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	What Is a "Section 123" Agreement?

Under existing law (Atomic Energy Act [AEA] of 1954, as amended [P.L. 83-703; 42 U.S.C. §2153 et seq.]), all significant U.S. nuclear cooperation with other countries requires a peaceful nuclear cooperation agreement. Significant nuclear cooperation includes the transfer of U.S.-origin special nuclear material subject to licensing for commercial, medical, and industrial purposes, and the export of reactors and critical parts of reactors. Section 123 agreements are required for the export of commodities under NRC export licensing authority (10 C.F.R. 110).
Such agreements, which are "congressional-executive agreements" requiring congressional approval, do not guarantee that cooperation will take place or that nuclear material will be transferred, but rather set the terms of reference and authorize cooperation. The AEA includes requirements for an agreement's content, conditions for the President to exempt an agreement from those requirements, presidential determinations and other supporting information to be submitted to Congress, conditions affecting the implementation of an agreement once it takes effect, and procedures for Congress to consider and approve the agreement.
Section 123 of the AEA requires that any agreement for nuclear cooperation meet nine nonproliferation criteria and that the President submit any such agreement to the House Committee on Foreign Affairs and the Senate Committee on Foreign Relations. The Department of State is required to provide the President with an unclassified Nuclear Proliferation Assessment Statement (NPAS), which the President is to submit, along with the agreement, to those two committees. The State Department is also required to provide a classified annex to the NPAS, prepared in consultation with the Director of National Intelligence. The NPAS is meant to explain how the agreement meets the AEA nonproliferation requirements. The President must also make a written determination "that the performance of the proposed agreement will promote and will not constitute an unreasonable risk to, the common defense and security."

		Requirements Under the Atomic Energy Act

Section 123 of the AEA specifies the necessary steps for engaging in nuclear cooperation with another country.
Section 123a. states that the proposed agreement is to include the terms, conditions, duration, nature, and scope of cooperation and lists nine criteria that the agreement must meet. It also contains provisions for the President to exempt an agreement from any of several criteria described in that section and includes details on the kinds of information the executive branch must provide to Congress. Section 123b. specifies the process for submitting the text of the agreement to Congress. Section 123c. specifies the procedure for congressional approval of cooperation agreements that are limited in scope (e.g., do not transfer nuclear material or cover reactors larger than 5 megawatts electric [MWe]). This report does not discuss such agreements. Section 123d. specifies the procedure for congressional approval of agreements that do cover significant nuclear cooperation (transfer of nuclear material or reactors larger than 5 MWe), including exempted agreements.
Section 123a., paragraphs (1) through (9), lists nine criteria that an agreement with a nonnuclear weapon state must meet unless the President determines an exemption is necessary. These include guarantees that
safeguards on transferred nuclear material and equipment continue in perpetuity; International Atomic Energy Agency (IAEA) comprehensive safeguards are applied in nonnuclear weapon states; nothing transferred is used for any nuclear explosive device or for any other military purpose; the United States has the right to demand the return of transferred nuclear materials and equipment, as well as any special nuclear material produced through their use, if the cooperating state detonates a nuclear explosive device or terminates or abrogates an IAEA safeguards agreement; there is no retransfer of material or classified data without U.S. consent; physical security on nuclear material is maintained; there is no enrichment or reprocessing by the recipient state of transferred nuclear material or nuclear material produced with materials or facilities transferred pursuant to the agreement without prior approval; storage for transferred plutonium and highly enriched uranium is approved in advance by the United States; and any material or facility produced or constructed through use of special nuclear technology transferred under the cooperation agreement is subject to all of the above requirements.
Although some experts have advocated requiring governments to forgo enrichment and reprocessing (a nonproliferation commitment sometimes referred to as the "Gold Standard") as a condition for concluding a nuclear cooperation agreement, the Atomic Energy Act does not include such a requirement (see Appendix B ).

		Exempted vs. Nonexempted Agreements

The President may exempt an agreement for cooperation from any of the requirements in Section 123a. if he determines that the requirement would be "seriously prejudicial to the achievement of U.S. nonproliferation objectives or otherwise jeopardize the common defense and security." The AEA provides different requirements, conditions, and procedures for exempt and nonexempt agreements. To date, all of the Section 123 agreements in force are nonexempt agreements. Prior to the adoption of P.L. 109-401 , the Henry J. Hyde United States-India Peaceful Atomic Energy Cooperation Act of 2006, the President would have needed to exempt the nuclear cooperation agreement with India from some requirements of Section 123a. However, P.L. 109-401 exempted nuclear cooperation with India from some of the AEA's requirements.

	Congressional Review

Under the AEA, Congress has the opportunity to review a nuclear cooperation agreement for two time periods totaling 90 days of continuous session. The President must submit the text of the proposed agreement, along with required supporting documents (including the unclassified NPAS) to the House Foreign Affairs Committee and the Senate Foreign Relations Committee. The President is to consult with the committees "for a period of not less than 30 days of continuous session." After this period of consultation, the President is to submit the agreement to Congress, along with the classified annex to the NPAS and a statement of his approval of the agreement and determination that it will not damage U.S. national security interests. This action begins the second period, which consists of 60 days of continuous session. In practice, the President has sent the agreement to Congress at the beginning of the full 90-day period, which begins on the date of transmittal. Typically, the 60-day period has immediately followed the expiration of the 30-day period. The President transmits the text of the proposed agreement along with a letter of support with a national security determination, the unclassified NPAS, its classified annex, and letters of support for the agreement from the Secretary of State and the Nuclear Regulatory Commission.
If the President has not exempted the agreement from any requirements of Section 123a., it may enter into force after the end of the 60-day period unless, during that time, Congress adopts a joint resolution disapproving the agreement and the resolution becomes law. If the agreement is an exempted agreement, Congress must adopt a joint resolution of approval and it must become law by the end of the 60-day period or the agreement may not enter into force. At the beginning of this 60-day period, joint resolutions of approval or disapproval, as appropriate, are to be automatically introduced in each house. During this period, the committees are to hold hearings on the proposed agreement and "submit a report to their respective bodies recommending whether it should be approved or disapproved." If either committee has not reported the requisite joint resolution of approval or disapproval by the end of 45 days, it is automatically discharged from further consideration of the measure. After the joint resolution is reported or discharged, Congress is to consider it under expedited procedures, as established by Section 130.i. of the AEA. Congress has used procedures outside the above-described process to adopt legislation approving some nuclear cooperation agreements (see Appendix C ).
Section 202 of P.L. 110-369 , the United States-India Nuclear Cooperation Approval and Nonproliferation Enhancement Act, which President Bush signed into law October 8, 2008, amended Section 123 of the AEA to require the President to keep the Senate Foreign Relations Committee and the House Foreign Affairs Committee "fully and currently informed of any initiative or negotiations relating to a new or amended agreement for peaceful nuclear cooperation."

	Export Licensing

The AEA sets out procedures for licensing exports to states with which the United States has nuclear cooperation agreements. (Sections 126, 127, and 128 codified as amended at 42 U.S.C. 2155, 2156, 2157.) Each export of nuclear material, equipment, or technology requires a specific export license or other authorization. The Nuclear Regulatory Commission (NRC) is required to meet criteria in Sections 127 and 128 in authorizing export licenses. These criteria are as follows:
Application of IAEA safeguards to any material or facilities proposed to be exported, material or facilities previously exported, and to any special nuclear material used in or produced through the use thereof (these are not full-scope safeguards, but safeguards required under Article III.2 of the nuclear Nonproliferation Treaty [NPT]). Nothing exported can be used for any nuclear explosive device or for research on or development of any nuclear explosive device. Recipient states must have adequate physical security on "such material or facilities proposed to be exported and to any special nuclear material used in or produced through the use thereof." Recipient states are not to retransfer exported nuclear materials, facilities, sensitive nuclear technology, or "special nuclear material produced through the use of such material" without prior U.S. approval. Recipient states may not reprocess or alter in form or content exported nuclear material or special nuclear material produced though the use of exported nuclear material without prior U.S. approval. The foregoing conditions must be applied to any nuclear material or equipment that is produced or constructed under the jurisdiction of the recipient by or through the use of any exported sensitive nuclear technology. Section 128 requires that recipient nonnuclear weapon states must have full-scope IAEA safeguards.
The President must judge that the proposed export or exemption will "not be inimical to the common defense and security" or that any export of that type "would not be inimical to the common defense and security because it lacks significance for nuclear explosive purposes." The executive branch may also consider other factors, such as "whether the license or exemption will materially advance the nonproliferation policy of the United States by encouraging the recipient nation to adhere" to the NPT; whether "failure to issue the license or grant the exemption would otherwise be seriously prejudicial" to U.S. nonproliferation objectives; and whether the recipient nation has agreed to conditions identical to those laid out in Section 127.
Section 126b.(2) contains a provision for the President to authorize an export in the event that the NRC deems that the export would not meet Section 127 and 128 criteria. The President must determine "that failure to approve an export would be seriously prejudicial to the achievement of U.S. nonproliferation objectives or otherwise jeopardize the common defense and security." In that case, the President would submit his executive order, along with a detailed assessment and other documentation, to Congress for 60 days of continuous session. After 60 days of continuous session, the export would go through unless Congress were to adopt a concurrent resolution of disapproval.
Section 128b.(2) contains a provision for the President to waive termination of exports by notifying Congress that the state has adopted full-scope safeguards or that the state has made significant progress toward adopting such safeguards, or that U.S. foreign policy interests dictate reconsideration. Such a determination would become effective unless Congress were to adopt a concurrent resolution of disapproval within 60 days of continuous session.
Additionally, Section 129b.(1) forbids the export of "nuclear materials and equipment or sensitive nuclear technology" to any country designated as a state sponsor of terrorism. Section 129b.(3) allows the President to waive this provision.

