Medical Devices; Technical Amendment, 17397-17401 [E7-6290]
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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations
support of its assertion, FDA is denying
the request for a hearing on this point
because a hearing will not be granted on
the basis of mere allegations or denials
or general descriptions of positions and
contentions (21 CFR 12.24(b)(2)).
(5) Public Citizen asserts that by FDA
failing to comply with § 170.22, FDA
did not comply with § 170.20 (21 CFR
170.20), which states that ‘‘the
Commissioner will be guided by the
principles and procedures for
establishing the safety of food additives
stated in current publications of the
National Academy of Sciences National
Research Council.’’
Section 170.22 pertains to safety
factors to be applied to animal
experimentation data in determining
whether a proposed use of a food
additive is safe. As discussed previously
in item 4, no animal studies were
necessary nor were any conducted to
demonstrate that the use of 7.5 MeV xrays is safe for treating food. Because the
provisions of § 170.22 do not apply to
the agency’s review of FAP 3M4745,
Public Citizen’s assertion that FDA did
not comply with § 170.20 because it did
not comply with § 170.22 is without
merit. Therefore, this objection is not a
basis for a hearing because there is no
genuine and substantial issue of fact for
resolution (§ 12.24(b)(1)).
(6) Public Citizen asserts that FDA did
not comply with 21 U.S.C. 348(c)(3)(A),
which states that ‘‘No such regulation
shall issue if a fair evaluation of the data
before the Secretary—(A) fails to
establish that the proposed use of the
food additive, under the conditions of
use to be specified in the regulation,
will be safe: Provided, That no additive
shall be deemed to be safe if it is found
to induce cancer when ingested by
man.’’ Nor has FDA complied with
§ 170.3(i), which defines ‘‘safe’’ as
‘‘there is a reasonable certainty in the
minds of competent scientists that the
substance is not harmful under the
intended conditions of use.’’
Public Citizen has not provided any
evidence to support these allegations or
that contradicts or challenges the
agency’s safety determination. The
agency finds that this objection is
merely a general description of Public
Citizen’s position, and that it does not
raise a factual issue for resolution at a
hearing. Therefore, FDA is denying the
requests for a hearing on this point
because there is no genuine and
substantial issue of fact for resolution at
a hearing, and a hearing will not be
granted on the basis of mere allegations
or denials or general descriptions of
positions and contentions (§ 12.24(b)(1)
and (b)(2)).
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V. Summary and Conclusions
Section 409 of the act requires that a
food additive be shown to be safe prior
to marketing. Under § 170.3(i), a food
additive is ‘‘safe’’ if there is a reasonable
certainty in the minds of competent
scientists that the substance is not
harmful under the intended conditions
of use. In the final rule approving the
use of 7.5 MeV x-rays for treating food,
FDA concluded, based on its evaluation
of the data submitted in the petition and
other relevant material, that the use of
7.5 MeV x-rays proposed in the petition
for treating food is safe under the
conditions set forth in the regulation
codified at § 179.26. The petitioner has
the burden to demonstrate the safety of
the additive in order to gain FDA
approval. Once FDA makes a finding of
safety, the burden shifts to an objector,
who must come forward with evidence
that calls into question FDA’s
conclusion (American Cyanamid Co. v.
FDA, 606 F.2d 1307, 1314–1315 (D.C.
Cir. 1979)).
None of the objections received
contained evidence to support a genuine
and substantial issue of fact. Nor has
any objector established that the agency
overlooked significant information in
reaching its conclusion. Therefore, the
agency has determined that the
objections that requested a hearing do
not raise any substantial issue of fact
that would justify an evidentiary
hearing (§ 12.24(b)). Accordingly, FDA
is not making any changes in response
to the objections and is denying the
requests for a hearing.
Dated: March 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–6646 Filed 4–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 803, 814, 820, 821, 822,
874, 886, 1002, 1005, and 1020
[Docket No. 2007N–0104]
Medical Devices; Technical
Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending
certain medical device regulations to
correct typographical errors and to
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17397
ensure accuracy and clarity in the
agency’s regulations.
EFFECTIVE DATE: April 9, 2007.
FOR FURTHER INFORMATION CONTACT:
Philip Desjardins, Center for Devices
and Radiological Health (HFZ–215),
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240–
276–2343.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulations in parts 803,
814, 820, 821, 822, 874, 886, 1002, 1005,
and 1020 to correct typographical errors,
and update addresses, telephone
numbers, and wording to ensure
accuracy and clarity in the agencies
medical device regulations.
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
notice and public comment are
unnecessary because these errors are
nonsubstantive.
I. Highlights of the Final Rule
FDA is making changes to correct
typographical and other minor errors in
certain device regulations in parts 803,
814, 820, 821, 822, 874, 886, 1002, 1005,
and 1020 (21 CFR 803, 814, 820, 821,
822, 874, 886, 1002, 1005, and 1020).
1. FDA is revising § 803.11 and
replacing ‘‘301–443–8818’’ with ‘‘240–
276–3151.’’
2. FDA is revising § 803.11 and
replacing ‘‘https://www.fda.gov/cdrh/
mdr/mdr-forms.html’’ with ‘‘https://
www.fda.gov/medwatch/getforms.htm.’’
3. FDA is revising § 803.21(a) and
replacing ‘‘301–443–8818’’ with ‘‘240–
276–3151.’’
4. FDA is revising § 803.21(a) and
replacing ‘‘https://www.fda.gov/cdrh/
mdr/373.html’’ with ‘‘https://
www.fda.gov/cdrh/mdr/mdrforms.html.’’
5. FDA is revising § 814.20(g) and
replacing ‘‘FDA has issued a PMA
guidance document to assist the
applicant in the arrangement and
content of a PMA. This guidance
document is available on the Internet at
https://www.fda.gov/cdrh/dsma/
pmaman/front.html. This guidance
document is also available upon request
from the Center for Devices and
Radiological Health, Division of Small
Manufacturers Assistance (HFZ–220),
1350 Piccard Dr., Rockville, MD 20850,
FAX 301–443–8818’’ with ‘‘Additional
information on FDA policies and
procedures, as well as links to PMA
guidance documents, is available on the
Internet at https://www.fda.gov/cdrh/
devadvice/pma/.’’
