[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Notices]
[Page 16668-16669]
[DOCID:fr28mr08-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

March 21, 2008.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.

    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at 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. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Exempt:

------------------------------------------------------------------------
                                                        Presenter or
         Docket number            Date received          requester
------------------------------------------------------------------------
1. CP98-150-000...............  2-26-08..........  Hon. Michael A.
                                                    Arcuri.
2. CP98-150-000...............  3-4-08...........  Hon. Michael A.
                                                    Arcuri.
3. CP06-54-000................  3-17-08..........  Hon. Jodi Rell.
4. CP07-62-000................  2-28-08..........  Hon. Barbara A.
                                                    Mikulski; Hon.
                                                    Benjamin L. Cardin.
5. CP07-208-000...............  3-5-08...........  Hon. Robert J.
                                                    Bischoff.
6. CP08-31-000................  3-4-08...........  Hon. Andrew E.
                                                    Dinniman; Hon. Curt
                                                    Schroeder.
7. EL08-34-000................  3-11-08..........  Hon. Barbara A.
                                                    Mikulski; Hon.
                                                    Benjamin L. Cardin;
                                                    Hon. Steny H. Hoyer;
                                                    Hon. Wayne T.
                                                    Gilchrist; Hon.
                                                    Roscoe G. Bartlett;
                                                    Hon. Albert R. Wynn;
                                                    Hon. Elijah E.
                                                    Cummings; Hon C.A.
                                                    Dutch Ruppersberger;
                                                    Hon. Christopher
                                                    VanHollen; Hon. John
                                                    P. Sarbannes.
8. EL08-35-000................  2-25-08..........  Hon. Robert Menendez.
9. P-11858-000................  3-18-08..........  Karen A. Goebel.
------------------------------------------------------------------------

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-6310 Filed 3-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33310-33314]
[FR Doc No: 2011-14164]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0411]

Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New
Drug Applications and 97 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 70 new drug applications (NDAs) and 97 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: July 8, 2011.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 of 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 007289..................  Trigesic and          Bristol-Myers Squibb
                               Trigesic with         Co., P.O. Box 4000,
                               Codeine Tablets.      Princeton, NJ 08543-
                                                     4000.
NDA 008248..................  Wyamine               Baxter Healthcare
                               (mephentermine        Corp., 2 Esterbrook
                               sulfate) Sulfate      Lane, Cherry Hill,
                               Injection.            NJ 08003-4099.
NDA 008834..................  Tronothane HCl        Abbott Laboratories,
                               (pramoxine            Dept. PA76/Bldg.
                               hydrochloride         AP30-1E, 200 Abbott
                               (HCl)).               Park Rd., Abbott
                                                     Park, IL 60064-
                                                     6157.
NDA 009182..................  Gantrisin             Hoffman-La Roche,
                               (sulfisoxazole        Inc., 340 Kingsland
                               acetyl).              St., Nutley, NJ
                                                     07110-1199.
NDA 011835..................  Hydrodiuril           Merck & Co., Inc.,
                               (hydrochlorothiazid   P.O. Box 1000, UG2C-
                               e (HCTZ)) Tablets.    50, North Wales, PA
                                                     19454.
NDA 011971..................  Oretic (HCTZ)         Abbott Laboratories.
                               Tablets, 25
                               milligrams (mg) and
                               50 mg.
NDA 012302..................  Choloxin              Do.
                               (dextrothyroxine
                               sodium) Tablets, 1
                               mg, 2 mg, 4 mg, and
                               6 mg.
NDA 013402..................  Aldoril (methyldopa/  Merck & Co., Inc.
                               HCTZ) Tablets.
NDA 015539..................  Serax (oxazepam)      Alpharma U.S.
                               Capsules and          Pharmaceuticals
                               Tablets.              Division, c/o King
                                                     Pharmaceuticals,
                                                     Inc., 501 Fifth
                                                     St., Bristol, TN
                                                     37620.
NDA 016118..................  Teslac                Bristol-Myers Squibb
                               (testolactone)        Co.
                               Tablets.
NDA 016402..................  Alupent               Boehringer
                               (metaproterenol       Ingelheim, 900
                               sulfate) Inhalation   Ridgebury Rd., P.O.
                               Aerosol \1\.          Box 368,
                                                     Ridgefield, CT
                                                     06877-0368.
NDA 016666..................  Hippuran (hippuran I- Mallinckrodt Medical
                               131) Injection.       Inc., c/o Covidien,
                                                     675 McDonnell
                                                     Blvd., Hazelwood,
                                                     MO 63042.
NDA 016979..................  Megace (megestrol     Bristol-Myers Squibb
                               acetate) Tablets,     Co.
                               20 mg and 40 mg.
NDA 017015..................  Pavulon (pancuronium  Organon USA Inc., c/
                               bromide) Injection.   o Schering-Plough
                                                     Corp., 2000
                                                     Galloping Hill Rd.,
                                                     Kenilworth, NJ
                                                     07033-0530.
NDA 017352..................  Fastin (phentermine   GlaxoSmithKline,
                               HCl) Capsules.        P.O. Box 13398,
                                                     Five Moore Dr.,
                                                     Research Triangle
                                                     Park, NC 27709-
                                                     3398.

