Medical Devices; Technical Amendment, 16351-16353 [2010-7288]
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Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Rules and Regulations
(c) To ensure PMAs include readily
available information concerning actual
and potential pediatric uses of medical
devices.
■ 4. In § 814.20, revise paragraph
(b)(3)(i) to read as follows:
§ 814.20
Application.
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*
*
*
*
(b) * * *
(3) * * *
(i) Indications for use. (A) A general
description of the disease or condition
the device will diagnose, treat, prevent,
cure, or mitigate, including a
description of the patient population for
which the device is intended.
(B) Information concerning uses in
pediatric patients who are 21 years of
age or younger: The application must
include the following information, if
readily available:
(1) A description of any pediatric
subpopulations (neonates, infants,
children, adolescents) that suffer from
the disease or condition that the device
is intended to treat, diagnose, or cure;
and
(2) The number of affected pediatric
patients.
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*
*
*
*
■ 5. In § 814.37, revise the section
heading and paragraph (b) to read as
follows:
§ 814.37 PMA amendments and
resubmitted PMAs.
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*
*
*
*
(b)(1) FDA may request the applicant
to amend a PMA or PMA supplement
with any information regarding the
device that is necessary for FDA or the
appropriate advisory committee to
complete the review of the PMA or PMA
supplement.
(2) FDA may request the applicant to
amend a PMA or PMA supplement with
information concerning pediatric uses
as required under § 814.20(b)(3)(i).
*
*
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*
■ 6. In § 814.39, add paragraph (h) to
read as follows:
§ 814.39
PMA supplements.
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(h) The application must include the
following information, if readily
available:
(1) A description of any pediatric
subpopulations (neonates, infants,
children, adolescents) that suffer from
the disease or condition that the device
is intended to treat, diagnose, or cure;
and
(2) The number of affected pediatric
patients who are 21 years of age or
younger.
(3) If information concerning the
device that is the subject of the
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supplement was previously submitted
under § 814.20(b)(3)(i), that information
may be incorporated by reference to the
application or submission that contains
the information. However, if additional
information required under
§ 814.20(b)(3)(i) has become readily
available to the applicant since the
previous submission, the applicant must
submit that information as part of the
supplement.
■ 7. In § 814.44, redesignate paragraphs
(e)(1)(ii) through (e)(1)(iv) as paragraphs
(e)(1)(iii) through (e)(1)(v), respectively,
and add new paragraph (e)(1)(ii) to read
as follows:
§ 814.44
Procedures for review of a PMA.
*
*
*
*
*
(e) * * *
(1) * * *
(ii) The submission of additional
information concerning potential
pediatric uses required by
§ 814.20(b)(3)(i) that is readily available
to the applicant;
*
*
*
*
*
■ 8. Amend § 814.100 as follows:
■ a. Redesignate paragraphs (b) through
(e) as paragraphs (d) through (g),
respectively;
■ b. Redesignate paragraph (a) as
paragraph (b), and remove the first
sentence of newly redesignated
paragraph (b); and
■ c. Add new paragraphs (a) and (c) to
read as follows:
§ 814.100
Purpose and scope.
(a) This subpart H implements
sections 515A and 520(m) of the act.
*
*
*
*
*
(c) Section 515A of the act is intended
to ensure the submission of readily
available information concerning actual
and potential pediatric uses of medical
devices.
*
*
*
*
*
■ 9. Amend § 814.104 as follows:
■ a. Revise the last sentence of
paragraph (b)(4)(ii);
■ b. Revise the last sentence of
paragraph (b)(5); and
■ c. Add paragraph (b)(6) to read as
follows:
§ 814.104
Original applications.
*
*
*
*
*
(b) * * *
(4) * * *
(ii) * * * The effectiveness of this
device for this use has not been
demonstrated.
(5) * * * If the amount charged is
$250 or less, the requirement for a
report by an independent certified
public accountant or an attestation by a
responsible individual of the
organization is waived; and
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16351
(6) Readily available information
concerning actual and potential
pediatric uses of the device, as required
by § 814.20(b)(3)(i).
*
*
*
*
*
■ 10. In § 814.116, redesignate
paragraphs (c)(2) through (c)(4) as
paragraphs (c)(3) through (c)(5),
respectively, and add new paragraph
(c)(2) to read as follows:
§ 814.116
HDE.
