ML003704460
| ML003704460 | |
| Person / Time | |
|---|---|
| Issue date: | 04/18/2000 |
| From: | Shelton B NRC/OCIO |
| To: | Catherine Haney NRC/NMSS/IMNS/RGB |
| Stmary B | |
| References | |
| Download: ML003704460 (7) | |
Text
April 18, 2000 MEMORANDUM TO: Catherine Haney Rulemaking and Guidance Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards FROM:
Brenda Jo. Shelton, Chief Records Management Branch Office of the Chief Information Officer
SUBJECT:
CONCURRENCE IN THE REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL, FINAL RULE The Office of the Chief Information Officer has reviewed the subject rule and has the following major concern that must be resolved before the rule can be published or the clearance package forwarded to OMB. Because we deferred our review of the draft final rule, we did not review this change earlier. Although the concern also affects another section that was present in the proposed rule, unfortunately, we did not catch it until the language was strengthened in the final rule.
OMB as a general rule does not approve information collections that require both the submittal and the retention of the same information by a respondent. OMBs position is that if the information is reported, the agency has the information that it needs for its purposes, and therefore, there is no reason for the agency to require that respondents also maintain the records. Conversely, in the case of NRC licensees, if the licensee is required to maintain a record, the agency may examine the record during inspections and, therefore, should have no reason to require the licensee to submit the information. Two recordkeeping sections, 35.2045 and 35.2047, require information to be maintained that is virtually identical to the information to be reported in sections 35.3045 and 35.3047. Licensees commented that neither section 35.3045 nor section 35.3047 were needed. Because it appears that these sections cannot be deleted and still meet Congressional requirements, we suggest you delete the related recordkeeping sections. Section 35.3045 also contains a requirement to provide a copy of the section 35.2045 record to the referring physician. Because the only difference in the information required by sections 35.2045 and 35.3045 is that the record identifies the individual while the report does not, we suggest that section 35.3045 be amended to require that the NRC report be annotated with the individuals name and forwarded to the referring physician. This would obviate the need for NRC to require the record because all information required by the record would be provided to the physician. One would expect the licensees to maintain the records required by the proposed sections 35.2045 and 35.2047 as a part of good business practices. Should you decide to keep the two subject recordkeeping sections in the final rule, you must strongly defend your position in the preamble to the rule and in the OMB clearance package, but understand that OMB may reject these provisions.
C. Haney We recognize that, overall, the changes made in the final rule have produced a vastly improved rule. However, attached for your consideration is a list of suggested rule changes, areas where the preamble should be strengthened, and some editorial comments for clarifying the rule language or correcting minor errors. We are submitting our comments on the final rule clearance package directly to Sam Jones of your staff. However, we have not addressed sections 35.2045 and 35.2047 of the clearance package pending resolution of the rulemaking issue.
We have placed the rule on hold with the Office of Administration pending OCIO approval of the OMB clearance package. We will continue to work with you and cognizant staff to finalize the submittal. Should you have any questions on our concerns and comments, please contact Beth St. Mary at 415-5878 or e-mail bcs.
Attachment:
As stated cc:
D. Meyer, ADM D. Flack, NMSS D. Cool, NMSS F. Cardile, NMSS J. McCausland, NMSS DOCUMENT NAME: C: IMC35FR.wpd To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" =
No copy OFFICE OCIO/RMB OCIO/RMB NAME BStMary BShelton DATE 11/01/23 11/ /23 OFFICIAL RECORD COPY
Proposed Changes to the Final Rule and Statement of Considerations Additional Substantive Comments on the Regulatory Text:
Add sections 35.433 and 35.1000 to the information collections sections listed in section 35.8 of the rule. If you delete sections 35.2045 and 35.2047 in response to the concerns expressed in our memorandum, delete these sections from section 35.8.
Recent changes made in the final rule to section 35.24 appear to require the licensee to notify the Commission when a temporary Radiation Safety Officer (RSO) performs the functions of a RSO, in accordance with 35.14(b). However, section 35.14(b) appears to only require notification of a change of permanent RSO.
