[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Notices]
[Pages 28816-28818]
[FR Doc No: 2011-12190]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0061]

Federal Advisory Council on Occupational Safety and Health
(FACOSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of meeting and member appointment.

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SUMMARY: The Federal Advisory Council on Occupational Safety and Health
(FACOSH) will meet June 7, 2011, in Washington, DC. On January 12,
2011, the Secretary appointed one person to FACOSH. This Federal
Register notice also announces this appointment.

DATES: FACOSH meeting: FACOSH will meet from 1 p.m. to 4 p.m., Tuesday,
June 7, 2011.
    Submission of comments, requests to speak, and requests for special
accommodations: Comments, requests to speak at the FACOSH meeting, and
requests for special accommodations to attend the FACOSH meeting must
be submitted (postmarked, sent, transmitted) by May 31, 2011.

ADDRESSES: FACOSH meeting: FACOSH will meet in C-5521 Room 4, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210.
    Submission of comments and requests to speak: Comments and requests
to speak at the FACOSH meeting, identified by Docket No. OSHA-2011-

0061, may be submitted by one of the following methods:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for making submissions.
    Facsimile: If your submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Mail, express delivery, hand delivery, messenger or courier
service: You must submit a copy of your submission to the OSHA Docket
Office, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue,
NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (877) 889-
5627). Deliveries (hand, express mail, messenger and courier service)
are accepted during the Department of Labor's and OSHA Docket Office's
normal business hours, 8:15 a.m.-4:45 p.m., e.t.
    Requests for special accommodations for FACOSH meeting: Submit
requests for special accommodations by telephone, e-mail or hard copy
to Ms. Veneta Chatmon, OSHA, Office of Communications, Room N-3647,
U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    Instructions: All submissions must include the Agency name and
docket number for this Federal Register notice (Docket No. OSHA-2011-
0061). Because of security-related procedures, submissions by regular
mail may result in a significant delay in their receipt. Please contact
the OSHA Docket Office for information about security procedures for
making submissions by hand delivery, express delivery, and messenger or
courier service. For additional information on submitting comments and
requests to speak, see the SUPPLEMENTARY INFORMATION section below.
    Comments and requests to speak, including any personal information
provided, will be posted without change at http://www.regulations.gov.
Therefore, OSHA cautions interested persons about submitting certain
personal information such as social security numbers and birthdates.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Ms. Diana
Petterson, Office of Public Affairs, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202)-693-
1898; e-mail<EMAIL_ADDRESS>    For general information: Mr. Francis Yebesi, OSHA, Office of
Federal Agency Programs, U.S. Department of Labor, Room N-3622, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2122; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

FACOSH Meeting

    FACOSH will meet Tuesday, June 7, 2011, in Washington, DC. All
FACOSH meetings are open to the public.
    FACOSH is authorized by 5 U.S.C. 7902, section 19 of the
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 668),
and Executive Order 12196 to advise the Secretary of Labor (Secretary)
on all matters relating to the occupational safety and health of
Federal employees. This includes providing advice on how to reduce and
keep to a minimum the number of injuries and illnesses in the Federal
workforce and how to encourage each Federal Executive Branch Department
and Agency to establish and maintain effective occupational safety and
health programs.
    The tentative agenda for the FACOSH meeting includes:
     Emerging Issues Subcommittee update on its analysis of
Permissible Exposure Limits applicable to Federal agencies;
     Training Subcommittee update on its review of occupational
safety and health training requirements for Federal workers and
requirements of the Safety and Health Management and Industrial Hygiene
OPM job series;
     Presentation on the Department of Labor national outreach
initiative to protect workers from heat-related illnesses and its
application to Federal workers; and
     Update on a national outreach initiative to protect
workers from the hazard of distracted driving and its application to
Federal workers,
    FACOSH meetings are transcribed and detailed minutes of the
meetings are prepared. Meeting transcripts, minutes and other materials
presented at the meeting are included in the FACOSH meeting record,
which is posted at http://www.regulations.gov.

