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 Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.

FOR FURTHER INFORMATION CONTACT : C'Reda J. Weeden , Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington , DC 20201 ; (202) 690-5627 .

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) is the Federal government's lead agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS enhances the health and well-being of Americans by promoting 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 this year 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 .

In the rules outlined for this Agenda, HHS continues its work to build a better, smarter, and stronger health care delivery system. Our aspiration is for patients to receive higher quality of care, for medical information to be easy to understand, and for health care dollars to be spent more wisely. We welcome the opportunity to build a more transparent health care delivery system and strengthen partnerships with patients, physicians, governments, and businesses. We continue our work by helping more people get and keep health insurance coverage and making health care more affordable for working families.

In addition, HHS strives to lead in the advancement of scientific knowledge and innovation to enable our nation's scientists and researchers to continue making new and improved vaccines, cures, therapies, and rapid diagnostics. The accompanying regulations promote advancements in science, research, and innovation to attract the best experts to accelerate cures; reduce administrative burdens and duplication; and promote data sharing to protect the health of the American people.

HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process and promote increase transparency to the public regarding our regulatory activity. For example, to encourage public participation, we regularly update our regulatory webpage (http://www.HHS.gov/regulations) which includes links to HHS rules currently open for public comment, and also provides a "regulations toolkit" with background information on regulations, the commenting process, how public comments influence the development of a rule, and how the public can provide effective comments. HHS also actively encourages meaningful public participation in its retrospective review of regulations, through a comment form on the HHS retrospective review webpage

(http://www.HHS.gov/RetrospectiveReview).

The rulemaking abstracts included in this paper issue of the Federal Register 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 http://www.Reglnfo .gov.

NAME: C'Reda J. Weeden,

Executive Secretary to the Department.