NDA 017628..................  Tolectin (tolmetin    Ortho-McNeil
                               sodium) Tablets,      Pharmaceutical,
                               200 mg and 600 mg.    Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC,
                                                     1125 Trenton-
                                                     Harbourton Rd.,
                                                     Titusville, NJ
                                                     08560-0200.
NDA 017920..................  Tagamet (cimetidine)  GlaxoSmithKline.
                               Tablets, 100 mg,
                               200 mg, 300 mg, 400
                               mg, and 800 mg.
NDA 017924..................  Tagamet (cimetidine)  Do.
                               Oral Solution, 300
                               mg/5 milliliters
                               (mL).
NDA 017933..................  Lente Iletin          Eli Lilly and Co.,
                               (insulin zinc         Lilly Corporate
                               suspension purified   Center,
                               beef-pork).           Indianapolis, IN
                                                     46285.
NDA 017934..................  Similente Iletin      Do.
                               (insulin zinc
                               suspension purified
                               beef-pork).
NDA 017939..................  Tagamet (cimetidine)  GlaxoSmithKline.
                               Injection, 150 mg/
                               mL.
NDA 018084..................  Tolectin DS           Ortho-McNeil
                               (tolmetin sodium)     Pharmaceutical,
                               Capsules.             Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC.
NDA 018096..................  Dextrose and Sodium   Hospira, Inc.
                               Chloride Injection
                               USP.
NDA 018118..................  Lanoxicaps (digoxin)  GlaxoSmithKline.
                               Capsules.
NDA 018201..................  Moduretic (amiloride  Merck & Co., Inc.
                               HCl/HCTZ) Tablets.
NDA 018380..................  Sodium Chloride       Do.
                               Irrigation USP.
NDA 018590..................  Aminocaproic Acid     Baxter Healthcare
                               Injection USP, 250    Corp.
                               mg/mL.
NDA 018776..................  Norcuron (vecuronium  Organon USA Inc., c/
                               bromide) Injection.   o Schering-Plough
                                                     Corp.
NDA 018869..................  Nimotop (nimodipine)  Bayer Healthcare
                               Capsules.             Pharmaceuticals,
                                                     Inc., P.O. Box
                                                     1000, Montville, NJ
                                                     07045.
NDA 019008..................  Bretylium Tosylate    Hospira, Inc., 275
                               in Dextrose           North Field Dr.,
                               Injection USP.        Bldg. H2, Lake
                                                     Forest, IL 60045-
                                                     5046.
NDA 019030..................  Bretylium Tosylate    Hospira, Inc.
                               Injection USP, 50
                               mg/mL.
NDA 019058..................  Tenormin (atenolol)   AstraZeneca
                               Injection, 5 mg/10    Pharmaceuticals LP,
                               mL.                   1800 Concord Pike,
                                                     P.O. Box 8355,
                                                     Wilmington, DE
                                                     19803-89355.
NDA 019091..................  Ismo (isosorbide      Promius Pharma, LLC,
                               mononitrate)          200 Somerset
                               Tablets, 20 mg.       Corporate Blvd.,
                                                     7th Floor,
                                                     Bridgewater, NJ
                                                     08807.
NDA 019165..................  Protamine Zinc        Eli Lilly and Co.
                               (insulin zinc
                               suspension beef).
NDA 019168..................  Lente Insulin         Do.
                               (insulin zinc
                               suspension beef).
NDA 019204..................  Cartrol (carteolol    Abbot Laboratories.
                               HCl) Tablets.
NDA 019377..................  Humulin L (insulin    Do.
                               zinc suspension
                               recombinant human)
                               Injection.
NDA 019434..................  Tagamet (cimetidine   GlaxoSmithKline.
                               HCl) in Sodium
                               Chloride Injection,
                               Equivalent to (EQ)
                               6 mg Base/mL.
NDA 019546..................  Dynacirc              SmithKline Beecham
                               (isradipine)          Corp., d/b/a
                               Capsules.             GlaxoSmithKline,
                                                     One Franklin Plaza,
                                                     200 North 16th St.,
                                                     Philadelphia, PA
                                                     19102.
NDA 019561..................  Micro-K LS            KV Pharmaceutical
                               (potassium            Co., One Corporate
                               chloride).            Woods Dr.,
                                                     Bridgeton, MO
                                                     63044.
NDA 019571..................  Humulin U (insulin    Eli Lilly and Co.
                               zinc suspension
                               extended
                               recombinant human)
                               Injection.
NDA 019583..................  Relafen (nabumetone)  SmithKline Beecham
                               Tablets.              Corp., c/o
                                                     GlaxoSmithKline,
                                                     2301 Renaissance
                                                     Blvd., RN210, P.O.
                                                     Box 61540, King of
                                                     Prussia, PA 19406.
NDA 019591..................  Lariam (mefloquine    Hoffmann-La Roche
                               HCl) Tablets, 250     Inc.
                               mg.
NDA 019638..................  Arduan (pipecuronium  Organon USA Inc., c/
                               bromide) Injection.   o Schering-Plough
                                                     Corp.
NDA 019735..................  Floxin (ofloxacin)    Ortho-McNeil-Janssen
                               Tablets.              Pharmaceuticals,
                                                     Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC,
                                                     P.O. Box 300, 920
                                                     Route 202 South,
                                                     Raritan, NJ 08869-
                                                     0602.
NDA 019979..................  Ticlid (ticlopidine   Roche Palo Alto LLC,
                               HCl) Tablets.         c/o Hoffmann-La
                                                     Roche Inc., 340
                                                     Kingsland St.,
                                                     Nutley, NJ 07110-
                                                     1199.
NDA 020027..................  Cardizen (diltiazem   Biovail Technologies
                               HCl) Injection.       Ltd., On Behalf of
                                                     Biovail
                                                     Laboratories
                                                     International SRL,
                                                     700 Route 202/206
                                                     North, Bridgewater,
                                                     NJ 08807.
NDA 020100..................  Humulin 50/50         Eli Lilly and Co.
                               (insulin
                               recombinant human
                               and insulin
                               suspension isophane
                               recombinant human).
NDA 020269..................  Dobutamine HCl in 5%  Hospira, Inc.
                               Dextrose Injection.
NDA 020507..................  Teczem (enalapril     Biovail
                               maleate/diltiazem     Technologies, Ltd.
                               maleate) Extended-
                               Release Tablets.
NDA 020548..................  Flovent (fluticasone  GlaxoSmithKline.
                               propionate)
                               Inhalation Aerosol
                               \1\.
NDA 020549..................  Flovent (fluticasone  Do.
                               propionate)
                               Inhalation Powder.
NDA 020668..................  Lexxel (enalapril     AstraZeneca
                               maleate and           Pharmaceuticals LP.
                               felodipine)
                               Extended-Release
                               Tablets.
NDA 020792..................  Cardizem (diltiazem   Biovail
                               HCl) Injection.       Technologies, Ltd.
NDA 020906..................  Etopophos             Bristol-Myers Squibb
                               (estoposide           Co.
                               phosphate)
                               Injection.
NDA 020939..................  Diltiazem HCl         Biovail
                               Extended-Release      Technologies, Ltd.
                               Capsules, 120 mg,
                               180 mg, 240 mg, 300
                               mg, 360 mg, and 420
                               mg.

