ML23153A065

PR-030, 035 - 57FR24763 - Departures from Manufacturers Instructions; Elimination of Recordkeeping Requirements

ML23153A065
Person / Time
Issue date:	06/11/1992
From:	Taylor J NRC/EDO
To:
References
57FR24763, PR-030, PR-035
Download: ML23153A065 (1)

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{{#Wiki_filter:DOCUMENT DATE: TITLE: CASE

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KEYWORD: ADAMS Template: SECY-067 06/11/1992 PR-030,035 - 57FR24763 - DEPARTURES FROM MANUFACTURER'S INSTRUCTIONS;ELIMINATION OF RECORDKEEPING REQUIREMENTS PR-030,035 57FR24763 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-030,035 (57FR24763) In the Matter of DEPARTURES FROM MANUFACTURER'S INSTRUCTIONS; ELIMINATION OF RECORDKEEPING REQUIREMENTS DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT ~ 06/25/92 05/28/92 FEDERAL REGISTER NOTICE - PROPOSED RULE 06/30/92 06/24/92 COMMENT OF USAF RADIOISOTOPE COMMITTEE (COLONEL DAVID G. WOOD) (

1) 07/06/92 06/24/92 COMMENT OF DR. CAROLS. MARCUS (

2) 07/10/92 07/09/92 COMMENT OF ACNP AND SNM (DR. ROBERT J. LULL, PRESIDENT} (

3) 07/10/92 07/07/92 COMMENT OF SYNCOR (RICHARD E. KEESEE, VICE PRESIDENT) (

4) 07/13/92 07/09/92 COMMENT OF ACR (GARY W. PRICE, SENIOR DIRECTOR) (

5) 07/13/92 07/20/92 07/10/92 07/10/92 COMMENT OF ILLINOIS DEPT OF NUCLEAR SAFETY (STEVEN C. COLLINS, CHIEF) (

6)

COMMENT OF DR. MILTON A. FRIEDLANDER (

7) 07/24/92 07/22/92 COMMENT OF STEVE MATTMULLER, RPH,BCNP (

8) 07/27/92 07/23/92 COMMENT OF MR. MARVIN I. LEWIS (

9) 10/21/92 09/17/92 FEDERAL REGISTER NOTICE - FINAL RULE

OCKET NUMSER DR ROPOS'~D EUI E1--3 0.. cT5.S OOCK[i[O [S1 f-f2_ 1- '-/ 7 6 3) [7590-01] USNRC 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.

• 9z CT 21 P 3 :25

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 (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 Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3738. 1

SUPPLEMENTARY INFORMATION:

Background

On September 15, 1989 (54 FR 38239), the NRC published in the Federal Register 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 Register 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 (NOA). The Interim Final Rule also included 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. 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 Register that suggested amendments to 10 CFR Parts 30 and 35 to eliminate recordkeeping requirements involving the justification for and a precise 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. 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. 3

Brief descriptions of the issues raised in public comment letters and NRC's responses to these issues are presented 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 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 § 35.200 of the proposed rule which indicated paragraph (i) instead of paragraph (c). Response. This typographical error has been corrected. 4

4.

Comment. A convnenter suggested that if there are no public health and safety issues identified, the authorization to deviate should not expire on August 23, 1993. Response. 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 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 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 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

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 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, 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. 6

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 convnents 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 exception that a typographical error in the proposed rule, in § 35.200 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. 7

The public reporting burden for this collection of information is estimated to be reduced by.05 hour 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 Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-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 Register 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

be expected to reveal any significant new information. Therefore, the NRC believes that these recordkeeping requirements are no longer necessary. The estimated reduction in annual burden would be approximately 1000 hours 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. 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}(l}. 9

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, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237). 10

For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273); §§ 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. 220l(b)); § 30.10 is issued under sec. 16li, 68 Stat. 949, as amended (42 U.S.C. 220l(i)); and §§ 30.6, 30.9, 30.34(9), 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(0)).

2.

In § 30.34, paragraph (i) is revised to read as follows: § 30.34 Terms and conditions of licenses, (i){l) 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" (NOA), 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)(l) 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: 11

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); §§ 35.11, 35.13, 35.20(a) and (b), 35.2l(a) and (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.3l(a), 35.32(a), 35.49, 35.50(a)-(d), 35.5l(a)-(c), 35.53(a)-(b), 35.59(a)-(c), (e)(l), (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), 35.64l(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. 220l{b)); and§§ 35.14, 35.2l{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), _35.5l{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), 35.64l(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(0)).

4.