6. FDA is revising § 820.1(e) and
replacing ‘‘Division of Small
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Manufacturers Assistance (HFZ–220),
1350 Piccard Dr., Rockville, MD 20850,
U.S.A., telephone 1–800–638–2041 or
1–301–443–6597, FAX 301–443–8818’’
with ‘‘Division of Small Manufacturers,
International and Consumer Assistance
(HFZ–220), 1350 Piccard Dr., Rockville,
MD 20850, U.S.A., telephone 1–800–
638–2041 or 240–276–3150, FAX 240–
276–3151.’’
7. FDA is revising § 821.2(c) and
removing the words ‘‘and Surveillance.’’
8. FDA is revising § 822.7(b) and
replacing ‘‘(www.fda.gov/cdrh/
resolvingdisputes), and from the CDRH
Facts-on-Demand system (800–899–
0381 or 301–827–0111)’’ with ‘‘(https://
www.fda.gov/cdrh/ombudsman/
dispute.html).’’
9. FDA is revising § 822.15 and
replacing ‘‘You may obtain guidance
regarding dispute resolution procedures
from the Center for Devices and
Radiological Health’s (CDRH) Web site
(www.fda.gov/cdrh/resolvingdisputes/
ombudsman.html) and from the CDRH
Facts-on-Demand system (800–899–
0381 or 301–827–0111, document
number 1121)’’ with ‘‘You may obtain
guidance regarding dispute resolution
procedures from the Center for Devices
and Radiological Health’s (CDRH’s) Web
site (www.fda.gov/cdrh/ombudsman/).’’
10. FDA is revising § 822.22(b) and
replacing ‘‘You may obtain guidance
documents that discuss these
mechanisms from the CDRH Web site
and from the CDRH Facts-on-Demand
System (800–899–0381 or 301–827–
0111)’’ with ‘‘You may obtain guidance
documents that discuss these
mechanisms from the Center for Devices
and Radiological Health’s (CDRH’s) Web
site.’’
11. FDA is revising § 874.4420 and
replacing ‘‘tonsil suction tub’’ with
‘‘tonsil suction tube.’’
12. FDA is revising § 874.4420 and
replacing ‘‘ear suction tub’’ with ‘‘ear
suction tube.’’
13. FDA is revising the section title in
§ 886.1090 and replacing ‘‘Haidlinger’’
with ‘‘Haidinger.’’
14. FDA is revising § 886.1090(a) and
replacing ‘‘Haidlinger’’ with
‘‘Haidinger.’’
15. FDA is revising § 1002.7 and
replacing ‘‘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’’ with
‘‘shall be addressed to the Center for
Devices and Radiological Health, ATTN:
Electronic Product Reports, Radiological
Health Document Control (HFZ–309),
Office of Communication, Education,
and Radiation Programs, 9200 Corporate
Blvd, Rockville, MD 20850.
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16. FDA is revising § 1002.10 and
replacing ‘‘Center for Devices and
Radiological Health, Electronic Product
Reports, Office of Compliance (HFZ–
307), 2098 Gaither Rd., Rockville, MD
20850’’ with ‘‘Center for Devices and
Radiological Health, ATTN: Electronic
Product Reports, Radiological Health
Document Control (HFZ–309), Office of
Communication, Education, and
Radiation Programs, 9200 Corporate
Blvd, Rockville, MD 20850.’’
17. FDA is revising § 1002.20(b) and
replacing ‘‘Director, Center for Devices
and Radiological Health, 5600 Fishers
Lane, Rockville, MD 20857’’ with
‘‘Center for Devices and Radiological
Health, ATTN: Accidental Radiation
Occurrence Reports (HFZ–240), Office
of Communication, Education, and
Radiation Programs, 9200 Corporate
Boulevard, Rockville, MD 20850.’’
18. FDA is revising § 1002.50(c)(3)
and replacing ‘‘Office of Compliance
(HFZ–307)’’ with ‘‘Office of
Communication, Education, and
Radiation Programs (HFZ–240).’’
19. FDA is revising § 1005.11 and
replacing ‘‘5600 Fishers Lane, Rockville,
MD 20857’’ with ‘‘(HFZ–204), 9200
Corporate Blvd., Rockville, MD 20857.’’
20. FDA is revising § 1005.25(b) and
adding ‘‘(HFZ–240).’’
21. FDA is revising § 1020.30(c) and
replacing ‘‘Office of Compliance and
Surveillance’’ with ‘‘Office of
Communication, Education, and
Radiation Programs.’’
II. Environmental Impact
The agency has determined under 21
CFR 25.30(i) that this final rule 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
was required.
III. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866,
the Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Public Law 104–4).
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 not
a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
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options that would minimize any
significant impact of a rule on small
entities. Because this rule corrects only
typographical and nonsubstantive errors
in existing regulations and does not
change in any way how devices are
regulated, the agency certifies that the
final rule will not have a significant
economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $122
million, using the most current (2005)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
IV. Paperwork Reduction Act of 1995
FDA has determined that this final
rule contains no collections of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
V. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
VI. The Technical Amendments
This rule updates and corrects
existing regulations to ensure accuracy
and clarity. This administrative action is
limited to correcting typographical
errors; updating changes in addresses,
web site locations, and telephone
numbers; and clarifying regulation
terminology. It makes no changes in
substantive requirements.
For the effective date of this final rule
see EFFECTIVE DATE. Because this final
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rule is an administrative action, FDA
has determined that it has no
substantive impact on the public. It
imposes no costs, and merely makes
technical administrative changes in the
Code of Federal Regulations (CFR) for
the convenience of the public. FDA,
therefore, for good cause, finds under 5
U.S.C. 553(b)(3)(B) and (d)(3) that notice
and public comment are unnecessary.
List of Subjects
21 CFR Part 803
Imports, Medical devices, Reporting
and recordkeeping requirements.
21 CFR Part 814
Administrative practice and
procedure, Confidential business
information, Medical devices, Medical
research, Reporting and recordkeeping
requirements.
21 CFR Part 820
Medical devices, Reporting and
recordkeeping requirements.
