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68510 Federal Register / Vol. 67, No.

218 / Tuesday, November 12, 2002 / Rules and Regulations

Actions Compliance Procedures

(1) Inspect, using eddy current inspection, the Initially inspect upon the accumulation of In accordance with the Inspection Instructions
inboard forward flap bellcrank for cracks. 4,000 landings on the bellcrank or within of Cessna Service Bulletin No. CAB02–1,
the next 250 landings after December 31, dated February 11, 2002, and the applica-
2002 (the effective date of this AD), which- ble maintenance manual.
ever occurs later. Repetitively inspect there-
after at every 500 landings until 7,000 land-
ings are accumulated.
(2) Replace the inboard forward flap bellcrank. Prior to further flight when cracks are found; In accordance with the Inspection Instructions
and upon the accumulation of 7,000 land- of Cessna Service Bulletin No. CAB02–1,
ings or within the next 75 landings after De- dated February 11, 2002, and the applica-
cember 31, 2002 (the effective date of this ble maintenance manual.
AD), whichever occurs later.

Note 1: Inboard forward flap bellcranks Aircraft Company, Product Support, PO Box 1976 (the 1976 amendments), the Safe
with 7,000 landings or more do not have to 7706, Wichita, Kansas 67277; telephone: Medical Devices Act of 1990 (the
be replaced until 75 landings after the (316) 517–5800; facsimile: (316) 942–9006. SMDA), and the Food and Drug
effective date of this AD. You may view copies at the FAA, Central Administration Modernization Act of
Note 2: The compliance times of this AD Region, Office of the Regional Counsel, 901
Locust, Room 506, Kansas City, Missouri, or
1997 (FDAMA). Elsewhere in this issue
are presented in landings instead of hours. If of the Federal Register, FDA is
the number of landings is unknown, hours at the Office of the Federal Register, 800
North Capitol Street, NW, suite 700, publishing a notice of availability of the
time-in-service (TIS) may be used by
multiplying the number of hours TIS by 1.25. Washington, DC. guidance document that will serve as
(i) When does this amendment become the special control for this final rule.
(e) Can I comply with this AD in any other effective? This amendment becomes effective
way? You may use an alternative method of DATES: This rule is effective December
on December 31, 2002.
compliance or adjust the compliance time if: 12, 2002.
(1) Your alternative method of compliance Issued in Kansas City, Missouri, on
October 31, 2002. FOR FURTHER INFORMATION CONTACT:
provides an equivalent level of safety; and
(2) The Manager, Wichita Aircraft Susan Runner, Center for Devices and
Michael Gallagher,
Certification Office (ACO), approves your Radiological Health (HFZ–480), Food
Manager, Small Airplane Directorate, Aircraft
alternative. Submit your request through an and Drug Administration, 9200
Certification Service.
FAA Principal Maintenance Inspector, who Corporate Blvd., Rockville, MD 20850,
[FR Doc. 02–28408 Filed 11–8–02; 8:45 am]
may add comments and then send it to the 301–827–5283.
Manager, Wichita ACO. BILLING CODE 4910–13–P
SUPPLEMENTARY INFORMATION:
Note 3: This AD applies to each airplane
identified in paragraph (a) of this AD, I. Background
regardless of whether it has been modified, DEPARTMENT OF HEALTH AND
altered, or repaired in the area subject to the The act (21 U.S.C. 301 et seq.), as
