ML20044C022
| ML20044C022 | |
| Person / Time | |
|---|---|
| Issue date: | 09/25/1992 |
| From: | Lohaus P NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Meyer D NRC OFFICE OF ADMINISTRATION (ADM) |
| Shared Package | |
| ML20044C014 | List: |
| References | |
| FRN-57FR45566, RULE-PR-30, RULE-PR-35 AE23-2-007, AE23-2-7, NUDOCS 9303160289 | |
| Download: ML20044C022 (8) | |
Text
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MEMORANDUM FOR:
David Meyer, Chief Regulatory Publications Branch, Division of Information and Publications Service, Office of. Administration FROM:
Paul Loha'us, Acting Branch Chief Regulation Development-Branch, Division of Regulatory Applications,.
Office of Nuclear Regulatory Research-
SUBJECT:
IMPLEMENTATION OF EDO ACTION, FINAL RULE 10 CFR 30 AND 35 The ED0 has approved the final rule entitled, " Departures from Manufacturer's Instructions; Elimination of Recordkeeping Requirements" (Enclosure 1).
Please implement the ED0's action by arranging for publication of the final rule in the Federal Reaister. The date of publication needs to be inserted on-Page 1 of the Federal Register Notice in order to make.the rule effective immediately upon publication.
In addition, enclosed are Congressional letters.(Enclosure 2) for transmittal to OCA and copies of the public announcement (Enclosure 3) for transmittal to OPA.
W 5gned 8r,
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Paul Lohaus, Acting Branch' Chief Regulation Development Branch, Division of Regulatory Applications, Office of Nuclear Regulatory Research.
Enclosures:
1.
FR Notice (2 copies) 2.
Congressional letters 3.
Public announcement (2 copies)
Distribution:
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NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 35 RIN: 3150 - AE23 Departures From Manufacturer's Instructions; Elimination of Recordkeeping Requirements AGENCY: Nuclear Regulatory Commission.
ACTION:
Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations b
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 (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 recordkeeping are already discernible and collecting additional data is unnecessary.
EFFECTIVE DATE:
[ Insert date of publication.]
FOR FURTHER INFORMATION CONTACT: Samuel Z. Jones, Office of Nuclear i
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3738.
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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 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 package insert.
On August 23,1990 (55 FR 34513), the NRC published in the Federal Reaister an Interim Final Rule granting the petition, in part, to specifically allow departures from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals using generators and reagent kits for which the FDA has approved a New Drug Application (NDA). The Interim Final Rule also included recordkeeping requirements for the specific nature of the departure, a brief The statement of the reasons for the departure, and the number of departures.
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 might become permanent after further experience had been gained under the new-provision, including an assessment of licensee documentation of departures.
The NRC's original intent was to examine this documentation and make it 2
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 it permanent. The NRC staff has recently consulted with the FDA staff on the documentation collected to date.
Based on this documentation, the NRC and FDA staffs concluded that the major trends in departures are already clear and that collecting additional data would not be expected to reveal any significant new information. On 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 recordkeeping requirements involving the justification for and a precise i
description of the departure and the number of departures from the FDA approved manufacturer's instructions. The FDA staff had no objection to eliminating these recordkeeping requirements. The issue of whether 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.
Public Comments and NRC's Responses The NRC received nine comment letters in response to the proposed rule.
i In terms of the types of organizations, there were three comment letters from hospitals and clinics, two from professional associations, and one each from an Agreement State, a pharmacy, a Federal agency, and an individual member of the public.
Eight of the letters supported the proposed amendments and one letter opposed the rule.
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l Brief descriptions of the issues raised in public comment letters and NRC's responses to these issues are presented in the following paragraphs.
i 1.
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 i
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 this rule, licensees are no longer required to keep records of departures carried out under the Interim Final Rule.
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 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 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 6 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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Comment. A commenter suggested that t' there are no public health and safety issues identified, the authorization to deviate should not expire on August 23, 1993.
Responsg. The purpose of this rule is to provide relief to licensees 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
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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 legislative mandate to protect public health and safety must take precedence t
over an administrative goal; (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 i
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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 recordkeeping requirements addressed in this rule will not compromise public health and safety because this rule continues the requirement that departures 5
3 may only be made by following the directions of an authorized user physician.
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 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 The rationale for this rule is to eliminate a regulatory separate matters.
burden that is no longer needed. The NRC has colle:ted 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, 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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.4 The issue regarding unintended radiation exposures to an embryo, fetus, or breast-feeding infant from medical use of byproduct material is currently 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 6 35.200 exception that a typographical error in the proposed rule, in paragraph (i), 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, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.
