[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17163-17168]
[FR Doc No: 2014-06801]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0021]

Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated
New Drug Applications for Prescription Pain Medications Containing More
Than 325 Milligrams of Acetaminophen

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 108 abbreviated new drug applications (ANDAs) for prescription pain
medications containing more than 325 milligrams (mg) of acetaminophen.
The holders of these ANDAs have voluntarily requested that approval of
these applications be withdrawn and have waived their opportunity for a
hearing.

DATES: Effective March 27, 2014.

FOR FURTHER INFORMATION CONTACT: Rachel Turow, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-5094.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 2011
(76 FR 2691), FDA announced its plans to reduce the maximum dosage unit
strength of acetaminophen in prescription drug products. The notice

announced FDA's conclusion that, based on a reevaluation of the
relative risks and benefits of prescription acetaminophen products,
fixed-combination prescription drugs containing more than 325 mg of
acetaminophen per dosage unit (tablet or capsule) do not provide a
sufficient margin of safety to protect the public against the serious
risk of acetaminophen-induced liver injury. Accordingly, we asked
product sponsors to limit the maximum amount of acetaminophen per
dosage unit to 325 mg and, for those products containing more than 325
mg of acetaminophen per dosage unit, to submit requests that FDA
withdraw approval of their applications under Sec.  314.150(d) (21 CFR
314.150(d)). FDA asked that all such requests be made before January
14, 2014. Table 1 lists the applications for which FDA has received
such requests. The sponsors of the applications listed in table 1 have
also waived their opportunity for a hearing.

     Table 1--Applications for Which Withdrawal of Approval Has Been
                                Requested
------------------------------------------------------------------------
     Application No.          Drug product(s)       Applicant or holder
------------------------------------------------------------------------
ANDA 040199.............  Acetaminophen and       Actavis Totowa LLC,
                           Oxycodone               200 Elmora Ave.,
                           Hydrochloride           Elizabeth, NJ 07207.
                           Capsules, 500 mg/5 mg.
ANDA 040748.............  Acetaminophen and       Amneal
                           Hydrocodone             Pharmaceuticals, 85
                           Bitartrate Tablets,     Adams Ave.,
                           500 mg/7.5 mg.          Hauppauge, NY 11788.
ANDA 040754.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040757.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 040769.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040789.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 650 mg/10 mg.
ANDA 040813.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040729.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 040304.............  Acetaminophen and       Barr Laboratories
                           Oxycodone               Inc., 2 Quaker Rd.,
                           Hydrochloride           P.O. Box 2900,
                           Capsules, 500 mg/5 mg.  Pomona, NY 10956.
ANDA 040307.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg
                           Acetaminophen and
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040308.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040309.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040701.............  Acetaminophen,          Boca Pharmacal LLC,
                           Caffeine, and           3550 Northwest 126th
                           Dihydrocodeine          Ave., Coral Springs,
                           Bitartrate Tablets,     FL 33065.
                           712.8 mg/60 mg/32 mg.
ANDA 090265.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and       Caraco Pharmaceutical
                           Hydrocodone             Laboratories, Ltd.,
                           Bitartrate Tablets,     270 Prospect Plains
                           500 mg/10 mg.           Rd., Cranbury, NJ
                                                   08512.
ANDA 090380.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 088898.............  Acetaminophen and       Central
                           Hydrocodone             Pharmaceuticals Inc.,
                           Bitartrate Capsules,    110-128 East 3rd St.,
                           500 mg/5 mg.            Seymour, IN 47274.
ANDA 090177.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and       Coastal
                           Oxycodone               Pharmaceuticals, 1240
                           Hydrochloride           Sugg Pkwy.,
                           Tablets, 650 mg/10 mg.  Greenville, NC 27834.
ANDA 040289.............  Acetaminophen and       Duramed
                           Oxycodone Capsules,     Pharmaceuticals Inc.,
                           500 mg/5 mg.            Sub Barr Laboratories
                                                   Inc., 2 Quaker Rd.,
                                                   P.O. Box 2900,
                                                   Pomona, NY 10970-
                                                   0519.
ANDA 076202.............  Acetaminophen and       Gavis Pharmaceuticals,
                           Pentazocine             LLC, 400 Campus Dr.,
                           Hydrochloride           Somerset, NJ 08873.
                           Tablets, 650 mg/EQ 25
                           mg Base.
ANDA 089696.............  Acetaminophen and       Ivax Pharmaceuticals
                           Hydrocodone             Inc., 140 Legrand
                           Bitartrate Tablets,     Ave., Northvale, NJ
                           500 mg/5 mg.            07647.

