ML20044C021
| ML20044C021 | |
| Person / Time | |
|---|---|
| Issue date: | 09/15/1992 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20044C014 | List: |
| References | |
| FRN-57FR45566, RULE-PR-30, RULE-PR-35 AE23-2-005, AE23-2-5, NUDOCS 9303160287 | |
| Download: ML20044C021 (17) | |
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- WASHINGTON. D.C. 20555 SEP t5 1997 MEMORANDUM FOR:1 James M. Taylor Executive Director for Operation ~st
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FROM:
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
FINAL AMENDMENT TO 10 CFR PARTS 30 AND 35 DEPARTURES FROM MANUFACTURER'S INSTRUCTIONS; ELIMINATION OF RECORDKEEPING REQUIREMENTS The subject final rule is enclosed for your signature.
On May 28, 1992, you approved for publication the proposed amendment to 10 CFR Pari.
20_ and 35 to eliminate certain recordkeeping requirements related to the-pres,aration and.use of radiopharmaceuticals for a 30-day public. comment period. The staff received nine~ comment letters regarding the proposed rule; eight supported and one opposed the rule. The final rule is the same as:the -
proposed rule with the exception of correcting a typographical error. This final rulemaking has been coordinated with ADM, IRM,- NMSS, and 0GC.
I recommend that you approve issuance of the Federal Register Notice (Enclosure 1).
Following your approval, letters to-appropriate Congressional Committees (Enclosure 2) will be sent, daily staff notes (Enclosure 3) will be
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submitted, and a public announcement (Enclosure 4)' will. be issued.
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Whc tw Eric S. Beckjord,- Diref tor Office of Nuclear ReguTatory Research
Enclosures:
1.
FR Notice 2.
Congressional Letters 3.
Weekly Information. Report Item 4.
Public Announcement i
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3 9303160287 930309 30 5 45566
.PDR _
W SEP 15 1997 MEMORANDUM FOR:
James M. Taylor Executive Director for Operations FROM:
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
FINAL AMENDMENT T0 10 CFR PARTS 30 AND 35 - DEPARTURES FROM MANUFACTURER'S INSTRUCTIONS; ELIMINATION OF RECORDKEEPING REQUIREMENTS The subject final rule is enclosed for your signature.
On May 28, 1992, you approved for publication the proposed amendment to 10 CFR Parts 30 and 35 to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals for a 30-day public comment period. The staff received nine comment letters regarding the proposed rule; eight supported and one opposed the rule. The final rule is the same as the proposed rule with the exception of correcting a typographical error. This final rulemaking has been coordinated with ADM, IRM, NMSS, and OGC.
I recommend that you approve issuance of the Federal Register Notice (Enclosure 1).
Following your approval, letters to Oppropriate Congressional Committees (Enclosure 2) will be sent, daily staff notes (Enclosure 3) will be submitted, and a public announcement (Enclosure 4) will be issued.
ORIGINAL SIGNED BY Eric S. Beckjord, Director Office of Nuclear Regulatory Research
Enclosures:
1.
FR Notice 2.
Congressional letters 3.
Weekly Information Report item 4.
Public Announcement Distribution:
JMTaylor CHeltemes HLThompson BMorris GCranford FCostanzi PNorry LRiani MMalsch PLohaus RBernero JTelford EBeckjord SJones g
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MEMORANDUM FOR:
James M. Taylor Executive Director for Operations FROM:
Eric S. Beckjord, Director Office of Nuclear Regulatory Research FINALAMEthMENTT010CFRPARTS30AND35-DEPARTURESFRO
SUBJECT:
MANUFACTURER'S INSTRUCTIONS; ELIMINATION OF RECORDKEEPING REQUIREME14TS The subject final rule is e closed for your signature.
On May 28, 1992, you approve for publication t roposed amendment to 10 CFR Parts 30 and 35 to eliminate ertain record ing requirements related to the preparation and use of radiop armaceutic for a 30-day public comment-period. The staff received ni e comm letters regarding the proposed rule; eight supported and one opposec\\the ule. The final rule is the same as the proposed rule with the exceptioA correcting a typographical error. This final rulemaking has been coor ated with ADM, IRM, NMSS, and OGC.