NDA 020961..................  Vitravene             Novartis
                               (fomivirsen sodium)   Pharmaceuticals
                               Injection.            Corp., One Health
                                                     Plaza, East
                                                     Hanover, NJ 07936-
                                                     1080.
NDA 020966..................  Sporanox              Ortho-McNeil-Janssen
                               (itraconazole)        Pharmaceuticals,
                               Injection.            Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC.
NDA 021084..................  Skin Exposure         U.S. Army Medical
                               Reduction Paste       Material
                               Against Chemical      Development
                               Warfare Agent         Activity, c/o
                               (SERPACWA)            Office of Surgeon
                               (polyetrafluoroethy   General, 1430
                               lene and              Veterans Dr., Fort
                               perfluoropolymethyl   Detrick, MD 21702-
                               isopropyl ether).     9234.
NDA 021088..................  Viadur (leuprolide    Ortho-McNeil-Janssen
                               acetate) Implant.     Pharmaceutical,
                                                     Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research &
                                                     Development, LLC.
NDA 021281..................  Prevacid              Takeda Global
                               (lansoprazole).       Research and
                                                     Development Center,
                                                     Inc., One Takeda
                                                     Parkway, Deerfield,
                                                     IL 60015.
NDA 021435..................  Amvaz (amlodipine     Dr. Reddy's
                               maleate) Tablets,     Laboratories, Inc.,
                               2.5 mg, 5 mg, and     200 Somerset
                               10 mg.                Corporate Blvd.,
                                                     Bldg. II, 7th
                                                     Floor, Bridgewater,
                                                     NJ 08807-2862.
NDA 021486..................  Lidopel (lidocaine    Empi, Inc., P.O. Box
                               HCl and               709, Highway 22
                               epinephrine)          East, Clear Lake,
                               Solution.             SD 57226.
NDA 021507..................  Prevacid NapraPac     Takeda Global
                               250, Prevacid         Research and
                               NapraPac 375, and     Development Center,
                               Prevacid NapraPac     Inc.
                               500 (lansoprazole
                               and naproxen)
                               Tablets.
NDA 021566..................  Prevacid I.V.         Do.
                               (lansoprazole)
                               Injection.
NDA 021592..................  Foradil Certihaler    Novartis
                               (formoterol           Pharmaceuticals
                               fumarate)             Corp.
                               Inhalation Powder.
NDA 021850..................  Zegerid (omeprazole/  Santarus, Inc., 3721
                               sodium bicarbonate/   Valley Center Dr.,
                               magnesium             suite 400, San
                               hydroxide).           Diego, CA 92130.
ANDA 040013.................  Lidocaine HCl         Hospira, Inc.
                               Injection USP, 1%.
ANDA 040073.................  Naphazoline HCl       Bausch & Lomb, Inc.,
                               Ophthalmic Solution   7 Giralda Farms,
                               USP, 0.1%.            suite 1001,
                                                     Madison, NJ 07940.
ANDA 040095.................  Heparin Sodium        Hospira, Inc.
                               Injection USP,
                               10,000 Units/mL.
ANDA 040224.................  Chlorpromazine HCl    Pharmaceutical
                               Oral Concentrate      Associates, Inc.,
                               USP, 100 mg/mL.       201 Delaware St.,
                                                     Greenville, SC
                                                     29605.
ANDA 040360.................  Perphenazine Oral     Do.
                               Solution USP, 16 mg/
                               5 mL.
ANDA 040522.................  Norepinephrine        Metrics
                               Bitartrate            Pharmaceuticals
                               Injection USP, EQ 1   Ventures, LLC, c/o
                               mg (base)/1 mL.       Pharmaforce Inc.,
                                                     960 Crupper Ave.,
                                                     Columbus, OH 43229.
NDA 050521..................  Ceclor (cefaclor)     Eli Lilly and Co.
                               Capsules, 250 mg
                               and 500 mg.
NDA 050522..................  Ceclor (cefaclor)     Do.
                               Suspension.
NDA 050560..................  Cefizox (ceftizoxime  Astellas Pharma US,
                               sodium) Powder for    Inc., 3 Parkway
                               Injection.            North, Deerfield,
                                                     IL 60015.
ANDA 061394.................  Principen             Apothecon, Inc., c/o
                               (ampicillin for       Bristol-Myers
                               oral suspension       Squibb Co., P.O.
                               USP).                 Box 4000,
                                                     Princeton, NJ 08543-
                                                     4000.
ANDA 061886.................  Trimox (amoxicillin   Do.
                               for oral suspension
                               USP), 50 mg/mL, 125
                               mg/5 mL, and 250 mg/
                               5 mL.
ANDA 062336.................  Mutamycin (mitomycin  Bristol-Myers Squibb
                               for injection USP)    Co.
                               5 mg, 20 mg, and 40
                               mg Vials.
ANDA 062557.................  Kefzol (cefazolin     Eli Lilly and Co.
                               sodium for
                               injection USP).
ANDA 062563.................  Erythromycin          Elkins-Sinn, Inc., c/
                               Lactobionate for      o Baxter Healthcare
                               Injection USP.        Corp., 2 Esterbrook
                                                     Lane, Cherry Hill,
                                                     NJ 08003-4002.
ANDA 062885.................  Trimox (amoxicillin   Apothecon, Inc., c/o
                               for oral suspension   Bristol-Myers
                               USP), 125 mg/5 mL     Squibb Co.
                               and 250 mg/5 mL.
ANDA 062993.................  Erythromycin          Baxter Healthcare
                               Lactobionate for      Corp.
                               Injection USP, EQ
                               500 mg (base) and 1
                               gram (g) (base)
                               Vials.
ANDA 063294.................  Cefizox (ceftizoxime  Astellas Pharma US,
                               for injection USP),   Inc., Three Parkway
                               EQ 1 g (base) and 2   North, Deerfield,
                               g (base) Vials.       IL 60015-2548.
ANDA 070225.................  Verapamil HCl         Luitpold
                               Injection USP, 2.5    Pharmaceuticals,
                               mg/mL.                Inc., One Luitpold
                                                     Dr., P.O. Box 9001,
                                                     Shirley, NY 11967.
ANDA 070231.................  Carbamazepine         Inwood Laboratories,
                               Tablets USP, 200 mg.  Inc., Subsidiary of
                                                     Forest
                                                     Laboratories, Inc.,
                                                     Harborside
                                                     Financial Center,
                                                     Plaza Three, suite
                                                     602, Jersey City,
                                                     NJ 07311.
ANDA 070291.................  Methyldopate HCl      Baxter Healthcare
                               Injection USP, 50     Corp.
                               mg/mL.
ANDA 070617.................  Verapamil HCl         Luitpold
                               Injection USP, 2.5    Pharmaceuticals,
                               mg/mL.                Inc.
ANDA 070891.................  Bretylium Tosylate    Do.
                               Injection USP, 50
                               mg/mL.
ANDA 072058.................  Pancuronium Bromide   Elkins-Sinn, Inc., c/
                               Injection, 1 mg/mL.   o Baxter Healthcare
                                                     Corp.
ANDA 072059.................  Pancuronium Bromide   Do.
                               Injection, 2 mg/mL.
ANDA 072060.................  Pancuronium Bromide   Do.
                               Injection, 2 mg/mL.
ANDA 072272.................  Droperidol Injection  Hospira, Inc.
                               USP, 2.5 mg/mL.
ANDA 072335.................  Droperidol Injection  Luitpold
                               USP, 2.5 mg/mL.       Pharmaceuticals,
                                                     Inc.
ANDA 074188.................  Dipivefrin HCl        Bausch & Lomb, Inc.
                               Ophthalmic Solution
                               USP, 0.1%.
ANDA 074320.................  Etoposide Injection,  Hospira, Inc.
                               20 mg/mL.
ANDA 074351.................  Etoposide Injection,  Do.
                               20 mg/mL.
ANDA 074353.................  Cimetidine HCl        Luitpold
                               Injection USP.        Pharmaceuticals,
                                                     Inc.

