Records and Reports Regulations for Radiation Emitting Electronic Products
Federal RegisterSep 19, 1995
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1000 and 1002
[Docket No. 82N-0273]
RIN 0905-AD78
Records and Reports Regulations for Radiation Emitting Electronic
Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations regarding the requirements for recordkeeping and reporting
of adverse experiences and other information relating to radiation
emitting electronic products. This rule reduces recordkeeping and
reporting requirements for some products, requires only abbreviated
reporting for other products, and clarifies certain requirements. The
timing and content of certain reports will be revised to enhance the
usefulness of the information. These amendments will improve protection
of the public health while reducing regulatory burdens on
manufacturers, dealers, and distributors of radiation emitting
electronic products.
EFFECTIVE DATE: October 19, 1995.
FOR FURTHER INFORMATION CONTACT: Joanne Barron, Center for Devices and
Radiological Health (HFZ-300), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4654.
SUPPLEMENTARY INFORMATION:
I. Background
The Regulatory Flexibility Act (5 U.S.C. 601) and Executive Order
12866 require FDA to periodically conduct a comprehensive review of
existing regulations. This review is to analyze alternative regulatory
approaches and to identify regulations that need to be revised or
revoked because they impose an unnecessary burden on specific segments
of the public, such as manufacturers, dealers, small businesses, or the
general public. In the Federal Register of July 2, 1982 (47 FR 29004),
FDA announced its plan to review the records and reports regulations in
part 1002 (21 CFR part 1002). FDA recognized that, although part 1002
does not appear to have a major impact on the overall radiation
emitting electronic products industry, its impact on small
manufacturers
[[Page 48375]]
should not be overly burdensome and should be determined.
FDA recognizes that, for some products, meeting the full
recordkeeping and reporting requirements is not necessary to protect
the public health. Therefore, in the final rule, FDA has reduced the
recordkeeping and reporting requirements for some products and
determined that an abbreviated report is sufficient regulatory
monitoring for other products. FDA also recognizes that some sections
of the regulations need additional clarification to be more meaningful
and reduce regulatory burdens. Thus, FDA has adopted certain amendments
to clarify its regulations.
On October 25, 1990, FDA published in the Federal Register (55 FR
43066) a proposed rule amending its regulations regarding the
requirements for recordkeeping, reporting, and other information
relating to radiation emitting electronic products. FDA invited
interested parties to comment on the proposed rule by January 22, 1991.
The comment period was later extended until March 25, 1991 (56 FR
7316). FDA received 11 comments. A summary of these comments and FDA's
responses to them are set forth below. FDA is finalizing the proposed
rule at this time and incorporating changes that are the result of the
agency's review of the comments.
FDA is also amending references to statutory citations to reflect
changes in the law. On November 28, 1990, the President signed into law
the Safe Medical Devices Act of 1990 (the SMDA), which amended the
Federal Food, Drug, and Cosmetic Act (the act). Section 19 of the SMDA
transferred the Radiation Control for Health and Safety Act of 1968
from the Public Health Service Act (the PHS Act) into the act as
subchapter C. Thus, all references to the PHS Act in parts 1000 and
1002 (21 CFR parts 1000 and 1002) are being revised to reflect this
change. Additionally, the agency is changing all references to the
``Office of Compliance and Surveillance'' throughout parts 1000 and
1002 to the ``Office of Compliance'' to reflect an organizational
change within the Center for Devices and Radiological Health (CDRH).
The agency is also changing references to ``the Secretary'' and to
``the Director'' of CDRH in order to reflect the delegation of the
Secretary's authority in accordance with 21 CFR 5.90.
II. Highlights of the Final Rule
To reduce the regulatory burden on the industry, FDA is amending
regulations regarding the recordkeeping and reporting requirements for
certain radiation emitting electronic products.
First, the reporting requirements in Sec. 1002.12 (reports of model
changes) have been consolidated with the requirements of Sec. 1002.10
(initial reports), and the name ``initial report'' has been changed to
``product report.''
Second, FDA has developed two new categories of reports,
``supplemental reports'' in Sec. 1002.11, and ``abbreviated reports''
in Sec. 1002.12. New Sec. 1002.11 (supplemental reports), which
requires manufacturers to provide information on product safety and
testing, applies to a smaller subset of manufacturers, and reduces the
number of required reports by approximately 40 percent. New
Sec. 1002.12 (abbreviated reports) requires manufacturers to report
abbreviated information on product safety and testing and replaces the
existing requirements for many initial reports and model change
reports. Although the total combined number of product reports and
abbreviated reports will remain about the same as the former initial
reports and model change reports, the time necessary to complete the
reports will be reduced by approximately 60 percent.
Finally, FDA has limited the applicability of the records
requirements in Secs. 1002.30 and 1002.40. These changes have reduced
the number of records to be maintained by manufacturers and by dealers/
distributors by 50 percent and 99 percent, respectively.
Overall, this final rule will reduce the annual reporting and
recordkeeping burden hours on the industry by 81 percent, without
reducing public health protection.
III. Comments
The following is a summary of the comments and the agency's
responses to them.
A. Reporting Requirements
1. One comment stated that there are no relevant changes in the
content or format of the initial report to warrant a name change to
``product report.'' The comment states that the name change would
result in unnecessary additional costs because personnel, particularly
nonregulatory staff, who are familiar with the term initial report,
would need to be reeducated.
FDA recognizes that, as with any new requirement, the affected
parties may need some training in order to appreciate and understand
the changes. In this case, the change is intended to lessen the burden
of this requirement by clearly describing the reports that are
required, and the filing and content requirements of such reports. For
example, FDA has deleted the reference to a 90-day due date for filing
an initial report (see revised Sec. 1002.10) because that requirement
was applicable only to newly listed products. FDA believes that the
long-term benefits of such changes--clearer regulatory requirements, a
reduced regulatory burden on industry, and improved cost effectiveness
and efficiency--outweigh its short-term training costs. Because FDA and
the industry have used the previous term for 20 years, it is expected
that there will be a period of transition to the new term over the next
year for both the industry and FDA personnel.
