[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61426-61430]
[FR Doc No: 2015-25922]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3432]

Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug
Applications and 128 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 67 new drug applications (NDAs) and 128 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be withdrawn.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: November 12, 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 under 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 001104................  Doca                   Organon USA Inc.,
                             (desoxycorticosteron   Subsidiary of Merck
                             e acetate)             Sharp & Dohme Corp.,
                             Injection, 5           2000 Galloping Hill
                             milligrams (mg)/       Rd., Kenilworth, NJ
                             milliliter (mL).       07033.
NDA 004589................  Alcohol in Dextrose    B. Braun Medical
                             Injection USP, 10 mL/  Inc., 901 Marcon
                             100 mL and 5 grams     Blvd., Allentown, PA
                             (g)/100 mL.            18109.
NDA 006170................  Hyprotigen (modified   Do.
                             protein hydrolysate)
                             Injection, 5%.
NDA 012154................  Ureaphil (urea) for    Hospira, Inc., 275
                             Injection, 40 g/vial.  North Field Dr.,
                                                    Lake Forest, IL
                                                    60045.
NDA 012449................  Oratrol                Alcon Laboratories
                             (dichlorphenamide)     Inc., 6201 South
                             Tablets, 50 mg.        Freeway, P.O. Box
                                                    1959, Fort Worth, TX
                                                    76134.
NDA 012699................  Lomotil (atropine      G.D. Searle, LLC, 235
                             sulfate and            East 42nd St., New
                             diphenoxylate          York, NY 10017.
                             hydrochloride (HCl))
                             Solution 0.025 mg/5
                             mL and 2.5 mg/5 mL.
NDA 012892................  Uracil Mustard         Shire Development
                             Capsule.               Inc., 725
                                                    Chesterbrook Blvd.,
                                                    Wayne, PA 19087-
                                                    5637.
NDA 014738................  Mannitol Injection     B. Braun Medical Inc.
                             USP, 20%.
NDA 016080................  Mannitol Injection     Do.
                             USP.
NDA 016096................  Mintezol               Merck Sharp & Dohme
                             (thiabendazole)        Corp., 1 Merck
                             Tablets.               Drive, P.O. Box 100,
                                                    Whitehouse Station,
                                                    NJ 08889.
NDA 016097................  Mintezol               Do.
                             (thiabendazole) Oral
                             Suspension.
NDA 016695................  Dextrose Injection,    Baxter Healthcare
                             5% (in Ringer's).      Corp. 32650 N.
                                                    Wilson Rd., Round
                                                    Lake, IL 60073.
NDA 017390................  Plasma-Lyte M and      Do.
                             Dextrose 5%
                             Injection.
NDA 017438................  Plasma-Lyte R          Do.
                             Injection.
NDA 017451................  Plasma Lyte 148 and    Do.
                             Dextrose 5%
                             Injection.
NDA 017493................  Travasol (amino        Do.
                             acids) Injection,
                             10%.
NDA 017510................  Dextrose 5% Injection  B. Braun Medical Inc.
                             (in lactated
                             Ringer's).
NDA 017636................  Sorbitol-Mannitol      Hospira, Inc.
                             Irrigation, 2.7 g/
                             100 mL-540 mg/100 mL.
NDA 017698................  Serile Urea Injection  Do.
NDA 017911................  Clinoril (sulindac)    Merck Sharp & Dohme
                             Tablets, 150 mg and    Corp.
                             200 mg.
NDA 017957................  Novamine (amino        Hospira, Inc.
                             acids) Injection.
NDA 017995................  Dextrose Injection     B. Braun Medical Inc.
                             USP, 60%.
NDA 018191................  Drixoral Non-Drowsy    MSD Consumer Care,
                             (pseudoephedrine       Inc., 556 Morris
                             sulfate) Extended-     Ave., Summit, NJ
                             Release Tablets, 120   07901.
                             mg.
NDA 018242................  Sulfamethoxazole and   Teva Pharmaceuticals
                             Trimethorim Tablets    USA, 425 Privet Rd.,
                             USP.                   Horsham, PA 19044.
NDA 018258................  Dextrose Injection 5%  B. Braun Medical Inc.
                             (in acetated
                             Ringer's).
NDA 018268................  Dextrose, Sodium       Do.
                             Chloride, and
                             Potassium Chloride
                             Injection USP, 5%.
NDA 018307................  Thyro-Block            Meda Pharmaceuticals
                             (potassium iodide      Inc., 265 Davidson
                             tablets USP).          Ave., Suite 400,
                                                    Somerset, NJ 08873.
NDA 018308................  Thyro-Block            Do.
                             (potassium iodide
                             solution), 21 mg.
NDA 018312................  Calderol               Organon USA Inc.,
                             (calcifediol)          Subsidiary of Merck
                             Capsules.              & Co., Inc.
NDA 018376................  Dextrose and Sodium    B. Braun Medical Inc.
                             Chloride Injection,
                             2.5%/0.9%.
NDA 018531................  Nitroglycerin          Hospira, Inc.
                             Injection USP, 5 mg/
                             mL.
NDA 018533................  Nizoral                Janssen
                             (ketoconazole)         Pharmaceuticals,
                             Tablets, 200 mg.       Inc., c/o Janssen
                                                    Research &
                                                    Development, LLC,
                                                    920 Route 202 South,
                                                    P.O. Box 300,
                                                    Raritan, NJ 08869-
                                                    0602.
NDA 018684................  Branchamin (amino      Baxter Healthcare
                             acids) Injection, 4%.  Corp.
NDA 018722................  Sodium Chloride 0.9%,  B. Braun Medical Inc.
                             and Potassium
                             Chloride Injection.
NDA 018725................  Acetated Ringer's      Do.
                             Injection.