Section 35.40(a)(1) and (c)(1) require documentation of an oral directive. As written, this does not appear to be the same as the written directive. There is no record required for this documentation. Either the paragraphs should be rewritten to make it clear that the oral directive must be documented as the written directive, or a record should be added for the documentation required for the oral directive.
Section 35.400 has been modified to require that licensees using brachytherapy sealed sources for therapeutic medical uses for research obtain an Investigational Device Exemption from FDA. If NRC requires these licensees to submit proof of this exemption, please ensure that this burden is included in the clearance package for the final rule.
Section 35.610(b) requires the licensee to physically locate a copy of the procedures at the unit console, yet 35.610(c)(1) requires the licensee to post instructions at the unit console that tells where the procedures are. The intent is unclear. (Note that a commenter on the rule had the same concern, and we do not believe that the response provided in the Statement of Considerations clarifies what is intended by this requirement.)
Section 35.635(a)(3) has recently been amended in the final rule to require full calibration measurements at intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use and following damage to a helmet. Is this merely a clarification, or does it result in a reduction in the number of associated records that must be maintained. If it is the latter, please ensure that the OMB clearance package takes the reduction into account.
Editorial Changes to the Regulatory Text:
Multiple recordkeeping requirements often are included in each section contained in Subpart L. Therefore, when referencing a specific recordkeeping requirement, we suggest you indicate the specific paragraph of the section that contains the recordkeeping requirement, rather than just indicating the general overall section (e.g.,
section 35.67(d) should reference the leak test records in accordance with section 35.2067(a) and section 35.67(g) should reference section 35.2067(b).
We suggest you modify section 35.2080(a) to eliminate the awkward construction by replacing A licensee shall retain a copy of the letter(s) that permits the use of byproduct material at a clients address as required by section 35.80(a)(1). This letter.... with A 1
licensee shall retain a copy of each letter that permits the use of byproduct material at a clients address as required by section 35.80(a)(1). Each letter....
Substantive Comments on the Statement of Considerations (SOC):
On page 6 of the SOC, it states that approximately 1900 NRC and 5000 Agreement State licensees are affected by the requirements in Part 35. However, the clearance package states there are 1688 NRC licensee and 4222 Agreement State licensees.
These numbers need to be consistent and the burden adjusted for the clearance package if necessary.
On pages 79-80, Issue 8, the response concerning information collections must be specific. It is not clear how specific the comments were because they are discussed generally. If they were just general comments (e.g., we think your estimates overall are wrong), then you can answer generally. However, NRCs basis for its estimate must be stronger. You cant just say, OMB approved them, because OMB may not have questioned the estimates because it received no comments to the contrary, and OMB will certainly not accept this response. You might indicate ways in which staff has evaluated the actual burden involved, e.g., queried licensees, executed the requirements themselves, etc.
On page 116, the first paragraph of the Response does not seem to relate at all to the comments. It needs to be replaced with the proper response to the comments, or if it does relate, clarify the relationship in your response.
On page 125, the Issue 2 and 3 responses, which address the changes to section 35.12, appear to indicate that the number of license amendments will be reduced because applicants may file combined license applications. Therefore, presumably this will reduce the total burden attributable to the NRC Form 313, clearance number 3150-0120.
This clearance reduction should be included in the OMB clearance package for this rulemaking.
On page 128, the response to Issue 4 indicates that the revisions to section 35.12 will no longer require that certain procedures be submitted to NRC for approval as part of the licensees license/amendment application. This will reduce the total burden attributable to the NRC Form 313, clearance number 3150-0120, and should be included in the OMB clearance package for this rulemaking.
On page 130, Issue 6, indicates that 35.15 has been revised such that broad scope licensees do not need to request an amendment for emerging technologies. If this will result in a reduction in the expected number of license amendment requests, please include the reduction in the OMB clearance package for this rulemaking.
On page 160, the response to Issue 4 indicates that a 48-hour response is less restrictive than the suggested next working day. This is not the case when oral directive is given on Friday (which was the commenters concern). We suggest you modify your response, or modify the rule to reflect within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> or the next working day.
On page 203, Issue 1, commenters objected to the labeling requirement because it is the standard for medical and pharmacy practice and is regulated by FDA. The NRC response indicated why labeling is necessary but did not address whether or not this 2
labeling is the same as FDA or medical practice requires. If it is the same, commenters have a valid concern, and the need and duplication will need to be discussed in the OMB clearance package. If it is not, that information should be stated in the response.
