[Federal Register Volume 75, Number 1 (Monday, January 4, 2010)]
[Rules and Regulations]
[Page 42]
[FR Doc No: E9-30801]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0602; Airspace Docket No. 09-AEA-13]

Establishment of Class E Airspace; Spencer, WV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule; confirmation of effective date.

-----------------------------------------------------------------------

SUMMARY: This action confirms the effective date of a direct final rule
published in the Federal Register that establishes Class E Airspace at
Spencer, WV. This action enhances the safety and airspace management of
Boggs Field Airport, Spencer, WV.

DATES: Effective 0901 UTC, December 17, 2009. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Confirmation of Effective Date

    The FAA published a direct final rule with request for comments
establishing Class E Airspace at Boggs Field Airport, Spencer, WV, in
the Federal Register on October 19, 2009 (74 FR 53407), Docket No. FAA-
2009-0602; Airspace Docket No. 09-AEA-13. The FAA uses the direct final
rulemaking procedure for a non-controversial rule where the FAA
believes that there will be no adverse public comment. This direct
final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
December 17, 2009. No adverse comments were received, and thus this
notice confirms that effective date.
* * * * *

    Issued in College Park, Georgia, on December 15, 2009.
Barry A. Knight,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. E9-30801 Filed 12-31-09; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38264-38265]
[FR Doc No: 2011-16269]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Applications for Certificates of Public Convenience and Necessity
and Foreign Air Carrier Permits Filed Under Subpart B (Formerly Subpart
Q) During the Week Ending June 4, 2011

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2000-6796.
    Date Filed: June 2, 2011.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: June 23, 2011.
    Description: Application of Aerolineas Santo Domingo, S.A.
(``ASD'') requesting renewal of its exemption and for a foreign air
carrier permit, to conduct scheduled foreign air transportation of
persons, property and mail between the Dominican Republic and United
States. ASD also requests amendment of the exemption.

    Docket Number: DOT-OST-2011-0106.
    Date Filed: June 3, 2011.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: June 24, 2011.
    Description: Application of Strategic Airlines Pty Ltd (``Strategic
Airlines'') requesting the Department issue a foreign air carrier
permit to enable Strategic Airlines, consistent with the open skies,
U.S.-Australia Air Transport Agreement, to operate: (1) Scheduled
foreign air transportation of persons, property, and mail from points
behind Australia, via Australia and intermediate points, to a point or
points in the United States, and beyond; (2) scheduled all-cargo
services between any point or points in the United States and any point
or points in any third country or countries; (3) charter foreign air
transportation of persons, property, and mail between any point or
points in Australia and any point or points in the United States, and
between any point or points in the United States and any point or
points in third countries provided that, except with respect to cargo
charters, such services constitute part of a continuous operation that
includes service at a point or points in Australia for the purpose of
carrying local traffic between Australia and the United States; and (4)
other charters. Strategic Airlines also requests: (1) Exemption
authority, to the extent necessary and for an initial period of two
years or until the requested permit is issued, to enable it to hold out
and

provide the service described above; and (2) such additional or other
relief as the Department may deem necessary or appropriate.

Renee V. Wright,
Program Manager, Docket Operations Federal Register Liaison .
[FR Doc. 2011-16269 Filed 6-28-11; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72186-72188]
[FR Doc No: 2014-28541]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1795]

Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug
Applications and 68 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 23 new drug applications (NDAs) and 68 abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.

DATES: Effective Date: January 5, 2015.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications pursuant to the process in Sec.  314.150(c) (21 CFR
314.150(c)). The applicants have also, by their requests, waived their
opportunity for a hearing. Withdrawal of approval of an application or
abbreviated application under Sec.  314.150(c) is without prejudice to
refiling.

                                 Table 1
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 002852.............  Plexofer                 Mallinckrodt Inc., 675
                          (multivitamins) Syrup.   McDonnell Blvd.,
                                                   Hazelwood, MO 63042.
NDA 008719.............  Levo-Dromoran            Valeant
                          (levorphanol tartrate)   Pharmaceuticals North
                          Injection, 2             America LLC, 400
                          milligrams (mg)/         Somerset Corporate
                          milliliter (mL).         Blvd., Bridgewater,
                                                   NJ 08807.
NDA 008720.............  Levo-Dromoran            Do.
                          (levorphanol tartrate)
                          Tablets, 2 mg.
NDA 011777.............  Sodium Phosphate P 32    Mallinckrodt Inc.
                          Solution.
NDA 012366.............  Soma Compound with       Meda Pharmaceuticals
                          Codeine (carisoprodol,   Inc., 265 Davidson
                          aspirin, and codeine     Ave., Suite 300,
                          phosphate).              Somerset, NJ 08873-
                                                   4120.
NDA 012708.............  Diutensen-R              Do.
                          (methyclothiazide and
                          reserpine) Tablets,
                          2.5 mg/0.1 mg.
NDA 016245.............  Vercyte (pipobroman)     AbbVie, Inc., 1 North
                          Tablets.                 Waukegan Rd., Dept.
                                                   PA 77/Bldg. AP30,
                                                   North Chicago, IL
                                                   60064.
NDA 017463.............  Motrin (ibuprofen)       McNeil Consumer
                          Tablets, 300 mg, 400     Healthcare Division
                          mg, 600 mg, and 800 mg.  of McNeil-PPC, Inc.,
                                                   7050 Camp Hill Rd.,
                                                   Fort Washington, PA
                                                   19034-2299.
NDA 018310.............  Lymphazurin (isosulfan   Covidien, 60
                          blue), 1%.               Middletown Ave.,
                                                   North Haven, CT
                                                   06473.
NDA 018340.............  Aerobid (flunisolide)    Roche Palo Alto LLC, c/
                          Inhalation Aerosol \1\.  o Genentech Inc., 1
                                                   DNA Way, South San
                                                   Francisco, CA 94080-
                                                   4990.
NDA 018731.............  Buspar (buspirone        Bristol-Myers Squibb
                          hydrochloride (HCl))     Co., P.O. Box 4000,
                          Tablets, 5 mg, 10 mg,    Princeton, NJ 08543-
                          15 mg, and 30 mg.        4000.
NDA 019453.............  Drixoral                 Merck Consumer Care,
                          (dexbrompheniramine      556 Morris Ave.,
                          maleate,                 Summit, NJ 07901.
                          pseudoephedrine
                          sulfate, and
                          acetaminophen)
                          Extended-Release
                          Tablets, 3 mg, 60 mg,
                          and 500 mg.

