10CFR35PRssMedicalEvent071008

OMB SUPPORTING STATEMENT

FOR PROPOSED RULE

10 CFR PARTS 35

MEDICAL USE OF BYPRODUCT MATERIAL – AMENDMENTS / MEDICAL EVENT DEFINITIONS (3150-0010)

(RIN 3150-AI26)

DESCRIPTION OF THE INFORMATION COLLECTION

This proposed rule would amend 10 CFR 35.40 and 35.3045 to revise the criteria for defining medical events (ME) and clarify requirements for written directives (WD) for permanent implant brachytherapy. The proposed amendments would change the criteria for defining a ME for permanent implant brachytherapy from dose based to activity based, would add a requirement to report, as a ME, any administration requiring a WD if a WD was not prepared, would clarify requirements for WDs for permanent implant brachytherapy, and would make certain administrative and clarification changes.

The change from dose based to activity based criteria for defining MEs in permanent implant brachytherapy is necessary because 1) currently there is no suitable clinically used dose metric available for judging the occurrences of MEs and 2) clinicians have better control over activity being implanted than dose resulting from the implant. These proposed amendments to Part 35 on permanent implant brachytherapy were recommended in part by NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI) and by NRC’s Medical Radiation Safety Team.

Permanent implant brachytherapy procedures (such as seeds and microspheres) differ from other therapeutic procedures using byproduct material which require a WD (such as temporary implant brachytherapy and radiopharmaceuticals) and thus the criteria for MEs are different as well. MEs that are reportable under the current combined therapeutic procedures using byproduct material which require a WD may not be MEs for permanent implant brachytherapy.

Information that is required on a WD is crucial to insuring a patient receives the appropriate treatment. Changing from a dose based to an activity based criteria for defining a ME means the information required in a WD must reflect this change. This proposed rule affects all medical licensees that perform procedures using byproduct material that require a WD.

Proposed Amendments

This proposed rule would amend the following sections:

1. 10 CFR 35.40, Written directives.

2. 10 CFR 35.3045. Report and notification of a medical event.

Impact on Information Collections

10 CFR 35.40

The proposed changes in rule language in 10 CFR 35.40 would impact information collection burdens by changing the information required to be recorded on the written directive.

Information Required to be Documented on a Written Directive for Permanent Implant Brachytherapy
Current Regulations	Proposed Rule Change
(Before Implantation)	(Before Implantation*)
Date & signature of the Authorized User	Date & signature of the Authorized User
Treatment site	Treatment site
Radionuclide	Radionuclide
Dose	Intended dose
	Calculated total source strength
(After Implantation)	(After Implantation*)
Total source strength	Total source strength
Number of sources implanted	Date & signature of the Authorized User
Treatment site
Radionuclide
* The proposed rule language uses “administration” in lieu of “implantation.”

As noted in the table above, the information required on a WD for permanent implant brachytherapy under the proposed rule does not differ greatly from the current regulatory requirements. The proposed rule adds the requirement of documenting the calculated total source strength in the WD before implantation. Source strength must be known before a dose can be calculated and therefore this requirement is not a new burden on the medical licensee and requiring it to be documented in the WD is an insignificant change. The term “dose” in the current language means “intended dose” and is clarified in the proposed rule language and does not constitute a new requirement.

Under both the current regulations and the proposed rule the WD must be completed after implantation. Requiring the Authorized User (AU) to sign and dated the WD before the patient leaves the post-treatment area would ensure that the information added to the WD has been reviewed and approved by the AU. This change would clarify the intent of the current regulations that the AU approves all required information on the WD and is an insignificant change for the medical licensee.

The result of the proposed amendment to § 35.40 is that there would be a negligible increase of burden to the medical licensees.

10 CFR 35.3045

The proposed changes in rule language in 10 CFR 35.3045 would impact information reporting burdens by changing the number of medical events that medical licensees are required to report to the NRC.

The NRC staff, based on a review of historic reporting of MEs, anticipates a decrease in reported MEs from new ME criterion for permanent implant brachytherapy by approximately 4 per year. This would result in a reduction of cost by approximately $10,423.20.

Based on NRC staff estimates, the number of MEs will increase by approximately 2 per year from the new reporting requirements when a WD is not prepared when required. This would result in an increase of cost by approximately $5,211.60.

The net result is that the proposed amendments to § 35.3045 would decrease cost to medical licensees by $5211.60.