Procedures for review of an
*
*
*
*
*
(c) * * *
(2) The submission of additional
information concerning potential
pediatric uses required by
§ 814.20(b)(3)(i) that is readily available
to the applicant;
*
*
*
*
*
Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–7193 Filed 3–31–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1002, 1003, 1004, 1005,
1010, 1020, 1030, 1040, and 1050
[Docket No. FDA–2010–N–0010]
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 statutory and regulatory
references to ensure accuracy,
consistency, and clarity in the agency’s
regulations.
DATES: This rule is effective April 1,
2010.
FOR FURTHER INFORMATION CONTACT:
Bernice E. Noland, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4430, Silver Spring,
MD 20993–0002, 301–796–5742.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulations at part 1002
(21 CFR part 1002) to correct a
regulatory reference. FDA is revising
§ 1002.30(b) by deleting ‘‘paragraph (c)
of § 1002.61’’ and replacing it with
‘‘table 1 of § 1002.1.’’ FDA updated
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16352
Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Rules and Regulations
§ 1002.30(a) to reflect this change, but
inadvertently retained the reference to
‘‘paragraph (c) of § 1002.61’’ in
§ 1002.30(b). With this technical
amendment, the entirety of the
regulation at § 1002.30 accurately
references ‘‘table 1 of § 1002.1,’’ which is
the former paragraph (c) of § 1002.61.
In addition, FDA is amending its
regulations at part 1002 and parts 1005
and 1010 (21 CFR parts 1005 and 1010)
to correct statutory references. These
parts intermittently cite sections of the
Radiation Control for Health and Safety
Act of 1968 (Radiation Control Act)
(Public Law 90–602). However, ‘‘Act’’ is
defined in 21 CFR 1000.3(b), and
applicable throughout 21 CFR parts
1000 to 1050, subchapter J, to mean the
Federal Food, Drug, and Cosmetic Act
(FFDCA) (21 U.S.C. 360hh–360ss). The
Safe Medical Devices Act of 1990
(SMDA) (Public Law 101–629),
transferred the Radiation Control Act to
the FFDCA. With these technical
amendments, FDA is replacing citations
to the Radiation Control Act with
citations to the corresponding sections
of the FFDCA. FDA is revising
§§ 1002.41(a)(1) and 1002.42 by
replacing section ‘‘359’’ of the act with
section ‘‘535.’’ FDA is revising
§ 1005.25(c) by replacing section
‘‘360(d)’’ of the act with section ‘‘536(d).’’
FDA is revising § 1010.4(c)(3) by
replacing section ‘‘360A(e)’’ of the act
with section ‘‘537(e).’’
Finally, FDA is amending its
authority citations in parts 1003, 1004,
1005, 1010, 1020, 1030, 1040, and 1050
to correct statutory citations. These
parts cite to the Public Health Service
Act, which codified the Radiation
Control Act at 42 U.S.C. 263b–263n,
until the SMDA transferred the
Radiation Control Act to the FFDCA.
Section 19(a)(3) of the SMDA also
repealed section 354 of the Radiation
Control Act, codified at 42 U.S.C. 263b,
which contained Congress’s declaration
of purpose in enacting the program of
electronic product radiation controls.
The SMDA redesignated and transferred
the remaining sections to the FFDCA at
21 U.S.C. 360hh–360ss. The authority
citations in parts 1003, 1004, 1005,
1010, 1020, 1030, 1040, and 1050 to 42
U.S.C. 263b–263n were not
correspondingly updated to reflect the
transfer of the Radiation Control Act
from the Public Health Service Act to
the FFDCA. With these technical
amendments, FDA is replacing citations
to the Public Health Service Act with
citations to the corresponding sections
of the FFDCA. Thus, FDA is revising
parts 1003, 1004, 1010, 1030, 1040, and
1050 by replacing the authority citation
of ‘‘42 U.S.C. 263b–263n’’ with ‘‘21
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U.S.C. 360hh–360ss.’’ FDA is similarly
revising part 1005 by replacing the
authority citation of ‘‘42 U.S.C. 263d,
263h’’ with ‘‘21 U.S.C. 360ii, 360mm.’’
FDA is also revising part 1020 by
deleting the authority citation to 21
U.S.C. 360gg. Although section 354 of
the Radiation Control Act would have
been designated as 21 U.S.C. 360gg had
the provision been transferred to the
FFDCA, the SMDA repealed that
section. As a result, the citation to 21
U.S.C. 360gg in part 1020 is an
inadvertent error that this technical
amendment will correct by deleting that
part of the authority citation.