2. One comment stated that industrial x-ray systems should not be
included in the list of products for which abbreviated reports, rather
than initial reports (to be called ``product reports''), are required.
The comment expressed the belief that industrial x-ray systems should
follow the same reporting requirements as diagnostic x-ray and other x-
ray systems.
FDA included analytical and industrial x-ray equipment in the list
of products for which abbreviated reports are required because there is
no FDA radiation performance standard for these products and, unlike
diagnostic x-ray systems, any exposure of people to radiation would be
unintentional. In addition, the users of such equipment are trained to
be more aware of precautions necessary to reduce or eliminate
exposures. In the event that a public health concern arises, however,
the regulation would permit FDA to request additional safety
information from the manufacturer.
3. One comment asked whether FDA will exempt linear accelerators
and low-energy therapy x-ray devices from annual reporting
requirements.
Linear accelerators and low-energy therapy x-ray equipment are
included in Sec. 1002.1, Table 1, under the category of ``Products
Intended to Produce Particulate Radiation or X-rays Other Than
Diagnostic or Cabinet X-ray.'' The format of Table 1 has been modified
to make clear that the requirements are the same for all medical,
analytical, and industrial systems that fall within this product
category. Specifically, manufacturers are required to submit
abbreviated and annual reports and to maintain test and distribution
records for these products.
4. One comment expressed the concern that, unlike television
receivers, video display terminals (VDT's) are not specifically
delineated by FDA under the reporting and recordkeeping provisions of
the regulations. The comment stated that there is little
[[Page 48376]]
difference between television receivers and VDT screens and monitors
and, therefore, these products should be treated similarly in these
provisions. The comment stated that recent investigations of VDT use
have shown that low levels of electromagnetic radiation are emitted
from certain brands and models. The comment stated that the health and
safety effects of these emissions are unknown, but the nature of most
VDT work suggests that the effects may be detrimental. Given the health
concerns, and the fact that such emissions have generally not been
examined, the comment recommended that manufacturers be required to
provide product reports, supplemental reports, annual reports, and test
records to VDT purchasers, who in turn should be required to relay such
information to their employees and representatives. The comment
suggested that the hazard communication standard under the Occupational
Safety and Health Act (29 CFR 1910.1200) would provide a model for FDA
in constructing radiation recordkeeping requirements for VDT's.
FDA has used the designation ``television products'' in
Sec. 1002.1, Table 1, to reflect the scope of the product category that
is the subject of the performance standard for television receivers at
21 CFR 1020.10. The intent of that standard has been to reduce
unnecessary x-ray exposure to persons from any electronic product that
can display a viewable picture on a cathode ray tube (CRT). FDA agrees
that there are a number of clarifications that need to be made
regarding this category of products. FDA anticipates issuing a notice
of proposed rulemaking to amend the television receiver standard to
address the issues raised in this comment and other issues concerning
VDT's. FDA will propose the appropriate changes to part 1002 when the
performance standard for television receivers is amended.
With respect to the suggestion that manufacturers be required to
provide reports and records to users of VDT's, amended Sec. 1002.3 will
provide the mechanism for FDA to require manufacturers to provide the
ultimate purchaser of the product with necessary performance and
technical data.
5. One comment stated that a 25 kilovolt (kV) criterion should be
established for television receivers to differentiate between
television receivers that will be subject to relatively moderate
reporting requirements (abbreviated reports and annual reports) and
those that will be subject to more substantial reporting requirements
(product reports, supplemental reports, and annual reports).
FDA agrees with this comment and adopted a 25 kV criterion in the
rule. See Sec. 1002.1, Table 1.
6. One comment stated that television receivers with less than 25
kV and less than 0.1 milliroentgen per hour (mR/hr) should be relieved
of the annual report requirement of 1002.13 and the preservation and
inspection of records provisions of Sec. 1002.31. The comment asserted
that exemptions from these provisions already apply to receivers with
less than 25 kV pursuant to a 1987 letter to industry which stated that
only status identification is required for annual reports on these
products.
Consistent with the November 16, 1987, letter to manufacturers of
television receiver products from the Director of CDRH (Ref. 1),
television receivers which, when tested under phase III conditions,
will not equal or exceed 25 kV and for which the chassis power curve
will not reach or exceed the 0.1 mR/hr isoexposure rate limit curve
(IRLC) are relieved of the annual report requirement of Sec. 1002.13
and the preservation and inspection of records provisions of
Sec. 1002.31. Section 1002.1, Table 1, has been revised accordingly.-
7. One comment noted discrepancies between the preamble language
and Table 1 of the proposed rule. The preamble states that abbreviated
reports will replace initial and supplemental reports for ``certain
television products.'' The text further states that product reports,
but not supplemental reports, will be required for television receivers
emitting less than 0.1 mR/hr. However, Table 1 of the proposed rule
states that television receivers with less than 25 kV and less than 0.1
mR/hr will require abbreviated reports and television receivers
emitting greater than 0.1 mR/hr will require only product reports (not
supplemental reports). The comment supports the requirements as set
forth in Table 1, but recommends, consistent with the preamble, that
the requirement for supplemental reports be deleted for television
receivers with greater than 25 kV and less than 0.1 mR/hr.
FDA has corrected the errors appearing in Table 1. Since November
16, 1987, the policy at CDRH has been that certain categories of
television products may be exempt from some of the reporting and
recordkeeping requirements, depending on the maximum high voltage on
the picture tube and the possibility of emission of x-rays at or above
0.1 mR/hr. Manufacturers were given the responsibility to conduct phase
III tests and inform CDRH, through annual reports, which models qualify
for such exemptions. The agency's intention was to maintain the same
level of requirements under the amended reporting and recordkeeping
regulations that has previously been in effect for products that may
operate at or above 25 kV and products that may emit x-rays at a rate
of 0.1 mR/hr or above. The agency believes that these products
represent different levels of risks and that different levels of
recordkeeping and reporting requirements continue to be appropriate for
each category.
