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May 24,1996 HEMORANDUM T0: John L. Glenn, Chief Radiation Protection and Health Effects Branch Division of Regulator Applications Off ce of N lea 1 ory Research az . w FROM: 'da, Jo ' e n, h ef Informati n and Records Management Branch Office of Information Resources Management
SUBJECT:
10 CFR PARTS 20 AND 35, " CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIAL,* FINAL RULE We have reviewed the subject final rule, draft final guide, and the OMB l
clearance package for compliance with the Paperwork Reduction Act of 1995 (44 '
U.S.C. 3501 et seq.)
We request that the following changes be made in the rule:- l AU To TQt4 Add the blic rotection statement to the Paperwork Reductio Act S atement (Attachment 1). I flMioYt2N- Re) lace the "l35.8 Information collection requirements
- 0M3 approval" section with Attachment.2.
We have annotated the OMB clearance package (OCP) with comments. Because the-package will be submitted under the requirements of the Paperwork Reduction Act of 1995 (PRA), changes are needed to conform the supporting-statement and Federal Register Notice (FRN) to current PRA recuirements. A revised FRN format is included. Because the regulatory guice provides the detail for the information collections contained in the rule, the guide should be. included in-the OMB clearance submittal for the final rule. Additionally, it will be necessary to complete the attached certification form and include it with the final OCP submittal. If you prefer, an electronic form is available. i Publication of the rule has been placed on hold with the Office of Administration pending IRH's approval of the 0MB clearance package.
Should you require further assistance, please contact Beth St. Mary at 415-5878 or e mail BCS. f Attachments:
As stated
.cc: S. Schneider. RES
- 3. McGuire, RES H. sar. M
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20 62FR4120 PDR 9
PAPERWORK RE00CTION ACT STATEMEN1 This final rule amends information collection requirements that are /
subjecttothePaperworkReductionActof 1995 (44 U.S.C. 3501 et seq.). v These requirements were approved by the Office of Management and Budget, approval number 3150 0010.
The public reporting burden fur this collection of information is estimated to average 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 information. Send comments on any aspect of this collection of information, including suggestions for reducing the burden, to the Information and Records Management Branch (T 6 F33), U.S. Nuclear ,
Regulatory Commission. Washington, DC 20555 0001, or by Internet I slectronic mail at BJSl@NRC.G0V; and to the Desk Officer. Office of Information and Regulatory Affairs, NE0810202 (3150 0010), Office of Management and Budget. Washington, DC 20503.
Public Protection Notification /ccl M
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The NRC may not conduct or sponsor, and a person is not required to
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respond to, a collection of information unless it displays a currently valid OMB control number.
Attachment 1
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- i 535.8 Information collection requirements: OMB approval.
-(b) The a> proved information collection r uirements contained in this part a 35.21, 35.22, 35.23, 35.29, 35,31,ppear 35.50,in35.51, SL3LS/ 35.12, 35.52, 35.13, 35.53, 35.14,05.2 35,59, 35'60 35.61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35,415, 35.606,
- 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, 35.647, 35.980, and 35.981, ;
i Attachment 2
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l NUCLEAR REGULATORY COMISSION l
Occuments Containing Reporting or Recordkeeping Requirements; Office of Management and Budget (OMB) Review AGENCY: Nuclear Regulatory Comission (NRC).
ACTION: Notice of the OMB review of information-collection.
SUMMARY
- The Nuclear Regulatory Commission has recently submitted to OMB for review the following proposal for collection of information
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under the provisions of the Paperwork Reduction Act of-1980 l$15
~(44 U.S.C. Chapter 35).
- 1. Type of submission, new, revised, or extension: Revision.
- 2. The title of the information collection: Final amendments to 10 CFR 35.75 " Criteria for the Release of Individuals Administered Radioactive Material."
3.- The form number if applicable: Not applicable.
1 Attachment 7
- 4. How often-is the collection required: On occasion; when the release of a patient is based on other than standard assumptions or requires interruption or discontinuation of breast-feeding to meet the 5-mil 11 sievert (0.5-rem) dose limit.
- 5. Who will be required or asked to report: Medical licensees administering radiopharmaceuticals and permanent implants and releasing patients under the provisions of 10,CFR 35.75.
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estim t number of/~e r t: Approximately
- 4 1,350 NRC and Agreement State licensees.