Publication of this document
constitutes final action on the change
under the Administrative Procedure Act
(5 U.S.C. 553). These technical
amendments correct regulatory and
statutory references in the Code of
Federal Regulations. FDA therefore, for
good cause, has determined that notice
and public comment are unnecessary,
under 5 U.S.C. 553(b)(3)(B). Further,
this rule places no burden on affected
parties for which such parties would
need a reasonable time to prepare for
the effective date of the rule.
Accordingly, FDA, for good cause, had
determined this technical amendment to
be exempt under 5 U.S.C. 553(d)(3) from
the 30-day effective date from
publication.
FDA 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
is required. In addition, FDA has
determined that this final rule contains
no collections of information. Therefore,
clearance by the Office Management and
Budget under the Paperwork Reduction
Act of 1995 is not required.
For the effective date of this final rule,
see the DATES section of this document.
List of Subjects
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 1010
Administrative practice and
procedure, Electronic products, Exports,
Radiation protection.
21 CFR Part 1020
Electronic products, Medical devices,
Radiation protection, Reporting and
recordkeeping requirements, Television,
X-rays.
21 CFR Part 1030
Electronic products, Microwave
ovens, Radiation protection.
21 CFR Part 1040
Electronic products, Labeling, Lasers,
Medical devices, Radiation protection,
Reporting and recordkeeping
requirements.
21 CFR Part 1050
Electronic products, Medical devices,
Radiation protection.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR Chapter I is
amended as follows:
PART 1002—RECORDS AND
REPORTS
1. The authority citation for 21 CFR
part 1002 continues to read as follows:
■
Authority: 21 U.S.C. 352, 360, 360i, 360j,
360hh–360ss, 371, 374.
2. In § 1002.30, paragraph (b)
introductory text is revised to read as
follows:
■
§ 1002.30 Records to be maintained by
manufacturers.
*
*
*
*
*
(b) In addition to the records required
by paragraph (a) of this section,
manufacturers of products listed in table
1 of § 1002.1 shall establish and
maintain the following records with
respect to such products:
*
*
*
*
*
■ 3. In 1002.41, paragraph (a)(1) is
revised to read as follows:
21 CFR Part 1003
§ 1002.41 Disposition of records obtained
by dealers and distributors.
Administrative practice and
procedure, Electronic products,
Radiation protection.
(a) * * *
(1) The dealer or distributor elects to
hold and preserve such information and
to immediately furnish it to the
manufacturer when advised by the
manufacturer or the Director, Center for
Devices and Radiological Health, that
21 CFR Part 1004
Electronic products, Radiation
protection.
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Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Rules and Regulations
16353
such information is required for
purposes of section 535 of the Act; and
*
*
*
*
*
PART 1010—PERFORMANCE
STANDARDS FOR ELECTRONIC
PRODUCTS: GENERAL
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
4. Section 1002.42 is revised to read
as follows:
■
9. The authority citation for 21 CFR
part 1010 is revised to read as follows:
21 CFR Chapter I
§ 1002.42 Confidentiality of records
furnished by dealers and distributors.
Authority: 21 U.S.C. 351, 352, 360, 360e–
360j, 360hh–360ss, 371, 381.
[Docket No. FDA–2010–N–0148]
All information furnished to
manufacturers by dealers and
distributors pursuant to this part shall
be treated by such manufacturers as
confidential information which may be
used only as necessary to notify persons
pursuant to section 535 of the Act.
■
10. In 1010.4, paragraph (c)(3) is
revised to read as follows:
Revision of Organization and
Conforming Changes to Regulations
■
PART 1003—NOTIFICATION OF
DEFECTS OR FAILURE TO COMPLY
5. The authority citation for 21 CFR
part 1003 is revised to read as follows:
■
Authority: 21 U.S.C. 360hh–360ss.
PART 1004—REPURCHASE, REPAIRS,
OR REPLACEMENT OF ELECTRONIC
PRODUCTS
6. The authority citation for 21 CFR
part 1004 is revised to read as follows:
§ 1010.4
Variances.
AGENCY:
*
*
*
*
*
(c) * * *
(3) All applications for variances and
for amendments and extensions thereof
and all correspondence (including
written notices of approval) on these
applications will be available for public
disclosure in the office of the Division
of Dockets Management, except for
information regarded as confidential
under section 537(e) of the act.
