Exports of U.S.-Origin Highly Enriched Uranium (HEU) for Medical Isotope Production: Certification of Sufficient Supplies of Non-HEU-based Molybdenum-99 (Mo-99) To Meet Needs of Patients in the United States, 73270-73271 [2021-28017]

Download as PDF 73270 Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices On December 1, 2021, the Office of Nuclear Energy, Department of Energy, published a request for information in the Federal Register on how to site federal facilities for the temporary, consolidated storage of spent nuclear fuel using a consent-based approach. This document corrects broken hyperlinks to the Invitation for Public Comment and to the 2017 Draft Consent-Based Siting Process for Consolidated Storage and Disposal Facilities for Spent Nuclear Fuel and High-Level Radioactive Waste. FOR FURTHER INFORMATION CONTACT: Please send any questions to consentbasedsiting@hq.doe.gov, or to Alisa Trunzo at 301–903–9600. SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Correction In the Federal Register of December 1, 2021, FR Doc. 2021–25724, (86 FR 68244) under the SUPPLEMENTARY INFORMATION section, the following corrections are made: (1) First column, first paragraph, lines 9 thru 11, the weblink is corrected as follows: https://www.energy.gov/sites/prod/ files/2016/12/f34/Summary%20of %20Public%20Input%20Report %20FINAL.pdf. (2) First column, first paragraph, lines 22 thru 25, the weblink is corrected as follows: https://www.energy.gov/sites/prod/ files/2017/01/f34/Draft%20ConsentBased%20Siting%20Process%20and %20Siting%20Considerations.pdf. (3) First column, fourth paragraph, under the heading, Questions for Input, lines 9 thru 11, the weblink is corrected as follows: https://www.energy.gov/sites/prod/ files/2017/01/f34/Draft%20ConsentBased%20Siting%20Process%20and %20Siting%20Considerations.pdf. (4) Second column, under the heading, Area 1: Consent-Based Siting Process, paragraph 7, the weblink is corrected as follows: https://www.energy.gov/sites/prod/ files/2017/01/f34/Draft%20ConsentBased%20Siting%20Process%20and %20Siting%20Considerations.pdf. Reason for Correction: The change aims to fix the standard hyperlink format accepted by the FRN template. Signing Authority This document of the Department of Energy was signed on December 15, 2021, by Dr. Kathryn Huff, Principal Deputy Assistant Secretary for the Office of Nuclear Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative VerDate Sep<11>2014 19:11 Dec 23, 2021 Jkt 256001 purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register. Signed in Washington, DC, on December 21, 2021. Treena V. Garrett, Federal Register Liaison Officer, U.S. Department of Energy. [FR Doc. 2021–28009 Filed 12–23–21; 8:45 am] BILLING CODE 6450–01–P DEPARTMENT OF ENERGY National Nuclear Security Administration Exports of U.S.-Origin Highly Enriched Uranium (HEU) for Medical Isotope Production: Certification of Sufficient Supplies of Non-HEU-based Molybdenum-99 (Mo-99) To Meet Needs of Patients in the United States National Nuclear Security Administration (NNSA), Department of Energy (DOE). ACTION: Notice. AGENCY: DOE and Department of Health and Human Services (HHS), in accordance with the American Medical Isotopes Production Act of 2012 (AMIPA), have issued a joint Secretarial certification that there is a sufficient global supply of Mo-99 produced without the use of HEU available to meet the needs of patients in the United States and that it is not necessary to export United States-origin HEU for the purposes of medical isotope production in order to meet United States patient needs. This certification is effective as of January 2, 2022. FOR FURTHER INFORMATION CONTACT: Requests for additional information may be sent to Max Postman in the Office of Conversion OfficeofConversion@ nnsa.doe.gov or 202–586–9114. SUPPLEMENTARY INFORMATION: SUMMARY: Authority and Background: The American Medical Isotopes Production Act of 2012 (AMIPA) (subtitle F, Title XXXI of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112–139)), enacted on January 2, 2013, amended section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 2160d) by striking subsection c. and inserting language that prohibits PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 the Nuclear Regulatory Commission (NRC) from issuing a license for the export of HEU from the United States for the purposes of medical isotope production, effective seven years after enactment of AMIPA, subject to a certification regarding the sufficiency of Mo-99 supply in the United States. AMIPA requires the Secretary of Energy to either jointly certify, with the Secretary of Health and Human Services, that there is a sufficient supply of Mo-99 produced without the use of HEU available to meet U.S. patient needs, and that it is not necessary to export U.S.