Therefore, any television product that contains a CRT or other
component capable of producing x-rays, and which, when tested under
phase III conditions, will not equal or exceed 25 kV and for which the
chassis power curve will not reach or exceed the 0.1 mR/hr IRLC, will
require only abbreviated reports. A television product containing a
CRT, which, when tested under phase III conditions, may equal or exceed
25 kV but for which the chassis power curve does not reach or exceed
the 0.1 mR/hr IRLC, will require product reports, supplemental reports,
and annual reports. A television product containing a CRT, for which,
when tested under phase III conditions, the chassis power curve reaches
or exceeds the 0.1 mR/hr IRLC, will require product reports,
supplemental reports, annual reports, and maintenance of the records of
test results and distribution of products for 5 years.
Manufacturers must continue to conduct an adequate quality control
and testing program to ensure continued compliance of all models with
the performance standard. Products for which there is no requirement
that test results be kept for 5 years must, nevertheless, be tested
adequately and the results should be reviewed by a quality control
manager. These products should be rejected at a maximum limit of 0.1
mR/hr when tested under phase III conditions.
The agency retains the authority to inspect all documents
supporting the adequacy of the manufacturer's quality control and
testing program, including programs for these products for which it is
not necessary to retain test results for 5 years. The final rule has
added a footnote to Table 1 (footnote 1) to clarify this point.
8. One comment stated that FDA should codify its existing practice
concerning importation of products for compliance testing and other
related purposes to reduce the potential for confusion about the
precise terms and conditions surrounding these activities. The comment
stated that bulletins sent by FDA to the industry have stated, at
[[Page 48377]]
least with respect to television receivers and laser products, that FDA
performance standards do not apply to products ``that are imported for
purpose of research, investigations, studies, demonstrations, or
training, and that consist of 10 or fewer units per shipment,'' so long
as certain administrative safeguards are observed.
The scope of this rule is limited to the reporting andrecordkeeping
requirements in part 1002 and is not intended to amend FDA practices
and regulations regarding the scope of the applicability of performance
standards. Under current policies, FDA allows exemptions from
performance standards for 10 or fewer units of certain products (i.e.,
television products, microwave ovens, and certain laser products), that
are imported for test and evaluation and remain under the importer's
control, if such products are properly labeled. These exemptions are
referenced in FDA Compliance Program 7382.007 which is available from
the Division of Small Manufacturers Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 800-638-2041 or 301-443-6597. These
policies will be continued but this rule does not expand the scope of
that exemption to all products. However, the rule codifies procedures
that allow manufacturers to apply for special exemptions from the
reporting and recordkeeping requirements of part 1002 or the Director
of CDRH to grant such exemptions on his or her own. See
Secs. 1002.50(a)(3) and 1002.50(b).
9. One comment requested that FDA clarify the distinctionbetween
television receivers and CRT's and explain whether there are
differences in the regulations that apply to the products that fall
within these two categories. The comment noted that the majority of
television receivers use CRT's to display video images (a small
minority of receivers use liquid crystal displays), and the comment was
uncertain why television receivers remain subject to various reporting
requirements while CRT's will be generally exempt from reporting
requirements, with the exception of Sec. 1002.20. The comment further
stated that FDA's distinction apparently depends on whether a device is
limited by design to display only alphanumeric characters (CRT) or
whether it can also display other video images (television receiver).
The comment stated that FDA's distinction does not appear to be based
on public health considerations, and that confusion and potential
compliance problems would be avoided by adopting a definition of
television that is more consistent with that of the affected industry.
The comment suggests that FDA consider adopting the definition used by
the FCC, which defines television receiver as a ``device designed to
receive television pictures that are broadcast simultaneously with
sound on the television channels authorized under part 73 of the FCC's
rules.'' (See 47 CFR 15.3(w)(1990)).
Previously, the regulations required manufacturers to submit
initial, model change, and annual reports for television receivers and
to submit initial and model change reports for CRT's. A CRT is an
electronic product component and, as such, is subject to the general
radiation safety requirements, but not subject to a performance
standard. FDA has determined that the Joint Electron Device Engineering
Council/Tube Engineering Panel Advisory Council (JEDEC/TEPAC) data on
CRT's that is available from the Electronic Industries Association is
sufficient for FDA to assess the potential radiation hazards for CRT's;
therefore, any additional reports on the CRT's are not necessary.
However, the monitors and video display products that contain the CRT's
and associated electronics are subject to the television receiver
standard. Accordingly, manufacturers are required to demonstrate that
these products, including the CRT's contained in them, meet the
standard and to report how the products are tested for compliance. FDA
currently is reviewing whether to change the performance standard for
television receivers to clarify the definitions of products to which
the standard is applicable. This comment will be included in that
review.
B. Exemptions
10. One comment proposed that manufacturers of products forwhich
there is no applicable performance standard under 21 CFR part 1020 and
for which a 510(k) premarket notification (510(k)) has been submitted
and cleared in accordance with part 807, subpart E, be exempt from
submitting all reports listed in Table 1 of proposed Sec. 1002.1. The
comment believes it would be appropriate to include manufacturers of
these products in the exemption under proposed Sec. 1002.50(e), because
sufficient information regarding safety and effectiveness has been
obtained through FDA review of the 510(k) submission. Alternatively,
the comment suggests that the fact that any particular electronic
product is also a medical device subject to 510(k) notifications should
be included among the criteria for considering a special exemption
under proposed Sec. 1002.50(a).