21 CFR Part 821
Imports, Medical devices, Reporting
and recordkeeping requirements.
21 CFR Part 822
Medical devices, Reporting and
recordkeeping requirements.
21 CFR Part 874
Medical devices.
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2. Section 803.11 is revised to read as
follows:
to PMA guidance documents, is
available on the Internet at https://
www.fda.gov/cdrh/devadvice/pma/.
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§ 803.11 What form should I use to submit
reports of individual adverse events and
where do I obtain these forms?
PART 820—QUALITY SYSTEMS
REGULATION
If you are a user facility, importer, or
manufacturer, you must submit all
reports of individual adverse events on
FDA MEDWATCH Form 3500A or in an
electronic equivalent as approved under
§ 803.14. You may obtain this form and
all other forms referenced in this section
from any of the following:
(a) The Consolidated Forms and
Publications Office, Beltsville Service
Center, 6351 Ammendale Rd., Landover,
MD 20705;
(b) FDA, MEDWATCH (HF–2), 5600
Fishers Lane, Rockville, MD 20857,
301–827–7240;
(c) Division of Small Manufacturers,
International, and Consumer Assistance,
Office of Communication, Education,
and Radiation Programs, Center for
Devices and Radiological Health (CDRH)
(HFZ–220), 1350 Piccard Dr. Rockville,
MD 20850, by e-mail:
DSMICA@CDRH.FDA.GOV, or FAX:
240–276–3151;
(d) On the Internet at https://
www.fda.gov/medwatch/getforms.htm.
I 3. In § 803.21, paragraph (a) is revised
to read as follows:
§ 803.21 Where can I find the reporting
codes for adverse events that I use with
medical device reports?
21 CFR Part 886
Medical devices, Ophthalmic goods
and services.
21 CFR Part 1002
Electronic products, Radiation
protection, Reporting and recordkeeping
requirements.
21 CFR Part 1005
Administrative practice and
procedure, Electronic products, Imports,
Radiation protection, Surety bonds.
21 CFR Part 1020
Electronic products, Medical devices,
Radiation protection, Reporting and
recordkeeping requirements, Television,
X-rays.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 803,
814, 820, 821, 822, 874, 886, 1002, 1005,
and 1020 are amended as follows:
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Authority: 21 U.S.C. 352, 360, 360i, 360j,
371, 374.
PART 803—MEDICAL DEVICE
REPORTING
(a) The MEDWATCH Medical Device
Reporting Code Instruction Manual
contains adverse event codes for use
with FDA Form 3500A. You may obtain
the coding manual from CDRH’s Web
site at https://www.fda.gov/cdrh/mdr/
mdr-forms.html; and from the Division
of Small Manufacturers, International,
and Consumer Assistance, Center for
Devices and Radiological Health, 1350
Piccard Dr., Rockville, MD 20850, FAX:
240–276–3151, or e-mail to
DSMICA@CDRH.FDA.GOV.
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PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
1. The authority section for part 803
continues to read as follows:
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6. The authority section for part 820
continues to read as follows:
I
Authority: 21 U.S.C. 351, 352, 360, 360c,
360d, 360e, 360h, 360i, 360j, 360l, 371, 374,
381, 383.
7. In § 820.1, paragraph (e)(1) is
revised to read as follows:
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§ 820.1
Scope.
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(e) Exemptions or variances. (1) Any
person who wishes to petition for an
exemption or variance from any device
quality system requirement is subject to
the requirements of section 520(f)(2) of
the act. Petitions for an exemption or
variance shall be submitted according to
the procedures set forth in § 10.30 of
this chapter, the FDA’s administrative
procedures. Guidance is available from
the Center for Devices and Radiological
Health, Division of Small
Manufacturers, International and
Consumer Assistance (HFZ–220), 1350
Piccard Dr., Rockville, MD 20850,
U.S.A., telephone 1–800–638–2041 or
240–276–3150, FAX 240–276–3151.
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PART 821—MEDICAL DEVICE
TRACKING REQUIREMENTS
8. The authority section for part 821
continues to read as follows:
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Authority: 21 U.S.C. 331, 351, 352, 360,
360e, 360h, 360i, 371, 374.
9. In § 821.2, paragraph (c) is revised
to read as follows:
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§ 821.2
Exemptions and variances.
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(c) An exemption or variance is not
effective until the Director, Office of
Compliance, CDRH, approves the
request under § 10.30(e)(2)(i) of this
chapter.
PART 822—POSTMARKET
SURVEILLANCE
4. The authority section for part 814
continues to read as follows:
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Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
Authority: 21 U.S.C. 331, 352, 360i, 360l,
371, 374.
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10. The authority section for part 822
continues to read as follows:
5. In § 814.20, paragraph (g) is revised
to read as follows:
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§ 814.20
§ 822.7 What should I do if I do not agree
that postmarket surveillance is
appropriate?
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Application.
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(g) Additional information on FDA
policies and procedures, as well as links
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11. In § 822.7, paragraph (b) is revised
to read as follows:
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(b) You may obtain guidance
documents that discuss these
mechanisms from the Center for Devices
and Radiological Health’s (CDRH’s) Web
site (https://www.fda.gov/cdrh/
ombudsman/dispute.html).
I 12. Section 822.15 is revised to read
as follows:
§ 822.15 How long must I conduct
postmarket surveillance of my device?
The length of postmarket surveillance
will depend on the postmarket
surveillance question identified in our
order. We may order prospective
surveillance for a period up to 36
months; longer periods require your
agreement. If we believe that a
prospective period of greater than 36
months is necessary to address the
surveillance question, and you do not
agree, we will use the Medical Devices
Dispute Resolution Panel to resolve the
matter. You may obtain guidance
regarding dispute resolution procedures
from the Center for Devices and
Radiological Health’s (CDRH’) Web site
(www.fda.gov/cdrh/ombudsman/). The
36-month period refers to the
surveillance period, not the length of
time from the issuance of the order.
I 13. In § 822.22, paragraph (b) is
revised to read as follows:
§ 822.22 What recourse do I have if I do
not agree with your decision?
