Department of Health and Human Services March 19, 2007 – Federal Register Recent Federal Regulation Documents
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Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to change the location of a section in an over-the-counter (OTC) drug monograph. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Privacy Act of 1974: Report of Modified System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify a SOR titled, ``Long Term Care-Minimum Data Set'' (MDS), System No. 09-70-1517, most recently modified at 67 FR 6714 (February 13, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new identifying number for this system should read: System No. 09-70-0528. 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 also propose to modify existing routine use number 3 that permits disclosure to Peer Review Organizations (PRO). The name of PROs has been changed to read: ``Quality Improvement Organizations (QIO).'' QIOs will continue work to implement quality improvement programs, provide consultation to CMS, its contractors, and to state agencies. The modified routine use will remain as routine use number 3. 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 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 is to aid in the administration of the survey and certification, and payment of Medicare Long Term Care services, which include skilled nursing facilities (SNFs), nursing facilities (NFs) SNFs/NFs, and hospital swing beds, and to study the effectiveness and quality of care given in those facilities. Information in this system will also be used to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor or consultant; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) support Quality Improvement Organizations (QIO); (4) assist other insurers for processing individual insurance claims; (5) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (6) support litigation involving the Agency; (7) assist national accrediting organizations; and (8) 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.
Draft Guidance for Industry on Indexing Structured Product Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Indexing Structured Product Labeling.'' This guidance explains that the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drugs. This guidance also makes recommendations to industry on how to request a change to the indexing information in the SPL.
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