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n e of the federal Reaister notice I recommend that you approv (Enclosure 1).
Following our appr val, letters to appropriate Congressional Committees (Enclosure 2) ill be sen, daily staff notes (Enclosure 3) will be submitted, and a public announcement Enclosure 4) will be issued.
Eric S. Beckjord, Director-Office of Nuclear Regulatory Research
Enclosures:
1.
FR Notice 2.
Congressiona Letters 1
3.
Weekly Info.ation Report Item j
4.
Public Announcement g
t Distribution:
JMTaylor ieltemes j
HLThompson Morris GCranford FCostanzi PNorry LRiani MMalsch PLohaus RBernero JTel ford EBeckjord Jones
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y RES DD DRA RES D.DRA RES D:GIRRES D:RES Name: SJones A9c#--
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09/ f/92 09 2
09/ /92 ;
09/ /92 09/ /92 09/ /92 Date:
00/a//9? '
OFFICAL RECORD COPY e
00C. FILE NAME:
P135.TMP LONG DISPLAY:
Departures from Mfrs Instructions-CREATED:
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AUTiiOR:
SJones l
t REVISED:
08/28/92 08/28/92 09/01/92 09/02/92 09/04/92 TYPIST:
C. Jones CJ_
CJ CJ.
CJ TIME:
3:30 pm 3:25 pm 10:30 am 10:45 am 2:30 pm 09/14/92 09/14/92 09/15/92 CJ CJ CJ 1:05 pm 4:35 pm 8:45 am EXCERPT:
[7590-Ol]L NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 35 1
RIN:
3150 - AE23 l
Departures From Manufacturer's Instructions; 4
Elimination of Recordkeeping Requirements b
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LONG DISPLAY:
10 CFR PARTS 30 & 35 -- FINAL AMENDMENT 1
CREATED:
AUTHOR:
S. Jones REVISED:
09/03/92 09/04/92 TYPIST:
CJones CJ TIME:
4:15 pm 1:40 pm EXCERPT:
MEMORANDUM FOR:
James M. Taylor Executive Director for Operations FROM:
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
FINAL AMENDMENT TO 10 CFR PARTS 30 AND 35 - DEPARTURES FROM MANUFACTURER'S INSTRUCTIONS; ELIMINATION OF RECORDKEEPING REQUIREMENTS The subject final rule is enclosed for your signature.
1 On May 28, 1992, you approved for publication the proposed amendment to 10 CFR Parts 30 and 35 to eliminate certain recordkeeping requirements related to the j
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-i ADoroved for Publication j
The Commission has delegated to the EDO (10'CFR'1.31(c)) the authority to j
' develop and promulgate rules as defined in the APA (5 U.S.C. 551(4)) subject i
to the limitations in NRC Management Directive' 9.17, Organization and.
Functions,. 0ffice of.the Executive Director for Operations, paragraphs' 0213, l
038, 039, and-0310.
The enclosed final rule, entitled " Departures From Manufacturer's Instructions; Elimination of Recordkeeping Requirements," amends 10 CFR Parts 30 and 35 by eliminating certain recordkeeping requirements related. to the preparation and use of radiopharmaceuticals.
l This final rule does not constitute a:significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7, 8, or 9 Subpart-C concerning t
matters of policy.. I, therefore, find'that this rule is within the scope of i
my rulemaking authority and am proceeding to issue it.
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ecutive Dir(g/ctor for Operations.
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[7590-01]
i NUCLEAR REGULATORY-COMMISSION 10 CFR Parts 30 and 35 RIN:
3150 - AE23-j Departures From Manufacturer's. Instructions; t
Elimination of Recordkeeping Requirements.
AGENCY: Nuclear Regulatory Commission.
j ACTION:
Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals. Specifically, this rule eliminates.recordkeeping requirements related to the justification for and a precise description of the departure, and the number of departures from the food and Drug Administration
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(FDA) approved manufacturer's instructions.
Both the NRC and the FDA staffs agree that the major trends in departures that may be_ identified by this i
recordkeeping are already discernible and collecting additional. data is unnecessary.
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EFFECTIVE DATE:
[ Insert date of publication.]