In § 35.200, paragraph (c) is revised to read as follows: § 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. 12

{c){l) 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" (NOA), 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 § 35.300, paragraph (b) is revised to read as follows: § 35.300 Use of radiopharmaceuticals for therapy. (b)(l) 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" (NOA), provided that the authorized user physician has prepared a written directive as required by§ 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.17:J!day of -J,.,tf;L, 1992. For the Nuclear Regulatory Commission. or Operations. 13

Marvin I. Lewis 7801 Roosevelt Boulevard Suite 62 Phila., PA 19152 (215)624-1574 Secretary United States Nuclear Regulatory Commission Washington, D. C. 20555 Dear Mr. Secretary; DOtKEiEO t1::f'\\ usNRC v_; Y1. JL 21 P3 :08 Please accept the following letter as my comments on 10CFR30&35 Departures from Mfg's Instruction: Elimination of ordkeeping Requirements: Proposed Rule. FR50 Minor Modifications to Nuclear Power Reactor Event Reporting Requirements: Proposed Rule. 10CFR20&50 Reducing the Regulatory Burden on Nuclear Licensees: Proposed Rule. 10CFR Chapter I Review of Reactor Licensee Reporting Requirements: Request for Public Comments. Relatedness of above Federal Register Notices: I request that this letter be incorporated into the dockets associated with the above four (4) Federal Notices. All four notices are related strongly in that all four notices reduce or eliminate paperwork requirements for NRC licensees. The reduction or el imination of paperwork for licensees does not provide any protection of the health and safety of the public

• otection of the Health and Safety of the Public:

The Atomic Energy Act as amended and the Charter of the NRC both require the NRC to act to "protect the health and safety of the public." The above four Federal Notices are actions by the NRC which concern reducing or eliminating regulatory burdens withbut an increase in the pro t ection of the health and safety of the public. While reduction of regu l atory burden may be a wor~hy goal, the NRC ignores its legisl ative mandate to protect the health and safety of the public. Reduction of the regulatory burden is an admitted goal of the present administration. The protection of the health and safety of the public is an NRC goal which is l egislated in the Atomic Energy Act as amended. The will of Congress in the Atomic Energy Act as amended must take prece~ence over an administrative goal. SEP 18 1992 Aelmo\\vfedged by card................... ~... ::::-...

ll.S. NUCLEAn P.!:tJUL!~'I r-Jn'f CCMrl.lSSIOI\\ OGC:<Fr;tK~ ~.~:~H*!:C[ s121..:TION OFVi(,f: OF 7 H;.: SEC8tTARY Cr T1/2E COr1lr.'-13~lON

Elimination of Regulatory Burden Invites Harm: The TMl#2 accident is over a decade in the past. Many studies resulted from the TMl#2 accident. These studies concluded that the regulatory climate was responsible for an attitude or climate which invited disaster. These "modifications" in the four proposed rules present, invite and promote the same kind of att i tude or climate which resulted in the TMI#2 accident. Specifically, many of the lessons learned from the TMI#2 accident concerned departures from instructions and elimination of r e porting requirements. One departure from a,structions in the specifications concerned the leakage limits Wl':lr the reactor coolant. After the TMI#2 accident, the NRC found that the reactor was operating outside of specification because the reactor coolant was leaking out at a rate greater than allowed in its specifications. This leakage information was not widely available due to elimination of certain recordkeeping requirements. The reactor had been allowed to operate because of elimination of recordkeeping requirements and departures from manufacturers specifications. Partially, the accident was occurred because of elimination of recordkeeping requirements and departures from manufacturers* specifications. The Proposed

Rule, 10CFR30 ~ 35, is entitled, "Departures From Manufacturers*

Instructions: Elimination of Recordkeeping Requirements." The title of this Proposed

Rule, "Departures From Manufacturers*

Instructions: Elimination of Recordkeeping Rqu irements," presents the same attitude which lead to the TMI#2 .cident. Although the attitude is the same, the attitude or climate is only part of the problem. This attitude must present a danger to the health and safety of the public for the NRC to prohibit the modifications in the Proposed Rule; "Departures From Manufacturers' Instructions: Elimination of Recordkeeping Requirements." The NRC justifies the elimination of recordkeeping requirements on the ground, "that the major trends in departures are already clear and that collection of additional data would not reveal any significant new information." This "conclusion" by the NRC and FDA staffs directly contradicts a statement in the Federal Register Notice dated 6-22-92 for a workshop on 10CFR 30 and 35 to which the Proposed Rule is addressed: " It is a matter of record that some medical use licensees have administered byproduct material to patients of childbearing potential who were pregnant or breast feeding without knowing the patient's pregnancy or breast feeding status. The consequences were that unintended radiation exposures were delivered to an embryo, fetus, or breast-fed infant."

The contradiction is very clear. On one

hand, the NRC proposes a rule to eliminate record ke e ping requirements and allow departures from manufacturer's instructions in 10 CFR 30 and 35 in the Federal register Notice of 6-26-92.