NDA 019842.............  Motrin (ibuprofen)       McNeil Consumer
                          Suspension, 100 mg/5     Healthcare Division
                          mL.                      of McNeil-PPC, Inc.
NDA 020150.............  Nicotrol TD (nicotine    Do.
                          transdermal system), 5
                          mg/16 hour (hr), 10 mg/
                          16 hr, and 15 mg/16 hr.
NDA 020707.............  Skelid (tiludronate      Sanofi-Aventis U.S.
                          disodium) Tablets.       LLC, 55 Corporate
                                                   Dr., Mailstop 55C-
                                                   205A, Bridgewater, NJ
                                                   08807.
NDA 021043.............  RID Mousse (pyrethrins   Bayer Healthcare LLC,
                          0.33% and piperonyl      100 Bayer Blvd.,
                          butoxide 4.0%) Topical   Whippany, NJ 07981-
                          Aerosol.                 0915.
NDA 021082.............  Tavist Allergy Sinus     Novartis Consumer
                          Headache (clemastine     Health, Inc., 200
                          fumarate,                Kimball Dr.,
                          pseudoephedrine HCl,     Parsippany, NJ 07054.
                          and acetaminophen)
                          Tablets, 0.335 mg, 30
                          mg, and 500 mg.
NDA 021190.............  Buspar (buspirone HCl)   Bristol-Myers Squibb
                          Capsules, 5 mg, 7.5      Co.
                          mg, 10 mg, and 15 mg.
NDA 021335.............  Gleevac (imatinib        Novartis
                          mesylate) Capsules, 50   Pharmaceuticals
                          mg and 100 mg.           Corp., One Health
                                                   Plaza, East Hanover,
                                                   NJ 07936.
NDA 021745.............  Ryzolt (tramadol HCl)    Purdue Pharma Products
                          Extended-Release         L.P., One Stamford
                          Tablets, 100 mg, 200     Forum, Stamford, CT
                          mg, and 300 mg.          06901-3431.
NDA 022217.............  Valturna (aliskiren and  Novartis
                          valsartan) Tablets.      Pharmaceuticals Corp.
NDA 022470.............  Nexcede (ketoprofen)     Novartis Consumer
                          Oral Soluble Films,      Health, Inc.
                          12.5 mg.
ANDA 040034............  Theophylline Extended-   Inwood Laboratories,
                          Release Tablets, 450     Inc., Subsidiary of
                          mg.                      Forest Laboratories,
                                                   Inc., Harborside
                                                   Financial Center,
                                                   Plaza Five, Suite
                                                   1900, Jersey City, NJ
                                                   07311.
ANDA 040052............  Theophylline Extended-   Do.
                          Release Capsules, 100
                          mg, 125 mg, 200 mg,
                          and 300 mg.
ANDA 040365............  Dextroamphetamine        Nesher Pharmaceutical
                          Sulfate Tablets, 5 mg.   (USA) LLC, 13910
                                                   Saint Charles Rock
                                                   Rd., Bridgeton, MO
                                                   63044.
ANDA 040367............  Dextroamphetamine        Do.
                          Sulfate Tablets, 10 mg.
ANDA 060578............  Mycostatin Topical       Delcor Asset Corp., c/
                          Powder (nystatin         o Prestium Pharma
                          topical powder USP)      Inc., 411 South State
                          100,000 units/gram (g).  St., Suite E-100,
                                                   Newtown, PA 18940.
ANDA 062162............  Erythromycin Estolate    Barr Laboratories,
                          Capsules USP, 125 mg     Inc., Subsidiary of
                          and 250 mg.              Teva Pharmaceuticals
                                                   USA, 400 Chestnut
                                                   Ridge Rd., Woodcliff
                                                   Lake, NJ 07677.
ANDA 062256............  Erythromycin             Do.
                          Ethylsuccinate Tablets
                          USP, 400 mg.
ANDA 062773............  Cephalexin Capsules USP  Do.
                          250 mg.
ANDA 062850............  Cephradine Capsules USP  Do.
                          250 mg.
ANDA 062851............  Cephradine Capsules USP  Do.
                          500 mg.
ANDA 062858............  Cephradine for Oral      Do.
                          Suspension USP 125 mg/
                          5 mL.
ANDA 062859............  Cephradine for Oral      Do.
                          Suspension USP, 250 mg/
                          5 mL.
ANDA 063016............  Cefazolin for Injection  Teva Pharmaceuticals
                          USP 250 mg/vial, 500     USA, 425 Privet Rd.,
                          mg/vial, and 1 g/vial.   Horsham, PA 19044.
ANDA 063028............  Erythromycin Delayed-    Barr Laboratories,
                          Release Tablets USP,     Inc., Subsidiary of
                          333 mg.                  Teva Pharmaceuticals
                                                   USA.
ANDA 063086............  Erythromycin Delayed-    Do.
                          Release Tablets, 333
                          mg.
ANDA 063098............  Erythromycin Delayed-    Do.
                          Release Capsules USP,
                          250 mg.
ANDA 063179............  Erythromycin Stearate    ANI Pharmaceuticals,
                          Tablets USP 500 mg.      Inc., 210 Main St.
                                                   West, Baudette, MN
                                                   56623.
ANDA 064191............  Cefuroxime for           Teva Pharmaceuticals
                          Injection USP 7.5 g/     USA.
                          vial.
ANDA 064192............  Cefuroxime for           Do.
                          Injection USP 750 mg/
                          vial and 1.5 g/vial.
ANDA 065032............  Doxycycline Capsules     Sandoz Inc., 4700
                          USP 50 mg and 100 mg.    Sandoz Dr., Wilson,
                                                   NC 27893.
ANDA 065227............  Ceftriaxone for          Teva Pharmaceuticals
                          Injection USP, 250 mg/   USA.
                          vial, 500 mg/vial, 1 g/
                          vial, and 2 g/vial.
ANDA 065262............  Ceftriaxone for          Do.
                          Injection USP, 1 g/
                          vial and 2 g/vial.
ANDA 065274............  Ceftriaxone for          Do.
                          Injection USP, 10 g/
                          vial.
ANDA 070034............  Sulfamethoxazole and     Teva Pharmaceuticals
                          Trimethoprim Tablets     USA.
                          USP 400 mg/80 mg.
ANDA 070216............  Sulfamethoxazole and     Barr Laboratories
                          Trimethoprim Tablets     Inc., Subsidiary of
                          USP 800 mg/160 mg.       Teva Pharmaceuticals.
ANDA 072410............  Indomethacin Extended-   Inwood Laboratories,
                          Release Capsules, 75     Inc., Subsidiary of
                          mg.                      Forest Laboratories,
                                                   Inc.
ANDA 072499............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 60 mg.
ANDA 072500............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 80 mg.
ANDA 072501............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 120 mg.
ANDA 072502............  Propranolol HCl          Do.
                          Extended-Release
                          Capsules, 160 mg.
ANDA 072619............  Albuterol Sulfate        Teva Pharmaceuticals
                          Tablets USP 2 mg.        USA.
ANDA 072620............  Albuterol Sulfate        Do.
                          Tablets USP 4 mg.
ANDA 073095............  Clemastine Fumerate      Do.
                          Syrup, 0.5 mg/5 mL.
ANDA 073531............  Potassium Chloride       Do.
                          Extended-Release
                          Capsules USP, 8
                          milliequivalents (mEq).
ANDA 073532............  Potassium Chloride       Do.
                          Extended-Release
                          Capsules USP, 10 mEq.
ANDA 073667............  Nortriptyline HCl        Do.
                          Capsules, 10 mg, 25
                          mg, 50 mg, and 75 mg.
ANDA 074043............  Piroxicam Capsules USP,  Mylan Pharmaceuticals,
                          10 mg and 20 mg.         Inc., 781 Chestnut
                                                   Ridge Rd., P.O. Box
                                                   4310, Morgantown, WV
                                                   26505.

