Office of the Secretary

21 CFR Ch. I

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 with a view to offering summarized information about forthcoming regulatory actions for public review.

FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive Secretary, Department of Health and Human Services, Washington, D.C. 20201.


The information provided in the Agenda presents a forecast of the rulemaking activities that the Department of Health and Human Services (HHS) expects to undertake in the foreseeable future.

Rulemakings are grouped according to pre-rulemaking actions, proposed rules, final rules, long-term actions, and rulemaking actions completed since the spring 2011 Agenda was published.

Please note that the rulemaking abstracts included in this paper issue of the Federal Register relate strictly to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities, as required by the Regulatory Flexibility Act of 1980. Also available in this issue of the Register is the Department's submission to the Fiscal Year 2011 Regulatory Plan, required under Executive Order 12866.

The complete Regulatory Agenda of the Department is accessible online at in an interactive format that offers users enhanced capabilities to obtain information from the Agenda's database. The purpose of the Agenda is to encourage more effective public participation in the regulatory process.

NAME: Jennifer M. Cannistra,

Executive Secretary to the Department