DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Ch. I
25 CFR Ch. V
42 CFR Chs. I-V
45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual Regulatory Agenda
SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.
FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive Secretary, Department of Health and Human Services, Washington, DC 20201.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) is the Federal Government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The mission of HHS is to enhance the health and well-being of Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. This agenda presents the rulemaking activities that the Department expects to undertake in the foreseeable future to advance this mission. The agenda furthers several Departmental goals, including strengthening health care; advancing scientific knowledge and innovation; advancing the health, safety, and well-being of the American people; increasing efficiency, transparency, and accountability of HHS programs; and strengthening the Nation's health and human services infrastructure and workforce.
The purpose of the agenda is to encourage more effective public participation in the regulatory process. HHS is currently furthering this goal by engaging in a Department-wide effort to identify ways to make the rulemaking process more accessible to the general public. This effort is in response to President Obama's January 18, 2011, Executive Order 13563, "Improving Regulation and Regulatory Review," which requires ongoing retrospective review of current agency regulations and encourages Federal agencies to develop balanced regulations through a process that "allows for public participation and an open exchange of ideas." HHS's efforts include continuing to update its main regulatory website to highlight useful information for the public, such as HHS rules currently open for public comment, and actively encouraging meaningful public participation in retrospective review and rulemaking through education and outreach.
The rulemaking abstracts included in this paper issue of the Federal Register only cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant
economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the agenda's database.
Dated: August 30, 2012.
NAME: Jennifer M. Cannistra,
Executive Secretary to the Department.