ANDA 089907.............  ALLAY (Acetaminophen     Do.
                           and Hydrocodone
                           Bitartrate) Capsules,
                           500 mg/5 mg.
ANDA 088790.............  TYLOX (Acetaminophen    Janssen Research &
                           and Oxycodone           Development, LLC, 920
                           Hydrochloride)          U.S. Hwy. 202, P.O.
                           Capsules, 500 mg/5 mg.  Box 300, Raritan, NJ
                                                   08869.
ANDA 040084.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and       Mallinckrodt Chemical
                           Hydrocodone             Inc., 675 McDonnell
                           Bitartrate Tablets,     Blvd., Hazelwood, MO
                           660 mg/10 mg.           63042.
ANDA 040201.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040257.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Capsules, 500 mg/5 mg.
ANDA 087336.............  LORCET-HD                Do.
                           (Acetaminophen and
                           Hydrocodone
                           Bitartrate) Capsules,
                           500 mg/5 mg.
ANDA 088956.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 088991.............  BUCET (Acetaminophen     Do.
                           and Butalbital)
                           Capsules, 650 mg/50
                           mg.
ANDA 089006.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 089160.............  ANEXSIA (Acetaminophen   Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           500 mg/5 mg.
ANDA 089405.............  TENCON (Acetaminophen    Do.
                           and Butalbital)
                           Capsules, 650 mg/50
                           mg.
ANDA 089725.............  ANEXSIA 7.5/650          Do.
                           (Acetaminophen and
                           Hydrocodone
                           Bitartrate) Tablets,
                           650 mg/7.5 mg.
ANDA 040418.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;7.5 mg/15 mL.
ANDA 040468.............  ANEXSIA (Acetaminophen   Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           750 mg/10 mg.
ANDA 040508.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;10 mg/15 mL.
ANDA 040550.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 650 mg/10 mg.
ANDA 040085.............  ESGIC-PLUS              Mikart, Inc., 1750
                           (Acetaminophen,         Chattahoochee Ave.,
                           Butalbital, and         Atlanta, GA 30318.
                           Caffeine) Capsules,
                           500 mg/50 mg/40 mg.
ANDA 040496.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 750
                           mg/50 mg/40 mg.
ANDA 040676.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/10 mg.
ANDA 040679.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/2.5
                           mg.
ANDA 040687.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/5 mg.
ANDA 040692.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/10 mg.
ANDA 040698.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 400 mg/7.5
                           mg.
ANDA 040849.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/5 mg.
ANDA 081051.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL; 7.5 mg/15 mL.
ANDA 081067.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 081223.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 089008.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 089451.............  ESGIC-PLUS               Do.
                           (Acetaminophen,
                           Butalbital, and
                           Caffeine) Tablets,
                           500 mg/50 mg/40 mg.
ANDA 089689.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 089698.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.

ANDA 089699.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
ANDA 089988.............  BUTAPAP (Acetaminophen   Do.
                           and Butalbital)
                           Tablets, 650 mg/50 mg.
ANDA 089231.............  Acetaminophen and        Do.
                           Codeine Phosphate
                           Tablets, 650 mg/30 mg.
ANDA 089271.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 089363.............  Acetaminophen and        Do.
                           Codeine Phosphate
                           Tablets, 650 mg/60 mg.
ANDA 040109.............  Acetaminophen,           Do.
                           Caffeine, and
                           Dihydrocodeine
                           Bitartrate Capsules,
                           356.4 mg/30 mg/16 mg.
ANDA 040316.............  Acetaminophen,           Do.
                           Caffeine, and
                           Dihydrocodeine
                           Bitartrate Tablets,
                           712.8 mg/60 mg/32 mg.
ANDA 081068.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 081069.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 081070.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Capsules,
                           500 mg/5 mg.
ANDA 089557.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;5 mg/15 mL.
ANDA 089697.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 040883.............  Acetaminophen,          Mirror Pharmaceuticals
                           Butalbital, and         LLC, 140 New Dutch
                           Caffeine Tablets, 500   Lane, Fairfield, NJ
                           mg/50 mg/40 mg.         07004.
ANDA 040219.............  Acetaminophen and       Mutual Pharmaceutical
                           Oxycodone Capsules,     Co. Inc., 1100
                           500 mg/5 mg.            Orthodox St.,
                                                   Philadelphia, PA
                                                   19124.
ANDA 040236.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040240.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040061.............  ROXILOX (Acetaminophen  Roxane Laboratories
                           and Oxycodone           Inc., 1809 Wilson
                           Hydrochloride)          Rd., Columbus, OH
                           Capsules, 500 mg/5 mg.  43228.
ANDA 089775.............  ROXICET 5/500            Do.
                           (Acetaminophen and
                           Oxycodone
                           Hydrochloride)
                           Tablets, 500 mg/5 mg.
ANDA 040100.............  LORTAB (Acetaminophen   UCB Inc., 1950 Lake
                           and Hydrocodone         Park Dr., Bldg. 2100,
                           Bitartrate) Tablets,    Smyrna, GA 30080.
                           500 mg/10 mg.
ANDA 087722.............  LORTAB (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           500 mg/5 mg.
ANDA 087757.............  CO-GESIC                 Do.
                           (Acetaminophen and
                           Hydrocodone
                           Bitartrate) Tablets,
                           500 mg/5 mg.
ANDA 088831.............  PHRENILIN FORTE         Valeant
                           (Acetaminophen and      Pharmaceuticals North
                           Butalbital) Capsules,   America LLC, 700
                           650 mg/50 mg.           Route 202/206 North,
                                                   Bridgewater, NJ
                                                   08807.
ANDA 040106.............  Acetaminophen and       Vintage
                           Oxycodone               Pharmaceuticals, 150
                           Hydrochloride           Vintage Dr.,
                           Capsules, 500 mg/5 mg.  Huntsville, AL 35811.
ANDA 040143.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 040144.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
ANDA 040155.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040157.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040356.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/10 mg.
ANDA 040358.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
ANDA 040513.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 500
                           mg/50 mg/40 mg.
ANDA 040520.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Oral
                           Solution, 500 mg/15
                           mL;7.5 mg/15 mL.
ANDA 089971.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 089831.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.

