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

The Food and Drug Administration (FDA) is reopening to December 6, 2007 the comment period for the notice that published in the Federal Register of April 2, 2007 (72 FR 15701); this notice was related to the public hearing of April 27, 2007, concerning the electronic distribution of FDA-approved prescribing information currently contained in the package insert (PI) for prescription drug and biological products. FDA is reopening the comment period for the sole purpose of inviting interested persons to submit comments on the concept of electronic distribution of FDA-approved prescribing information currently contained in the PI for prescription animal drug products.

HRSA's BPHC has performed a formal review of an unsolicited proposal from NNOHA to establish a cooperative agreement with HRSA to provide services and resources to support the Health Center Program's oral health providers serving the oral health needs of underserved populations. BPHC has reviewed the proposal and has determined that it has merit. This request is of strategic importance to the Department of Health and Human Services (HHS) and is time critical. Funding for the proposed activities will promote access to oral health services as an integral component of primary health care, improve the quality of those services provided, and sustain the forward motion of departmental priorities in this area. The Cooperative Agreement with NNOHA will have a project period of 1 year with funding at $200,000. The funds will support selected activities described in the application to develop a national infrastructure to support improved access to oral health care, and improved quality and workforce development for the growing number of health center oral health programs. The key anticipated outcomes of the proposed cooperative agreement are as follows: The development of oral health clinical quality infrastructure to support HRSA in achieving its goal of improved quality of care; The development of a recruitment and retention strategy to address dentist and dental hygienist vacancies, including National Health Service Corps dentist and dental hygiene openings; and NNOHA will work in collaboration with HRSA to implement a strategy to integrate oral health as it moves all of its programs forward in Health Information Technology to assure that oral health strategies are included. There is a strategic importance of access to oral health as part of the primary care services supported by BPHC's Health Center Program. The Health Center Program has had significant growth as part of the President's Health Center Initiative. The number of patients seen by the Health Center Program has increased by 90 percent. Health centers have reported significant challenges recruiting and retaining oral health providers. Consequently, HRSA has determined that the scope of this proposal is immediate and necessary. The proposed outcomes will contribute to the success and quality of oral health programs and are essential for long term sustainability and viability of health centers funded by HRSA. This award is being made non-competitively because there is no current, pending, or planned funding opportunity announcement under which this proposal could be competed. HRSA/BPHC has identified three key reasons to support rationale for not awarding competitively: 1. NNOHA is uniquely positioned to provide oral health program support services on a national basis to community health centers. As the only organization of health center dental providers, NNOHA is dedicated to increasing the effectiveness of dental programs in reaching all underserved populations by supporting efforts to strengthen existing health center dental programs; manage the growth of new health center dental programs; and manage the quality improvement in health center dental programs. 2. With this experience, and its nationwide membership of health center dentists, NNOHA has a proven track record of effective collaborations with health center dental programs. Increased access to quality oral health is enhanced through NNOHA's partnerships with organizations and governmental agencies at the local, State and national levels. 3. No other organization has the national scope of respected experience in the area of health center oral health leadership and can perform immediately, especially given the complexity of activities that are critical to HRSA.