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@ An estimate of the number of hours annually needed to complete the requirement or request: 17,126 hours0.00146 days <br />0.035 hours <br />2.083333e-4 weeks <br />4.7943e-5 months <br /> (includes NRC and Agreement State licensees).
] 'A The average annual burden per respondent: 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br />.
/ An indication of whether Section 3504(h), Pub. l.96-511 applies: Applicable.
Y l l 104 - Abstract: The Nuclear Regulatory Commission (NRC) is amending the criteria for release' of individuals administered radioactive material under 10 CFR Part 35. The amendment requires the licensee to provide the patient with 2 Attachment 7
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written instructions on how to maintain doses to other individuals as low as is reasonably achievable if the dose to an individual exposed to the patient is likely to exceed 0.1 rem, in those cases where the released individual may be a breast-feeding woman, the instructions must also include guidance on the interruption or discontinuation of breast-feeding and information on the consequencer af failure to follow the guidance. The amendment also requires the licensee to maintain a record of the basis for the release if the release is authorized using other than standard assumptions or that instructions were provided to a breasty eeding woman if the dose to the child from continued br ash eding could result in a total effective dose V
equivalent exceeding 0.5 rem. These requirements are necessary to ensure adequate protection of the public health and safety and that doses to other individuals are maintained as low as reasonably achievable.
N1gbmittal may bc inspected or obtained for a fee from-tWE30-
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Public Document Room, 2T20-l~ reet NW. (Lower Level)7 W,ashington, DC.
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Comnia s and questions can be directed by mail to the OMB reviewer:
\ Peter francis /
\qfficeofInformationandRegulatoryAffajr's (315Q-0010)
NE0B-102Q2 Offics of Management and Budge Washingtsn, D 20503 Connents may also be communicated,, y telephone at (202) 395-3084.
The NRC Clearance Officer is Brenda Jo.\Shelton, (301) 415-7230.
Dated at Rockville, Marylend, this day of , 1996.
N For the Nuclear Regulatory Commission.
Gerald F. Cranford,\ Designated Senior Official for Information Resources Management. \
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4 Attachment 7
[F dacAnwed h Submit. by (insert date 30 days af ter publication in the Federal Reaister),
coments that address the following questions:
- 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
- 2. Is the burden estimate accurate?
- 3. Js there a way to enhance the quality, utility, and clarity of the information to be collected?
- 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
A copy of the submittal may be viewed free of charge at the NRC Public Document Room. 2120 L Street NW. (lower level). Washington, DC. Members of the public who are in the Washington, DC, area can access this document via modem on the Public Document Room Bulletin Board (4RC's Advanced Copy Document Library). NRC subsystem at FedWorld. 703-321-3339. Members of the public who are located outside of the Washington DC, area can dial FedWorld. 1-800-303-9672. or use the FedWorld Internet address: fedworld. gov (Telnet). The document will be available on the bulletin board for 30 days after the signature date this notice. If assistance is needed in accessing the document, please contact the FedWorld help desk at 703-487-4608. Additional assistance in locating the document is available from the NRC Public Document Room. nationally at 1-800-397 4209. or within the Washington, DC, area at 202-634-3273.
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Comments and questions should be directed to the OMB reviewer by (insert date 30 days after publication in the Federal Reaister):
Peter Francis Office of Information and Regulatory Affairs (3150- )
NE0B 10202 Office of Management and Budget Washington DC 20503 Comments can also be submitted by telephone at (202) 395-3084.
The NRC Clearance Officer is Brenda Jo. Shelton, (301) 415-7233.
Dated at Rockville. Maryland, this day of . 1996.
For the Nuclear Regulatory Commission.
Gerald F. Cranford Designated Senior Official for Information Resources Management DOCUMENT NAME: C: u - we copy n e.e.iv. . copy . ini. ooeum.nt indic.i. in sn. be : c - copy without .ii.chmenti ncio.or. t - copy witn .tt.enm nti.ncic3ur.
0FFICE Originator Office IRMB/lRM OGC 1RM NAME BShelton GFehst GFCranford DATE OFFICIAL RECORD COPY
OMB SUPPORTING STATEMENT FOR 10 CFR PART 35,
" Criteria for the Release of Individuals Administereo Radioactive Material" (3150-0010)
Description of Information Collection This clearance package covers the recordkeeping and reporting "equirements of amendments to 10 CFR Part 35, " Medical Use of Byproduct Materi 1," l 35.75,
" Release of individuals centaining radiopharmaceuticals or permanent l implants." The existing i 35.75 contains no information collection requirements. The revision to i 35.75 incorporates the information collection required below.
