3646 Mercury Vapor Lamp Products Radiation Safety Report

Form Approved: OMB No. 0910-0025
Expiration Date: August 31, 2023

FORM FDA 3646 (09/20)
Mercury Vapor Lamp Products Radiation Safety Report

Public reporting burden for this collection of information is estimated to average 24 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
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paper Reduction Act (PRA) Staff
[email protected]
*Please do NOT send your completed document to this PRA Staff email address.*
An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number.

This guidance was written prior to the February 27, 1997 implementation of FDA’s
Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
This guidance will be updated in the next revision to include the standard elements of GGP’s.

More industry guidance and assistance can be found at the FDA homepage, see:
http://www.fda.gov/Radiation-EmittingProducts/.

Send your completed report to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
Questions about reporting and suggestions for changes to this guide may be sent to the above
address or may be discussed by calling 1-800-638-2041.

FORM FDA 3646 (09/20)

REPORTING GUIDE
FOR PRODUCT REPORTS ON
HIGH INTENSITY MERCURY VAPOR DISCHARGE LAMPS
(21 CFR 1002)

Compiled by:
Center for Devices and
Radiological Health

September 1995

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Silver Spring, MD 20993
FORM FDA 3646 (09/20)

This page is deliberately blank.

FORM FDA 3646 (09/20)

Foreword
The Center for Devices and Radiological Health (CDRH) developed this guide. This guide will assist manufacturers¹ of
electronic products which emit radiation in providing adequate reporting of radiation safety testing and compliance with
federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify Reporting
and Notification requirements²,³.
Reports submitted on radiation safety of electronic products must follow the appropriate guide (21 CFR 1002.7). If the
report does not follow an applicable guide it must contain a sufficient justification for any deviations. The submitter of
the report will receive an acknowledgment letter with the accession number we assign to the report. Please reference this
accession number in the future when providing additional information about this model family in either a supplement or the
annual report. If a report is incomplete or inadequate CDRH may reject it and return it for completion. CDRH will not
enter a rejected report into our database. Also, a rejected report will not receive an accession number.
WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is the manufacturer’s
responsibility to certify that their products comply with all applicable standards (21 CFR 1010 - 1050), based on a testing
program in accordance with good manufacturing practices. Prior to the shipment of products in interstate commerce
21 CFR 1002 requires the manufacturer to submit the report and to comply with all applicable importation requirements
(21 CFR 1005). If there are deficiencies, we may disapprove the firm’s quality control and testing program, determine
that the product contains a radiation defect, or determine that the product fails to comply with a standard. We will notify
the manufacturer if we make such a determination. CDRH may require the manufacturer to cease introduction into U.S.
commerce until deficiencies are corrected, and to initiate a corrective action program (21 CFR 1003 - 1004) for products
already introduced into commerce.
Please mail your reports to the address below (FDA can not process electronic submissions at this time). Provide the
original report with appropriate signature(s) (no facsimiles, please). Provide extra copies only if this guide specifically
requires them. Submit the report written in the English language. Translate any text that appears in a language other than
English into English in a complete and accurate manner. Keep a copy of the completed reports in your records.
We are making our reporting guides and other regulatory information available on the Internet under
http://www.fda.gov/Radiation-EmittingProducts/. No copyright exists for these guides. Reproduce these guides as needed.
If you would like to comment on the reporting guides, web site, or future electronic submissions, you may direct the comments
to the address below. If you need additional regulations for electronic products or medical devices, you should contact the
Division of Small Manufacturers, International and Consumer Assistance by telephone at 1-800-638-2041.

E-MAIL ADDRESS: [email protected]
MAILING ADDRESS (see 21 CFR 1002.7 for further information):
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
¹

Manufacturer (see 21) CFR § 1000.3(n)) means any person engaged in the business of manufacturing, assembling, or importing electronic products.

²

Accidental Radiation Occurrences: 21 CFR 1002.20 requires manufacturers to immediately report accidental radiation occurrences (see 21 CFR
1000.3(a) for the definition).

³

Notification: Title 21 CFR Part 1003 requires manufacturers to provide Notification of Defects or Failure to Comply. Send these notifications to the
above address.

FORM FDA 3646 (09/20)

CONTENTS
Page
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

i

............................. ................................

iii

DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iv

PART 1 - MANUFACTURER, PRODUCT, AND REPORT IDENTIFICATION FOREWORD . . . .