Generally, a 510(k) notice on a medical device is submitted to FDA
to demonstrate that a design specification is substantially equivalent
to the specifications of a predicate device. The radiation safety
reporting required by this part of the regulations is intended to
provide information on actual production testing and quality control
and on the actual product design as produced. If the two are redundant
in any particular circumstance, the Director of CDRH can issue
exemptions from the reporting and recordkeeping requirements in
accordance with Sec. 1002.50(b). FDA does not believe a general
exemption from the reporting requirement is in the interest of public
health.-
11. One comment objected to the exemption of distributors and
dealers from the recordkeeping requirement for microwave ovens. The
comment states that if such an exemption is granted, these products
would be much more difficult to locate to ensure their safety. The
comment notes that customer warranty registrations are not sufficient
to locate products because such registrations are returned by the
customers at such a low rate. The comment states that if the dealer/
distributor records are no longer required, the burden of locating the
microwave oven shifts to the manufacturer who would have no other
alternative but to launch an advertising campaign that would be more
expensive, less effective, and slower than any recordkeeping on the
part of distributors or dealers.
It has been FDA's experience that dealer and distributor records
are rarely needed for the intended purpose of notifying purchasers of
product noncompliance. In light of the fact that there have been
limited recalls of microwave ovens in the past 10 years (due in part to
prototype examinations by FDA), FDA believes that it would be overly
burdensome to require distributors and dealers to comply with the
recordkeeping requirement. When recalls are necessary, FDA believes
that purchasers can be notified by other means, such as general media
announcements.
12. One comment recommended that FDA exempt televisionreceivers
whose voltage on the CRT is less than 5 kV at zero beam current from
the recordkeeping and reporting requirements of part 1002, with the
exception of Sec. 1002.20. The comment stated that there is no evidence
to suggest that products with such a low voltage (generally,
videocamera
[[Page 48378]]
viewfinders and televisions with 2 or 3 inch screens) are capable of
generating x-rays, which is the primary concern in part 1002. Another
comment contended that it would be inappropriate to impose testing and
reporting requirements on television receivers with less than 5 kV on
the CRT, while CRT's with comparable or even greater voltages are
exempted.
Under the amended reporting and recordkeeping requirements,
television products whose voltage on the CRT is less than 5 kV will
require only abbreviated reports and annual reports, and manufacturers
may apply for special exemption from these requirements under the new
regulations in Sec. 1002.50. FDA will include these comments in the
agency's review of possible amendments to the television performance
standard.
13. One comment noted that the preamble to the proposed rule states
that television receivers emitting less than 0.1 mR/hr will be exempt
from the requirements of maintaining manufacturer's testing and
distribution records. The preamble also notes that other products,
including ``television receivers,'' are already exempt from these
requirements. In comparison, Table 1 of the proposed rule exempts all
television receivers from the requirements to maintain manufacturer
testing and distribution records. The comment supports the exemption
for all television receivers as reflected in Table 1.
A similar concern about the discrepancy between the preamble and
Table 1 was addressed above in comment 7. There was an error in the
printing of Table 1 of the proposed rule. For television receivers for
which the chassis power curve reaches or exceeds the 0.1 mR/hr IRLC,
there should have been an X in the following columns: Supplemental
reports, Test records, and Manufacturer distribution records. These
reports and records are important for FDA to monitor the safety of
those products which, by design, can emit radiation levels above
background. Table 1 has been amended accordingly.
14. One comment noted an inadvertent error with respect
tomanufacturer distribution recordkeeping requirements under
Sec. 1002.30(b). The comment stated that FDA has eliminated these
requirements for class I lasers and products containing such lasers.
Proposed Table 1 to Sec. 1002.1, however, appears to state that class I
lasers and products containing class I lasers will be subject to
manufacturer distribution recordkeeping requirements under Sec.
1002.30(b). The comment requested FDA to clarify, by amendment of
proposed Table 1, that class I lasers and products containing such
lasers will retain the exemptions that already apply, including the
exemption for manufacturer's distribution records.
Table 1 has been amended to clarify that the exemption for these
products from certain reporting requirements remains in effect. FDA has
added to Table 1 a category for ``Class I lasers and laser products
containing such lasers,'' that will have X's in the columns for Product
Reports, Annual Reports, Manufacturer's Test Records, but not for
Supplemental Reports, Abbreviated Reports, Manufacturer's Distribution
Records, or Dealer/Distributor Distribution Records.
FDA will determine which reporting category is applicable to a
product that may have more than one class of laser on the basis of the
worst-case hazard in the product. Thus, a class I laser product
containing a class IV laser and a class II alignment laser will fall in
the category ``Class IIIb and IV lasers and products containing such
lasers,'' because this represents the worst-case hazard within the
product. Table 1 has been supplemented with a footnote to explain this
policy (footnote 7).
15. One set of comments supported the agency's efforts to minimize
the reporting and recordkeeping requirements for radiation emitting
electronic products. Another comment disagreed with the intent to
eliminate initial reports for diagnostic ultrasound equipment. Instead,
that comment proposed that diagnostic ultrasound equipment be added to
the category of products for which an abbreviated report is required,
and that such products be exempt from annual reports. The comment
stated that this proposal would reduce the burden on the industry from
the medical device premarket clearance process.
Currently, diagnostic ultrasound devices are subject to initial
reports but not annual reports. However, in a letter to all
manufacturers of diagnostic ultrasound products from the CDRH Director
dated February 24, 1986 (Ref. 2), these devices were exempted from the
initial reports as long as a 510(k) was filed. CDRH issued this letter
to reduce the burden and duplication of paperwork on the industry. The
agency recognizes the increase in the timeframe necessary to gather all
the information that must be submitted in the 510(k) notification,
including production test information that otherwise would be contained
in the initial report. Therefore, FDA has amended Table 1 to include
abbreviated reports for diagnostic ultrasound equipment in order to
retain its ability to obtain production test information about these
products. However, CDRH intends to continue to exempt these products
from the abbreviated (formerly initial) report requirement until
documentation submitted for premarket clearance or for special controls
is no longer duplicative of information that would be contained in the
abbreviated report.
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the provisions of the final rule reduce or
simplify the records and reporting requirements for manufacturers,
dealers, and distributors of radiation emitting electronic products,
the agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
A copy of the document supporting this determination, ``Report of the
CDRH Task Force for Retrospective Review of the Recordkeeping and
Reporting Requirements of 21 CFR 1002,'' is on file at the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested
persons in
[[Page 48379]]
that office between 9 a.m. and 4 p.m., Monday through Friday.