On the other

hand, the NRC admits that departures from instructions and elimination recordkeeping have led to unintended radiation exposures to

bryo, fetus and breast fed infants in a Notice of a meeting on 10CFR 30 and 35 in the Federal Register of 6-22-92.

The actions arising from these contradictions are very clear. Historically, these actions have lead to the TMI#2 accident. Presently, these actions have lead to unintended radiation exposures of fetus, embryo and bre~~ fed inf~nt. These actions in the Pr'oposed

Rule, "Departures From Manufacturers' Instructions:*

• Elimination of Rec:ordkeeping Requirements,"

contradict the mandate of the Atomic Energy Act as amended to protect the health and safety for the public. I, respectfully, request that the Proposed

Rule, "Departures From Manufacturers' Instructions:

Elimination of Recordkeeping Requirements," be taken back and vacated. "reduce the burden" and "delete requirements." A The Proposed Rules, 10CFR50 Minor Modifications to Nuclear wwer Reactor Event Reporting Requirements and 10CFR20&50 Reduc ing the Regulatory Burden on Nuclear Licensees, attempt to delete reporting requirements for some events that have been determined to be of little or no safety significance and reduce the burden of government regulation without reducing the protection of the public health and safety. These proposed rules suffer from the same attitudes which lead to the TMI#2 accident and which were described above for the Proposed Rule on 10 CFR 30' & 35. The Proposed Rules on 10 CFR 50 and 10 CFR 20 50 also suffer from additional inadequacies. The NRC states, "The reporting of certain types of events are no longer contributing useful information to the operating reactor events database and, therefore, are no longer necessary." I questioned ~ry. this repor~ing was~ longer contributing useful information. I wondered whether e information was no longer J; usefu! or whether the data was being~trsefully evaluated. I sent a short letter to Chairman Selin with my questions on 5-24-92. Mr. Edward L. Jordan answered my letter on 6-26-92. His answer strongly suggests that preconceptions flavor the usefulness of reported i nforma tion.

LL "We would not expect violations to be correlated with plant

age, geographic

location, or other physical characteristics of the plant.**

There may be some correlation with capacity factor,<sic} however, this is not a parameter that we monitor as a measure of safety." Several questions immediately spring to mind. "We would not expect violations to be correlated *** "

1. One reason to develop a database is to discover unexpected correlations.

Not expecting to find a correlation is a very counterproductive attitude to use in the assessment of data bases. "There may be some correlation with capacity factor,(sic> however, this is not a parameter that we monitor as a measure of safety." If you expect a correlation, you should monitor that expected Wlrrelation for safety and other factors. This seems an obvious inadequacy. The reason that the NRC has stated that the deletion of reporting requirement s would have little or no safety significance and that the regulatory burdens can be reduced without in any way reducing the protection for the public health and safety is that the NRC has performed inadequately. The NRC has admitted that the database has not been used to investigate unexpected correlations and has not monitored expected correlations for safety and other factors. (See above.) Ignoring unexpected correlations and not monitoring expected correlations will lead to almost any conclusion. The problem is that the conclusion is merely conclusory and inadequate.

Again, let's not have the climate and attitude which lead to the TMI#2 accident. I, respectfully, suggest and request that f.

ese t wo Proposed Rules, CFR50 Minor Modifications to Nuclear Power Reactor Event eporti ng Requirements: Proposed Rule. 10CFR20&50 Reducing the Regulatory Burden on Nuclear Licensees: Proposed Rule, be taken back and eliminated from consideration. Reactor Licensee Reporting Requirements<10CFR Chapter I>.

Everyday, more and more inadequacies surface. In June, there were six information notices about events and deficiencies which were dangerous. So far in 1992, there are 52 information notices about the dangers surfacing in nuclear power plants.

Considering the many changes, such as plant life extension, low level waste storage on plant sites, higher density spent fuel

pools, more reporting and regulation is required to maintain safety; not less.

I, respectfully, request reactor licensee reporting safety rather than sink back fostered the TMI#2 accident. that the NRC decide to increase to maintain the present modicum of to the attitudes and climate which