1

PART 2 - DESCRIPTION OF THE REPORTED LAMP MODEL FOREWORD . . . . . . . . . . . . . .

3

PART 3 - COMPLIANCE WITH THE GENERAL LABELING REQUIREMENTS FOREWORD . .

5

PART 4 - COMPLIANCE WITH THE REQUIREMENTS FOR NON-SELFEXTINGUISHING LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

PART 5 - QUALITY CONTROL TESTS FOR NON-SELF-EXTINGUISHING
LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

PART 6 - COMPLIANCE WITH THE REQUIREMENTS FOR SELF-EXTINGUISHING
LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

PART 7 - QUALITY CONTROL, LIFE, AND RELIABILITY TESTS FOR SELFEXTINGUISHING LAMPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

INTRODUCTION

ii
FORM FDA 3646 (09/20)

INTRODUCTION

Manufacturers of products subject to performance standards under the Federal Food,
Drug, and Cosmetic Act, Chapter V, Subchapter C-Electronic Product Radiation
Control are required to furnish various reports to the Center for Devices and
Radiological Health (CDRH). This reporting guide has been prepared for use by
manufacturers in the preparation of product reports concerning high intensity mercury
vapor discharge lamps which are designed, intended, or promoted for illumination
purposes, as required by paragraph 1002.12 of Title 21 CFR (Code of Federal
Regulations).
The material submitted in the report is expected to be concise and to-the-point. As
required in 21 CFR 1002.7(b), the material submitted shall conform to the guide to the
extent that it is possible or appropriate to do so.
Mercury Vapor Lamp Abbreviated Reports must be submitted to CDRH at the address
below prior to the introduction of the reported products into commerce. (This includes
products imported into the U.S.)
An Abbreviated Report is required for each mercury vapor lamp model or model family.
Product Reports were formerly called Initial or Model Change Reports.
To avoid any unnecessary burden of reporting, the concept of model family is
emphasized. You are requested to group your products into as small a number of
model families as possible. A model family is a group of one or more mercury vapor
lamp models having basically similar design with regard to the performance
requirements in the standard, and which are manufactured using the same or very
similar quality control and testing procedures. Mercury vapor lamp models within the
same model family may have different wattage values, different shapes, and different
sizes of sockets. The information reported for any model within a model family will be
largely the same as the information for every other model within the same family.
The manufacturer must be sure that referenced information is accurate, current, and
applicable to the reported models. Information that is applicable to more than one model
family, but cannot be referenced in accordance with the above guidance, should be
duplicated and included in each report.
An Abbreviated Report is acceptable for "R" and “T” type mercury vapor lamps. For such
lamps, completion of applicable Parts of this report based on the non-self-extinguishing
or self-extinguishing design will serve as the abbreviated report.
When new models of a lamp are introduced, if the models do not involve changes in
radiation emission or performance requirements, then the manufacturer need not report
the models prior to introduction into commerce.

All symbols, units, and unusual terms in the report must be adequately defined and
consistently used. Please use the terms as defined in Section 1040.20(b) and in the IEEE

FORM FDA 3646 (09/20)

Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).
Your reports and correspondence are to be submitted to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER − WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
When a report is received at CDRH, an accession number will be assigned to the report.
The submitter will be informed of the accession number in a letter acknowledging
receipt of the report. The acknowledgement letter is not a technical review of the
report. The report will be reviewed by CDRH technical staff as soon as possible and the
submitter will be advised of the results. Report supplements should be clearly identified
with accession number of the original report.
The Product Reporting Guides and Annual Reporting Guides are available from the
Division of Small Manufacturers, International and Consumer Assistance in Rockville,
Maryland at 1-800-638-2041. DSMICA should be contacted for requests of any current
documents and the reporting guides mentioned here.
If you have specific questions regarding regulations or filling out these reports, call
DSMICA at 1-800-638-2041.