ANDA 074381.................  Dobutamine Injection  Baxter Healthcare
                               USP, 12.5 mg (base)/  Corp.
                               mL.
ANDA 074545.................  Dobutamine Injection  Luitpold
                               USP, 12.5 mg/mL.      Pharmaceuticals,
                                                     Inc.
ANDA 074634.................  Dobutamine Injection  Hospira, Inc.
                               USP, 12.5 mg/mL.
ANDA 074643.................  Minoxidil Topical     Bausch & Lomb, Inc.
                               Solution, 2%.
ANDA 074743.................  Minoxidil Topical     Sight
                               Solution, 2%.         Pharmaceuticals,
                                                     Inc., 7 Giralda
                                                     Farms, suite 1001,
                                                     Madison, NJ 07940.
ANDA 074824.................  Atracurium Besylate   Baxter Healthcare
                               Injection USP, 10     Corp.
                               mg/mL.
ANDA 074825.................  Atracurium Besylate   Do.
                               Injection USP, 10
                               mg/mL.
ANDA 075341.................  Ketoconazole Tablets  AAIPharma Service
                               USP, 200 mg.          Corp., 2320
                                                     Scientific Park
                                                     Dr., Wilmington, NC
                                                     28405.
ANDA 075456.................  Enalaprilat           Hospira, Inc.
                               Injection, 1.25 mg/
                               mL.
ANDA 075542.................  Amrinone (inamrinone  Baxter Healthcare
                               injection USP) EQ 5   Corp.
                               mg/mL.
ANDA 076617.................  Fluconazole in        Hospira, Inc.
                               Sodium Chloride
                               0.9% Injection.
ANDA 076656.................  Fenoldopam Mesylate   Luitpold
                               Injection USP, EQ     Pharmaceuticals,
                               10 mg (base)/mL.      Inc.
ANDA 076695.................  Ondansetron           Hospira, Inc.
                               Injection USP, EQ 2
                               mg (base)/mL.
ANDA 076696.................  Ondansetron           Do.
                               Injection USP, EQ 2
                               mg (base)/mL.
ANDA 077065.................  Terbinafine HCl       Gedeon Richter PLC,
                               Tablets, EQ 250 mg    c/o Gedeon Richter
                               (base).               USA, Inc., 1200
                                                     East Ridgewood
                                                     Ave., Ridgewood, NJ
                                                     07450.
ANDA 077333.................  Amlodipine Besylate   Do.
                               Tablets, EQ 2.5 mg
                               (base), 5 mg
                               (base), and 10 mg
                               (base).
ANDA 077389.................  Carboplatin           Teva Parenteral
                               Injection.            Medicines, Inc., 19
                                                     Hughes, Irvine, CA
                                                     92618.
ANDA 077392.................  Lamotrigine Tablets,  Roxane Laboratories,
                               25 mg, 100 mg, 150,   Inc., 1809 Wilson
                               mg, and 200 mg.       Rd., Columbus, OH
                                                     43228.
ANDA 077994.................  Ironotecan HCl        Sandoz, Inc., 2555
                               Injection.            West Midway Blvd.,
                                                     Broomfield, CO
                                                     80038-0446.
ANDA 080416.................  Procaine HCl          Hospira, Inc.
                               Injection USP, 1%
                               and 2%.
ANDA 083346.................  Isoproterenol HCl     Do.
                               Injection USP, 0.2
                               mg/mL.
ANDA 084178.................  Methyltestosterone    KV Pharmaceutical
                               Tablets, 5 mg.        Co., One Corporate
                                                     Woods Dr.,
                                                     Bridgeton, MO
                                                     63044.
ANDA 084179.................  Methyltestosterone    Do.
                               Tablets, 25 mg.
ANDA 084312.................  Methyltestosterone    Do.
                               Tablets, 10 mg.
ANDA 084767.................  Dimenhydrinate        Baxter Healthcare
                               Injection USP.        Corp.
ANDA 085284.................  Aminophylline         KV Pharmaceutical
                               Tablets, 100 mg.      Co.
ANDA 085285.................  Secobarbital Sodium   Do.
                               Capsules, 100 mg.
ANDA 085289.................  Aminophylline         Do.
                               Tablets, 200 mg.
ANDA 085363.................  Acetaminophen and     Do.
                               Codeine Phosphate
                               Tablets, 325 mg/45
                               mg.
ANDA 085384.................  Triprolidine HCl      Do.
                               Syrup, 1.25mg/5 mL.
ANDA 085385.................  Promethazine HCl      Do.
                               Syrup, 25 mg/5 mL.
ANDA 085388.................  Promethazine HCl      Do.
                               Syrup, 6.25 mg/5 mL.
ANDA 085466.................  Brompheniramine       Do.
                               Maleate Elixir, 2
                               mg/5 mL.
ANDA 085492.................  Acetic Acid with      Do.
                               Hydrocortisone Otic
                               Solution, 2%/1%.
ANDA 085493.................  Acetic Acid Otic      Do.
                               Solution, 2%.
ANDA 085551.................  Hydroxyzine HCl       Baxter Healthcare
                               Injection USP, 25     Corp.
                               mg/mL and 50 mg/mL.
ANDA 085621.................  Diphenhydramine HCl   KV Pharmaceutical
                               Elixir, 12.5 mg/5     Co.
                               mL.
ANDA 085810.................  Prednisone Tablets,   Do.
                               5 mg.
ANDA 086619.................  Hydrocortisone        Baxter Healthcare
                               Sodium Succinate      Corp.
                               for Injection USP,
                               EQ 100 mg (base)/
                               Vial.
ANDA 086661.................  Donnatal              A.H. Robins Co., c/o
                               (phenobarbital,       Wyeth
                               hyoscyamine           Pharmaceuticals,
                               sulfate, atropine     Inc., P.O. Box
                               sulfate,              8299, Philadelphia,
                               scopolamine (HBr))    PA 19101-8299.
                               Elixir.
ANDA 086676.................  Donnatal              Do.
                               (phenobarbital,
                               hyoscyamine
                               sulfate, atropine
                               sulfate,
                               scopolamine (HBr))
                               Tablets.
ANDA 086677.................  Donnatal              Do.
                               (phenobarbital,
                               hyoscyamine
                               sulfate, atropine
                               sulfate,
                               scopolamine (HBr))
                               Capsules.
ANDA 086797.................  Novocain (procaine    Hospira, Inc.
                               HCl injection USP)
                               10%.
ANDA 086906.................  Methylprednisolone    Elkins-Sinn, Inc., c/
                               Sodium Succinate      o Baxter Healthcare
                               for Injection USP,    Corp.
                               EQ 40 mg (base),
                               125 mg (base), 500
                               mg (base), and 1 g
                               (base) Vials.
ANDA 087239.................  Aminophylline         Do.
                               Injection USP, 25
                               mg/mL.
ANDA 087240.................  Aminophylline         Luitpold
                               Injection USP, 25     Pharmaceuticals,
                               mg/mL.                Inc.
ANDA 087311.................  Chlorthalidone        KV Pharmaceutical
                               Tablets, 25 mg.       Co.
ANDA 087312.................  Chlorthalidone        Do.
                               Tablets, 50 mg.
ANDA 087506.................  Muro Opcon            Bausch & Lomb, Inc.
                               (naphazoline HCl
                               ophthalmic solution
                               USP, 0.1%).
ANDA 087567.................  Hydrocortisone        Baxter Healthcare
                               Sodium Succinate      Corp.
                               for Injection USP,
                               EQ 250 mg (base)/
                               Vial.
ANDA 087568.................  Hydrocortisone        Do.
                               Sodium Succinate
                               for Injection USP,
                               EQ 500 mg (base)/
                               Vial.

