Department of Health and Human Services August 1, 2006 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration's (HRSA) Healthcare Systems Bureau, Division of Healthcare Preparedness Bioterrorism Training and Curriculum Development Program (BTCDP) will provide supplemental funding to approximately five fiscal year (FY) 2006 BTCDP awardees to plan, test and evaluate the expansion of regional healthcare preparedness training efforts to a nationwide focus. A limited competition within the existing 19 awardees will be used to identify the recipients. Authority: This activity is under that authority of the Public Health Service Act, Title III, Section 319F(g), 42 U.S.C. 247d-6(g). Purpose: The purpose of supplemental awards is to expand the reach of the originally approved BTCDP awards from the currently approved geographic region to include the entire Nation. The intended recipients of this limited eligibility program expansion will be the successfully competed and objectively reviewed applicants from the already supported 19 regional BTCDP awardees. The program expansion will enhance consistency in preparedness training by providing proven training through a nationwide focus. Previous efforts have consisted of a more limited approach focusing training at a local/regional level. Amount: The anticipated award amount of $1.8 million will be distributed among the 4 or 5 most highly ranked (by objective review) applicants from the existing 19 BTCDP awardees. Awards will average $360,000. Project Period: The period of support is from September 30, 2006, to August 31, 2007, and will align with the existing budget period. Justification for the Exception to Competition: Open competition applications for the BTCDP program were received and reviewed by an objective review panel in the summer of FY 2005, at which time BTCDP's local and regional training plans, curriculum and evaluation strategies were reviewed and approved. A total of 74 Continuing Education applications were reviewed and 50 applications were approved. Nineteen projects were funded after careful review from a strongly competitive pool of applicants, emerging as the strongest entities with proven experience and track records to expand their accomplishments to a nationwide target of healthcare providers. Since that time, the awardees have continued to use Federal funds to align their training with the National Preparedness Goal and to deliver training consistent with HRSA's goals. BTCDP funded programs are uniquely suited to participate in this geographic expansion based upon their authorship and mastery of tested curriculum. BTCDP awardees have been awarded funds specifically to develop training strategies for all healthcare professionals. Their experiences have made them uniquely aware of potential pitfalls to be overcome in developing and testing a national training plan and have the expertise to respond to such barriers as they arise. Since the inception of the program in FY 2003, BTCDP awardees have been responsible for the training of 225,000 healthcare providers on a locality-by-locality basis and stand ultimately poised to deploy and evaluate national training strategies. BTCDP awardees are highly regarded academic institutions which have dedicated staff and infrastructure to create quality training opportunities for healthcare providers. Curriculum created with BTCDP dollars has already been approved by the academic institutions from which they emanate and has already secured the approval of healthcare professional continuing education accreditation bodies. Awardees possess the building blocks of the infrastructure necessary to efficiently test a national training system, and they have the knowledge and experience necessary to ensure the efficient use of funds for healthcare preparedness training. The BTCDP is the only Federal program solely committed to the preparedness training of healthcare providers. As such, BTCDP awardees share curriculum, accomplishments and lessons learned through an established network on a regular basis, a network vital to the development of a national plan. Awardees stand uniquely prepared to respond to congressional demand for an efficient and effective national training strategy within the fiscal and time constraints of this supplement. This supplement is the first step in meeting this demand through the efficient use of proven curriculum by experienced trainers on a national basis.

The Food and Drug Administration (FDA) is issuing a final rule to amend the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to add phenylephrine bitartrate (PEB), both individually and in combination drug products in an effervescent dosage form, as generally recognized as safe and effective (GRASE). An effervescent dosage form is intended to be dissolved in water before taking by mouth. This final rule is part of FDA's ongoing review of OTC drug products.

The purpose of this memorandum of understanding (MOU) is to set forth an agreement between the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) (collectively ``the Parties'', or individually as a ``Party'') to provide a framework for coordination and collaborative efforts between these two agencies which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information exchanges between FDA and CDC shall take place. This memorandum supersedes the Memorandum of Understanding between the Centers for Disease Control and the Food and Drug Administration, dated June 26, 2000, and numbered 225-03-8001.