NDA 018744................  Dextrose and           Do.
                             Potassium Chloride
                             Injection.
NDA 018818................  Metronidazole Tablets  Mutual Pharmaceutical
                             USP, 250 mg and 500    Co., Inc., 1100
                             mg.                    Orthodox St.,
                                                    Philadelphia, PA
                                                    19124.
NDA 018840................  Dextrose 5%, and       Baxter Healthcare
                             Electrolyte No. 75     Corp.
                             Injection.
NDA 019037................  Imodium (loperamide    Janssen
                             HCl) Oral Solution,    Pharmaceuticals,
                             1 mg/5 mL.             Inc., c/o Janssen
                                                    Research &
                                                    Development, LLC,
                                                    1125 Trenton-
                                                    Harbourton Rd., P.O.
                                                    Box 200, Titusville,
                                                    NJ 08560.
NDA 019047................  Plasma-Lyte 56         Baxter Healthcare
                             (electrolyte           Corp.
                             solution) Injection.
NDA 019439................  K-Dur (potassium       Merck Sharp & Dohme
                             chloride) Extended-    Corp.
                             Release Tablets, 10
                             milliequivalents
                             (mEq) and 20 mEq.
NDA 019645................  Toradol (ketorolac     Roche Palo Alto LLC,
                             tromethamine)          c/o Genetech, Inc.,
                             Tablets, 10 mg.        1 DNA Way, South San
                                                    Francisco, CA 94080-
                                                    4990.
NDA 019681................  Aminosyn II in         Hospira, Inc.
                             Dextrose Injection.
NDA 019682................  Aminosyn II with       Do.
                             Electrolytes and
                             Adjusted Phosphate
                             in Dextrose
                             Injection.
NDA 019683................  Aminosyn II with       Do.
                             Electrolytes in
                             Dextrose with
                             Calcium Injection.
NDA 019718................  Isolyte E (multi-      B. Braun Medical Inc.
                             electrolyte)
                             Injection.
NDA 019778................  Prinzide (lisinopril   Merck Sharp & Dohme
                             and                    Corp.
                             hydrochlorothiazide)
                             Tablets, 10 mg/12.5
                             mg, 20 mg/12.5 mg,
                             and 20 mg/25 mg.
NDA 019843................  Isolyte S (multi-      B. Braun Medical Inc.
                             electrolyte) in
                             Dextrose 5%
                             Injection.
NDA 019864................  Isolyte R (multi-      Do.
                             electrolyte) in
                             Dextrose 5%
                             Injection.
NDA 019867................  Isolyte E (multi-      Do.
                             electrolyte) in
                             Dextrose 5%
                             Injection.
NDA 020004................  Sodium Lactate         Do.
                             Injection USP, 1/6
                             molar.
NDA 020173................  Travasol (amino        Baxter Healthcare
                             acids) Injection       Corp.
                             With Electrolytes in
                             Dextrose.
NDA 020177................  Travasol (amino        Do.
                             acids) Injection
                             With Electrolytes.
NDA 020536................  Nicotrol (nicotine     McNeil Consumer
                             transdermal system),   Healthcare, 7050
                             15 mg.                 Camp Hill Rd., Fort
                                                    Washington, PA
                                                    19034.
NDA 020004................  Sodium Lactate         B. Braun Medical Inc.
                             Injection USP, 1/6
                             molar.
NDA 020173................  Travasol (amino        Baxter Healthcare
                             acids) Injection       Corp.
                             With Electrolytes in
                             Dextrose.
NDA 020177................  Travasol (amino        Do.
                             acids) Injection
                             With Electrolytes.
NDA 020811................  Acular PF (ketorolac   Allergan, Inc., 2525
                             tromethamine)          Dupont Dr., P.O. Box
                             Ophthalmic Solution,   19534, Irvine, CA
                             0.5%.                  92623-9534.
