ML20206F920

Request for OMB Review & Supporting Statement Re Registration Certificate - in Vitro Testing with Byproduct Matl Under General License.Estimated Respondent Burden in 42 H

ML20206F920
Person / Time
Issue date:	05/04/1999
From:	Shelton B NRC
To:
Shared Package
ML20206F380	List: ML20206F376 ML20206F920
References
OMB-3150-0038, OMB-3150-38, NUDOCS 9905070008
Download: ML20206F920 (9)

Text

" des /c W 7ED CM MPAPERWORK REDUCTION ACT SUBMISSION

• pg Please read the instrucbons befora comp _leting this form. For additiord forms or assistnce in compliting this form, cont'ct vour egency's P:perw:rk Clurance Ome:r. S:nd two copi:s of this f:rm tha colliction instrumInt to be TIvliw:d, thD Sug) porting Stat:mont, cnd Env Edditional docum:nt:tiin to: Offim cf Inif rmatinn and R*aul:ttry Affilts, Offica cf if* Management and Budget, Docket Library, Room 10102,72517th Street NW, Washington, DC 20503.

1. Agency / Subagency onginating request - 2. OMB control number U.S. Nuclear Regulatory Commission y a. 3150-0038 b.None

3. Type of information collecten (check one) 3 Type of review requested (check one) _

a. New collection g a. Regular c. Delegated

b. Revnion of a currently approved collection b. Emergency - Approval requested by (date):

)

c. Extension of a currently approved conecten

d. Reinstatement, without change, of a previously approved

5. Will this information collection have a senincent economic impact on a su'bstantial number of small entities?

a.Yes collecten for which approval has expired Y b.N0 i for app h e e!p Requested g a Three years from approval date

6. expiration date

f. Existing collochon in use without an OMB control number 3 .

7 Title Registration Certificate -in vitro Testing with Byproduct Material Under General License

8. Agency form number (s) (if appleabJe)

NRC Form 483

9. Keywedis Radioactive Materials, Radiation Safety

'k Atctrut P4rsons wishing to use radioactive byproduct material for in vitro clinical or laboratory testing under the ge:eral license in 10 CFR 31.11, must register with NRC by submitting NRC Form 483. The certificate, when vclidated by NRC, serves as evidence to suppliers of byproduct material that the registrant is entitled to receive th misterial.

11. Affected public maera pnmay mm v amr as amers mar apr own 'x") 12. Obiegation to respond pews pamwy mm eamt as amers mer awy wrn v;

s. Individuals or households d. Farms a. Voluntary T b. Business or other for profit T

e. Federal Govemment T

b. Required to obtain or retain benefits T c. Not-for profit institutions f. State.1 ocal or Tribal Govemment c. Mandatory

13. Annual reporting and recordkeep ng hour burden 14. Annual reporting and recordkeeping cost burden (m mousamse ordosers;

c. Number of respondents 364 a. Total annualized capital /startup costs

b. Totalannualresponses 364 b. Total annual costs (O&M)

1. Percentage of these responses c. Total annualized cost requested collected electroncally 71.4  % d. Current OMB inventory

c. Total annual hours requested ,

42 .. oiv,,,,ne ,

d. Current OMB inventory 42

e. Difference 0

f. Explanation of difference I' D '** #8"9'

1. Program change

2. Adjustnwnt

2. Adjustment

15. Purpose of information collection 16. Frequency of recordkeeping or reporting (check as met appry)

(M penary M

• and a# omers met appy wem M s. Recordkeeping b. Third-party disclosure

] a. Application for benefits b, Program evaluation

] e. Program planning or management

f. Research

] c. Reportmg

1. On occasion

2. Weekly

3. Monthly

~ ~ - -

c. General purpose statstics "P" g. Regulatory or compliance 4. Quarterly 5. Semi-annually 6. Annually

~

d. Audit 7. Biennially 7 8. Other(describe) G time

17. Statstcal methods 18. Agency contact (person who can best answer questsons reparamp me Does this information collection employ statistical methods?