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FOR FURTHER INFORMATION CONTACT:
Samuel Z. Jones, Office of Nuclear
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Regulatory Research, U.S. Nuclear. Regulatory Commission, Washington, DC 20555, telephone (301) 492-3738.
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i SUPPLEMENTARY INFORMATION:
Background
On September 15, 1989 (54 FR 38239), the NRC published in the Federal Reaister a notice of receipt of a petition for rulemaking (PRM-35-9) from the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM). The ACNP and SNM requested, among other things, that the NRC l
amend its regulations in 10 CFR Part 35, " Medical Use of Byproduct Material,"
to recognize their appropriate practice of medicine and to allow (1) departures from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals and (2) the use of radiopharmaceuticals for therapeutic indications and methods of administration not included in the FDA approved j
package insert.
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On August 23,1990 (55 FR 34513), the NRC published in the Federal
.j Reaister an Interim Final Rule granting the petition, in part, to specifically
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allow departures from the manufacturer's instructions for preparing diagnostic j
radiopharmaceuticals using generators and reagent kits for which the FDA has j
approved a New Drug Application (NDA). The Interim Final Rule also included recordkeeping requirements for the specific nature of the departure, a brief l
statement of the reasons for the departure, and the number of departures. The Interim Final Rule is effective through August 23, 1993'.- This action was taken after consulting with the FDA and with the intention that the provision f
might become permanent after furthe~r experience had been gained under the'new l
l provision, including an assessment of licensee documentation of departures.
The NRC's original intent was to examine this documentation and make it -
2 i
' available-to the FDA.and to consult with the FDA prior to any decision;
' regarding either revision or continuation.of' the Interim Final-Rule or making:-
j it permanent. The NRC staff has recently consulted with the FDA staff on th'e-1 l
documentation collected to date.-
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' Based on this documentation,- the NRC and FDA 'staffstconcluded that: the f
i major trends in departures are'already clear and that' collecting. additional
-I data would not be expected to reveal' any significant new information.- On
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. June 11,1992 (57 FR 24763), the NRC published a proposed. rule in the Federal Reaister that suggested. amendments to 10 CFR Parts 30 and 35 to eliminate
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recordkeeping requirements involving the justification for and a precise j
description of the departure and the number.of departures from the FDA1
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approved manufacturer's instructions. The FDA staff had no objection to eliminating these recordkeeping requirements. -The issue of whether i'
departures, as set out in the Interim Final Rule,'should be allowed on a' permanent basis is currently under consideration by the'NRC as part of its effort to resolve PRM-35-9.
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Public Comments and NRC's Responses.
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The NRC received nine comment letters 'in response to the proposed rule.
In terms of the types of organizations,-there were three comment letters from-hospitals and clinics, two from professional associations, and one each from :
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an Agreement -State, a pharmacy, a Federal agency, and-an individual. member of j
d the public.
Eight of the letters'suppoEted the proposed amendments and one letter opposed:the rule.
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Brief descriptions of the issues raised in public comment letters and NRC's responses to these issues are presanted in the following paragraphs.
I.
Comment. A commenter suggested that the NRC allow the disposition of records of departures generated under the Interim Final Rule after 3 years (instead of 5 years as specified in the Interim Final Rule) because the -
records have apparently served their purpose.
Response. The NRC agrees that the records have served their purpose and additional retention of these records is not necessary. This rule eliminates the retention period for these records. Thus, as of the effective date of T
this rule, licensees are no longer required to. keep records of departures carried out under the Interim Final Rule.
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2.
Comment. A commenter suggested the termination of the remainder of the Interim Final Rule in favor of the provisions detailed in the ACNP-SNM e
Petition (PRM-35-9).
Response. The NRC is currently considering all issues raised in the ACNP-SNM Petition. NRC consideration includes the continuation of departures as set out in the Interim Final Rule.
However, at this time the NRC is limiting this rulemaking to the recordkeeping requirements and has determined l
not to expand this rulemaking to include the termination of the remainder.of the Interim Final Rule. That subject, the termination of the remainder of Interim Final Rule, will be covered when the NRC has completed its consideration of the ACNP/SNM petition.
3.
Comment. A commenter noted a typographical error in the text of 5 35.200 of the proposed-rule which indicated paragraph-(i) instead of paragraph (c).