NDA 021260................  Avinza (morphine       King Pharmaceuticals
                             sulfate) Extended-     LLC, 235 East 42nd
                             Release Capsules.      St., New York, NY
                                                    10017.
NDA 021415................  Metvixia (methyl       Galderma
                             aminolevulinate HCl)   Laboratories, L.P.,
                             Cream, 16.8%.          14501 North Freeway,
                                                    Fort Worth, TX
                                                    76177.
NDA 021460................  Metaglip (glipizide    Bristol-Myers Squibb,
                             and metformin HCl)     P.O. Box 4000
                             Tablets, 2.5 mg/250    (Mailstop D12-02),
                             mg, 2.5 mg/500 mg,     Princeton, NJ 08543-
                             and 5 mg/500 mg.       4000.
NDA 021788................  Synthetic Conjugated   Teva Women's Health,
                             Estrogens, A Vaginal   Inc., 41 Moores Rd.,
                             Cream, 0.625 mg/gram   P.O. Box 4011,
                             (g).                   Frazer, PA 19355.
NDA 021961................  Simvastatin Orally     Synthon
                             Disintegrating         Pharmaceuticals,
                             Tablets, 10 mg, 20     Inc., 9000
                             mg, 40 mg, and 80 mg.  Development Dr.,
                                                    P.O. Box 110487,
                                                    Research Triangle
                                                    Park, NC 27709.
ANDA 040093...............  Digoxin Injection USP  Hospira, Inc.
                             Carpuject, 250
                             micrograms (mcg)/mL.
ANDA 040233...............  Methotrexate Tablets   Barr Laboratories,
                             USP, 2.5 mg.           Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 040285...............  Hydrocodone            Ivax Pharmaceuticals,
                             Bitartrate and         Inc., Subsidiary of
                             Homatropine            Teva Pharmaceuticals
                             Methylbromide Syrup,   USA, 400 Chestnut
                             5 mg/5 mL and 1.5 mg/  Ridge Rd., Woodcliff
                             5 mL.                  Lake, NJ 07677.
ANDA 040287...............  Prednisolone Syrup,    Do.
                             15 mg/5 mL.
ANDA 040435...............  Extended Phenytoin     ANI Pharmaceuticals,
                             Sodium Capsules USP,   Inc., 210 Main St.
                             100 mg.                West, Baudette, MN
                                                    56623.
ANDA 040443...............  Acetaminophen and      Watson Laboratories,
                             Codeine Phosphate      Inc.--Florida, 2945
                             Tablets USP, 300 mg/   West Corporate Lakes
                             15 mg, 300 mg/30 mg,   Blvd., Suite B,
                             and 300 mg/60 mg.      Weston, FL 33331.
NDA 050336................  Tao (troleandomycin)   Pfizer, Inc., 235
                             Capsule.               East 42nd St., New
                                                    York, NY 10017.
NDA 050520................  Spectrobid             Do.
                             (bacampicillin HCl)
                             Tablets.
NDA 050556................  Spectrobid             Do.
                             (bacampicillin HCl)
                             Oral Suspension.
NDA 050809................  Azithromycin for       Teva Parenteral
                             Injection, 500 mg/     Medicines, Inc.,
                             vial and 2.5 g/vial.   Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    19 Hughes, Irvine,
                                                    CA 92618-1902.
ANDA 061370...............  Ampicillin Trihydrate  Teva Pharmaceuticals
                             for Oral Suspension,   USA, 425 Privet Rd.,
                             125 mg/5 mL, 250 mg/   Horsham, PA 19044.
                             5 mL.
ANDA 061461...............  Erythromycin Stearate  ANI Pharmaceuticals,
                             Tablets USP, 250 mg    Inc.
                             and 500 mg.
ANDA 062338...............  Eryc (erythromycin     Warner Chilcott (US)
                             delayed-release        Inc., 100 Enterprise
                             capsules USP), 250     Dr., Rockaway, NJ
                             mg.                    07866.
ANDA 062391...............  Doxycycline Hyclate    Mutual Pharmaceutical
                             Tablets USP, 100 mg.   Co., Inc.
ANDA 062418...............  Doxycycline Hyclate    Do.
                             Capsules USP, 50 mg
                             and 100 mg.
ANDA 062645...............  Griseofulvin Tablets   Barr Laboratories,
                             USP, 165 mg.           Inc.
ANDA 062646...............  Ultramicrosize         Do.
                             Griseofulvin Tablets
                             USP, 330 mg.

