10 CFR Part 33 FINAL Supporting Statement

10 CFR Part 33 FINAL Supporting Statement.doc

10 CFR Part 33, Specific Domestic Licenses of Broad Scope for ByProduct Material

OMB: 3150-0015

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FINAL OMB SUPPORTING STATEMENT FOR

10 CFR PART 33

SPECIFIC DOMESTIC LICENSES OF

BROAD SCOPE FOR BYPRODUCT MATERIAL

(3150-0015)


EXTENSION



Description of the Information Collection


The NRC regulations in 10 CFR Part 33 specify requirements for applying for and being granted licenses authorizing broad scope use of byproduct material. Three types of licenses may be issued: Type A, Type B, or Type C, with Type A being the largest program. The types of licenses are defined by Section 33.11. Applicants and licensees are primarily medical institutions, colleges, universities, government agencies, and large private companies engaged in broad educational, research, and development activities.


A. Justification


1. Need for and Practical Utility of the Collection of Information


Section 33.12 specifies that an applicant for a broad license must complete NRC Form 313, "Application for Material License." The NRC Form 313 has previously been cleared under OMB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden, and cost data.


Sections 33.13, 33.14, and 33.15 specify the information that must be included in an application. The NRC needs this information to determine that the public health and safety will be adequately protected before issuing a license.


  • Type A broad license. Section 33.13 specifies the requirements for the issuance of a Type A broad license. It requires that an applicant have equipment and facilities adequate to protect health and minimize danger to life or property, have personnel with adequate training and experience, and have adequate administrative controls and procedures, including a radiation safety committee and radiation safety officer. The applicant must describe the program for meeting these requirements when the applicant submits a license application, in order to establish that radioactive material can be used safely.


  • Type B Broad License. Section 33.14 specifies the requirements for the issuance of a Type B broad license. The requirements are similar to those specified in Section 33.13, except that the applicant need not demonstrate as extensive experience in use of radioactive materials as is required for a Type A broad license, and need not have a radiation safety committee. The application submitted by the applicant must demonstrate that he can meet these requirements.


  • Type C broad license. Section 33.15 specifies the requirements for the issuance of a Type C broad license. It requires that an applicant have equipment and facilities adequate to protect health and minimize danger to life or property, have personnel meeting certain training and experience requirements, supervise use of radioactive material, and have adequate administrative controls and procedures to assure safe use of radioactive material. The application submitted by the applicant must demonstrate that he can meet these requirements.


2. Agency Use of Information


The NRC reviews the information submitted in order to determine whether the applicant's training, personnel experience, equipment, facilities, and procedures for the use of byproduct material are adequate to protect the public health and safety as required by the Atomic Energy Act, as amended, and the Energy Reorganization Act of 1974, as amended, so that the Commission may determine whether to issue, amend, or renew a broad scope license.


3. Reduction of Burden through Information Technology


There are no legal obstacles to reducing the burden associated with this information collection. The NRC encourages respondents to use information technology when it would be beneficial to them. NRC issued a regulation on October 10, 2003 (68 FR 58791), consistent with the Government Paperwork Elimination Act, which allows its licensees, vendors, applicants, and members of the public the option to make submissions electronically via CD-ROM, e-mail, special Web-based interface, or other means. There are no current information technology applications that would reduce the burden of these information collection requirements. Currently, the percentage of electronic submission is zero.


4. Effort to Identify Duplication and Use Similar Information


No sources of similar information are available. There is no duplication of requirements. NRC has in place an ongoing program to examine all information collections with the goal of eliminating all duplication and/or unnecessary information collections. The information is not a duplication of other information the affected licensee must submit for other purposes. The nature of the information being requested is unique to licensed activities at the facilities, and is necessary so that the Commission may determine whether to issue, amend, or renew a broad license.


5. Effort to Reduce Small Business Burden


While a number of the licensees are considered small businesses, the health and safety consequences of improper use of radioactive material are the same for large and small entities. There is a minimum amount of information that must be provided in order for the Commission to determine if an applicant's facilities, equipment, and procedures are adequate to protect the public health and safety. Therefore, it is not possible to reduce the burden on small businesses by less frequent submission or less complete applications.


6. Consequences to Federal Program or Policy Activities if the Collection is Not Conducted or is Conducted Less Frequently


Applications on NRC Form 313 for a new license are submitted only once, while applications for renewal of a license are submitted every 10 years. Amendments are submitted as needed by the licensee. This is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of the public health and safety. If the information is not collected, the NRC will have no way to determine the adequacy of licensees' programs to protect the public health and safety.


7. Circumstances which Justify Variation from OMB Guidelines


There are no variations from OMB guidelines.


8. Consultations Outside the NRC


Opportunity for public comment on the information collection requirements for this clearance package was published in the Federal Register on May 30, 2008 (73 FR 31150). No comments were received.


9. Payment or Gift to Respondents


Not applicable.


10. Confidentiality of the Information


None.


11. Justification for Sensitive Questions


No sensitive information is requested under these regulations.


12. Estimated Industry Burden and Costs


All of the Information Collection burden in Part 33 is captured under OMB clearance number 3150-0120 for NRC Form 313.


13. Estimate of Other Additional Cost


Part 33 has no additional costs.


14. Estimated Annualized Cost to the Federal Government


The NRC cost to review applications and other efforts attributable to an application for broad scope use of byproduct material would be incurred with the submission of the application, NRC Form 313, previously approved by OMB under clearance number 3150-0120.

15. Reasons for Changes in Burden or Cost


There are no changes in burden or responses. All burden is captured under NRC Form 313, previously approved under OMB clearance 3150-0120.


16. Publication for Statistical Use


There is no information that will be published for statistical use.


17. Reason for Not Displaying the Expiration Date


The requirement is contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become out of date, would confuse the public.


18. Exceptions to the Certification Statement


There are no exceptions.


B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS


Not applicable.

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