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(b) You may obtain guidance
documents that discuss these
mechanisms from the Center for Devices
and Radiological Health’s (CDRH’s) Web
site.
PART 874—EAR, NOSE, AND THROAT
DEVICES
14. The authority section for part 874
continues to read as follows:
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Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
15. In § 874.4420, paragraph (a) is
revised to read as follows:
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(a) Identification. An ear, nose, and
throat manual surgical instrument is one
of a variety of devices intended for use
in surgical procedures to examine or
treat the bronchus, esophagus, trachea,
larynx, pharynx, nasal and paranasal
sinus, or ear. This generic type of device
includes the esophageal dilator; tracheal
bistour (a long, narrow surgical knife);
tracheal dilator; tracheal hook; laryngeal
injection set; laryngeal knife; laryngeal
saw; laryngeal trocar; laryngectomy
tube; adenoid curette; adenotome; metal
tongue depressor; mouth gag; oral
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PART 886—OPHTHALMIC DEVICES
16. The authority section for part 886
continues to read as follows:
I
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
and Radiation Programs, 9200 Corporate
Blvd., Rockville, MD 20850.
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20. In § 1002.10, the introductory text
is revised to read as follows:
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§ 1002.10
Product reports.
Every manufacturer of a product or
component requiring a product report as
set forth in table 1 of § 1002.1 shall
submit a product report to the Center for
Devices and Radiological Health, ATTN:
Electronic Product Reports, Radiological
Health Document Control (HFZ–309),
Office of Communication, Education,
and Radiation Programs, 9200 Corporate
Blvd., 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:
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21. In § 1002.20, paragraph (b) is
revised to read as follows:
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17. In § 886.1090, the section title and
paragraph (a) are revised to read as
follows:
§ 1002.20 Reporting of accidental radiation
occurrences.
§ 886.1090
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Haidinger brush.
(a) Identification. A Haidinger brush
is an AC-powered device that provides
two conical brushlike images with
apexes touching which are viewed by
the patient through a Nicol prism and
intended to evaluate visual function. It
may include a component for measuring
macular integrity.
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PART 1002—RECORDS AND
REPORTS
18. The authority section for part 1002
continues to read as follows:
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Authority: 21 U.S.C. 352, 360, 360i, 360j,
360hh–360ss, 371, 374.
19. In § 1002.7, the introductory text
is revised to read as follows:
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§ 1002.7
§ 874.4420 Ear, nose, and throat manual
surgical instrument.
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screw; salpingeal curette; tonsillectome;
tonsil guillotine; tonsil screw; tonsil
snare; tonsil suction tube; tonsil
suturing hook; antom reforator; ethmoid
curette; frontal sinus-rasp; nasal curette;
nasal rasp; nasal rongeur; nasal saw;
nasal scissors; nasal snare; sinus
irrigator; sinus trephine; ear curette; ear
excavator; ear rasp; ear scissor, ear
snare; ear spoon; ear suction tube;
malleous ripper; mastoid gauge;
microsurgical ear chisel; myringotomy
tube inserter; ossici holding clamp;
sacculotomy tack inserter; vein press;
wire ear loop; microrule; mirror;
mobilizer; ear, nose, and throat punch;
ear, nose and throat knife; and ear, nose,
and throat trocar.
*
*
*
*
*
Submission of data and reports.
All submissions such as reports, test
data, product descriptions, and other
information required by this part, or
voluntarily submitted to the Director,
Center for Devices and Radiological
Health, shall be filed with the number
of copies as prescribed by the Director,
Center for Devices and Radiological
Health, and shall be signed by the
person making the submission. The
submissions required by this part shall
be addressed to the Center for Devices
and Radiological Health, ATTN:
Electronic Product Reports, Radiological
Health Document Control (HFZ–309),
Office of Communication, Education,
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*
*
*
*
(b) Such reports shall be addressed to
the Center for Devices and Radiological
Health, ATTN: Accidental Radiation
Occurrence Reports (HFZ–240), Office
of Communication, Education, and
Radiation Programs, 9200 Corporate
Blvd., Rockville, MD 20850, and the
reports and their envelopes shall be
distinctly marked ‘‘Report on 1002.20’’
and shall contain all of the following
information where known to the
manufacturer:
(1) The nature of the accidental
radiation occurrence;
(2) The location at which the
accidental radiation occurrence
occurred;
(3) The manufacturer, type, and
model number of the electronic product
or products involved;
(4) The circumstances surrounding
the accidental radiation occurrence,
including causes;
(5) The number of persons involved,
adversely affected, or exposed during
the accidental radiation occurrence, the
nature and magnitude of their exposure
and/or injuries and, if requested by the
Director, Center for Devices and
Radiological Health, the names of the
persons involved;
(6) The actions, if any, which may
have been taken by the manufacturer, to
control, correct, or eliminate the causes
and to prevent reoccurrence; and
E:\FR\FM\09APR1.SGM
09APR1
Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations
(7) Any other pertinent information
with respect to the accidental radiation
occurrence.
*
*
*
*
*
I 22. In § 1002.50, paragraph (c)(3) is
revised to read as follows:
§ 1002.50
Special exemptions.
*
*
*
*
*
(c) * * *
(3) Such conditions as are deemed
necessary to protect the public health
and safety. Copies of exemptions shall
be available upon request from the
Center for Devices and Radiological
Health, Office of Communication,
Education, and Radiation Programs
(HFZ–240), 9200 Corporate Blvd.,
Rockville, MD 20850.
*
*
*
*
*
PART 1005—IMPORTATION OF
ELECTRONIC PRODUCTS
23. The authority section for part 1005
continues to read as follows:
I
Authority: 42 U.S.C. 263d, 263h.
24. Section 1005.11 is revised to read
as follows:
I
§ 1005.11
Payment for samples.
The Department of Health and Human
Services will pay for all import samples
of electronic products rendered
unsalable as a result of testing, or will
pay the reasonable costs of repackaging
such samples for sale, if the samples are
found to be in compliance with the
requirements of the Radiation Control
for Health and Safety Act of 1968.
