts and its annual input-output tables.

The Leader, Information Management Case Services Team, Regulatory Information Management Services, Office of the Chief Information Officer invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is issuing proposed regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drug products. The regulations are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. We are proposing to establish CGMP requirements for approved PET drug products. For investigational and research PET drugs, the proposed rule states that the requirement to follow CGMP may be met by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are proposing to establish these CGMP requirements for all PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance entitled ``PET Drug Products Current Good Manufacturing Practice (CGMP).''

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.

At the initiation of the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (USW) and the National Stone, Sand and Gravel Association (NSSGA), and with the concurrence of other interested parties, we (the Mine Safety and Health Administration) are delaying the applicability date of 30 CFR 57.5060(b) addressing ``Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners (DPM)'' published in the Federal Register on January 19, 2001 (66 FR 5706) from January 20, 2006 to May 20, 2006, to provide sufficient time to complete the September 7, 2005 proposal to amend the 2001 DPM rule. Section 57.5060(b) is also being revised to reflect this new applicability date. By a separate document published in today's Federal Register we are extending the period for comments on the proposed rule published on September 7, 2005 (70 FR 53280) and rescheduling the public hearings on the proposed rule from September 26, 28, and 30, 2005 to January 5, 9, 11, and 13, 2006. The comment period on that rulemaking will close on January 27, 2006. We find these actions necessary to provide sufficient time and an orderly process for affected parties to comment on that proposed rule.