		Iran-Related Restrictions

The Comprehensive Iran Sanctions, Accountability, and Divestment Act (CISADA) of 2010 ( P.L. 111-195 ), which became law July 1, 2010, contains additional restrictions on licensing nuclear exports to countries with entities that have been sanctioned for conducting certain types of nuclear weapons-related transactions with Iran. Section 102a.(2)(A) of the law states that "no license may be issued for the export, and no approval may be given for the transfer or retransfer" of "any nuclear material, facilities, components, or other goods, services, or technology that are or would be subject to an agreement for cooperation between the United States" and such countries. Section 102 a.(2)(B), however, allows the President to waive these restrictions. Section 102a.(2)(C) allows the President to authorize licenses for nuclear exports "on a case-by-case basis" to entities (which have not been sanctioned) in countries subject to the restrictions described above.

	Subsequent Arrangements

Section 131 of the AEA details procedures for subsequent arrangements to nuclear cooperation agreements concluded pursuant to Section 123. Such arrangements are required for forms of nuclear cooperation requiring additional congressional approval, such as transfers of nuclear material or technology and recipient states' enrichment or reprocessing of nuclear materials transferred pursuant to the agreement. Subsequent arrangements may also include arrangements for physical security, storage, or disposition of spent nuclear fuel; the application of safeguards on nuclear materials or equipment; or "any other arrangement which the President finds to be important from the standpoint of preventing proliferation."
Before entering into a subsequent arrangement, the Secretary of Energy must publish in the Federal Register a determination that the arrangement "will not be inimical to the common defense and security." A proposed subsequent arrangement shall not take effect before 15 days after publication of both this determination and notice of the proposed arrangement. The Secretary of State is required to prepare an unclassified Nuclear Proliferation Assessment Statement (NPAS) if, "in the view of" the Secretary of State, Secretary of Energy, Secretary of Defense, or the Nuclear Regulatory Commission, a proposed subsequent arrangement "might significantly contribute to proliferation." The Secretary of State is to submit the NPAS to the Secretary of Energy within 60 days of receiving a copy of the proposed subsequent arrangement. The President may waive the 60-day requirement if the Secretary of State so requests, but must notify both the House Foreign Affairs Committee and Senate Foreign Relations Committee of any such waiver and the justification for it. The Secretary of Energy may not enter into the subsequent arrangement before receiving the NPAS.
Section 131 specifies requirements for certain types of subsequent arrangements. Section 131b. describes procedures for the executive branch to follow before entering into a subsequent arrangement involving the reprocessing of U.S.-origin nuclear material or nuclear material produced with U.S.-supplied nuclear technology. These procedures also cover subsequent arrangements allowing the retransfer of such material to a "third country for reprocessing" or "the subsequent retransfer" of more than 500 grams of any plutonium produced by reprocessing such material. The Secretary of Energy must provide both the House Foreign Affairs Committee and Senate Foreign Relations Committee with a report describing the reasons for entering into the arrangement. Additionally, 15 days of continuous session must elapse before the Secretary may enter into the arrangement, unless the President judges that "an emergency exists due to unforeseen circumstances requiring immediate entry" into the arrangement. In such a case, the waiting period would be 15 calendar days.
If a subsequent arrangement described in the above paragraph involves a facility that has not processed spent nuclear reactor fuel prior to March 10, 1978 (when the Nuclear Nonproliferation Act of 1978 was enacted), the Secretaries of State and Energy must judge that the arrangement "will not result in a significant increase of the risk of proliferation." In making this judgment, the Secretaries are to give "foremost consideration ... to whether or not the reprocessing or retransfer will take place under conditions that will ensure timely warning to the United States of any diversion well in advance of the time at which the non-nuclear weapon state could transform the diverted material into a nuclear explosive device." For a subsequent arrangement involving reprocessing in a facility that has processed spent nuclear reactor fuel prior to March 10, 1978, the Secretary of Energy will "attempt to ensure" that reprocessing "shall take place under conditions" that would satisfy the timely-warning conditions described above. Section 131f. specifies procedures for congressional approval of subsequent arrangements involving the storage or disposition of foreign spent nuclear fuel in the United States.
Section 133 states that, before approving a subsequent arrangement involving certain transfers of special nuclear material, the Secretary of Energy must consult with the Secretary of Defense "on whether the physical protection of that material during the export or transfer will be adequate to deter theft, sabotage, and other acts of international terrorism which would result in the diversion of that material." If the Secretary of Defense determines that "the export or transfer might be subject to a genuine terrorist threat," that Secretary is required to provide a written risk assessment of the risk and a "description of the actions" that he or she "considers necessary to upgrade physical protection measures."

		Examples of Subsequent Arrangements

			U.S.-Japan Agreement

The first test of the subsequent arrangement provisions came in August 1978, when the Department of Energy informed the House and Senate foreign relations committees of a Japanese request for approval of the transfer of spent fuel assemblies from Japan to the United Kingdom for reprocessing. This was the first "subsequent arrangement" approved. The United States and Japan entered into similar arrangements until 1988, when the two governments revised their nuclear cooperation agreement. That agreement included an "implementing agreement," which provided 30-year advance consent for the transfer of spent fuel from Japan to Europe for reprocessing. While controversial, Congress did not block the nuclear cooperation agreement.
A subsequent arrangement was also necessary for the sea transport from Europe to Japan of plutonium that had been separated from the Japanese spent fuel. The Department of Energy approved a Japanese request for 30-year advance consent for the sea transport of plutonium. It was submitted to Congress as a subsequent arrangement, and took effect in October 1988.

			U.S.-India Agreement

The U.S. nuclear cooperation agreement with India grants New Delhi consent to reprocess nuclear material transferred pursuant to the agreement, as well as "nuclear material and by-product material used in or produced through the use of nuclear material, non-nuclear material, or equipment so transferred." However, the agreement also includes a requirement that India first build a new national reprocessing facility to be operated under IAEA safeguards. The two countries signed a subsequent arrangement July 30, 2010, which governs the procedures for operating two new reprocessing facilities in India. The agreement also describes procedures for U.S. officials to inspect and receive information about physical protection measures at the new facilities. The arrangement would not have taken effect if Congress had adopted a joint resolution of disapproval within 30 days of continuous session; Congress did not adopt such a resolution. If India were to construct any additional facilities to reprocess fuel from U.S.-supplied reactors, a new subsequent arrangement would need to be submitted to Congress.