ANDA 040280.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
ANDA 040281.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040288.............  ZYDONE (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           400 mg/5 mg.
                          ZYDONE (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           400 mg/7.5 mg.
                          ZYDONE (Acetaminophen    Do.
                           and Hydrocodone
                           Bitartrate) Tablets,
                           400 mg/10 mg.
ANDA 040303.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Capsules, 500 mg/5 mg.
ANDA 040341.............  PERCOCET                 Do.
                           (Acetaminophen and
                           Oxycodone
                           Hydrochloride)
                           Tablets, 500 mg/7.5
                           mg.
                          PERCOCET                 Do.
                           (Acetaminophen and
                           Oxycodone
                           Hydrochloride)
                           Tablets, 650 mg/10 mg.
ANDA 040371.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Tablets, 500 mg/7.5
                           mg.
                          Acetaminophen and       Watson Laboratories,
                           Oxycodone               311 Bonnie Circle,
                           Hydrochloride           Corona, CA 92880.
                           Tablets, 650 mg/10 mg.
ANDA 040094.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/10 mg.
ANDA 040234.............  Acetaminophen and        Do.
                           Oxycodone
                           Hydrochloride
                           Capsules, 500 mg/5 mg.
ANDA 040267.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 500
                           mg/50 mg/40 mg.
ANDA 081079.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
ANDA 081080.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
ANDA 081083.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040122.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040123.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/2.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/7.5 mg.
                          Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           650 mg/10 mg.
ANDA 089883.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           500 mg/5 mg.
ANDA 040493.............  Acetaminophen and       Watson Laboratories
                           Hydrocodone             Inc.--Florida, 2945
                           Bitartrate Tablets,     West Corporate Lakes
                           500 mg/5 mg.            Blvd., Suite B,
                                                   Weston, FL 33331.
ANDA 040494.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           750 mg/7.5 mg.
ANDA 040495.............  Acetaminophen and        Do.
                           Hydrocodone
                           Bitartrate Tablets,
                           660 mg/10 mg.
ANDA 040441.............  CODRIX (Acetaminophen    Do.
                           and Codeine
                           Phosphate) Tablets,
                           500 mg/30 mg.
ANDA 040447.............  CODRIX (Acetaminophen    Do.
                           and Codeine
                           Phosphate) Tablets,
                           500 mg/15 mg.
ANDA 040488.............  CODRIX (Acetaminophen    Do.
                           and Codeine
                           Phosphate) Tablets,
                           500 mg/60 mg.
ANDA 040261.............  Acetaminophen,          West-Ward
                           Butalbital, and         Pharmaceutical Corp.,
                           Caffeine Capsules,      435 Industrial Way
                           500 mg/50 mg/40 mg.     West, Eatontown, NJ
                                                   07724.

ANDA 040336.............  Acetaminophen,           Do.
                           Butalbital, and
                           Caffeine Tablets, 500
                           mg/50 mg/40 mg.
ANDA 040688.............  Acetaminophen,          WraSer Pharmaceuticals
                           Caffeine, and           LLC, 121 Marketridge
                           Dihydrocodeine          Dr., Ridgeland, MS
                           Bitartrate Capsules,    39157.
                           356.4 mg/30 mg/16 mg.
------------------------------------------------------------------------

    Therefore, under Sec.  314.150(d), and under authority delegated to
the Director, Center for Drug Evaluation and Research, by the
Commissioner of Food and Drugs, approval of the applications for the
drug products listed in table 1 of this document, and all amendments
and supplements thereto, is withdrawn (see DATES). Distribution of
these products in interstate commerce without an approved application
is illegal and subject to regulatory action (see sections 505(a) and
301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
    The safety issue discussed in this document and the January 14,
2011, Federal Register document is limited to products containing more
than 325 mg of acetaminophen per dosage unit. Thus, the withdrawal of
approval of products containing more than 325 mg of acetaminophen per
dosage unit listed in table 1 does not change the approval status of
any products with 325 mg or less of acetaminophen per dosage unit that
were approved under the same application. In addition, the withdrawal
of approval of products containing more than 325 mg of acetaminophen
per dosage unit does not change the approval status of products with
325 mg or less of acetaminophen per dosage unit that refer to or rely
on the withdrawn products. For example, this withdrawal action will not
affect the approval status of an ANDA for a product that contains 325
mg or less per dosage unit that references a product listed in table 1,
but for which FDA approved a suitability petition for a lower strength
under section 505(j)(2)(C) of the FD&C Act and Sec.  314.93 (21 CFR
314.93)).

    Dated: March 24, 2014.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2014-06801 Filed 3-26-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Pages 77004-77005]
[FR Doc No: 2014-30091]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL 9920-79-OGC]

Proposed Settlement Agreement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Proposed Settlement Agreement; Request for Public
Comment.