ANDA 087569.................  Hydrocortisone        Do.
                               Sodium Succinate
                               for Injection USP,
                               EQ 1 g (base)/Vial.
ANDA 087584.................  Potassium Chloride    Luitpold
                               for Injection         Pharmaceuticals,
                               Concentrate USP.      Inc.
ANDA 087601.................  Aminophylline         Hospira, Inc.
                               Injection USP, 25
                               mg/mL.
ANDA 087956.................  Vitamin K1            Do.
                               (phytonadione
                               injection emulsion
                               USP), 10 mg/mL.
ANDA 088279.................  Meperidine HCl        Baxter Healthcare
                               Injection USP, 25     Corp.
                               mg/mL.
ANDA 088280.................  Meperidine HCl        Do.
                               Injection USP, 50
                               mg/mL.
ANDA 088281.................  Meperidine HCl        Do.
                               Injection USP, 75
                               mg/mL.
ANDA 088282.................  Meperidine HCl        Do.
                               Injection USP, 100
                               mg/mL.
ANDA 088326.................  Lidocaine HCl         Hospira, Inc.
                               Injection USP, 1.5%.
ANDA 088331.................  Lidocaine HCl         Do.
                               Injection USP, 2%.
ANDA 088368.................  Lidocaine HCl         Do.
                               Injection USP, 20%.
ANDA 088371.................  Cyclophosphamide for  Baxter Healthcare
                               Injection USP, 100    Corp.
                               mg/Vial.
ANDA 088372.................  Cyclophosphamide for  Do.
                               Injection USP, 200
                               mg/Vial.
ANDA 088373.................  Cyclophosphamide for  Do.
                               Injection USP, 500
                               mg/Vial.
ANDA 088374.................  Cyclophosphamide for  Do.
                               Injection USP, 1 g/
                               Vial.
ANDA 089649.................  Lidocaine HCl and     Hospira, Inc.
                               Epinephrine
                               Injection.
ANDA 089703.................  Prochlorperazine      Do.
                               Edisylate Injection
                               USP, EQ 5 mg (base)/
                               mL.
ANDA 089707.................  Perphenazine Tablets  Ivax Pharmaceuticals
                               USP, 2 mg.            Inc., 400 Chestnut
                                                     Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 090954.................  Cromolyn Sodium Oral  Pack
                               Solution              Pharmaceuticals,
                               Concentrate, 100 mg/  LLC, 1110 West Lake
                               5 mL.                 Cook Rd., suite
                                                     152, Buffalo Grove,
                                                     IL 60089.
------------------------------------------------------------------------
\1\ This product was an oral pressurized metered-dose inhaler that
  contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
  longer be used as a propellant for any metaproterenol sulfate or
  fluticasone propionate metered-dose inhalers (see 75 FR 19213-19241,
  April 14, 2010; 71 FR 70870-70873, December 7, 2006).

    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 of Food and Drugs, approval of the applications listed
in table 1 of this document, and all amendments and supplements
thereto, is hereby withdrawn, effective July 8, 2011. 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 of this document 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: May 31, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-14164 Filed 6-7-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Rules and Regulations]
[Pages 51887-51890]
[FR Doc No: 2011-21185]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0426]
RIN 1625-AA00

Safety Zone; Patuxent River, Patuxent River, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone during
the ``NAS Patuxent River Air Expo '11,'' which consists of aerial
practices, performance demonstrations and air shows, to be held over
certain waters of the Patuxent River adjacent to Patuxent River,
Maryland from September 1, 2011 through September 4, 2011. This rule is
necessary to provide for the safety of life on navigable waters during
the event. This action is intended to temporarily restrict vessel
traffic in portions of the Patuxent River during the event.

DATES: This rule is effective from September 1, 2011 through September
4, 2011.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2011-0426 and are available online by going to
http://www.regulations.gov, inserting USCG-2011-0426 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. Ronald Houck, U.S. Coast Guard
Sector Baltimore, MD; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On June 22, 2011, we published a notice of proposed rulemaking
(NPRM) entitled ``Safety Zone; Patuxent River, Patuxent River, MD'' in
the Federal Register (76 FR 36447). 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 less than 30 days after
publication in the Federal Register. Due to the need for immediate
action, the restriction of vessel traffic is necessary to protect life,
property and the environment; therefore, a 30-day notice is
impracticable. Delaying the effective date would be contrary to the
safety zone's intended objectives of protecting persons and vessels,
and enhancing public and maritime safety.

Background and Purpose

    U.S. Naval Air Station Patuxent River, Maryland is hosting the
``NAS Patuxent River Air Expo '11'' on September 3, 2011 and September
4, 2011. The public event will consist of military and civilian
aircraft performing low-flying, high-speed precision maneuvers and
aerial stunts over both the airfield at Naval Air Station Patuxent
River and the waters of the Patuxent River. Federal Aviation
Administration restrictions require that portions of the Blue Angels
and aerobatic performance boxes take place over the waters of the
Patuxent River. In addition to the air show dates, on September 3, 2011
and September 4, 2011, military and civilian aircraft performing in the
air show will conduct practice and demonstration maneuvers and stunts
over both the airfield at Naval Air Station Patuxent River and
specified waters of the Patuxent River. To provide for the safety of
participants, spectators, and transiting vessels, the Coast Guard
proposes to temporarily restrict vessel traffic on specified waters of
the Patuxent River in the vicinity of the air shows, practices and
demonstrations, and during other scheduled activities related to the
air show. To address safety concerns during the event, the Captain of
the Port, Baltimore is establishing a safety zone upon certain waters
of the Patuxent River.

Discussion of Comments and Changes

    The Coast Guard received no comments in response to the NPRM. No
public meeting was requested and none was held.

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. Although this safety zone restricts
vessel traffic through the affected area, the effect of this regulation
will not be significant due to the limited size and duration that the
regulated area will be in effect. In addition, notifications will be
made to the maritime community via marine information broadcasts so
mariners may adjust their plans accordingly.

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 rule may affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to operate or transit through or within the safety zone during the
enforcement period. The safety zone will not have a significant
economic impact on a substantial number of small entities for the
following reasons. The safety zone is of limited size and duration.
Smaller vessels not constrained by their draft, which are more likely
to be small entities, may transit around the safety zone. Maritime
advisories will be widely available to the maritime community before
the effective period.

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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

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 (adjusted for
inflation) 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 cause 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 does not create an
environmental risk to health or risk to safety that may
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
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
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
(34)(g), of the Instruction. This rule involves establishing a
temporary safety zone. An environmental analysis checklist and a
categorical exclusion determination are available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add temporary Sec.  165.T05-0426 to read as follows:

Sec.  165.T05-0426  Safety Zone; Patuxent River, Patuxent River, MD.

    (a) Regulated area. The following locations are regulated areas:
    (1) All waters of the lower Patuxent River, near Patuxent River,
Maryland, located between Fishing Point and the base of the break wall
marking the entrance to the East Patuxent Basin at Naval Air Station
Patuxent River, within an area bounded by a line connecting position
latitude 38[deg]17'39'' N, longitude 076[deg]25'47'' W; thence to
latitude 38[deg]17'47'' N, longitude 076[deg]26'00'' W; thence to
latitude 38[deg]18'09'' N, longitude 076[deg]25'40'' W; thence to
latitude 38[deg]18'00'' N, longitude 076[deg]25'25'' W, located along
the shoreline at U.S. Naval Air Station Patuxent River, Maryland.
    (2) All waters of the lower Patuxent River, near Patuxent River,
Maryland, located north of the West Patuxent Basin at Naval Air Station
Patuxent River, within an area bounded by a line drawn from a position
at latitude 38[deg]18'04'' N, longitude 076[deg]27'35'' W; to latitude
38[deg]18'09'' N, longitude 076[deg]27'33'' W; thence to latitude
38[deg]17'51'' N, longitude 076[deg]26'22'' W; thence to latitude
38[deg]17'46'' N, longitude 076[deg]26'23'' W; thence to point of
origin, located adjacent to the shoreline at U.S. Naval Air Station
Patuxent River, Maryland. All coordinates reference Datum NAD 1983.
    (b) Definitions. As used in this section:
    (1) Captain of the Port Baltimore means the Commander, U.S. Coast
Guard Sector Baltimore, Maryland.
    (2) Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Baltimore to assist in enforcing the safety zone described in
paragraph (a) of this section.
    (c) Regulations. (1) All persons are required to comply with the
general regulations governing safety zones found in 33 CFR 165.23.
    (2) Entry into or remaining in this zone is prohibited unless
authorized by the Coast Guard Captain of the Port Baltimore. Vessels
already at berth, mooring, or anchor at the time the safety zone is
implemented do not have to depart the safety zone. All vessels underway
within this safety zone at the time it is implemented are to depart the
zone.
    (3) Persons desiring to transit the area of the safety zone must
first request authorization from the Captain of the Port Baltimore or
his designated

