ML20044C023
| ML20044C023 | |
| Person / Time | |
|---|---|
| Issue date: | 09/28/1992 |
| From: | Meyer D NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Callahan M NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| Shared Package | |
| ML20044C014 | List: |
| References | |
| FRN-57FR45566, RULE-PR-30, RULE-PR-35 AE23-2-008, AE23-2-8, NUDOCS 9303160293 | |
| Download: ML20044C023 (12) | |
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UNITED STATES c,
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,E NUCLEAR REGULATORY COMMISSION 8
WASHINGTON, D.C. 20565 o
SEP 2 81992 MEMORANDUM FOR:
Michael Callahan Senior Congressional Liaison Officer Office of Congressional. Affairs FROM:
David L. Meyer, Chief Rules and Directives Review Branch Division of Freedom of Information and Publications Services Office of Administration
SUBJECT:
TRANSMITTAL OF CONGRESSIONAL LETTERS Attached are 3 copies of Congressional letters prepared for the following Federal Register notice, Final Rule, " Departures From Manufacturer's Instructions; Elimination of-Recordkeeping Requirements."
Also attached is a copy of the public announcement concerning this final rule.
The notice was forwarded on September 29,- 1992, to the Of'
' of the Federal Register for publication.
/
/'
David L. Meyer,. Chief Rules and Directives Review Branch Division of Freedom of Information and Publications Services Office of Administration Attachments:
As stated 9303160293 930309 PDR PR 30 57FR45566-PDR
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October 5,.1992 The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to:
be published in the Federal Reaister, t
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to _the preparation or use of radiopharmaceuticals.
These requirements have been in' place since August 23, 1990.
Specifically, this rule will eliminate recordkeeping requirements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting i
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.
t l
Sincerely, I
Original signed by/
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Dennis K. Rathbun, Director I
Office of Congressional Affairs
Enclosure:
J f ederal Rechter Notice cc: Senator Alan K. Simpson
- See previous concurrences-Offc: DDB:DRA*
RDB:DRA*
RDB:DRA*
DD:DRA:RES-D:DRA:RES DD:MRES D:RES Name:
SJones JTelford PLohaus FCostanzi'F BMorris V' CHeTQmes KBeckjrd.
Date: 09/04/92 09/040/92 09/04/92 7 /! /92 g/ n /92 q/O}/92 t/p;/92 D:0 @ M) [N Offc:
ED0 Name: JMTa71or DRathbun Date:
Q/ (\\ /92 ef /p'//92 0FFICIAL RECORD COPY
The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaister.
The Nuclear Regulatory Commission (NRC) is amending its regulations to y-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 /y 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, a.lso, 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.
7 The estimated reduction in annual burden wou]d 'be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
/
/
Sincerely,
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6 Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Reaister Notice l
SenatorAlanIISimpson cc:
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October 5,1992 The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Commiti.ee 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.
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements have been in place since August 23, 1990. Specifically, this rule will eliminate recordkeeping requirements related to the justification for and a precise description.of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions.
The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
Sincerely, Original signed by/
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc:
Representative Carlos J. Moorhead
- See previous concurrences Offc: DDB:DRA*
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0FFICIAL RECORD COPY
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.
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 eli_minate 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 jThe 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 alr'eady discernible and collecting additional data is unnecessary.
/
The estimated reduction in annual.birden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
/
/
Sincerely,
/
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Dennis K. Rathbun, Director
/
Office of Congressional Affairs
Enclosure:
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Federal Reaister Notice
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Representati've Carlos J. Moorhead cc:
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October 5, 1992 The Honorable Peter H. Kostmayer, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a final rule to be published in the Federal Reaister.
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals.
These requirements have been in place since August 23, 1990.
Specifically, this rule will eliminate recordkeeping requirements related to the-justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. The FDA staff, also, has no objection to eliminating these recordkeeping requirements.
Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
The estimated reduction in annual burden would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
Sincerely.
Original signed by/
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc:
Representative John J. Rhodes
- See previous concurrences s
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Date:
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/ /92 0FFICIAL RECORD COPY
7 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 cc 'y of a final rule to be published in the Federal Reaister.