Public Participation

    FACOSH meetings are open to the public. Interested persons may
submit a request to make an oral presentation to FACOSH by one of the
methods listed in the ADDRESSES section. The request must state the
amount of time requested to speak, the interest represented (e.g.,
organization name), if any, and a brief outline of the presentation.
Requests to address FACOSH may be granted as time permits and at the
discretion of the FACOSH chair.
    Interested persons also may submit comments, including data and
other information, using one of the methods listed in the ADDRESSES
section. OSHA will provide all submissions to FACOSH members prior to
the meeting and put them in the public docket for that meeting.
    Individuals who need special accommodations and wish to attend the
FACOSH meeting must contact Ms. Chatmon by one of the methods listed in
the ADDRESSES section.

Submissions and Access to Public Record

    You may submit comments, requests to speak and requests for special
accommodations (1) electronically, (2) by facsimile, or (3) by hard
copy. All submissions, including attachments and other materials, must
identify the Agency name and the OSHA docket number for this notice
(Docket No. OSHA-2011-0061). You may supplement electronic submissions
by uploading documents electronically. If, instead, you wish to submit
hard copies of supplementary documents, you must submit a copy to the
OSHA Docket Office using the instructions in the ADDRESSES section. The
additional materials must clearly identify your electronic submission
by name, date and docket number.
    Because of security-related procedures, the use of regular mail may
cause a significant delay in the receipt of submissions. For
information about security procedures concerning the delivery of
submissions by hand, express delivery, messenger or courier service,
please contact the OSHA Docket Office at<PHONE_NUMBER> (TTY (877) 889-
5627).
    Written comments and requests to speak are posted without change at
http://www.regulations.gov. Therefore, OSHA cautions interested parties
about submitting certain personal information such as Social Security
numbers and birthdates.
    Meeting transcripts, minutes, written comments and requests to
speak are included in the public record of the FACOSH meeting. To read
or download documents in the public record, go to Docket No. OSHA-2011-
0061 at http://www.regulations.gov or to the OSHA Docket Office.
Although all documents in the public listed in the http://www.regulations.gov index, some documents (e.g., copyrighted material)
are not publicly available to read or download through that Webpage.
All documents in the public record, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.

    Information on using the http://www.regulations.gov to make
submissions and to access the docket and exhibits is available at that
Webpage. Contact the OSHA Docket Office for information about materials
not available through the Webpage and for assistance in using the
Internet to locate documents in the public record.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, is also available at OSHA's Web page at
http://www.osha.gov.

Announcement of FACOSH Appointments

    The Secretary has appointed Mr. Edward A. Hamilton, Sr., U.S.
Department of Justice, to complete the unexpired term of a FACOSH
management member who is no longer able to serve on the Council. FACOSH
is comprised of 16 members; eight who represent Federal agency
management and eight from labor organizations that represent Federal
employees.

Authority and Signature

    David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this notice
under the authority granted by section 19 of the Occupational Safety
and Health Act of 1970 (OSH Act) (29 U.S.C. 668), 5 U.S.C. 7902, the
Federal Advisory Committee Act (5 U.S.C. App. 2) and regulations issued
under FACA (41 CFR part 102-3), section 1-5 of Executive Order 12196,
and Secretary of Labor's Order No. 4-2010 (75 FR 55335 (9/10/2010)).

    Signed at Washington, DC, on May 13, 2011.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2011-12190 Filed 5-17-11; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Rules and Regulations]
[Page 34857-34861]
[DOCID:fr19jn08-8]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 800, 801, 808, 814, 821, 860, 876, 882, 884, 886, 890,
1005, and 1010

[Docket No. FDA-2008-N-0332]

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 typographical errors and to
ensure accuracy and clarity in the agency's regulations.

DATES: This rule is effective June 19, 2008.

FOR FURTHER INFORMATION CONTACT: Paul S. Gadiock, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is amending its regulations in parts 800, 801, 808, 814, 821,
860, 876, 882, 884, 886, 890, 1005, and 1010 (21 CFR parts 800, 801,
808, 814, 821, 860, 876, 882, 884, 886, 890, 1005, and 1010) to correct
typographical errors and to update addresses, telephone numbers, and
wording to ensure accuracy and clarity in the agency's 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.