representative. To seek permission to transit the area, the Captain of
the Port Baltimore and his designated representatives can be contacted
at telephone number<PHONE_NUMBER> or on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz). The Coast Guard vessels enforcing this section
can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz).
Upon being hailed by a U.S. Coast Guard vessel, or other Federal,
State, or local agency vessel, by siren, radio, flashing lights, or
other means, the operator of a vessel shall proceed as directed. If
permission is granted, all persons and vessels must comply with the
instructions of the Captain of the Port Baltimore or his designated
representative and proceed at the minimum speed necessary to maintain a
safe course while within the zone.
    (4) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (d) Enforcement periods. This section will be enforced as follows:
    (1) During the air show practice from 8 a.m. until 6 p.m. on
September 1, 2011.
    (2) Air show practice and modified show from 9 a.m. until 6 p.m. on
September 2, 2011.
    (3) Twilight performance from 4:30 p.m. until 8:30 p.m. on
September 2, 2011.
    (4) Air show performances from 8 a.m. until 7 p.m. on September 3,
2011 and from 8 a.m. until 7 p.m. on September 4, 2011.

    Dated: August 4, 2011.
Mark P. O'Malley,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2011-21185 Filed 8-18-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 22, 2010 (Volume 75, Number 204)]
[Notices]
[Page 65401]
[DOCID:fr22oc10-142]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[AC 187-1D]

Schedule of Charges Outside the United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of availability.

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

SUMMARY: The Federal Aviation Administration (FAA) is announcing the
availability of Advisory Circular (AC) 187-1D which transmits an
updated schedule of charges for services of FAA Flight Standards
Aviation Safety Inspectors outside the United States. The advisory
circular has been updated in accordance with the procedures listed in
14 CFR part 187, Appendix A.

DATES: This AC is effective on October 1, 2010.

ADDRESSES: How to obtain copies: A copy of this publication may be
downloaded from: http://www.faa.gov/documentLibrary/media/Advisory_
Circular/AC%20187-1D.pdf.

FOR FURTHER INFORMATION CONTACT: Ms. Tish Thompkins-Imafidon, Flight
Standards Service, AFS-50, Federal Aviation Administration, 800
Independence Avenue, SW., Washington, DC 20591, telephone (202) 385-
8097.

    Issued in Washington, DC on September 29, 2010.
Raymond Towels,
Deputy Director, Flight Standards Service.
[FR Doc. 2010-26322 Filed 10-21-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53594-53595]
[FR Doc No: 2023-16865]

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

DEPARTMENT OF TRANSPORTATION

Bureau of Transportation Statistics

[Docket Number OST-2023-0115]

Agency Information Collection Activity; Notice of Request for
Approval To Collect New Information: Safe Maritime Transportation
System (SafeMTS)--Voluntary Near-Miss Incident Reporting and Analysis
System

AGENCY: Bureau of Transportation Statistics (BTS), Office of the
Assistant Secretary for Research and Technology (OST-R), U.S.
Department of Transportation.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the requirements of section 3506(c)(2)(A)
of Title 44 of the U.S. Code (Paperwork Reduction Act of 1995), this
notice announces the intention of BTS to request the Office of
Management and Budget (OMB) to approve a new data collection: SafeMTS--
Voluntary Near-Miss Reporting and Analysis System.

DATES: Written comments should be submitted by October 10, 2023.

ADDRESSES: To ensure that your comments are not entered more than once
into the docket, submit comments by only one of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov and follow the instructions for sending your
comments electronically. Docket Number: OST-2023-0115.
     Mail: Docket Services, 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. EST, Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. Note that all comments received will be posted without
change to https://www.regulations.gov, including any personal
information provided. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov, and follow the
online instructions for accessing the docket, or go to the street
address listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Allison Fischman, Office of Safety
Data and Analysis, Bureau of Transportation Statistics, Office of the
Assistant Secretary for Research and Technology, U.S. Department of
Transportation, RTS-35, 1200 New Jersey Avenue SE, Washington, DC
20590-0001, [email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    In August 2022, the Maritime Administration's (MARAD) Office of
Safety and BTS signed an Interagency Agreement (IAA) to develop and
implement SafeMTS, a voluntary program for confidential reporting of
`near-misses' occurring on vessels within the Maritime Transportation
System (MTS). The SafeMTS program provides a trusted, proactive means
for the maritime industry to report sensitive and proprietary safety
information, and to identify early warnings of safety problems and
potential safety issues by uncovering hidden, at-risk conditions not
previously exposed from analysis of reportable accidents and incidents.
Companies participating in SafeMTS are voluntarily submitting safety
data. There is no regulatory requirement to submit such data.
    The scope of SafeMTS includes a broad range of data categories to
promote safe operations and appropriate risk management, which adds a
learning component to assist the maritime industry in achieving
improved safety performance. BTS will be the repository for the data
and will analyze and aggregate information proffered under this
program. BTS will publish aggregated analyses providing information on
potential causal factors and trends or patterns before safety is
compromised and affording continuous improvement opportunities by
focusing on repairing impediments to safety. This information
collection is necessary to aid MARAD, the maritime industry, and other
stakeholders in identifying safety trends and causes of near-miss
incidents.
    Title: SafeMTS--Near-Miss Reporting and Analysis Program for the
Maritime Transportation System.
    OMB Control Number: Not yet known.
    Type of Request: New collection.
    Affected Public: Businesses in the maritime industry that involve
ownership or operation of vessels.
    Number of Potential Responses: One hundred, submitted on a
quarterly basis.
    Estimated Total Annual Burden: 400 hours.
    Abstract: The Confidential Information Protection and Statistical
Efficiency Act of 2002 (CIPSEA) (44 U.S.C. 3501 note), can provide
strong confidentiality protection for information acquired for
statistical purposes under a pledge of confidentiality. CIPSEA guidance
from the Office of Management and Budget advises that a non-statistical
agency or unit (MARAD) that wishes to acquire information with CIPSEA
protection may consider entering into an agreement with a Federal
statistical agency or unit (BTS). BTS and MARAD have determined that it
is in the public interest to collect and process near-miss incident
related data under a pledge of confidentiality for statistical purposes
only.
    Working with subject matter experts, BTS will then aggregate and
further analyze these reports to identify potential causal factors and
trends. All data reviewers would be subject to nondisclosure
requirements mandated by CIPSEA. The results of these aggregated
analyses will be distributed by BTS through publications, meetings, and
other forms. Periodic industry meetings may be scheduled by MARAD or
industry to discuss the data analysis and trend results, as well as
share ideas and process improvements for preventing recurrence.
    In August 2022, BTS and MARAD signed an IAA to develop and
implement SafeMTS, a voluntary program for confidential reporting of
`near-misses' occurring on vessels. The goal of the voluntary near-miss
reporting system is to provide BTS with essential information about
accident precursors and other hazards. Under the program, BTS will
develop and publish aggregate analyses that the industry and all MTS
stakeholders can use--in conjunction with incident reports and other
sources of information--to reduce safety and environmental risks and
continue building a more robust safety culture within the maritime
industry.
    BTS, within the U.S. Department of Transportation (U.S. DOT), is an
objective supplier of statistically sound baseline, contextual, and
trend information used to shape