The Nuclear Regulatory Commission (NRC) is amending,fts regulations to eliminate certain recordkeeping requirements related to the preparation or use of radiopharmaceuticals. These requirements havegteen in place since August 23, 1990. Specifically, this rule will eJiminate recordkeeping requirements related to the justification for apd a precise description of the departure, and the number of departures from t,he 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 theFDAstaffsagreethatthemajortrends/indeparturesthatmaybe identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
/
j The estimated reduction in annual burde/
n would be approximately 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> for NRC licensees.
/
Sincerely,
[
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Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
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Federal Reaister Notice [
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RepresentativeJohnJ. Rhodes
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,3 NRC ELIMINATES CERTAIN RECORDKEEPING REQUIREMENTS 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 l
Administration (FDA).
Specifically, the revisions to Parts 30.
and 35 of the Commission's regulations eliminate recordkeeping i
requirements related to the justification for each departure, a precise description of each departure, and the number of departures.
'{
On August 23, 1990, the NRC issued an interim final rule granting, in part, a petition from the American College of l
i Nuclear Physicians (ACNP) and the Society of Nuclear Medicine j
(SNM).
The ACNP and SNM had asked the NRC to amend its l
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 j
package insert containing the approved manufacturer's J
instructions.
The interim final rule allowed departures from the
-j manufacturer's instructions for preparing-diagnostic radiopharmaceuticals using generators and reagent kits for which-1 a
the FDA has approved a New Drug Application.
It also included 1
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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 ne NRC and the Food and Drug Administration staffs agree that the major trends in departures that might be identified by.the recordkeeping requirements are already clear;. collection _of additional data would not be expected to reveal any significant 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 l'
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45568 Feder:1 Regi:ler / Vol. 57, No.192 / Frid:y, October 2,1992 / Rules end Regnhtions l 1137.7 l$uspended in Partl
Background
requirernents. The lasue of whether
- 2. In i 1137.7fb), for the months of On September 15,1989 (54 FR 38239),
departures, as set out in the Interim September 1992 through February 1993, the NRC published in the Federal Final Rule, should be allowed on a in the second sentence of i 1137.7[b),
Register a notice of receipt of a petition permanent basis is currently under the words " plant which hae quahfied as for rulemaking (PRM-35-e) fmm the consideration by the NRC as part of its a" and the words "of March through American College of Nudear Physicians effort to resolve PRM-35-9.
August"; and (ACNP) and the Society of Nuclear Public Comments and NRC's Responses Medicine (SNM).De ACNP and SNM
$ 1 37.12 iSuspended in Partl requested, among other things, th6t the The NRC received nine comment
- 3. In i 1137.12(s)(1), for the months of NRC amend its regulations in 10 CFR letters in response to the proposed rule.
September 11N2 through August 1993:
part 35, " Medical Use of Byproduct In terms of the types of organizations, in the first sentence of i 1137.12(al(1). Material" to recognize their appmpriate thene were three comment letters from the words "from whom at least three practice of medicine and to allow:(1) hospitals and clinics, two from deliveries of milk are received during Departures from the manufacturer's professional associations, and one each the month at a distnbuting pool plant":
instructions for preparing diagnostic from an Agreement State, a pharmacy, a and in the second sentence "30% in the radiopharmaceuticals and (2) the use of Federal agency, and an individual months of March, April. May, June, July, radiopharmaceuticals for therapeutic member of the public. Eight of the letters and December and 20 pertent in other indications and methods of suppoded the proposed amendments months of", as well as the word administration not included in the mA and one letter opposed the rule.
~s
" distributing".
approved package insert.
Brief descriptions of the issues raised Dated. Smemter 29.1991 On August 23,1990 (55 FR 34513), the in public comment letters and NRCs LP. Massam, NRC published in the Federal Reg! ster ' responses to these issuas are presented Acting Administrator.
an bMai Final Rule granting the in the following paragraphs.
pet tion. in part, to specificahy aHow 1 Comment A commenter suggested
[FR Doc. 92-23958 filed 10-1-92,8.45 mm]
departures from the manufacturer's that the NRC allow the disposition of instructions for preparing diagnostic records of departures generated under
__ radiopharmaceuticals using generators the Interim Final Rufe after 3 years and reagent kita for which the FDA has (Instead of 5 years as specified in the NUCLEAR REGULATORY approved a New Drug Application Interim Final Rule) because the records COMMISSION (NDA). He Interim Final Rule aise have apparently served their purpose.