	Termination of Cooperation

Section 129a. of the AEA requires that the United States end exports of nuclear materials and equipment or sensitive nuclear technology to any nonnuclear weapon state that, after March 10, 1978, the President determines to have detonated a nuclear explosive device; terminated or abrogated IAEA safeguards; materially violated an IAEA safeguards agreement; or engaged in activities involving source or special nuclear material and having "direct significance" for the manufacture or acquisition of nuclear explosive devices, and "has failed to take steps which, in the President's judgment, represent sufficient progress toward terminating such activities."
Section 129a. also requires that the United States halt exports to any nation the President determines to have materially violated the terms of an agreement for cooperation with the United States; assisted, encouraged, or induced any nonnuclear weapon state to obtain nuclear explosives or the materials and technologies needed to manufacture them; or retransferred or entered into an agreement for exporting reprocessing equipment, materials, or technology to a nonnuclear weapon state, unless in connection with an international agreement to which the United States subscribes.
The President can waive termination of exports if he determines that "cessation of such exports would be seriously prejudicial to the achievement of United States nonproliferation objectives or otherwise jeopardize the common defense and security." The President must submit his determination to Congress, which is then referred to the House Committee on Foreign Affairs and the Senate Foreign Relations Committee for 60 days of continuous session. The determination becomes effective unless Congress adopts a joint resolution opposing the determination.

	Part 810 Agreements

Section 57.b. (2) of the Atomic Energy Act allows for limited forms of nuclear cooperation related to the "development or production of any special nuclear material outside of the United States" if that activity has been authorized by the Secretary of Energy following a determination that it "will not be inimical to the interest of the United States." The Secretary may only make such a finding with "the concurrence of the Department of State, and after consultation with the Nuclear Regulatory Commission [NRC], the Department of Commerce, and the Department of Defense." Authorizations of such activities are also known as "Part 810 authorizations," after 10 Code of Federal Regulations (C.F.R.) Part 810. Part 810 regulations describe activities that are "generally authorized" by the Secretary of Energy and activities that require "specific authorization" by the Secretary. Some "generally authorized activities" are limited to a list of "generally authorized destinations." These regulations also detail "reporting requirements for authorized activities."
Part 810 authorizations mostly involve unclassified nuclear technology transfer and services, such as nuclear reactor designs, nuclear facility operational information and training, and nuclear fuel fabrication. Such an authorization is not required for exports of components and materials licensed by NRC governed by 10 C.F.R. Part 110. Civilian nuclear cooperation agreements under Section 123 of the Atomic Energy Act of 1954, as amended (hereinafter Atomic Energy Act or AEA), are not required for an 810 authorization or for transmission of nuclear-related information, except for restricted data. Such agreements are, however, required for such forms of nuclear cooperation as the transfer of U.S.-origin special nuclear material subject to licensing for commercial, medical, and industrial purposes; the export of reactors and critical parts of reactors; and other commodities under NRC export licensing authority (10 C.F.R. 110). The NRC may also authorize activities governed by Part 810 authorizations under a 123 agreement or under a subsequent arrangement to such an agreement.
It is worth noting that Part 810.9 includes "[w]hether the United States has an agreement for cooperation in force covering exports to the country or entity involved" as a factor for the Secretary of Energy to use in determining that an activity "will not be inimical to the interest [sic] of the United States." Moreover, the list of "generally authorized destinations" is "based principally on the United States agreements for civil nuclear cooperation," according to guidance from the National Nuclear Security Administration.

	Recent Legislative Activity

		S. 3785/H.R. 7350

On December 19, 2018, Senators Markey and Rubio introduced S. 3785 , the No Nuclear Weapons for Saudi Arabia Act of 2018, and Representatives Sherman and Messer introduced the companion bill, H.R. 7350 . The bills would require a joint resolution of approval for a 123 agreement with Saudi Arabia. In addition, the bills' text includes the sense of Congress that no 123 agreement should be approved until Saudi Arabia has "been truthful and transparent with regard to the death of Jamal Khashoggi" and prosecuted those responsible, "renounced uranium enrichment and reprocessing on its territory," concluded an IAEA Additional Protocol, and made "substantial progress on the protection of human rights, including the release of political prisoners." The bills require the President to submit a report assessing progress on the above actions along with a proposed agreement. The text also includes a statement of policy that the United States should oppose sales of nuclear technology to Saudi Arabia through the Nuclear Suppliers Group (NSG) until Saudi Arabia has renounced enrichment and reprocessing.