ANDA 062777...............  Cephalexin for Oral    Barr Laboratories,
                             Suspension USP, 250    Inc., Subsidiary of
                             mg/5 mL.               Teva Pharmaceuticals
                                                    USA, 425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 062778...............  Cephalexin for Oral    Do.
                             Suspension USP, 125
                             mg/5 mL.
ANDA 062826...............  Cephalexin Tablets     Do.
                             USP, 250 mg.
ANDA 062827...............  Cephalexin Tablets     Do.
                             USP, 500 mg.
ANDA 062895...............  Cyclacillin Tablets,   Teva Pharmaceuticals,
                             250 mg and 500 mg.     USA.
ANDA 062930...............  Clindamycin Phosphate  Vintage
                             Topical Solution, 1%.  Pharmaceuticals, 150
                                                    Vintage Dr.,
                                                    Huntsville, AL
                                                    35811.
ANDA 064061...............  Cefaclor Capsules      Ivax Pharmaceuticals,
                             USP, 250 mg and 500    Inc.
                             mg.
ANDA 064070...............  Cefaclor Oral          Do.
                             Suspension USP, 375
                             mg/5 mL.
ANDA 064085...............  Cefaclor Oral          Do.
                             Suspension USP, 250
                             mg/5 mL.
ANDA 064086...............  Cefaclor Oral          Do.
                             Suspension UPS, 187
                             mg/5 mL.
ANDA 064087...............  Cefaclor Oral          Do.
                             Suspension USP, 125
                             mg/5 mL.
ANDA 065297...............  Azithromycin for Oral  Sandoz Inc., 4700
                             Suspension, 100 mg/5   Sandoz Dr., Wilson,
                             mL and 200 mg/5 mL.    NC 27893.
ANDA 070067...............  Indomethacin Capsules  Mutual Pharmaceutical
                             USP, 25 mg.            Co., Inc.
ANDA 070068...............  Indomethacin Capsules  Do.
                             USP, 50 mg.
ANDA 070081...............  Ibuprofen Tablets,     McNeil Consumer
                             400 mg.                Healthcare, 7050
                                                    Camp Hill Rd., Fort
                                                    Washington, PA
                                                    19034.
ANDA 070215...............  Sulfamethoxazole and   Pliva Inc.,
                             Trimethoprim Tablets   Subsidiary of Teva
                             USP, 400 mg/80 mg.     Pharmaceuticals USA,
                                                    425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 070466...............  Allopurinol Tablets    Mutual Pharmaceutical
                             USP, 100 mg.           Co., Inc.
ANDA 070467...............  Allopurinol Tablets    Do.
                             USP, 300 mg.
ANDA 070472...............  Lorazepam Tablets      Do.
                             USP, 0.5 mg.
ANDA 070473...............  Lorazepam Tablets      Do.
                             USP, 1 mg.
ANDA 070474...............  Lorazepam Tablets      Do.
                             USP, 2 mg.
ANDA 070482...............  Verapamil HCl          Do.
                             Tablets, 80 mg.
ANDA 070483...............  Verapamil HCl          Do.
                             Tablets, 120 mg.
ANDA 070578...............  Furosemide Injection   Hospira, Inc.
                             USP, 10 mg/mL.
ANDA 070795...............  Amiloride HCl and      Teva Pharmaceuticals
                             Hydrochlorothiazide    USA.
                             Tablets USP, 5 mg/50
                             mg.
ANDA 070819...............  Metoclopramide Oral    Do.
                             Solution USP, 5 mg/5
                             mL.
ANDA 071259...............  Trimethoprim Tablets,  Do.
                             200 mg.
ANDA 071315...............  Metoclopramide Oral    Do.
                             Solution USP, 5 mg/5
                             mL.
ANDA 071769...............  Ibuprofen Tablets      Ivax Pharmaceuticals,
                             USP, 800 mg.           Inc.
ANDA 072126...............  Methyldopa Tablets,    Barr Laboratories,
                             125 mg.                Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 072127...............  Methyldopa Tablets,    Do.
                             250 mg.
ANDA 072128...............  Methyldopa Tablets,    Do.
                             500 mg.
ANDA 072557...............  Fenoprofen Calcium     Ivax Pharmaceuticals,
                             Tablets USP, 600 mg.   Inc.
ANDA 072779...............  Albuterol Tablets      Teva Pharmaceuticals
                             USP, 2 mg.             USA.
ANDA 072780...............  Albuterol Tablets      Do.
                             USP, 4 mg.
ANDA 073115...............  Amantadine HCl Oral    Do.
                             Solution USP, 50 mg/
                             5 mL.
ANDA 073478...............  Loperamide HCl Oral    Do.
                             Solution, 1 mg/5 mL.
ANDA 073497...............  Lactulose Solution     Do.
                             USP, 10 g/15 mL
                             (Evalose).
ANDA 073504...............  Lactulose Solution     Do.
                             USP, 10 g/15 mL
                             (Heptalac).
ANDA 074101...............  Atenolol Tablets, 25   Pliva, Inc.,
                             mg, 50 mg, and 100     Subsidiary of Teva
                             mg.                    Pharmaceuticals USA.
ANDA 074103...............  Piroxicam Capsules     Teva Pharmaceuticals
                             USP, 10 mg and 20 mg.  USA.
ANDA 074148...............  Piroxicam Capsules     Ivax Pharmaceuticals,
                             USP, 10 mg and 20 mg.  Inc.
ANDA 074344...............  Cimetidine Injection   Hospira, Inc.
                             USP, 300 mg/2 mL.
ANDA 074345...............  Cimetidine Injection   Do.
                             USP, 300 mg/2 mL.
ANDA 074347...............  Cholestyramine for     Teva Pharmaceuticals
                             Oral Suspension USP,   USA.
                             4 g.
ANDA 074348...............  Cholestyramine for     Do.
                             Oral Suspension USP,
                             4 g.
ANDA 074368...............  Nadolol Tablets USP,   Do.
                             80 mg, 120 mg, and
                             160 mg.
ANDA 074390...............  Diclofenac Sodium      Do.
                             Delayed-Release
                             Tablets USP, 75 mg.
ANDA 074401...............  Cimetidine Tablets     Ivax Pharmaceuticals,
                             USP, 200 mg, 300 mg,   Inc.
                             and 400 mg.
ANDA 074402...............  Cimetidine Tablets     Do.
                             USP, 800 mg.
ANDA 074411...............  Flurbiprofen Tablets   Do.
                             USP, 50 mg and 100
                             mg.
ANDA 074500...............  Minoxidil Topical      Copley
                             Solution, 2%.          Pharmaceutical,
                                                    Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 074530...............  Terazosin HCl          Ivax Pharmaceuticals,
                             Tablets, 1 mg, 2 mg,   Inc.
                             5 mg, and 10 mg.
ANDA 074590...............  Captopril Tablets      Do.
                             USP, 12.5 mg, 25 mg,
                             50 mg, and 100 mg.
ANDA 074619...............  Glipizide Tablets      Barr Laboratories,
                             USP, 5 mg and 10 mg.   Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 074859...............  Cimetidine HCl Oral    ANI Pharmaceuticals,
                             Solution, 300 mg/5     Inc.
                             mL.
ANDA 074873...............  Tretinoin Topical      Teva Pharmaceuticals
                             Solution USP, 0.05%.   USA.
ANDA 074899...............  Etodolac Capsules      ANI Pharmaceuticals,
                             USP, 200 mg and 300    Inc.
                             mg.
ANDA 074920...............  Clonazepam Tablets     Teva Pharmaceuticals
                             USP, 0.5 mg, 1 mg,     USA.
                             and 2 mg.

