ML20056G513
| ML20056G513 | |
| Person / Time | |
|---|---|
| Issue date: | 07/09/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| FRN-58FR26938, FRN-58FR39130, RULE-PR-30, RULE-PR-35 AE58-2-009, AE58-2-9, NUDOCS 9309030214 | |
| Download: ML20056G513 (10) | |
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,c 10 CFR Parts 30 and 35 RIN:
3150 - AE58 Authorization to Prepare Radiopharmaceutical Reagent Kits and Elute Radiopharmaceutical Generators; Use of Radiopharmaceuticals for Therapy; Extension of Expiration Date AGENCY: Nuclear Regulatory Commission.
ACTION:
Final rule:
Extension of expiration date.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is extending the expiration date of the Interim Final Rule related to the preparation and therapeutic use of radiopharmaceuticals from August 23, 1993, to December 31, 1994.
The
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action allows licensees to continue to use byproduct material under the provisions of the Interim Final Rule until the NRC completes a related rulemaking to address broader issues for the medical use of byproduct material (including those issues addressed by the Interim Final Rule).
The NRC expects that this broader rule would be completed and issued as a final rule before the end of 1994.
This extension of the expiration date is necessary to maintain the relief provided by the Interim Final Rule.
EFFECTIVE DATE:
(30 days after publication in the Federal Register).
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9309030214 930709
FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3797. SUPPLEMENTARY INFORMATION:
===. Background=== On June 5,1989, the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) submitted a petition for rulemaking (PRM-35-9), requesting the Commission to amend its regulations to permit licensed nuclear pharmacists and physicians greater flexibility in the preparation and use of radiopharmaceuticals. After reviewing the petition and consulting with the U.S. Food and Drug Administration (FDA), the NRC l determined that some issues raised in the petition needed to be resolved expeditiously. Subsequently, on August 23, 1990 (55 FR 34513), the Commission published an Interim Final Rule in the Federal Register to allow medical use licensees, under certain conditions and limitations, to use therapeutic radiopharmaceuticals for indications and methods of administration not listed in the FDA-approved package inserts. In addition, the Interim Final Rule allows medical use licensees and commercial nuclear pharmacies in depart from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals using radionuclide generators and reagent kits, provided that the licensees follow the directions of a physician authorized user. The NRC amended the t Interim Final Rule to eliminate certain recordkeeping requirements related to 2
...~_ the preparation and use of radiopharmaceuticals (57 FR 45566; October 2, t 1992). The Interim Final Rule will expire on August 23, 1993 unless it is j extended. The NRC has published for comment a broader proposed rule in response to i PRM-35-9 (58 FR 33396; June 17, 1993) that would resolve the issues raised in j the petition, including the issues addressed by the Interim Final Rule. The i Commission intends to replace the provisions of the Interim Final Rule with i the provisions of this broader rule. The NRC expects that this broader rule [ will be promulgated and effective before the end of 1994. The Proposed Rule and Public Comment l The NRC proposed to extend the expiration date of the Interim Final Rule from August 23, 1993, to December 31, 1994 (58 FR 26938; May 6, 1993). A l I 30-day public comment period expired on June 7,1993. Comments were received j i from three respondents. All three commenters supported, without i modifications, the proposed extension of the expiration date of the Interim i Final Rule l 1 l i f Di:cussion of the Final Rule l Because no suggestions were made to modify the proposed rule, the j. regulatory text in the final rule is the same as the proposed rule. i ) i 3 l l
~ - ~. I l Section 30.34 Terms and conditions of licenses. The NRC is extending the expiration date in paragraph (i)(1) of this section from August 23, 1993, to December 31, 1994. This extension is i necessary to allow commercial nuclear pharmacies to continue to prepare l i byproduct material under the provisions of the Interim Final Rule until the { broader rule is effective. Section 35.200 Use of radiopharmaceuticals. aenerators. and reaaent kits for l imaaina and localization studies. The NRC is extending the expiration date in paragrapt (c)(1) of this l section from August 23, 1993, to December 31, 1994. This extension is necessary to allow medical use licensees to continue to use byproduct material i under the provisions of the Interim Final Rule until the broader rule is effective. d Section 35.300 Use of radiopharmaceuticals for theraov. 2 The NRC is extending the expiration date in paragraph (b)(1) of this section from August 23, 1993, to December 31, 1994. This extension is necessary to allow medical use licensees to continue to use byproduct material under the provisions of the Interim Final Rule until the broader rule is { effective. Also, the NRC is replacing the word " method" with the word " methods" in ' I paragraph (b)(1) of this section to correct a typographical error. l l i 4 i b
