( printed page 42507)

SUPPLEMENTARY INFORMATION:

I. Background

A. FDA's Regulatory Mission

FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges.

This document is seeking comments and information solely on general regulations and approved information collections affecting multiple FDA Centers and/or Offices.

B. The Regulatory Reform Agenda: Executive Orders 13771 and 13777

On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that:

• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.

II. Request for Comments and Information

To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.

The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.

• Is the regulation still current, or is it outdated or unnecessary in some way?

○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?

○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.

○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.

• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (e.g., International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius)? Do the entities covered by these standards or guidance take steps to meet the standards and to document that they meet the standards? If met, do the standards achieve the same level of public health protection as the FDA regulation? Are there entities who are not covered by these standards or guidances or who choose not to observe them?
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,e.g., reporting, recordkeeping, or labeling requirements? Explain in your response why the information is redundant, outdated, or unnecessary.
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?

The most current version of FDA regulations may be found at https://www.ecfr.gov. We request that comments be as specific as possible, include any supporting data or other information, such as cost information, provide a Code of Federal Regulations (CFR) citation when referencing a specific regulation, and provide specific suggestions regarding repeal, replacement, or modification. For comments relating to an information collection, cite to the approved information collection request and include the Office of Management and Budget (OMB) control number.

In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document. ( printed page 42508)

III. References

The following references are on display in the Dockets Management Staff office (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register , but Web sites are subject to change over time.

1. Executive Order 13771 (January 30, 2017); available at https://www.federalregister.gov/​documents/​2017/​02/​03/​2017-02451/​reducing-regulation-and-controlling-regulatory-costs.

2. Executive Order 13777 (February 24, 2017); available at https://www.federalregister.gov/​documents/​2017/​03/​01/​2017-04107/​enforcing-the-regulatory-reform-agenda.