ANDA 075020...............  Hydroxyurea Capsule    Barr Laboratories,
                             USP, 250 mg and 500    Inc., Subsidiary of
                             mg.                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 075055...............  Captopril and          Ivax Pharmaceuticals,
                             Hydrochlorothiazide    Inc.
                             Tablets USP, 25/15
                             mg, 25/25 mg, 50/15
                             mg, and 50/25 mg.
ANDA 075110...............  Cimetidine HCl         ANI Pharmaceuticals,
                             Solution, 300 mg/5     Inc.
                             mL.
ANDA 075448...............  Isosorbide             Ivax Pharmaceuticals,
                             Mononitrate Extended-  Inc.
                             Release Tablets, 30
                             mg, 60 mg, and 120
                             mg.
ANDA 075482...............  Enalapril Maleate      Do.
                             Tablets USP, 2.5 mg,
                             5 mg, 10 mg, and 20
                             mg.
ANDA 075734...............  Hydroxyurea Tablets    Barr Laboratories,
                             USP, 1,000 mg.         Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 075763...............  Nefazodone HCl         Ivax Pharmaceuticals,
                             Tablets USP, 50 mg,    Inc.
                             100 mg, 150 mg, 200
                             mg, and 250 mg.
ANDA 076136...............  Ciprofloxacin Tablets  Teva Pharmaceuticals
                             USP, 250 mg, 500 mg,   USA.
                             and 750 mg.
ANDA 076169...............  Fexofenadine HCl       Barr Laboratories,
                             Capsules, 60 mg.       Inc., 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 076752...............  Levothyroxine Sodium   Merck KGaA, c/o Icon
                             Tablets USP, 25 mcg,   Clinical Research,
                             50 mcg, 75 mcg, 88     212 Church Rd.,
                             mcg, 100 mcg, 112      North Wales, PA
                             mcg, 125 mcg, 150      19454.
                             mcg, 175 mcg, 200
                             mcg, and 300 mcg.
ANDA 076988...............  Prednisolone Sodium    Nesher
                             Phosphate Oral         Pharmaceuticals
                             Solution USP,          (USA) LLC, 13910
                             Prednisolone Base 15   Saint Charles Rock
                             mg/5 mL.               Rd., Bridgeton, MO
                                                    63044.
ANDA 077176...............  Metoprolol Succinate   Do.
                             Extended-Release
                             Tablets, 50 mg.
ANDA 077779...............  Metoprolol Sucinate    Do.
                             Extended-Release
                             Tablets, 25 mg.
ANDA 080391...............  Edetate Calcium        Watson Laboratories,
                             Disodium Injection.    Inc., Morris
                                                    Corporate Center
                                                    III, 400 Interpace
                                                    Parkway, Parsippany,
                                                    NJ 07054.
ANDA 080505...............  Carmol HC Cream......  Fougera
                                                    Pharmaceuticals
                                                    Inc., 60 Baylis Rd.,
                                                    P.O. Box 2006,
                                                    Melville, NY 11747.
ANDA 080701...............  Prednisone Tablets     Mutual Pharmaceutical
                             USP, 5 mg.             Co., Inc.
ANDA 081054...............  Hydroxyzine HCl        Pliva, Inc.,
                             Tablets, 100 mg.       Subsidiary of Teva
                                                    Pharmaceuticals USA.
ANDA 083729...............  Imipramine HCl         Teva Pharmaceuticals
                             Tablets USP, 10 mg,    USA.
                             25 mg, and 50 mg.
ANDA 083734...............  Probenecid and         Ivax Pharmaceuticals,
                             Colchicine Tablets     Inc.
                             USP, 500 mg/0.5 mg.
ANDA 083740...............  Probenecid Tablets     Do.
                             USP, 500 mg.
ANDA 084106...............  Hydralazine HCl        Mutual Pharmaceutical
                             Tablets USP, 25 mg.    Co., Inc.
ANDA 084107...............  Hydralazine HCl        Do.
                             Tablets USP, 50 mg.
ANDA 084506...............  Diphenhydramine HCl    Do.
                             Capsules USP, 25 mg.
ANDA 084595...............  Procainainde HCl       Ivax Pharmaceuticals,
                             Capsules USP, 375 mg.  Inc.
ANDA 084606...............  Procainamide HCl       Do.
                             Capsules USP, 500 mg.
ANDA 084634...............  Prednisone Tablets     Mutual Pharmaceutical
                             USP, 20 mg.            Co., Inc.
ANDA 084978...............  Micrainin (aspirin     Meda Pharmaceuticals
                             and meprobamate)       Inc.
                             Tablets, 325 mg/200
                             mg.
ANDA 085627...............  Amitriptyline HCl      Mutual Pharmaceutical
                             Tablets USP, 25 mg.    Co., Inc.
ANDA 085742...............  Amitriptyline HCl      Do.
                             Tablets USP, 100 mg.
ANDA 085743...............  Amitriptyline HCl      Do.
                             Tablets USP, 75 mg.
ANDA 085744...............  Amitriptyline HCl      Do.
                             Tablets USP, 10 mg.
ANDA 085745...............  Amitriptyline HCl      Do.
                             Tablets USP, 50 mg.
ANDA 085836...............  Amitriptyline HCl      Teva Pharmaceuticals
                             Tablets USP, 100 mg.   USA.
ANDA 086595...............  Prednisone Tablets     Mutual Pharmaceutical
                             USP, 10 mg.            Co., Inc.
ANDA 087265...............  Spironolactone         Do.
                             Tablets USP, 25 mg.
ANDA 087267...............  Spironolactone and     Do.
                             Hydrochlorothiazide
                             Tablets USP, 25 mg/
                             25 mg.
ANDA 087292...............  Chlorthalidone         Do.
                             Tablets USP, 25 mg.
ANDA 087293...............  Chlorthalidone         Do.
                             Tablets USP, 50 mg.
ANDA 087857...............  Hydroxyzine HCl        Do.
                             Tablets USP, 25 mg.
ANDA 087860...............  Hydroxyzine HCl        Do.
                             Tablets USP, 50 mg.
ANDA 087913...............  Methyclothiazide       Ivax Pharmaceuticals,
                             Tablets USP, 2.5 mg.   Inc.
ANDA 088409...............  Hydroxyzine HCl        Mutual Pharmaceutical
                             Tablets USP, 10 mg.    Co., Inc.
ANDA 088626...............  Bromodiphenhydramine   Wockhardt Bio AG, c/o
                             HCl and Codeine        Morton Grove
                             Phosphate Syrup,       Pharmaceuticals,
                             12.5 mg/5 mL and 10    Inc., 6451 Main St.,
                             mg/5 mL.               Morton Grove, IL
                                                    60053.
ANDA 088728...............  Hydralazine HCl        Mutual Pharmaceutical
                             Tablets USP, 10 mg.    Co., Inc.
ANDA 088804...............  Trimethobenzamide HCl  Hospira, Inc.
                             Injection USP, 100
                             mg/mL.
ANDA 088883...............  Amitriptyline HCl      Pliva, Inc.,
                             Tablets USP, 10 mg.    Subsidiary of Teva
                                                    Pharmaceuticals USA.
ANDA 088884...............  Amitriptyline HCl      Pliva Hrvatska
                             Tablets USP, 25 mg.    d.o.o., Subsidiary
                                                    of Teva
                                                    Pharmaceuticals USA,
                                                    425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 088885...............  Amitriptyline HCl      Pliva, Inc.,
                             Tablets USP, 50 mg.    Subsidiary of Teva
                                                    Pharmaceuticals USA.
ANDA 088886...............  Amitriptyline HCl      Do.
                             Tablets USP, 75 mg.
ANDA 088887...............  Amitriptyline HCl      Do.
                             Tablets USP, 100 mg.
ANDA 088888...............  Amitriptyline HCl      Pliva Hrvatska
                             Tablets USP, 150 mg.   d.o.o., Subsidiary
                                                    of Teva
                                                    Pharmaceuticals USA.
ANDA 088891...............  Ergoloid Mesylates     Mutual Pharmaceutical
                             Tablets USP, 1 mg.     Co., Inc.