Paperwork Reduction Act 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 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 infort.:ation, to the Information and Records Management 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 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 rule that would delete these recordkeeping requirements (57 FR 24763). Nine comment letters were received, eight supported and one opposed this rule.
The only alternative 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
4 be expected to reveal any significant new information. Therefore, the NRC t
believes that these recordkeeping requirements are no longer necessary.
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 i
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 I
This requirements that the NRC and FDA staffs agree are no longer necessary.
action will reduce the regulatory burden on medical use licensees, including l
some small entities.
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 involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(1).
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4 List of Subjects Part 30 - Byproduct material, Criminal penalty, Government contracts, Intergovernmental' relations, Isotopes, Nuclear materials, Radiation 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, 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, i
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);
il 30.3, 30.10, 30.34(b), (c), (f), (g) and (i), 30.41 (a) and (c), and 30.53 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b));
I 30.10 is issued under sec. 161i, 68 Stat. 949, as amended (42 U.S.C.
2201(i)); and il 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)).
2.
In 5 30.34, paragraph (i) is revised to read as follows:
5 30.34 Terms and conditions of licenses.
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(i)(1)
From August 23, 1990, to August 23, 1993, 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 Application" (NDA), may depart from the manufacturer's elution and preparation 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.
(3) Nothing in this section relieves the licensee from complying with other applicable NRC, FDA, and other Federal or State regulations.
PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL 3.
The authority citation for Part 35 is revised to read as follows:
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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);
16 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),-
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),
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 !I 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 5 35.200, paragraph (c) is revised to read as follows:
5 35.200 Use of radiopharmaceuticals. aenerators. and reaaent kits for imaaina and localization studies.
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f (c)(1) From August 23, 1990, to August 23, 1993, a licensee may depart 4
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 5 35.300, paragraph (b) is revised to read as follows:
5 35.300 Use of radiopharmaceuticals for theraov.
(b)(1) From August 23, 1990, to August 23, 1993, a licensee may depart 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 prenared a written directive as required by 6 35.32(a).
(2) Nothing in this section relieves the licensee from complying with other applicable NRC, FDA, and other Federal or State regulations.
Dated at Rockville, Maryland, this
/7 day of 1992.
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For the Nuclear Regulatory Commission.
James
. Taylor,f Exe ive Direct 6r for Operations.
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es-09-15-92 11:20 301 492 3a55 994 PD2 j
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_Acoroved for Publication The Commission has delegated to the EDO (10 CFR 1.3.(c)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 55)(4)) subject i
to the limitations in NRC Management Directive 9.17, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039, and 0310.
i 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.
This final rule does not constitute a significant question of policy, nor does r
it amend regulations contained in 10 CFR Parts 7, 8, or 9 Subpart'C concerning i'
matters of policy.
I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
Wn/PA LRf ~
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ecutive Dirdtor for Operations
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The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate g
Washington, DC 20510 i
Dear Mr. Chairman:
N Enclosed for the information of the subcommittee is a copy of a final rule to a
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,5also, has no Both the NRC and objection to eliminating these recordkeeping requirements.
the FDA staffs agree that the major trends in departures.that may be.
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~ identified by this recordkeeping are already discernible and collecting additional data _is unnecessary.
The estimated reduction in annual burden would be approximately'ID00 hours' for NRC licensees.
t Sincerely, i
Dennis K. Rathbun, Director Office of Congressional Affairs 1
Enclosure:
l Federal Register Notice q
cc: Senator Alan K. Simpson-i t
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NUCLEAR REGULATORY COMMISSION.
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o 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:
t 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 alsof has no Both the.NRC and objection to eliminating these recordkeeping requirements'.
j 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 j
NRC licensees.
Sincerely, l
Dennis K. Rathbun, Director Office of Congressional' Affairs -
Enclosure:
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Federal Register Notice I
Representative Carlos J. Moorhead cc:
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WASHINGTON. D.C. 20555 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:
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.egulaiions 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
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NRC ELIMINATES CERTAIN RECORDKEEPING REQUIREMENTS
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FOR RADIOPHARMACEUTICALS The Nuclear' Regulatory Commission is amending its-regulations to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals.
The requirements are associated with departures from manufacturer's instructions approved by'the Food and Drug, Administration (FDA).
Specifically, the revisions to Parts 30 f
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 departures.
I On August 23, 1990, the NRC issued an interim final rule granting, in part, a petition from the American College of 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 New Drug Application.
It also included
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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 st'affs 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 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 have been made as a result of the comments received.
The final rule eliminating these requirements is effective immediately upon publication of the Federal Register notice on 6,
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