Department of Health and Human Services November 15, 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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing system of records titled, ``Unique Physician/Practitioner Identification Number (UPIN),'' System No. 09-70-0525, most recently modified at 69 FR 75316 (December 16, 2004). We propose to delete published routine use number 1 that permits the release of the identification of each physician or non-physician practitioner who has been assigned a UPIN and who is participating in the Medicare program. Selected UPIN information to carry out this requirement is available as a public use file, and as such, should not be treated as a routine use disclosure. We will broaden the ``Purpose'' section of this notice to include this requirement as one of the primary purposes of this system. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charges with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 6 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 8 and 9, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We also propose to add a routine use for the release of information to assist an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment-related projects. The added routine use will be numbered as routine use number 3. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to: (1) Collect and maintain an unique identification of each physician, non-physician practitioner, or medical group practice requesting or receiving Medicare payment, and (2) provide beneficiaries and other interested entities with the identification of each physician or non-physician practitioner assigned an UPIN and who are participating in the Medicare program. Information retrieved from this SOR will be used to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor or consultant, or CMS grantee; (2) assist another Federal and/or State agency, agency of a State government, an agency established by State law, or its fiscal agent; (3) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (4) assist Quality Improvement Organizations; (5) provide the American Medical Association with information needed for them to assist us in identifying physicians; (6) support litigation involving the Agency; and (7) combat fraud, waste, 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.

The Food and Drug Administration (FDA) is announcing the availability of a final Compliance Policy Guide (CPG) 160.900 entitled ``Prescription Drug Marketing ActPedigree Requirements under 21 CFR Part 203'' (PDMA CPG). This CPG describes how the agency intends to prioritize its enforcement efforts in the first year after the December 1, 2006, effective date of 21 CFR Sec. Sec. 203.3(u) and 203.50. In addition, the FDA is announcing the availability of ``Guidance for Industry: Prescription Drug Marketing Act (PDMA) Pedigree Requirements Questions and Answers'' (PDMA Q & A). The PDMA Q & A guidance is issued in response to the many questions received regarding the Prescription Drug Marketing Act (PDMA) pedigree requirements. The two guidance documents explain FDA's current thinking on issues related to the pedigree requirements of the PDMA.