8 RC3Ponse.The NRC agrees that the 10 CFR Parts 30 and 35 the specific nature of the brief statement of the rea, departure.arecords have served their purpose and sons for the additional retention of these records is departure, and the number of not necessary.%is rule eliminates the Departures From Manufacturer's departures. The Interim Final Rule is retention period for these records.ms, instructions; Elimination of effective through August 23,1993.Tlu.s as of the effective date of this rule.
R:cordkeeping Requirements acWn was taken after consulung wMa licensees are no longer required to keep the FDA and with the intention that the records of departures carried out under AQtMCY: Nuclear Regulatory provision might become permanent after the Interim Final Rule.
Commission.
further experience had been gained
- 2. Commera A commenter suggested t.CTior Final rule.
under the new provision, including an the termination of the rernainder of the assessment of bcensee documentation Interim Final Rule in favor of the SUMM A RY:The Nuclear Regulatory of departures.The NRCs ortsmalintent provisions detailed in the ACNP-Sf&l Comnussion (NRC) is amending its was to examine this documentation and regulations to eliminate certain rnake it available to the FDA and to Petition (PRM-35-9).
recordkeeping requirements related to consult with the FDA prior to any RerPanse. %e NRC is currently tha preparation and use of decision regarding either revision or considering allissues raised in the ra diopha rmaceu ticals. SpecificaDy, tids continuation of the laterim Final Rule or ACNP-SNM Petition. NRC consideration rule eliminates recordkeeping making it permanent.The NRC staff has includes the continnation of departures as cet out in the Interim Final Rule.
requirements reisted to the justification recently consulted with the FDA staff on for and a precise description of the the documentation collected to date.
liowever, at this time the NRC is departure, and the number of departures Based on this documentation, the NRC limiting this rulemaking to the from the Food and Drug Administration and FDA staffs concluded that the major recordkeeping requirements and has (FDA) approved manufacturer's trends in departures are already clear determined not to expand this instructions. Both the NRC and the FDA and that collecting additional data rulemaking to include the termination of staffs agree that the maior trends in would not be expected to reveal any the remainder of the Intedm Final Rule.
departures that may be identified by this significant new informa tion. On June 11 That subject. the termination of the recordkeeping are already discernible 1992 (57 FR 24763), the NRC published a remainder of Interim Final Rule, wt!! be and coIIecting additional data is proposed rule in the Federal Reg
- ster covered when the NRC has completed urmecessary.
that suggested amendments 1o 10 CFR its consideration of the ACNP/SNM ErrtcTivt part: October 2.1992.
parts 30 and 35 to eliminate
- petition, recordkeeping requirerments involving
- 3. Comment. A commenter noted a FOR PURTMER MORMATION CONTACM the justification for and a preclSe typographical CITor in the text of Samuel Z. Jones, Offree of Nuclear description of the departure and the i 35.200 of the proposed rule which Regulatory Research. U.S. Nucicar ruumber of departures from the FDA indicated paragraph (i)instead of Regulatory Comrnission. Washington, approved manufacturer's instructions.
paragraph (c).
DC 20555. telephone (301) 493-3738.
The FDA staff had no objection to Response. This typographical emir SUPPtIMENTARY WO8udAThonc elimina ting these recordkeeping has beca correcter.k 6
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)*.
Federal Reg! ster / Vol. 57, No.192 / Frey Octhber 2,1992 / Rul:s an8 Regulations 45567
- 4. Comment A commenter suggeeted eliminate a regulatory burden that is no instructions searching existing data that if there are no public health ard longer needed.The NRC has collected sources, gathering and maintaining the safety issues identified, the data specific to hoensees' departares data needed, and completing and euthorization to deviate should not from manufactu.rer's instructions.The reviewing the collection of information.
expire on August 23,1993.
NRC and FDA staffs have mncluded Send comments regarding this burden Response. The purpose of this rule is that the major trends in departures are estimate or any other aspect of this to provide relief to licensees concerning already clear and that collecting collection of information, to the the recordkeeping burden related to the additional data would not be expected Information and Records Management requirements in the Interim Fmal Rule.
to reveal any significantly new Branch (MNB&7714), U.S. Nuclear Therefore, the effective period of this information. This rule is not mnnected Regulatory Commission, Washington, rule was intentionally used to be to the issue concerning inadvertent DC 20555; and to the Desk Officer, consistent with the effective period of radiatica exposures to an embryo, fetus. Office ofInformation and Regulatory the Interim Final Rule.
or bmast. feeding inicnt. In particular.
