Department of Health and Human Services August 22, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on a 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 a study of consumer evaluations of variations in communicating risk information in direct- to-consumer (DTC) prescription drug broadcast advertisements.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of glycerol ester of tall oil rosin (GETOR) to adjust the density of citrus oils used in the preparation of beverages and to provide for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. This action is in response to a petition filed by Georgia-Pacific Resins, Inc.

This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from April 1, 2007, through June 30, 2007. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.

In accordance with the requirements of the Privacy Act of 1974, we propose to modify an existing system titled, ``National Emphysema Treatment Trial (NETT), System No. 09-70-0531,'' established at 65 Federal Register 47995 (August 4, 2000). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged 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 remain as routine use number 1. We will delete routine use number 4 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 5 and 6, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary or recipient practices that result in unnecessary cost to all federally-funded health benefit programs. Additionally, we will broaden the scope of this system by including the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' apply when ever the system collects or maintain PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' will apply to the data disclosed from this system. 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 system of records is to collect and maintain data that will allow CMS to provide secure data on participants in the randomized phase of the study, pay claims, and to monitor and evaluate the clinical trial. 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 to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support 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; (4) support litigation involving the agency; and (5) 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 proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATE section for comment period.