Billing for reimbursement shall be made
by the owner or consignee to the Center
for Devices and Radiological Health
(HFZ–204), 9200 Corporate Blvd.,
Rockville, MD 20857. Payment for
samples will not be made if the sample
is found to be in violation of the Act,
even though subsequently brought into
compliance pursuant to terms specified
in a notice of permission issued under
§ 1005.22.
I 25. In § 1005.25, paragraph (b) is
revised to read as follows:
§ 1005.25 Service of process on
manufacturers.
rwilkins on PROD1PC63 with RULES
*
*
*
*
*
(b) A manufacturer designating an
agent must address the designation to
the Center for Devices and Radiological
Health (HFZ–240), 9200 Corporate
Blvd., Rockville, MD 20850. It must be
in writing and dated; all signatures must
be in ink. The designation must be made
in the legal form required to make it
valid and binding on the manufacturer
under the laws, corporate bylaws, or
other requirements governing the
VerDate Aug<31>2005
18:47 Apr 06, 2007
Jkt 211001
making of the designation by the
manufacturer at the place and time
where it is made, and the persons or
person signing the designation shall
certify that it is so made. The
designation must disclose the
manufacturer’s full legal name and the
name(s) under which the manufacturer
conducts the business, if applicable, the
principal place of business, and mailing
address. If any of the products of the
manufacturer do not bear his legal
name, the designation must identify the
marks, trade names, or other
designations of origin which these
products bear. The designation must
provide that it will remain in effect until
withdrawn or replaced by the
manufacturer and shall bear a
declaration of acceptance duly signed
by the designated agent. The full legal
name and mailing address of the agent
must be stated. Until rejected by the
Secretary, designations are binding on
the manufacturer even when not in
compliance with all the requirements of
this section. The designated agent may
not assign performance of his function
under the designation to another.
*
*
*
*
*
PART 1020—PERFORMANCE
STANDARDS FOR IONIZING
RADIATION EMITTING PRODUCTS
26. The authority section for part 1020
continues to read as follows:
I
Authority: 21 U.S.C. 351, 352, 360e–360j,
360gg–360ss, 371, 381.
27. In § 1020.30, paragraph (c) is
revised to read as follows:
I
§ 1020.30 Diagnostic x-ray systems and
their major components.
*
*
*
*
*
(c) Manufacturers’ responsibility.
Manufacturers of products subject to
§§ 1020.30 through 1020.33 shall certify
that each of their products meet all
applicable requirements when installed
into a diagnostic x-ray system according
to instructions. This certification shall
be made under the format specified in
§ 1010.2 of this chapter. Manufacturers
may certify a combination of two or
more components if they obtain prior
authorization in writing from the
Director of the Office of
Communication, Education, and
Radiation Programs of the Center for
Devices and Radiological Health.
Manufacturers shall not be held
responsible for noncompliance of their
products if that noncompliance is due
solely to the improper installation or
assembly of that product by another
person; however, manufacturers are
responsible for providing assembly
instructions adequate to assure
PO 00000
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17401
compliance of their components with
the applicable provisions of §§ 1020.30
through 1020.33.
*
*
*
*
*
Dated: March 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–6290 Filed 4–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300 and 1313
[Docket No. DEA–292I]
RIN 1117–AB06
Implementation of the Combat
Methamphetamine Epidemic Act of
2005; Notice of Transfers Following
Importation or Exportation
Drug Enforcement
Administration (DEA), Justice.
ACTION: Interim Final Rule with Request
for Comment.
AGENCY:
SUMMARY: This regulation implements
section 716 of the Combat
Methamphetamine Epidemic Act
(CMEA) of 2005 (21 U.S.C. 971 as
amended), which was enacted on March
9, 2006. DEA is amending its regulations
to require additional reporting for
import, export, and international
transactions involving all List I and List
II chemicals. This rule implements
section 716 of the CMEA which extends
current reporting requirements for
importations, exportations, and
international transactions involving List
I and List II chemicals.
DATES: This rule is effective May 9,
2007. Written comments must be
postmarked, and electronic comments
must be sent, on or before May 9, 2007.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–292’’ on all written and
electronic correspondence. Written
comments being sent via regular mail
should be sent to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Attention: DEA Federal Register
Representative/ODL. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/ODL,
2401 Jefferson-Davis Highway,
Alexandria, VA 22301. Comments may
be directly sent to DEA electronically by
sending an electronic message to
dea.diversion.policy@usdoj.gov.
E:\FR\FM\09APR1.SGM
09APR1
]]>Agencies
[Federal Register Volume 72, Number 67 (Monday, April 9, 2007)]
[Rules and Regulations]
[Pages 17397-17401]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6290]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 803, 814, 820, 821, 822, 874, 886, 1002, 1005, and
1020
[Docket No. 2007N-0104]
Medical Devices; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending certain
medical device regulations to correct typographical errors and to
ensure accuracy and clarity in the agency's regulations.
EFFECTIVE DATE: April 9, 2007.
FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-2343.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts
803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 to correct
typographical errors, and update addresses, telephone numbers, and
wording to ensure accuracy and clarity in the agencies medical device
regulations.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because these
errors are nonsubstantive.
I. Highlights of the Final Rule
FDA is making changes to correct typographical and other minor
errors in certain device regulations in parts 803, 814, 820, 821, 822,
874, 886, 1002, 1005, and 1020 (21 CFR 803, 814, 820, 821, 822, 874,
886, 1002, 1005, and 1020).
1. FDA is revising Sec. 803.11 and replacing ``301-443-8818'' with
``240-276-3151.''
2. FDA is revising Sec. 803.11 and replacing ``https://www.fda.gov/
cdrh/mdr/mdr-forms.html'' with ``https://www.fda.gov/medwatch/
getforms.htm.''
3. FDA is revising Sec. 803.21(a) and replacing ``301-443-8818''
with ``240-276-3151.''
4. FDA is revising Sec. 803.21(a) and replacing ``https://
www.fda.gov/cdrh/mdr/373.html'' with ``https://www.fda.gov/cdrh/mdr/mdr-
forms.html.''