Affairs. NEOW3019. (3150-0010 and The NRC anticipates that the ACNP-the NRC has not stated that departures 31504X)17), Office of Management and SNM petition (pRM-35-9), including the from manufacturer's instructions have Budget. Washington, DC 20503.
issues associated with the Interm fmal led to an unintended radiation exposure Rule will be resolved prior to August 23, to an embryo, fetus, or breast-feeding Regulatory Analysis 1993 infant. Also, the NRC staff is not aware in August 1990, the NRC tmplemented
- 5. Cociment A connnenter opposed of any cases involving an unintended an Inter:m Final Rn!c allowing licensees l
this rule. The commenter pmvided the radiation exposure to an embryo, fetus, to depart from the manufacturer's I
following rationale:
or breast-feeding infant that has been instructions for preparing diagnostic (a) While reduction of regulatory caused by a licensee departing from a radiopharmaceuticals, and to depart burden may be a worthy goal, the manufacturer's instructions. Therefore, from the package insert instructions legislative mandate to pmtect public the NRC sees no contradiction between regarding use of radiopharmaceuticals health and safety must tak e precedence the rationale for this rule and the for therapy, provided that certain over an administrative goal; statement made in the public workshop cor.ditions were met. One of the (b) The modification in this rule would notice.
conditions was for licensees to maintain invite and promote an attitude or The issue regarding unintended records of such departures.
climate which resulted in the nree Mile radiation exposums to en embryo, fetus, On June 11.1992, the NRC published Island accident, and thus, would present or breast-feeding infant hem medical in the Federal Register a proposed rule a danger to the health and safety of the use of byproduct materialis currently that would delete these recordkeeping public: and under study by the NRC to determine requirements (57 FR 24763). Nine (c) The NRC,s rat,onale for tids rule whether any regulatory action is comment letters were received. eight i
contradicts a statement made by the necessary.
- suppoded and one opposed this rule..
NRC, in a Federal Register notice announcing a public workshop (57 FR Discussion of the Final Rule Text ne only alternative to tids action is 27711: June 22,1992), that some snedical Based on public comments and NRC's ee e
d a
s have use licensees have administered responses discussed above, no c nel ded that the major trends in byproduct material to patients who are substantive changes to the final rule are t ru pregnant or breast-feeding without necessary.hs, the text of the final rule knowing the patient s pregnancy or remains the same as the text of the 8 ad it 1
a d
be expected to reveal any significant new breast-feeding status.
proposed rule with the exception that a inf rmation. Therefore, the NRC Response. With respect to the first typograpidcal error in the proposed rule.
believes that these recordkeeping point, the elimination of the in i 35.200 paragra ph (i), has been mquements are m longer nessam recordkeeping requirements addressed correctly identified as paragraph (c).
in this rule wdl not compromise public The estimated reduction in annual health and safety because this rule EnvironmentalImpact: Categorical burden would be apprcrximately 1000 continues the requirement that Exclusion hours for NRC liceres.De NRC j
departures may only be made by The NRC has determined that this concludes that this acdon is Justified following the d:rections of an authorized final regulation is the type of action due to the net armual savings to NRC user physician. Therefore, since there is described in categorical exclusion 10 licensees and because eliminating these no reduction in the protection of the CFR 51.22(c)(3)(ii). ncrefore, neither an recordkeeping requirements would not public health and safety, the NRC environmental impact statement nor an affect public health and safety.
continues to meet its legislative environmental assessment has been Regulatory Flexibility Certification mandate. With respect to the second prepared for this final rule, point, licensees must continue to comply As required by the Regulatory with all applicable regulatory Paperwork Reduction Act Flexibility Act of 1980,5 U.S.C. 005(b),
requirements and will continue to be This final asle eliminates information the Commission certifies that this rule sub}ect to the same inspection and collection requirements that are subject will not have a significant economic enforcement efforts. Therefore, the NRC to the paperwork Reduction Act of1930 impact on a substantial number of small believes that licensees
- attitudes will not (44 U.S.C. 3501 et seq.). The reduction in entities.This rule would affect medical be negatively affected by this rule, and information collection requirements was use licensees including some private thus will not present a danger to the approved by the Office of Msnagement practice physicians.Some of these health and safety of the public.