Response. This typographical error has been corrected.
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4.
Comment. A commenter suggested that if there are no public health-and safety issues identified, the authorization to deviate should not expire on.. August 23, 1993.
l Response. The purpose of this rule is to provide relief to licensees 7
concerning the recordkeeping burden related to the requirements in the Interim' Final Rule. Therefore, the effective period of this rule was intentionally-used to be consistent with the effective period of the Interim Final Rule.
The NRC anticipates that the ACNP-SNM petition (PRM-35-9), including the issues associated with the Interim Final Rule, will be resolved prior to August 23, 1993.
5.
Comment. A commenter opposed this rule. The commenter provided the following rationale:
(a)
While reduction of regulatory burden may be a worthy goal, the l
4 legislative mandate to protect public health and safety must take precedence over an administrative goal; t
(b)
The modification in this rule would invite and promote an attitude or climate which resulted in the Three Mile Island accident, and thus, would present a danger to the health and safety of the public; and (c)
The NRC's rationale for this rule contradicts a statement made by the NRC, in a Federal Register notice announcing a public workshop (57 FR 27711, June 22, 1992), that some medical use licensees have administered byproduct material to patients who are pregnant or breast-feeding without knowing the patient's pregnancy or breast-feeding status.
Response. With respect.to the first point, the elimination of the i
recordkeeping requirements addressed in this rule will not compromise public health and safety because this rule continues the requirement that departures 5
t i
s may only be mada by following the directions of an authorized user physician.
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.Therefore, since there is no reduction in the protection of the public health and safety, the NRC continues to meet its legislative mandate. With respect to the second point, licensees must continue to comply with all applicable i
regulatory requirements and will continue to be subject to the same inspection and enforcement efforts. Therefore, the NRC believes that licensees' attitudes will not be negatively affected by this rule, and thus will not present a danger to the health and safety of the public.
Concerning the statement made in the public workshop notice as related to the rationale for this rule, the NRC views these two regulatory issues as t
separate matters. The rationale for this rule is to eliminate a regulatory burden that is no longer needed. The NRC has collected data specific to licensees' departures from manufacturer's instructions. The NRC and FDA staffs have concluded that the major trends in departures are already clear and that collecting additional data would not be expected to reveal any significantly new information. This rule is not connected to the issue concerning inadvertent radiation exposures to an embryo, fetus, or breast-feeding infant.
In particular, the NRC has not stated that departures -
from manufacturer's instructions have led to an unintended radiation exposure to an embryo, fetus, or breast-feeding infant. Also, the NRC staff is not aware of any cases involving an unintended radiation exposure to an embryo, l
fetus, or breast-feeding infant that has been caused'by a licensee departing from a manufacturer's instructions. Therefore, the NRC sees no contradiction between the rationale for this rule and/the statement made in the public workshop notice.
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The issue regarding. unintended radiation exposures to an embryo, fetus, or breast-feeding infant from medical use of byproduct material is currently i
under study by the NRC to determine whether any regulatory action is necessary.
Discussion of the Final Rule Text Based on public comments and NRC's responses discussed above, no substantive changes to the final rule are necessary. Thus, the text of the final rule remains the same as the text of the proposed rule with the f-exception that a typographical error in the proposed rule, in s 35.200 paragraph (1), has been correctly identified as paragraph (c).
Environmental Impact:
Categorical Exclusion The NRC has determined that this final regulation is the type of action described in categorical exclusion 10 CFR 51.22 (c)(3)(ii). Therefore, neiti;er an environmental impact statement nor an environmental assessment has 1
been prepared for this final rule.
i Paperwork Reduction Act i
This final rule eliminates information collection requirements that are subject to the Paperwork Reduction Act of-1980 (44 U.S.C. 3501 et seq.). The reduction in information collection requirements was approved by the Office of
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Management and Budget under approval numbers 3150-0010 and 3150-0017.
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The public reporting burden for this collection of information is estimated to be reduced by.05 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspect of this collection of information, to the Information and Records Management i
Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555; and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-3019, (3150-0010 and 3150-0017), Office of Management and Budget, Washington, DC 20503.