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

SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``Act''), notice is hereby given of a proposed settlement
agreement to address lawsuits filed by Oxy Vinyls, LP; The Vinyl
Institute, Inc. (``Vinyl Institute''); PolyOne Corp. (now, Mexichem
Specialty Resins, Inc.); Saint-Gobain Corp. and CertainTeed Corp.
(collectively ``Petitioners'') in the United States Court of Appeals
for the District of Columbia Circuit (Case Nos. 12-1260, 12-1265, 12-
1266, and 12-1267). Between June 14, 2012 and June 18, 2012,
Petitioners filed petitions for review of EPA's final rule entitled
``National Emission Standards for Hazardous Air Pollutants for
Polyvinyl Chloride and Copolymers Production,'' (April 17, 2012). The
proposed settlement agreement establishes deadlines for EPA to take
action.

DATES: Written comments on the proposed settlement agreement must be
received by January 22, 2015.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2014-0899, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Mark M. Kataoka, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Settlement Agreement

    The proposed settlement agreement will partially resolve lawsuits
seeking review of EPA's final rule entitled ``National Emission
Standards for Hazardous Air Pollutants for Polyvinyl Chloride and
Copolymers Production,'' 77 FR 22848, April 17, 2012, (``PVC NESHAP''
or ``2012 Rule). On June 18, 2012, Petitioner Vinyl Institute and
others petitioned for reconsideration and to stay the 2012 Rule pending
reconsideration with EPA, and on September 28, 2012, EPA granted
administrative reconsideration of the 2012 Rule on at least
Petitioners' claims that the public was not afforded a reasonable
opportunity to comment on emission limits in the final 2012 Rule for
process wastewater. The proposed settlement agreement states that no
later than January 21, 2015, EPA will sign a direct final rule and
parallel proposal withdrawing the total non-vinyl chloride organic
hazardous air pollutant (``TOHAP'') process wastewater emission limits
for new and existing area sources. The proposed settlement agreement
provides that to the extent that EPA establishes new TOHAP process
wastewater emission limits for existing and new area sources, those
emission limits will be set pursuant to the reconsideration process or
other separate rulemaking, and not through the direct final or final
rule described in the settlement agreement. Under the proposed
settlement agreement, if EPA receives adverse comments on and withdraws
the direct final rule, EPA will make its best efforts to sign a notice
taking final action on the parallel proposal within 15 days of the
close of the comment period. In addition, the proposed settlement
agreement states that Oxy Vinyls, LP will move to dismiss its petition
for review, and the remaining Petitioners will move to dismiss the
issue of the existing and new area source TOHAP process wastewater
emission limits from their petitions for review within 7 days following
the effective date of the direct final rule or a final rule withdrawing
the existing and new area source TOHAP process wastewater limits.
Nothing in the proposed settlement agreement limits or modifies EPA's
discretion under the Clean Air Act in either the related direct final
rulemaking process or otherwise.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed settlement agreement from persons who were not named as
parties or intervenors to the litigation in question. EPA or the
Department of Justice may withdraw or withhold consent to the proposed
settlement agreement if the comments disclose facts or considerations
that indicate that such consent is inappropriate, improper, inadequate,
or inconsistent with the requirements of the Act. Unless EPA or the
Department of Justice determines that consent to this settlement
agreement should be withdrawn, the terms of the agreement will be
affirmed.

II. Additional Information About Commenting on the Proposed Settlement
Agreement

A. How can I get a copy of the settlement agreement?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2014-0899) contains a copy of the proposed settlement
agreement. The official public docket is available for public viewing
at the Office of Environmental Information (OEI) Docket in the EPA
Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    An electronic version of the public docket is available through
www.regulations.gov. You may use the www.regulations.gov to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or

other information whose disclosure is restricted by statute.
Information claimed as CBI and other information whose disclosure is
restricted by statute is not included in the official public docket or
in the electronic public docket. EPA's policy is that copyrighted
material, including copyrighted material contained in a public comment,
will not be placed in EPA's electronic public docket but will be
available only in printed, paper form in the official public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the EPA Docket Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: December 15, 2014.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2014-30091 Filed 12-22-14; 8:45 am]
BILLING CODE 6560-50-P


Evi Huffer: I think that, is your point the fact that you're claiming that widespread electronic record keeping is already going on in various programs across the board.

Jamie Conrad: I'm thinking if GPEA says that agencies should make electronic reporting available where that's a practical option, and that they should ensure that electronic records aren't denied legal validity and enforceability and so on. If in fact that's what seems to be occurring, then one interpretation of the GPEA no obligations on EPA to do anything further. It's only in those instances where the word paper is used in the regulation that creates an obstacle. The GPEA would say you've got to take that, you know, paper word out of the regulations, but that otherwise, if it ain't broke don't fix it.

Michael LeDesma: Well, I mean, unless industry stands up as a whole and says we want you to declare to us that our current 96 record keeping, electronic record keeping report, well,

recordkeeping is illegal, the agency is not proposing to do that.

The agency is proposing that whatever the current status is,

we're going to .... GPEA requires that we define how that electronic reporting is going to take place, and how that electronic record keeping is going to take place in the future.

But I don't think, through GPEA, I mean through CROMERRR, we're trying, we're attempting to speak to the past.

Jamie Conrad: But the, I mean there is, I went back and checked after you raised the question, issue earlier. GPEA does say that electronic record keeping once, I'm sorry that the CROMERRR, once CROMERRR becomes effective, it says that there can only be electronic record keeping where it's been turned on. The turn on thing is in both reporting and recordkeeping Which would suggest that all current electronic record keeping practices would be illegal once CROMERRR becomes effective, unless those are not electronic records somehow.