Name: Frank Cardile Yes  % No Phone: 301-415-6185 0008 83-4 The fami wee esegned unne womm 10/95 9905070008 990504 PDR ORO EUSOMB PDR

19.C:rtifir.ti n far Prperwsrk Reducti:n Ast Subml;ci:n3 On behalf of this Federal agency, I certify that the collection ofinformation encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8 (b)(3), appear at the end of the instructions. The certification is to be made with reference to those regulatoryprovisions as setforth in she instructions.

The following is a summary of the topics, regarding the proposed collection ofinformation, that the certification covers:

(a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements; (g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3):

(i) Why the information is being collected; (ii) Use ofinformation; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature of extent of confidentiality; and (vi) Need to display currently valid OMB control number; (h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected (see note in item 19 of the instructions);

(i) It uses effective and efficient statistical survey methodology; and (j) It makes appropriate use ofinformation technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement. y i

l i

I i

Sgnature of Authonzed Agency Official Date Signatur of Senior Omci desgnea 4 /; Date ,

o. on. learan. OL,r, Omco of the Chief Information Officer OM813-1 N ' 10/95

, , {

I 1

FINAL SUPPORTING STATEMENT FOR NRC FORM 483 REGISTRATION CERTIFICATE -

IN VITRO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE 10 CFR 31.11 (3150-0038) )

EXTENSION REQUEST I Descriotion of the Information Co!!edion -

. Section 31.11 of 10 CFR Part 31 establishes a generallicense authorizing any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to possess certain small quantities of byproduct material forJD.Y1[p i clinical or laboratory tests not involving j the intamal or extemal administration of the byproduct material or the radiation to human beings 1 or animals. Possession of byproduct material under 10 CFR 31.11 is not authorized until the

- physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with a registration number. A registration certificate is usually validated within 7 days of its receipt and is used by the licensee to obtain byproduct material from a supplier.

NRC Form 483, " Registration Certificate -JDyji[g Testing with Byproduct Material Under General License," contains the terms and conditions of the general license and provides a means of assurance to the NRC that the general licensee is aware of those terms and conditions prior to receipt of byproduct material.

A. JUSTIFICATION

1. Need for and Practical Utility of the Collection of information Section 31.11(a) provides for a general license for the use of lodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, and mock iodine-125 by any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital for the purpose of certain3D.Yji[p clinical or laboratory testing. The general license sets forth the conditions pertaining to possession, use, and storage of the byproduct material.

Section 31.11(b) specifies that in order for the physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to use the general license, NRC Form 483, " Registration Certificate .Lnyji[9 Testing with Byproduct Material Under General License," must be completed and submitted to NRC. The licensee must then receive a validated copy of NRC Form 483 with a registration number to corrplete the licensing process.

Suppliers of byproduct material are required to determine that the person receiving the material is authorized to receive it. The validated certificate, maintained by the licensee, serves as evidence for the supplier that a physician, clinical laboratory,

\

veterinarian in the practice of veterinary medicine, or hospital is a general licensee authorized to receive the byproduct material.

Section 31.11(e) requires that a general licensee under this section report in writing any change in a previously validated registration certificate. The licensee must report the change to the NRC within 30 days after the effective date of such change.

Updating the information on the registration certificate is necessary so that NRC is aware of any changes in either the name or the location of all persons authorized to receive radioactive byproduct material under Section 31.11.

2. Aaency Use of the Information The information derived from NRC Form 483 provides NRC with the name of each physician, clinical laboratory, veterinarian, or hospital using byproduct material under the generallicense. The registration certificate contains the terms and conditions of the generallicense and provides a means of assurance to the NRC that the general licensee is aware of those terms and conditions prior to receipt of byproduct material. The NRC incorporates the information from Form 483 into a data base. This data base is used when manufacturers and suppliers call NRC to verify that a physician, clinical laboratory, veterinarian, or hospital is authorized to receive byproduct material.