5. FDA is revising Sec. 814.20(g) and replacing ``FDA has issued a
PMA guidance document to assist the applicant in the arrangement and
content of a PMA. This guidance document is available on the Internet
at https://www.fda.gov/cdrh/dsma/pmaman/front.html. This guidance
document is also available upon request from the Center for Devices and
Radiological Health, Division of Small Manufacturers Assistance (HFZ-
220), 1350 Piccard Dr., Rockville, MD 20850, FAX 301-443-8818'' with
``Additional information on FDA policies and procedures, as well as
links to PMA guidance documents, is available on the Internet at http:/
/www.fda.gov/cdrh/devadvice/pma/.''
6. FDA is revising Sec. 820.1(e) and replacing ``Division of Small
[[Page 17398]]
Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD
20850, U.S.A., telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-
8818'' with ``Division of Small Manufacturers, International and
Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850,
U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.''
7. FDA is revising Sec. 821.2(c) and removing the words ``and
Surveillance.''
8. FDA is revising Sec. 822.7(b) and replacing ``(www.fda.gov/
cdrh/resolvingdisputes), and from the CDRH Facts-on-Demand system (800-
899-0381 or 301-827-0111)'' with ``(https://www.fda.gov/cdrh/ombudsman/
dispute.html).''
9. FDA is revising Sec. 822.15 and replacing ``You may obtain
guidance regarding dispute resolution procedures from the Center for
Devices and Radiological Health's (CDRH) Web site (www.fda.gov/cdrh/
resolvingdisputes/ombudsman.html) and from the CDRH Facts-on-Demand
system (800-899-0381 or 301-827-0111, document number 1121)'' with
``You may obtain guidance regarding dispute resolution procedures from
the Center for Devices and Radiological Health's (CDRH's) Web site
(www.fda.gov/cdrh/ombudsman/).''
10. FDA is revising Sec. 822.22(b) and replacing ``You may obtain
guidance documents that discuss these mechanisms from the CDRH Web site
and from the CDRH Facts-on-Demand System (800-899-0381 or 301-827-
0111)'' with ``You may obtain guidance documents that discuss these
mechanisms from the Center for Devices and Radiological Health's
(CDRH's) Web site.''
11. FDA is revising Sec. 874.4420 and replacing ``tonsil suction
tub'' with ``tonsil suction tube.''
12. FDA is revising Sec. 874.4420 and replacing ``ear suction
tub'' with ``ear suction tube.''
13. FDA is revising the section title in Sec. 886.1090 and
replacing ``Haidlinger'' with ``Haidinger.''
14. FDA is revising Sec. 886.1090(a) and replacing ``Haidlinger''
with ``Haidinger.''
15. FDA is revising Sec. 1002.7 and replacing ``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'' with ``shall be addressed to the Center for Devices and
Radiological Health, ATTN: Electronic Product Reports, Radiological
Health Document Control (HFZ-309), Office of Communication, Education,
and Radiation Programs, 9200 Corporate Blvd, Rockville, MD 20850.
16. FDA is revising Sec. 1002.10 and replacing ``Center for
Devices and Radiological Health, Electronic Product Reports, Office of
Compliance (HFZ-307), 2098 Gaither Rd., Rockville, MD 20850'' with
``Center for Devices and Radiological Health, ATTN: Electronic Product
Reports, Radiological Health Document Control (HFZ-309), Office of
Communication, Education, and Radiation Programs, 9200 Corporate Blvd,
Rockville, MD 20850.''
17. FDA is revising Sec. 1002.20(b) and replacing ``Director,
Center for Devices and Radiological Health, 5600 Fishers Lane,
Rockville, MD 20857'' with ``Center for Devices and Radiological
Health, ATTN: Accidental Radiation Occurrence Reports (HFZ-240), Office
of Communication, Education, and Radiation Programs, 9200 Corporate
Boulevard, Rockville, MD 20850.''
18. FDA is revising Sec. 1002.50(c)(3) and replacing ``Office of
Compliance (HFZ-307)'' with ``Office of Communication, Education, and
Radiation Programs (HFZ-240).''
19. FDA is revising Sec. 1005.11 and replacing ``5600 Fishers
Lane, Rockville, MD 20857'' with ``(HFZ-204), 9200 Corporate Blvd.,
Rockville, MD 20857.''
20. FDA is revising Sec. 1005.25(b) and adding ``(HFZ-240).''
21. FDA is revising Sec. 1020.30(c) and replacing ``Office of
Compliance and Surveillance'' with ``Office of Communication,
Education, and Radiation Programs.''
II. Environmental Impact
The agency has determined under 21 CFR 25.30(i) that this final
rule 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 was
required.
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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 not a significant regulatory action 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 this rule corrects only typographical and
nonsubstantive errors in existing regulations and does not change in
any way how devices are regulated, the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
IV. Paperwork Reduction Act of 1995
FDA has determined that this final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
V. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VI. The Technical Amendments
This rule updates and corrects existing regulations to ensure
accuracy and clarity. This administrative action is limited to
correcting typographical errors; updating changes in addresses, web
site locations, and telephone numbers; and clarifying regulation
terminology. It makes no changes in substantive requirements.
For the effective date of this final rule see EFFECTIVE DATE.
Because this final
[[Page 17399]]
rule is an administrative action, FDA has determined that it has no
substantive impact on the public. It imposes no costs, and merely makes
technical administrative changes in the Code of Federal Regulations
(CFR) for the convenience of the public. FDA, therefore, for good
cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and
public comment are unnecessary.
List of Subjects
21 CFR Part 803
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 820
Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 821
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 822
Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 874
Medical devices.
21 CFR Part 886
Medical devices, Ophthalmic goods and services.
21 CFR Part 1002
Electronic products, Radiation protection, Reporting and
recordkeeping requirements.
21 CFR Part 1005
Administrative practice and procedure, Electronic products,
Imports, Radiation protection, Surety bonds.
21 CFR Part 1020
Electronic products, Medical devices, Radiation protection,
Reporting and recordkeeping requirements, Television, X-rays.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 are amended as
follows:
PART 803--MEDICAL DEVICE REPORTING
0
1. The authority section for part 803 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
2. Section 803.11 is revised to read as follows:
Sec. 803.11 What form should I use to submit reports of individual
adverse events and where do I obtain these forms?