Regulatory Analysis i
In August 1990, the NRC implemented an Interim Final Rule allowing licensees to depart from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals, and to depart from the package insert instructions regarding use of radiopharmaceuticals for therapy, provided that certain conditions were met. One of the conditions was for licensees to maintain records of such departures.
On June 11, 1992, the NRC published in the Federal Reaister a proposed i
rule that would delete these recordkeeping requirements (57 FR 24763). Nine comment letters were received, eight supported and one opposed this rule.
4 The only alterne.tive to this action is to continue to keep these records. However, the NRC and FDA staffs have concluded that the major trends in departures are already clear and that collecting additional data would not 8
be expected to reveal any significant new information. Therefore, the NRC believes that these recordkeeping requirements are no longer necessary.
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The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees. The NRC concludes that this action is justified due to the net annual savings to NRC licensees and because eliminating these recordkeeping requirements would not affect public health and safety.
Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),
the Commission certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect medical use licensees including some private practice physicians. Some of these licensees would be considered small entities under the NRC's size standards (56 FR 56672; November 6, 1991). This rule eliminates recordkeeping requirements that the NRC and FDA staffs agree are no longer necessary. This action will reduce the regulatory burden on medical use licensees, including some small entities.
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Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this rule, and therefore, a backfit analysis is not required for this rule, because these amendments do not in'volve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(1).
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List of Subjects Part 30 - Byproduct material, Criminal penalty, Government contracts, 3
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
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protection, Reporting and recordkeeping requirements.
Part 35 - Byproduct material, Criminal penalty, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Radiation protection, Reporting and recordkeeping requirements.
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, 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 APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL 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, i
954, 955, as amended,'sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 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).
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).
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For the purposes-of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);.
ss 30.3, 30.10, 30.34(b), (c), (f), (g) and (i), 30.41 (a) and (c), and 30.53 f
i are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b));
9 30.10 is issued under sec. 161i, 68 Stat. 949, as amended-(42 U.S.C.
2201(i)); and is 30.6, 30.9, 30.34(g), 30.36, 30.50 30.51, 30.52, 30.55, and 30.56(b) and (c) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
l 2.
In 5 30.34, paragraph (i) is revised to read as follows:
9 30.34 Terms and conditions of licenses.
i (i)(1) From August 23, 1990, to August 23, 1993, each licensee eluting l
generators and processing radioactive material with diagnostic reagent kits for which the Food and Drug Administration (FDA) has approved a "New Drug Application" (NDA), may depart from the manufacturer's elution and preparation i
i instructions (for radiopharmaceuticals authorized for use pursuant to 10 CFR 35.200), provided that the licensee follows the directions of an authorized user physician.
(2) The actions authorized in paragraph (i)(1) of this section are permitted in spite of more restrictive language in license conditions.
l (3) Nothing in this section relieves the licensee from complying with other applicable NRC, FDA, and other Federal or State regulations.
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i PART 35 - MEDICAL USE OF 8YPRODUCT MATERIAL -
e 3.
The authority citation for Part 35 is revised to read as follows:
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l AUTHORITY: Secs. 81, 161, 182, 183~, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201,.88 Stat. 1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);-
is 35.11, 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.31(a), 35.32(a), 35.49, 35.50(a)-(d), 35.51(a)-(c),
4 35.53(a)-(b), 35.59(a)-(c), (e)(1), (g), and (h), 35.60, 35.61, 35.70(a)-(f),
35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.120, 35.200(b) and (c), 35.204(a) and (b), 35.205, 35.220, 35.300, 35.310(a), 35.315, 35.320, 35.400, 35.404(a),
r 35.406(a) and (c), 35.410(a), 35.415, 35.420, 35.500, 35.520, 35.605, 35.606, 35.610 (a) and (b), 35.615, 35.620, 35.630(a) and (b), 35.632(a)-(f),
35.634(a)-(e), 35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b),
35.645(a) and (b), 35.900, 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941, 35.950, 35.960, 35.961, 35.970, and 35.971 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and 9s 35.14, 35.21(b),
35.22(b), 35.23(b), 35.27(a) and (c), 35.29(b), 35.32(b)-(f), 35.33(a)-(b),-
35.36(b), 35.50(e), 35.51(d), 35.53(c), 35.59(d), (e)(2), (g), and (i),
35.70(g), 35.80(f), 35.92(b), 35.204(c), 35.310(b), 35.315(b), 35.404(b),
35.406(b) and (d), 35.410(b), 35.415(b), 35.610(c), 35.615(d)(4), 35.630(c),
35.632.(g), 35.634(f), 35.636(c), 35.641(c), 35.643(c), 35.645, and 35.647(c) are issued under sec. 1610, 68 Stat. 950, as amended (42.U.S.C. 2201(o)).