l + 1 l Environmental Impact: Categorical Exclusion l l The NRC has determined th;t this final rule is the type of action l described in categorical exclusion 10 CFR 51.22(c)(2). Therefore, neither an i environmental impact statement nor an environmental assessment has been l prepared for this final rule. l Paperwork Reduction Act Statement i This final rule does not contain a new or amended information collection l requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 l l et seq.). Existing requirements were approved by the Office of Management and Budget under approval numbers 3150-0010 and 3150-0017. l t Regulatory Analysis j l In August 1990, the NRC implemented an Interim Final Rule allowing licensees to depart from (a) the manufacturer's instructions for preparing diagnostic radiopharmaceuticals and (b) the package insert instructions l regarding use of radiopharmaceuticals for therapy. The effective period for the rule is from August 23, 1990, to August 23, 1993. j The NRC is extending the expiration date from August 23, 1993, to a i' December 31, 1994. This extension allows licensees to continue to use byproduct material under the provisions of the Interim Final Rule until there ? I is an' effective final rule in a related rulemaking in response to the ACNP-SNM petition to address broader issues for the medical use of byproduct material {.t 5 1 e k
I f I (including those issues addressed by the Interim Final Rule). The NRC expects that this broader rule would be completed and effective before the end of i 1994. This extension of the expiration date is necessary to continue the )q relief from restrictions provided by the Interim Final Rule until the effective date of the broader rule. i The alternative to this extension is to maintain the existing expiration f date. Under this alternative, the provisions in the Interim Final Rule would expire on August 23, 1993, as would the relief from restrictions provided by i the Interim Final Rule. The NRC concludes that this extension is justified to continue to allow - l licensees to use byproduct material under the provisions of the Interim Final i Rule until the broader rule is effective. l i Regulatory Flexibility Certification ) As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), i the Commission certifies that this rule does not have a significant economic impact on a substantial number of small entities. This rule affects medical use licensees including some private practice physicians.' Some of these licensees would be considered small entities under the NRC's size standards published in the Federal Register on November 6, 1991 (56 FR 56672). This rule extends the expiration date of the Interim Final Rule from August 23, 1993, to December 31, 1994. The extension allows licensees to continue to use byproduct material under the provisions of the Interim Final Rule until the NRC ccmpletes a related rulemaking to address broader issues for the medical use of byproduct material (including those issues addressed by the Interim 6 1 l l 1 I -n-. 4
4 I Final Rule). Therefore, for the reasons provided above, this rule does not j i have a significant economic impact on a substantial number of small entities. ] i Backfit Analysis l t The NRC has determined that the Sackfit rule,10 CFR 50.109, does not i apply to this final rule because this amendment does not impose requirements j on existing nuclear power reactor licensees. Therefore, a backfit analysis i was not prepared for this final rule. { List of Subjects I r l 10 CFR Part 30 i 1 Byproduct material, Criminal penalties, Government contracts, .t Intergovernmental relations, Isotopes, Nuclear materials, Radiation .j protection, Reporting and recordkeeping requirements. j i 10 CFR Part 35 L Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Medical devices, Nuclear materials, Occupational safety and l .I 2 health, Radiation protection, Reporting and recordkeeping requirements. l For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, I 7 i i 'h
9' 1 i as amended, and 5 U.S.C. 552 and 553, the NRC is adopting-the following amendments to 10 CFR Parts 30 and 35. PART 30--RULES OF GENERAL APPLICABillTY TO DOMESTIC LICENSING ) 0F BYPRODUCT MATERIAL f .l t 1. The authority citation for Part 30 continues to read as follows: AUTHORITY: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, l i 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, i 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846). j i Section 30.7 also issued under Pub. L. 95-601, sec.10, 92 Stat. 2951 (42 U.S.C. 5851). Section 30.34(b) also issued under sec.184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec.187, 68 Stat. 955 (42 U.'S.C. 2237). ~ 2. In 5 30.34, paragraph (i)(1) is revised to read as follows: .i 6 30.34 Terms and conditions of licenses. 1 (i)(1) from August 23, 1990, to December 31, 1994, each licensee eluting generators and processing radioactive material with diagnostic reagent kits for which the Food and Drug Administration (FDA) has approved a "New Drug -i Application" (NDA), may depart from the manufacturer's elution and preparation l 'l instructions (fo radiopharmaceuticals authorized for use pursuant to 1 l ) 8 1 i l J
.x--.i u..s .--u-- a.. a. I I l 10 CFR 35.200), provided that the licensee follows the directions of an l l authorized user physician. l PART 35--MEDICAL USE OF BYPRODUCT MATERIAL r l r 3. The authority citation for Part 35 continues to read as l follows: l AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as f I' amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). 4. In s 35.200, paragraph (c)(1) is revised to read as follows: 9 35.200 Use of radiopharmaceuticals, generators, and reagent kits'for l imaging and localization studies. l (c)(1) From August 23, 1990, to December 31, 1994, a licensee may depart from the manufacturer's instructions for eluting generators and l preparing reagent kits for which the Food and Drug Administration (FDA) has approved a "New Drug Application" (NDA), by following the directions of an authorized user physician. 4 9 i a ---n..-
f,- 5. In 6 35.300, paragraph (b)(1) is revised to read as follows: 9 35.300 Use of radiopharmaceuticals for therapy. (b)(1) From August 23, 1990, to December 31, 1994, a licensee may 1 depart from the package insert instructions regarding indications or methods of administration for a radiopharmaceutical for which the Food and Drug Administration (FDA) has approved a "New Drug Application" (NDA), provided that the authorized user physician has prepared a written directive as required by s 35.32(a). I Dated at Rockville, Maryland, this 97 day of Is,xI - 1993. For the Nuclear - lad y Commission. l jl noem 's1.Taylorg~forOperations. J tive Director xe f k i 10 i}}