If you are a user facility, importer, or manufacturer, you must
submit all reports of individual adverse events on FDA MEDWATCH Form
3500A or in an electronic equivalent as approved under Sec. 803.14.
You may obtain this form and all other forms referenced in this section
from any of the following:
(a) The Consolidated Forms and Publications Office, Beltsville
Service Center, 6351 Ammendale Rd., Landover, MD 20705;
(b) FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857,
301-827-7240;
(c) Division of Small Manufacturers, International, and Consumer
Assistance, Office of Communication, Education, and Radiation Programs,
Center for Devices and Radiological Health (CDRH) (HFZ-220), 1350
Piccard Dr. Rockville, MD 20850, by e-mail: DSMICA@CDRH.FDA.GOV, or
FAX: 240-276-3151;
(d) On the Internet at https://www.fda.gov/medwatch/getforms.htm.
0
3. In Sec. 803.21, paragraph (a) is revised to read as follows:
Sec. 803.21 Where can I find the reporting codes for adverse events
that I use with medical device reports?
(a) The MEDWATCH Medical Device Reporting Code Instruction Manual
contains adverse event codes for use with FDA Form 3500A. You may
obtain the coding manual from CDRH's Web site at https://www.fda.gov/
cdrh/mdr/mdr-forms.html; and from the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX: 240-
276-3151, or e-mail to DSMICA@CDRH.FDA.GOV.
* * * * *
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
4. The authority section for part 814 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
0
5. In Sec. 814.20, paragraph (g) is revised to read as follows:
Sec. 814.20 Application.
* * * * *
(g) Additional information on FDA policies and procedures, as well
as links to PMA guidance documents, is available on the Internet at
https://www.fda.gov/cdrh/devadvice/pma/.
* * * * *
PART 820--QUALITY SYSTEMS REGULATION
0
6. The authority section for part 820 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383.
0
7. In Sec. 820.1, paragraph (e)(1) is revised to read as follows:
Sec. 820.1 Scope.
* * * * *
(e) Exemptions or variances. (1) Any person who wishes to petition
for an exemption or variance from any device quality system requirement
is subject to the requirements of section 520(f)(2) of the act.
Petitions for an exemption or variance shall be submitted according to
the procedures set forth in Sec. 10.30 of this chapter, the FDA's
administrative procedures. Guidance is available from the Center for
Devices and Radiological Health, Division of Small Manufacturers,
International and Consumer Assistance (HFZ-220), 1350 Piccard Dr.,
Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150,
FAX 240-276-3151.
* * * * *
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS
0
8. The authority section for part 821 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.
0
9. In Sec. 821.2, paragraph (c) is revised to read as follows:
Sec. 821.2 Exemptions and variances.
* * * * *
(c) An exemption or variance is not effective until the Director,
Office of Compliance, CDRH, approves the request under Sec.
10.30(e)(2)(i) of this chapter.
PART 822--POSTMARKET SURVEILLANCE
0
10. The authority section for part 822 continues to read as follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
0
11. In Sec. 822.7, paragraph (b) is revised to read as follows:
Sec. 822.7 What should I do if I do not agree that postmarket
surveillance is appropriate?
* * * * *
[[Page 17400]]
(b) You may obtain guidance documents that discuss these mechanisms
from the Center for Devices and Radiological Health's (CDRH's) Web site
(https://www.fda.gov/cdrh/ombudsman/dispute.html).
0
12. Section 822.15 is revised to read as follows:
Sec. 822.15 How long must I conduct postmarket surveillance of my
device?
The length of postmarket surveillance will depend on the postmarket
surveillance question identified in our order. We may order prospective
surveillance for a period up to 36 months; longer periods require your
agreement. If we believe that a prospective period of greater than 36
months is necessary to address the surveillance question, and you do
not agree, we will use the Medical Devices Dispute Resolution Panel to
resolve the matter. You may obtain guidance regarding dispute
resolution procedures from the Center for Devices and Radiological
Health's (CDRH') Web site (www.fda.gov/cdrh/ombudsman/). The 36-month
period refers to the surveillance period, not the length of time from
the issuance of the order.
0
13. In Sec. 822.22, paragraph (b) is revised to read as follows:
Sec. 822.22 What recourse do I have if I do not agree with your
decision?
* * * * *
(b) You may obtain guidance documents that discuss these mechanisms
from the Center for Devices and Radiological Health's (CDRH's) Web
site.
PART 874--EAR, NOSE, AND THROAT DEVICES
0
14. The authority section for part 874 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
15. In Sec. 874.4420, paragraph (a) is revised to read as follows:
Sec. 874.4420 Ear, nose, and throat manual surgical instrument.
(a) Identification. An ear, nose, and throat manual surgical
instrument is one of a variety of devices intended for use in surgical
procedures to examine or treat the bronchus, esophagus, trachea,
larynx, pharynx, nasal and paranasal sinus, or ear. This generic type
of device includes the esophageal dilator; tracheal bistour (a long,
narrow surgical knife); tracheal dilator; tracheal hook; laryngeal
injection set; laryngeal knife; laryngeal saw; laryngeal trocar;
laryngectomy tube; adenoid curette; adenotome; metal tongue depressor;
mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil
guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil
suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp;
nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors;
nasal snare; sinus irrigator; sinus trephine; ear curette; ear
excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction
tube; malleous ripper; mastoid gauge; microsurgical ear chisel;
myringotomy tube inserter; ossici holding clamp; sacculotomy tack
inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear,
nose, and throat punch; ear, nose and throat knife; and ear, nose, and
throat trocar.
* * * * *
PART 886--OPHTHALMIC DEVICES
0
16. The authority section for part 886 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
17. In Sec. 886.1090, the section title and paragraph (a) are revised
to read as follows:
Sec. 886.1090 Haidinger brush.
(a) Identification. A Haidinger brush is an AC-powered device that
provides two conical brushlike images with apexes touching which are
viewed by the patient through a Nicol prism and intended to evaluate
visual function. It may include a component for measuring macular
integrity.
* * * * *
PART 1002--RECORDS AND REPORTS
0
18. The authority section for part 1002 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371,
374.
