ML24162A180
| ML24162A180 | |
| Person / Time | |
|---|---|
| Issue date: | 07/01/2024 |
| From: | Raymond Furstenau NRC/NMSS/DMSST |
| To: | Davies S Teen Cancer of America |
| Shared Package | |
| ML24099A193 | List: |
| References | |
| LTR-24-0075 | |
| Download: ML24162A180 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON , D.C . 20555-0001
July 1, 2024
Mr. Simon Davies, Executive Director Teen Cancer America 11845 Olympic Blvd. #775W Los Angeles, CA 90064
Dear Mr. Davies:
I am responding to your letter dated April 3, 2024 (Agencywide Documents Access and Management System (ADAMS) Accession No . ML24099A192). In the letter, you shared concerns regarding the Office of the Inspector General's (OIG) Special Inquiry into the Appearance of Conflict of Interest Involving Members of the Advisory Committee on the Medical Uses of Isotopes (ACMUI).
The U .S . Nuclear Regulatory Commission (NRC) takes the integrity of its decision-making processes seriously, particularly when it comes to matters that impact public health and safety.
The OIG investigation into the appearance of a conflict of interest involving members of the ACMUI highlights areas where our internal processes led to questions about the integrity of decision-making. In response, I tasked the staff to notify the OIG of actions taken to address the issues raised in the OIG 's investigation. The staff conducted a thorough review of its policies to identify program enhancements to ensure continued avoidance of actual conflict of interests, as well as future apparent conflicts of interest with ACMUI members. The NRC staff detailed their program enhancements in their response to the OIG, dated June 28, 2024 {ML24180A124) .
These program enhancements will ensure that the NRC is upholding the public trust as we provide reasonable assurance of adequate protection of public health and safety .
The NRC's rulemaking effort regarding the reporting of nuclear medicine extravasations is informed by a balanced set of views, well beyond the individuals cited in the special inquiry as having apparent conflicts of interest. The staff's independent evaluation considered input from a variety of stakeholders, including the petitioner, ACMUI, Agreement States, published literature, and the medical community. The recommendation set forth by the staff in its proposal to the Commission was unanimously supported by the 13-member ACMUI, which underscores the validity of the staff's approach to this rulemaking. Although the NRC solicits the views of the ACMUI related to the use of byproduct material in diagnosis and therapy, and values the ACMUl's counsel, the Committee does not determine or direct the actual decisions of the staff or the Commission.
The staff continues with their rulemaking effort, as directed by the Commission, which requires reporting of radiopharmaceutical extravasations that may result in radiation injury. The staff plans to submit the proposed rule package to the Commission in the fall of 2024. The proposed rule package will be published for public comment, following approval by the Commission. In the meantime, the draft proposed rule package that was provided to the ACMUI for their review is available for public inspection (ML24156A187) .
S. Davies 2
In accordance with 10 CFR 2.390, "Public inspections, exemptions, requests for withholding," a copy of this letter will be available electronically for public inspection in the NRC Public Document Room and at ADAMS Accession No. ML24162A180. ADAMS is accessible at https://www .nrc .gov/reading - rm/adams .html.
Thank you for bringing your concerns to our attention and we value your engagement in the NRC 's rulemaking process . We continue to work to ensure and maintain transparency in our decision-making processes . If you have any other questions or need additional information ,
please contact me or Kevin Williams, Director, Division of Materials Safety, Security, State, and Tribal Programs, at 301-415-3340 or Kevin .Williams@nrc.gov .
Sincerely, 4~/~
Raymond V. Furstenau Executive Director for Operations S. Davies 3
SUBJECT:
LTR-24-0075 LETTER TO SIMON DAVIES, PATIENTS FOR SAFER NUCLEAR MEDICINE COALITION, REGARDING OIG SPECIAL INQUIRY ON APPEARANCE OF CONFLICT OF INTEREST ACMUI DATED: July 1, 2024
DISTRIBUTION: L TR-24-0075 Public RFurstenau, EDO OIG SMorris, DEDR OGC JMartin, Acting AO SECY SMiotla, DAO ACRS MMeyer, DAO JJolicoeur, ETA ABilloch, ETA Jlubinski, NMSS RLewis, NMSS KWilliams, NMSS TCampbell, OGC CEinberg, NMSS LArmstead, NMSS
ADAMS Accession Number: ML24162A180 *via email OFFICE NMSS/MSST NMSS/MSST NMSS/MSST NMSS TechEd NAME CValentin- CEinberg KWilliams Rodriquez THerrera DATE 6/10/2024 6/10/2024 6/10/2024 6/14/2024 OFFICE NMSS OEDO OEDO OEDO NAME JLubinski JJolicoeur JMartin RFurstenau DATE 6/21/2024 06/27/24 06/28/24 07/01/24 OFFICIAL RECORD COPY