Department of Health and Human Services November 16, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy SymptomsRecommended Prescribing Information for Health Care Providers and Patient Labeling.'' The draft guidance is intended to assist applicants in developing labeling for new drug applications (NDAs) for such drug products. This is the fifth draft of the guidance, which FDA initially published for comment in October 1998.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for use of tylosin soluble powder in honey bees for the control of American foulbrood (Paenibacillus larvae).

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in cheese and cheese products at a level above that currently allowed by the regulations. This action is in response to a petition filed by Kraft Foods Global, Inc. (Kraft).

In accordance with the requirements of the Privacy Act of 1974, we propose to create a new system of records titled, ``Medicare True Out-of-Pocket (TrOOP) Expenditures System,'' HHS/CMS/OIS, System No. 09-70-0557. The TrOOP facilitation process is mandated by the Medicare Prescription Drug Benefit Program enacted into law December 8, 2003 under provisions of Section 101 of Title 1 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). MMA amends Title XVIII, Section 1860D of the Social Security Act (the Act). Section 1860D-2 of the Act requires the tracking of beneficiaries' TrOOP expenditures. TrOOP costs are treated as ``incurred'' only if they were paid by the individual (or by another person, such as a family member, on behalf of the individual), paid on behalf of a low-income subsidy-eligible individual under the Sec. 1860D-14 provisions, or paid under a State Pharmaceutical Assistance Program (SPAP) as defined in Sec. 1860D-23. Section 1860D- 2(b)(4)(D)(i) of the MMA authorizes CMS to establish procedures for determining whether costs for Part D enrollees are being reimbursed by excluded payers and alerting Part D plans about the existence of such payers. The purpose of this system is to collect and maintain a master file to establish a ``TrOOP'' facilitation process, maintain information on individuals and entities that make payments on covered drugs under the Medicare Part D Program, and coordinate TrOOP relevant data from State Pharmaceutical Programs (SPAPs) and other health insurers. 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) support Medicare Prescription Drug Plans (PDP) and Medicare Advantage Prescription Drug Plans (MAPD) directly or through a CMS contractor for the administration of Title XVIII of the Act; (3) 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; (4) assist Quality Improvement Organization (QIO) in connection with review of claims; (5) assist insurance companies and other groups providing protection against medical expenses of their enrollees; (6) assist an individual or organization engaged in the performance activities of the demonstration or in 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; (7) support constituent requests made to a congressional representative; (8) support litigation involving the agency; and (9) combat fraud 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 proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATE section for comment period.