4.
In 9 35.200, paragraph (c) is revised to read as follows:
f s 35.200 Use of radiopharmaceuticals. aenerators. and reaaent kits for imaoina and localization studies.
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(c)(1)
From August 23, 1990, to August 23, 1993, a licensee may depart from the manufacturer's instructions for eluting generators and 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.
(2) Nothing in this section relieves the licensee from complying with other applicable NRC, FDA, and other Federal or State regulations.
5.
In s 35.306, paragraph (b) is revised to read as follows:
s 35.300 Use of radiopharmaceuticals for theraov.
(b)(1)
From August 23, 1990, to August 23, 1993, a licensee may depart i
from the package insert instructions regarding indications or method 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).
(2) Nothing in this section relieves the. licensee from complying with other applicable NRC, FDA, and other Federal or State regulations.
1 Dated at Rockville, Maryland, this
/7 day of w
1992.
,r-l For the Nuclear Regulatory Commission.
James '. Taylor,g
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Ese ive Direct 5r for Operations.
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c UNITED STATES o
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,E NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555
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o, The Honorable Peter H. Kostmayer, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515 i
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaister.
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements have been in place since August 23, 1990.
Specifically, this rule will eliminate recordkeeping requirements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and-the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc:
Representative John J. Rhodes t
4
The Honorable Peter H. Kostmayer, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaister.
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements have been in place since August 23, 1990. Specifically, this rule will eliminate recordkeeping requirements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc:
Representative John J. Rhodes
- See previous concurrences s
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Date:
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i The Honorable Peter H. Kostmayer, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington,.DC 20515
Dear Mr. Chairman:
1 Enclosed for the information of the subcommittee is a copy 'of a final rule to be published in the Federal Reaister.
ts regulations to The Nuclear Regulatory Commission (NRC) is amendingd to the preparation or use eliminate certain recordkeeping requirements relat9 of radiopharmaceuticals. TheserequirementshaveAeeninplacesince August 23, 1990. Specifically, this rule will iminate recordkeeping requirements related to the justification for a precise description of the' departure, and the number of departures from t e Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeepin requirements. Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are alre dy discernible and collecting additional data is unnecessary.
The estimated reduction in annual bur en would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for l
NRC licensees.
Sincerely, Dennis K. Rathbun, Director
't Office of Congressional Affairs
Enclosure:
i Federal Reaister Notice i
cc: Representative Jo J. Rhodes Offc:
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8 UNITED STATES o
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g The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaister.
i The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements have been in place since 23, 1990.
Specifically, this rule will eliminate recordkeeping August i
requirements related to the justification for and a precise-description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
l The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for i
NRC licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice i
i Representative Carlos J. Moorhead cc:
i l
j
The Honorable Philip R. Sharp, Chairman Subcommittee on' Energy and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515 c
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Feo'eral Reaister.
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements have been in place since.
August 23, 1990. Specifically, this rule will eliminate recordkeeping requirements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions.
The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
Sincerely, 1
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Representative Carlos J. Moorhead b
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The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515-
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaiste_r.
The Nuclear Regulatory Commission (NRC) is amending its r.egulations to eliminate certain recordkeeping requirements related to. the preparation or use of radiopharmaceuticals.
These requiremen_ts have been'in place since August 23, 1990. Specifically, this rule will eliminate recordkeeping requirements related to the ' justification for and'a precise description of the
-departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. yThe FDA staff, also, has no objection to eliminating these recordkeeping requirements. Both the NRC and the FDA staffs agree that the major trends ~ in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
/
The estimated reduction in annual bbrden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
/
/
Sincerely,
/
/
/
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Dennis K. Rathbun, Director
/
Office of Congressional Affairs y
Enclosure:
/
Federal Reaister Nptice Representat[ve Carlos J. Moorhead cc:
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The" Honorable Bob Graham, Chairman l
- Subcommittee on Nuclear Regulation-Connittee on Environment and' Public Works United States Senate Washington, DC 20510
.i
Dear Mr. Chairman:
5 i
Enclosed for the information of the subcommittee is a' copy of a -final rule-to -
be published in the Federal Reaister.