ANDA 074126............  Atenolol Tablets USP,    Do.
                          25 mg, 50 mg, and 100
                          mg.
ANDA 074589............  Minoxidil Topical        Teva Pharmaceuticals
                          Solution, 2%.            USA.
ANDA 074828............  Acyclovir Capsules, 200  Do.
                          mg.
ANDA 074849............  Clomipramine HCl         Do.
                          Capsules, 25 mg, 50
                          mg, and 75 mg.
ANDA 074879............  Ketoprofen Extended-     Alkermes Gainesville
                          Release Capsules, 200    LLC, 1300 Gould Dr.,
                          mg.                      Gainesville, GA
                                                   30504.
ANDA 074976............  Acyclovir Tablets USP,   Mylan Pharmaceuticals,
                          400 mg and 800 mg.       Inc.
ANDA 074977............  Acyclovir Capsules USP,  Do.
                          200 mg.
ANDA 075161............  Ticlopidine HCl Tablets  Do.
                          USP, 250 mg.
ANDA 075472............  Enalapril Maleate        Do.
                          Tablets USP, 2.5 mg, 5
                          mg, 10 mg, and 20 mg.
ANDA 075934............  Nizatidine Capsules      Do.
                          USP, 150 mg and 300 mg.
ANDA 076036............  Quinapril Tablets USP,   Do.
                          5 mg, 10 mg, 20 mg,
                          and 40 mg.
ANDA 076969............  Metoprolol Succinate     Sandoz, Inc.
                          Extended-Release
                          Tablets USP, 25 mg, 50
                          mg, 100 mg, and 200 mg.
ANDA 077136............  Terbinafine HCl          Mylan Pharmaceuticals,
                          Tablets, 250 mg.         Inc.
ANDA 077163............  Sumatriptan Succinate    Do.
                          Tablets, 25 mg, 50 mg,
                          and 100 mg.
ANDA 077254............  Divalproex Sodium        Do.
                          Delayed-Release
                          Tablets USP, 125 mg,
                          250 mg, and 500 mg.
ANDA 077486............  Glimepiride Tablets      Do.
                          USP, 1 mg, 2 mg, and 4
                          mg.
ANDA 077705............  Fosinopril Sodium and    Do.
                          Hydrochlorothiazide
                          Tablets, 10 mg/12.5 mg
                          and 20 mg/12.5 mg.
ANDA 077934............  Meloxicam Tablets USP,   Do.
                          7.5 mg and 15 mg.
ANDA 077976............  Cromolyn Sodium Nasal    HH & P LLC, c/o Kuker
                          Solution USP, 5.2 mg/1   Regulatory
                          spray.                   Consulting, LLC, 18
                                                   Dunbar Way,
                                                   Mahtomedi, MN 55115.
ANDA 078638............  Alendronate Sodium       Mylan Pharmaceuticals,
                          Tablets USP, 35 mg and   Inc.
                          70 mg.
ANDA 078731............  Levetiracetam Tablets,   Do.
                          250 mg, 500 mg, 750
                          mg, and 1,000 mg.
ANDA 079184............  Ursodiol Tablets USP,    Teva Pharmaceuticals
                          250 mg and 500 mg.       USA.
ANDA 081295............  Estradiol Tablets USP,   Bristol-Myers Squibb
                          0.5 mg.                  Co.
ANDA 084499............  Estradiol Tablets USP,   Do.
                          1 mg.
ANDA 084500............  Estradiol Tablets USP,   Do.
                          2 mg.
ANDA 085794............  Acetaminophen and        Mutual Pharmaceutical
                          Codeine Phosphate        Co., Inc., 1100
                          Tablets USP, 300 mg/30   Orthodox St.,
                          mg.                      Philadelphia, PA
                                                   19124.
ANDA 085795............  Acetaminophen and        Do.
                          Codeine Phosphate
                          Tablets USP, 300 mg/15
                          mg.
ANDA 087176............  Chlorthalidone Tablets   Ivax Pharmaceuticals,
                          USP, 50 mg.              Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, 400 Chestnut
                                                   Ridge Rd., Woodcliff
                                                   Lake, NJ 07677.
ANDA 087653............  Acetaminophen and        Mutual Pharmaceutical
                          Codeine Phosphate        Co., Inc.
                          Tablets USP, 300 mg/60
                          mg.
ANDA 088833............  Triprolidine HCl,        Wockhardt Bio AG, c/o
                          pseudoephedrine HCl,     Morton Grove
                          and Codeine Phosphate    Pharmaceuticals,
                          Cough Syrup, 1.25 mg/5   Inc., 6451 Main St.,
                          mL, 30 mg/5 mL, and 10   Morton Grove, IL
                          mg/5 mL.                 60053.
ANDA 088896............  Promethazine VC with     Do.
                          Codeine (promethazine
                          HCl, phenylephrine
                          HCl, and codeine
                          phosphate) Cough
                          Syrup, 6.25 mg/5 mL, 5
                          mg/5 mL, and 10 mg/5
                          mL.
NDA 202343.............  Juvisync (sitagliptin    Merck Sharp & Dohme
                          and simvastatin)         Corp., 351 North
                          Tablets, 100 mg/10 mg,   Sumneytown Pike, P.O.
                          100 mg/20 mg, and 100    Box 1000, UG2CD-015,
                          mg/40 mg.                North Wales, PA
                                                   19454.
------------------------------------------------------------------------
\1\ This product included an oral pressurized metered-dose inhaler that
  contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
  longer be used as a propellant for any flunisolide metered-dose
  inhalers (see 75 FR 19213, April 14, 2010).