-origin HEU for the purposes of medical isotope production in order to meet U.S. patient needs, or to unilaterally certify that there is insufficient supply of Mo-99 produced without the use of HEU available to satisfy the domestic market and that the export of U.S.-origin HEU for the purposes of medical isotope production is the most effective temporary means to increase the supply of Mo-99 to the domestic U.S. market, thereby delaying the enactment of the export license ban for up to six years. DOE published a Federal Register notice (85 FR 3362) on January 21, 2020 certifying that, at the time, there was an insufficient global supply of Mo-99 produced without the use of HEU and that the export of U.S.-origin HEU for the purposes of medical isotope production was the most effective temporary means to increase the supply of Mo-99 to the domestic U.S. market. This certification was effective for no more than two years from the effective date of January 2, 2020. The Federal Register notice stated that DOE would conduct periodic reviews of the domestic U.S. and global Mo-99 market and would work toward a certification to Congress, regarding the sufficiency of supply as soon as the statutory conditions are satisfied. Based on an expert third party market analysis, as well as the assessment of subject matter experts in both agencies, the Secretary of Energy and the Secretary of Health and Human Services have jointly certified that there is a sufficient global supply of Mo-99 produced without the use of HEU available to meet the needs of patients in the United States. Furthermore, while there is the potential for future shortages of other medical isotopes, including iodine-131 and xenon-133, the export of HEU would not mitigate these risks. Therefore, the Secretaries also have jointly certified that it is not necessary to export United States-origin HEU for the purposes of medical isotope production in order to meet United States patient needs. E:\FR\FM\27DEN1.SGM 27DEN1 Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices This joint certification reflects DOE’s progress in working with international partners to convert medical isotope production facilities to the use of low enriched uranium (LEU) and in supporting the establishment of domestic supplies of Mo-99 produced without use of HEU. Three of the four major global producers now produce Mo-99 using LEU. The other major producer still relies partially on HEU but is on track to convert to LEU-based processes in 2022. The Department of Health and Human Services has also played a critical role in achieving this milestone, including approval of LEU Mo-99 technologies and through the 2018 approval of a New Drug Application for the first domestic production of Mo-99 in nearly 30 years. The global market is now capable of producing enough Mo-99 using LEU to meet U.S. demand, but ongoing engagement between producers, radiopharmaceutical companies, and other private sector stakeholders will be needed to ensure that U.S. patient needs continue to be met. Mo-99 producers must continue to coordinate regarding the security of global supply and must maintain the ability to ramp up production where needed to compensate for shortfalls from other producers and maintain accessibility of Mo-99 through the supply chain. DOE will reinforce this message through its ongoing engagements with the Mo-99 community. khammond on DSKJM1Z7X2PROD with NOTICES Signing Authority This document of the Department of Energy was signed on December 8, 2021, by Corey Hinderstein, Deputy Administrator for Defense Nuclear Nonproliferation, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register. Signed in