Department of Health and Human Services July 24, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the guidance for industry on Continuous Marketing Applications: Pilot 2Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the bar code label requirements for human drug and biological products.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Medicare Care Management for High Cost Beneficiaries (CMHCB), System No. 09-70- 0580.'' The program is authorized under provisions of the Social Security Act (42 U.S.C. Section 1395b-1(a)), which gives the Secretary the broad authority to, `develop and engage in experiments and demonstration projects.' The CMHCB program seeks to improve beneficiary self-care and provide beneficiaries and their providers enhanced information and support in order to increase adherence to evidence- based care. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the payments. Each CMHCB program is an experimental design involving assignment of beneficiaries to either an intervention or control group. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who are potential participants in the CMHCB program. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, 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) support 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 litigation involving the agency; and (5) combat fraud and abuse in certain Federally-funded 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 proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.