II. Highlights of the Final Rule

    FDA is making changes to correct typographical and other minor
errors in certain device regulations in parts 800, 801, 808, 814, 821,
860, 876, 882, 884, 886, 890, 1005, and 1010.
    1. FDA is revising Sec.  800.12(d) by removing ``This information
collection requirement has been approved by the Office of Management
and Budget under number 0910-0150.''
    2. FDA is revising Sec.  801.420(d) by replacing ``Bureau of
Medical Devices and Diagnostic Products, Division of Compliance, HFK-
116, 8757 Georgia

Ave., Silver Spring, MD 20910'' with ``Office of Compliance, Division
of Enforcement A, 2094 Gaither Rd., Rockville, MD 20850.''
    3. FDA is revising Sec.  808.1(d)(9) by replacing ``the Radiation
Control for Health and Safety Act of 1968 (Pub. L. 90-602 (42 U.S.C.
263b et seq.))'' with ``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).'' FDA is also
replacing ``Atomic Energy act'' with ``Atomic Energy Act.''
    4. FDA is revising Sec.  814.20(b)(5) by replacing ``the Radiation
Control for Health and Safety Act of 1968 (42 U.S.C. 263b et seq.)''
with ``section 534 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).''
    5. FDA is revising Sec.  814.45(b) by replacing ``515(d)(3)'' with
``515(d)(4).''
    6. FDA is revising Sec.  821.1(c) by replacing ``501(t)(2)'' with
``502(t)(2).''
    7. FDA is revising Sec.  860.134(a) by replacing ``513(f)(2)'' with
``513(f)(3).''
    8. FDA is revising Sec.  876.5250(b)(2) by replacing ``subject to
the limitations in Sec.  876.9'' with ``the device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec.  876.9.'' FDA is also
replacing ``regulations'' with ``requirements of the quality system
regulation.''
    9. FDA is revising Subpart E of the Table of Contents of Part 882
by replacing ``882.4700 Neurosurgical paddle'' with ``882.4700
Neurosurgical paddie.''
    10. FDA is revising Subpart F of the Table of Contents of Part 882
by replacing ``882.5800 Cranial electrotheraphy stimulator'' with
``882.5800 Cranial electrotherapy stimulator.''
    11. FDA is revising the section heading in Sec.  882.5800 by
replacing ``electrotheraphy'' with ``electrotherapy.''
    12. FDA is revising Sec.  882.5800(a) by replacing
``electrotheraphy'' with ``electrotherapy.''
    13. FDA is revising Sec.  884.5435(b) by replacing ``interlabial''
with ``intralabial.''
    14. FDA is revising Sec.  886.1 by adding paragraph (e) reading
``Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.''
    15. FDA is revising Sec.  890.1 by adding paragraph (e) reading
``Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.''
    16. FDA is revising Sec.  1005.11 by replacing ``the Radiation
Control for Health and Safety Act of 1968'' with ``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).''
    17. FDA is revising Sec.  1005.25(a) by replacing ``section 360(d)
of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C.
263h(d))'' with ``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)).''
    18. FDA is revising Sec.  1005.25(c) by replacing ``section 360(d)
of the Radiation Control for Health and Safety Act of 1968'' with
``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)).''
    19. FDA is revising Sec.  1010.1 by replacing ``section 358 of the
Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f)''
with ``section 534 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.
360kk).''
    20. FDA is revising Sec.  1010.4(a)(1) by replacing ``the Radiation
Control for Health and Safety Act of 1968'' with ``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).''

III. 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 is
required.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and 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 $127 million, using the most current (2006) 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.

V. 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.

VI. 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.

VII. 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 the DATES section of
this document. Because this final 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 800

    Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping
requirements.

21 CFR Part 808

    Intergovernmental relations, Medical devices.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 821

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.

21 CFR Part 876

    Medical devices.

21 CFR Part 882

    Medical devices.