David Schwarz: I think we talked a little bit about that this morning. That wasn't the intent. And if it turns out that that is in fact the effect, then we need to reconsider that.

Jamie Conrad: Okay. I guess my last question is, did EPA ever conduct the risk analysis that's discussed in the OMB's GPEA guidance talks about doing a risk analysis of the likelihood of fraud and the potential degree of harm if there was fraud 97 versus the costs in terms of money and operability and the kinds of remedies that might prevent that.

Male Participant/ EPA: Where our primary focus on the risk analysis is ( inaudible) wide range of ( inaudible) from the record keeping ( inaudible)

Jamie Conrad: Is there a document in the docket somewhere that represents that risk analysis?

Male Participant/ EPA: I believe that there ( inaudible) I'm not really sure.

Evi Huffer: GPEA ( inaudible)

Jamie Conrad: Is it something you'd be willing to put in the docket, or is it ( inaudible)?

Evi Huffer: ( inaudible)

Jamie Conrad: Okay, thanks.

Mark Duvall: I'm Mark Duvall with the Dow Chemical Company. I wanted to follow up on Howard Kruger's comment about the cost and the arithmetic that he did. I'd like to offer a different view.

According to the EPA cost benefit analysis, there are 1.2 million facilities with EPA reporting obligations, either reporting to EPA itself or to states and tribes and so forth.

It seems reasonable to assume that if there are 1.2 million reporting facilities, there are at least that many facilities subject to EPA and related record keeping facilities, record 98 keeping requirements.

So if we use for working purposes 1.2 million as the number of facilities which have record keeping obligations, and if we assume that all of them use computers in keeping at least some of those records at least some of the time, then that's the number that we would multiply by whatever the cost of the record keeping provisions would be.

So if we take EPA's cost benefit analysis figures of $ 40,000 for an initial cost plus continuing costs, if we just focus on the $ 40,000 and multiply that by 1.2 million facilities, it comes to a total of $ 48 billion, just for the record keeping piece, just for the initial investment. My question is, in EPA's evaluation of the rule, have you done any justification for a number on that order of magnitude for costs?

David Schwarz: I think the question really goes ultimately to this question about whether or not the rule is voluntary. From our perspective, at the time we were writing this rule, we understood that this rule was voluntary.

And in fact, I mean as a legal matter it is voluntary.

With limited exception, very limited exception, electronic record keeping is still voluntary. So, I mean I guess the issue is really, the question that you're asking really goes to the question of whether or not it's voluntary, and the agency's 99 again taking a look at that.

Mark Duvall: Thank you.

Kathleen Barrowclough: I haven't got this one written down ahead of time so I may stumble a little bit. Kathy Barrowclough, DuPont. And when you're talking about electronic document receiving systems, EPA puts certain criteria associated with an electronic document receiving system; these are over and above electronic record keeping requirements.

You've only indicated nine electronic record keeping requirements. And then you also distinguish between and electronic record and an electronic document, indicating that an electronic document is one that is transmitted over the wires.

And there are specific requirements for electronic documents that are also not applied to electronic records.

When we look at all of those different requirements, we see an opportunity to apply any of those to electronic records, and we would just like to, I guess, hear clarification from you in that the requirements for electronic document receiving systems, which are a robustness that we would associate with our electronic record keeping systems, our data collection systems.

But you're not applying those to electronic record keeping systems. Nor are you, there are some particular things around 100 electronic signatures, in the electronic document requirements.

You are not also applying those to electronic record keeping is what it appears in the rule. And I just want a clarification from EPA on that.

Male Participant/ EPA: Yes, and again I guess we will have to make sure that this is absolutely clear in the final rule, but the criteria for what we call electronic document receiving systems are meant to apply to systems created and maintained by state or local agencies that operate a localized program ( inaudible) allegation.

They are not meant to apply to companies that are regulated by EPA or by these state or local agencies. So in this completely different universe of entities that are being addressed by these criteria for document receiving systems.

Paul Toll: I'm Paul Toll with Bayer Corporation. And just to kind of second everything that's already been said today from the other companies, I was wondering since there are so many questions, so many uncertainties, so many things that you said you had to clarify, would you consider clarifying those and then open it up for another public commentary?

Male Participant/ EPA: ( inaudible)

Kathleen Barrowclough: Since we seem to be getting down to the end of the line here, Kathy Barrowclough, DuPont. And what I'd like to do is go back, several people have mentioned about 101 getting a group of the right people, stakeholders together, in some sort of a working group. And it's one of the things that the GLP community has encouraged over the past year.

We know we'd like to participate as well as probably several of the other interested stakeholders who are here. And I guess we're just wanting to hear something from EPA about how and when something like that might go forward other than just this public meeting forum, but a working group kind of meeting.

Evi Huffer: This is something that EPA can take back and consider, but right now we do not have any plans for such,

performing such a working group at this time.

Joe Retzer: ( inaudible) public comment ( inaudible) get the comments in ( inaudible) a good suggestion ( inaudible)

Michael LeDesma: I guess just one other point about that, and that's why I kind of turned the mike. If we had such a group in conjunction with the rule making, it would probably need to be constituted under something called a federal advisory ( inaudible) ...

