Federal Register executive orders — 2025-08-19

Enabling Competition in the Commercial Space Industry

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1. Purpose. In 1969, the United States landed the first humans on the Moon. In the years since, premier space companies from around the world have been drawn to launch rockets and satellites from the United States, incentivized by its infrastructure and support for commercial space activities. Americans are more prosperous because of the space research and development occurring here.

It is imperative that we build on the far-reaching actions taken by my Administration during my first term to ensure that new space-based industries, space exploration capabilities, and cutting-edge defense systems are pioneered in America rather than by our adversaries. Ensuring that United States operators can efficiently launch, conduct missions in space, and reenter United States airspace is critical to economic growth, national security, and accomplishing Federal space exploration objectives.

Sec. 2. Policy. It is the policy of the United States to enhance American greatness in space by enabling a competitive launch marketplace and substantially increasing commercial space launch cadence and novel space activities by 2030. To accomplish this, the Federal Government will streamline commercial license and permit approvals for United States-based operators.

Sec. 3. Reforming Regulatory Barriers to Commercial Launch and Reentry. (a) The Secretary of Transportation, in consultation with the Chair of the Council on Environmental Quality, shall, consistent with applicable law, use all available authorities to eliminate or expedite the Department of Transportation's environmental reviews for, and other obstacles to the granting of, launch and reentry licenses and permits. Such measures shall include the exercise of authority by the Secretary of Transportation under 51 U.S.C. 50905(b)(2)(C) as applicable; determining which Department of Transportation functions are not subject to the National Environmental Policy Act (NEPA); and, as appropriate, establishing categorical exclusions under NEPA (or relying on existing categorical exclusions) for launch and reentry licenses and permits within certain parameters.

(b) The Secretary of Transportation shall reevaluate, amend, or rescind, as appropriate and consistent with applicable law, the regulations at Part 450 of title 14, Code of Federal Regulations. The Secretary's evaluation, amendment, or rescission shall specifically address:

(i) what regulatory requirements should be inapplicable for a launch or reentry vehicle that possesses a flight termination system or automated flight safety system;

(ii) what regulatory requirements should be inapplicable or waived for hybrid launch or reentry vehicles that hold valid Federal Aviation Administration airworthiness certificates;

(iii) whether to expand the conditions that demonstrate reliability for a reentry vehicle, sufficient to protect against a high-consequence event on reentry; and

(iv) whether other existing requirements are too attenuated to a vehicle's actual launch or reentry to warrant retention in Part 450.

(c) Within 120 days of the date of this order, the Secretary of Transportation shall report to the Assistant to the President for Economic Policy a description of the actions that have been or will be taken pursuant to subsection (b) of this section.

Sec. 4. Reforming Regulatory Barriers to Next Generation Spaceport Infrastructure. (a) The Secretary of Commerce, in consultation with the Secretary of Defense, the Secretary of Transportation, and the Administrator of the National Aeronautics and Space Administration (NASA), shall, within 180 days of the date of this order, conduct an evaluation of relevant States' compliance under the Coastal Zone Management Act pursuant to 16 U.S.C. 1458, the effect of any lack of compliance on the development of spaceport infrastructure, and whether State approvals under that Act should be revoked. The Secretary of Defense, the Secretary of Commerce, the Secretary of Transportation, and the Administrator of NASA shall also notify the Department of Justice of any State or local limitations on spaceport development on Federal lands that may be inconsistent with Federal law.

(b) Within 180 days of the date of this order, the Secretary of Defense, the Secretary of Transportation, and the Administrator of NASA shall execute a memorandum of understanding that aligns review processes for spaceport development across agencies, eliminates those that are duplicative, and preserves required Federal space-exploration and National Security Space Launch capacity.

(c) The Secretary of Defense, the Secretary of the Interior, the Secretary of Transportation, and the Administrator of NASA shall, consistent with applicable law, use all available authorities to expedite their respective environmental and administrative reviews for authorizations, permits, approval, real property leases, and any other activity relevant to spaceport infrastructure development. The Chair of the Council on Environmental Quality shall coordinate with relevant executive departments and agencies (agencies) on the establishment of new categorical exclusions under NEPA for actions related to spaceport development that normally do not have a significant effect on the quality of the human environment. Agencies shall, for purposes of establishing these categorical exclusions, rely on any sufficient basis to do so as each such agency determines.

(d) The Secretary of Defense, the Secretary of Transportation, and the Administrator of NASA shall, mindful of the significant national security imperatives inherent in commercial space advancement, consider for all spaceport development projects whether to submit an application to the Endangered Species Committee pursuant to 16 U.S.C. 1536(e).

Sec. 5. Reforming Novel Space Activity Authorization. Within 150 days of the date of this order, the Secretary of Commerce shall propose a process for individualized mission authorizations for activities that are covered by Article VI of the Outer Space Treaty of 1967, but not clearly or straightforwardly governed by existing regulatory frameworks, with the goal of expediting and streamlining authorizations to enable American space competitiveness and superiority. This proposal must solicit and consider affected agencies' feedback on the authorization process, contain a definitive timeline for the grant or denial of authorization for proposed activities, and include clear and consistent requirements for applicants. The Secretary of Commerce shall transmit the proposal to the Assistant to the President for Economic Policy, the Assistant to the President for National Security Affairs, and the Assistant to the President for Science and Technology. Nothing in this section shall be construed to apply to human spaceflight.