fESt.Johns~ Medical Center 615 South New Ballas Road St. Louis, MO 63141-8277 314/569-6000 July 22, 1992 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Gentlemen and Ladies: Ji..t\\t.it. t.: USNHC '92 JUL 24 P 2 : ),$Member of the Sisters of Mercy Health System-St. Louis Please consider this letter in full support of the proposed rule in the Federal Register Volume 57, No. 113, Thursday, June 11, 1992, (RIN 3150-AE23). The elimination of recordkeeping requirements from departures of manufacturer's instructions will certainly relieve the Nuclear Medicine Community of a recordkeeping burden which interferes with the appropriate practice of medicine and pharmacy. At our institution alone of 7800 doses dispensed in a year approximately 4000 would qualify as departures from the manufacturer's instructions. At 0.05 hours per response, the total manhour burden for compliance is an additional three weeks for the year. Not only is this intrusion into the practice of medicine and pharmacy unnecessary it is also very expensive to maintain compliance. Please proceed with a rapid implementation of this proposed rule. Sincerely, ~ Steve Mattmuller, RPh, BCNP Director of Nuclear Pharmacy SEP 18 1992 Acknowfa,t,.,ed by _. QUW C81u.............. "'....... "'""'" St. John's Mercy Medical Center includes St. John's Mercy Hospital (Washington, Missouri), St. John's Mercy Home Health Services, St John's Mercy Skilled Nursing Center, St John's Surgery Center, The Edgewood Program and Meacham Park Health Center. St John's Mercy Medical Center is an equal opportunity employer and equal access provider of health care services.

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Dean M. Brockmole, M.D. Medical Director, Department of Radiology [ i., 1., 1'\\l i i I Associates: U5NkC Jinan O Bahia, M.D. G. Thomas Balsbaugh, M.D. Joseph B. Bellissimo, M.D. Richard R. Brock, M.D. Richard M. Fence!, M.D., FACR Milton A Friedlander, M.D., FACR Leonard C. Griff, M.D.

• 92 Jll 20 Pl2 :41 2601 North Third Street Harrisburg, Pennsylvania 17110 Mork A Guenin, M.D.

Joachim J. Huerter, M.D. Michael J. Mandell, M.D. John C. Morton. M.D. Frederick C. Newton, M.D. Richard J. Pawelski, M.D. Albert R. Porter, M.D. James W. Warren, M.D. Theodore A Tristan, M.D., FACR Consulting Staff Robert M. Olley, R.T. Administrative Director Secretary of Commission U.S.N.R. C. Washington, D.C. 20555 10 July 1992 Attention: Docketing and Service Branch

Dear Gentlemen:

Telephone (717) 782-4250 Fax (717) 782-4256 Divisions: Angiography Computed Tomography Diagnostic Radiology Nuclear Medicine Radiation Oncology Radiologic Sciences Ultrasound I would like to go on record as favoring a change in the rules with respect to administering drugs in a manner not approved on the package insert. It i s time for physicians in the Nuclear Medicine community to practice medicine the way all other physicians must practice medicine, without respect to package inserts. These are good for guidance, but should not be considered "hard and fast rules." This occurs in the rest of the medical practice, and there is no reason for the Nuclear Regulatory Commission to be overzealous in making physicians adhere to package insert guidelines. After all, when physicians make mistakes with respect to patient care, legal action is a much more prompt and effective control than NRC regulation. Thank you for your interest. MAF/crd SEP 18 \\992

U.S. NUCLEAR REGULATORY COMMISSIOt-. DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARV Of THE COMMISSION Document Statistics Postmark Date 0/1~,/9..:>- Copiis Received _ ____.,_ __ Add'I Copies Reproduced - -"----- Special Distribution,...L.l,{.J...J.~i.--c.....t...!U=:::'...- C

THOMAS W. 0RTCIGER DIRECTOR

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. :~Ui',1!jt:t1 PROPuSED RULE R 3 0 J-o S" (_ 5 7 F rz 2 t-/ 7 6 3} 1 0 Lt\\[ 1 LO u::it-mc

• 92 JUL 13 P3 :51 STATE OF ILLIN0IS

. ~*, .. _. ; v DEPARTMENT OF NUCLEAR SAFEfii'cYl-,T~G:,,;,l~~i, 1t1 1u uCl:-f-.t * ~ ~

• 1035 OUTER PARK DRIVE

,!{ANC ~ SPRINGFIELD, IL 62704 (217) 785-9900 July 10, 1992 JIM EDGAR GOVERNOR Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch Re: Proposed Rule, "Departures From Manufacturer' s Instructions; El imi nation of Recordkeeping Requirements" Gentlemen: The Illinois Department of Nuclear Safety* (Department) hereby submits its comments on the above-identified proposed rule. The proposed rule represents changes to 10 CFR Parts 30 and 35 that would eliminate recordkeeping requirements related to the justification for and a precise description of departure from the Food and Drug Administration ' s (FDA) approved manufacturer' s instructions for preparing radiopharmaceuticals. The Department agrees that these recordkeeping requirements should be deleted from the regulations, especially if there is no furth~r benefit from collecting and analyzing the data. However, the Department is concerned about the language contained in the proposed rule. The proposed rule is confusing since one of the sections designates paragraphs incorrectly, and the effective dates of the proposed rule appear to be set arbitrarily. For example, Item 4 of the proposed rule indicates that 10 CFR 35.200(c) [Note typogr aph ical error in text of rule indicating paragraph (i) instead of paragraph (c) ] would be revised to allow departures from the manufacturer's instruct ions only from August 23, 1990 to August 23, 1993. 10 CFR 35.200(b) still requires licensees to elute generators and prepare kits in accord~nce with the manufacturer's instructions. Does this mean that licensees would be allowed to deviate from the manufacturer's instructions until August 23, 1993, and then they could no longer deviate? This seems inconsistent with the information obtained in NRC and FDA's evaluation of the major trends in deviations from manufacturer's instructions. If there is no public health and safety issue identified, the authorization to deviate should not expire on August 23, 1993. @*oyolobo