3. Reduction of Burden Throuah Information Technoloav There are no legal obstacles to reducing the burden associated with this information collection. The NRC encourages applicants and licensees to use new automated information technology when it would be beneficial to them. However, NRC Form 483 does not lend itself readily to the use of automated information technology for submission because of the type of information and the infrequency of submission.

Consequently, the current percentage of electronic submissions is zero.

4. Effort to Identify Duolication and Use Similar Information The Information Requirements Control Automated System (IRCAS) was searched to determine duplication. None was found. The collection of the specified information is not a duplication of other information that the affected licensee must submit for other purposes. The nature of the information being requested is unique to NRC's activities at the facilities. There is no similar information available to the NRC that can be used to keep track of the general license'es authorized under Section 31.11 of 10 CFR Part 31 to possess small quantities of byproduct material for certain 10 yitre clinical or laboratory tests.

l

5. Effort to Reduce Small Business Burden The majority of the registrants who use byproduct material are small businesses. l The health and. safety consequences of improper use or handling of radioactive byproduct material are the same for large and small entities. The burden of providing the small amount of information required on NRC Form 483 is minimal. In E ,

1

r=

1 addition, NRC Form 483 is only submitted once, unless there is a change of {

information from a previously registered license. Therefore, it is not possible to reduce the burden on small businesses by less frequent or less complete submittal.

6. Conseauences to Federal Proaram or Policy Activities if the Collection is Not Conducted or is Conducted Less Freauentiv If NRC Form 483 la not submitted, the NRC will not have necessary information to certify general licensees authorized under Section 31.11 of 10 CFR Part 31 to possess, use, and store byproduct material. If the information on NRC Form 483 is collected less frequently, it could result in the NRC having outdated addresses and .

phone numbers for its generallicensees. Up-to-date information on NRC Form 483 {

is required for NRC to fulfill its responsibility to ensure adequate protection of the public health and safety during the possession, use, or transfer of radioactive byproduct material.

7. Circumstances Which Justifv Variation from OMB Guidelines {

l Contrary to OMB guidelines in 5 CFR 1320.5(d), Section 31.11(e) requires general licensees to report in writing any change in a previously validated registration certificate within 30 days after the effective date of such a change. The NRC ]

I needs this information within 30 days to keep current on where the radioactive material is being used in order to reach users immediately in the event of a problem {

j and to provide registrants with immediate notification when there is a generic problem involving the radioactive material.

8. Consultations Outside the NRC An opportunity to comment on the information collection requirements for this clearance extension was published in the Federal Register on February 2,1999 (64 FR 5078). No comments were received.  !

9. Payment or Gift to Resoondents Not applicable.

10. Confidentiality of the Information Information submitted on Form 483 is generally subject to public disclosure in  !

accordance with 10 CFR 2.790 and 10 CFR Part 9. Section 2.790 allows the NRC to withhold certain proprietary information (information of commercial value or " trade secrets") if, at the time of submittal of the report, the requirements for withholding the information are met (refer to 10 CFR 2.790(b)). Also, there are provisions in 10 i CFR Part 9 for the NRC to withhold some documents, such as reports of radiation '

l exposure to individuals and other personal records, from public disclosure.

11. Justification for Sensitive Questions This information collection does not involve sensitive questions.

3

I'

12. Estimated Burden and Burden Hour Cost NRC licensees- -

The NRC receives approximately 104 registration certificates annually from persons i who wish to be generallicensees. The time required for completion of NRC Form 483 is approximately 7 minutes. Completion of the form requires filling in the name and address, checking one of the categories of licensees, signing, and dating the registration certificate. The total burden for all general licensees is approximately 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> annually (104 registrations /yr using Form 483 X 7 minutes per Form 483). Since preparation of the form is essentially an administrative / clerical function, the cost is estimated to be approximately $45 per hour. Therefore, the total annual >

cost for preparation of the 104 certificates is approximately $540 (12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> X l

$45/hr).-  !

Aareement State licensees: i The Agreement State licensees submit approximately 260 registration certificates )

annually, based on the assumption that they prepare 2.5 times as many registration i certificates as do the NRC licensees. The total annual burden for all the Agreement State licensees is approximately 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />, or 7 minutes per registration certificate.