    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective January 5, 2015. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in Table 1 that
are in inventory on the date that this notice becomes effective (see
the DATES section) may continue to be dispensed until the inventories
have been depleted or the drug products have reached their expiration
dates or otherwise become violative, whichever occurs first.

    Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28541 Filed 12-4-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80810-80812]
[FR Doc No: 2023-25551]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[DOT-NHTSA-2023-0037]

Emergency Medical Services Education Agenda 2050: Request for
Information

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: NHTSA published a request for information on October 13, 2023,
seeking comments from all sources (public, private, government,
academic, professional, public interest groups, and other interested
parties) on the planned re-envisioning of the 2000 EMS Education Agenda
for the Future: A Systems Approach. Due to the limited comments
received and some informal feedback indicating that the initial comment
period was too short, NHTSA is announcing the reopening of the comment
period for the RFI in order to solicit additional comments and request
responses to specific questions provided in the document. The comment
period for the RFI was originally scheduled to end on October 31, 2023.
It will now be reopened and will end on March 31, 2024.

DATES: The comment period for the RFI published on October 13, 2023 at
88 FR 71081 is reopened and extended to March 31, 2024.

FOR FURTHER INFORMATION CONTACT: Clary Mole, EMS Specialist, National
Highway Traffic Safety Administration, U.S. Department of
Transportation is available by phone at<PHONE_NUMBER> or by email at
[email protected].

ADDRESSES: Comments must be submitted by one of the following methods:
     Federal eRulemaking Portal: go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m. Eastern
Time, Monday through Friday, except Federal holidays. To be sure
someone is there to help you, please call<PHONE_NUMBER> before coming.
    Regardless of how you submit your comments, you must include the
docket number identified in the heading of this document.
    Note that all comments received, including any personal information
provided, will be posted without change to http://www.regulations.gov.
Please see the ``Privacy Act'' heading below.
    You may call the Docket Management Facility at<PHONE_NUMBER>. For
access to the docket to read background documents or comments received,
go to http://www.regulations.gov or the street address listed above. We
will continue to file relevant information in the docket as it becomes
available. To be sure someone is there to help you, please call (202)
366-9322 before coming. We will continue to file relevant information
in the Docket as it becomes available.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to inform its decision-making process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at https://www.transportation.gov/privacy. Anyone is able to search the
electronic form of all comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION: On October 13, 2023, NHTSA published a RFI
to obtain public comments to inform EMS Education Agenda 2050, and
request responses to specific questions provided in this document. For
convenience purposes, NHTSA is republishing introductory information,
background materials and questions from its RFI in this notice.

I. Introductory Information

    In 2012, the National EMS Advisory Council (NEMSAC) convened a
national roundtable meeting on EMS Education Agenda for the Future: A
Systems Approach. In a 2014 report on these proceedings, NEMSAC advised
that stakeholders at the State and local level had just begun to
experience the full impact of the evolution toward a national
integrated system of education for EMS personnel. While stakeholders
were reticent to move forward with a new education agenda, they did
provide feedback about themes that should be considered in the future
publication. From the feedback collected at the meeting, NEMSAC
developed recommendations to be used in the eventual re-envision of the
agenda for EMS. These recommendations are summarized below:
     Educational content should retain the flexibility accorded
by the National EMS Education standards, but programs should use
nationally recognized evidence-based guidelines to drive local
curriculum development.
     The National EMS Information System data, evidence-based
research, and practice analyses should be sourced in developing
evidence-based guidelines and curriculum.
     Mobile Integrated Healthcare has received considerable
attention from the EMS Community. This and other alternative community-
based healthcare