The information collection requirements in the proposed rule were submitted to OMB and approved under OMB control number 3150-0010. The entire collection is being resubmitted at the final rule stage because of some major changes in the information collections.
A. JUSTIFICATION The amendment to i 35.75 revises the criteria for authorizing the release of individuals administered radioactive material under 10 CFR Part 35 to permit a 7'
'maximu dose of 5 millisieverts (0.5 rem) tc an individual member of e the publi equires written instruction on how to maintain doses to others as low as is reasonably achievable if the dose to an individual exposed to a released patient is likely to exceed 1 mil 11 sievert (0.1 rem). In those cases
,where the released individual may be a breast-feeding woman, the instructions must also include guidance on the interruption or discontinuation of breaste4yding and information on the consequences of failure to follow the guidance. The amendment also establishes recordkeeping requirements when the release is authorized using other than standard assumptions or when instructions were provided to a breast-feeding woman because the dose to the child from continued breast-feeding could result in a total effective dose equivalentexceedingmp (0.5 re ,
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- 1. Need for e Collection of Inf n The information collection requirements of the amendments to 10 CFR Part 35 are identified below.
6 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
Paragraph (b) of this section requires licensees to provide, upon release, the patient with written instructions on how to maintain doses to other individuals as low as reasonably achievable if the total effective dose equivalent to any individual other than the released patient is likely to Attachment 7 1
exceed 1 millisievert (0.1 rem). In those cases where the released i ividual may be a breast-feeding woman, paragraph (b) also requires the instruc ions to include guidance on the interruption or discontinuation of breastQeedi and information on the consequences of failure to follow the guidance.W-The instructions should be specific to the type of treatment given and may in lude additional information regarding individual situations. The instructions should include a contact and phone number in case the patient has any questions. Instructions should include, as appropriate: (1) maintaining distance from other individuals, including sleeping arrangements and the need to minimize use of public transportation; (2) the interruption period for breast-feeding and the consequences to the breast-feeding child upon failure to follow the guidance, if applicable; (3) minimizing time in public placas
( uch as grocery stores, shopping centers, restaurants, and sporting events);
-) hygiene; and (5) the length of time precautions should be taken. Written istructions are needed to provide a reference available after the )atient's release # if questions regarding patient care arise,end to reduce tie chance of misuKderstanding the licensee's instructions as vsrT;hl instructions may not be properly conveyed to persons not present at the time of release. The written instructions are also necessary to permit the NRC to verify the t gr
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of instructions generally given to p6tients. I /
h, __ N,e MQ O %r h Paragraph record of the(c) of this for section requires licensees to maintain, for 3 er G/a'k otyears ,15 .i y i
basis the release if the release is authorized using than standard assumptions. The records are necessary so that the NRC ,9 F@ M inspector can review the method for calculating the dose to determine tha the method is adequate to show that the requirements g1r)- dre met / ,
Paragraph (d) of this section requires licensees to maintain, fqr 3 yearsd record that instructions were provided to a breast-feeding woman if the administered activity could result in a total effective dose equivalent to the breast-feeding infant exceeding 5 millisieverts (0.5 rem) if the woman did not '
interrupt or discontinue breastMeefng.AThe records are necessary so that the NRC inspector can verify that instructions were given to the /-
breast-feeding woman to inform her of the need to interrupt or discontinue i breas ng.
- 2. Aaency Use of Information Records kept, and written instructions provided by the licensee, will be used by NRC inspectors to evaluate compi ulce with NRC regulations to assure that the public health and safety are protected.
- 3. Reduction of Burden Throuah Information Technolooy No responses are submitted to NRC. NRC encourages licensees to utilize any
, technology which would reduce the burden of recordkeeping and reporting.
Archival storage of (1) surveys and prcspective evaluations and (2) the content of written instructions lend themselves readily to the use of automated information technology.
2 Attachment 7
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- 4. Effort to identify Duplication and Use similar Information There is no similar information available to the NRC. The Information
- Requirements Control Automated System (IRCAS) was searched for duplication, and none was found.
- 5. Effort to Reduce Small Business Burden The NRC believes that there is no way to reduce the burden on small businesses by less frequent or less complete records ile maintaining the required level of safety. tW
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- 6. Consecuences less Freauentd eH ect en The consequences of less frequent cordkeepin and reporting would be that there would be no basis for demonstrating comp iance with the required level of safety through the NRC inspection program.
