Department of Health and Human Services December 13, 2006 – Federal Register Recent Federal Regulation Documents

On November 1, 2006, the U.S. Department of Health and Human Services (HHS) issued a notice in the Federal Register (FR Doc. Vol 71, No. 211, pages 64282-64284) to request input from the public and private sectors on plans for developing and using resources involving health information technology and genetic and molecular medicine, with specific reference to incorporating these capacities in evidence-based clinical practice, health outcomes evaluations, and research. A 60 day comment period was established upon publication of that notice. The purpose of this notice is to inform all interested parties that the comment period originally identified in the November 1, 2006 Federal Register has been extended for thirty days, in order to maximize the opportunity for interested individuals and organizations to provide comments to HHS on this subject.

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to approved new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effect of a manufacturing change on the identity, strength, quality, purity, and potency of a drug as those factors relate to the safety or effectiveness of the drug. The final rule sets forth requirements for changes requiring submission and approval of a supplement before the distribution of the drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the drug, changes requiring the submission of a supplement at the time of distribution of the drug, and changes to be described in an annual report.

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to establish a new system of records (SOR) titled ``Medicare Integrated Data Repository (IDR),'' System No. 09-70- 0571. In December 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), that amends Title XVIII of the Social Security Act (the Act) by adding Part D, the voluntary prescription drug benefit program. The IDR will provide an organized structure for reaching the data through a consistent application of access policies, processes and procedures, common services, governance, and framework. The IDR will integrate and load data from various CMS systems consisting of Medicare Parts A, B, C, and D entitlement, enrollment and utilization data. It is proposed that the IDR will also contain demographic information on Medicaid beneficiaries, Medicare providers and physicians, and employer plans that are receiving a subsidy from CMS for providing creditable drug coverage to their retirees. It is through the integration of this data with other data (e.g., historic data, Part A and Part B data) that the IDR will have value for quality improvement, research on outcomes and effectiveness of drugs, post-market surveillance, and other analytic efforts. The primary purpose of this system is to establish an enterprise resource that will provide one integrated view of all CMS data to administer the Medicare and Medicaid programs. 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 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 providers and suppliers of services for administration of Title XVIII; (4) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (5) assist Medicare Advantage Plans and Part D Prescription Drug Plans; (6) support Quality Improvement Organizations (QIO); (7) assist other insurers for processing individual insurance claims; (8) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (9) support litigation involving the agency; and (10) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new 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 routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is amending its nutrition labeling regulations for dietary supplements to provide that the quantitative amount and the percent of Daily Value of a dietary ingredient may be voluntarily presented on a ``per day'' basis in addition to the required ``per serving'' basis when a recommendation is made on the label that the dietary supplement be consumed more than once per day. This final rule responds to a citizen petition requesting that FDA amend our dietary supplement nutrition labeling regulations to include this provision. FDA is taking this action to give manufacturers of dietary supplements the option to present nutrition information on a ``per day'' basis to consumers.