VI. Paperwork Reduction Act of 1980
This final rule contains information collections which are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1980 (44 U.S.C. Chapter 35). The title,
description, and respondent description of the information collection
are shown below with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: Reporting and Recordkeeping Requirements for Electronic
Products Under Pub. L. 90-602--General Requirements. -
Description: The Food and Drug Administration is amending its
regulations regarding the requirements for recordkeeping, reporting,
and other information relating to radiation emitting electronic
products. The timing and content of certain reports will be revised to
enhance the usefulness of the information. The purpose of these changes
is to improve the protection of the public health while also reducing
the regulatory burden on manufacturers, dealers, and distributors of
radiation emitting electronic products. -
Description of Respondents: Businesses or other for profit
organizations.
----------------------------------------------------------------------------------------------------------------
Estimated annual reporting and recordkeeping burden
-----------------------------------------------------------------------------------------------------------------
Annual number of Average burden per
Section reports and records response (hours) Annual burden (hours)
----------------------------------------------------------------------------------------------------------------
1002.10, 1002.12 .................... ..................... .....................
Existing:...................................
Initial..................................... 320 34 10,880
Model Change................................ 725 42 30,450
Supplements................................. 2,520 0.5 1,260
Subtotal.................................. 3,565 avg 11.9 42,590
Amended:....................................
Product..................................... 850 24 20,400
Supplements................................. 1,500 0.5 750
Abbreviated................................. 150 5 750
Subtotal.................................. 2,500 avg 8.8 21,900
Total Reports Reduction..................... .................... ..................... 20,690
1002.30.....................................
Existing:................................... 4,000,000 0.12 480,000
Amended:.................................... 1,904,000 0.12 480,000
Reduction:................................ .................... ..................... 251,520
1002.40.....................................
Existing:................................... 17,000,000 0.048 816,000
Amended:.................................... 145,000 0.048 6,960
Reduction:................................ .................... ..................... 809,040
Total Records Reduction..................... .................... ..................... 1,060,560
Total existing annual burden hours.......... .................... ..................... 1,338,590
Total amended annual burden hours........... .................... ..................... 257,340
Total difference in annual burden hours..... .................... ..................... 1,081,250
.................... ..................... (81% reduction)
----------------------------------------------------------------------------------------------------------------
As required by section 3504(h) of the Paperwork Reduction Act of
1980, FDA has submitted a copy of this rule to OMB for its review of
these information collection requirements. Other organizations and
individuals desiring to submit comments regarding this burden estimate
or any aspects of these information collection requirements, including
suggestions for reducing the burden, should direct them to FDA's
Dockets Management Branch (address above) and to the Office of
Information and Regulatory Affairs, OMB, rm. 3208, New Executive Office
Bldg., Washington, DC 20503, Attn: Desk Officer for FDA.
VII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Director, CDRH, FDA, letter to manufacturers of television
receiver products, dated November 16, 1987.
2. Director, CDRH, FDA, letter to manufacturers of ultrasound
products, dated February 24, 1986.
List of Subjects
21 CFR Part 1000
Electronic products, Radiation protection, Reporting and
recordkeeping requirements, X-rays.
[[Page 48380]]
21 CFR Part 1002
Electronic products, Radiation protection, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Radiation Control for Health and Safety Act, and under authority
delegated to the Commissioner of Food and Drugs, 21 CFR parts 1000 and
1002 are amended as follows:
PART 1000--GENERAL
1. The authority citation for 21 CFR part 1000 is revised to read
as follows:
Authority: Secs. 530-542 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360hh-360ss).
2. Section 1000.3 is revised to read as follows:
Sec. 1000.3 Definitions.
As used in this Subchapter J:
(a) Accidental radiation occurrence means a single event or series
of events that has/have resulted in injurious or potentially injurious
exposure of any person to electronic product radiation as a result of
the manufacturing, testing, or use of an electronic product.
(b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360hh-360ss).
(c) Chassis family means a group of one or more models with all of
the following common characteristics:
(1) The same circuitry in the high voltage, horizontal oscillator,
and power supply sections;
(2) The same worst component failures;
(3) The same type of high voltage hold-down or safety circuits; and
(4) The same design and installation.
(d) Commerce means:-
(1) Commerce between any place in any State and any place outside
thereof, and
(2) Commerce wholly within the District of Columbia.
(e) Component, for the purposes of this part, means an essential
functional part of a subassembly or of an assembled electronic product,
and which may affect the quantity, quality, direction, or radiation
emission of the finished product.
(f) Dealer means a person engaged in the business of offering
electronic products for sale to purchasers, without regard to whether
such person is or has been primarily engaged in such business, and
includes persons who offer such products for lease or as prizes or
awards.
(g) Director means the Director of the Center for Devices and
Radioloical Health.
(h) Distributor means a person engaged in the business of offering
electronic products for sale to dealers, without regard to whether such
person is or has been primarily or customarily engaged in such
business.
(i) Electromagnetic radiation includes the entire electromagnetic
spectrum of radiation of any wavelength. The electromagnetic spectrum
illustrated in Figure 1 includes, but is not limited to, gamma rays, x-
rays, ultra-violet, visible, infrared, microwave, radiowave, and low
frequency radiation.
[[Page 48381]]
[GRAPHIC][TIFF OMITTED]TR19SE95.010
BILLING CODE 4160-01-C
[[Page 48382]]
(j) Electronic product means:
(1) Any manufactured or assembled product which, when in operation:
(i) Contains or acts as part of an electronic circuit and
(ii) Emits (or in the absence of effective shielding or other
controls would emit) electronic product radiation, or -
(2) Any manufactured or assembled article that is intended for use
as a component, part, or accessory of a product described in paragraph
(j)(1) of this section and which, when in operation, emits (or in the
absence of effective shielding or other controls would emit) such
radiation.