Therefore, the total annual cost for the preparation of the 260 registration certificates by the administrative / clerical staff of the Agreement State licensees is approximately $1350 (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> X $45/hr). I The total estimated burden is 42 hours4.861111e-4 days <br />0.0117 hours <br />6.944444e-5 weeks <br />1.5981e-5 months <br /> (12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> + 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />). The total burden hour cost is $1,890 ($540 + $1,350).

13. Estimate of Other Addi#onal Costs None.  !

14. Estimated Annualized Cost to thc Federal Government The average time needed for processing an NRC Form 483 is approximately 30 minutes. This time includes researching the files to check for duplicate i registration certificates, maintaining and updating the data base on registration certificates, and preparing the letter and validated copy of NRC Form 483 for each ]

licensee. At a rate of $121 per hour for professional staff, the annual cost to the j Federal government to process the 104 registration certificates is $6,292 (104  ;

registrations /yr using Form 483 X 30 minutes per Form 483 X $121/hr). This cost  !

is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR j Parts 170 and/or 171.  !

15. Reasons for Chances in Burden or Cost l J

There is no change in burden. There is a small change in costs to reflect the difference in professional staff rates. ,

j 4  !

l J

r ,

16. Publication for Statistical Use This information will not be published for statistical use.

17. Reason for Not Disolavino the Exoiration Date The expiration date is displayed on NRC Form 483.

18. Exceptions to the Certification Statement There are no exceptions.

B. COLLECTIONS OF INFORMATION EMPLOYING ST TISTICAL METHODS Not applicable.

I I

5

i l

,. NRC FORM 4a3 U.S. NUCLEAR REGULATORY COMMISSION APMtOVED aY 00Aa: No.318e Seas EXPIRES MINDOrYmr l

" ": C","l::'tl.":llll""lll"l1*.*,J:."2"il:'lllll::

. REGISTRATION CERTIFICATE -In vitro TESTING WITH BYPRODUCT MATERIAL UNDER k $s-3 % % h'h {=[a3 8a 85

• l,'a"pgao,',,, g,l"j,,0",=l4";;l' a gt";;gg

, o, j o

• GENERAL LlcENSE f,',,",,, ?,a gl,W,. ::L*,',ag'ag,,'",,a',,,4 l

,  ;% T'.": f ""O".J:"",*." "!.: .'.::1~ "" i Section 31.11 of 10 CFR 31 establishes a generallicense authorizing physicians, cinical laboratories, hospitals, and veterinarians in the practice of veterinary medicine to possess certain smal quantities of byproduct materia for in vitro clinical or laboratory tests not invoMng l

the internal or external administration of the byproduct material or the radiation therefrom to human beings or animais. Possession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, hospdal, or veterinarian in the practice of veterinary medcine, has filed NRC Form 483 and received from the Commission a vaidated copy of NRC Form 483 with a registration number.

1. NAME AND AooRESS OF APPUCANT (See insewton 3.a. asew) 2. APPLICATION (Check one box only)

, I hereby apply for a registration number pursuant to 10 CFR 31, Section 31.11, for use of byproduct materials for.

Myself, a duty Econsed physician authorized to disperse drugs in the practice of medicine.

Z The above-named cEnicallaboratory.

TEmPNoNE manER p Arse coder O The above named hospital.

Veterinarian in the practice of veterinary medicine.

INSRUCTIONS 4. REGISTRATION A. Submit this form in duplicate to: Rea REGISTRATION NUMBER: i Materials Safety Branch (T-8 F5)  %*

Division of Industrial and Medical Nuclear Safety 8 Office of Nuclear Material Safety and Safeguards g U.S. Nuclear Regu! story Commission o<

Washington, DC 20555-0001 (At NRC, a registration number will be assigned and a validated *****

copy of NRC Form 483 will be retumed.)

in the box above, print or type the name, address (including ZlP (if this an initialregistration, leave this space blank - number to Code), and telephone number of the registrant physician, be assigned by NRC. If this is a change ofinfbrmation kom a clinicallaboratory, hospital, or veterinarian in the practice of previously registered generallicense, include your registration veterinary medicine for whom or for which thss registration form number.)

is filed e e o..e un a em own i e.a enem e. mes= we a

6. CERTIFICATION

, I hereby cc:9y that A. Allinformation in this registration certificate is true and complete.