- 7. Circumstances __Which Justify Variation from OMB Guidelines There are no variations from OMB guidelines.
- 8. Consultatibutside the Agency
'O A public meeting to discuss the concepts and aaproaches of a previous version of the proposed rule with representatives of t1e Agreement States was held in
.i July 1992 and October 1993. In addition, a draft rule package was sent to the 4 Agreement States for their review and comment in July 1993. The final rule was discussed with the States at a meeting in October 1994. The proposed rule was also discussed with the Advisory Committee on Medical Uses of Isotopes (ACMUI) during public meetings held in October 1992, May 1993, and November 4
1993. The final rule was discussed with the ACMUI in November 1994, May 1995, and October 1995. The Agreement States and the ACMUI were generally l i
uppo g @ ge g ac g t,h,e, g V
g // o N Y M b Information No information normally considered confidential is requested.
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v Justificatio Sensitive Information No sensitive information requested under these regulations.
{y J4di, Estimated AnnuaMC8st to the Federal Government The estimated burden on the-NRC to review records is estimated to be I hour q/' Jer NRC licensee per year, or 450 hours0.00521 days <br />0.125 hours <br />7.440476e-4 weeks <br />1.71225e-4 months <br /> for all NRC licensees. At 3 cost
/ d.h oT183.per hour, the annual cost to NRC is $5h8M. annually. This cost is fullyrecoveredthroughfeeassessmentstoNRCllicenseespursuantto '
10 CFR Part 171. f i
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i 4e-additlon,Iha estimated burden on the Agreement States to review records is estimated to se I hour per Agreement State licensee per year, or 900 hours0.0104 days <br />0.25 hours <br />0.00149 weeks <br />3.4245e-4 months <br /> for all Agreement State licensees. At, a cost of $gperAour, the annual cost to AgreementStatesisg anpily. V
- 12. EstimataleG Burden a~/Mh M boJf w'is l -The total burden to provide instructions and maintain release records O"gm a
- estimated to be about 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> per licensee annually, or a total of approximately17,126hoursannually.forall1,350NRCandAgreementSt(te medical use of byproduct material licensees. Seeattachedtablefordeta11Q
/ )SIA Reasons for Chanaesin Garden m Q>C h5 % '
b Sw Gack The amendment adds recordkeeping and reporting requirements to 10 CFR 35.75 to g g 7 protect individuals likely to be exposed to patients administered radiopharmaceuticals or permanent implants, for demonstrating compliance with'~3 7dbtl the annual limit for individuals due to the release of patients administered l radioactive material. The final rule reflects a burden decrease from that of l the proposed rule from 19 to 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> per licensee. The proposed rule required records for releases if the total effective dose equivalent to any individual other than the released patient exceeded 0.1 rem. The final rule requires records only for exceptions to standard assumptions and when instructions were provided to a breast-feeding woman if the dose to the child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem).
/6-lb Publication for Statistical Use There is no application to statistics in the _information collected. There is o publication of this information.
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
\ Not applicable.
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Table 1.
Reporting Requirements ,
No. of Procedures Requiring Written Instructions llours Per Total Burden Section Per Year Procedure Hours ,
35.75(b) exceeding 0.1 rem 62,000* 1/6 10,333 breast-feeding mothers 27,000' 1/6 4,500 <
Recordkeeping Requirements No. of Procedures Requiring Records Hours Per Total Burden Section Per Year Licensee Hours 35.75(c) 10,000' 2/15 1,333 35.75(d) 7,200' / 716 960
! Total burden = 17,126 hours0.00146 days <br />0.035 hours <br />2.083333e-4 weeks <br />4.7943e-5 months <br /> or 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> per lic see (17,126 + 1,350) at a <
cost of $2,277,758 ($133 x 17,126).
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'50,000 iodine administrations for thyroid ablation + 10,000 iodine administrations for thyroid cancer + 2,000 iodine permanent implants - 62,000.
'8,000,000 administrations x 0.5 fraction ',f the administrations potentially requiring instructions x v.135 fraction of females of child bearing age (from Table 4.3 of NUREG-1492) x 0.05 breast-feeding = 27,000.
' Iodine treatment for '.hyroid cancer patients.
'(60,000 iodine + 1,000,000 technetium-99m per'.echnetate) v 0.135 fraction i of females of child bearing age x 0.05 breast feed'ng - 7,20.'
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