(k) Electronic product radiation means:
(1) Any ionizing or nonionizing electromagnetic or particulate
radiation, or
(2) Any sonic, infrasonic, or ultrasonic wave that is emitted from
an electronic product as the result of the operation of an electronic
circuit in such product.
(l) Federal standard means a performance standard issued pursuant
to section 534 of the Federal Food, Drug, and Cosmetic Act.
(m) Infrasonic, sonic (or audible) and ultrasonic waves refer to
energy transmitted as an alteration (pressure, particle displacement or
density) in a property of an elastic medium (gas, liquid or solid) that
can be detected by an instrument or listener.
(n) Manufacturer means any person engaged in the business of
manufacturing, assembling, or importing electronic products.
(o) Model means any identifiable, unique electronic product design,
and refers to products having the same structural and electrical design
characteristics and to which the manufacturer has assigned a specific
designation to differentiate between it and other products produced by
that manufacturer.
(p) Model family means products having similar design and radiation
characteristics but different manufacturer model numbers.
(q) Modified model means a product that is redesigned so that
actual or potential radiation emission, the manner of compliance with a
standard, or the manner of radiation safety testing is affected.
(r) Particulate radiation is defined as:
(1) Charged particles, such as protons, electrons, alpha particles,
or heavy particles, which have sufficient kinetic energy to produce
ionization or atomic or electron excitation by collision, electrical
attractions or electrical repulsion; or
(2) Uncharged particles, such as neutrons, which can initiate a
nuclear transformation or liberate charged particles having sufficient
kinetic energy to produce ionization or atomic or electron excitation.
(s) Phototherapy product means any ultraviolet lamp, or product
containing such lamp, that is intended for irradiation of any part of
the living human body by light in the wavelength range of 200 to 400
nanometers, in order to perform a therapeutic function.
(t) Purchaser means the first person who, for value, or as an award
or prize, acquires an electronic product for purposes other than
resale, and includes a person who leases an electronic product for
purposes other than subleasing.
(u) State means a State, the District of Columbia, the Commonwealth
of Puerto Rico, the Virgin Islands, Guam, and American Samoa.
PART 1002--RECORDS AND REPORTS
3. The authority citation for 21 CFR part 1002 is revised to read
as follows:
Authority: Secs. 502, 510, 519, 520, 531-542, 701, 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i,
360j, 360hh-360ss, 371, 374).
4. Section 1002.1 is revised to read as follows:
Sec. 1002.1 Applicability.
The provisions of this part are applicable as follows:
(a) All manufacturers of electronic products are subject to
Sec. 1002.20.
(b) Manufacturers, dealers, and distributors of electronic products
are subject to the provisions of part 1002 as set forth in Table 1 of
this section, unless excluded by paragraph (c) of this section, or
unless an exemption has been granted under Sec. 1002.50 or
Sec. 1002.51.
(c) The requirements of part 1002 as specified in Table 1 of this
section are not applicable to:
(1) Manufacturers of electronic products intended solely for export
if such product is labeled or tagged to show that the product meets all
the applicable requirements of the country to which such product is
intended for export.
(2) Manufacturers of electronic products listed in Table 1of this
section if such product is sold exclusively to other manufacturers for
use as components of electronic products to be sold to purchasers, with
the exception that the provisions are applicable to those manufacturers
certifying components of diagnostic x-ray systems pursuant to
provisions of Sec. 1020.30(c) of this chapter.
(3) Manufacturers of electronic products that are intended for use
by the U.S. Government and whose function or design cannot be divulged
by the manufacturer for reasons of national security, as evidenced by
government security classification.
(4) Assemblers of diagnostic x-ray equipment subject to the
provisions of Sec. 1020.30(d) of this chapter, provided the assembler
has submitted the report required by Sec. 1020.30(d)(1) or (d)(2) of
this chapter and retains a copy of such report for a period of 5 years
from its date.
[[Page 48383]]
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Table 1.--Record and Reporting Requirements By Product
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Manufacturer
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Supplemental Abbreviated Distribution Dealer Distributor--
Products Product reports reports Sec. reports Sec. Annual reports Test records Sec. records Sec. Distribution records
Sec. 1002.10 1002.11 1002.12 Sec. 1002.13 1002.30(a)1 1002.309(b)2 1002.40 and 1002.41
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DIAGNOSTIC X ............... ............... .............. .............. .................. ................... ...........................
RAY3 (1020,30,
1020,31,
1020.32,
1020.33)
Computed X X .............. X X X X
tomography
X-ray system4 X X .............. X X X X
Tube housing X X .............. X X X ...........................
assembly
X-ray control X X .............. X X X X
X-ray high X X .............. .............. X X X
voltage
generator
X-ray table or ............... ............... X .............. X X X
cradle
X-ray film ............... ............... X .............. X X X
changer
Vertical ............... ............... X .............. X X X
cassette
holders mounted
in a fixed
location and
cassette
holders with
front panels
Beam-limiting X X .............. X X X X
devices
Spot-film X X .............. X X X X
devices and
image
intensifiers
manufactured
after April 26,
1977
Cephalometric ............... ............... X .............. X X ...........................
devices
manufactured
after February
25, 1978
Image receptor ............... ............... X .............. X X ...........................
support devices
for
mammographic x-
ray systems
manufactured
after September
5, 1978
CABINET X RAY ............... ............... .............. .............. .................. ................... ...........................
(Sec. 1020.40)
Baggage X X .............. X X X X
inspection
Other X X .............. X X X ...........................
[[Page 48384]]
PRODUCTS ............... ............... .............. .............. .................. ................... ...........................
INTENDED TO
PRODUCE
PARTICULATE
RADIATION OR X-
RAYS OTHER THAN
DIAGNOSTIC OR
CABINET X-RAY
Medical ............... ............... X X X X ...........................
Analytical ............... ............... X X X X ...........................
Industrial ............... ............... X X X X ...........................
TELEVISION ............... ............... .............. .............. .................. ................... ...........................
PRODUCTS (Sec.
1020.10)
........... ............... X X6 .................. ................... ...........................