and Dudget under approval numbers licensees would be considered small Conmrning the statement made in the 3150-0010 and 315M017.
entities under the NRC's size standards public workshop notice as related to the The public reporting burden for this (56 FR 50672; November 6,1971). This rationale for this rt!c. the NRC views collection ofinformation is estimated to rule eliminates recordkeeping these two regulatory issues as separate 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, requirements that the NRC and FDA matters. The rationale for this rule is to including the time for reviewing staffs agree are no longer necessary.
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'45568 Federal Regi;ter / Vol.'57. No.192 / Friday; October 2.1992 / Rules and'R:guhtions This action will reduce the regulatory 9 30.34 Terms and conditions of Ilcenses. generators and preparing reagent kits for which the Food and Drug burden on medical use licensees.
including some small entities..
(!)(1) From August 23,1990, to August Administration (FDA) has approved a -
Backfit Analysis 23,1993, each licensee eluting generators "New Drug Application"(NDA) by The NRC has determine' that 'the
- and processing radioactive material following the dimctions of an authorized d
- with diagnostic reagent kits for which user physician.
backfit rule,10 CFR 50.109, does not the Food and Drug Administration (2) Nothing in this r,ection rdieves the apply to this rule, and therefore.a (FDA) has approved a New Drug licensee from complying with other backfit analysis is not required for this Application" (NDA), may depart from applicable NRC, FDA, and other federal rule, because these amendments do not the manufacturer's elution and or State regulations.
involve any provisions which would preparation instructions (for
- 5. In 5 35.300, paragraph (b) is revised impose backfits as defined in 10 CFR.
radiopharmaceuticals authorized for use to read as follows:
50.109(a)(1).
pursuant to 10 CFR 35.200), provided 5.300 use champhannsceuticaMor,
List of Subjects that the licensee follows the directions
,py' of an authonzed user physician.
CFR Port 30 (2) The actions authorized in Dyproduct material. Criminal penalty, paragraph (i)(1) of this section are (b)(1) From August 23,1990, to August Government contracts, permitted in spite of more restrictive 23.1993, a licensee may depart from the '
package insert instructions regarding Intergovernmental relations. Isotopes, language in license conditions.
Nuclear materials, Radiation protection.
-(3) Nothing in this section relieves the indications or method of administration -
Reporting and recordkeeping licenue from complying with other for a radiopharmaceutical for which the requirements, applicable NRC, FDA, and other Federal Food and Drug Administration (FDA) or State regulations.
has approved a "New Drug Application **
CER Part 35 (NDA), provided that the authorized Byproduct material, Criminal penalty..PART 35-MEDlCAL USE OF user physician has prepared a written Drugs. Health facilities. Health BYPRODUCT MATERIAL directive as required by I 35.32(a).
professions. Incorporation by reference, 3.The authority citation for part 35 is licensee from compl tng with other "E "
Medical devices. Nuclear materials, n sed to mad as foHows:
3 Occupational safety and health, applicable NRC, FDA, and other Federal Radiation protection, Reporting and Avtbority: Secs. 31.161.182,183. 68 Stat.
or State regulations.
8.
as a ded 2 S 11 recordkeeping requirements.
Dated at Rockville. Maryland, this 17th day gg For the reasons set out in the of September 1992, amended (42 US.C 5841).
preamble and under the authority of the For the purposes of sec. 223,68 Stat. 958, as For the Nuclear Regulatory Commission.
Atomic Energy Act of1954, as amended, amended (42 U.S.C 2273): il 35.11,3513, James M. Taylor, the Energy Reorganization Act of1974 35.20(a) and (b) 35.21(a) and (b),35.22. 3523 Erecutive Directorfor Operations, as amended, and 5 U.S.C. 552 and 553, 35.25, 35.27(a), (c) and (d), 35.31(a), 35.32(a).
