Department of Health and Human Services January 15, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for sponsors and foreign manufacturers of finished drug products and active pharmaceutical ingredients (APIs) intended for human use imported by a secure supply chain to apply to participate in a voluntary Secure Supply Chain (SSC) pilot program to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA). The goal of the pilot program is to allow FDA to determine the practicality of developing a secure supply chain program. The information obtained from this pilot program will assist FDA in its determination. A Secure Supply Chain program would assist the agency in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the agency to focus its resources on imported drugs outside the program that may pose such risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and APIs imported into the United States that meet the criteria for selection under the program.

The Food and Drug Administration (FDA) is proposing to revoke its regulations on the standards of identity for lowfat yogurt and nonfat yogurt and amend the standard of identity for yogurt in numerous respects. This action is in response, in part, to a citizen petition submitted by the National Yogurt Association (the NYA). FDA tentatively concludes that this action will promote honesty and fair dealing in the interest of consumers and, to the extent practicable, will achieve consistency with existing international standards of identity for yogurt.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Adverse Event ReportingImproving Human Subject Protection.'' This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to institutional review boards (IRBs). FDA developed this guidance in response to concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting, rather than enhancing, the ability of IRBs to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs. Elsewhere in this issue of the Federal Register, FDA is issuing the final rule entitled ``Institutional Review Boards; Registration Requirements.''

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), is adding a new subpart E to the HHS protection of human subjects regulations, which requires institutional review boards (IRB) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS. The registration information includes contact information, approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. The registration requirements will make it easier for OHRP to convey information to IRBs and will support the current IRB registration system operated by OHRP. Under this final rule, the IRB registration system is compatible with the IRB registration requirements of the Food and Drug Administration (FDA), which are simultaneously published as a final rule in this issue of the Federal Register, allowing the operation of a single HHS IRB registration system.