ML20198J119
| ML20198J119 | |
| Person / Time | |
|---|---|
| Issue date: | 03/24/1997 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-032, AF70-1-32, NUDOCS 9801140041 | |
| Download: ML20198J119 (6) | |
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.go I UNITED STATES -
." e NUCLEAR REGULATORY COMMISSION WASHINGTON. CJJ. 2066Mm01 3 .. 4 J March 24 1997 MEMORANDUM T0: David t.. Morrison. Director Oifice of--Nuclear Regulatory Research n FROM: Carl J. Pa)eriello. Director )' .Ata Office of luclear Material Safety and Safeguards
SUBJECT:
PROPOSED RULE: EXEMPT DISTRIBUTION OF A RADIOACTIVE DRUG CONTAINING ONE MICR0 CURIE OF CARBON-14/ UREA (10 CFR PARTS 30 AND 32)-
I am responding to your memorandum dated February 28. 1997. requesting
- concurrence on the Commitsion paper responding to .the Tri-Med Specialties.
.Inc.'s petition for rulemaking. I concur with the Commission paper.
attachments, and Federal Reaister notice. Attached are specific comments that should be considered for clarity, NMSS interprets the term "in vivo diagnostic use" used in the rule to refer to human use. Thic interpretation is based on the petitioner's request to distribute the drug for use in humans. the statements of consideration, the regulatory analysis, and the environmental assessment. All of these documents focus on the use /
of the drug for determining H. pylori in people with ulcers, medical availability '
/
and cost to human patients. Therefore, we believe that any use outside of human use would require additional evaluativi and analysis.
Attachment:
As stated CONTACT: Donna-Beth Howe, NMSS/IMNS
'(301) 415-7848 7
e.
p 11 41 900109 30 62FR32552 'PDR
_ ___ 032-
NMSS COMMENTS COMMISSION PAPER
- 1. Since NRC recognizes both FDA and State registration as drug manufacturers, the phrase *(e g., be registered or licensed with FDA as a drug manufacturer...)" should read *(e.g., be registered or licensed with the FDA er State as a drug manufacturer...)" (page 1)
- 2. Why is the OMB clearance omitted from the Note? (page 2)
ENCLOSURE 1- FExRAL REGISTER NOTICE
- 3. Since NRC puts no restrictions on who can receive the drugs, phrases such as
' physicians (or other persons) who are not ' authorized users' under Part 35" or
" physicians, or any other person," should be revised to say " persons (including physicians who are not ' authorized users' under Part 35)." (paga 5) or 'any person, including physicians" (page 9). This makes it clear NRC will not restrict the distribution.
- 4. The sentence "hence, the drug should be distributed to any pemon who is permitted to receive and use the drug under the appropriate Federal or State law goveming drugs." may be misinterpreted and it might be inferred that NRC would restrict the distribution to only those individuals permitted to receive it under another agency regulations, inspect, or take enforcement action if it went to someone else.
Suggested change. "Hence, the drug can be distributed to any person.
However, other Federal or State agencies may limit the receipt and use of the drug in accordance with their own requirements." (page 9)
- 5. The sentence *Thus after the manufacture and distribution of the drug " on page 10 should read "Thus, after the manufacture and distritution of the drug, NRC and the Agreement States would not regulate as user of the drug ss long as its use was for "in vivo" diagnostic use."
- 6. The next sentence should read "This means that under NRC and Agreement State regulations, primary care physicians would not need to be " authorized users" in order to administer the drug, and would not necessarily need to refer their patients to nuclear medicine physicians."
- 7. The sentence " Regulation of the use of the drug..
- on page 10 should read "Other Federal and State organizations with responsibilities for regulating drugs
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l would be left to determine and regulate who could receive and use the diug for "in vivo' diagnostic use."
- 8. Correct four typos on pages 11,12, and 13.
- 9. Should the sentence explaining Paragraph 30.21 (c) be revised from
" repackage or transfer for commercial distribution such capsules." to
" repackage or transfer such capsules for commercial distribution." (page 15)
- 10. The sentence explaining Paragraph 30.21(d) should be revised from
" goveming the administration and use of drugs." to "...goveming the receipt, administration, and use of drugs."
- 11. How long do the Agreement States have to implement exempt distribution requirements? (page 16) 12 What is basis for the sentence "Also, it is expected that there would be no nor.-
radiological impacts if the proposed rule is adopted." is this sentence necessary? (page 17)
' 13. Why is the estimated average for the burden blank? (page 17) How can the public answer the question on the estimate of the burden being correct if there was no value given? (page 18)
- 14. Section 30.21(c) " ..such capsules shall apply for a specific.