B. The registrant has appropriate radiation measuring instruments to carry out the tests for which byproduct material will be used under the general Econse of 10 CFR 31.11. The tests will be performed only by personnel competent in the use of the instruments and in the handkng of the byproduct materials.

C. I understand that Commission regulations require that any change in the information fumished by a registrant on this registration certificate be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the effective date of such change.

D. I have read and understand the provisions of Section 31.11 of NRC regulations 10 CFR 31 (reprinted on the reverse side of this

)

form); and I understand that the registrant is required to comply with those provisions as to all byproduct material which he j receives, acquires, possesses, uses, or transfers under the generallicense for which this Registration Certificate is filed with the i U.S. Nuclear Regulatory Commission. i PRINTED OR TYPED NAM! AND TITM OF APPUCANT s4GNATURE DATE WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CML ANDIOR CRIMINAL PENALTIES. NRC 1 REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS. l 18 U.S.C.1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO j ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHlN ITS JURISDICTION.

NRC poRu ans psyvyyj PRedED ON RECYCLED PAPER This form nas de.qpn d unene informs

CCNDmONS AND UMITATIONS CF CENERAL UCENSE 10 CFR 31.11

, e

{31.11 Gener:J Econee for use of byproduct materials for certain (2) Th3 generd Econsee shal st:ra th3 byproduct materitsi, m v&o dnicalorlaboratorytesung

• unti used, in the original shipping container or in a container

• providing equivalent radiabon protection. .

(a) A generalIcense is hereby issued to any phyescsan, (3) The general Econsee shal use the byproduct material only veterinarian in the practice of veterinary medicine, clinicallaboratory for the uses authortzed by paragraph (a) of the section.

or hospital to receive, acquire, possess, transfer, or use, for any of (4 The general Econsee shal not transfer the byproduct the fotowing stated tests, in accordance with the provisions of maten)al, except by transfer to a person authorized to receiv Paragraphs (b), (c), (d), (e), and (f) of this section, the folowing Heense pursuant to this chapter or from an Agreement State, nor Dyproduct materials in prepackaged units: transfer the byproduct materialin any manner other than in the (1) lodine 125,in units not exceedng 10 microcuries each for unopened, labeled shipping container as required by $20.301 of use in h v#ro clinical or laboratory tests not invoMng intamal or this chapter.

extemal administrabon of byproduct material, or the redabon (5) The general Econsee shal dispose of the Mock lodine-125 therefrom, to human beings or animals. reference or cabbration sources described in paragraph (a)(7) of (2) lodine 131,in units no exceeding 10 microcuries each for this section, as required by $20.301 of this chapter, use in h vbo cinical or laboratory tests not invoMng intomal or (d) The generai Econsee shal not receive, acquire, possess, or extemal administration of byproduct material, or the radabon use byproduct material pursuant to paragraph (a) of this section:

therefrom, to human beings or animals. (1) Except e prepeckeged un.5 which c.c labt.kd ir, (3) Carbon-14, in units not exceedng 10 microcuries each for accordance with the provisions of a specific Econee issued under use in h vbo cinical or laboratory tests not invoMng intomai or the provisions of 532.71 of this chapter or in accordance with the extemal administration of byproduct material, or the redation provisions of a specsRc heense issued by an Agreement State that I therefrom, to human beings or animals, authorizes manufacture and distribution ofiodne-125, iodine-131, j