U.S. f\\:I,,. *

* ~: * **i.>,W COMMISSIOt-.

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_*tMCE SECTION U~., 1-:.:~ ()* T,iE SECRETARY Or Tnc crn.~~;liSSION Documer.! St;)t:st*cs

Proposed Rule Page 2 10 CFR Parts 30 and 35 Sections 30.34(i), 35.200(c) and 35.300(b) in the proposed rule should be amended to allow deviations to continue beyond the August 23, 1993 date, in accordance with directions from an authorized user physician. The Department suggests in all three circumstances, that the language be changed to read, "From (the effective date of this part),... " In addition to the changes described above, additional changes should be made to avoid confusion. Section 35.200(b) should be deleted because it requires licensees to prepare kits in accordance with the manufacturer's instructions, which would be contradictory to the revised Section 35.200(c). Section 35.300(a) also should be amended by deleting the sentence stating, "The licensee shall comply with the package insert instructions regarding indications and method of administration" because it would be contradictory to the revised Section 35.300(b). In general, t he Department agrees with the proposed rule, with the modifications described above. If you have any questions regarding these comments, do not hesitate to call me or Kathy Allen at (217) 785-9947. Sincerely, d6~ ~ Steven C. Coll ins, Chief Division of Radioactive Materials SCC:KAA:ka cc: B.J. Holt SEP 18 1992 Acknowledged by card................... "............,

DOCKET NU.~BER PROPOSED RULE PR 3 tJ r}---~S ( 51 Ffl- ;J..L/ 7&'3) July 9, 1992 Secretary of the Commission Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Services Branch

Dear Secretary:

JLr,L r * {} USNi~C

• 92 JUL 13 A11 : 1 8 On behalf of the over 28,000 physician and physicist members which comprise the American College of Radiology (ACR), I respectfully submit the following comments concerning the NRC proposed rule on "Departures from manufacturer's instructions; elimination of recordkeeping requirements," as published in the Federal Register, June 11, 1992.

The ACR applauds the decision rendered by the NRC in the proposed rule to eliminate the unnecessary recordkeeping requirements related to the preparation and use of radiopharmaceuticals. The ACR appreciates the fact that the NRC has weighed the relative merits of continuing the recordkeeping requirements and has proposed to eliminate those requirements because they would provide little additional information while continuing to impose unnecessary costs to the industry. The ACR looks forward to an expeditious implementation of this proposed rule to alleviate the continuance of any unnecessary additional costs to NRC medical licensees. If you have any questions or concerns, please do not hesitate to call. Sincerely, r Gary Senior Director Government Relations Department GWP/bws A SEP 18 1992 cknowfedged by card....................... :~ AMERICAN COLLEGE 0 F RADIOLOGY 1891 Preston White Drive, Reston, Virginia 22091 (703) 648-8900

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• ';.t'r. SECTION
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syncor* DOCKET NUMBER PR 3 A L :- r ROPOSED RULE..:..;,:___,_v _o_, -v.7 l51 Ffl 1. L/763 [ ul t\\[ l U.J USNRC July 7, 1992

• 92 JUL 10 P12 :57 Mr. Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C.

20555 Re: Proposed Amendment of 10 C.F.R. Parts 30 and 35

Dear Mr. Chilk:

On June 11, 1992, the Nuclear Regulatory Commission (NRC} published in the Federal Register, 57 E.rui- ~- 24763, a notice of proposed rulemaking to amend its regulations concerning certain record.keeping requirements related to the preparation and use of radiopharmaceuticals. The public was invited to comment by July 13, 1992. Syncor International Corporation (Syncor) fully supports the proposed amendment to 10 C.F.R. parts 30 and 35 and commends the NRC for eliminating this unnecessary and costly requirement. The record.keeping requirements which NRC now proposes to eliminate were part of a regulation which the NRC termed an "Interim Final Rule" which was published in the Federal Register of August 23, 1990, 55 Fed. Reg. 34513. That rule was promulgated in response to a petition for rulemaking filed in 1989 by the American College of Nuclear Physicians and the Society of Nuclear Medicine (ACNP/SNM} which complained that the NRC's requirement that physicians and pharmacists follow verbatim the package insert of approved radiopharmaceutical products failed to recognize the historic state-governed rights to practice medicine and pharmacy. The NRC granted part of the requested relief by issuing an interim final rule which permitted certain deviations from package inserts provided certain record.keeping requirements were met. The NRC said that the record.keeping requirements would permit it to gather data on departures and consult with the FDA before taking further regulatory action. The interim rule allows NRC licensees who elute generators and prepare reagent kits to depart from the manufacturer's instructions in the package insert provided certain record.keeping requirements are met. 10 C.F.R. S 35.200. In addition, the interim final rule permits licensees using byproduct material in a radiopharmaceutical for a therapeutic use to depart from the package insert regarding indications and method of administration if certain record.keeping requirements are met. 10 C.F.R. § 35.300.

==E:-.JI SEP 18 1992 Innovators in high-tech pharmacy services Acknowledged by eard........................ _.,,,,.. Syncor International Corporation

• 20001 Prairie Street
• Chatsworth, California 91311 (818) 886-7400
• FAX 886-6028
• Telex MCI 67-18642 Syncor CHATS

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Mr. Samuel J. Chilk July 7, 1992 Page 2 The interim final rule amended 10 C.F.R. S 30.34 to permit commercial nuclear pharmacies to engage in activities within the scope of S 35.200. For situations not within the scope of S 30.34, a commercial nuclear pharmacy l icensee may file an application to have its license amended to permit specific departures from the manufacturer's instructions for identified products. The proposed amendment deletes the recordkeeping requirements of the interim rule based upon a determination by the NRC that "major trends in departures are already clear and that further collection of additional data would not reveal any significant new information." 57 Fed. Reg. 24764. Syncor agrees with that assessment and believes it evidences a further recognition by the NRC that overly intrusive "restrictions governing the preparation of radiopharmaceuticals and the indications and the methods of administration for therapeutic use of radiopharmaceuticals would not permit proper patient care to be provided to some pati ents." 55 Fed. Reg. 34514. syncor supports these efforts by the NRC to reduce the regulatory burden on the medical and pharmacy professions and to recognize the appropriate scope of the practice of pharmacy. As the NRC continues to consider other issues raised in the ACNP/SNM petition, Syncor urges the adoption of a regulatory philosophy which removes federal obstacles currently preventing nuclear pharmacists from compounding radiopharmaceuticals in a manner consistent with their professional licenses granted by State Boards of Pharmacy. 72;:Jr.~ ~ Ri chard E. Keesee, Pharm.ti., B.C.N.P. Vice President, Quality and Regulatory

__ I ,. u.,!tJCr\\ ~n r-Fr;0?0sEo RULE r 3 0--J--3J g 11_0_1 _C_on_n_e_ct_ic_u_t A_v_e_nu_ec_' _N 5 _w_ 7 _. _: _~-tltet1a7bf: \\t.*:+~~Batr:_. 6 _in_} _o_: _, D_.C_._2_00_3_6 _ _ ~~ (202) 429-5120 USNHC Fax (202) 223-4579 The Society of Nuclear Medicine American College of Nuclear Physicians July 9, 1992 Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention: Docketing and Service Branch

Dear Mr. Chilk,

• 92 JUL 10 A 9 :14 G)

We are writing on behalf of the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) in support of the proposed rule to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals (57 Federal Register 34764). The ACNP and SNM represent 12,000 nuclear medicine physicians, scientists, radiopharmacists and technologists involved in nuclear medicine clinical practice and research. In comments submitted previously to the Nuclear Regulatory Commission (NRC), the ACNP and SNM objected to the recordkeeping requirement associated with departures from the Food and Drug Administration's (FDA) approved manufacturer's instructions. The criteria included in the interim final rule (in response to the ACNP and SNM petition for rulemaking) are overly restrictive and limit the physician's ability to exercise medical judgement, particularly in situations of emergent care. The ACNP and SNM also believe that the requirement for recordkeeping and retention of records, which would be subject to inspection, created a regulatory burden for medical licensees. We are not aware that our colleagues in other medical specialties are subject to similar recordkeeping requirements or inspection of records. SEP 18 1M Acknowtedged by card............................ :.:...