(kV) and 1,2
=24kV X X .............. X X X ...........................
and 5
=0.1m X X .............. X X X ...........................
R/hr IRLC5
MICROWAVE/RF ............... ............... .............. .............. .................. ................... ...........................
MW ovens (Sec. X X .............. X X X ...........................
1030.10)
MW diathermy ............... ............... X .............. .................. ................... ...........................
MW heating, ............... ............... X .............. .................. ................... ...........................
drying,
security
systems
RF sealers, ............... ............... X .............. .................. ................... ...........................
electromagnetic
induction and
heating
equipment,
dielectric
heaters (2-500
megahertz)
OPTICAL ............... ............... .............. .............. .................. ................... ...........................
Phototherapy X X .............. .............. .................. ................... ...........................
products
Laser products ............... ............... .............. .............. .................. ................... ...........................
(Secs. 1040.10,
1040.11)
Class I lasers X ............... .............. X X ................... ...........................
and products
containing such
lasers2
Class I laser X ............... .............. X X X ...........................
products
containing
class IIa, II,
IIIa, lasers7
[[Page 48385]]
Class IIa, II, X ............... X X X X
IIIa lasers and
products other
than class I
products
containing such
lasers7DX
Class IIIb and X X .............. X X X X
IV lasers and
products
containg such
lasers7
Sunlamp products ............... ............... .............. .............. .................. ................... ...........................
(Sec. 1040.20)
Lamp only X ............... .............. .............. .................. ................... ...........................
Sunlamp products X X .............. X X X X
Mercury vapor ............... ............... .............. .............. .................. ................... ...........................
lamps (Sec.
1040.30)
T lamps X X .............. X .................. ................... ...........................
R lamps ............... ............... X .............. .................. ................... ...........................
ACOUSTIC ............... ............... .............. .............. .................. ................... ...........................
Ultrasonic X X .............. X X X X
therapy
(1050.10)
Diagnostic ............... ............... X .............. .................. ................... ...........................
ultrasound
Medical X X .............. .............. .................. ................... ...........................
ultrasound othe
than therapy or
diagnostic
Nonmedical ............... ............... X .............. .................. ................... ...........................
ultrasound
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\1\However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\The requirement includes Secs. 1002.31 and 1002.42, if applicable.
\3\Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).
\4\Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c).
\5\Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (1020.10(c)(3)(iii)).
\6\Annual report is for production status information only.
\7\Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.
Sec. 1002.2 [Removed]-
5. Section 1002.2 Definitions is removed from subpart A.
6. Section 1002.3 is revised to read as follows:
Sec. 1002.3 Notification to user of performance and technical data.
As authorized by Sec. 5.90 of this chapter, the Director and Deputy
Director of the Center for Devices and Radiological Health may require
a manufacturer of a radiation emitting electronic product, to provide
to the ultimate purchaser at the time of original purchase, such
performance data and other technical data related to safety of the
product as the Director or Deputy Director finds necessary.
7. Section 1002.7 is amended by adding a new sentenceto the end of
the introductory text, by revising the first sentence in paragraph (b),
and by adding new paragraph (c) to read as follows:
Sec. 1002.7 Submission of data and reports.
* * * The submissions required by this part shall be addressed to
the Center for Devices and Radiological Health, Electronic Product
Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., Rockville,
MD 20850.
* * * * *
(b) Where guides or instructions have been issued by the Director
for the submission of material required by this part, such as test
data, product reports, abbreviated reports, supplemental reports, and
annual reports, the material submitted shall conform to the applicable
reporting guides or instructions.
* * *
(c) Where the submission of quality control and testing information
is common to more than one model, or model family of the same product
[[Page 48386]]
category, a ``common aspects report'' consolidating similar information
may be provided, if applicable.
8. Subpart B, consisting of Secs. 1002.10 through 1002.13, is
revised to read as follows:
Subpart B--Required Manufacturers' Reports for Listed Electronic
Products
Sec.
1002.10 Product reports.
1002.11 Supplemental reports.
1002.12 Abbreviated reports.
1002.13 Annual reports.
Subpart B--Required Manufacturers' Reports for Listed Electronic
Products
Sec. 1002.10 Product reports.
Every manufacturer of a product or component requiring aproduct
report as set forth in Table 1 of Sec. 1002.1 shall submit a product
report to the Center for Devices and Radiological Health, Electronic
Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd.,
Rockville, MD 20850, prior to the introduction of such product into
commerce. The report shall be distinctly marked ``Radiation Safety
Product Report of (name of manufacturer)'' and shall:
(a) Identify which listed product is being reported.
(b) Identify each model of the listed product together with
sufficient information concerning the manufacturer's code or other
system of labeling to enable the Director to determine the place of
manufacture.
(c) Include information on all components and accessories provided
in, on, or with the listed product that may affect the quantity,
quality, or direction of the radiation emissions.
(d) Describe the function, operational characteristics affecting
radiation emissions, and intended and known uses of each model of the
listed product.
(e) State the standard or design specifications, if any, for each
model with respect to electronic product radiation safety. Reference
may be made to a Federal standard, if applicable.
(f) For each model, describe the physical or electrical
characteristics, such as shielding or electronic circuitry,
incorporated into the product in order to meet the standards or
specifications reported pursuant to paragraph (e) of this section.
(g) Describe the methods and procedures employed, if any, in
testing and measuring each model with respect to electronic product
radiation safety, including the control of unnecessary, secondary, or
leakage electronic product radiation, the applicable quality control
procedures used for each model, and the basis for selecting such
testing and quality control procedures.
(h) For those products which may produce increased radiation with
aging, describe the methods and procedures used, and frequency of
testing of each model for durability and stability with respect to
electronic product radiation safety. Include the basis for selecting
such methods and procedures, or for determining that such testing and
quality control procedures are not necessary.
(i) Provide sufficient results of the testing, measuring, and
quality control procedures described in accordance with paragraphs (g)
and (h) of this section to enable the Director to determine the
effectiveness of those test methods and procedures.