HUMAN SERVICES
requirements of this AD. For airplanes that amended by the 1976 amendments
have been modified, altered, or repaired so Food and Drug Administration (Public Law 94–295), the SMDA (Public
that the performance of the requirements of Law 101–629), and the FDAMA (Public
this AD is affected, the owner/operator must 21 CFR Part 872 Law 105–115), established a
request approval for an alternative method of comprehensive system for the regulation
compliance in accordance with paragraph (e) [Docket No. 02N–0010] of medical devices intended for human
of this AD. The request should include an use. Section 513 of the act (21 U.S.C.
assessment of the effect of the modification, Dental Devices; Classification for
alteration, or repair on the unsafe condition
360c) established three categories
Intraoral Devices for Snoring and/or (classes) of devices, depending on the
addressed by this AD; and, if you have not Obstructive Sleep Apnea
eliminated the unsafe condition, specific regulatory controls needed to provide
actions you propose to address it. AGENCY: Food and Drug Administration, reasonable assurance of their safety and
(f) Where can I get information about any HHS. effectiveness. The three categories of
already-approved alternative methods of ACTION: Final rule. devices are class I (general controls),
compliance? Contact Paul Nguyen, class II (special controls), and class III
Aerospace Engineer, FAA, Aircraft SUMMARY: The Food and Drug (premarket approval).
Certification Office, 1801 Airport Road, Administration (FDA) is classifying the Under section 513 of the act, devices
Room 100, Wichita, Kansas 67209; telephone: intraoral devices for snoring and/or that were in commercial distribution
316–946–4125; facsimile: 816–946–4407.
(g) What if I need to fly the airplane to
obstructive sleep apnea into class II before May 28, 1976 (the date of
another location to comply with this AD? The (special controls). These devices are enactment of the 1976 amendments), are
FAA can issue a special flight permit under used to control or treat simple snoring generally referred to as preamendments
§§ 21.197 and 21.199 of the Federal Aviation and/or obstructive sleep apnea. This devices, and are classified after FDA
Regulations (14 CFR 21.197 and 21.199) to classification is based on the has: (1) Received a recommendation
operate your airplane to a location where you recommendations of the Dental Devices from a device classification panel (an
can accomplish the requirements of this AD. Panel (the Panel), and is being taken to FDA advisory committee); (2) published
(h) Are any service bulletins incorporated establish sufficient regulatory controls the panel’s recommendation for
into this AD by reference? Actions required that will provide reasonable assurance comment, along with a proposed
by this AD must be done in accordance with
Cessna Service Bulletin No. CAB02–1, dated
of the safety and effectiveness of these regulation classifying the device; and (3)
February 11, 2002. The Director of the devices. This action is being taken published a final regulation classifying
Federal Register approved this incorporation under the Federal Food, Drug, and the device. FDA has classified most
by reference under 5 U.S.C. 552(a) and 1 CFR Cosmetic Act (the act), as amended by preamendments devices under these
part 51. You may get copies from Cessna the Medical Device Amendments of procedures.

