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

The Food and Drug Administration (FDA) has determined the regulatory review period for CLINACOX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an abbreviated new animal drug application (ANADA) for isoflurane, U.S.P., from Rhodia UK Ltd. to Nicholas Piramal India Ltd. UK.

The Food and Drug Administration (FDA) is amending the animal drug regulations to remove inactive ingredients from the specifications for an oral suspension and for tablets containing kanamycin, bismuth subcarbonate, and activated attapulgite; and to consolidate and reformat these sections. These actions are being taken to improve the accuracy and readability of the animal drug regulations.

This notice announces the eighth meeting of the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

This notice announces the eighth meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the development of Set 20 Toxicological Profiles. Set 20 Toxicological Profiles consists of one new draft and six updated drafts. These profiles will be available to the public on or about October 17, 2006.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2007. The Federal Food, Drug, and Cosmetic Act, as amended by the Prescription Drug User Fee Amendments of 2002 (Title 5 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PDUFA III)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts for application fees, establishment fees, and product fees for FY 2007 were established by PDUFA III. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will approximate the revenue levels established in the statute, after those amounts have been first adjusted for inflation and workload. This notice establishes fee rates for FY 2007 for application fees for an application requiring clinical data ($896,200), for an application not requiring clinical data or a supplement requiring clinical data ($448,100), for establishment fees ($313,100), and for product fees ($49,750). These fees are effective on October 1, 2006, and will remain in effect through September 30, 2007. For applications and supplements that are submitted on or after October 1, 2006, the new fee schedule must be used. Invoices for establishment and product fees for FY 2007 will be issued in August 2006, using the new fee schedule.

The Food and Drug Administration (FDA) is publishing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2007. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), authorizes FDA to collect user fees for certain medical device applications. The FY 2007 fee rates are provided in this notice. For all applications submitted on or after October 1, 2006, and through September 30, 2007, fees must be paid at the FY 2007 rates at the time the applications are submitted to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your check is received. This notice provides details on how fees for FY 2007 were determined and payment procedures for medical device applications subject to user fees.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Assessment of Unreimbursed Care among Community Primary Care Physicians.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

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.