DEFINITIONS

NOTE: These definitions have been revised.
Abbreviated Report (21 CFR 1002.12) - An Abbreviated Report is allowed for "R" a n d “ T ”
type high intensity mercury vapor discharge lamps. Completing and submitting only the
applicable Parts of this report based on the non-self-extinguishing or self-extinguishing
design will fulfill the reporting requirements for the manufacturer of such products.

iv

FORM FDA 3646 (09/20)

PART 1: MANUFACTURER, PRODUCT, AND REPORT IDENTIFICATION
1.1

Identification of Manufacturer
Prime contact/responsible person
Name of manufacturing firm
Address

Email

Telephone
Importer (if applicable)
Address

Telephone

Email

Person preparing this report:
Signature
Name & Title
Telephone
1.2

Email

Identification of Report
1.2.1

Is this report submitted pursuant to paragraph (c) of 21 CFR 1002.61?
YES

NO

1.2.2

Date of this report

1.2.3

Is this a complete Product Report
Supplemental Report

Mercury Vapor Lamp Report (9/95)
FORM FDA 3646 (09/20)

,

, or Abbreviated Report

?

Page 1

1.2.4

If this is a Supplemental Report, give CDRH accession number and date of the Product Report
that it supplements.
Accession Number
Date

1.3

Identification of Product
1.3.1

Specify the type of lamp being reported.
non-self-extinguishing

,

self-extinguishing

,

mercury vapor
metal halide

,
,

other (specify)
1.3.2

Provide the model family designation.

1.3.3

Describe the model designation system within the family (ANSI designation system
may be used).

1.3.4

Identify the model detailed in this report:

1.3.5

List all other models in the model family and specify if supplements are attached.
(If not, explain why not.)

1.3.6

Supply the following information if the reported lamp is manufactured for and/or sold to other
manufacturers or suppliers for sale under a different name. Provide a copy of each label and
lamp packaging label.

Brand name

Model number

Mercury Vapor Lamp Report (9/95)
FORM FDA 3646 (09/20)

Name & address of firm under
whose name the lamp is sold

Page 2

PART 2: DESCRIPTION OF THE REPORTED LAMP MODEL
2.1

Description of the product
2.1.1

Provide a description of the exterior, including information on the base or socket of the reported
model. The descriptions may include the photographs or drawings with dimension reference
scale.

photographs or drawings attached
2.1.2

Provide a description of the interior structures of the reported model. The description may
consist of photographs or drawings of the interior structures with parts and component
identification and with scale dimensions.

photographs or drawings attached
2.2

Description of the operation
2.2.1

Provide a brief general description of the theory and process of operation, including the start,
the warm-up, and the steady-state condition of the reported model.

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Page 3

2.2.2

Provide information on lamp starting voltage, and operating current, of the reported model
(reference may be made to ANSI standard).

2.2.3

Specify the type of ballast that meets the specifications of the reported model's ratings for
starting and operation (reference may be made to ANSI standard).

2.2.4

Provide information on the life and warm-up time of the lamp.

2.2.5

If the reported model is a self-extinguishing lamp, provide descriptions in detail of the selfextinguishing mechanism, including its functioning theory and the conditions under which it
renders the lamp inoperable.

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Page 4

PART 3: COMPLIANCE WITH THE GENERAL LABELING REQUIREMENTS
3.1

Does the reported lamp model have a label certifying that the lamp conforms to the provisions of 21 CFR
1040.30 as required by 21 CFR 1010.2?
YES

NO

3.1.1

Where is the certification label? On the lamp
packaging
.

, or on the lamp

3.1.2

Submit a sample of the required certification label for the reported model, or a facsimile
of the label if the label is inscribed on the lamp.
Sample attached
Facsimile attached

3.2

Does the reported lamp model have an identification label that conforms to the provisions
of 21 CFR 1010.3?
YES

NO

3.2.1

Where is the identification label? On the lamp
on the lamp packaging
.

3.2.2

Submit a sample of the required identification label for the reported model, or a
facsimile of the label if the label is inscribed on the lamp.

, or

Sample attached
Facsimile attached
3.2.3

3.3

How is the identification label permanently affixed, inscribed, or marked on the lamp
and/or the lamp packaging?

Is the reported lamp model permanently labeled or marked in such a manner that the name of the
manufacturer and the month and year of manufacture of the lamp can be determined on the intact lamp
and after the outer envelope is broken or removed?
YES

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FORM FDA 3646 (09/20)

NO

Page 5

3.3.1

Submit a facsimile of the above identification label or mark for the reported
model.
Facsimile attached

3.3.2

If the name of the manufacturer and month and year of manufacture are expressed in code
or symbols, you must provide the following information.
code

key or explanation

The location of the coded information or symbols (please include picture, drawing,
or diagram showing location).

