1. An Overview of Federal Agency Rulemaking Meeting of The Secretary’s Advisory Committee on Human Research Protections October 27, 2008 Christian C. Mahler, Senior Attorney Office of the General Counsel Public Health Division U.S. Department of Health & Human Services 5600 Fishers Lane, Suite 4A-53 Rockville, Maryland 20857

2. Rulemaking Under the Administrative Procedure Act (APA) The APA (1946) established basic framework of administrative law governing federal agencies, including rulemaking. 5 U.S.C. § 553, et seq. Current federal agency rulemaking process consists of additional congressional (statutes) and presidential (executive orders) requirements built on to the original APA framework starting in the 1970s

3. Rulemaking Under the APA APA adopted “formal rulemaking” and “informal rulemaking” procedures “Formal rulemaking” occurs only when a statute other than APA requires rulemaking on the record after an agency hearing The human subjects protection regulation (45 C.F.R. Part 46) is a product of “informal rulemaking” procedures

4. Informal Rulemaking Procedures--1 Referred to as “notice-and-comment” rulemaking Basic 3-step process, or procedural “floor” – Publication of Notice of Proposed Rulemaking (“NPRM”) in the Federal Register – Public Participation through written comments – Publication of a “final rule” not less than 30 days before rule’s effective date

5. Informal Rulemaking--2 NPRM components: preamble, rule text, and analyses required by statute or executive order Draft NPRM usually prepared by agency program office (OHRP) NPRM submitted to internal agency clearance process—OPHS and OS levels After internal clearance, submitted to OMB, for review and comment by affected agencies

6. Informal Rulemaking--3 After notice-and-comment period agency reviews comments and prepares response; revises text of final rule and analyses as appropriate Proposed “final rule” then submitted for internal agency and OMB review as with NPRM Published as final rule in the Federal Register Final rules have the force and effect of law

7. Common Rule Promulgation Regulations are typically promulgated by individual agencies For a regulation to have federalwide effect, the the regulation will go a through a process of joint agency promulgation to become a “common rule” Part 46 was promulgated as a common rule

8. Timing Issues-1 Drafting NPRM+internal agency clearance+ OMB review (90-120 days)+comment period (60 days)+analysis of comment revisions + agency clearance of final rule+OMB review=? Often 1 year or more (sometimes substantially more) between publication of NPRM and the final rule

9. Timing Issues-2 Subpart C—NPRM 1/5/78; Final Rule 11/16/78 Subpart D—NPRM 7/21/78; Final Rule 3/8/83 Subpart B—NPRM 5/20/98; final 1/17/01