[Fil Doc. 92-23933 Filed 10-1-42; 8:45 am) the NRC is adopting the following 35.49. 35.50(aHd). 35.51[a He), 35.53(al -(b)..
amendments to 10 CFR parts 30 and 35.
35.59(aHc). (e)(1). (s), and th), 35.co. 35.61,
'****75'**'
35.70(aHO, a75. 35.aa(aHel. 35.90,3s92(a),
PART 30-RULES OF GENERAL 31120,35.200(b) and (c). 35204(a) and (b),
'~
APPLICABILITY TO DOMESTIC 35405, n22a 35m n310(ab n315. 35m DEPARTMENT OF THE TREASURY LICENSING OF BYPRODUCT 35.400, 35.404(a), 35 406(s) and (c), 31410(a).
n415,35m 35n 3532a n605,35m Internal Revenue Service MATERIAL 35.610(a) and (b). 35.615, 35 620, 35.630(a) and 1.The authority citation for Part 30 (b),35.632(aHO. 35 634(aHe). 35.636(a) and 26 CFR Part 1 continues to read as follows:
(b),35.641(a) and (b). 35.643(a) and (b).
35.645(a) and (b). 35.900. 35.910. 35 920,35.930, IT.D' 8441} '
Authority: Secs.81. 82,161.182,183.186,68 35.932, 35.934.35.940, 35.941.35.950.35.900, Stat. 935, 948, 953, 954, 955, as amended. sec.
35.901,35.970, and 35.971 are issued under N#
234. 83 Stat. 444. as amended (42 US.C 2111, sec.161b. 68 Stat. 948, as amended (42 U.S.C 2112, 2201, 2232, 2233, 2236, 2282); seca. 201.
2201(b)); and Ii 35.14. 35.21(b), 35.22(b).
Bank Bad Debts' C "*tual**
as amended. 202,206. 88 Stat.1242, as 35.23(b), 35.27(a) and (c). 3529(b),35.32(bHO, Presumption amended,1244,1246 (42 U.S.C 5841,5842.
35.33(aH b). 35.as(b). 35.50(e), 35.51(d),
- I8 AGt'NCY.' Internal Revenue Service, Se tion 30.7 also issued under Pub. L 95-35 92 b 5 c) easum 601, sec.10. 92 Stat. 2951 [42 US.C. 5851).
35.315(b). 35.404(b), 35.40S(b) and (d).
Section 30.34(b) also lasued under sec.164,68 35.410(b). 35.415(b). 35.610(c), 35.615(d)(4), -
ACTION: Temporary regulations.
Stat. 954, aa amended (42 US.C. 2234).
35 630(c),35.632(g). 35.634[0,35.636(c).
SUMMARY
- This document contains Section 30.61 also issued under sec.187 S8 35.641(c). 35.643(c),35.645, and 35.647(c) are Stat. 955 (42 US C. 2237).
Issued under sec.181o. 6a Stat. 950, as temporary regulations that clarify the For the purposes of sec. 223,68 Stat. 958, as amended (42 US C. 2201(o)).
scope of the express determination that amended (42 US C 2273); iI 30.3. 30.10, ia requtred under i 1.166-2(d)(3) m' order 30.34!b) (c), (0, (g) and (1). 30.41 (a) and (c).
- 4. In 6 35.200, paragraph (c)is revised I r a bank to elect to use a method of and 30.53 are issued under sec.161b 60 Stat.
to read as follows:
948. as amended 142 US.C 2201(b)): I 30.10 accounting that conforms tax accounting is issued under sec.1611. 68 Stat 949, as
$ 35.200 Use of radiopharmaceuticals, for bad debts to regulatory accounting amended (42 US.C 2201(i)); and il 30.6, 30.9, Generators, and reagent kits for imaging by providing a conclusive presumption 30.34(g),30.36. 30.50 30.51. 30.52,30.55, and and locattzation studies.
of worthlessness for debts charged off 30.So(b) and (c) are issued under sec.181a. 68 for regulatory purposes. The temporary Stat. 950, as amended (42 US.C 2201(o)).
(c)(1) From August 23.1990, to August regulations affect b8nks that have made -
- 2. In i 30.34, paragraph (i) is revised to 23,1993, a licensee may depart from the or intend to make an election under.
read as follows:
manufacturer's instructions for eluting.
I1.166-2(d)(3),The text of the
.