		H.R. 7351

On December 19, 2018, Representative Brad Sherman introduced H.R. 7351 , the Nuclear Cooperation Agreements Reform Act of 2018, which would amend the Atomic Energy Act to require nonexempt nuclear cooperation agreements to include several additional provisions. These provisions include a legally binding "commitment" from the cooperating government stipulating that "no enrichment or reprocessing activities, or acquisition or construction of such facilities, [would] occur within the territory over which the cooperating party exercises sovereignty"; "a guaranty by the cooperating party that no nationals of a third country" would be "permitted access to any reactor, related equipment, or sensitive materials transferred under" the agreement without prior U.S. consent; a "commitment to maintain" or enact "a legal regime providing for adequate protection from civil liability that will allow for the participation of United States suppliers in any effort by the country to develop civilian nuclear power"; and a stipulation that the United States can demand the return of transferred items if the cooperating government "violates or abrogates any provision" of its IAEA safeguards agreement.
H.R. 7351 would also require a cooperating party to sign, ratify, and implement an Additional Protocol to its IAEA safeguards agreement; implement a number of export control-related measures; comply with "all United Nations conventions to which the United States is a party and all [UN] Security Council resolutions regarding the prevention of the proliferation of weapons of mass destruction"; and be party to, as well as fully implement, "the provisions and guidelines" of the Biological Weapons Convention and the Chemical Weapons Convention, as well as "all other international agreements to which the United States is a party regarding the export of nuclear, chemical, biological, and advanced conventional weapons, including missiles and other delivery systems." In addition, the bill would prohibit nuclear cooperation agreements with a country designated as a Destination of Diversion Concern pursuant to the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010 ( P.L. 111-195 ). The bill would also prohibit such agreements with a country that is not "closely cooperating with the United States to prevent state sponsors of terrorism" from "acquiring or developing" nuclear, chemical, or biological (NBC) weapons "or related technologies" or "destabilizing numbers and types of advanced conventional weapons."
H.R. 7351 would also limit the duration of a nuclear cooperation agreement to 15 years, as well as prohibit nuclear-related exports to a country identified in the most recent version of a report mandated by the National Defense Authorization Act for Fiscal Year 1998 ( P.L. 105-85 ) as possessing or seeking to "acquire or develop" NBC weapons, ballistic missiles, or cruise missiles. Moreover, the bill would amend the AEA's congressional notification provisions concerning ongoing nuclear cooperation agreement negotiations by requiring the President to "consult" with the Senate Foreign Relations Committee and the House Foreign Affairs Committee
concerning such initiative or negotiations beginning not later than 15 calendar days after the initiation of any such negotiations, or the receipt or transmission of a draft agreement, whichever occurs first, and monthly thereafter until such time as the negotiations are concluded.
These consultations would include the provision of "current working drafts and proposed text put forward for negotiation by the parties for inclusion in such agreement."
The bill would also require the President to submit a report to the House Foreign Affairs and Senate Foreign Relations Committees "on the extent to which each country that engages in civil nuclear exports ... requires nuclear nonproliferation requirements as conditions for export comparable to those" in the AEA as amended by the bill, which would also stipulate that the report include "the extent to which the exports of each such country incorporate United States-origin components, technology, or materials that require United States approval for re-export"; "the civil nuclear-related trade and investments in the United States by any entity from each such country"; and a list of "any United States grant, concessionary loan or loan guarantee, or any other incentive or inducement to any such country or entity related to nuclear exports or investments in the United States."
H.R. 7351 contains provisions concerning U.S. foreign assistance. For example, the bill would prohibit "assistance (other than humanitarian assistance) under any provision of law ... to a country that has withdrawn" from the NPT. H.R. 7351 would also require the United States to "seek the return of any material, equipment, or components transferred under" a nuclear cooperation agreement with such a country, as well as the return of any "special fissionable material produced through the use" of such transferred items. In addition, the bill would prohibit any assistance
under the Foreign Assistance Act of 1961 [FAA], the Arms Export Control Act [AECA], the Foreign Military Sales Act [FMSA], the Food for Peace Act, the Peace Corps Act, or the Export-Import Bank Act of 1945 to any country if the Secretary of State determines that the government of the country has repeatedly provided support for acts of proliferation of equipment, technology, or materials to support the design, acquisition, manufacture, or use of weapons of mass destruction or the acquisition or development of missiles to carry such weapons.
This section of the bill includes a reporting requirement and a presidential waiver provision. H.R. 7351 would also require the U.S. government to "take into consideration whether" proposed recipients of assistance pursuant to the AECA, FAA, or FMSA, have Additional Protocols to their IAEA safeguards agreements. The bill would also permit joint resolutions approving nuclear cooperation agreements to "include any other provisions to accompany such proposed agreement for cooperation.'' Lastly, H.R. 7351 would require Congress to enact a joint resolution of approval for subsequent arrangements to nuclear cooperation agreements.
Appendix A. Key Dates for Bilateral Civilian Nuclear Cooperation ("Section 123") Agreements
Appendix B. Enrichment and Reprocessing Restrictions
Although some experts have advocated requiring governments to forgo enrichment and reprocessing (a nonproliferation commitment sometimes referred to as the "Gold Standard") as a condition for concluding a nuclear cooperation agreement, the Atomic Energy Act (AEA) does not include such a requirement. In recent years, the United States has attempted to persuade certain countries with which it is negotiating nuclear cooperation agreements to forgo enrichment and reprocessing and conclude Additional Protocols to their International Atomic Energy Agency (IAEA) safeguards agreements; past U.S. nuclear cooperation agreements have not included these additional components. The AEA does mandate that U.S. nuclear cooperation agreements require U.S. consent for any "alteration in form or content" (to include enrichment or reprocessing) of U.S.-origin material or any material processed in a plant containing transferred U.S. nuclear technology. Such agreements also require U.S. consent for any retransfer of material or technology.
The United States has argued that its December 2009 nuclear cooperation agreement with the United Arab Emirates (UAE) could set a useful precedent for mitigating the dangers of nuclear proliferation. For example, President Barack Obama's May 21, 2009, letter transmitting the agreement to Congress argued that the agreement had "the potential to serve as a model for other countries in the region that wish to pursue responsible nuclear energy development." Similarly, then-State Department spokesperson P.J. Crowley described the agreement as "the gold standard" during an August 5, 2010, press briefing, although the Obama Administration generally did not use this term when describing its nuclear cooperation policies.
The U.S.-UAE agreement's status as a potential model is grounded in two nonproliferation provisions not found in other U.S. nuclear cooperation agreements. First, the agreement requires the country to bring into force the Additional Protocol to its safeguards agreement before the United States licenses "exports of nuclear material, equipment, components, or technology" pursuant to the agreement. Second, the agreement states that the UAE
shall not possess sensitive nuclear facilities within its territory or otherwise engage in activities within its territory for, or relating to, the enrichment or reprocessing of material, or for the alteration in form or content (except by irradiation or further irradiation or, if agreed by the Parties, post-irradiation examination) of plutonium, uranium 233, high enriched uranium, or irradiated source or special fissionable material.
The U.S.-UAE agreement also provides the United States with the right to terminate nuclear cooperation and to require the return of any nuclear "material, equipment or components ... and any special fissionable material produced through their use" if, after the agreement's entry into force, the UAE "possesses sensitive nuclear facilities within its territory or otherwise engages in activities within its territory relating to enrichment of uranium or reprocessing of nuclear fuel."
Notwithstanding its characterization of the U.S.-UAE agreement, the Obama Administration announced in December 2013 after an interagency review that renouncing domestic enrichment and reprocessing would not be a prerequisite to concluding a nuclear cooperation agreement for all countries, and each partner country would be considered individually. The U.S. nuclear cooperation agreement with Vietnam, which the two governments concluded in 2014, did not include a provision requiring the country to forgo enrichment and reprocessing, although the agreement's preamble includes a political commitment stating that Vietnam intends to rely on international markets for its nuclear fuel supply, rather than acquiring sensitive nuclear technologies.
Appendix C. Nuclear Cooperation Agreements Approved Outside Atomic Energy Act Process
Congress has used legislation to approve nuclear cooperation agreements that did not use the legislative process mandated by the Atomic Energy Act (AEA) of 1954, as amended.
Australia
On May 5, 2010, President Barack Obama submitted a renewed U.S.-Australia nuclear cooperation agreement to Congress for approval. H.R. 6411 , which the House adopted on November 30, 2010, would have approved the agreement even if there had not been sufficient legislative days remaining in the 111 th Congress; the Senate did not adopt its version of the bill ( S. 3844 ). These bills were not needed because the 111 th Congress contained a sufficient number of days for the agreement to enter into force.
China
In 1985, President Ronald Reagan submitted the first U.S.-China nuclear cooperation agreement to Congress, which adopted a joint resolution, P.L. 99-183 , requiring that the President make certain nonproliferation-related certifications in order for the agreement to be implemented. P.L. 99-183 required a presidential certification and a report followed by a period of 30 days of continuous session of Congress. P.L. 101-246 , the Foreign Relations Authorization Act for Fiscal Years 1990 and 1991, imposed sanctions on China, including suspending nuclear cooperation and requiring an additional presidential certification on Beijing's nuclear nonproliferation assurances. Before a summit with China, President William Clinton on January 12, 1998, signed the required certifications regarding China's nuclear nonproliferation policy and practices. Clinton also issued a certification and waived a sanction imposed under P.L. 101-246 . Congressional review ended on March 18, 1998, allowing the agreement to be implemented.
India
P.L. 109-401 , which became law on December 18, 2006, permitted the President to waive several provisions of the AEA with respect to a nuclear cooperation agreement with India. On September 10, 2008, President George W. Bush submitted to Congress a determination that P.L. 109-401 's requirements for such an agreement to proceed had been met. President Bush signed P.L. 110-369 , which approved the agreement, into law on October 8, 2008.
Norway
The President submitted an extension of the U.S.-Norway nuclear cooperation agreement to Congress on June 14, 2016. P.L. 114-320 , which became law on December 16, 2016, approved the agreement "[n]otwithstanding the provisions for congressional consideration" in the AEA, thereby addressing concerns that that there was an insufficient number of legislative days remaining in the 114 th Congress for congressional consideration.

Output: In order for the United States to engage in significant civilian nuclear cooperation with other states, it must conclude a framework agreement that meets specific requirements under Section 123 of the Atomic Energy Act (AEA). Significant nuclear cooperation includes the export of reactors, critical parts of reactors, and reactor fuel. The AEA also provides for export control licensing procedures and criteria for terminating cooperation. Congressional review is required for Section 123 agreements; the AEA establishes special parliamentary procedures by which Congress may act on a proposed agreement.