ANDA 089238...............  Acetaminophen and      Mikart, Inc., 1750
                             Codeine Phosphate      Chattahoochee Ave.,
                             Tablets USP, 300 mg/   Atlanta, GA 30318.
                             30 mg.
ANDA 089244...............  Acetaminophen and      Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             60 mg.
ANDA 089423...............  Amitriptyline HCl      Mutual Pharmaceutical
                             Tablets USP, 150 mg.   Co., Inc.
ANDA 090849...............  Oxaliplatin for        Sandoz Inc., 506
                             Injection USP, 50 mg/  Carnegie Center,
                             vial and 100 mg/vial.  Suite 400,
                                                    Princeton, NJ 08540.
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director of Food and Drugs, 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 November 12, 2015. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the 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: October 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25922 Filed 10-9-15; 8:45 am]
 BILLING CODE 4164-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance/ Office of Compliance 2. OMB control number b. G None a. 2060 0041 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Sulfuric Acid Plants ( 40 CFR part 60, subpart H) ( Renewal)

8. Agency form number( s) ( If applicable) ICR Number 1057.10 9. Keywords Elemental sulfur, alkylation acid, hydrogen sulfide, organic sulfides, acid sludge.

10. Abstract Owners/ operators must notify EPA of construction, modification, startups, shutdowns, malfunctions, and the date and results of initial performance test. Respondents shall install, calibrate, and maintain a continuous emissions monitor for SO2 and record equipment operating parameters including calculations of conversion factors semiannual reports of excess emissions shall be submitted.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 103 b. Total annual responses 206 1. Percentage of these responses collected electronically 20 % c. Total hours requested 26,177 d. Current OMB inventory 23,320 e. Difference 2,857 f. Explanation of difference 1. Program Change 0 2. Adjustment 2,857 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 464 c. Total annualized cost requested 464 d. Current OMB inventory 477 e. Difference ( 13) f. Explanation of difference 1. Program change 0 2. Adjustment ( 13)

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Initially 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Learia A. Williams Phone: ( 202) 564 4113 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number." OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Proposed Rules]
[Pages 58137-58139]
[FR Doc No: 2017-26571]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0688; Product Identifier 2017-NE-23-AD]
RIN 2120-AA64

Airworthiness Directives; Zodiac Seats France, Cabin Attendant
Seats

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain

Zodiac Seats France, 537 series cabin attendant seats. This proposed AD
was prompted by operator reports that safety belt wear was found at the
attachment to the cabin attendant seat. This proposed AD would require
inspecting the safety belt webbing, and modifying and re-marking each
affected cabin attendant seat. We are proposing this AD to correct the
unsafe condition on these products.

DATES: We must receive comments on this NPRM by January 25, 2018.

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.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this NPRM, contact Zodiac
Seats France, Rue Robert Marechal Senior B.P. 69, 36100 Issoudun,
France; phone: +33 (0) 9 70 83 08 30; fax: +33 (0) 2 54 03 39 00;
email: [email protected]; Internet: http://www.services.zodiacaerospace.com. You may view this service information
at the FAA, Engine & Propeller Standards Branch, Policy and Innovation
Division, 1200 District Avenue, Burlington, MA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0688; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The address for the Docket Office (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dorie Resnik, Aerospace Engineer, FAA,
Boston ACO Branch, Compliance and Airworthiness Division, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

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-2017-0688;
Product Identifier 2017-NE-23-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
with FAA personnel concerning this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2016-0163, dated August 10, 2016 (referred to hereafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Cases were reported by operators of finding safety belt worn out
at the attachment to the cabin attendant seat. This kind of belt
damage is due to chafing between the belt and the surrounding metal
lap belt fitting of the cabin attendant seat. This condition, if not
detected and corrected, could lead to failure of the attendant seat
to perform its intended function, possibly resulting in injury to
the seat occupant. Prompted by these occurrences, Zodiac Seats
France issued Service Bulletin (SB) No. 537-25-003, providing
instructions to modify the affected seats. For the reason described
above, this AD requires a modification of the seat pan shaft by
installing new seat pan spacers, and subsequent re-identification
with a new P/N.

    You may obtain further information by examining the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2017-0688.

Related Service Information Under 1 CFR Part 51

    We reviewed Zodiac Seats France Service Bulletin (SB) No. 537-25-
003, Revision 1, dated August 29, 2016. The SB describes procedures for
installing an anti-rotation device on the seat pan shaft to limit the
rotation of the safety belt on ATR 42 and ATR 72 airplanes. We also
reviewed Service Information Letter (SIL) 537-01, dated July 31, 2015.
The SIL provides details to identify if the safety belt must be removed
and replaced and provides instructions on safety belt storage to avoid
this premature wear. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are proposing this AD because we evaluated all information
provided by EASA and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.
This proposed AD would require inspecting, modifying, and re-marking
certain cabin attendant seats.

Costs of Compliance

    We estimate that this proposed AD affects 55 seat assemblies
installed on, but not limited to, ATR 42 and ATR 72 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Seat inspection and modification......  0.5 work-hours x $85 per            $300         $342.50      $18,837.50
                                         hour = $42.50.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines and propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

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),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) 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.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, 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

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Zodiac Seats France (formerly SICMA Aero Seat): Docket No. FAA-2017-
0688; Product Identifier 2017-NE-23-AD.

(a) Comments Due Date

    We must receive comments by January 25, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Zodiac Seats France cabin attendant
seats, 537 series, part numbers 53701-( )( )-( )( )( ).
    These appliances are installed on, but not limited to, ATR 42
and ATR 72 airplanes of U.S. registry.