, (4) Hydrogen 3 (tntium), in units not exceeding 50 microcuries carbon-14, hydrogen-3 (tritium), solenium-75, iron-59 or Mock i each for use in in vbo clinical or laboratory tests not invoMng lodne-125 for distribu6on to persons generely Econsed by the j intomal or extemal administration of byproduct material, or the Agreement State. '

radiation therefrom, to human beings or animals. (2) Unless the folowing statement, or a substantially simiar (5) iron 59, in units not exceeding 20 microcuries each for use statement which contains the information caned for in the foRowing in in vitro clinical or laboratory tests not invcMng intomal or extemal statement, appears on a label afftxed to each prepackaged unit or ,

administration of byproduct material, or the redation therefrom, to appears in a leaflet or brochure which accompanies the package:

human beings or animals. This radioac6ve material may be received, acquired, I (S) Selenium-75,in units not exceeding 10 microcuries each possessed, and used only by physicians, veterinarians in the j f r use in in vbo clinical or laboratory tests not invoMng intomal or practice of veterinary medicine, clinicallaboratories or hospitais and )

cxtemal administration of byproduct material, or the rada6on only for in vitro chnical or laboratory tests not invoMng intomal or j th:refrom, to human beings or animals. extemal adminstra6on of the material or the radiation therefrom, to I (7) Mock lodine-125 reference or calibration sources, in units human beinge or animals. Its receipt, acquisition, possession, use, l not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie and transfer are subject to the regulations and a general Econse of j cf americum-241 each for use in in vitro cRnical or laboratory tests the U.S. Nuclear Regulatory Commission or of a State wtth which not invoMng internal or extemal administration of byproduct the Commission has entered into an agreement for the exercise of material, or the radiation therefrom, to human beings or animals. regulatory authority.

(b) A person shal not receive, acquire, possess, use or trtnsfer byproduct material under the general license established by paragraph (a) of this section unless that person:

(1) Has filed NRC Form 483 " Registration Certificate -in vitro e munce Tee 6ng with Byproduct Material dnder General Ucense," with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear (e) The registrant posseeming or using byproduct material Regulatory Commission, Washington, DC 20555-0001, and under the generallicense of paragraph (a) of this section shaN received from the Commission a validated copy of NRC Form 483 report in wnting to the Director of Nuclear Material Safety and wtth registration number assigned; or Safeguards any changes in the information fumished by him in (2 NRC Form 241, " Registration Certificate -in vitro Testing with maten)al that was issued under Part 35 of this chapter.Has a Econse Byproduct that Material authorizes Under the medcal General Ucense." useshal The report of byproduct be (c) A person who receives, acquires, possesses or uses fumished within 30 days after the effective date of such change.

byproduct material pursuant to the general heense established by (f) Any person using byproduct material pursuant to the paragraph (a) of this section shen comply with the foNowing: generalicense of paragraph (a) of this section is exempt from the (1) The general Econsee shal not possess, at any one time, requirements of Parts 19,20, and 21 of this chapter wtth respect to pursuant to the generallicense in paragraph (a) of this section, et byproduct materials covered by that general license, except that cny one location of storage or use, a total amount of iodine 125, such persons using the Mock lodine 125 described in paragraph iodine 131, selenium-75, and/or iron 59 in excess of 200 (a)(7) of this sec6on shal comply with the provisions of $20.301, microcuries. 20.402, and 20.403 of this chapter.

NOTES 1

A State to which certain regulatory authority over radioactive material has been transferred by formal agreement, pursuant to secton 274 of the Atomic Energy Act of 1954, as amended.

2 Material generely Econsed under this section prior to January 19,1975, may bear labels authorized by the regulations in effect on January 1,1975.

8 A new triplicate set of this Registration Certificate, NRC Form 483, may be used to report any change ofinformation fumished by a registrant as required by 531.11(e).

If larger quantities or other forms of byproduct material than those specified in the general Econee of 10 CFR 31.11 are required, file NRC Form 313,"AppNcation for Byproduct Material Ucense," to obtain a specific byproduct materiallicense. Copies of application and j registra6on forms may be obtained from the Medical, Academic and commercial Use Safety Branch (0-6 H3), Division of Industrial and i Medical Nuclear Safety, United States Nuclear Regulatory Commission, Washington, DC 20555-0001, 1

_. 3