Washington, DC, on December 21, 2021. Treena V. Garrett, Federal Register Liaison Officer, U.S. Department of Energy. [FR Doc. 2021–28017 Filed 12–23–21; 8:45 am] BILLING CODE 6450–01–P VerDate Sep<11>2014 19:11 Dec 23, 2021 Jkt 256001 page of any filing should include docket number P–1888–038. For further information, contact Alicia Burtner at (202) 502–8038 or Alicia.Burtner@ferc.gov. DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 1888–038] York Haven Power Company, LLC; Notice of Availability of Environmental Assessment In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission’s (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for a temporary variance from flow requirements for the York Haven Hydroelectric Project, located on the Susquehanna River in Dauphin, Lancaster, and York counties, Pennsylvania, and has prepared an Environmental Assessment (EA) for the project. The project does not occupy Federal lands. The EA contains the staff’s analysis of the potential environmental effects of the temporary variance and concludes that licensing the variance would not constitute a major federal action that would significantly affect the quality of the human environment. The EA may be viewed on the Commission’s website at http:// www.ferc.gov using the ‘‘elibrary’’ link. Enter the docket number (P–1888) in the docket number field to access the document. At this time, the Commission has suspended access to the Commission’s Public Reference Room, due to the proclamation declaring a National Emergency concerning the Novel Coronavirus Disease (COVID–19), issued by the President on March 13, 2020. For assistance, contact FERC Online Support at FERCOnlineSupport@ferc.gov or tollfree at 1–866–208–3372, or for TTY, (202) 502–8659. All comments must be filed within 30 days from the date of this notice. The Commission strongly encourages electronic filing. Please file comments using the Commission’s eFiling system at http://www.ferc.gov/docs-filing/ efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http:// www.ferc.gov/docs-filing/ ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support. In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 73271 Dated: December 20, 2021. Kimberly D. Bose, Secretary. [FR Doc. 2021–28025 Filed 12–23–21; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP22–29–000] Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization and Establishing Intervention and Protest Deadline Take notice that on December 8, 2021, Columbia Gas Transmission, LLC (Columbia), 700 Louisiana Street, Suite 1300, Houston, Texas 77002–2700, filed in the above referenced docket a prior notice pursuant to sections 157.205 and 157.216(b) of the Commission’s regulations under the Natural Gas Act (NGA) and its blanket certificate issued in Docket No. CP83–76–000 requesting authorization to abandon 11 injection/ withdrawal wells, 12 associated storage pipelines, and appurtenances at its Holmes and Wayne Storage Field in Holmes and Wayne Counties, Ohio. Columbia states that these wells provide little value with each contributing a de minimis amount to the total deliverability of the storage field and plugging and abandoning each well will reduce integrity risk. Columbia also seeks to abandon 0.99 miles of storage lines in place and 0.14 miles of storage lines by removal; Columbia will no longer have a use for these lines once the wells are abandoned. Columbia estimates the cost of the project to be approximately $7 million. Columbia avers that the proposed abandonment will have no impact on its existing customers or affect its existing storage operations. Columbia states that there will be no change its the existing boundary, total inventory, reservoir pressure, reservoir and buffer boundaries, or certificated capacity of the Holmes and Wayne Storage Field as a result of the proposed abandonment, all as more fully set forth in the request which is on file with the Commission and open to public inspection. In addition to publishing the full text of this document in the Federal Register, the Commission provides all interested persons an opportunity to E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73270-73271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28017]