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	Background

		FDA Medical Device Review Process

FDA classifies each medical device type intended for human use into one  of three classes based on the level of risk it poses to the patient or the  user and the controls necessary to reasonably ensure its safety and  effectiveness. Examples of types of devices in each class include the  following:
Class I: tongue depressors, elastic bandages, reading glasses, and
Class II: electrocardiographs, powered bone drills, and mercury
Class III: pacemakers and replacement heart valves.
Before medical devices may be legally marketed in the United States,  they are generally subject to one of two types of FDA premarket review  processes.
Premarket approval (PMA) process: Class III device types are  typically required to obtain FDA approval through the PMA process.  Under this process, the medical device sponsor must submit an  application that includes—among other things—full reports of  investigations, typically including clinical data, providing reasonable  assurance that the new device is safe and effective. The PMA  process is the most stringent type of premarket review. A successful  application results in FDA’s approval to market the device. From 2001  through 2016, medical device sponsors submitted 651 PMA  applications, and FDA approved for marketing 506 of those  submissions. (See fig. 1.)
Premarket notification, or 510(k), process: Most medical devices  requiring premarket review are subject to FDA’s premarket notification  or 510(k) process. This includes class I and II device types that are  not specifically exempted from the 510(k) notification requirement.  Under this process, the medical device sponsor must notify FDA at  least 90 days before it intends to market a new device and  demonstrate to FDA that the new device is substantially equivalent to  a predicate device, and therefore does not require a PMA. For most  510(k) notifications, clinical data are not required and substantial  equivalence will normally be determined based on comparative  descriptions of intended device uses and technological  characteristics, and may include performance data. A successful  510(k) submission results in FDA’s clearance to market the device.  From 2001 through 2016, medical device sponsors submitted 61,439  premarket notifications and FDA cleared 51,028 devices for market.  (See fig. 2.)
During premarket review under both the PMA and 510(k) processes, FDA  and the medical device sponsor may engage in an interactive process. To  start, there may be a pre-submission meeting between FDA and the  sponsor, during which the parties discuss the upcoming review and try to  resolve potential obstacles for approval or clearance. Then, FDA receives  the premarket submission, makes a determination to accept or not accept  the submission, and assigns a reviewer. In making its assessment  whether to approve, or clear, a submission, FDA relies on the sponsor to  provide supporting data as part of the submission. However, the agency  can request additional information in the course of the review in order to  make a determination of reasonable assurance of safety and  effectiveness, or of substantial equivalence. This additional information  can be obtained through informal interactions, such as a phone call or  email. Alternatively, for more significant issues, FDA may make a more  formal request for additional information, known as a deficiency letter in  the case of a PMA application and additional information (AI) letter for a  510(k) notification. FDA will issue such requests if the submission lacks  significant information necessary for FDA to complete its review, and the  agency will request the sponsor amend the submission to provide the  necessary information regarding the device.
If a sponsor disagrees with an FDA regulatory decision concerning a  medical device submission, including a CDRH employee’s decision to  request additional information or a significant decision regarding approval  or clearance of a medical device, it can take multiple actions.  Specifically, a sponsor can, among other things, (1) contact the CDRH  Ombudsman for assistance, (2) file an internal appeal of an FDA  decision, or (3) request that the disagreement be resolved through  CDRH’s Medical Device Dispute Resolution Panel, as described below.
Ombudsman: According to FDA’s guidance, prior to the agency  reaching a regulatory decision, the most effective means of resolving  a dispute between CDRH and an external stakeholder is through  discussion and agreement. The CDRH Ombudsman is available to  assist in clarifying issues, mediate meetings and teleconferences, and  conduct discussions with the parties in an effort to resolve  disagreements short of a formal review or internal appeal.
Internal Appeal: Once FDA makes a regulatory decision, a sponsor  can request a supervisory review of that decision, which we refer to as  an internal appeal. For this process, the supervisor of an FDA  employee will, at the request of a medical device sponsor, review a  decision or action of the employee and issue a decision. The decision  rendered by the supervisor, acting as the review authority, customarily  takes one of the following forms: overturning the decision of the  employee; upholding the employee decision; or, in some  circumstances, referring the matter back to the employee for  reconsideration under defined conditions.
Medical Device Dispute Resolution Panel: If the dispute remains  unresolved, the sponsor may request that FDA convene the Medical  Device Dispute Resolution Panel. The panel is intended to provide a  means for independent review of a scientific controversy or dispute  between a sponsor and FDA, and make a recommendation to the  Center director. According to FDA’s guidance, the panel is primarily  intended to address scientific controversies rather than other issues  such as regulatory, legal, or statutory authority disputes.
As part of its commitments associated with the Medical Device User Fee  Amendments of 2012 (MDUFA III), FDA agreed to participate in an  independent, comprehensive assessment of the medical device  submission review process. Acting on recommendations from the  contractor that conducted the assessment, FDA established working  groups for each submission type, including PMAs and 510(k)s, which  studied existing review processes and made recommendations. In  August 2017, the Medical Device User Fee Amendments of 2017  (MDUFA IV) reauthorized FDA’s medical device user fee program, and  FDA committed to another independent assessment. FDA has  committed to hiring a contractor to conduct this assessment by the end of  December 2017 with a second phase to begin in 2020.

		FDA Least Burdensome Requirements

In 1997, FDAMA added a requirement that the agency use the least  burdensome approach during certain parts of PMA and 510(k) reviews.  These requirements were intended to reduce unnecessary burdens  associated with the premarket approval and clearance processes;  however, they did not lower the statutory criteria for demonstrating a  reasonable assurance of safety and effectiveness or substantial  equivalence. While the language in FDAMA differs slightly for the PMA  and 510(k) processes, in both instances FDA was directed to consider the  “least burdensome” means of requesting information needed for its  review. Specifically, FDAMA requires that when the agency specifies data  that must be submitted as part of a PMA application, the agency must  consider the least burdensome appropriate means of evaluating device  effectiveness that would have a reasonable likelihood of resulting in  approval. The agency must similarly consider the least burdensome  appropriate means of demonstrating substantial equivalence when  requesting information under the 510(k) notification process. In both  cases, FDA is statutorily required to request only information that is  necessary to support the determination that there is reasonable  assurance of effectiveness or substantial equivalence, respectively.
Subsequent laws have clarified the least burdensome requirements. In  2012, the Food and Drug Administration Safety and Innovation Act clarified that the term “necessary” means the minimum required  information that would support either a determination that a PMA  application provides reasonable assurance of the effectiveness of the  device or a determination, for a 510(k) notification, of substantial  equivalence between a new device and a predicate device. In 2016, the  21st Century Cures Act added a provision applying the least burdensome  concept to FDA’s requests for additional information in the PMA  process. The law also applied the least burdensome concept to  significant decisions, such as denials of PMA applications, requiring such  decisions to include a brief statement regarding how least burdensome  requirements were considered and applied. Additionally, the law  mandated each FDA employee involved in premarket submission  reviews, including supervisors, to receive training on the least  burdensome provisions, and required the agency to conduct an audit of  the training, among other things, no later than June 2018.
Although FDA officials have noted that the least burdensome principles  are broad and could apply to all activities within the PMA and 510(k)  premarket review process, they noted that the requests for additional  information represent a key juncture for the application of least  burdensome requirements. According to agency officials and industry  representatives, the requests for additional information—deficiency letters  in the case of PMAs and AI letters for its 510(k) reviews—are when FDA  and the sponsor could disagree on whether the requested information is  necessary for the agency to reach a final decision on the medical device  under review.

		FDA Implementation of the Least Burdensome Requirements

Following the enactment of FDAMA in 1997, FDA went through a process  in collaboration with the medical device industry to define the least  burdensome concept and develop an approach to implement the  provisions. Based on this, FDA released multiple guidance documents  related to least burdensome requirements from 2000 through 2002.
In November 2000 guidance, FDA outlined a four-part approach— referred to as “four-part-harmony” by FDA staff—for communicating  deficiencies to medical device sponsors in accordance with the least  burdensome requirements. The guidance helps reviewers describe  deficiencies identified in submissions in ways that are direct, concise,  and complete, thus ensuring a more effective use of reviewers’ and  sponsors’ time, effort, and resources. It also provides a suggested  format for sponsors to respond to FDA. FDA updated this guidance in  September 2017.
In 2002 guidance, FDA described its principles for implementing the  least burdensome requirements and its activities to assess  implementation. The guidance outlines FDA’s interpretation of the  least burdensome concept as described in FDAMA, and explains its  application to activities associated with PMA and 510(k) reviews. The  guidance also states that FDA was in the process of developing tools  to be used by both agency staff and its stakeholders to periodically  assess the implementation of the least burdensome principles. It  noted some measurement tools had already been developed and that  additional tools were also needed to assess the impact of the least  burdensome approach on expediting the development of new medical  technologies.
In addition, FDA has included language about those requirements in other  guidance documents. For example, in 2014, FDA issued guidance on the  510(k) program that describes how the least burdensome principles may  affect the type of information necessary to demonstrate substantial  equivalence at different decision points in the review of a 510(k).

	FDA Frequently Requested Additional Information to Support Medical Device Reviews, and Sponsor Disagreements Often Related to Least Burdensome Requirements

		FDA Issued Deficiency and Additional Information Letters for a Significant Proportion of PMAs and 510(k)s

FDA requested sponsors provide additional information for a majority of  the PMAs and 510(k)s it reviewed. For the period 2001 through 2016,  FDA issued a large number of deficiency and AI letters relative to the  number of submissions, although there was variation annually. For  PMAs, the number of deficiency letters as a percentage of new PMA  applications submitted ranged from about 54 percent to 113 percent  annually, or 82 percent on average, from 2001 through 2016. For the  years 2006 through 2010, this percentage, as well as the total number of  letters was higher, and FDA issued more deficiency letters than there  were PMA applications submitted. Similarly, AI letters as a percentage of  total 510(k) notifications received ranged from about 58 percent to more than 174 percent annually, or about 106 percent on average, from 2001  through 2016. While the number of 510(k) notifications remained similar  across the time period we examined, from 2009 through 2012, the  number of AI letters issued each year was, on average, nearly double the  number in other years. During this period, FDA issued more AI letters  than there were 510(k) notifications submitted. Since 2014, these  percentages have been lower for both PMAs and 510(k)s.
FDA officials acknowledged the historical increase in the number of  deficiency and AI letters and noted the more recent decrease. The  officials attributed this decrease to a number of changes the agency  agreed to in MDUFA III. For example, FDA implemented a policy to  review submissions for administrative completeness prior to accepting the  submission. They said this allowed the agency to limit deficiency and AI  letters to issues related to the quality of the data provided and the studies  conducted in support of the submission rather than to administrative  issues. Also as a result of MDUFA III, the agency implemented an  interactive review process to increase informal interaction between FDA  and applicants and to minimize the number of review questions  communicated through deficiency and AI letters. (See table 1.)
We identified changes in how the deficiency letters and AI letters  referenced the least burdensome requirements. Based on our sample of  73 letters from 1997 through 2016, FDA included an explicit  acknowledgment of the least burdensome requirements in the letters  issued from 2001 through 2009. However, based on our review, this  practice ended in 2010, and later letters did not include this standard  language. Representatives from the medical device industry told us that  including the least burdensome language in the deficiency letters was a  good practice because it raised awareness of the least burdensome  principles. In September 2017, FDA released updated deficiencies  guidance that, according to FDA officials, instructs staff how to better  articulate the reason that the information is needed in accordance with  the least burdensome requirements. This guidance does not set forth  boilerplate language regarding the least burdensome requirements for  use in deficiency letters, but does include examples of well-constructed  deficiencies, definitions for major and minor deficiencies, and a statement  that FDA will attempt to resolve minor deficiencies interactively.

