Department of Health and Human Services February 22, 2007 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; LEVEMIR
The Food and Drug Administration (FDA) has determined the regulatory review period for LEVEMIR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Privacy Act of 1974; Report of a Modified or Altered System of Records
The Privacy Act of 1974 and section 1106 of the Social Security Act (the Act) explain when and how CMS may release the personal data of people with Medicare. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) added requirements for releasing and using personal data. The primary purpose of this system is to collect, maintain, and process information on all Medicare covered, and as many non-covered drug events as possible, for people with Medicare who have a Medicare Part D plan. The system will help CMS determine appropriate payment of covered drugs. It will also provide for processing, storing, and maintaining drug transaction data in a large-scale database, while putting data into data marts to support payment analysis. CMS would allow the release of information in this system to: (1) Support regulatory, analysis, oversight, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or a CMS grantee; (2) help another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) help Medicare Part D plans; (4) support an individual or organization for a research, an evaluation, or an epidemiological or other project related to protecting the public's health, the prevention of disease or disability, the restoration or maintenance of health, or for payment related purposes; (5) help Quality Improvement Organizations; (6) support lawsuits involving the agency; and (7) combat fraud, waste, and abuse in certain health benefits programs. To meet these additional requirements, CMS proposes to modify the existing system of records (SOR) titled ``Medicare Drug Data Processing System (DDPS),'' System No. 09-70-0553, established at 70 Federal Register (FR) 58436 (October 6, 2005). Under this modification we are clarifying the statutory authorities for which these data are collected and disclosed. The original SOR notice cited the statutory section governing CMS's payment of Part D plan sponsors (Social Security Act (the Act) Sec. 1860D-15) that limits the uses of the data collected to plan payment and oversight of plan payment. However, the broad authority of Sec. 1860D-12(b)(3)(D) authorizes CMS to collect, use and disclose these same claims data for broader purposes related to CMS's responsibilities for program administration and research. Furthermore the authority under Sec. 1106 of the Act allows the Secretary to release data pursuant to a regulation, which in this case would be 42 CFR 423.322 and 423.505. CMS has published a Notice of Proposed Rulemaking (NPRM) in order to clarify our statutory authority and explain how we propose to implement the broad authority of Sec. 1860D- 12(b)(3)(D). This SOR is being revised to reflect our intended use of this broader statutory authority. CMS proposes to make the following modifications to the DDPS system: Revise routine use number 1 to include CMS grantees that perform a task for the agency. Add a new routine use number 2 to allow the release of information to other Federal and state agencies for accurate payment of Medicare benefits; to administer a Federal health benefits program, or to fulfill a requirement or allowance of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and help Federal/state Medicaid programs that may need information from this system. Broaden the scope of routine use number 4 to allow the release of data to an individual or organization for a research, evaluation, or epidemiological or other project related to protecting the public's health, the prevention of disease or disability, the restoration or maintenance of health, or payment-related projects. Delete routine use number 5 which authorizes disclosure to support constituent requests made to a congressional representative. Broaden the scope of routine use number 7 and 8, to include combating ``waste,'' fraud, and abuse that results in unnecessary cost to all Federally-funded health benefit programs. Revise language regarding routine uses disclosures to explain the purpose of the routine use and make clear CMS's intention to release personal information contained in this system. Reorder and prioritize the routine uses. Update any sections of the system affected by the reorganization or revision of routine uses because of MMA provisions. Update language in the administrative sections to be consistent with language used in other CMS SORs. Although the Privacy Act allows CMS to only ask for comments on the modified routine uses, CMS is asking for comments on all proposed changes discussed in this notice. See the EFFECTIVE DATES section below for the comment period.
Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use; Request for Information and Comments
The Food and Drug Administration (FDA) is seeking information to formulate a regulatory position on insect repellent products that contain over-the-counter (OTC) sunscreen ingredients. FDA is considering amending its monograph for OTC sunscreen drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded) to add conditions for marketing insect repellent-sunscreen drug products. The insect repellent ingredients in these products are regulated by the Environmental Protection Agency (EPA). Elsewhere in this issue of the Federal Register is a companion document in which EPA is also requesting information and comments on these products. The decision on what regulations, if any, to propose will be based, in part, on information and comments submitted in response to this request for data and information.
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