Comment Needed on Draft Guidance on "Important Considerations for When Participation of Human Subjects in Research Is Discontinued"
Office for Human Research Protections

The Office for Human Research Protections (OHRP) is announcing the availability of a draft guidance document and is seeking comments to be considered before issuing the final guidance document. The proposed document provides guidance on important considerations for when participation of human subjects in research is discontinued. The document addresses the following topics: (1) What does the word participation, as used in HHS regulations, mean? (2) What does discontinuation of a subject's participation in research mean? (3) The distinction between a complete versus a partial discontinuation of a subject's participation in research. (4) Clarification that investigators may continue to analyze already collected individually identifiable private information about a subject even when the subject's participation has been completely discontinued. (5) Considerations regarding the discontinuation of a subject's participation in emergency research for which the requirements for obtaining informed consent were waived by the IRB. (6) Clarification that research can continue to involve human subjects even when the participation of all subjects has been completed or discontinued. (7) Recommendations for documenting the discontinuation of subjects' participation in research.

Submit comments through January 30, 2009, by email or by mail or fax to: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, Fax: (301) 402-2071.

CDC Immunization Safety Office (ISO) Draft Scientific Agenda on Vaccine Safety
Centers for Disease Control and Prevention

ISO has drafted a scientific agenda that identifies vaccine safety issues to consider for scientific study over the next five years, in addition to any new questions that may arise. Since not all questions and issues can be addressed at once, setting priorities is important. Through this RFI, HHS is seeking comments from everyone, including stakeholders and the broad public. HHS requests input in three broad areas: (1) Concerns about vaccines and immunization safety, (2) comments on what values, considerations, or factors are most important to consider in prioritizing scientific research, and (3) specific comments on the draft ISO Scientific Agenda.

Submit comments by 5 p.m. on February 2, 2009, by email.

National Coverage Determination for Positron Emmision Tomography (FDG) for Solid Tumors
Centers for Medicare and Medicaid Services

CMS received public input indicating that the current coverage framework for FDG PET, which required cancer-by-cancer consideration of diagnosis, staging, restaging and monitoring response to treatment, should be replaced by a more omnibus consideration. Therefore, CMS requests public comment on a draft decision memo, which proposes a new coverage framework that would replace the four-part diagnosis, staging, restaging and monitoring response to treatment categories with a two-part framework that differentiates FDG PET imaging used to inform the initial treatment strategy from other uses related to guiding subsequent treatment strategies after the completion of initial treatment. CMS proposes to make this change for all NCDs that address coverage of FDG PET for oncologic conditions.

Submit comments online by 5 p.m. on February 5, 2009. Submit comments through email, noting CAG-00181N in the subject line.

Participation of Certain Population Subsets in Clinical Drug Trials
Food and Drug Administration

The Food and Drug Administration (FDA) is seeking information and comments on issues related to the enrollment of certain populations in clinical drug trials. Particularly, we are requesting information and comments addressing best practice approaches on increasing the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials. FDA requests that those with information on possible approaches to increase participation of these groups in clinical drug trials submit comments.

Submit comments online by February 27, 2009.

Office of Dietary Supplements Welcomes Comments for Next Strategic Plan: 2010 - 2014
National Institutes of Health

The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has initiated a strategic planning process that will culminate in the ODS Strategic Plan for 2010-2014. To assist with this process, the ODS requests input from research communities--academic, government, and industry--and from other interested parties. The overall purpose of the strategic planning effort is to identify both new opportunities and emerging needs for incorporation in the programmatic efforts of the Office. A background paper has been prepared, A Report to the Public, that summarizes progress in four key areas of ODS activity.

Submit comments at any time, until March 31, 2009, by email or by mail or fax to: Julia B. Freeman, Ph.D., Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, Room 3B01, Bethesda, MD 20892-7517, Fax: (301) 480-1845.

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.