21 CFR Part 884

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 890

    Medical devices.

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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
800, 801, 808, 814, 821, 860, 876, 882, 884, 886, 890, 1005, and 1010
are amended as follows:

PART 800--GENERAL

0
1. The authority citation for 21 CFR part 800 continues to read as
follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k,
361, 362, 371.

Sec.  800.12  [Amended]

0
2. In Sec.  800.12, paragraph (d) is amended by removing the last
sentence.

PART 801--LABELING

0
3. The authority citation for 21 CFR part 801 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

0
4. In Sec.  801.420, paragraph (d) is revised to read as follows:

Sec.  801.420  Hearing aid devices; professional and patient labeling.

* * * * *
    (d) Submission of all labeling for each type of hearing aid. Any
manufacturer of a hearing aid described in paragraph (a) of this
section shall submit to the Food and Drug Administration, Office of
Compliance, Division of Enforcement A, 2094 Gaither Rd., Rockville, MD
20850, a copy of the User Instructional Brochure described in paragraph
(c) of this section and all other labeling for each type of hearing aid
on or before August 15, 1977.

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL
MEDICAL DEVICE REQUIREMENTS

0
5. The authority citation for 21 CFR part 808 continues to read as
follows:

    Authority: 21 U.S.C. 360j, 360k, 371.

0
6. In Sec.  808.1, paragraph (d)(9) is revised to read as follows:

Sec.  808.1  Scope.

* * * * *
    (d) * * *
    (9) Section 521(a) does not preempt State or local requirements of
the types that have been developed under the Atomic Energy Act of 1954
(42 U.S.C. 2011 note), as amended, 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), and other
Federal statutes, until such time as the Food and Drug Administration
issues specific requirements under the Federal Food, Drug, and Cosmetic
Act applicable to these types of devices.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
7. The authority citation for 21 CFR 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
8. In Sec.  814.20, paragraph (b)(5) is revised to read as follows:

Sec.  814.20  Application.

* * * * *
    (b) * * *
    (5) Reference to any performance standard under section 514 of the
act or under section 534 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) in effect or
proposed at the time of the submission and to any voluntary standard
that is relevant to any aspect of the safety or effectiveness of the
device and that is known to or that should reasonably be known to the
applicant. The applicant shall--
    (i) Provide adequate information to demonstrate how the device
meets, or justify any deviation from, any performance standard
established under section 514 of the act or under section 534 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), and
    (ii) Explain any deviation from a voluntary standard.
* * * * *

0
9. In Sec.  814.45, paragraph (b) is amended by revising the last
sentence to read as follows:

Sec.  814.45  Denial of approval of a PMA.

* * * * *
    (b) * * * The order will include a notice of an opportunity to
request review under section 515(d)(4) of the act.
* * * * *

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

0
10. The authority citation for 21 CFR part 821 continues to read as
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.

0
11. In Sec.  821.1, paragraph (c) is revised to read as follows:

Sec.  821.1  Scope.

* * * * *
    (c) The primary burden for ensuring that the tracking system works
rests upon the manufacturer. A manufacturer or any other person,
including a distributor, final distributor, or multiple distributor,
who distributes a device subject to tracking, who fails to comply with
any applicable requirement of section 519(e) of the act or of this
part, or any person who causes such failure, misbrands the device
within the meaning of section 502(t)(2) of the act and commits a
prohibited act within the meaning of sections 301(e) and 301(q)(1)(B)
of the act.
* * * * *

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
12. The authority citation for 21 CFR part 860 continues to read as
follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

0
13. In Sec.  860.134, paragraph (a) is amended by revising the first
sentence of the introductory text to read as follows:

Sec.  860.134  Procedures for ``new devices'' under section 513(f) of
the act and reclassification of certain devices.

    (a) Section 513(f)(3) of the act applies to proceedings for
reclassification of a device currently in class III by operation of
section 513(f)(1) of the act. * * *
* * * * *

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
14. The authority citation for 21 CFR part 876 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
15. In Sec.  876.5250, paragraph (b)(2) is revised to read as follows:

Sec.  876.5250  Urine collector and accessories.