(d) Subject

    Joint Aircraft System Component (JASC) 2500 Code, Cabin
Equipment/Furnishings.

(e) Reason

    This AD was prompted by operator reports that safety belt wear
was found at the attachment to the cabin attendant seat. We are
issuing this AD to prevent failure of these attendant seats.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    Within 720 flight cycles after the effective date of this AD,
inspect safety belt webbing, modify and re-mark each affected cabin
attendant seat using sections (2)(A) through (2)(B) of Zodiac Seats
France Service Bulletin (SB) No. 537-25-003, Revision 1, dated
August 29, 2016 and Zodiac Seats France Service Information Letter
537-01, dated July 31, 2015.

(g) Installation Prohibition

    After the effective date of this AD, do not install any affected
cabin attendant seat on any aircraft.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, FAA, Boston ACO Branch, Compliance and
Airworthiness Division, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the Boston ACO
Branch, send it to the attention of the person identified in
paragraph (i)(1) of this AD. You may email your request to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Dorie Resnik,
Aerospace Engineer, FAA, Boston ACO Branch, Compliance and
Airworthiness Division, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email: [email protected].
    (2) Refer to MCAI European Aviation Safety Agency AD 2016-0163,
dated August 10, 2016, for more information. You may examine the
MCAI in the AD docket on the Internet at http://www.regulations.gov
by searching for and locating it in Docket No. FAA-2017-0688.
    (3) Zodiac Seats France SB No. 537-25-003, Revision 1, dated
August 29, 2016, and Zodiac Seats France Service Information Letter
537-01, dated July 31, 2015 can be obtained from Zodiac Seats
France, using the contact information in paragraph (i)(4) of this
proposed AD.
    (4) For service information identified in this proposed AD,
contact Zodiac Seats France, Rue Robert Marechal Senior B.P. 69,
36100 Issoudun, France; phone: +33 (0) 9 70 83 08 30; fax: +33 (0) 2
54 03 39 00; email: [email protected]; Internet: http://www.services.zodiacaerospace.com.
    (5) You may view this referenced service information at the FAA,
Engine and Propeller Standards Branch, Policy and Innovation
Division, 1200 District Avenue, Burlington, MA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on December 5, 2017.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2017-26571 Filed 12-8-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Notices]
[Pages 371-372]
[FR Doc No: 2017-28323]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-53-000]

Calpine Corporation and LS Power Associates, L.P. v. ISO New
England Inc.; Notice of Complaint

    Take notice that on December 21, 2017, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824(e), 825e, and Rule 206 of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206, Calpine Corporation and LS
Power Associates, L.P. (Complainants) filed a formal complaint against
ISO New England Inc. (ISO-NE or Respondent) alleging that ISO-NE's
Transmission, Markets & Services Tariff (Tariff) is unjust and
unreasonable because it requires ISO-NE to treat a new resource that
has chosen to lock-in its price under the new entry pricing provisions
of the Tariff as effectively having submitted offers into subsequent
Forward Capacity Auctions priced at zero, even in circumstances where
the development of such resource has been delayed so that it is not
expected to be available for the relevant Capacity Commitment Period,
all as more fully explained in the complaint.
    Complainants certify that copies of the complaint were served on
the contacts for ISO-NE, as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.

    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on January 4, 2018.

    Dated: December 22, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-28323 Filed 1-2-18; 8:45 am]
 BILLING CODE 6717-01-P


     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

                             OFFICE OF CHEMICAL SAFTEY
AND POLLUTION PREVENTION

RE:  	Conference Call with Adam Pugh of National Association of Counties (NACo) and EPA on Risk Management under TSCA Section 6, Aliphatic Cyclic Bromide Cluster (HBCD)

List of Documents
 Meeting Summary
 Attendees
Meeting Summary
On April 6, 2021, EPA held a conference call with Adam Pugh, Associate Legislative Director for Environment, Energy and Land Use at NACo, to discuss the information EPA is seeking for the HBCD rulemaking and the need for input from small government entities. EPA presented an overview of the HBCD Risk Evaluation, an explanation of the planned rulemaking, and technical background.

Attendees
EPA:
Susan Slotnick
Sarah Cox

National Association of Counties:
Adam Pugh


[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36739-36740]
[FR Doc No: 2021-14848]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-103-000]

Rockies Express Pipeline LLC; Notice of Extension of Time Request

    Take notice that on June 23, 2021, Rockies Express Pipeline LLC
(Rockies Express) requested that the Federal Energy Regulatory
Commission (Commission) grant an extension of time, until September 20,
2023, to complete the construction of six new 5,350 horsepower (hp)
natural gas reciprocating compressor units (32,100 hp total) at its
existing Cheyenne Compressor Station (Cheyenne Hub Enhancement Project)
in Weld County, Colorado, as authorized as part of the Cheyenne Hub
Enhancement Project in the September 20, 2019 Order Issuing
Certificates \1\ (September 20 Order). The September 20 Order required
Rockies Express to complete construction and make the facilities
available for service within two years of the Order date. Rockies
Express has since completed construction of four of the six authorized
compressor units, placing units 1-3 into service on July 26, 2020,\2\
and unit 4 into service on December 17, 2020.\3\ Compressor units 5 and
6 remain unconstructed.
---------------------------------------------------------------------------

    \1\ Cheyenne Connector, LLC, 168 FERC ] 61,180 (2019), order
amending certificate, 171 FERC ] 61,055 (2020). In the Order the
Commission also approved the Cheyenne Connector Pipeline Project in
Docket No. CP18-102-000.
    \2\ Notice of Commencement of Service of Rockies Express
Pipeline LLC, Docket No. CP18-103-000 (July 13, 2020).
    \3\ Notice of Commencement of Service of Rockies Express
Pipeline LLC, Docket No. CP18-103-000 (December 17, 2020).
---------------------------------------------------------------------------