Letter to Mr. Chilk July 9, 1992 Page 2 We commend the staff of the NRC and the FDA in their coordinated effort to eliminate the recordkeeping requirement of the interim final rule. We look forward to further coordination between the agencies as rulemaking proceeds on other unresolved issues related to the ACNP and SNM petition. Robert J. Lull, M. D. President American College of Nuclear Physicians Sincerely, Paul H. Murphy, Ph. D. President Society of Nuclear Medicine

June 24, 1992 Samuel Chilk, Secretary USNRC 11555 Rockville Pike Rockville, MD 20852 Re: RIN 3150-AE23; FR 11 June 92

Dear Mr. Chilk:

UCLA SCHOOL OF MEDICINE HARBOR - UCLA MEDICAL CENTER DEPARTMENT OF RADIOLOGY 1000 CARSON STREET TORRANCE, CALIFORNIA 90509 I wish to support the termination of the recordkeeping requirements of the Immediately Effective Interim Final Rule. I wish to support the termination of the rest of the Rule as well, in favor of the provisions detailed in the ACNP/SNM Petition of June, 1989. The Petition, unresolved after three years, has appropriate language to serve both nuclear medicine physicians and nuclear pharmacists. The Immediately Effective Interim Final Rule serves physicians poorly and incompletely and pharmacists not at all. Thank you for your attention and consideration. Sincerely, ~ Carols. Marcus, Ph.D., M.D. Director, Nuclear Med. Outpt. Clinic and Assoc. Prof. of Radiological Sciences UCLA cc: Kristen Morris CSM:sfd

U.S. f*llJfl ::A;:i AEGULATOAY COlv:MISSIOf\\ QO~t<,.:T:NG & SERVICE SECTION OrTICE or 7L~f SECEE, 11.RY OF THE: CO~ifv~!BSlON n~cu;r,er.t Statistics Postnarr. 03t".l _ 6 /:L 'JJ. fL __ _ Copies Rec:ei*.;cre _ ...,/ ______ _ /*dd'I Copies Al1pro,juced..l_ Spocial Dl~hibu!aon iZLO~ Po~ _:rone r

REPLY TO ATTN OF:

SUBJECT:

TO: LJVvf\\c 1.-..umccn PR PROPOSED RULE ) O d-3S (5"1 F- /2. 2-~17 63) DEPARTMENT OF THE AIR FORCE HEADQUARTERS AIR FORCE OFFICE OF MEDICAL SUPPORT BROOKS AIR FORCE BASE, TEXAS 78235-5000 84:JUN 199P2 JUN 30 P 3 :47 SGPR ,-,rr,c:~ OF SL\\l~CiAtd OOCKi-T tNG,;*~ 1.r_11V\\Cl. Departures From Manufacturer's Instructions ; El lmlnatlo n of BR f.NC~ Recordkeeplng Requirements - Proposed Rule Secretary of the Commission U. S. Nuclear Regulatory Commission ATTN: Docketing and Service Branch Washington DC 20555 1. Please reference subject proposed rule In the Federal Register, Vol 57, No. 113, Thursday, June 11, 1992. We strongly support the proposed el lmlnatlon of records keeping requirements. 2. Consistent with other records disposition practices of NRC, we suggest al lowlng the disposition of records of departure ted under th curr e nt rule after three years since the have appar n ly served their purpose. cc : HQ USAF/SGP

U.S. NU'..:.,,.. ~E:G:JtAT:)~ COMMISSIOtc oc* ~ *(~1},1i SERVICE SECTION L*.---: ;.: or THE S!:CRETARY Oi THE CQM;v11SSION Document Statistics Postmark Date 6 / LS /1l... Copies Received __ .._/ ____ _ Addi Coples Reproduced.:i,:;J ____ ____,_ Speeial Oiiilribulion fl iaf>, P),J ~. _;;Ian~s

4 ~ ~y~~-~:41 ~ S8ftt l) t.r.~* Offl&8 of Ul8 F4'dnra! Rogistti '.or D~,L\\. _.- DOCKET NUMBER PROPOSED AULS Pl 3 0 J-3 S (57 Ff<2-'o/7t,) [JO(;K!-.1 [, [7590-lGil{llC -/illkAJoi/111 /./PAI-NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 35 RIN: 3150 - AE23 '92 JUN 25 Pl2 :44 Departures From Manufacturer's Instructions; Elimination of Recordkeeping Requirements AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals. Specifically, the proposed rule would eliminate recordkeeping requi rements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration's (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. 7 /;3/Cj1.. DATE: Submit comments by (30 days foll owing publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

ADDRESSES: Mail written convnents to the Secretary of the Comission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m., and 4:15 p.m. on Federal workdays. Copies of any public conunents received may be examined at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC 20555. FOR FURTHER INFORMATION CONTACT: Samuel Z. Jones, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555, telephone (301) 492-3738. SUPPLEMENTARY INFORMATION:

Background

On September 15, 1989 (54 FR 38239), the NRC published in the Federal Register 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 radiophannaceuticals and (2) the* use of radiophannaceuticals for therapeutic 2

