U.S. NUCLEAR REGULATORY COMMISSION September 2008

Revision 3

REGULATORY GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH 

REGULATORY GUIDE 10.8 

(Draft was issued as DG-0018, dated April 2008) 

GUIDE FOR THE PREPARATION OF 

APPLICATIONS FOR MEDICAL USE PROGRAMS 

A. INTRODUCTION 

This regulatory guide directs the reader to the type of information acceptable to the U.S. Nuclear 

Regulatory Commission (NRC) staff for preparing and reviewing an application for a medical use license. 

Title 10, Part 35, “Medical Use of Byproduct Material,” of the Code of Federal Regulations (10 CFR 

Part 35) (Ref. 1) regulates the medical use of byproduct material. In addition to the requirements of 

10 CFR Part 35, medical use licensees may be subject to those portions of 10 CFR Part 20, “Standards for 

Protection Against Radiation” (Ref. 2), that relate to radiation safety and the sections of 10 CFR Part 30, 

“Rules of General Applicability to Domestic Licensing of Byproduct Material” (Ref. 3), that relate to 

licensing and the noncommercial transfer of specific radioactive drugs to medical use licensees within a 

consortium. 

This regulatory guide endorses the methods and procedures for medical licensing applications 

contained in the current revision of NUREG-1556, Volume 9, “Consolidated Guidance about Materials 

Licenses: Program-Specific Guidance about Medical Use Licenses” (Ref. 4), as a process that the NRC 

staff finds acceptable for meeting the regulatory requirements. 

Volume 9 of NUREG-1556 addresses the issues that an applicant must respond to when preparing 

a license application on NRC Form 313, “Application for Materials License,” and the NRC Form 313A 

series of forms. The NUREG also includes (for clarification purposes) descriptions of certain key 

elements of a medical use program that do not require a response on NRC Form 313. 

This regulatory guide contains information collection requirements covered by 10 CFR Parts 20, 

30, and 35 and NRC Form 313 that the Office of Management and Budget (OMB) approved under OMB 

The NRC issues regulatory guides to describe and make available to the public methods that the NRC staff considers acceptable 

for use in implementing specific parts of the agency’s regulations, techniques that the staff uses in evaluating specific problems 

or postulated accidents, and data that the staff needs in reviewing applications for permits and licenses. Regulatory guides are not 

substitutes for regulations, and compliance with them is not required. Methods and solutions that differ from those set forth in 

regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a 

permit or license by the Commission. 

This guide was issued after consideration of comments received from the public. 

Regulatory guides are issued in 10 broad divisionsC1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials 

Facilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health; 

9, Antitrust and Financial Review; and 10, General. 

Electronic copies of this guide and other recently issued guides are available through the NRC’s public Web site under the 

Regulatory Guides document collection of the NRC’s Electronic Reading Room at http://www.nrc.gov/reading-rm/doccollections/ and through the NRC’s Agencywide Documents Access and Management System (ADAMS) at 

http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML081960579. 
Rev. 3 of RG 10.8, Page 2 

control numbers 3150-0014, 3150-0017, 3150-0010, and 3150-0120, respectively. The NRC may neither 

conduct nor sponsor, and a person is not required to respond to, an information collection request or 

requirement unless the requesting document displays a currently valid OMB control number. 

B. DISCUSSION 

As part of its redesign of the materials licensing program, the NRC consolidated and updated 

numerous guidance documents for materials licenses into the multivolume NUREG-1556. Various 

volumes in the NUREG-1556 series provide current, program-specific guidance on testing, licensing, 

decommissioning, and terminating materials licenses. 

Volume 9 of NUREG-1556 provides program-specific guidance about medical use licenses. It 

identifies the information needed to complete NRC Form 313 and the NRC Form 313A series of forms. 

NUREG-1556 provides an overview of the types of licenses issued by the NRC, the commitments and 

responsibilities that a licensee must undertake, applicable regulations, the process for filing a license 

application, and the contents of applications for different medical uses of byproduct material. In 

particular, Volume 9 of NUREG-1556 gives an item-by-item description of the information the applicant 

should provide. Because of the wide variety in the types of medical use programs, NUREG-1556 

contains indicators to alert applicants for particular types of medical use licenses to information that 

pertains to those types of uses. The NRC is placing added emphasis on conducting its regulatory 

activities in a risk-informed and performance-based manner. The agency intends for this approach to be 

less prescriptive and to allow licensees the flexibility to implement the agency’s regulations in a manner 

that is more specific to their needs yet still meets the regulatory requirements. By supplying examples, 

the NRC seeks to provide information to meet the needs of applicants for licensure without being 

prescriptive. Guidance in NUREG-1556 represents one means of complying with NRC regulations. It is 

not the only means of satisfying the regulatory requirements. 

C. REGULATORY POSITION 

This regulatory guide endorses the method(s) of preparing a medical use program license 

application or revision request described in the current revision of NUREG-1556, Volume 9, as a process 

that the NRC has found to be acceptable for meeting the regulatory requirements. 

D. IMPLEMENTATION 

The purpose of this section is to provide information to applicants and licensees regarding the 

NRC’s plans for using this regulatory guide. The NRC does not intend or approve any imposition or 

backfit in connection with its issuance. 

In some cases, applicants or licensees may propose or use a previously established acceptable 

alternative method for complying with specified portions of the NRC’s regulations. Otherwise, the 

methods described in this guide will be used in evaluating compliance with the applicable regulations for 

license applications, license amendment applications, and amendment requests. 
Rev. 3 of RG 10.8, Page 3 

REFERENCES 

1. 10 CFR Part 35, “Medical Use of Byproduct Material,” U.S. Nuclear Regulatory Commission, 

Washington, DC.1

2. 10 CFR Part 20, “Standards for Protection Against Radiation,” U.S. Nuclear Regulatory 

Commission, Washington, DC. 

3. 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material,” 

U.S. Nuclear Regulatory Commission, Washington, DC. 

4. NUREG-1556, Volume 9, “Consolidated Guidance about Materials Licenses: Program-Specific 

Guidance about Medical Use Licenses,” U.S. Nuclear Regulatory Commission, Washington, DC, 

most current date and revision.2

 (http://www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1556/) 

 

1

 All NRC regulations listed herein are available electronically through the Electronic Reading Room on the NRC’s 

public Web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Copies are also available for inspection 

or copying for a fee from the NRC’s Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; 

the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; 

fax (301) 415-3548; and email PDR@nrc.gov. 

2

 All NUREG-series reports listed herein are published by the U.S. Nuclear Regulatory Commission. These volumes are 

available electronically through the Electronic Reading Room on the NRC’s public Web site, at 

http://www.nrc.gov/reading-rm/doc-collections/nuregs/. Copies are also available for inspection or copying for a fee 

from the NRC’s Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is 

USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and email 

PDR@nrc.gov. In addition, copies are available at current rates from the U.S. Government Printing Office, 

P.O. Box 37082, Washington, DC 20402-9328, telephone (202) 512-1800; or from the National Technical Information 

Service (NTIS), at 5285 Port Royal Road, Springfield, VA 22161, online at http://www.ntis.gov, by telephone at (800) 

553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.