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Federal Register / Vol. 67, No. 218 / Tuesday, November 12, 2002 / Rules and Regulations 68511

Devices that were not in commercial IV. Analysis of Comment and FDA’s document that is the special control for
distribution prior to May 28, 1976, are Response the devices. The agency, therefore,
generally referred to as postamendments The one comment FDA received certifies that this final rule will not have
devices, and are classified automatically expressed concerns about the effect the a significant economic impact on a
by statute (section 513(f) of the act) into guidance document would have on substantial number of small entities. In
class III without any FDA rulemaking dental laboratories. FDA has concluded addition, this final rule will not impose
process. Those devices remain in class that the guidance document does not costs of $100 million or more on either
III and require premarket approval, change the regulatory requirements for the private sector or State, local, and
unless and until: (1) The device is dental laboratories. tribal governments in the aggregate, and,
reclassified into class I or II; (2) FDA Therefore, under section 513 of the therefore, a summary statement of
issues an order classifying the device act, FDA is adopting the summary of analysis under section 202(a) of the
into class I or II in accordance with new reasons for the Panel’s recommendation Unfunded Mandates Reform Act of 1995
section 513(f)(2) of the act), as amended and the summary of data upon which is not required.
by the FDAMA; or (3) FDA issues an the Panel’s recommendation is based, in VII. Federalism
order finding the device to be their entirety. FDA also agrees with the
substantially equivalent, under section Panel’s assessment of the risks to public FDA has analyzed this final rule in
513(i) of the act, to a predicate device health stated in the proposed rule accordance with the principles set forth
that does not require premarket published on April 5, 2002. FDA is in Executive Order 13132. FDA has
approval. issuing this final rule, which classifies determined that the rule does not
The agency determines whether new these generic type of intraoral devices contain policies that have substantial
devices are substantially equivalent to for snoring and obstructive sleep apnea direct effects on the States, on the
previously offered devices by means of into class II. relationship between the National
premarket notification procedures in Government and the States, or on the
section 510(k) of the act (21 U.S.C. V. Environmental Impact distribution of power and
360(k)) and 21 CFR part 807 of the The agency has determined under 21 responsibilities among the various
regulations. CFR 25.34(b) that this action is of a type levels of government. Accordingly, the
A preamendments device that has that does not individually or agency has concluded that the rule does
been classified into class III may be cumulatively have a significant effect on not contain policies that have
marketed, by means of premarket the human environment. Therefore, federalism implications as defined in
notification procedures, without neither an environment assessment nor the Executive order and, consequently,
submission of a premarket approval an environmental impact statement is a federalism summary impact statement
application (PMA) until FDA issues a required. is not required.
final regulation under section 515(b) of VIII. Paperwork Reduction Act of 1995
the act (21 U.S.C. 360e(b)) requiring VI. Analysis of Impacts
premarket approval. FDA has examined the impacts of the FDA concludes that this final rule
Consistent with the act and the final rule under Executive Order 12866 contains no collections of information.
regulations, FDA consulted with the and the Regulatory Flexibility Act (5 Therefore, clearance by the Office of
Panel, an FDA advisory committee, U.S.C. 601–612), and the Unfunded Management and Budget under the
regarding the classification of these Mandates Reform Act of 1995 (Public Paperwork Reduction Act of 1995 (44
devices. Law 104–4). Executive Order 12866 U.S.C. 3501–3520) is not required.
directs agencies to assess all costs and IX. Reference
II. Regulatory History of the Device
benefits of available regulatory
In the Federal Register of April 5, alternatives and, when regulation is The following reference has been
2002 (67 FR 16338), FDA issued a necessary, to select regulatory placed on display in the Dockets
proposed rule to classify the intraoral approaches that maximize net benefits Management Branch (HFA–305), 5630
devices for snoring and/or obstructive (including potential economic, Fishers Lane, rm. 1061, Rockville, MD
sleep apnea, used to control or treat environmental, public health and safety, 20852, and may be seen by interested
simple snoring and/or obstructive sleep and other advantages; distributive persons between 9 a.m. and 4 p.m.,
apnea into class II. The agency also impacts; and equity). The agency Monday through Friday.
issued a guidance document as the believes that this final rule is consistent 1. FDA, Center for Devices and
Radiological Health, Office of Device
special control. Interested persons were with the regulatory philosophy and
Evaluation, ‘‘Class II Special Controls
given until July 5, 2002, to comment on principles identified in the Executive Guidance Document: Intraoral Devices for
the proposed regulation and guidance order. In addition, the final rule is not Snoring and/or Obstructive Sleep Apnea;
document. a significant regulatory action as defined Guidance for Industry and FDA,’’ April 5,
FDA received one comment from the by the Executive order and so is not 2002.
National Association of Dental subject to review under the Executive
order. List of Subjects in 21 CFR Part 872
Laboratories.
The Regulatory Flexibility Act Medical devices.
III. Summary of Final Rule
requires agencies to analyze regulatory Therefore, under the Federal Food,
As required by 21 CFR 860.84(g)(2) of options that would minimize any Drug, and Cosmetic Act and under
the regulations, FDA is classifying significant impact of a rule on small authority delegated to the Commissioner
intraoral devices for snoring and/or entities. The classification of these of Food and Drugs, 21 CFR part 872 in
obstructive sleep apnea into class II devices into class II is not adding any subpart F is amended as follows:
with the guidance document ‘‘Class II additional burden to manufacturers,
Special Controls Guidance Document: because most manufacturers, including PART 872—DENTAL DEVICES
Intraoral Devices for Snoring and/or small manufacturers, are already
Obstructive Sleep Apnea’’ (Ref. 1), as substantially in compliance with the 1. The authority citation for 21 CFR
the special control. recommendations of the guidance part 872 continues to read as follows:

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68512 Federal Register / Vol. 67, No. 218 / Tuesday, November 12, 2002 / Rules and Regulations