		Though Data are Limited, Least Burdensome Requirements were a Significant Contributing Factor in Disagreements Raised by Medical Device Sponsors

The least burdensome requirements were often a significant contributing  factor in disagreements raised by medical device sponsors, according to  FDA officials and available FDA data. According to FDA, the most  effective means of resolving disagreements is through discussion and  mediation, and to that end, the Ombudsman’s office is routinely involved  in discussions between firms and medical device reviewers during the  review process. For example, in 2016, the CDRH Ombudsman was  involved with PMA and 510(k) medical device reviews 360 times out of  3,444 submissions. Although the agency was unable to identify which of  these interactions were related to least burdensome requirements,  agency officials told us that a substantial number likely resulted from a  difference of opinion between the applicant and FDA on the appropriate  level of scientific evidence, a portion of which likely have a least  burdensome component.
The least burdensome provisions were also frequently related to issues  that applicants raised during internal agency appeals of FDA decisions of  PMA and 510(k) reviews. Although FDA did not have readily available  data on appeals that occurred prior to 2013, the agency was able to  provide information about the 63 appeals of significant decisions that  occurred from 2013 through 2016. Of these 63 appeals, FDA identified  33 appeals—2 related to PMAs and 31 related to 510(k)s—in which the  issue identified by the sponsor was related to least burdensome  principles. According to medical device industry representatives,  sponsors may not always pursue an appeal, so the number of official  appeals may not represent the extent of least burdensome-related issues  that sponsors experience. They said the sponsor may determine it is best  to avoid conflict that could complicate future device submissions and  comply with the request for additional information, even if it disagrees.
Of these 33 appeals, FDA agreed, or partially agreed with the sponsor for  11 appeals, which resulted in FDA overturning the decision or reopening  the file and continuing the review. For the remaining 22 appeals, the  agency upheld the initial reviewer decision. The following presents  examples of appeals where the issue identified by the sponsor was  related to the least burdensome requirements.
In one appeal related to a 510(k) review, the sponsor objected to the  reviewer’s finding that the device was not substantially equivalent to a  device already on the market. The sponsor stated that it had provided  sufficient data for a substantial equivalence determination, and the  FDA reviewer’s request for additional risk mitigation measures and  supplemental testing was unwarranted and inappropriate. The review  authority determined that, while the information provided in the 510(k)  premarket submission was not sufficient to establish substantial  equivalence, some of FDA’s requests were unwarranted. As a result  of the appeal, FDA reopened the file and provided the sponsor an  opportunity to respond to a new set of requests for additional  information.
In an appeal related to a PMA review, the sponsor contended that  FDA’s not approvable decision reflected an inconsistent and  erroneous interpretation of the clinical data supporting the safety and  effectiveness of the subject device, and that the data it had provided  was sufficient for FDA to reach an approved decision. The sponsor  further contended that the review staff failed to utilize the principles  outlined in FDA guidance. The review authority upheld FDA’s initial  decision and determined there was not sufficient valid scientific  evidence to demonstrate a reasonable assurance that the subject  device was safe and effective under the proposed conditions of use.
The Medical Device Dispute Resolution Panel, which provides another  avenue to resolve disagreements between sponsors and the agency, has  also addressed issues related to the least burdensome requirements.  Since the panel was created following FDAMA in 1997, medical device  sponsors have requested that FDA resolve three disagreements through  this avenue, each related to PMAs. Although not tracked by FDA, at our  request, officials reviewed the records and found that one of the three  disputes was related to the least burdensome requirements. Specifically,  for a September 2001 dispute, FDA officials said the sponsor requested  the panel after FDA initially found that the data from the clinical study  submitted by the sponsor did not sufficiently support effectiveness. After  reviewing evidence from the applicant and from FDA, the dispute  resolution panel determined that the sponsor had provided sufficient  evidence to prove effectiveness, and the device was ultimately approved.

	FDA Offered Some Training on the Least Burdensome Requirements, and Evaluates its Training for Effectiveness

		FDA Offered Some Early Least Burdensome Training at Limited Times, and Has Incorporated Related Information in Broader Training

FDA officials indicated that training specific to the least burdensome  requirements was held in the years following the enactment of FDAMA in  1997. FDA was unable to provide records of that training, including its  content. However, officials told us that the training was specific to the  least burdensome requirements and offered from 1997 through 1999.  FDA officials said the agency offered other presentations in subsequent  years that they said covered similar least burdensome topics. For  example, the agency provided slides from a presentation created in 2000  that provided an overview of FDA’s implementation of the requirements.
Although FDA officials told us this least burdensome specific training was  not offered after 1999, they identified various other trainings that they said  incorporated the least burdensome concept. For example, a 2005  presentation on clinical trial design has multiple slides on least  burdensome requirements, and specifically states that a course objective  is to “understand how least burdensome principles apply.” Least  burdensome requirements are also mentioned in other training materials  where they may not be the focus—for example one slide of a presentation  on biomarkers included a mention of least burdensome requirements.  Officials also identified the training program for new reviewers that FDA  implemented in 2011 as a source of training on least burdensome  principles. Specifically, the Reviewer Certification Program is a training  curriculum that FDA has required most new device reviewers to complete  since 2011. The training curriculum covers a wide variety of courses on  topics related to a reviewer’s responsibilities. While none of these  courses is specific to the least burdensome requirements, there are  courses covering related topics. For example, there is one course on  technical writing that includes FDA’s guidance on developing deficiencies  with least burdensome principles. Five other courses on different topics  mention either the least burdensome requirements or related principles,  such as a course on FDA’s legislative history that included a slide  identifying the least burdensome statutory provisions as an element of  FDAMA, though the slide did not explain the least burdensome  requirements or provide additional context. Of the 490 staff assigned to  review PMAs and 510(k)s, FDA indicated that as of the end of calendar  year 2016, 335 had completed the Reviewer Certification Program, 150  started working on premarket submissions prior to the beginning of 2011,  and the remaining 5 individuals did not complete the training for varying  reasons.
In response to the 21st Century Cures Act, enacted in December 2016,  FDA is providing mandatory online training specific to the least  burdensome requirements. FDA indicated that the training focuses on key  behaviors that reflect the least burdensome approaches as documented  in updated guidance that FDA issued in September 2017. FDA officials  told us that, as of October 31, 2017, 91 percent of CDRH staff had  received the new least burdensome specific training. In addition to the  online training, FDA plans other activities, such as follow-up office-level  briefings to address questions or concerns and an introductory podcast  from the CDRH director. In addition to providing this training to current  employees, FDA plans to incorporate least burdensome requirement  training into new employee orientation and the Reviewer Certification  Program, and plans to include ongoing support and promotion of least  burdensome principles through a center working group on the least  burdensome requirements. In addition to course-based training, FDA  officials told us that least burdensome concepts are conveyed to  reviewers through mentoring. Officials explained that much of the training  on the least burdensome requirements occurs through mentoring and  conversations with supervisors, and that those encounters are not  documented.

