Public Comment Needed on Healthy People 2020
Department of Health and Human Services

We invite you to give us your comments and suggestions as part of the collaborative process of building Healthy People 2020. You may choose to provide us with feedback on various conceptual aspects and proposals for specific elements, including vision, mission, overarching goals, organizing framework, users, and implementation. Your general comments also are welcome.

To be considered by the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020, submit comments electronically by close-of-business on Tuesday, September 2, 2008.

Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs
Office for Human Research Protections

The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments from affected entities and individuals about (a )whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research, or (b) whether HHS should develop a regulation requiring the implementation of such training and education programs.

Submit comments by email to humansubjectstraining@hhs.gov with "Human Subjects Protection Training and Education" in the subject line by September 29, 2008.

Draft Guidance on Convening FDA Advisory Committee Meetings - Comment Needed
Food and Drug Administration

To enhance the transparency of FDA's advisory committee program, the FDA is publishing this draft guidance to provide its current thinking on when to bring a matter to an advisory committee. In some instances, FDA refers a matter to an advisory committee because it is required to do so by law. In others, FDA convenes an advisory committee meeting at its own discretion. Regardless, FDA recognizes that advisory committee meetings demand significant resource commitments by advisory committee members, sponsors, and other public participants, as well as for FDA itself, and should be used for important matters. The draft guidance is intended to clarify how the agency identifies which matters should be referred.

Submit electronic comments using Docket number FDA-2008-D-0417 by October 6, 2008.

Ideas for Innovation in Delivery of Healthcare
Agency for Healthcare Research and Quality

AHRQ is establishing a new research portfolio, the Innovations Portfolio. The Portfolio goal is to identify and support research that has the potential to accelerate improvements in the organization, delivery, and management of healthcare. AHRQ seeks ideas on priority topics and activities that should be addressed as components of the Innovations Portfolio. Research and activities supported under the Innovations Portfolio will reflect ideas substantially different from those already being pursued by AHRQ. The portfolio will fund a transformative research agenda to solve pressing healthcare problems. Thus, the main focus of the portfolio is problem solving in order to accelerate improvement in healthcare.

Submit ideas by e-mail with an attachment in a standard word processing format to francis.chesley@ahrq.hhs.gov by October 14, 2008.

Guidance on Determining Conflict of Interest for Participation in FDA Advisory Committees - Comment Needed
Food and Drug Administration

The purpose of this guidance is to simplify and streamline the process by which FDA considers meeting participation, increase the transparency, clarity, and consistency of the process, and enhance public trust in this important function. The guidance incorporates a progressively more stringent cap on the numbers of waivers issued per fiscal year in accordance with FDAAA. If an individual or his spouse or minor child has disqualifying financial interests whose combined value exceeds $50,000, she generally would not participate in the meeting, regardless of the need for her expertise. FDA will not issue a waiver in certain circumstances where the agency has determined that the conflict of interest is significant.

Submit electronic comments using Docket number FDA-2007-D-0424 at any time.

Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation Devices - Comment Needed
Food and Drug Administration

The Food and Drug Administration (FDA) is requesting comments on whether a registry could facilitate standardization of feasibility trials studying local treatment of small breast cancers with different thermal ablation devices and therapies (i.e. cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). FDA is specifically interested in understanding how breast cancer ablation feasibility trials can be constructed so that there exists standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens.

Submit electronic comments using Docket number FDA-2008-N-0280 by November 24, 2008.