- should be
" such capsules shall apply for and receive a specific.. "(page 24)
- 15. Section 30.21 (d)"... State requirements goveming use of drugs. " should read
" State requirements goveming receipt and use of drugs "(page 24)
ENCLOSURE 2
- 16. Objectives. Why isn't the objective to "... distribution of 14 C-urea capsules for in vivo diagnostic use as an ...'?
- 17. Why isn't the burden to the state to change its requirements mentioned in attematives 2 and 3. The States don't have to change their regulations for altemative 1. All that is mentioned is the burt.an to the states for assessing license and registration fee for general license holders.
111. Summary of Proposed Amendments Manufactu,er and_ Distributors A new section would be added to 10 CFR Part 32 to permit the distribution of the drug to persons who are exempt from licensing.
Ma ,ufacture. distribution, and transfer of carbon-6 32.21 Radioactive diua:
14 urea capsules net exceedina one microcurie each for "in vivo" diagnostic use: Reautrements for a license Section 32,21. Paranraph (a) ihrough this paragraph the Commission would allow the drug to be distributed to persons exempt from licensing.
Section 32,21. Paraaraoh (a), item (1)
The NRC would limit issuance of an " exempt distribution license" for distribution of the capsules to persons exempt from licensing to only those who possess either a NRC or Agreement State " specific license" for possession and use of byproduct material.
Section 32.21. Paragranh (a). Item (2)
+ h a. n X To assure that the capsules contain no more one microcurie of carbon-14 and present no other radiological risks, the Commission would require that the persons nailuf acturing and/or distributing the capsules for "in vivo" diagnostic use must also meet the requirements of i 32.72(a)(2).
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Specifically, these persons must be:
(1) registered with or licensed by the FDA as a drug manufacturer; or (2) registered with or licensed by a state agency as a drug manufacturer; or
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(3) licensed as pharmacy by a State Board of Pharmacy; or (4) operating as a nuclear pharmacy within a federal m.. dical institution.
Section 32.21. Paragraph (a), item (3)
Applicants would be required to provide evidence that each carbon-14 urea capsule will not exceed one microcurie. The Commission's evaluation that the capsules would not result in significant radiation risks was based on the Therefore, applicants capsulescontainin(onemicrocurieofcarbon-14 urea.
must demonstrate that the activity of each carbon-14 capsule will not exceed one microcurie.
Section 32.21. Paragraph (a). Item (4)
The Coisission would prohibit carbon-14 urea from being contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion, or inhalation by or application to a human being, except for the capsules as described in this section, because exempt distribution of this drug has only been evaluated for "in vivo" diagnostic use in the form of a capsule containing one microcurie of carbon-14 urea.
Section 32.21. Paracraoh (a), item (5)
Again, because the exempt distribution of this drug has only been evaluated for "in vivo" diagnostic use in the form of a capsule containing one 12
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I microcurie of carbon-14 urea, the Commissica will prohibit incorporat.on of the capsules into any manufactured or assembled commodity, product, or device Further, even thougn the drug is being intended for commercial distribution.
distributed to persons exempt from licensing, the Commission will require the carbon-14 urea to be identified as radioactive, because the drug is being used ahend user should be provided with '
for its radioactive content, and therefore,g information that the drug contains a radioactive material.
Section 32.21. Paragraph (a), item (6) 4 As with any product approved for distribution to persons exempt from licensing, the Commission would require persons who apply for a license to manuf acture or distribute such capsules to submit copies of prototype labels or brochures for Commission approval. This will allow the NRC to confirm that the labels or brochures meet the requirements of n 32.21a (a) and (5).
Section 32.21. Paragraph (b).
Through this paragraph the Commission declares that nothing in these regulations relieves licensees or license applicants from complying with applicable FDA, other Federal, and State requirements governing manuf acturing and distribution of drugs.
s Section 32.21a Same: Conditions of licer_e in this secticn the Commission states the conditions for a license to distribute the capsules to persons exempt from licensing.
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Paul H. Lohaus. Deputy Director Omce of State Prograrns U.S. Nuclear Regulatory Commission Washington, D.C. 20$55 0001
Dear Mr. Lohnus:
This is in response to your letter dated March 7,1997, t SP 97 0IS), and the paper entitled. " Final Rulemaking Plan Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon 14 Urca." in your letter you requested that we state nur position on two question.s in order to assist you in your consideration of the change from the original NRC staff position of recommending miemaking authorizing general beense distribution of capsules containing one microcurie of carbon 14 Urca to recommending authorizing exempt distribution of these capsules to any person for diagnostic testing.