Sec. 6. Reforming Regulatory Leadership and Accountability. (a) Within 60 days of the date of this order, the Secretary of Transportation shall establish a position in the Office of the Secretary with the responsibility of advising the Secretary of Transportation on fostering innovation and deregulation in the commercial space transportation industry. The Secretary of Transportation shall further direct the Administrator of the Federal Aviation Administration to take all necessary steps to appoint a senior executive noncareer employee to be the Associate Administrator for Commercial Space Transportation.

(b) Within 60 days of the date of this order, the Secretary of Commerce shall elevate the Office of Space Commerce into the Office of the Secretary.

Sec. 7. Administrative Note. Where applicable, the functions assigned to the Secretary of Transportation in sections 1 through 5 of this order shall be carried out by the Administrator of the Federal Aviation Administration under the direction of the Secretary of Transportation.

Sec. 8. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The costs for publication of this order shall be borne by the Department of Transportation.

Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1 . Purpose. During my first term, my Administration acted to protect the health and security of the American people by restoring capacity for domestic production of essential pharmaceutical products. Executive Order 13944 of August 6, 2020 (Combatting Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States), directed certain executive departments and agencies (agencies) to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, as defined in section 7 of that order, and to identify supply chain vulnerabilities. The Food and Drug Administration published a list of Essential Medicines, Medical Countermeasures, and Critical Inputs in October 2020. The Office of the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services later reduced the list to 86 essential medicines.

Nearly two in five prescription finished drug products are made in the United States, including many of the essential medicines. However, when it comes to Active Pharmaceutical Ingredients (APIs), the biologically active components of finished drug products, only about 10 percent of the APIs by volume for the finished drug products used in the United States are made here.

During my first term, my first Administration created a Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to stockpile APIs. Stockpiling APIs is advantageous as APIs are generally lower-cost and have longer shelf lives than the finished drug products they make. Filling the SAPIR will also insulate the United States from the concentration of foreign, sometimes adversary, nations in the world-wide supply of the Key Starting Materials used to make APIs. Moreover, Government purchases of APIs to fill the SAPIR can encourage more domestic production of APIs.

Unfortunately, the Biden Administration failed to advance the goal of ensuring domestic sources for essential medicines and their precursors despite spending billions of dollars on efforts to secure supply chains. Domestic production and procurement did not increase and the SAPIR is nearly empty.

Sec. 2 . Filling the SAPIR with APIs for the Most Critical Medicines. (a) Within 30 days of the date of this order, the ASPR shall develop a list, in consultation with agencies with scientific expertise, the Assistant to the President for Economic Policy (APEP), and the Assistant to the President and Homeland Security Advisor (APHSA), of approximately 26 drugs that are especially critical to the health and security interests of the Nation (the critical drugs) and an accounting of existing, available funds that can be utilized, consistent with statutory authorities, to finance the preparation and opening of the SAPIR repository and to obtain and maintain the 6-month supply of APIs for the critical drugs referenced in subsection (c) of this section shall be provided to the Director of the Office of Management and Budget (OMB). The OMB shall provide assistance to the Secretary of Health and Human Services to facilitate the repurposing of available funds, consistent with law.

(b) Within 120 days of the date of this order and subject to the availability of funds identified pursuant to subsection (a) of this section, the ASPR shall, in coordination with such other agencies as are necessary, take all measures to ready the existing SAPIR repository so that it can begin receiving and maintaining APIs.

(c) Subject to the availability of funds identified pursuant to subsection (a) of this section, the ASPR shall obtain a 6-month supply of the APIs needed to make the critical drugs to fill the SAPIR, with a preference for obtaining domestically manufactured APIs if possible. The ASPR shall place such APIs within the SAPIR repository no later than 30 days after the repository is certified by the ASPR as ready to receive and maintain APIs.

Sec. 3 . Ensuring SAPIR Resilience. (a) Within 90 days of the date of this order, the ASPR shall provide the APHSA, the APEP, and the OMB with an update to the ASPR's 2022 list of 86 essential medicines and medical countermeasures, along with a plan to:

(i) obtain from domestic manufacturers, where possible;

(ii) store; and

(iii) maintain a 6-month supply of APIs for drugs on the updated essential medicines list if they have not already been addressed in the list of critical drugs identified pursuant to section 2(a) of this order.

(b) The plan provided pursuant to subsection (a) of this section shall include a proposal and cost estimate for opening a second SAPIR repository in the United States within 1 year of the date of this order.

Sec. 4 . General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The costs for publication of this order shall be borne by the Department of Health and Human Services.

Revocation of Executive Order on Competition

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1. Revocation. Executive Order 14036 of July 9, 2021 (Promoting Competition in the American Economy), is hereby revoked.

Sec. 2. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The costs for publication of this order shall be borne by the Department of Justice.