3.3.3

How are the name of the manufacturer and the date of the manufacture permanently
labeled or marked on the lamp?

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Page 6

PART 4: COMPLIANCE WITH THE REQUIREMENTS FOR
NON-SELF-EXTINGUISHING LAMPS

[This part should be completed when reporting non-self-extinguishing types of high intensity mercury vapor
discharge lamps as defined in 21 CFR 1040.30(b) (1).]
4.1

Lamp labeling (submit explanations for all "NO" answers as attachments)
4.1.1

Is the reported lamp model clearly marked with the letter "R" on the outer
envelope?
YES

4.1.2

NO

Does the reported lamp model have the letter "R" also marked on another part of
the lamp?
YES

NO

If yes:
(a)

Identify the location of the letter "R" (include picture, drawing, or diagram
showing location).

(b)

How is the letter "R" marked on the lamp?

(c)

Is the letter "R" visible after the outer envelope of the lamp is broken or removed?
YES

4.2

NO

Lamp packaging (submit explanations for all "NO" answers as attachments)
4.2.1

Does the lamp packaging for the reported lamp model clearly and prominently
display the letter "R"?
YES

Mercury Vapor Lamp Report (9/95)
FORM FDA 3646 (09/20)

NO
Page 7

4.2.2

Does the lamp packaging for the reported lamp model clearly and prominently
display the words:

"WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave
ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people
will remain for more than a few minutes unless adequate shielding or other safety precautions are
used. Lamps* that will automatically extinguish when the outer envelope is broken or punctured are
commercially available"?
YES

NO

*The words "certain types of" may be inserted before "lamps that will . . ."

4.2.3

The required warning statement for a non-self-extinguishing lamp appears on the lamp
carton
, outer wrapping
, and/or
other means of containment (specify)
for the
reported model.

4.2.4

Submit a sample or facsimile of the label on lamp packaging as required by 1040.30(e) (2)
for the reported model.
Sample attached
Facsimile attached

4.2.5

Describe other radiation safety-related information, if any, provided on or with the lamp
packaging for the reported model and the reason for providing that information.

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4.3

Lamp advertisement (submit explanations for all "NO" answers as attachments)
4.3.1

Does the advertising for the reported model prominently display the words:

"WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave
ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people
will remain for more than a few minutes unless adequate shielding or other safety precautions are
used. Lamps* that will automatically extinguish when the outer envelope is broken or punctured are
commercially available"?
YES

NO

*The words "certain types of" may be inserted before "lamps that will . . ."
4.3.2

The required warning statement in advertisement for a non-self-extinguishing lamp is
included in the catalog
, specification sheet
,
price list
, and other description or commercial brochure and
literature
for the reported model.

4.3.3

Submit copies of all advertisements containing the warning label as required by
1040.30(e) (3) for the reported model. (Material may be submitted in draft form
as long as it is marked as a draft, and final copies are to be submitted as report
supplements when available.)
Copies of finals attached
Copies of drafts attached

4.3.4

Describe other radiation safety-related information, if any, provided in advertisement for
the reported model and the reason for providing that information.

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Page 9

PART 5: QUALITY CONTROL TESTS FOR NON-SELF-EXTINGUISHING LAMPS

[This part should be completed by manufacturers of non-self-extinguishing types of high intensity mercury vapor
discharge lamps as defined in 21 CFR 1040.30(b) (1).]
5.1

Quality control tests
What tests or checks are conducted to assure the presence of the required labels and markings prior to
and after completion of the manufacturing process?
Information attached
If not, explain

5.2

Action upon rejection
Describe actions to be taken for rejected units and rejected lots.
Information attached
If not, explain

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Page 10

PART 6: COMPLIANCE WITH THE REQUIREMENTS FOR SELF-EXTINGUISHING LAMPS
[This part should be completed when reporting self-extinguishing types of high intensity mercury vapor
discharge lamps as defined in 21 CFR 1040.30(b) (1) and (7).]
6.1

6.2

Maximum cumulative operating time
6.1.1

The reported lamp model is designed to cease operation within a cumulative operating time not to
minutes, following complete breakage or removal of the outer
exceed
envelope (with no fragment of the outer envelope extending more than 50 millimeters from
the base shell).