*
*
*
*
*
PART 1020—PERFORMANCE
STANDARDS FOR IONIZING
RADIATION EMITTING PRODUCTS
■
Authority: 21 U.S.C. 360hh–360ss.
7. The authority citation for 21 CFR
part 1005 is revised to read as follows:
■
Authority: 21 U.S.C. 360ii, 360mm.
8. In 1005.25, paragraph (c) is revised
to read as follows:
■
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*
*
*
*
(c) Service of any process, notice,
order, requirement, or decision
specified in section 536(d) of
Subchapter C—Electronic Product
Radiation Control of the Federal Food,
Drug, and Cosmetic Act (formerly the
Radiation Control for Health and Safety
Act of 1968) (21 U.S.C. 360mm(d)) may
be made by registered or certified mail
addressed to the agent with return
receipt requested, or in any other
manner authorized by law. In the
absence of such a designation or if for
any reason service on the designated
agent cannot be effected, service may be
made as provided in section 536(d) by
posting such process, notice, order,
requirement, or decision in the Office of
the Director, Center for Devices and
Radiological Health and publishing a
notice that such service was made in the
Federal Register.
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PART 1030—PERFORMANCE
STANDARDS FOR MICROWAVE AND
RADIO FREQUENCY EMITTING
PRODUCTS
12. The authority citation for 21 CFR
part 1030 is revised to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360, 360e–
360j, 360hh–360ss, 371, 381.
§ 1005.25 Service of process on
manufacturers.
*
11. The authority citation for 21 CFR
part 1020 is revised to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360e–360j,
360hh–360ss, 371, 381.
PART 1005—IMPORTATION OF
ELECTRONIC PRODUCTS
PART 1040—PERFORMANCE
STANDARDS FOR LIGHT-EMITTING
PRODUCTS
13. The authority citation for 21 CFR
part 1040 is revised to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360, 360e–
360j, 360hh–360ss, 371, 381.
PART 1050—PERFORMANCE
STANDARDS FOR SONIC,
INFRASONIC, AND ULTRASONIC
RADIATION-EMITTING PRODUCTS
14. The authority citation for 21 CFR
part 1050 is revised to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360, 360e–
360j, 360hh–360ss, 371, 381.
Dated: March 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–7288 Filed 3–31–10; 8:45 am]
BILLING CODE 4160–01–S
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Food and Drug Administration
Sfmt 4700
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
final rule to amend the regulations to
reflect organization change in the
agency and to make other conforming
changes. This action is editorial in
nature and is intended to improve the
accuracy of the agency’s regulations.
DATES: This rule is effective April 1,
2010.
FOR FURTHER INFORMATION CONTACT:
Vanessa Starks, Office of Management
Programs (HFA–410), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4654; or
Sharon Burgess, Division of Human
Capital Management (HFA–410), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
2065.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this final rule to
amend its regulations by updating the
organizational information in part 5 (21
CFR part 5).
The agency has updated the
references to part 5, subpart M.
The portion of this final rule updating
the organizational information in part 5,
subpart M is a rule of agency
organization, procedure, or practice.
FDA is issuing these provisions as a
final rule without publishing a general
notice of proposed rulemaking because
such notice is not required for rules of
agency organization, procedure, or
practice under 5 U.S.C. 553(b)(3)(A). For
the conforming changes to the other
regulations, the agency finds good cause
under 5 U.S.C. 553(b)(3)(B) to dispense
with prior notice and comment, and
good cause under 5 U.S.C. 553(d)(3) to
make these conforming changes
effective less than 30 days after
publication because such notice and
comment and delayed effective date are
unnecessary and contrary to the public
interest. These conforming changes
merely update the footnotes in part 5,
subpart M. These changes do not result
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]]>Agencies
[Federal Register Volume 75, Number 62 (Thursday, April 1, 2010)]
[Rules and Regulations]
[Pages 16351-16353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7288]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1002, 1003, 1004, 1005, 1010, 1020, 1030, 1040, and
1050
[Docket No. FDA-2010-N-0010]
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 statutory and regulatory
references to ensure accuracy, consistency, and clarity in the agency's
regulations.
DATES: This rule is effective April 1, 2010.
