[Federal Register Volume 75, Number 62 (Thursday, April 1, 2010)]
[Rules and Regulations]
[Pages 16351-16353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7288]
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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.
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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.
0
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
0
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.
0
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:
* * * * *
0
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
* * * * *
0
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
0
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
0
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
0
7. The authority citation for 21 CFR part 1005 is revised to read as
follows:
Authority: 21 U.S.C. 360ii, 360mm.
0
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
0
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.
0
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
0
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
0
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
0
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
0
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