-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

National Nuclear Security Administration


Exports of U.S.-Origin Highly Enriched Uranium (HEU) for Medical 
Isotope Production: Certification of Sufficient Supplies of Non-HEU-
based Molybdenum-99 (Mo-99) To Meet Needs of Patients in the United 
States

AGENCY: National Nuclear Security Administration (NNSA), Department of 
Energy (DOE).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: DOE and Department of Health and Human Services (HHS), in 
accordance with the American Medical Isotopes Production Act of 2012 
(AMIPA), have issued a joint Secretarial certification that there is a 
sufficient global supply of Mo-99 produced without the use of HEU 
available to meet the needs of patients in the United States and that 
it is not necessary to export United States-origin HEU for the purposes 
of medical isotope production in order to meet United States patient 
needs. This certification is effective as of January 2, 2022.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
may be sent to Max Postman in the Office of Conversion 
[email protected] or 202-586-9114.

SUPPLEMENTARY INFORMATION:

Authority and Background:

    The American Medical Isotopes Production Act of 2012 (AMIPA) 
(subtitle F, Title XXXI of the National Defense Authorization Act for 
Fiscal Year 2013 (Pub. L. 112-139)), enacted on January 2, 2013, 
amended section 134 of the Atomic Energy Act of 1954 (42 U.S.C. 2160d) 
by striking subsection c. and inserting language that prohibits the 
Nuclear Regulatory Commission (NRC) from issuing a license for the 
export of HEU from the United States for the purposes of medical 
isotope production, effective seven years after enactment of AMIPA, 
subject to a certification regarding the sufficiency of Mo-99 supply in 
the United States.
    AMIPA requires the Secretary of Energy to either jointly certify, 
with the Secretary of Health and Human Services, that there is a 
sufficient supply of Mo-99 produced without the use of HEU available to 
meet U.S. patient needs, and that it is not necessary to export U.S.-
origin HEU for the purposes of medical isotope production in order to 
meet U.S. patient needs, or to unilaterally certify that there is 
insufficient supply of Mo-99 produced without the use of HEU available 
to satisfy the domestic market and that the export of U.S.-origin HEU 
for the purposes of medical isotope production is the most effective 
temporary means to increase the supply of Mo-99 to the domestic U.S. 
market, thereby delaying the enactment of the export license ban for up 
to six years.
    DOE published a Federal Register notice (85 FR 3362) on January 21, 
2020 certifying that, at the time, there was an insufficient global 
supply of Mo-99 produced without the use of HEU and that the export of 
U.S.-origin HEU for the purposes of medical isotope production was the 
most effective temporary means to increase the supply of Mo-99 to the 
domestic U.S. market. This certification was effective for no more than 
two years from the effective date of January 2, 2020. The Federal 
Register notice stated that DOE would conduct periodic reviews of the 
domestic U.S. and global Mo-99 market and would work toward a 
certification to Congress, regarding the sufficiency of supply as soon 
as the statutory conditions are satisfied.
    Based on an expert third party market analysis, as well as the 
assessment of subject matter experts in both agencies, the Secretary of 
Energy and the Secretary of Health and Human Services have jointly 
certified that there is a sufficient global supply of Mo-99 produced 
without the use of HEU available to meet the needs of patients in the 
United States. Furthermore, while there is the potential for future 
shortages of other medical isotopes, including iodine-131 and xenon-
133, the export of HEU would not mitigate these risks. Therefore, the 
Secretaries also have jointly certified that it is not necessary to 
export United States-origin HEU for the purposes of medical isotope 
production in order to meet United States patient needs.

[[Page 73271]]

    This joint certification reflects DOE's progress in working with 
international partners to convert medical isotope production facilities 
to the use of low enriched uranium (LEU) and in supporting the 
establishment of domestic supplies of Mo-99 produced without use of 
HEU. Three of the four major global producers now produce Mo-99 using 
LEU. The other major producer still relies partially on HEU but is on 
track to convert to LEU-based processes in 2022. The Department of 
Health and Human Services has also played a critical role in achieving 
this milestone, including approval of LEU Mo-99 technologies and 
through the 2018 approval of a New Drug Application for the first 
domestic production of Mo-99 in nearly 30 years.
    The global market is now capable of producing enough Mo-99 using 
LEU to meet U.S. demand, but ongoing engagement between producers, 
radiopharmaceutical companies, and other private sector stakeholders 
will be needed to ensure that U.S. patient needs continue to be met. 
Mo-99 producers must continue to coordinate regarding the security of 
global supply and must maintain the ability to ramp up production where 
needed to compensate for shortfalls from other producers and maintain 
accessibility of Mo-99 through the supply chain. DOE will reinforce 
this message through its ongoing engagements with the Mo-99 community.

Signing Authority

    This document of the Department of Energy was signed on December 8, 
2021, by Corey Hinderstein, Deputy Administrator for Defense Nuclear 
Nonproliferation, pursuant to delegated authority from the Secretary of 
Energy. That document with the original signature and date is 
maintained by DOE. For administrative purposes only, and in compliance 
with requirements of the Office of the Federal Register, the 
undersigned DOE Federal Register Liaison Officer has been authorized to 
sign and submit the document in electronic format for publication, as 
an official document of the Department of Energy. This administrative 
process in no way alters the legal effect of this document upon 
publication in the Federal Register.

    Signed in Washington, DC, on December 21, 2021.
Treena V. Garrett,
Federal Register Liaison Officer, U.S. Department of Energy.
[FR Doc. 2021-28017 Filed 12-23-21; 8:45 am]
BILLING CODE 6450-01-P