		FDA Is Implementing Evaluations of All Training Courses for Medical Device Review Staff, including Courses that Address the Least Burdensome Requirements

While FDA has not had processes in place to evaluate its medical device  training, it is implementing such processes for all training, including  courses related to the least burdensome requirements. In its June 2014  report, the contractor performing the independent evaluation noted that  CDRH did not have mechanisms in place to measure the quality and  effectiveness of its training programs. The report noted that FDA should  identify metrics and incorporate methods to better assess review process  training satisfaction, learning, and staff behavior changes. FDA officials  explained that while they had customer reaction evaluations for trainings  for at least 24 years, they started evaluating training participant learning  with the Reviewer Certification Program starting in 2010.
FDA is in the process of implementing a training evaluation model, which  includes various levels of evaluation, from assessing participant response  to the training to evaluating its impact on the agency. As of 2017, FDA  reported it was evaluating training programs to determine participant  learning and preparing to evaluate whether that learning changed  participant behavior. Officials told us they anticipate beginning to conduct  evaluations that assess agency impact in fiscal year 2018, and they plan  to have the model completely implemented for all trainings by fiscal year  2020. FDA currently evaluates its Reviewer Certification Program to  determine participant learning, and though the least burdensome  requirements are not specifically addressed in the Reviewer Certification  Program evaluation materials FDA provided to us, they did include  questions on topics related to least burdensome requirements.
In addition to its current training evaluation plan, FDA is also required by  the 21st Century Cures Act to conduct an audit of the training and its  effectiveness in implementing the least burdensome requirements.  Specifically, the training audit is to be conducted by the ombudsman  responsible for premarket reviews, identified by FDA as the CDRH  Ombudsman. According to a draft plan, FDA plans to conduct training  evaluations, a process review of 510(k) and PMA documentation to  assess reviewer compliance with FDA procedures, and seek feedback  from industry on its experience with the premarket review process and  how the least burdensome requirements are applied. Officials indicated  that criteria are still under development and that they hoped to have them  further developed in the first quarter of 2018, with the authorizing  legislation requiring completion of the audit by June 2018, 18 months  after enactment of the law.

	FDA is Taking Steps that May Improve Its Requests for Additional Information Overall, but Has Not Fully Evaluated Its Implementation of the Least Burdensome Requirements

		FDA Is Implementing Processes to Improve the Consistency and Clarity of Its Requests for Additional Information during Medical Device Reviews

Some stakeholders and others have raised concerns about the  consistency and clarity of FDA’s requests for additional information during  medical device reviews. For the past 17 years, FDA has required  reviewers to only request information that is necessary to make a PMA  determination of “reasonable assurance of safety and effectiveness” or a  510(k) determination of “substantial equivalence” in their review of a  submission. Representatives of one of the organizations representing  the medical device industry noted the high percentages of medical device  submissions that involve a letter, and some of their member companies  have said that FDA reviewers may request additional information as a  result of intellectual curiosity rather than a “need to know.” In addition, the  independent assessment’s 2014 report, funded by FDA as part of  MDUFA III, found inconsistent decision-making among FDA review staff  throughout various stages of the review process, including additional  information requests. While the 2014 report did not address least  burdensome requirements explicitly, it examined related processes. For  example, according to the report, there was inconsistent decision-making  among FDA review staff throughout various stages of the review process,  including a lack of clarity regarding FDA reviewer thresholds for triggering  deficiency letters. The report recommended that FDA develop criteria and  establish mechanisms to improve consistency in decision-making  throughout the review process.
To address problems identified during the independent assessment, FDA  is implementing several initiatives to improve center processes. FDA  officials told us that, in anticipation of MDUFA IV, they recognized a need  for a dedicated quality management infrastructure. In 2014, FDA  established a Quality Management Unit to improve center processes,  which they said would include those related to the least burdensome  requirements. The unit completed a framework that outlined its vision and  mission and established organizational objectives, such as developing a  document control system, providing training, and conducting quality  assessments, audits, and management reviews.
In addition, FDA officials told us that starting in October 2017, FDA  planned to fulfill its MDUFA IV commitments to improve the clarity and  consistency of its deficiency letters and AI letters after releasing updated  guidance.
In September 2017, FDA published guidance reflecting the  commitments under MDUFA IV that all deficiency letters and AI letters  include a statement indicating the specific basis for any cited  deficiencies. According to FDA officials, this new approach will help  ensure that the letters more consistently ground requests for  information in the specific reason that FDA is requesting the  information from the sponsor. For example, FDA may cite a law, final  rule, or specific scientific issue as the basis for its request, rather than  providing a more general statement of the request’s relevance.  According to industry representatives, in the past, FDA reviewers  have, at times, asked for additional information without including  justification, and may have requested additional information as a  result of intellectual curiosity rather than a “need to know.” The  representatives stated that this new policy may better ensure the  reviewers apply the least burdensome approach to their review.
The updated guidance also explains that all deficiency letters and AI  letters will undergo supervisory review prior to issuance to ensure that  the information requested is relevant to a marketing authorization  decision, all four elements of the deficiency are included, deficiencies  are prioritized from most to least significant, and each deficiency is  appropriate to include in light of the totality of all deficiencies. Officials  told us that while supervisory concurrence was previously needed,  under the new guidance, supervisors are now expected to review for  certain criteria. For example, in the past, supervisors may have  considered whether four-part harmony was addressed in each  deficiency letter, but under the updated guidance this is now an  expected practice. Officials said this will increase the extent to which  deficiency letters are consistently constructed.
In the MDUFA IV commitment letter, FDA agreed to base all  deficiency letters and AI letters on a complete review of the  submission and include all deficiencies. Therefore, FDA officials told  us that any deficiencies identified following that letter would generally  be limited to issues raised as a result of new information. For  example, if FDA asked for information on bio-compatibility testing,  FDA will first review that information, and based on that review may  ask for new information. In that instance, the information responding  to the initial deficiency is new information. FDA officials said that past  letters should also have included all deficiencies, but this may have  been done inconsistently.
To further standardize its process for reviewing medical device  submissions and developing requests for additional information, FDA is  developing and implementing smart templates. FDA officials told us that  these templates guide device reviewers through a standardized process  for each submission. For example, they help reviewers identify the types  of information necessary and include prewritten deficiency letters that  have been approved by internal experts. FDA has had a smart template  in place for the 510(k) process since 2013, according to FDA reports.  FDA indicated that the template is already required for certain offices and  divisions within CDRH, and plans for full adoption in the future. FDA  officials told us that the agency also developed templates for de novo  premarket submissions, which are currently available for voluntary use  and will likely be mandatory in fiscal year 2018. Officials told us they  plan to hire a person to develop a template to guide PMA reviews, which  will likely take most of 2018. They told us the use of the smart template  for PMAS will likely become mandatory for use by all reviewers in 2019.  In addition to improving the consistency of deficiency letters, FDA officials  said the information generated from the templates could be used to track  deficiencies and requests for additional information, as well as provide  information on the number and type of deficiencies in the letters. FDA  officials told us that the plans for database and back-end analytical  capabilities using information from the smart templates were less certain  and dependent on available resources, and they pointed out that the  information technology infrastructure can present unforeseen challenges.

		FDA Has Not Developed Metrics to Evaluate Implementation of the Least Burdensome Requirements, and While a New Audit Process Could Aid Oversight, Its Scope Is Still Unclear