delivery models (of the future) should evoke an expanded foundational
knowledge and critical thinking capabilities that will poise future EMS
practitioners to be able to evolve with the changing healthcare system
or rapidly adjust to emerging healthcare crises.
     EMS educators should begin a career in academia with
expertise in adult learning, educational theory, curriculum
development, and competency evaluation but also possess experiential
knowledge in evidence-based care.
    In the 10 years since NEMSAC's roundtable meeting, the national EMS
education system continued to evolve--especially during the COVID-19
pandemic. In late 2021, the Federal Interagency Committee on EMS
(FICEMS) began sponsoring listening sessions to inform a consensus-
driven, national report entitled, FICEMS: EMS and 911 COVID-19 Response
White Paper. This publication cited challenges and solutions collected
during stakeholder listening sessions for the EMS education system.
Among the challenges, EMS education stakeholders cited scarcity (in
some cases deficits) in resources for education, rigidity of curriculum
delivery modalities, the increased employer demands on students, and
inconsistent or delayed responses to the needs of the national EMS
education system as major contributors that led to the breakdown in the
EMS workforce pipeline.
    Prior to the COVID-19 pandemic, NHTSA published EMS Agenda 2050: A
People-centered Vision for the Future of EMS (Agenda 2050). This
collaborative project set a vision for a people-centered EMS systems
that serves every individual in every community across the Nation.
Later this year, NHTSA and its partners will begin a new project to
develop EMS Education Agenda 2050. This project will not replace but
build upon the achievements of the 2000 EMS Education Agenda for the
Future: A Systems Approach to lead a national conversation around the
future vision for EMS Education and EMS as a profession.

II. Background

    NHTSA, in partnership with Health Resources and Services
Administration, published EMS Education Agenda for the Future: A
Systems Approach (Education Agenda) in 2000. This document was founded
on the broad national EMS education system concepts introduced in the
EMS Agenda for the Future (1996). The Education Agenda described a
consensus vision of an EMS education system with a high degree of
structure, coordination, and interdependence. It proposed a less
prescriptive system that offered educators flexibility in creating a
student-centered learning environment and a process for accommodating
future advancements in technology and medicine. The proposed system
maximized efficiency, consistency in instructional quality, and entry
level graduate competency by prescribing a high degree of structure,
coordination, and interdependence. To achieve this vision, the
education system of the future centered on five integrated primary
components:

 National EMS Core Content
 National EMS Scope of Practice Model
 National EMS Education Standards
 National EMS Education Program Accreditation
 National EMS Certification
    After the Education Agenda was published, stakeholders began
implementing their respective integrated system components. Almost 25
years later, the national EMS education system has successfully evolved
into one that exemplifies both consistency and flexibility. System
interdependencies have helped to avoid duplication of effort in
curriculum and education program development, evaluating the minimum
competencies of graduates, certification and licensing processes, and
facilitation of practitioner reciprocity.
    In 2020, the EMS education system interdependencies modernized by
the Education Agenda were tested. Challenges presented by the COVID-19
pandemic forced a variety of adaptations. Traditional education
programs reported a lag in students' capabilities of achieving the
programmatic competencies requirements for graduation. The lag was
attributed to a variety of causes including a focus on pandemic
response activities over training and education, employer demands on
working students, and the rigidity of in-person, classroom-based
education delivery models. After the majority of programs adjusted to
the challenges, lags in graduation were cured, and students achieved
programmatic competencies at rates similar to those pre-pandemic. The
response to the pandemic did not impact education programs only. The
impact to EMS agency daily operations was felt as well. During the
COVID pandemic, agencies experienced increases in EMS activation and
response rates which created additional stressors for student EMS
practitioners already working in a high stress job environment but also
enrolled in an EMS education program. These stressors were a major
contributor to a migration of practitioners away from the EMS
workforce. Agencies and organizational stakeholders asserted that it
could be education program graduation requirements causing breakdown in
the workforce pipeline; however, there were no observed decreases in
graduation or certification testing rates. These observations prompt
two questions: If graduation and certification testing rates have
remained unchanged, why have agencies reported recruitment and
retention issues? If graduates are not entering the EMS workforce,
where are they finding jobs?
    With agencies experiencing increased demand and a deficiency in
qualified EMS practitioners to respond to it, service delivery models
had to evolve. To bridge the gap in community-based care resources,
community paramedicine and mobile integrated healthcare (CP-MIH)
service delivery models increased in prevalence, and improvised
training programs were used to close new job-specific competency gaps
among existing EMS practitioners and individuals in training. Other
themes brought to the forefront during the pandemic include addressing
healthcare disparities; the use of EMS data as a tool for surveillance
and nationwide quality of care improvements; and a greater value to
having an EMS workforce that is not only equitable, inclusive, and
accessible, but as diverse as the community it serves. These themes,
evolving service delivery models, and the subsequent evolution of
competencies needed by practitioners suggest that it is time for NHTSA
to gather our partners to begin a new conversation about the future of
EMS Education and EMS as a profession in the United States.

III. Questions Regarding EMS Education Agenda 2050

    Responses to the following questions are requested to help plan the
revision of the Education Agenda. Please be as specific as possible and
as appropriate please provide references.
    1. What are the most critical issues facing EMS education system
that should be addressed in the revision of the EMS Education Agenda?
Please provide specific examples.
    2. What progress has been made in implementing the EMS Education
Agenda since 2000?
    3. How have you used EMS Education Agenda? Please provide specific
examples.