On page 208, the second paragraph indicates that licensees may use case-specific information in place of the values used in NUREG 1556, Volume 9. This should be stated in the guidance if it is not.
Page 259 indicates that licensees may need to buy equipment to meet the section 35.432 requirements. This cost must be included in the clearance package under Other Costs. (We have annotated the supporting statement with this requirement.)
On page 273, the response to Issue 3 indicates that certain voluminous emergency procedures do not need to be posted. Please indicate where this exemption is stated?
We cannot find it in the revised Part 35.
The last paragraph on page 329 indicates what other changes were made in section 35.2045. A rationale for the changes should also be included.
As indicated in our memorandum, added paragraph 35.2047, discussed on page 330, is likely to be disapproved by OMB. Should you decide to keep it in the rule, you should strongly justify it in the Statement of Considerations and in the OMB clearance package.
On page 338, the response to Issue 1 does not adequately justify why the NRC needs the licensee to retain a record that instructions were provided to a breast-feeding female, i.e., there doesnt appear to be any reason why NRC wants to see the record. As written, the response merely seems to require the licensee to abide by good business practices, which should not be an NRC regulatory requirement.
On page 351, the response to the comment should provide the basis for NRCs belief that records of the surveys required by section 35.2652 should be retained for life.
On page 366, the Issue 10 comments and the response are handled generally, rather than specifically as required by OMB. The wording of the comment is so general that it is not clear why the commenters believe providing a written report to the individual may lead to a misunderstanding of the consequences for the patient. Either address each comment specifically or clarify the commenters basis for concern.
On page 381, the response to Issue 6 on section 35.3047, does not address the commenters issue of requiring a written response within 15 days.
On page 383, the first paragraph addresses the certification required by the new paragraph 35.3047(d)(1)(vii). Please add NRCs use of this information.
On page 383, last paragraph, our comments on paragraph 35.3047(f) are included in the cover memorandum.
Editorial Changes to the Statement of Considerations:
On page 9, last paragraph, end of third line, replace the double quote with a single 3
quote.
On page 65, because of the renumbering, Issue 10, which refers to final section 35.292 (that does not exist in the final rule), and the response to the issue which references section 35.190 (which has been renumbered) are extremely confusing as to what is intended. We suggest that you address the renumbering so that the response is clearer.
On page 67, Issue 12 refers to other changes made to these sections. It is not clear what these sections are, especially in light of the apparent error in Issue 10. For clarity, we suggest you replace all occurrences of this section and these sections with the applicable section number(s).
On page 78, eighth line, replace the single quote after commenters with an apostrophe.
On page 84, last paragraph, fifth line, we suggest that for clarity, you insert after time required for the words Radiation Safety Committee to make it clear what meetings you are referencing.
On page 91, last line, insert a space in Issue1.
On page 128, last line, replace ? with.
On page 158, second full paragraph, sixth line, the parenthetical expression seems unclear. We suggest you replace it with e.g., they were administered but not prepared when physicians were present if this is your intent.
On page 190, response to Issue 4, we suggest you add, These changes are further discussed in section 35.2060.
On page 193, for clarity, we suggest you reword the first sentence to read, Proposed paragraph (b) was deleted in the final rule.
On page 198, response to Issue 2, work should be changed to word.
Starting on page 226 and throughout the remainder of the SOC, there are many sections that conclude with Were there any other changes made in this section between the proposed and final rule? In many of these sections, this change is the only change.
The word other should be dropped from all such sections.
On page 231, first comment, the commenter recommended that section 35.310(a)(5) be modified to require personnel to be instructed to notify the RSO or designee. The NRC response indicated that the RSO had flexibility in designating who should be notified. It is not clear that this answers the concern. We suggest that you restructure your response to state that the RSO has the authority to and should require personnel to notify him or his or her designee, if this is your intent.
On page 327, we suggest you revise the last sentence to read In addition, review of the written directive may be useful.... The present wording implies that the licensee must also keep a copy of the written directive.
On page 389, first line, change Xof to X of.
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