The Btueau of Radiological Health recormnends that NRC reconsider its latest proposal, and pursue the original rulemaking plan authorizing distribution of Carbon 14 Urea to persons generally licensed. However, should the NRC choose to proceed with the exempt distribution rulemaking proposal, we recommend that the NRC contact the boards of phannacies in each of the states to assure that adequate laws and regulations are currently in place to allow such control as is necessary to assure the health and safety of the public. One particular conecrn in this regard is whether the "dispensmg practices" section of state phannacy acts or regulations gise broader authorizations than intended, and that persons such as nurses, physicians assistants, dentist, podiatrist, and others outside the scope of practice could prescribe the C-14 Urea study. The telephone numbe,* for New Hampshire's Board of Pharmacy is 603-271 2350. We suggest that you also consider contacting othe related state boards to discuss this issue. (We can provide you with a listing and telephone rmnhers for these. upon request). It also appears to us that promulgating a rule exempting persons from licensure for a particular use of radioactive material, but restricting its distribution <>nly to a particular occupation (e.g., physicians) or category of recipient is not only withou' precedent, but is somewhat in contradiction to granting an exemption from licensint, v oo 4n,,,: ari.snim m m Rortas of Madioletical Healiti H) MI-8588 60- /t 6-lI .
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. pe,..pg.g 9 7 gg,3;f41 FPCF1 f)4 RAD K ALTH 603 2;$ 2315 P[ N U.S. Nuclear Regulatory Commission March 21.1997 h(k-Page 2 i 's As to the second question, we in the Bureau are not aware of other state regulations in New Harnpshire that may be a concem if the espsules are authorized to be distributed to persons exempt from licensing. This is not to say howeser that other states laws and rules may not apply.
We therefore suggest that you contact. as mentioned above, state boards of piiarmacy, but also with regard tu unused capsules, state and local environmental protection agencies.
In closing, we pose a few questions below. which we believe NRC . eds to address prior to going forward with the plan for exempt distribution of C 14 Urea. Wh/ it it that the in vnv general license concept which already is in place in seseral states not considered an adequate basis to further pursue that mechanism? Has the NRC taken into consideration that in granting this excmption. that other medical uses of radionuclides such as those authorized unde: 10 CFR 35.100 for uptake, dilution and excretion studies. may be sub.iect to petition for use by those outside the scope of those authorized cunently. (i e., qualified nuclear medicine and radiological physicians? The rationale behind granting this exemption needs to be clear and sound,in order to provide a basis for any future considerations of similar requests.
Whatever the final decision or the directinn taken, we sincerely hope that the NRC will continue to invohe the Agreement States in all aspects of the rulemaking and decisions. especially if they are to be considered division 1.
Thank you for giving us the opponunity to offer our position on this matter.
Sincerely, L .c Diane E. Tefn, Adivinistrator Bureau of Radiological Health ec: Dennis P. O'Dowd asum u w on w 4
@C.)/ 6[O ry' l l Barry R. McBee, Gelrman 6CJ ,
R. E.
- Ralph
- Marques. Commlutoner l 1 xQg John M. Baker. Commiuloner Dan Pearm Esecutin Director Q .
TEXAS NATURAL RESOURCE CONSERVATION COMMISSION 4# 70 -/ ,
howcting Tuas & Reducing and Newnting IWIution pk l
March 21,1997 Mr. Pau' H. Lohaus, Deputy Director Office of State Programs Nuclear Regulatory Commission -
Washington, D.C. 20666 0001 Re: SP 97-015 Rulemaking Plan,10 CFR Parts 30 & 32, C-14 Urea H. Pylori Diagnostic Test
Dear Mr. Lohaus:
We have received your request for comments regarding 10 CFR Parts 30 & 32, C 14 Urea H. Pylori Diagnostic Test. Please note that the Texas Department of Health (TDH), not the Texas Natural Resource Conservation Commission (TNRCC), has jurisdiction over this matter; therefore, TNRCC declines to comment on these rules.
S rely, ygu Minor Hibbs, P.E., Director
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Industrial & Hazardous Waste Division ,
MH/KV/jb cc: Mr. Richard Ratliff, TDH t:\UURW\KvAll\UREATEST.LTR sP-4 4 P.O. Ilos 13087
- 512/23 S1000
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