J The Nuclear Regulatory Commission (NRC) is, amending its regulations:to
- eliminate certain recordkeeping requirements related to the preparation or. use 1
of radiopharmaceuticals. These requirements have been in place since
.j August 23, 1990. Specifically, this. rule will eliminate'-recordkeeping
'i requirements related to the justification for and'a precise description of the.-
departure, and the' number of departures from the' food-and Drug l Administration-j (FDA) approved manufacturer's instructions The FDA ' staff, _also, has no l
objection to eliminating these recordkeeping requirements. :Both the NRC and i!
the FDA-staffs agree that.the major. trends in. departures-that may be.
Li identified by~.this recordkeeping are already discernible an'd collecting-4 additional data is unnecessary..
The estimated reduction in annual burden would be approximately 1000-hours for-0 NRC licensees.
i Sincerely, j
i i
Dennis K. Rathbun, Director j
Office of Congressional Affairs Enclosure.
Federal Register Hotice cc: Senator Alan K. -Simpson l
1
'I i
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Tbc tionorable Bob Graham, Chairman
.%ocommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaister.
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements have been in place since August 23, 1990. Specifically, this rule will eliminate recordkeeping requirements related to the justification for and a precise description of the departure, and the number of-departures from the. Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Alan K. Simpson b
- See previous concurrences Offt: DDB:DRA*
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Name: JMTa~ or DRathbun Date:
O(/('T/92
/ /92 0FFICIAL RECORD COPY t
The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
t Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaister.
The Nuclear Regulatory Commission (NRC) is amending its regulations to p
eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements have been in place since August 23, 1990. Specifically, this rule will eliminate recordkeeping.
requirements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeeping requirements..<Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
The estimated reduction in annual burden would~be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
l 7
Sinierely, Dennis K. Rathbun, Director I
Office of Congressional Affairs
/
Enclosure:
i Federal Reaister Notice SenatorAlanK'Simpson cc:
2 Offc:
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'I NRC ELIMINATES CERTAIN RECORDKEEPING REQUIREMENTS-FOR RADIOPHARMACEUTICALS f
}
The Nuclear Regulatory Commission is amending its regulations to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals.
f f
The requirements are associated with departures from
)
I manufacturer's instructions approved by the Food and Drug i
Administration (FDA).
Specifically, the revisions to Parts 30 and 35 of the Commission's regulations eliminate recordkeeping~
~
requirements related to the justification for each departure, a precise description of each departure, and the number of-l departures.
On August 23, 199G, the NRC issued an interim final rule i
granting, in part, a petition from the American College of j
Nuclear Physicians (ACNP) and the Society of Nuclear Medicine
- ~
(SNM).
The ACNP and SNM had asked the NRC to amend-its regulations to allow (1) departures from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals and (2) the use of radiopharmaceuticals for therapeutic indications and methods of administration not included in the FDA-approved package insert containing the approved manufacturer's instructions.
The interim final rule allowed departures from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals using generators and reagent kits for which the FDA has approved a luni Drug Application.
It also included
o
+
recordkeeping requirements.for the specific nature of the-departure, a brief statement of the reasons for the departure and the number of departures.
The interim final rule is effective through August 23, 1993.
After examining'the documentation collected to date and consulting the FDA staff, the NRC decided that these information collection requirements are no longer necessary.
Both the NRC and the Food and Drug Administration staffs agree that the' major-trends in departures that might be identified by the' recordkeeping requirements are already clear; collection of additional data would not be expected to reveal any.significant i
new information and is therefore unnecessary.
A proposed rule on this subject was published in the Federal-Register for comment on June 11, 1992.
No substantive changes l
t have been made as a result of the comments received.
i The final rule eliminating these requirements is effective immediately upon publication of the Federal Register notice on L
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