Authority: 21 U.S.C. 351, 360, 360c, 360e, review and update its transportation Issued on: November 5, 2002.
360j, 371. plan by waiving the regulatory James A. Rowland,
2. Section 872.5570 is added to requirement for a triennial plan update Chief Counsel, Federal Highway
subpart F to read as follows: for the New York City metropolitan area Administration.
for up to three years, until September [FR Doc. 02–28643 Filed 11–8–02; 8:45 am]
§ 872.5570 Intraoral devices for snoring
and intraoral devices for snoring and 30, 2005. The docket number that BILLING CODE 4910–22–P
obstructive sleep apnea. appeared at the heading of the final rule
(a) Identification. Intraoral devices for was incorrect. This notice provides the
snoring and intraoral devices for snoring current docket number regarding the DEPARTMENT OF THE TREASURY
and obstructive sleep apnea are devices Metropolitan Transportation Planning
that are worn during sleep to reduce the and Programming final rule as FHWA– Internal Revenue Service
incidence of snoring and to treat 2001–10836.
obstructive sleep apnea. The devices are 26 CFR Part 1
EFFECTIVE DATE: October 7, 2002.
designed to increase the patency of the [TD 9020]
airway and to decrease air turbulence FOR FURTHER INFORMATION CONTACT: Mr.
and airway obstruction. The John Humeston, Metropolitan Planning RIN 1545–BB19
classification includes palatal lifting and Policies Team (HEPM), (404) 562–
3667 (metropolitan planning), 60 Substantiation of Incidental Expenses
devices, tongue retaining devices, and
mandibular repositioning devices. Forsyth Street, Suite 8M5; Atlanta, AGENCY: Internal Revenue Service (IRS),
(b) Classification. Class II (special Georgia 30303–3104; or Mr. Reid Alsop, Treasury.
controls). The special control for these Office of the Chief Counsel (HCC–31), ACTION: Final and temporary
devices is the FDA guidance document (202) 366–1371; 400 Seventh Street, regulations.
entitled ‘‘Class II Special Controls SW., Washington, D.C. 20590. Office
Guidance Document: Intraoral Devices hours are from 7:45 a.m. to 4:15 p.m., SUMMARY: This document contains
for Snoring and/or Obstructive Sleep e.t., Monday through Friday, except amendments to regulations relating to
Apnea; Guidance for Industry and Federal holidays. the requirement to substantiate business
FDA.’’ expenses for traveling expenses while
SUPPLEMENTARY INFORMATION:
Dated: October 28, 2002. away from home. The regulations affect
Linda S. Kahan, Electronic Access taxpayers who deduct expenses for
incidental expenses while traveling
Deputy Director, Center for Devices and An electronic copy of this document
Radiological Health.
away from home. The text of the
may be downloaded using a computer, temporary regulations also serves as text
[FR Doc. 02–28549 Filed 11–8–02; 8:45 am] modem and suitable communications for the proposed regulations set forth in
BILLING CODE 4160–01–S software from the Government Printing the notice of proposed rulemaking on
Office’s Electronic Bulletin Board this subject in the Proposed Rules
Service at (202) 512–1661. Internet users section in this issue of the Federal
DEPARTMENT OF TRANSPORTATION may reach the Office of the Federal Register.
Register’s home page at: http://
Federal Highway Administration DATES: Effective Date: These regulations
www.archives.gov and the Government
Printing Office’s Web page at: http:// are effective November 12, 2002.
23 CFR Part 450 Applicability Date: For dates of
www.access.gpo.gov/nara.
applicability, see § 1.274–5T(m).
[FHWA Docket No. FHWA–2001–10836]
Background FOR FURTHER INFORMATION CONTACT: John
FHWA RIN 2125–AE92 Moriarty (202) 622–4930 (not a toll free
On October 7, 2002, at 67 FR 62370, call).
Metropolitan Transportation Planning the FHWA, jointly with the FTA, issued
SUPPLEMENTARY INFORMATION:
and Programming a final rule to provide the New York
City metropolitan area additional time Background and Explanation of
AGENCY: Federal Highway to review and update its transportation Provisions
Administration (FHWA), DOT. plan by waiving the regulatory
ACTION: Correction to final rule. Section 274(d) provides that a
requirement for a triennial plan update
taxpayer is not allowed a deduction or
for the New York City metropolitan area
SUMMARY: This document corrects a credit for certain expenses unless the
for up to three years, until September
typographical error in the FHWA final expense is substantiated. These
30, 2005. This action was necessary
rule, published jointly with the Federal substantiation requirements apply to
Transit Administration (FTA), on because the New York City Metropolitan deductions under section 162 or 212 for
October 7, 2002, at 67 FR 62370. The Transportation Council’s (NYMTC) any traveling expense (including meals
final rule amends the regulation on offices were destroyed by the terrorist and lodging) while away from home.
Planning and Assistance Standards that attacks that occurred on September 11, Under section 274(d), the Secretary may
govern the development of 2001, and without this waiver, Federal issue regulations that provide that some
transportation plans and programs for highway and transit funding could be or all of the substantiation requirements
urbanized (metropolitan) areas. The disrupted after September 30, 2002. The will not apply to expenses that do not
FTA has codified the FHWA regulations purpose of this notice is to correct the exceed a prescribed amount. Section
for Metropolitan Transportation docket number to the final rule. The 1.274–5(j)(1) of the regulations permits
Planning and Programming into its correct docket number for the final rule the Commissioner to establish a method
regulations at 49 CFR 613 and joins the is FHWA–2001–10836. under which a taxpayer may
FHWA in making this change. The final Authority: 23 U.S.C. 134, 135, 217(g), 315; substantiate the amount of meal
rule provides the New York City 42 U.S.C. 7410 et seq.; 49 U.S.C. 5303–5306; expenses paid or incurred while
metropolitan area additional time to 49 CFR 1.48(b) and 1.51. traveling away from home by means of

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