FOR FURTHER INFORMATION CONTACT: Bernice E. Noland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4430, Silver Spring, MD 20993-0002, 301-
796-5742.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations at part 1002
(21 CFR part 1002) to correct a regulatory reference. FDA is revising
Sec. 1002.30(b) by deleting ``paragraph (c) of Sec. 1002.61'' and
replacing it with ``table 1 of Sec. 1002.1.'' FDA updated
[[Page 16352]]
Sec. 1002.30(a) to reflect this change, but inadvertently retained the
reference to ``paragraph (c) of Sec. 1002.61'' in Sec. 1002.30(b).
With this technical amendment, the entirety of the regulation at Sec.
1002.30 accurately references ``table 1 of Sec. 1002.1,'' which is the
former paragraph (c) of Sec. 1002.61.
In addition, FDA is amending its regulations at part 1002 and parts
1005 and 1010 (21 CFR parts 1005 and 1010) to correct statutory
references. These parts intermittently cite sections of the Radiation
Control for Health and Safety Act of 1968 (Radiation Control Act)
(Public Law 90-602). However, ``Act'' is defined in 21 CFR 1000.3(b),
and applicable throughout 21 CFR parts 1000 to 1050, subchapter J, to
mean the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 360hh-
360ss). The Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-
629), transferred the Radiation Control Act to the FFDCA. With these
technical amendments, FDA is replacing citations to the Radiation
Control Act with citations to the corresponding sections of the FFDCA.
FDA is revising Sec. Sec. 1002.41(a)(1) and 1002.42 by replacing
section ``359'' of the act with section ``535.'' FDA is revising Sec.
1005.25(c) by replacing section ``360(d)'' of the act with section
``536(d).'' FDA is revising Sec. 1010.4(c)(3) by replacing section
``360A(e)'' of the act with section ``537(e).''
Finally, FDA is amending its authority citations in parts 1003,
1004, 1005, 1010, 1020, 1030, 1040, and 1050 to correct statutory
citations. These parts cite to the Public Health Service Act, which
codified the Radiation Control Act at 42 U.S.C. 263b-263n, until the
SMDA transferred the Radiation Control Act to the FFDCA. Section
19(a)(3) of the SMDA also repealed section 354 of the Radiation Control
Act, codified at 42 U.S.C. 263b, which contained Congress's declaration
of purpose in enacting the program of electronic product radiation
controls. The SMDA redesignated and transferred the remaining sections
to the FFDCA at 21 U.S.C. 360hh-360ss. The authority citations in parts
1003, 1004, 1005, 1010, 1020, 1030, 1040, and 1050 to 42 U.S.C. 263b-
263n were not correspondingly updated to reflect the transfer of the
Radiation Control Act from the Public Health Service Act to the FFDCA.
With these technical amendments, FDA is replacing citations to the
Public Health Service Act with citations to the corresponding sections
of the FFDCA. Thus, FDA is revising parts 1003, 1004, 1010, 1030, 1040,
and 1050 by replacing the authority citation of ``42 U.S.C. 263b-263n''
with ``21 U.S.C. 360hh-360ss.'' FDA is similarly revising part 1005 by
replacing the authority citation of ``42 U.S.C. 263d, 263h'' with ``21
U.S.C. 360ii, 360mm.'' FDA is also revising part 1020 by deleting the
authority citation to 21 U.S.C. 360gg. Although section 354 of the
Radiation Control Act would have been designated as 21 U.S.C. 360gg had
the provision been transferred to the FFDCA, the SMDA repealed that
section. As a result, the citation to 21 U.S.C. 360gg in part 1020 is
an inadvertent error that this technical amendment will correct by
deleting that part of the authority citation.
Publication of this document constitutes final action on the change
under the Administrative Procedure Act (5 U.S.C. 553). These technical
amendments correct regulatory and statutory references in the Code of
Federal Regulations. FDA therefore, for good cause, has determined that
notice and public comment are unnecessary, under 5 U.S.C. 553(b)(3)(B).
Further, this rule places no burden on affected parties for which such
parties would need a reasonable time to prepare for the effective date
of the rule. Accordingly, FDA, for good cause, had determined this
technical amendment to be exempt under 5 U.S.C. 553(d)(3) from the 30-
day effective date from publication.
FDA 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 is required. In
addition, FDA has determined that this final rule contains no
collections of information. Therefore, clearance by the Office
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
For the effective date of this final rule, see the DATES section of
this document.
List of Subjects
21 CFR Part 1002
Electronic products, Radiation protection, Reporting and
recordkeeping requirements.