transportation policy and investment decisions across the United
States. BTS is responsible for providing timely, accurate, and reliable
information on U.S. passenger and freight transportation systems and
the impact on the economy, society, and the environment. Further, BTS
has experience developing and administering near-miss safety data
collection programs for transportation and offshore energy sectors. As
a federal statistical agency, BTS has the authority to collect data
confidentially for statistical purposes under CIPSEA, which allows the
program to overcome legal concerns among companies about sharing
sensitive near-miss and safety data.
    There is currently no reporting regime in place for maritime
industry near-miss or safety incidents and other non-casualty/
reportable safety matters. Marine casualties and many other incidents
are reportable via separate regulations under either OSHA (Occupational
Safety and Health Administration) or USCG (U.S. Coast Guard)
jurisdiction. However, near-miss reporting is not required under
current regulations, and no industrywide database of near-miss events
exists for the maritime industry. A consolidated database of near-miss
incident data would allow for analysis and dissemination of key
findings to the industry for use in advancing maritime transportation
safety.
    The SafeMTS program, established by MARAD and BTS as a joint
program, aims to fill this gap by establishing a confidential safety
data system to collect and analyze voluntarily reported, safety-related
data from the maritime industry to advance marine transportation
safety. A broad set of existing data will be captured from industry
partners and analyzed to identify critical safety-related trends that
could prevent incidents or identify otherwise non-correlated events.
With a broad set of data that includes protection from discovery as
mandated by industry and robust data analytics, potential hazards of
maritime operations can be identified and shared across the industry so
corrective actions can be taken to improve safety. The benefit of data
analytics in this area has been discussed in numerous studies, National
Academies publications, reports, and articles for over two decades.
This program will provide MARAD, in partnership with industry, with the
ability to identify critical safety issues and concerns and leverage
this information to advance maritime safety.
    Respondents who report near-miss incidents will be asked to submit
their data and pertinent supplemental information. Respondents will
submit the report electronically to BTS. Respondents will be asked to
provide information such as: time and location of the event; a short
description of the event and operating conditions that existed at the
time of the event; contributing factors to the event; results of an
investigation or safety analysis report; any corrective actions taken
as a result of the event; and any other information that might be
useful in determining ways to prevents such events from occurring.
    Data Confidentiality Provisions: The confidentiality of near miss
and safety event information submitted to BTS is protected under the
BTS confidentiality statute (49 U.S.C. 6307) and the Confidential
Information Protection and Statistical Efficiency Act (CIPSEA) of 2018
(Pub. L. 115-435, Title III of the Foundations for Evidence-Based
Policymaking Act of 2018). In accordance with these confidentiality
statutes, only aggregated and non-identifying data will be made
publicly available by BTS through its reports for statistical purposes
only. BTS will not release to information that might reveal the
identity of individuals or organizations mentioned in event notices or
reports without explicit consent of the respondent and any other
affected entities.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) whether the proposed
collection is necessary for the performance of BTS's functions; (2) the
accuracy of the estimated burden; (3) ways for BTS to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information. Comments received after the comment closing
date will be included in the docket and will be considered to the
extent practicable.

Allison Fischman,
Acting Office Director.
[FR Doc. 2023-16865 Filed 8-7-23; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Rules and Regulations]
[Pages 72094-72097]
[FR Doc No: 2011-30096]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 30814; Amdt. No. 497]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This amendment adopts miscellaneous amendments to the required
IFR (instrument flight rules) altitudes and changeover points for
certain Federal airways, jet routes, or direct routes for which a
minimum or maximum en route authorized IFR altitude is prescribed. This
regulatory action is needed because of changes occurring in the
National Airspace System. These changes are designed to provide for the
safe and efficient use of the navigable airspace under instrument
conditions in the affected areas.

DATES: Effective Date: 0901 UTC, December 15, 2011.

FOR FURTHER INFORMATION CONTACT: Rick Dunham, Flight Procedure
Standards Branch (AMCAFS-420), Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail addresses: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes,

ensure navigation aid coverage that is adequate for safe flight
operations and free of frequency interference. The reasons and
circumstances that create the need for this amendment involve matters
of flight safety and operational efficiency in the National Airspace
System, are related to published aeronautical charts that are essential
to the user, and provide for the safe and efficient use of the
navigable airspace. In addition, those various reasons or circumstances
require making this amendment effective before the next scheduled
charting and publication date of the flight information to assure its
timely availability to the user. The effective date of this amendment
reflects those considerations. In view of the close and immediate
relationship between these regulatory changes and safety in air
commerce, I find that notice and public procedure before adopting this
amendment are impracticable and contrary to the public interest and
that good cause exists for making the amendment effective in less than
30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95

    Airspace, Navigation (air).

    Issued in Washington, DC on November 11, 2011.
John McGraw,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, December 15, 2011.

PART 95--IFR ALTITUDES

0
1. The authority citation for part 95 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44719, 44721.

0
2. Part 95 is amended to read as follows:

REVISIONS TO IFR ALTITUDES & CHANGEOVER POINTS AMENDMENT 497 EFFECTIVE
DATE December 15, 2011

------------------------------------------------------------------------
               From                           To                 MEA
------------------------------------------------------------------------
                       &95.6001 Victor Routes-U.S.
       &95.6014 VOR Federal Airway V14 is Amended to Read in Part
------------------------------------------------------------------------
Will Rogers, OK VORTAC...........  Totes, OK FIX...........         3700
Drops, OK FIX....................  Tulsa, OK VORTAC........
                                   NE BND..................         2800
                                   SW BND..................         3800
------------------------------------------------------------------------
       &95.6017 VOR Federal Airway V17 is Amended to Read in Part
------------------------------------------------------------------------
Fator, TX FIX....................  *Nelee, TX FIX..........       **4000
    *5500-MRA....................
    **2800-MOCA..................
Centex, TX VORTAC................  Waco, TX VORTAC.........         3600
------------------------------------------------------------------------
       &95.6054 VOR Federal Airway V54 is Amended to Read in Part
------------------------------------------------------------------------
Sandhills, NC VORTAC.............  *RAEFO, NC FIX..........       **6000
    *6000-MRA....................
    **2000-MOCA..................
    **3000-GNSS MEA..............
*Raefo, NC FIX...................  Fayetteville, NC VOR/DME       **2800
    *6000-MRA....................
    **1900-MOCA..................
------------------------------------------------------------------------
       &95.6104 VOR Federal Airway V104 Is Amended to Read in Part
------------------------------------------------------------------------
Malae, NY FIX....................  Plattsburgh, NY VORTAC..        *7000
    *6100-MOCA...................
    *6100-GNSS MEA...............
------------------------------------------------------------------------
       &95.6113 VOR Federal Airway V113 is Amended to Read in Part
------------------------------------------------------------------------
Helena, MT VORTAC................  Lewistown, MT VOR/DME...        11100
------------------------------------------------------------------------
       &95.6137 VOR Federal Airway V137 is Amended to Read in Part
------------------------------------------------------------------------
Palmdale, CA VORTAC..............  Vicky, CA FIX...........        *8000
    *5800-MOCA...................
Vicky, CA FIX....................  Jeffy, CA FIX...........
                                   E BND...................         8000
                                   W BND...................         9000
Jeffy, CA FIX....................  Gorman, CA VORTAC.......
                                   E BND...................         8000