* * * * *
    (b) * * *
    (2) Class I (general controls). For a urine collector and
accessories not intended to be connected to an indwelling catheter, the
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
876.9. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
requirements of the quality system regulation in part 820 of this
chapter, with the exception of Sec.  820.180, with respect to general
requirements concerning records, and Sec.  820.198, with respect to
complaint files.

PART 882--NEUROLOGICAL DEVICES

0
16. The authority citation for 21 CFR part 882 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
17. In the Table of Contents of Part 882, in Subpart E, Sec.  882.4700
is amended by removing the word ``paddle'' and adding in its place the
word ``paddie''.

0
18. In the Table of Contents of Part 882, in Subpart F, Sec.  882.5800
is amended by removing the word ``electrotheraphy'' and by adding in
its place the word ``electrotherapy''.

0
19. In Sec.  882.5800, the section heading and paragraph (a) are
revised to read as follows:

Sec.  882.5800  Cranial electrotherapy stimulator.

    (a) Identification. A cranial electrotherapy stimulator is a device
that applies electrical current to a patient's head to treat insomnia,
depression, or anxiety.
* * * * *

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
20. The authority citation for 21 CFR part 884 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
21. In Sec.  884.5435, paragraph (b) is amended by revising the last
sentence to read as follows:

Sec.  884.5435  Unscented menstrual pad.

* * * * *
    (b) * * * This exemption does not include the intralabial pads and
reusable menstrual pads.

PART 886--OPHTHALMIC DEVICES

0
22. The authority citation for 21 CFR part 886 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
23. Section 886.1 is amended by adding paragraph (e) to read as
follows:

Sec.  886.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.

PART 890--PHYSICAL MEDICINE DEVICES

0
24. The authority citation for 21 CFR part 890 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
25. Section 890.1 is amended by adding paragraph (e) to read as
follows:

Sec.  890.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

0
26. The authority citation for 21 CFR part 1005 continues to read as
follows:

    Authority: 42 U.S.C. 263d, 263h.

0
27. 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 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). Billing for reimbursement
shall be made by the owner or consignee to the Center for Devices and
Radiological Health, 5600 Fishers Lane, 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
28. Section 1005.25 is amended by revising paragraph (a) and the first
sentence of paragraph (c) to read as follows:

Sec.  1005.25  Service of process on manufacturers.

    (a) Every manufacturer of electronic products, prior to offering
such product for importation into the United States, shall designate a
permanent resident of the United States as the manufacturer's agent
upon whom service of all processes, notices, orders, decisions, and
requirements may be made for and

on behalf of the manufacturer as provided 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)) and this section. The agent
may be an individual, a firm, or a domestic corporation. For purposes
of this section, any number of manufacturers may designate the same
agent.
* * * * *
    (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. * * *

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

0
29. The authority citation for 21 CFR part 1010 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263b-263n.

0
30. Section 1010.1 is revised to read as follows:

Sec.  1010.1  Scope.

    The standards listed in this subchapter are prescribed pursuant to
section 534 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. 360kk) and are
applicable to electronic products as specified herein, to control
electronic product radiation from such products. Standards so
prescribed are subject to amendment or revocation and additional
standards may be prescribed as are determined necessary for the
protection of the public health and safety.

0
31. In Sec.  1010.4, paragraph (a)(1) is revised to read as follows:

Sec.  1010.4  Variances.

    (a) Criteria for variances. (1) Upon application by a manufacturer
(including an assembler), the Director, Center for Devices and
Radiological Health, Food and Drug Administration, may grant a variance
from one or more provisions of any performance standard under
subchapter J of this chapter for an electronic product subject to such
standard when the Director determines that granting such a variance is
in keeping with the purposes 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), and:
    (i) The scope of the requested variance is so limited in its
applicability as not to justify an amendment to the standard, or
    (ii) There is not sufficient time for the promulgation of an
amendment to the standard.
* * * * *

    Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13915 Filed 6-18-08; 8:45 am]

BILLING CODE 4160-01-S