    Rockies Express states it has been delayed in reaching full
commercialization for compressor units 5 and 6, with the economic
slowdown and fallout from the COVID-19 pandemic. The final two
compressor units that have not yet been constructed will be installed
at the existing Cheyenne Compressor Station on land already owned by
Rockies Express under the terms and conditions of the existing
certificate. Rockies Express states that the extension of time will not
result in any environmental impacts not already examined on the record
in the certificate proceeding and will provide Rockies Express with the
time necessary to install these remaining two units.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Rockies Express'
request for an extension of time may do so. No

reply comments or answers will be considered. If you wish to obtain
legal status by becoming a party to the proceedings for this request,
you should, on or before the comment date stated below, file a motion
to intervene in accordance with the requirements of the Commission's
Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the Natural Gas Act (18 CFR 157.10).\4\
---------------------------------------------------------------------------

    \4\ Only motions to intervene from entities that were party to
the underlying proceeding will be accepted. Algonquin Gas
Transmission, LLC, 170 FERC ] 61,144, at P 39 (2020).
---------------------------------------------------------------------------

    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance.\5\ For those extension requests that are contested, the
Commission will aim to issue an order acting on the request within 45
days.\6\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\7\ The Commission will not consider arguments that re-
litigate the issuance of the certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\8\
At the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\9\ The OEP Director, or
his or her designee, will act on all of those extension requests that
are uncontested.
---------------------------------------------------------------------------

    \5\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2019).
    \6\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \7\ Id. at P 40.
    \8\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \9\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and three copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on July 22, 2021.

    Dated: July 7, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-14848 Filed 7-12-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Proposed Rules]
[Pages 25550-25552]
[FR Doc No: 2017-11004]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0519; Directorate Identifier 2017-NM-001-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 757-200, -200CB, and -300 series
airplanes. This proposed AD was prompted by a report of fatigue
cracking found in a certain fuselage frame web. This proposed AD would
require inspecting the fuselage frame for existing repairs, repetitive
inspections of the frame, and applicable repairs. We are proposing this
AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by July 17, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740; telephone
562-797-1717; Internet https://www.myboeingfleet.com. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0519.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0519; 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 (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Muoi Vuong, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5205; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
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-2017-0519;
Directorate Identifier 2017-NM-001-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

    We have received a report indicating a 6-inch-long crack in the
fuselage frame web at station (STA) 1681, below the floor line at
stringer S-17L, was found during a routine maintenance visit. The crack
was not easily detected because it was hidden by adjacent structure.
Analysis revealed that the crack was caused by fatigue. Cracking of the
fuselage frame, if not detected and corrected, could result in reduced
structural integrity of the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 757-53A0100, dated
November 14, 2016. The service information describes procedures for
inspecting the fuselage frame for existing frame and floor beam
repairs, and repetitive high frequency eddy current inspections for
cracking in any area with no existing frame repair, repetitive high and
low frequency eddy current inspections for cracking in any area with no
existing frame or floor beam repair, and repair. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishment of the actions
identified as ``RC'' (required for compliance) in the Accomplishment
Instructions of Boeing Alert Service Bulletin 757-53A0100, dated
November 14, 2016, described previously, except for differences between
this proposed AD and the service information that are identified in the
regulatory text of this proposed AD.
    For information on the procedures and compliance times, see this
service information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0519.

Costs of Compliance

    We estimate that this proposed AD affects 606 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection for existing frame    1 work-hour x $85 per                $0  $85...............  $51,510.
 and floor beam repairs.          hour = $85.
Repetitive inspections.........  Up to 32 work-hours x                $0  Up to $2,720......  Up to $1,648,320.
                                  $85 per hour = up to
                                  $2,720 per inspection
                                  cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition repair specified in this proposed
AD.

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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, 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

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2017-0519; Directorate Identifier
2017-NM-001-AD.

(a) Comments Due Date

    We must receive comments by July 17, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 757-200, -200CB, and
-300 series airplanes, certificated in any category, as identified
in Boeing Alert Service Bulletin 757-53A0100, dated November 14,
2016.

(d) Subject

    Air Transport Association (ATA) of America Code 53; Fuselage.

(e) Unsafe Condition

    This AD was prompted by a report of fatigue cracking found in
the fuselage frame web at station (STA) 1681. We are issuing this AD
to detect and correct cracking of the fuselage frame at STA 1681,
which could result in reduced structural integrity of the airplane.

(f) Compliance

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

(g) Actions Required for Compliance

    Except as required by paragraph (h) of this AD: Do all
applicable actions identified as required for compliance (``RC'')
in, and in accordance with, the Accomplishment Instructions of
Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016.
Do the actions at the applicable times specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 757-53A0100, dated
November 14, 2016.

(h) Exceptions

    (1) Where Boeing Alert Service Bulletin 757-53A0100, dated
November 14, 2016, uses the phrase ``after the original issue of
this service bulletin'' for determining compliance, for purposes of
this AD, compliance is based on the effective date of this AD.
    (2) Where Boeing Alert Service Bulletin 757-53A0100, dated
November 14, 2016, specifies contacting Boeing for instructions, and
specifies that action as ``RC'' (Required for Compliance): This AD
requires using a method approved in accordance with the procedures
specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) Except as required by paragraph (h)(2) of this AD: For
service information that contains steps that are labeled as Required
for Compliance (RC), the provisions of paragraphs (i)(4)(i) and
(i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures

identified in an RC step, must be done to comply with the AD. If a
step or substep is labeled ``RC Exempt,'' then the RC requirement is
removed from that step or substep. An AMOC is required for any
deviations to RC steps, including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    (1) For more information about this AD, contact Muoi Vuong,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5205; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740;
telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington, on May 19, 2017.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-11004 Filed 6-1-17; 8:45 am]
BILLING CODE 4910-13-P