2019-17060. Release of Patients Administered Radioactive Material

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Draft regulatory guide; extension of comment period.

SUMMARY:

On July 29, 2019, the U.S. Nuclear Regulatory Commission (NRC) requested comments on draft regulatory guide (DG), DG-8057, “Release of Patients Administered Radioactive Material.” The public comment period was originally scheduled to close on August 26, 2019. The NRC is extending the public comment period to allow more time for members of the public to submit their comments.

DATES:

The due date of comments requested in the document published on July 29, 2019 (84 FR 36127) is extended. Comments should be filed no later than September 26, 2019. Comments received after this date will be considered, if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

ADDRESSES:

You may submit comments by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0154. Address questions about NRC dockets IDs in Regulations.gov to Jennifer Borges; telephone: [phone]; email: [e-mail]. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.
• Mail comments to: Office of Administration, Mail Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Program Management, Announcements and Editing Staff.

For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Vered Shaffer, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone], email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments

A. Obtaining Information

Please refer to Docket ID NRC-2019-0154 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0154
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/​reading-rm/​adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [e-mail]. The DG-8057 is available in ADAMS under Accession No. ML19108A463.
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

Please include Docket ID NRC-2019-0154, in your comment submission. The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Discussion

On July 29, 2019, the NRC published a document in the Federal Register (84 FR 36127) requesting comments on DG-8057, “Release of Patients Administered Radioactive Material.” This draft guide, Revision 1, provides licensees with more detailed instructions to provide to patients before and after they have been administered radioactive material than was in Revision 0. In addition, the guide includes a new section on “Death of a Patient Following Radiopharmaceutical or Implants Administrations,” as well as requirements for recordkeeping. Also, Table 3, “Dosages of Radiopharmaceuticals that Require Instructions and Records When Administered to Patients who are Breastfeeding an Infant or Child,” has been revised to provide information for the recommended duration of interruption of breastfeeding to ensure that the dose to an infant or child meets the NRC's regulatory requirements. The public comment period was originally scheduled to close on August 26, 2019. The NRC staff has decided to extend the public comment period on this document until September 26, 2019, to allow more time for members of the public to submit their comments.

Dated at Rockville, Maryland, this 6th day of August, 2019.

For the Nuclear Regulatory Commission.

Thomas H. Boyce,

Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research.