    4. As an EMS Stakeholder, how might a revised EMS Education Agenda
be most useful to you?
    5. What significant changes have occurred in the EMS education
system at the national, Federal, State, and local levels since 2000?
    6. What significant changes will impact the EMS education system in
the next 25 years?
    7. How might the revised EMS Education Agenda contribute to
enhanced EMS for children?
    8. How might the revised EMS Education Agenda support and/or
promote data-driven and evidence-based improvements in EMS education
systems and EMS practitioner practice?
    9. How could the revised EMS Education Agenda enhance collaboration
among EMS systems, health care providers and facilities, public safety
answering points, public health, public safety, emergency management,
insurers, and others?
    10. How could the revised EMS Education Agenda be used to promote
community sustainability and resilience?
    11. How could the revised EMS Education Agenda contribute to
improved coordination for disaster response, recovery, preparedness,
and mitigation?
    12. How could the revised EMS Education Agenda enhance the exchange
of evidence-based practices between national, Federal (and military),
State, and local levels?
    13. How could the revised EMS Education Agenda support the seamless
and unimpeded transfer of military EMS personnel to roles as civilian
EMS providers?
    14. How could the revised EMS Education Agenda support interstate
credentialing of EMS personnel?
    15. How could the revised EMS Education Agenda support improved
patient outcomes in rural and frontier communities?
    16. How could the revised EMS Education Agenda lead to improved EMS
systems in tribal communities?
    17. How could the revised EMS Education Agenda promote a culture of
safety among EMS personnel, agencies, and organizations?
    18. Are there additional EMS attributes that should be included in
the revised EMS Education Agenda? If so, please provide an explanation
for why these additional EMS attributes should be included.
    19. Are there EMS attributes in the 2000 EMS Education Agenda that
should be eliminated from the revised edition? If so, please provide an
explanation for why these EMS attributes should be eliminated.
    20. What are your suggestions for the process that should be used
in revising the EMS Education Agenda?
    21. What specific agencies/organizations/entities are essential to
involve, in a revision of the EMS Education Agenda?
    22. Do you have any additional comments regarding the revision of
the EMS Education Agenda?

(Authority: 23 U.S.C. 403(b)(1)(A)(iv); 49 CFR 1.95; 501.8)
    Issued in Washington, DC.

Nanda Narayanan Srinivasan,
Associate Administrator, Research and Program Development.
[FR Doc. 2023-25551 Filed 11-17-23; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14139-14140]
[FR Doc No: 2015-06130]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Cardiovascular and Renal Drugs Advisory Committee; Amendment of
Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Cardiovascular and Renal
Drugs Advisory Committee. This meeting was

announced in the Federal Register of February 27, 2015 (80 FR 10700).
The amendment is being made to reflect a change in the Agenda portion
of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Kristina Toliver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). Please call the Information Line for up-to-date
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 27,
2015, FDA announced that a meeting of the Cardiovascular and Renal
Drugs Advisory Committee would be held on April 15, 2015. On page
10700, in the first column, the Agenda portion of the document is
changed to read as follows:
    The committee will discuss the new drug application (NDA) 204958,
cangrelor injection, submitted by The Medicines Company, for the
proposed indication of reduction of thrombotic cardiovascular events in
patients with coronary artery disease (CAD) undergoing percutaneous
coronary intervention (PCI)--(PCI refers to the opening of narrowed
blood vessels supplying the heart muscle by a balloon inserted through
an artery puncture with or without a stent) who have not received an
oral P2Y12 inhibitor prior to the PCI procedure and in whom oral
therapy with P2Y12 inhibitors is not feasible or desirable (P2Y12 is a
protein involved in blood clotting. Inhibiting this protein is a key
mechanism of action of cangrelor).
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06130 Filed 3-17-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 15, 2009 (Volume 74, Number 198)]
[Rules and Regulations]
[Page 52887-52888]
[DOCID:fr15oc09-8]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0348]
RIN 1625-AA09

Drawbridge Operation Regulation; East River, New York City, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard has temporarily changed the drawbridge
operating regulations governing the operation of the Roosevelt Island
Bridge, mile 6.4, across the East River at New York City, New York.
This temporary final rule allows the Roosevelt Island Bridge to remain
in the closed position for eleven months to facilitate a major
rehabilitation of the bridge.

DATES: This rule is effective October 15, 2009 through August 31, 2010.

ADDRESSES: Comments and related materials received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2009-0348 and are available online by
going to http://www.regulations.gov, inserting USCG-2009-0348 in the
``Keyword'' box, and then clicking ``Search.'' This material is also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Mr. Joe Arca, Project Officer, First
Coast Guard District Bridge Branch,<PHONE_NUMBER><EMAIL_ADDRESS>
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On August 13, 2009, we published a notice of proposed rulemaking
(NPRM) entitled Drawbridge Operation Regulation; East River, New York
City, NY, in the Federal Register (74 FR 40802). We received no
comments on the proposed rule. No public meeting was requested, and
none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective in less than 30 days after
publication in the Federal Register. A delay or cancellation of this
ongoing bridge rehabilitation project is not in the public interest and
would further disrupt the flow of vehicular and maritime traffic. The
rehabilitation project is necessary to ensure the continued safe and
reliable operation of the bridge.

Background and Purpose

    The Roosevelt Island Bridge has a vertical clearance of 40 feet at
mean high water, and 47 feet at mean low water in the closed position.
The existing drawbridge operating regulations listed at 33 CFR 117.781,
require the bridge to open on signal if at least a two hour advance
notice is given.
    The bridge owner, New York City Department of Transportation, has
requested a temporary rule to facilitate electrical and mechanical
rehabilitation at the Roosevelt Island Bridge.
    Under this temporary final rule the Roosevelt Island Bridge will
remain in the closed position from October 1, 2009 through August 31,
2010. Vessel traffic may transit the East River utilizing the alternate
route around the other side of the island.

Discussion of Comments and Changes

    The Coast Guard received no comment letters in response to the
notice of proposed rulemaking. As a result, no changes have been made
to this temporary final rule.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. This conclusion is based upon the fact
that vessel traffic will still be able to transit the East River using
the alternate route around the island.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This conclusion is based upon the fact that vessel traffic
will still be able to transit the East River using the alternate route
round the island.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. From, October 15, 2009 through August 31, 2010, Sec.  117.781 is
amended by suspending paragraph (c) and adding a temporary paragraph
(d) to read as follows:

Sec.  117.781  East River.

* * * * *
    (d) The draw of the Roosevelt Island Bridge at mile 6.4, at New
York City, need not open for the passage of vessel traffic from October
1, 2009 through August 31, 2010.