21 CFR Part 1003
Administrative practice and procedure, Electronic products,
Radiation protection.
21 CFR Part 1004
Electronic products, Radiation protection.
21 CFR Part 1005
Administrative practice and procedure, Electronic products,
Imports, Radiation protection, Surety bonds.
21 CFR Part 1010
Administrative practice and procedure, Electronic products,
Exports, Radiation protection.
21 CFR Part 1020
Electronic products, Medical devices, Radiation protection,
Reporting and recordkeeping requirements, Television, X-rays.
21 CFR Part 1030
Electronic products, Microwave ovens, Radiation protection.
21 CFR Part 1040
Electronic products, Labeling, Lasers, Medical devices, Radiation
protection, Reporting and recordkeeping requirements.
21 CFR Part 1050
Electronic products, Medical devices, Radiation protection.
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Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
Chapter I is amended as follows:
PART 1002--RECORDS AND REPORTS
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1. The authority citation for 21 CFR part 1002 continues to read as
follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371,
374.
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2. In Sec. 1002.30, paragraph (b) introductory text is revised to read
as follows:
Sec. 1002.30 Records to be maintained by manufacturers.
* * * * *
(b) In addition to the records required by paragraph (a) of this
section, manufacturers of products listed in table 1 of Sec. 1002.1
shall establish and maintain the following records with respect to such
products:
* * * * *
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3. In 1002.41, paragraph (a)(1) is revised to read as follows:
Sec. 1002.41 Disposition of records obtained by dealers and
distributors.
(a) * * *
(1) The dealer or distributor elects to hold and preserve such
information and to immediately furnish it to the manufacturer when
advised by the manufacturer or the Director, Center for Devices and
Radiological Health, that
[[Page 16353]]
such information is required for purposes of section 535 of the Act;
and
* * * * *
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4. Section 1002.42 is revised to read as follows:
Sec. 1002.42 Confidentiality of records furnished by dealers and
distributors.
All information furnished to manufacturers by dealers and
distributors pursuant to this part shall be treated by such
manufacturers as confidential information which may be used only as
necessary to notify persons pursuant to section 535 of the Act.
PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
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5. The authority citation for 21 CFR part 1003 is revised to read as
follows:
Authority: 21 U.S.C. 360hh-360ss.
PART 1004--REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC
PRODUCTS
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6. The authority citation for 21 CFR part 1004 is revised to read as
follows:
Authority: 21 U.S.C. 360hh-360ss.
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS
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7. The authority citation for 21 CFR part 1005 is revised to read as
follows:
Authority: 21 U.S.C. 360ii, 360mm.
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8. In 1005.25, paragraph (c) is revised to read as follows:
Sec. 1005.25 Service of process on manufacturers.
* * * * *
(c) Service of any process, notice, order, requirement, or decision
specified in section 536(d) of Subchapter C--Electronic Product
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly
the Radiation Control for Health and Safety Act of 1968) (21 U.S.C.
360mm(d)) may be made by registered or certified mail addressed to the
agent with return receipt requested, or in any other manner authorized
by law. In the absence of such a designation or if for any reason
service on the designated agent cannot be effected, service may be made
as provided in section 536(d) by posting such process, notice, order,
requirement, or decision in the Office of the Director, Center for
Devices and Radiological Health and publishing a notice that such
service was made in the Federal Register.
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
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9. The authority citation for 21 CFR part 1010 is revised to read as
follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371,
381.
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10. In 1010.4, paragraph (c)(3) is revised to read as follows:
Sec. 1010.4 Variances.
* * * * *
(c) * * *
(3) All applications for variances and for amendments and
extensions thereof and all correspondence (including written notices of
approval) on these applications will be available for public disclosure
in the office of the Division of Dockets Management, except for
information regarded as confidential under section 537(e) of the act.
* * * * *
PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS
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11. The authority citation for 21 CFR part 1020 is revised to read as
follows:
Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381.
PART 1030--PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY
EMITTING PRODUCTS
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12. The authority citation for 21 CFR part 1030 is revised to read as
follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371,
381.
PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
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13. The authority citation for 21 CFR part 1040 is revised to read as
follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371,
381.
PART 1050--PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND
ULTRASONIC RADIATION-EMITTING PRODUCTS
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14. The authority citation for 21 CFR part 1050 is revised to read as
follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371,
381.
Dated: March 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7288 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S