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 I Register an inte~im 1final rule granting the petition,. in part, to specifically I allow departures from the manufacturer's instructions for preparing diagnostic radiopharmaceutitals using generators and reagent kits for which the FDA has I approved a Ne~ 1 Drug Application (NOA). The interim final rule included a I provision wlyich terminates the rule on August 23, 1993. This action was taken ) after coniulting with the FDA and with the intention that the provision might becom~;~~rm~nent after further experience had been gained under the new //i~ion, including an assessment of data documenting the departures. The J'NRC's original intent was to examine this documentation and make it 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. The NRC and FDA staffs have concluded that the major trends in departures are already clea~ and that collection of additional data would not reveal any significant new information. The NRC is, therefore, proposing to amend 10 CFR Parts 30 and 35 to eliminate recordkeeping requirements involving the justification for and a precise description of the departure, and the number of departures from the FDA-approved manufacturer's instructions. Also, the FDA staff has no objection to eliminating these recordkeeping requirements. 3

Environmental Impact: Categorical Exclusion The NRC has determined that this proposed 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 proposed rule. Paperwork Reduction Act ~---~ This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements. Public reporting burden for this collection of infonnation is estimated to be reduced by.05 hours 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 infonnation. Send comments regarding this burden estimate or any other aspect of this collection of infonnation, to the Information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Conunission, Washington, DC 20555; and to the Desk Officer, Office of Infonnation and Regulatory Affairs, NEOB-3019, (3150-0010 and 3150-0017), Office of Management and Budget, Washington, DC 20503. 4

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 are met. One of the conditions is for licensees to maintain records of such departures. The NRC is now proposing to amend 10 CFR Parts 30 and 35 to delete these recordkeeping requirements. The alternative to this proposed action is to maintain the status quo. However, the NRC and FDA staffs have concluded that the major trends in departures are already clear and that collection of additional data would not reveal any significant new information. Therefore, the NRC believes that these recordkeeping requirements are no longer necessary. The estimated reduction in annual burden would be approximately 1000 hours for NRC licensees. The NRC concludes that this proposed action is justified due to the net annual savi_ngs to NRC licensees without compromising 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, if adopted, will not have a significant economic impact on a substantial number of small entities. This proposed rule would affect medical use licensees including some private practice physicians. Some of these licensees would be considered small 5

entities under the NRC's size standards (56 FR 56672; November 6, 1991). The proposed rule would eliminate recordkeeping requirements that the NRC and FDA staffs agree are no longer necessary. This would reduce the regulatory burden on all medical use licensees, including small entities. Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule, and therefore, a backfit analysis is not required ) for this proposed rule, because these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(l). 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. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 30 and 35. 6

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, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec.

187, 68 Stat. 955 (42 U.S.C. 2237). For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273); §§30.3, 30.10, 30.34(b), (c), (f), {g) and (i), 30.41 {a) and (c), and 30.53 are issued under secs. 161b, 68 Stat. 948, as amended {42 U.S.C. 2201{b)); §30.10 is issued under sec. 1611, 68 Stat. 949~ as amended (42 U.S.C. 220l(i)); and §§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(0)).

2.

In § 30.34, paragraph (i) is revised to read as follows: § 30.34 Terms and conditions of licenses. (i)(l) From August 23, 1990, to August 23, 1993, each licensee eluting generators and processing radioactive material with diagnostic reagent kits 7

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)(l) 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: 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); §§35.11, 35.13, 35.20(a) and (b), 35.2l(a) and (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.3l(a), 35.32(a), 35.49, 35.SO(a)-(d), 35.Sl(a)-(c), 35.53(a)-(b), 35.59(a)~(c), {e){l), {g) and (h), 35.60, 35.61, 35.70(a)-(f), 35.75~ 35.BO(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), 8

35.634{a)-(e), 35.636{a) and {b), 35.64l{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. 220l{b)); and §§35.14, 35.2l(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.Sl(d), 35.53{c), 35.59{d) and (e)(2), 35.59(g} and {i), 35.70(9), 35.BO(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(9), 35.634(f), 35.636(c), 35.64l(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(0)).

4.

In § 35.200, paragraph (c) is revised to read as follows: § 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. {c)(l) 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 ApplicationR {NOA), 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. 9

5.

In § 35.300, paragraph (b) is revised to read as follows: § 35.300 Use of radiopharmaceuticals for therapy. (b){l) 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 prepared a written directive as required by§ 35.32(a). (2) Nothing in this section relieves the licensee from complying with other applicable NRC, FDA, and other Federal or State regulations. el: Dated at Rockville, Maryland, this,;J.f day of May 1992. For the Nuclear Regulatory Comission. ~~ tyecutive Director for Operations}}