    Dated: September 28, 2009.
Joseph L. Nimmich,
Rear Admiral, U.S. Coast Guard Commander, First Coast Guard District.
[FR Doc. E9-24744 Filed 10-14-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: January 18, 2008 (Volume 73, Number 13)]
[Proposed Rules]
[Page 3419-3422]
[DOCID:fr18ja08-14]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0031; Directorate Identifier 2007-NM-313-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-8-31, DC-8-
32, DC-8-33, DC-8-41, DC-8-42, and DC-8-43 Airplanes; Model DC-8-50
Series Airplanes; Model DC-8F-54 and DC-8F-55 Airplanes; Model DC-8-60
Series Airplanes; Model DC-8-60F Series Airplanes; Model DC-8-70 Series
Airplanes; and Model DC-8-70F Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
McDonnell Douglas airplanes identified above. This proposed AD would
require revising the FAA-approved maintenance program to incorporate
new airworthiness limitations for fuel tank systems to satisfy Special
Federal Aviation Regulation No. 88 requirements. This proposed AD
results from a design review of the fuel tank systems. We are proposing
this AD to prevent the potential for ignition sources inside fuel tanks
caused by latent failures, alterations, repairs, or maintenance
actions, which, in combination with flammable fuel vapors, could result
in a fuel tank explosion and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by March 3, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Data and Service Management,
Dept. C1-L5A (D800-0024).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Samuel Lee, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0031;
Directorate Identifier 2007-NM-313-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address

unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, single failures in
combination with another latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    We have determined that the actions identified in this proposed AD
are necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in a fuel tank explosion and consequent loss of the airplane.

Relevant Service Information

    We have reviewed the following appendixes of the Boeing DC-8
Special Compliance Item Report, MDC-02K9030, Revision A, dated August
8, 2006 (hereafter referred to as ``Report MDC-02K9030''):
     Appendix B, Critical Design Configuration Control
Limitations (CDCCLs).
     Appendix C, Airworthiness Limitation Instructions (ALIs).
     Appendix D, Short-Term Extensions.
    Appendixes B and C of Report MDC-02K9030 describe new airworthiness
limitations (AWLs) for fuel tank systems. The new AWLs include:
     CDCCLs, which are limitation requirements to preserve a
critical ignition source prevention feature of the fuel tank system
design that is necessary to prevent the occurrence of an unsafe
condition. The purpose of a CDCCL is to provide instruction to retain
the critical ignition source prevention feature during configuration
change that may be caused by alterations, repairs, or maintenance
actions. A CDCCL is not a periodic inspection; and
     AWL inspections, which are inspections of certain features
for latent failures that could contribute to an ignition source.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the(se) same type
design(s). This proposed AD would require revising the FAA-approved
maintenance program by incorporating the information in Appendixes B,
C, and D of Report MDC-02K9030.

Difference Between the Proposed AD and Service Information

    Although Report MDC-02K9030 specifies to submit certain information
to the manufacturer, this proposed AD does not include that
requirement.

Explanation of Compliance Time

    In most ADs, we adopt a compliance time allowing a specified amount
of time after the AD's effective date. In this case, however, the FAA
has already issued regulations that require operators to revise their
maintenance/inspection programs to address fuel tank safety issues. The
compliance date for these regulations is December 16, 2008. To provide
for efficient and coordinated implementation of these regulations and
this proposed AD, we are using this same compliance date in this
proposed AD.

Rework Required When Implementing AWLs Into an Existing Fleet

    The maintenance program revision specified in paragraph (f) of this
proposed AD for the fuel tank systems, which involves incorporating the
information specified in Report MDC-02K9030, would affect how operators
maintain their airplanes. After doing the maintenance program revision,
operators would need to do any maintenance on the fuel tank system as
specified in the CDCCLs. Maintenance done before the maintenance
program revision specified in paragraph (f) would not need to be redone
in order to comply with paragraph (f). For example, the AWL that
requires fuel pumps to be repaired and overhauled per the FAA-approved
component maintenance manual (CMM) applies to fuel pumps repaired after
the maintenance programs are revised; spare or on-wing fuel pumps do
not need to be reworked.

Changes to Fuel Tank System AWLs

    Paragraph (f) of this proposed AD would require revising the FAA-
approved maintenance program by incorporating certain information
specified in Report MDC-02K9030. Paragraph (f) allows accomplishing the
revision in accordance with later revisions of Report MDC-02K9030 as an
acceptable method of compliance if they are approved by the Manager,
Los Angeles Aircraft Certification Office (ACO), FAA. In addition,
Appendix B of Report MDC-02K9030 specifies that any deviations from the
published AWL instructions, including AWL intervals, must be approved
by the Manager, Los Angeles ACO. Therefore, after the maintenance
program, any further revision to an AWL or AWL interval should be done
as an AWL change, not as an alternative method of compliance (AMOC).
For U.S.-registered airplanes, operators must make requests through an
appropriate FAA Principal Maintenance Inspector (PMI) or Principal
Avionics Inspector (PAI) for approval by the Manager, Los Angeles ACO.
A non-U.S. operator should coordinate changes with its governing
regulatory agency.

Exceptional Short-Term Extensions

    Appendix D of Report MDC-02K9030 has provisions for an exceptional
short-term extension of 30 days. An exceptional short-term extension is
an increase in an AWL interval that may be needed to cover an
uncontrollable or unexpected situation. For U.S.-registered airplanes,
the FAA PMI or PAI must concur with any exceptional short-term
extension before it is used, unless the operator has identified another
appropriate procedure with the local regulatory authority. The FAA PMI
or PAI may grant the exceptional short-term extensions described in
Appendix D without consultation with the Manager, Los Angeles ACO. A
non-U.S. operator should coordinate changes with its governing
regulatory agency. As explained in Appendix D, exceptional short-term
extensions must not be used for fleet AWL extensions. An exceptional
short-term extension should not be confused with an operator's short-
term escalation authorization approved in accordance with the
Operations Specifications or the operator's reliability program.