FDA has not established performance metrics that would allow it to  evaluate its implementation of the least burdensome provisions. FDA  officials told us that the agency does not track concerns related to the  least burdensome requirements, such as by examining dispute data to  identify those that may be related. According to FDA’s 2002 guidance, the  agency was in the process of developing tools to be used by both agency  staff and its stakeholders to periodically assess the implementation of the  least burdensome requirements. The FDA guidance identified a need  for additional tools to accurately assess the agency’s incorporation of the  least burdensome principles into its various regulatory activities and to  assess the impact of the least burdensome approach on expediting the  development of new medical technologies. Agency officials told us FDA  had not developed these tools, but was now in the process of making  other tools available. For example, they cited the development of the  smart templates that will guide reviewers as they evaluate medical device  submissions and generate deficiency letters. Officials noted that, given  the scientific nature of the inquiry, and because least burdensome is a  general principle, developing a metric specific to the least burdensome  requirements is a challenge. While this can be a challenge, FDA officials  have noted that they are attempting to identify surrogate measures that  can provide an indication that the reviewer considered the least  burdensome requirements when making a request. According to federal  standards for internal control, performance metrics are important for  management to have relevant, reliable, and timely information available  for management decision–making and external reporting purposes.  Without such a metric, FDA may be asking medical device sponsors to  provide information unnecessarily or in less efficient ways that are not in  compliance with the requirement to use the least burdensome approach  to medical device reviews.
FDA is in the process of developing an audit program that could provide it  with information on its implementation of the least burdensome  requirements. FDA has committed to conducting annual quality audits,  which will be led by CDRH’s Quality Management Unit. Accordingly, FDA  plans to identify, with industry input, areas to audit at least once per year.  Initially, the agency has agreed to complete an audit of deficiency letters  and pre-submissions by the end of fiscal year 2020. As of August 2017,  FDA was still planning the deficiency letters audit, and developing its  methodology and identifying audit outcomes. FDA officials told us the  agency plans to finalize a deficiency letters audit plan by the spring of  2018 and begin data collection by early summer of 2018. Officials  explained that the audit will focus on processes—for example, the audit  will not examine the scientific content of deficiency letters but will instead  focus on whether CDRH has followed existing policies and procedures  surrounding deficiency letters. In addition, the Quality Management Unit  was still in the process of hiring most of its staff. As of August 2017, FDA  officials told us the unit had 6 staff reporting to an Associate Director, and  CDRH plans to gradually hire 20 more staff by 2020, starting once  MDUFA IV funds are available beginning in October 2017.
In addition to these more specific efforts, FDA also plans to continue its  overall evaluation of the medical device review process. The 2016  independent assessment resulting from MDUFA III broadly evaluated  FDA’s device review process, and although it mentioned least  burdensome requirements only briefly, it addressed a number of related  elements, including the quality of the review process and staff training.  Under MDUFA IV, FDA committed to another independent assessment in  two phases: (1) an evaluation of FDA’s implementation of the corrective  action plan FDA developed in response to the MDUFA III assessment  and (2) an evaluation of FDA’s premarket device review program to  identify efficiencies that should be realized as a result of the process  improvements and investments under MDUFA III and IV, among other  things. As with the prior assessment, the new assessment will likely  examine processes related to the least burdensome requirements, though  the extent to which it will address the requirements is not yet known.  Agency officials told us that FDA has committed to hiring a contractor by  the end of December 2017.

	Conclusions

FDA must balance the need to obtain sufficient data to determine the  safety and effectiveness of medical devices under review, with the  potential for undue burden and approval delays if unnecessary data is  requested. Assuring that the agency uses the least burdensome method  to complete its review helps to ensure it is able to make decisions about  medical device approval in a timely way. While FDA implemented  guidance and training related to the least burdensome requirements  following the passage of FDAMA in 1997, it has taken few steps to  develop performance metrics to evaluate the extent to which reviewers  are using a least burdensome approach when reviewing medical device  submissions. Recently, FDA implemented several changes that have the  potential to improve its oversight of the least burdensome requirements  and the clarity with which reviewers communicate the need for additional  information. While planned audits of FDA’s medical device review  process have the potential to provide the agency with evaluation tools  through which to assess performance, these audits are still early in their  development and the extent to which they will allow FDA to assess  implementation of the least burdensome requirements is unclear. A  complete and thorough assessment will be important for the agency to  assure itself and external stakeholders that its reviews adhere to the least  burdensome principles and requirements and thus are appropriately  balanced.

	Recommendation for Executive Action

We are making the following recommendation to FDA:  The Commissioner of FDA should develop performance metrics and use  them to evaluate the implementation of the least burdensome  requirements, such as during its planned audits of medical device  deficiency letters. (Recommendation 1)

	Agency Comments

We provided a draft of this report to HHS. HHS concurred with our  recommendation and provided written comments, which are reprinted in  appendix I. In its written comments, HHS agreed that appropriate  implementation of the least burdensome requirements is essential to  FDA’s evaluation of its PMA and 510(k) medical device submissions, and  agreed that it is important for FDA to evaluate how successfully it is  implementing the requirements. HHS also reiterated FDA’s commitment  to the least burdensome principles and provided an overview of its related  efforts, several of which were noted in our draft report. HHS noted its  concern that our draft report did not sufficiently capture all of FDA’s  efforts. While HHS cited FDA’s efforts related to improving the science  underlying its regulatory decisions, which could reduce burden on medical  device sponsors, our review focused on the steps involved in FDA’s  review process. In this regard, HHS concurred with our recommendation  that it develop performance metrics and use them to evaluate the  implementation of the least burdensome requirements, such as during its  planned audits of medical device deficiency letters. In response to this  recommendation, HHS indicated that FDA intends to assess how it  follows least burdensome requirements as part of these audits. We  continue to encourage FDA to develop the evaluation tools necessary to  ensure it conducts a complete and thorough assessment of its  implementation of the least burdensome requirements. In addition to  these general comments, HHS provided technical comments, which we  incorporated as appropriate.
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If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or crossem@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made major contributions to  this report are listed in appendix II.

Appendix I: Comments from the Department of Health and Human Services

Appendix II: GAO Contact and Staff Acknowledgments

	GAO Contact

	Staff Acknowledgments

In addition to the contact above, William Hadley (Assistant Director),  Matthew Byer (Analyst-in-Charge), Luke Baron, and William Garrard  made key contributions to this report. Also contributing were Sam  Amrhein and Jennifer Rudisill.

Output:
Why GAO Did This Study

Determining that a new medical device is safe and effective is a substantial investment of time and resources for the sponsor and FDA, the agency that regulates medical devices. FDA relies on the device sponsor to provide supporting data at the time of its original submission, and the agency can request additional information during the review. The Federal Food, Drug, and Cosmetic Act, as amended, requires that when FDA requests additional information from sponsors, the agency consider the least burdensome means of evaluating a medical device.
GAO was asked to provide information on FDA's implementation of the least burdensome requirements in its medical device review process. This report (1) describes FDA's requests for additional information and sponsor disagreements, (2) describes its least burdensome training efforts, and (3) describes FDA actions to improve its requests for additional information and examines the extent to which it has evaluated its implementation of the least burdensome requirements. GAO reviewed FDA documents and guidance and interviewed agency officials. GAO also interviewed officials from four relevant medical device manufacturing associations.

What GAO Found

Since 1997, the Food and Drug Administration (FDA) has been required to consider the least burdensome means of evaluating certain types of medical devices for marketing, including when requesting that sponsors—generally manufacturers—seeking to market their medical devices provide information in addition to what was provided in their submissions. GAO found that, from 2001 through 2016, FDA issued letters asking sponsors to provide such information for a majority of the more than 62,000 medical device submissions that it reviewed. Sponsors may formally disagree with the request on the grounds that it is not the least burdensome method needed for FDA to review the submission. For example, sponsors appealed FDA decisions internally to agency management 63 times from 2013 through 2016, and of these, FDA identified 33 such appeals in which the sponsor raised an issue related to least burdensome requirements. FDA agreed or partially agreed with the sponsors in 11 of these appeals. Medical device industry representatives noted that these appeals may not fully represent the number of such disagreements, because applicants are generally concerned that an appeal would damage their relationship with FDA and potentially negatively affect future device applications.
FDA provided staff training that was specifically dedicated to addressing the least burdensome requirements from 1997 through 1999. Since 1999, FDA has not offered a course dedicated to the least burdensome requirements, but has incorporated related concepts into other training programs, such as in a training mandatory for most new reviewers. In response to the 21st Century Cures Act, enacted in 2016, FDA is providing new least burdensome training to all relevant employees, and said that 80 percent had received the training as of October 2, 2017. Although FDA did not specifically evaluate the effectiveness of past training on least burdensome requirements, it is implementing an evaluation of all device-related training, including the new least burdensome training. It also plans to complete a required audit of training on least burdensome requirements by June 2018.
FDA has not specifically evaluated implementation of the least burdensome requirements. However, in response to broader evaluations, such as an independent assessment of its medical device review process, the agency is in the early stages of developing processes that may improve its requests for additional information. For example, FDA plans to conduct an audit of letters requesting additional information. FDA is developing the audit's methodology and expects it will assess whether the agency's process was followed. However, due to their early stage, the extent to which these efforts will allow FDA to assess implementation of the least burdensome requirements is unclear. In 2002, FDA stated that it planned to periodically assess the implementation of the least burdensome principles, and federal internal control standards identify the importance of performance metrics for such assessments. However, the agency has yet to develop performance metrics to do so. Until such measures are developed and used, FDA will not be able to evaluate whether it effectively and consistently applies a least burdensome approach in its medical device reviews.

What GAO Recommends

GAO is making one recommendation that FDA develop and use performance metrics to evaluate the implementation of the least burdensome requirements. The Department of Health and Human Services agreed with GAO's recommendation.