Evi Huffer: Thank you very much.

David Schwarz: Thank you for coming.

( ADJOURN)


[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Page 60514]
[FR Doc No: 2011-25146]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3318-EM; Docket ID FEMA-2011-0001]

North Dakota; Amendment No. 6 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
State of North Dakota (FEMA-3318-EM), dated April 7, 2011, and related
determinations.

DATES: Effective Date: September 14, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Deanne
Criswell, of FEMA is appointed to act as the Federal Coordinating
Officer for this emergency.
    This action terminates the appointment of Willie G. Nunn as Federal
Coordinating Officer for this emergency.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-25146 Filed 9-28-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80809-80810]
[FR Doc No: 2010-32271]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9242-4]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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

SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA''), 42 U.S.C. 7413(g), notice is hereby given of a
proposed consent decree, to address a lawsuit filed by Sierra Club in
the United States District Court for the District of Columbia: Sierra
Club v. Jackson, No. 10-cv-0859 (D.D.C.) Plaintiff filed a deadline
suit to compel the Administrator to respond to an administrative
petition seeking EPA's objection to a CAA Title V operating permit
issued by the Kentucky Department of Air Quality to the Tennessee
Valley Authority's Paradise Fossil Plant in Drakesboro, Kentucky. Under
the terms of the proposed consent decree, EPA has agreed to respond to
the petition by February 9, 2011.

DATES: Written comments on the proposed consent decree must be received
by January 24, 2011.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2010-1051, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Gautam Srinivasan, Air and Radiation
Law Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    This proposed consent decree would resolve a lawsuit alleging that
the Administrator failed to perform a nondiscretionary duty to grant or
deny, within 60 days of submission, an administrative petition to
object to a CAA Title V permit issued by the Kentucky Department of Air
Quality to the Tennessee Valley Authority's Paradise Fossil Plant in
Drakesboro, Kentucky. Under the terms of the proposed consent decree,
EPA has agreed to respond to the petition by February 9, 2011. In
addition, the proposed consent decree further states that EPA shall
deliver notice of such action to the Office of the Federal Register for
prompt publication and shall within 15 business days following
signature, if EPA's response contains an objection in whole or in part,
transmit the signed response to the Kentucky Department of Air Quality.
The proposed consent decree states that after EPA fulfills its
obligations under the decree, the case shall be dismissed with
prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the CAA. Unless EPA or the Department of
Justice determines that consent to this consent decree should be
withdrawn, the terms of the decree will be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2010-1051) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use http://www.regulations.gov to
submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, key in the appropriate docket identification number then select
``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: December 15, 2010.
Richard B. Ossias,
Associate General Counsel.
[FR Doc. 2010-32271 Filed 12-22-10; 8:45 am]
BILLING CODE 6560-50-P


Relevant Meetings with External Stakeholders since Publication of the 2012 HCFC Proposed Rule:
January 10, 2012  -  EPA staff attended Alliance for Responsible Atmospheric Policy board meeting
January 19, 2012  -  Meeting with representatives from Rapid Recovery
January 30, 2012  -  Meeting with representatives from DuPont
January 31, 2012  -  EPA staff attended the Alliance Refrigerant Imports Committee Meeting
February 2, 2012  -  Meeting with a group of reclaimers (see attached list)
February 3, 2012  -  Meeting with representatives from the Department of Energy
February 6, 2012  -  Meeting with representatives from United Technologies (Carrier)
February 8, 2012  -  Meeting with representatives from the Air-Conditioning, Heating, and Refrigeration Institute (AHRI)
February 15, 2012  -  Meeting with representatives from Honeywell
February 22, 2012  -  Meeting with representatives from Hudson Technologies
March 5, 2012  -  Meeting with representatives from Solvay
March 19, 2012  -  Meeting with representatives from the Food Marketing Institute
March 21, 2012  -  EPA staff presented at the AHRI Media Roundtable
March 21  -  Meeting with representatives from the Air Conditioning Contractors of America (ACCA) and Heating, Air-conditioning & Refrigeration Distributors International (HARDI)
June 6, 2012  -  Meeting with representatives from HARDI and Johnstone Supply
June 29, 2012  -  Meeting with representatives from DuPont
January 16, 2013  -  Meeting with representatives from DuPont
February 12, 2013  -  Meeting with representatives of Honeywell

This document does not reflect meetings held at the Office of Management and Budget while the rule was being reviewed in accordance with E.O. 12866 and E.O. 13563 . For a list of those meetings and the participants, please visit http://www.whitehouse.gov/omb/oira_2060_meetings/.