(j) Report for each model all warning signs, labels, and
instructions for installation, operation, and use that relate to
electronic product radiation safety.
(k) Provide, upon request, such other information as the Director
may reasonably require to enable him/her to determine whether the
manufacturer has acted or is acting in compliance with the Act and any
standards prescribed thereunder, and to enable the Director to carry
out the purposes of the Act.
Sec. 1002.11 Supplemental reports.
Prior to the introduction into commerce of a new or modified model
within a model or chassis family of a product listed in Table 1 of
Sec. 1002.1 for which a report under Sec. 1002.10 is required, each
manufacturer shall submit a report with respect to such new or modified
model describing any changes in the information previously submitted in
the product report. Reports will be required for changes that:
(a) Affect actual or potential radiation emission.
(b) Affect the manner of compliance with a standard or manner of
testing for radiation safety.
Sec. 1002.12 Abbreviated reports.
Manufacturers of products requiring abbreviated reports as
specified in Table 1 of Sec. 1002.1 shall submit, prior to the
introduction of such product, a report distinctly marked ``Radiation
Safety Abbreviated Report'' which shall include:
(a) Firm and model identification.
(b) A brief description of operational characteristics that affect
radiation emissions, transmission, or leakage or that control exposure.
(c) A list of applications or uses.
(d) Radiation emission, transmission, or leakage levels.
(e) If necessary, additional information as may be requested to
determine compliance with the Act and this part.
Sec. 1002.13 Annual reports.
(a) Every manufacturer of products requiring an annual report as
specified in Table 1 of Sec. 1002.1 shall submit an annual report
summarizing the contents of the records required to be maintained by
Sec. 1002.30(a) and providing the volume of products produced, sold, or
installed.
(b) Reports are due annually by September 1. Such reports shall
cover the 12-month period ending on June 30 preceding the due date of
the report.
(c) New models of a model family that do not involve changes in
radiation emission or requirements of a performance standard do not
require supplemental reports prior to introduction into commerce. These
model numbers should be reported in quarterly updates to the annual
report.
9. Section 1002.20 is amended by adding a sentence at the end of
paragraph (c) to read as follows:
Sec. 1002.20 Reporting of accidental radiation occurrences.
* * * * *
(c) * * * A manufacturer need not file a separate report under this
section if an incident involving an accidental radiation occurrence is
associated with a defect or noncompliance and is reported pursuant to
Sec. 1003.10 of this chapter.
10. Section 1002.30 is amended in the first sentence of paragraph
(a) introductory text, by removing ``paragraphs (b) and (c) of
Sec. 1002.61'' and adding in its place ``Table 1 of Sec. 1002.1''; and
adding new paragraph (a)(5) to read as follows:
Sec. 1002.30 Records to be maintained by manufacturers.
(a) * * *
(5) Data on production and sales volume levels if available.
* * * * *
Sec. 1002.31 [Amended]
11. Section 1002.31 Preservation and inspection of records is
amended in paragraph (c) by removing ``paragraph (c) of Sec. 1002.61''
and adding in its place ``Table 1 of Sec. 1002.1''.
12. Section 1002.40 is amended by revising paragraph (a) to read as
follows:
Sec. 1002.40 Records to be obtained by dealers and distributors.
(a) Dealers and distributors of electronic products for which there
are performance standards and for which
[[Page 48387]]
the retail price is $50 or more shall obtain such information as is
necessary to identify and locate first purchasers if the product is
subject to this section by virtue of Table 1 of Sec. 1002.1.
* * * * *
13. Section 1002.50 is revised to read as follows:
Sec. 1002.50 Special exemptions.
(a) Manufacturers of electronic products may submit to the Director
a request, together with accompanying justification, for exemption from
any requirements listed in Table 1 of Sec. 1002.1. The request must
specify each requirement from which an exemption is requested. In
addition to other information that is required, the justification must
contain documented evidence showing that the product or product type
for which the exemption is requested does not pose a public health risk
and meets at least one of the following criteria:
(1) The products cannot emit electronic product radiation in
sufficient intensity or of such quality, under any conditions of
operation, maintenance, service, or product failure, to be hazardous;
(2) The products are produced in small quantities;
(3) The products are used by trained individuals and are to be used
by the same manufacturing corporation or for research, investigation,
or training.
(4) The products are custom designed and used by trained
individuals knowledgeable of the hazards; or
(5) The products are produced in such a way that the requirements
are inappropriate or unnecessary.
(b) The Director may, subject to any conditions that the Director
deems necessary to protect the public health, exempt manufacturers from
all or part of the record and reporting requirements of this part on
the basis of information submitted in accordance with paragraph (a) of
this section or such other information which the Director may possess
if the Director determines that such exemption is in keeping with the
purposes of the Act.
(c) The Director will provide written notification of the reason
for any denial. If the exemption is granted, the Director will provide
written notification of:
(1) The electronic product or products for which the exemption has
been granted;
(2) The requirements from which the product is exempted; and
(3) Such conditions as are deemed necessary to protect the public
health and safety. Copies of exemptions shall be available upon request
from the Office of Compliance (HFZ-307), Center for Devices and
Radiological Health, 2098 Gaither Rd., Rockville, MD 20850.
(d) The Director may, on the Director's own motion, exempt certain
classes of products from the reporting requirements listed in Table 1
of Sec. 1002.1, provided that the Director finds that such exemption is
in keeping with the purposes of the act.
(e) Manufacturers of products for which there is no applicable
performance standard under parts 1020 through 1050 of this chapter and
for which an investigational device exemption has been approved under
Sec. 812.30 of this chapter or for which a premarket approval
application has been approved in accordance with Sec. 814.44(d) of this
chapter are exempt from submitting all reports listed in Table 1 of
Sec. 1002.1.
Subpart G--[Removed]
14. Subpart G, consisting of Sec. 1002.61 List of specific product
groups, is removed.
Dated: September 11, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-23130 Filed 9-18-95; 8:45 am]
BILLING CODE 4160-01-F
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