A. JUSTIFICATION

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

NRC regulates and licenses the medical use of byproduct materials, as provided by the Atomic Energy Act (AEA) as amended, and the Energy Reorganization Act of 1974, in order to provide for the radiation safety of workers, the general public, and patients. Licensees must perform certain tasks, maintain records, and prepare reports to demonstrate their fulfillment of regulatory requirements. The records required by Part 35 are the least burdensome way for licensees to demonstrate compliance with the NRC’s requirements. However, certain events, such as medical events, are of such significance that they must be reported to the NRC, to patients or human research subjects, and to referring physicians. Collection of this information enables the NRC to determine what steps must be taken by other licensees to prevent such events, whether required notifications have been made, and whether corrective actions have been taken. In addition, NRC has the responsibility, pursuant to section 208 of the Energy Reorganization Act of 1974, as amended, to inform Congress and the public of those events constituting "abnormal occurrences" and to also inform NRC medical use licensees of generic issues identified by the NRC review of medical events.

Description of Proposed Changes

Section 35.40 Written directives.

This section is being amended to create specific requirements for a WD for permanent implant brachytherapy. Information that is required on a WD is crucial to insuring a patient receives the appropriate treatment. The specific WD requirements for permanent implant brachytherapy will change from dose based to activity based and require the AU to sign and date the WD after administration but before the patient leaves the post-treatment area. This ensures the information that is added to the WD has been reviewed and approved by the AU.

This section was restructured to accommodate the specific requirements for a WD for permanent implant brachytherapy. Additionally, there was an administration change to the paragraph numbering.

As noted in Impact on Information Collection, the proposed changes to the information collection requirements of § 35.40 would result in a negligible increase of burden to the medical licensees.

Section 35.3045 Report and notification of a medical event.

This section is being amended primarily to establish the criteria for MEs involving permanent implant brachytherapy from dose based to activity based. Other amendments include adding a requirement to report, as a ME, any administration requiring a WD if a WD was not prepared and certain administrative and clarification changes.

This section was restructured to create separate paragraphs specifically for ME criteria for permanent implant brachytherapy (such as seeds and microspheres). Regulations for all other use of byproduct material which require a WD (such as temporary implant brachytherapy and radiopharmaceuticals) was left combined. Because of the separation, language in this section was amended to ensure current regulatory requirements were retained. Additionally, the NRC Operations Center phone number was amended to reflect the current number in use.

2. Agency Use of the Information

The NRC uses the records and reports required in this part to ascertain that licensees’ medical use programs are adequate to protect public health and minimize danger to life and property and that licensees’ personnel are aware of and follow up on the information and steps needed to perform licensed activities in a safe manner. The staff makes use of the records and reports to determine whether the licensee has individuals with adequate training and experience to safely use byproduct material or radiation from byproduct material to be administered to patients or human research subjects, and has the facilities and equipment necessary to assure protection of public health and safety. NRC also uses the information to develop reports to inform Congress and the public about the measures taken to provide for the radiation safety of workers, the general public, and patients, and to alert licensees to issues of general concern. Reports of medical events are required to ensure that NRC is notified of significant events. These reports also allow NRC to determine whether to take actions, such as to conduct inspections, or to alert other medical use licensees, to prevent similar events that may have generic implications. In addition, collection of this information enables the NRC to ascertain whether such events are evaluated by the licensee, reported to patients or human research subjects, and referring physicians, and that corrective action is taken.

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. Currently, no responses are filed electronically.

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.

5. Effort to Reduce Small Business Burden

While a number of medical licensees are considered small businesses under the NRC’s current definitions, the health and safety consequences of improper use of byproduct material are the same for large and small entities. It is not possible to reduce the burden on small businesses by less frequent or less complete reporting, recordkeeping, or accounting and control procedures while maintaining the required level of safety.

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

If the information is not collected, NRC will not be in a position to assess whether this category of licensee is operating within the specific radiation safety requirements applicable to the medical use, possession, or transfer of byproduct material for medical use. In addition, NRC will not be able to report to Congress and evaluate those medical events constituting "abnormal occurrences" or to ensure that patients, human research subjects, and referring physicians are informed of "medical events."

Collection of the specific information at the required frequency from licensees that administer byproduct material to patients or human research subjects is essential to protect the health and safety of workers, patients and human research subjects, and the public.

7. Circumstances Which Justify Variation from OMB Guidelines

Contrary to OMB's implementing regulation at 5 CFR 1320.5(d), some of the provisions in the revision of Part 35 require licensees to maintain records for more than three years or to report information to the NRC or to patients’ physicians within less than 30 days following an occurrence.

Section 35.2041 requires that a copy of the procedures for administrations requiring a written directive, required by § 35.41 and detailed in § 35.40, be retained for the duration of the license. Retention of these procedures for the duration of the license will allow NRC to investigate medical events where an administered dose or dosage was not in accordance with the written directive.

Paragraph 35.3045(d) requires that licensees submit a written report to the appropriate NRC Regional Office listed in § 30.6 within 15 calendar days after discovery of a medical event. This requirement balances the time required for the licensee to evaluate the event and prepare a written report against the needs of the NRC to take timely action, as necessary, to address the medical event.