[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Page 55011]
[FR Doc No: 2022-19384]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]

Notice of Approval of Product Under Voucher: Rare Pediatric
Disease Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of approval of product redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by
the Food and Drug Administration Safety and Innovation Act (FDASIA),
authorizes FDA to award priority review vouchers to sponsors of
approved rare pediatric disease product applications that meet certain
criteria. FDA is required to publish notice of the issuance of priority
review vouchers as well as the approval of products redeeming a
priority review voucher. FDA has determined that VABYSMO (faricimab-
svoa), for which a priority review voucher was redeemed, was approved
January 28, 2022.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the approval of product
redeeming a rare pediatric disease priority review voucher. Under
section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by
FDASIA, FDA will report the issuance of rare pediatric disease priority
review vouchers and the approval of products for which a voucher was
redeemed. FDA has determined that VABYSMO (faricimab-svoa), approved
January 28, 2022, meets the redemption criteria.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about VABYSMO (faricimab-svoa), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19384 Filed 9-7-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47491-47492]
[FR Doc No: 2021-18295]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG21-221-000.
    Applicants: Montague Solar, LLC.
    Description: Notice of Self-Certification of EG or FC of Montague
Solar, LLC of Exempt Wholesale Generator Status.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5080.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: EG21-222-000.
    Applicants: Fairbanks Solar Holdings LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Fairbanks Solar Holdings LLC.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5126.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: EG21-223-000.
    Applicants: Fairbanks Solar Energy Center LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Fairbanks Solar Energy Center LLC.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5127.
    Comment Date: 5 p.m. ET 9/9/21.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER21-2392-001.
    Applicants: Power Authority of the State of New York, New York
Independent System Operator, Inc.
    Description: Tariff Amendment: Power Authority of the State of New
York submits tariff filing per 35.17(b): Amendment filing of NYPA Cost
Containment Mechanism for Segment A to be effective 9/15/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5103.
    Comment Date: 5 p.m. ET 8/26/21.

    Docket Numbers: ER21-2632-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Second Quarter 2021
Capital Budget Report.
    Filed Date: 8/9/21.
    Accession Number: 20210809-5232.
    Comment Date: 5 p.m. ET 8/30/21.

    Docket Numbers: ER21-2712-000.
    Applicants: Heartland Generation Ltd.
    Description: Baseline eTariff Filing: Baseline Tariff to be
effective 10/19/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5052.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2713-000.
    Applicants: SE Athos I, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 8/20/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5081.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2714-000.
    Applicants: SE Athos II, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization and Request for Waivers to be effective 8/20/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5082.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2715-000.
    Applicants: Fairbanks Solar Energy Center LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 10/19/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5121.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2716-000.
    Applicants: Fairbanks Solar Holdings LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 10/19/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5122.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2717-000.

    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2021-08-19_Att X Generator
Replacement Transfer Restriction Reform Filing to be effective 10/19/
2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5128.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2719-000.
    Applicants: NextEra Energy Seabrook, LLC.
    Description: Baseline eTariff Filing: Engineering and Procurement
Agreement Between NextEra Energy Seabrook and NECEC to be effective 8/
20/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5129.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2720-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2021-08-19_Clarifying
ineligibility of DIRs to provide online STR to be effective 12/7/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5135.
    Comment Date: 5 p.m. ET 9/9/21.

    Docket Numbers: ER21-2721-000.
    Applicants: ITC Midwest LLC.
    Description: Sec.  205(d) Rate Filing: NSPM Lakefield Junction CIAC
to be effective 8/20/2021.
    Filed Date: 8/19/21.
    Accession Number: 20210819-5150.
    Comment Date: 5 p.m. ET 9/9/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 19, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-18295 Filed 8-24-21; 8:45 am]
BILLING CODE 6717-01-P


 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

1650 Arch Street

Philadelphia, Pennsylvania 19103-2029

DATE:

August 11, 2009

SUBJECT:

	Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Opacity Variance for Rocket Testing Operations Atlantic
Research Corporation’s Orange County Facility

Technical Support Document

FROM:

	Gregory Becoat, Environmental Scientist /s/

Air Quality Planning Branch (3AP21)

TO:

REVIEWED BY:	SIP Docket File

                  /s/

Cristina Fernandez, Branch Chief

Air Quality Planning Branch (3AP21)

I.	Affected Regulation

In accordance with §10.1-1307 of the Virginia Air Pollution Control
Law, 40 CFR Part 51 (Requirements for Preparation, Adoption, and
Submittal of Implementation Plans), and the requirements of section 110
of the federal Clean Air Act (CAA), the Commonwealth of Virginia
requested approval of a revision to the State Implementation Plan (SIP).
 This revision to the Commonwealth of Virginia’s SIP consists of a
variance (9 VAC 5 Chapter 220) for the rocket motor test operations at
Atlantic Research Corporation’s Orange County Facility from the
standard for visible emissions in 9 VAC 5-50-80.

II.	 Background

  SEQ CHAPTER \h \r 1 On January 26, 2004, the Commonwealth of Virginia
submitted to EPA a regulation revision CV-1, which consisted of an
opacity variance for the rocket motor test operations at Aerojet
Corporation’s Orange County facility.  The variance is included in
Title 9 of the Virginia Administrative Code (9 VAC Chapter 220) and was
effective on December 1, 2002.  Virginia adopted, in lieu of opacity
limits established in 9 VAC 5-50-80, a variance that requires the
facility to limit total particulate matter (PM) emissions from its
rocket motor test operations to 714 pounds per hour (9 VAC 5-220-30.B).
Along with regulation revision CV-1, the Commonwealth of Virginia
included in their submittal, proposed and final regulations,
certification of public participation activities and compliance with
state administrative procedures, a record of hearing, summary of
testimony, and a technical support document (TSD).