                                   W BND...................        10100
------------------------------------------------------------------------
       &95.6271 VOR Federal Airway V271 is Amended to Read in Part
------------------------------------------------------------------------
Muskegon, MI VORTAC..............  WELKO, MI FIX...........        *3000
    *2500-MOCA...................
Welko, MI FIX....................  Manistee, MI VOR/DME....        *4000
    *2400-MOCA...................
------------------------------------------------------------------------
       &95.6276 VOR Federal Airway V276 is Amended to Read in Part
------------------------------------------------------------------------
Manta, NJ FIX....................  *Prepi, OA FIX..........       **6000
    *8000-MRA....................
    **2000-MOCA..................
    **3000-GNSS MEA..............
------------------------------------------------------------------------
       &95.6287 VOR Federal Airway V287 is Amended to Read in Part
------------------------------------------------------------------------
Fort Jones, CA VOR/DME...........  Klama, OR FIX...........       *12000
    *9800-MOCA...................
Klama, OR FIX....................  *Rogue Valley, OR VORTAC
                                   SE BND..................        12000
                                   NW BND..................         8000
    *7000-MCA Rogue Valley, OR
     VORTAC, SE BND.
------------------------------------------------------------------------
       &95.6296 VOR Federal Airway V296 is Amended to Read in Part
------------------------------------------------------------------------
Hustn, NC FIX....................  *Raefo, NC FIX..........       **5000
    *6000-MRA....................
    **2300-MOCA..................
    **2400-GNSS MEA..............
*Raefo, NC FIX...................  Fayetteville, NC VOR/DME       **2800
    *6000-MRA....................
    **1900-MOCA..................
------------------------------------------------------------------------
       &95.6465 VOR Federal Airway V465 is Amended to Read in Part
------------------------------------------------------------------------
Miles City, MT VOR/DME...........  Williston, ND VORTAC....        *7000
    *5200-MOCA...................
    *6000-GNSS MEA...............
------------------------------------------------------------------------
       &95.6545 VOR Federal Airway V545 is Amended to Read in Part
------------------------------------------------------------------------
Miles City, MT VOR/DME...........  Williston, ND VORTAC....        *7000
    *5300-MOCA...................
    *6000-GNSS MEA...............
------------------------------------------------------------------------
   &95.6319 ALASKA VOR Federal Airway V319 is Amended to Read in Part
------------------------------------------------------------------------
Vidda, AK FIX....................  Weeke, AK FIX...........
                                   SW BND..................        *3000
                                   NE BND..................        *6000
    *2100-MOCA...................
------------------------------------------------------------------------
   &95.6440 ALASKA VOR Federal Airway V440 is Amended to Read in Part
------------------------------------------------------------------------
Yucon, AK FIX....................  Unalakleet, AK VOR/DME..
                                   W BND...................         4600
                                   E BND...................         8000
------------------------------------------------------------------------
    &95.6423 HAWAII VOR Federal Airway V23 is Amended to Read in Part
------------------------------------------------------------------------
Jessi, HI FIX....................  *Fires, HI FIX..........         8000
    *13000-MRA...................
------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                      From                                         To                       MEA          MAA
----------------------------------------------------------------------------------------------------------------
                                               &95.7001 JET ROUTES
                                &95.7037 Jet Route J37 is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
Brooke, VA VORTAC...............................  Nales, DE FIX.......................        18000        31000
----------------------------------------------------------------------------------------------------------------

                                &95.7060 Jet Route J60 is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
Philipsburg, PA VORTAC..........................  Sparta, NJ VORTAC...................        18000        45000
----------------------------------------------------------------------------------------------------------------
                               &95.7204 Jet Route J204 is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
Miles City, MT VOR/DME..........................  Hilgr, MT FIX.......................        19000        45000
Hilgr, MT FIX...................................  Great Falls, MT VORTAC..............        18000        45000
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                    Airway Segment                                          Changeover Points
----------------------------------------------------------------------------------------------------------------
                      From                                         To                     Distance       From
----------------------------------------------------------------------------------------------------------------
              &95.8003 VOR Federal Airway Changeover Points V104 is Amended to Add Changeover Point
----------------------------------------------------------------------------------------------------------------
Massena, NY VORTAC..............................  Plattsburgh, NY VORTAC..............           16      Massena
----------------------------------------------------------------------------------------------------------------
                                     V271 is Amended to Add Changeover Point
----------------------------------------------------------------------------------------------------------------
Muskegon, MI VORTAC.............................  Manistee, MI VOR/DME................           37     Muskegon
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-30096 Filed 11-21-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 227 (Monday, November 26, 2012)]
[Notices]
[Pages 70425-70426]
[FR Doc No: 2012-28468]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No. 13946-001]

Tarrant Regional Water District; Notice of Application for
Amendment of Exemption and Soliciting Comments, Motions To Intervene,
and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amendment of Exemption.
    b. Project No.: P-13946-001.
    c. Date Filed: October 26, 2012.
    d. Applicant: Tarrant Regional Water District.
    e. Name of Project: Arlington Outlet Hydroelectric Project.
    f. Location: The Arlington Outlet Hydroelectric Project is located
at the Arlington Outlet Discharge Facility, a flow control facility in
Tarrant Regional Water District's water distribution system located in
Tarrant County, Texas. The project does not affect federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Dena Wiggins, Partner, Ballard Spahr LLP,
1909 K Street NW., 12th Floor, Washington, DC, 20006; Telephone: (202)
661-2225.
    i. FERC Contact: Any questions on this notice should be addressed
to Christopher Chaney, Telephone<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: 30 days from the issuance date of this notice.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site (http://www.ferc.gov/docs-filing/efiling.asp). Commenters can submit brief comments up to
6,000 characters, without prior registration, using the eComment system
(http://www.ferc.gov/docs-filing/ecomment.asp) and must include name
and contact information at the end of comments. The Commission strongly
encourages electronic filings.
    All documents (original and seven copies) filed by paper should be
sent to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. Please include the project number (P-
13946-001) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
interveners

filing documents with the Commission to serve a copy of that document
on each person whose name appears on the official service list for the
project. Further, if an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of any motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    k. Description of Application: The exemptee proposes to amend the
site and powerhouse arrangements and the installed capacity based on
the project's final design. Under the proposed amendment, the
powerhouse footprint would increase from 39 feet by 42 feet to 46 feet
by 46 feet, the powerhouse would be constructed approximately 40 feet
to the northwest, the discharge pipe would be relocated from the south
side to the east side of the powerhouse, and the authorized installed
capacity would increase from 1,300 kilowatts (kW) to 1,350 kW. No
change in project operation is proposed.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site using the ``eLibrary'' link at http://elibrary.ferc.gov/idmws/search/fercgensearch.asp. Enter the docket
number excluding the last three digits (P-13946) in the docket number
field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of
new filings and issuances related to this or other pending projects.
For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: November 16, 2012.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-28468 Filed 11-23-12; 8:45 am]
BILLING CODE 6717-01-P