Department of Health and Human Services July 9, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove essential-use designations for certain oral pressurized metered-dose inhalers (MDIs). In the Federal Register of June 11, 2007 (72 FR 32030), the agency proposed to remove the essential use designation for MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking.

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 FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with ``due diligence.''

Section 340B of the Public Health Service Act (section 340B) and section 1927(a) of the Social Security Act (section 1927(a)) implement a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (section 6004) added children's hospitals to the list of covered entities eligible to access 340B discounted drugs. The purpose of this notice is to inform interested parties of proposed guidelines regarding the addition of children's hospitals that meet certain requirements, specifically: (1) The process for the addition of children's hospitals to the 340B Program; and (2) the obligation of manufacturers to provide the statutorily mandated discount to children's hospitals. These proposed guidelines will not take effect until final guidelines are issued.

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 paperwork associated with applications for new animal drugs.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage'' dated July 2007. The draft guidance provides to sponsors recommendations about certain information that should be included in an investigational device exemption (IDE) or investigational new drug application (IND) for a product intended to repair or replace knee cartilage. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 14, 2007 (72 FR 32852). The agency issued a withdrawal of a new drug application (NDA) for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets held by Otsuka Pharmaceutical Co., Ltd. (Otsuka), c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. The document published with typographical errors and cited a section of the Code of Federal Regulations that no longer exists. This document corrects those errors. The agency is also announcing the removal of RAXAR Tablets from the list of approved drug products in FDA's ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (the Orange Book).

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 information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).

This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panama and (b) train community health workers, clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America (i.e. Latin America), (c) facilitate partnerships between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health training and program efforts in Latin America. These efforts will help engage significantly more areas of these countries to prepare for and respond to public health emergencies such as pandemic influenza, and they will contribute to improved and expanded provision of prevention and primary health care. This training of nurses, community health workers and physicians will focus on improving and expanding coverage and access to both public health emergency care and preventive and primary health care in underserved parts of Latin America (i.e., both underserved rural and poor urban communities). It is anticipated that as a result of this project, the healthcare work force will be better prepared to respond to public health emergencies such as pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to provide their health and medical care skills in underserved areas within the region. In addition to all appropriate medical care and health education or communication subjects, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, among other subjects so graduates of training programs will be prepared to play contributing roles to any pandemic preparation and response.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.