Attachment A - Statement of Work Regulatory Support Services BPA

Draft Statement of Work
U.S. Food and Drug Administration
Regulatory Support Services BPA

Introduction

The Food and Drug Administration’s (FDA) mission is to protect public health by assuring the safety, efficacy and quality of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for planning, managing, directing and coordinating major tobacco program objectives to support the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Federal Food, Drug, and Cosmetic Act for tobacco products.

Background

FDA develops rules and guidance documents that are aligned with FDA’s mission to promote and protect public health. This regulatory process is governed by laws including but not limited to the Administrative Procedure Act (APA) (5 U.S.C. Chapter 5), Congressional Review Act, Paperwork Reduction Act, and the Regulatory Flexibility Act. One area outlined in the APA is the notice-and-comment rulemaking process, which is often used when creating FDA regulations. During the notice-and-comment process, the FDA, at a minimum, must publish a notice of proposed rulemaking, give the public an opportunity to comment on the proposal, and consider the comments that have been submitted.

Publishing a notice of proposed rulemaking, involves many steps, including drafting the document, different levels of review and clearance, and finally, publication in the Federal Register in accordance with the requirements of the Office of the Federal Register (OFR) and the Government Publishing Office (GPO). After the notice of proposed rulemaking is published, there is a public comment period (typically between 60 and 90 days). This comment period gives the public an opportunity to provide information to agencies on the potential effects of a rule or to suggest alternatives for agencies to consider. The FDA must analyze and consider all relevant and substantive comments and information. Based on the comments and information submitted, the FDA might decide to end the rulemaking process, issue a new proposed rule, or to issue a final rule. If the FDA decides to issue a final rule, the agency must develop the regulatory text along with a preamble explaining the rule’s basis and purpose and responding to all significant issues raised in the comments.

The E-Government Act of 2002 requires agencies, to the extent practical, to accept comments “by electronic means” and to make the public comments and other materials included in the official rulemaking docket (a folder for documents or other information related to an agency’s rulemaking activities) available online. To meet these requirements the FDA uses the Federal Docket Management System (FDMS) and the public-facing Regulations.gov. FDMS is a federal government-wide document management system structured by dockets (or file folders) that offer an adaptable solution to service a wide range of regulatory activities routinely performed by federal agencies. Agency- approved users accessing FDMS.gov can, based on the user role, review and import data from public submissions; update document metadata; and/or publish submissions to Regulations.gov (excluding inappropriate, unrelated, incomplete, duplicate, CBI documents). The public-facing website of FDMS is Regulations.gov, which is an interactive website that allows the public to comment on regulatory documents, review comments submitted by others, and access federal regulatory information.