Upon administrative and technical review of regulation revision CV-1,
the U.S. Environmental Protection Agency (EPA) determined that the
dispersion modeling submitted in the TSD was inadequate.  On April 20,
2005, the company provided a more comprehensive TSD to provide
additional modeling information to the EPA.  However, the EPA had
additional comments and questions concerning the submittal.  EPA
determined that the Open Burn/Open Detonation (OB/OD) dispersion model
used to estimate the PM emissions from the rocket motor testing
operations was not an EPA-approved model and therefore, Virginia must
request written approval from the EPA Regional Administrator for the use
of the OB/OD model and provide public notice of the use of an
alternative model.  See 40 CFR 51.112(a)(2).

On February 27, 2006, EPA received a letter dated February 21, 2006,
officially requesting withdrawal of the Commonwealth of Virginia’s
January 28, 2004 submittal.  Pursuant to Virginia’s withdrawal letter,
EPA returned the January 28, 2004 SIP revision to the Commonwealth of
Virginia for further review.

On May 5, 2008, the Virginia Department of Environmental Quality (VADEQ)
requested EPA’s approval to allow the use of the OB/OD dispersion
model for a variance from Virginia’s standard for visible emissions, 9
VAC 5-50-80.  EPA reviewed VADEQ rationale for allowing Aerojet
Corporation to use the OB/OD dispersion model for the air quality
analyses for the facility in Orange County.  On July 24, 2008, EPA
approved that the detailed discussion of the criteria under section
3.2.2(e) of the Guideline on Air Quality Models fulfilled the criteria
for selecting OB/OD as an alternative to the generally preferred
American Meteorological Society/EPA Regulatory Model. See Appendix W to
40 CFR Part 51.

On February 19, 2009, VADEQ resubmitted a request for approval of a
revision to the Commonwealth of Virginia’s SIP.  The revision consists
of information in support of a variance (9 VAC 5 Chapter 220) for the
rocket motor test operations at Aerojet Corporation’s Orange County
Facility from the standard for visible emissions in 9 VAC 5-50-80.  The
submittal contains a comprehensive TSD with additional air dispersion
modeling information requested by EPA, as well as EPA’s approval of
the OB/OD dispersion model.

III.	Summary of Action

  SEQ CHAPTER \h \r 1 On January 26, 2004, the Commonwealth of Virginia
submitted a revision to its SIP designated as revision CV-1.   As part
of the rulemaking for revision CV-1, Virginia submitted an opacity
variance for the rocket motor test operations at Aerojet Corporation’s
Orange County facility.  The variance, adopted on September 30, 2002, is
included in Title 9 of the Virginia Administrative Code (9 VAC Chapter
220) and was effective on December 1, 2002.  Virginia, in lieu of
opacity limits established in 9 VAC 5-50-80, a variance that requires
the facility to limit total PM emissions from its rocket motor test
operations to 714 pounds per hour (9 VAC 5-220-30.B).  The following
provisions are affected by this revision:

9 VAC 5-220-10 - Applicability and designation of affected facility.
(added)

9 VAC 5-220-20 - Definitions.  (added)

9 VAC 5-220-30 - Applicability of standard for visible emissions and
standard for particulate matter.  (added)

9 VAC 5-220-40 - Compliance determination, monitoring, recordkeeping,
and reporting.  (added)

9 VAC 5-220-50 - Transfer of ownership.  (added)

9 VAC 5-220-60 - Applicability of future regulations.  (added)

On February 19, 2009, VADEQ submitted additional information to support
the variance for the rocket motor test operations, which included a
comprehensive TSD that provides additional air dispersion modeling
information requested by EPA for approval of the addition of 9 VAC
5-220-30.

 IV.  Evaluation

EPA recommends approval of the “Variance for Rocket Motor Test
Operations at Atlantic Research Corporation Orange County Facility” (9
VAC 5 Chapter 220) in order to add regulations 9 VAC 5-220-10, 9 VAC
5-220-20, 9 VAC 5-220-30, 9 VAC 5-220-40, 9 VAC 5-220-50, and 9 VAC
5-220-60.  EPA recommends approval of this revision to the SIP because
the additions pertain to Atlantic Research Corporation Orange County
Facility in terms of applicability and designation, definitions,
applicability of standard for visible emissions and standard for PM,
compliance determination, monitoring, recordkeeping, and recording,
transfer of ownership, and applicability of future regulation
amendments.  This revision does not change the substance of the SIP, and
consequently, does not interfere with the timely attainment or progress
towards attainment of a national ambient air quality standard (NAAQS),
nor interfere with any other provision of the CAA, 42 U.S.C. 7401 et
seq.

EPA recommends approval of the addition of 9 VAC 5-220-30,
“Applicability of standard for visible emissions and standard for
particulate matter” in order to establish PM emission limits for
Aerojet Corporation’s rocket test operations in lieu of opacity
standards established in 9 VAC 5-50-80.  EPA approves this revision
because the modeling analysis included in Virginia’s “Technical
Support Documentation for Opacity Variance for Rocket Test Facility”
appears to show that emissions from Aerojet Corporation’s Orange
County Facility will not cause or significantly contribute to violations
of the PM NAAQS.  Further details of EPA’s modeling analysis can be
found in a TSD prepared by Timothy A. Leon Guerrero.

V.   Conclusion

This SIP revision request satisfies all requirements for an acceptable
SIP revision.

VI.  Recommended Agency Action

The SIP revision request should be approved.

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