6.1.2

The reported lamp model is designed to cease operation within a cumulative operating
time not to exceed
minutes, following breakage or removal of
at least 3 square centimeters of continuous surface of the outer envelope.
Not applicable?

Lamp labeling (submit explanations for all "NO" answers as attachments)
6.2.1

Is the reported lamp model clearly marked with the letter "T" on the outer envelope?
YES

6.2.2

NO

Does the reported lamp model have the letter "T" on another part of the lamp?
YES

NO

If yes:
(a)

Identify the location of the letter "T" (include picture, drawing, or diagram showing
location).

(b)

How is the letter "T" marked on the lamp?

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(c)

Is the letter "T" visible after the outer envelope of the lamp is broken or removed?
YES

6.3

NO

Lamp packaging (submit explanations for all "NO" answers as attachments)
6.3.1

Does the lamp packaging for the reported lamp model clearly and prominently display
the letter "T"?
YES

6.3.2

NO

Does the lamp packaging for the reported lamp model clearly and prominently display
the words:
"This lamp should self-extinguish within 15 minutes after the outer envelope is broken or
punctured. If such damage occurs, TURN OFF AND REMOVE LAMP to avoid possible
injury from hazardous shortwave ultraviolet radiation"?
YES

NO

6.3.3

The required warning statement for a self-extinguishing lamp appears on the lamp carton
, and/or other means of
, outer wrapping
containment (specify)
, for the reported model.

6.3.4

Submit a sample or a facsimile of the label on lamp packaging as required by
21 CFR 1040.30(d) (3) for the reported model.
Sample attached
Facsimile attached

6.3.5

Describe other radiation safety-related information, if any, provided on or with the lamp
packaging for the reported model and the reason for providing that information.

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Page 12

PART 7: QUALITY CONTROL, LIFE, AND RELIABILITY TESTS FOR
SELF-EXTINGUISHING LAMPS
[This part should be completed by manufacturers of self-extinguishing types of high intensity mercury vapor
discharge lamps as defined in 21 CFR 1040.30(b) (7). Wherever appropriate, information attached should include
quality control procedures for the tests performed, parameters measured, physical conditions under which tests are
conducted, measurement instrumentation and techniques, uncertainty evaluations of the measurements, sampling
plans, the rejection criteria or confidence limits used, and the justification for the particular choice of such limits,
methods of data analysis, etc.]
7.1

Quality control tests conducted before the lamp is manufactured.
7.1.1

What tests were conducted on preproduction or prototype models prior to initiation of
manufacturing to assure that the lamp was adequately designed for compliance within the
performance standard?

Information attached
If not, explain

7.1.2

What tests are conducted on the components of the self-extinguishing mechanism of the
lamp prior to their incorporation into the lamp?
Information attached
If not, explain

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7.2

Quality control tests done during and after manufacture of the lamp.
7.2.1

What tests or checks are conducted on the components of the self-extinguishing mechanism
of the lamp prior to their incorporation into the lamp?

Information attached
If not, explain

7.2.2

What tests or checks are conducted to assure proper functioning of the self-extinguishing
mechanism after completion of the manufacturing process?
Information attached
If not, explain

7.2.3

What tests or checks are conducted to assure the presence of the required labels and markings
prior to and after completion of the manufacturing process?
Information attached
If not, explain

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7.3

Action upon rejection
Describe actions to be taken for rejected units and rejected lots if they have been rejected for problems
concerning compliance with 21 CFR 1040.30. If retesting is required, state the criteria and procedures for
retesting.
Information attached
If not, explain

7.4

Life and reliability tests
Provide descriptions of the life and reliability tests of the self-extinguishing mechanism of the reported model,
including testing procedures, accept or reject criteria, lot and sample size, and action following rejection.

Information attached
If not, explain

7.5

Results of tests
7.5.1

Identify the type of tests related to compliance with 21 CFR 1040.30 for which results are
presented, including reference to applicable portions of this part of the report as appropriate.

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7.5.2

Identify the time period represented by results presented for each test.

7.5.3

Provide information on the total number of units manufactured or received in the case of
components, the number of units tested, and the number of units that initially failed to
meet the quality control acceptance criteria for each test related to compliance with
21 CFR 1040.30.

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Page 16