Paragraph 35.3045(e) requires that if an individual affected by a medical event has been notified verbally about the medical event, the licensee must furnish a written report of the medical event to the individual upon request. This requirement ensures that complete written information will be furnished to an individual upon request so that adequate follow-up medical care can be provided, if needed.

Paragraph 35.3045(g) requires a licensee to provide a copy of the annotated medical event report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event. This requirement balances the time required for the licensee to evaluate the event and prepare a written report against the needs of the referring physician to provide timely follow-up medical care, if needed.

8. Consultations Outside the NRC

The opportunity for public comment has been published in the Federal Register.

These proposed amendments to Part 35 on permanent implant brachytherapy were recommended in part by NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI). ACMUI developed recommendations on permanent implant brachytherapy from several public meetings. Early public input on the preliminary proposed language was solicited via the NRC’s Medical List Server and regulations.gov with a notice in the Federal Register on February 15, 2008 (73 FR 8830). Changes were made in the preliminary proposed language as a result of several responses from the public.

The rulemaking process used a working group team that included not only members from the NRC headquarters offices, but also a member from the regional licensing and inspection staff who has frequent contact with NRC’s medical licensees and a representative of the Agreement States. State participation in the process enhanced development of corresponding rules in State regulations and provided an early opportunity for State input.

9. Payment or Gifts to Respondents

Not applicable.

10. Confidentiality of Information

Confidential and proprietary information is protected in accordance with NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).

11. Justification for Sensitive Questions

No sensitive information is requested under these regulations.

12. Estimated Burden and Burden Hour Cost

As indicated in the Regulatory Analysis for this proposed rulemaking, there would be a reduction in burden and cost of approximately 2 medical events required to be reported by NRC and Agreement State licensees covered by this rulemaking. There is no recordkeeping burden from this proposed rule. Assuming that 1 reduction would be from a NRC licensee and 1 reduction would be from an Agreement State licensee, Table 1 summarizes the estimated reduction in reporting burden.

A summary is presented below:

Total respondents: 1 reduction for NRC licensees

1 reduction for Agreement State licensees

Total respondents: 2 reductions

Total reduction in burden/cost: $5,211.60 (-20.2 hours x $258/hour)

Table 1

Annual Reporting Requirements for Part 35.3045

Proposed Amendment (3150-AI26)

For NRC Licensees

Section	No. of Respon- dents	Responses per Respondent	Total Responses	Burden/ Response (Hrs)	Total Annual Burden Hours	Cost @ $258/hr
35.3045(a) & (b):	Burden covered in 35.3045(c) &(d)
35.3045(c)	-1	1	-1	0.5	-0.05	-12.90
35.3045(d)	-1	1	-1	8	-8	-2064.00
35.3045(e)	-1	1	-1	2	-2	-516.00
35.3045(g)	-1	1	-1	0.5	-0.05	-12.90
Total Reporting					-10.1	-$2605.80

For Agreement State Licensees

Section	No. of Respon- dents	Responses per Respondent	Total Responses	Burden/ Response (Hrs)	Total Annual Burden Hours	Cost @ $258/hr
35.3045(a) & (b):	Burden covered in 35.3045(c) &(d)
35.3045(c)	-1	1	-1	0.5	-0.05	-12.90
35.3045(d)	-1	1	-1	8	-8	-2064.00
35.3045(e)	-1	1	-1	2	-2	-516.00
35.3045(g)	-1	1	-1	0.5	-0.05	-12.90
Total Reporting					-10.1	-$2605.80

13. Estimate of Other Additional Costs

The quantity of records to be maintained is roughly proportional to the recordkeeping burden. Based on the number of pages maintained for a typical amendment, the records storage cost has been determined to be equal to .0004 times the recordkeeping burden cost. Therefore, the storage cost for this amendment is estimated to be $0 ( 0 X $214 X .0004).

14. Estimated Annualized Cost to the Federal Government

NRC will incur one-time costs to support development of the rule following publication in the Federal Register through publication of the final rule. NRC may also need to revise guidance documentation during this implementation time period.

15. Reasons for Change in Burden

Section 35.3045(a) of the proposed rule would increase the number of reported medical events from medical licensees by approximately 2 per year. Section 35.3045(a)(2) of the proposed rule would decrease the number of reported medical events from medical licensees by approximately 4 per year. This results in a net reduction of 2 per year in expected reporting from NRC and Agreement State medical licensees.

The anticipated reduction of 2 reports per year reduces the burden and cost by $5,211.60 (-20.2 hours x $258/hour).

As noted in Impact on Information Collection, the proposed changes to the information collection requirements of § 35.40 would result in a negligible increase of burden to the medical licensees.

16. Publication for Statistical Use

The information requested would not be published for statistical use.

17. Reason for Not Displaying the Expiration Date

The requirement would be contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.

18. Exceptions to the Certification Statement

Not applicable.

2. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

Not applicable.

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