0
19. In Sec. 1002.7, the introductory text is revised to read as
follows:
Sec. 1002.7 Submission of data and reports.
All submissions such as reports, test data, product descriptions,
and other information required by this part, or voluntarily submitted
to the Director, Center for Devices and Radiological Health, shall be
filed with the number of copies as prescribed by the Director, Center
for Devices and Radiological Health, and shall be signed by the person
making the submission. The submissions required by this part shall be
addressed to the Center for Devices and Radiological Health, ATTN:
Electronic Product Reports, Radiological Health Document Control (HFZ-
309), Office of Communication, Education, and Radiation Programs, 9200
Corporate Blvd., Rockville, MD 20850.
* * * * *
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20. In Sec. 1002.10, the introductory text is revised to read as
follows:
Sec. 1002.10 Product reports.
Every manufacturer of a product or component requiring a product
report as set forth in table 1 of Sec. 1002.1 shall submit a product
report to the Center for Devices and Radiological Health, ATTN:
Electronic Product Reports, Radiological Health Document Control (HFZ-
309), Office of Communication, Education, and Radiation Programs, 9200
Corporate Blvd., 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:
* * * * *
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21. In Sec. 1002.20, paragraph (b) is revised to read as follows:
Sec. 1002.20 Reporting of accidental radiation occurrences.
* * * * *
(b) Such reports shall be addressed to the Center for Devices and
Radiological Health, ATTN: Accidental Radiation Occurrence Reports
(HFZ-240), Office of Communication, Education, and Radiation Programs,
9200 Corporate Blvd., Rockville, MD 20850, and the reports and their
envelopes shall be distinctly marked ``Report on 1002.20'' and shall
contain all of the following information where known to the
manufacturer:
(1) The nature of the accidental radiation occurrence;
(2) The location at which the accidental radiation occurrence
occurred;
(3) The manufacturer, type, and model number of the electronic
product or products involved;
(4) The circumstances surrounding the accidental radiation
occurrence, including causes;
(5) The number of persons involved, adversely affected, or exposed
during the accidental radiation occurrence, the nature and magnitude of
their exposure and/or injuries and, if requested by the Director,
Center for Devices and Radiological Health, the names of the persons
involved;
(6) The actions, if any, which may have been taken by the
manufacturer, to control, correct, or eliminate the causes and to
prevent reoccurrence; and
[[Page 17401]]
(7) Any other pertinent information with respect to the accidental
radiation occurrence.
* * * * *
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22. In Sec. 1002.50, paragraph (c)(3) is revised to read as follows:
Sec. 1002.50 Special exemptions.
* * * * *
(c) * * *
(3) Such conditions as are deemed necessary to protect the public
health and safety. Copies of exemptions shall be available upon request
from the Center for Devices and Radiological Health, Office of
Communication, Education, and Radiation Programs (HFZ-240), 9200
Corporate Blvd., Rockville, MD 20850.
* * * * *
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS
0
23. The authority section for part 1005 continues to read as follows:
Authority: 42 U.S.C. 263d, 263h.
0
24. Section 1005.11 is revised to read as follows:
Sec. 1005.11 Payment for samples.
The Department of Health and Human Services will pay for all import
samples of electronic products rendered unsalable as a result of
testing, or will pay the reasonable costs of repackaging such samples
for sale, if the samples are found to be in compliance with the
requirements of the Radiation Control for Health and Safety Act of
1968. Billing for reimbursement shall be made by the owner or consignee
to the Center for Devices and Radiological Health (HFZ-204), 9200
Corporate Blvd., Rockville, MD 20857. Payment for samples will not be
made if the sample is found to be in violation of the Act, even though
subsequently brought into compliance pursuant to terms specified in a
notice of permission issued under Sec. 1005.22.
0
25. In Sec. 1005.25, paragraph (b) is revised to read as follows:
Sec. 1005.25 Service of process on manufacturers.
* * * * *
(b) A manufacturer designating an agent must address the
designation to the Center for Devices and Radiological Health (HFZ-
240), 9200 Corporate Blvd., Rockville, MD 20850. It must be in writing
and dated; all signatures must be in ink. The designation must be made
in the legal form required to make it valid and binding on the
manufacturer under the laws, corporate bylaws, or other requirements
governing the making of the designation by the manufacturer at the
place and time where it is made, and the persons or person signing the
designation shall certify that it is so made. The designation must
disclose the manufacturer's full legal name and the name(s) under which
the manufacturer conducts the business, if applicable, the principal
place of business, and mailing address. If any of the products of the
manufacturer do not bear his legal name, the designation must identify
the marks, trade names, or other designations of origin which these
products bear. The designation must provide that it will remain in
effect until withdrawn or replaced by the manufacturer and shall bear a
declaration of acceptance duly signed by the designated agent. The full
legal name and mailing address of the agent must be stated. Until
rejected by the Secretary, designations are binding on the manufacturer
even when not in compliance with all the requirements of this section.
The designated agent may not assign performance of his function under
the designation to another.
* * * * *
PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS
0
26. The authority section for part 1020 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360e-360j, 360gg-360ss, 371, 381.
0
27. In Sec. 1020.30, paragraph (c) is revised to read as follows:
Sec. 1020.30 Diagnostic x-ray systems and their major components.
* * * * *
(c) Manufacturers' responsibility. Manufacturers of products
subject to Sec. Sec. 1020.30 through 1020.33 shall certify that each
of their products meet all applicable requirements when installed into
a diagnostic x-ray system according to instructions. This certification
shall be made under the format specified in Sec. 1010.2 of this
chapter. Manufacturers may certify a combination of two or more
components if they obtain prior authorization in writing from the
Director of the Office of Communication, Education, and Radiation
Programs of the Center for Devices and Radiological Health.
Manufacturers shall not be held responsible for noncompliance of their
products if that noncompliance is due solely to the improper
installation or assembly of that product by another person; however,
manufacturers are responsible for providing assembly instructions
adequate to assure compliance of their components with the applicable
provisions of Sec. Sec. 1020.30 through 1020.33.
* * * * *
Dated: March 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6290 Filed 4-6-07; 8:45 am]
BILLING CODE 4160-01-S?>