Ensuring Compliance With Fuel Tank System AWLs

    Boeing has revised the applicable maintenance manuals and task
cards to address AWLs and to include notes about CDCCLs. Operators that
do not use Boeing's revision service should revise their maintenance
manuals and task cards to highlight actions tied to CDCCLs to ensure
that maintenance personnel are complying with the CDCCLs.

Recording Compliance With Fuel Tank System AWLs

    The applicable operating rules of the Federal Aviation Regulations
(14 CFR parts 91, 121, 125, and 129) require operators to maintain
records with the identification of the current inspection

status of an airplane. The AWLs contained in Appendix C of Report MDC-
02K9030 are inspections for which the applicable sections of the
operating rules apply. The AWLs contained in Appendix B of Report MDC-
02K9030 are CDCCLs, which are tied to conditional maintenance actions.
An entry into an operator's existing maintenance record system for
corrective action is sufficient for recording compliance with CDCCLs,
as long as the applicable maintenance manual and task cards identify
actions that are CDCCLs.

Changes to Component Maintenance Manuals (CMMs) Cited in Fuel Tank
System AWLs

    Some of the AWLs in Appendix B of Report MDC-02K9030 refer to
specific revision levels of the CMMs as additional sources of service
information for doing the AWLs. Boeing is referring to the CMMs by
revision level in the applicable AWL for certain components rather than
including information directly in the AWL because of the volume of that
information. As a result, the Manager, Los Angeles ACO, must approve
the CMMs. Any later revision of those CMMs will be handled like a
change to the AWL itself. Any use of parts (including the use of parts
manufacturer approval (PMA) approved parts), methods, techniques, and
practices not contained in the CMMs need to be approved by the Manager,
Los Angeles ACO, or governing regulatory authority. For example,
certain pump repair/overhaul manuals must be approved by the Manager,
Los Angeles ACO.

Changes to Airplane Maintenance Manual Referenced in Fuel Tank System
AWLs

    In other AWLs in Report MDC-02K9030, the AWLs contain all the
necessary data. The applicable section of the maintenance manual is
usually included in the AWLs. Boeing intended this information to
assist operators in maintaining the maintenance manuals. A maintenance
manual change to these tasks may be made without approval by the
Manager, Los Angeles ACO, through an appropriate FAA PMI or PAI, by the
governing regulatory authority, or by using the operator's standard
process for revising maintenance manuals. An acceptable change would
have to maintain the information specified in the AWL such as the pass/
fail criteria or special test equipment.

Costs of Compliance

    We estimate that this proposed AD would affect 125 airplanes of
U.S. registry. We also estimate that it would take about 1 work-hour
per product to comply with this proposed AD. The average labor rate is
$80 per work-hour. Based on these figures, we estimate the cost of this
proposed AD to the U.S. operators to be $10,000, or $80 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979), and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

McDonnell Douglas: Docket No. FAA-2008-0031; Directorate Identifier
2007-NM-313-AD.

Comments Due Date

    (a) We must receive comments by March 3, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all McDonnell Douglas Model DC-8-31, DC-
8-32, DC-8-33, DC-8-41, DC-8-42, and DC-8-43 airplanes; Model DC-8-
51, DC-8-52, DC-8-53, and DC-8-55 airplanes; Model DC-8F-54 and DC-
8F-55 airplanes; Model DC-8-61, DC-8-62, and DC-8-63 airplanes;
Model DC-8-61F, DC-8-62F, and DC-8-63F airplanes; Model DC-8-71, DC-
8-72, and DC-8-73 airplanes; and Model DC-8-71F, DC-8-72F, and DC-8-
73F airplanes; certificated in any category.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections and maintenance
actions. Compliance with these limitations is required by 14 CFR
43.16 and 91.403(c). For airplanes that have been previously
modified, altered, or repaired in the areas addressed by these
limitations, the operator may not be able to accomplish the actions
described in the revisions. In this situation, to comply with 14 CFR
43.16 and 91.403(c), the operator must request approval for revision
to the airworthiness limitations (AWLs) in the Boeing DC-8 Special
Compliance Item Report, MDC-02K9030, according to paragraph (f) or
(h) of this AD, as applicable.

Unsafe Condition

    (d) This AD results from a design review of the fuel tank
systems. We are issuing this AD to prevent the potential for
ignition sources inside fuel tanks caused by latent failures,
alterations, repairs, or maintenance actions, which, in combination
with flammable fuel vapors, could result in a fuel tank explosion
and consequent loss of the airplane.

Compliance

    (e) Comply with this AD within the compliance times specified,
unless already done.

Revise the FAA-Approved Maintenance Program

    (f) Before December 16, 2008, revise the FAA-approved
maintenance program to

incorporate the information specified in Appendixes B, C, and D of
the Boeing DC-8 Special Compliance Item Report, MDC-02K9030,
Revision A, dated August 8, 2006. Accomplishing the revision in
accordance with a later revision of the Boeing DC-8 Special
Compliance Item Report, MDC-02K9030, is an acceptable method of
compliance if the revision is approved by the Manager, Los Angeles
Aircraft Certification Office (ACO), FAA.

No Reporting Requirement

    (g) Although the Boeing DC-8 Special Compliance Item Report,
MDC-02K9030, Revision A, dated August 8, 2006, specifies to submit
certain information to the manufacturer, this AD does not require
that action.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Los Angeles ACO, FAA, ATTN: Samuel Lee,
Aerospace Engineer, Propulsion Branch, ANM-140L, 3960 Paramount
Boulevard, Lakewood, California 90712-4137; telephone (562) 627-
5262; fax<PHONE_NUMBER>; has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

    Issued in Renton, Washington, on January 9, 2008.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
 [FR Doc. E8-854 Filed 1-17-08; 8:45 am]

BILLING CODE 4910-13-P