List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period, 42827-42828 [2015-17729]

Download as PDF Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices presented supports the conclusion that the conduct upon which Dr. Brancato’s debarment was based is unlikely to recur. For these reasons, the Agency finds that termination of Dr. Brancato’s debarment serves the interest of justice and will not pose a threat to the integrity of the drug approval process. Under section 306(d)(4)(D) of the FD&C Act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Dr. Brancato’s period of debarment, which commenced on January 6, 1994, has lasted more than 1 year. Accordingly, the Director of the Office of Enforcement and Import Operations, under section 306(d)(4) of the FD&C Act and under authority delegated to the Director (Staff Manual Guide 1410.35), finds that David J. Brancato’s application for special termination of debarment should be granted, and that the period of debarment should terminate immediately, thereby allowing him to provide services in any capacity to a person with an approved or pending drug product application. The Director of Enforcement and Import Operations further finds that because the Agency is granting Dr. Brancato’s application, an informal hearing under section 306(d)(4)(C) of the FD&C Act is unnecessary. As a result of the foregoing findings, Dr. David J. Brancato’s debarment is terminated effective (see DATES) (21 U.S.C. 335a(d)(4)(C) and (d)(4)(D)). Dated: July 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–17712 Filed 7–17–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1196] List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period AGENCY: Food and Drug Administration, mstockstill on DSK4VPTVN1PROD with NOTICES HHS. ACTION: Notice; extension of nomination period. Electronic Submissions Submit electronic nominations in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written nominations in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. FDA– 2015–N–1196. All nominations received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting nominations, see the ‘‘Request for Nominations’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or nominations received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary Medicine, Food and Drug Administration (HFV– 210), 7519 Standish Pl., Rockville, MD 20855, 240–402–5745, neal.bataller@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is extending the nomination period for the notice that appeared in the Federal Register of May 19, 2015. In the notice, FDA requested nominations for a list of bulk drug SUMMARY: VerDate Sep<11>2014 substances that may be used by facilities registered as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs from bulk substances, in accordance with FDA’s draft guidance for industry (GIF) #230, ‘‘Compounding Animal Drugs from Bulk Drug Substances.’’ The FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit nominations. DATES: Submit either electronic or written nominations for the bulk drug substances list by November 16, 2015. ADDRESSES: You may submit nominations by any of the following methods: 16:30 Jul 17, 2015 Jkt 235001 I. Background In the Federal Register of May 19, 2015 (80 FR 28622), FDA published a notice with a 90-day nomination period for the list of bulk drug substances that PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 42827 may be used by a facility registered as an outsourcing facility under section 503B of the FD&C Act (21 U.S.C. 353B) to compound drugs for use in animals in accordance with FDA’s draft GFI #230, ‘‘Compounding Animal Drugs from Bulk Drug Substances.’’ That notice describes the information that should be provided to the FDA in support of each nomination. FDA has received a request for a 90day extension of the nomination period as the requestor wanted more time to nominate drugs to the list and to provide supporting data. FDA has considered the request and is extending the nomination period for 90 days, until November 16, 2015. The FDA believes that a 90-day extension allows adequate time for interested persons to submit nominations without significantly delaying consideration of these nominations. II. Nomination Process The process for nominations for bulk drug substances that may be used by facilities registered as outsourcing facilities under section 503B of the FD&C Act to compound animal drugs from bulk drug substances is described in the previous notice published May 19, 2015. FDA cannot guarantee that all drugs nominated during the nomination period will be considered for initial inclusion in Appendix A at the time of its initial publication. Nominations submitted during the nomination period (ending on November 16, 2015) that are not evaluated and included in Appendix A at the time of its initial publication will receive consideration for later addition to Appendix A. In addition, individuals and organizations may petition FDA, in accordance with 21 CFR 10.30, to make additional amendments to Appendix A after the nomination period. III. Request for Nominations Interested persons may submit either electronic nominations to http:// www.regulations.gov or written nominations to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of nominations. Identify nominations with the docket number found in brackets in the heading of this document. Received nominations may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. E:\FR\FM\20JYN1.SGM 20JYN1 42828 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices Dated: July 15, 2015. Leslie Kux, Associate Commissioner for Policy. meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2015–17729 Filed 7–17–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–2412] Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they SUMMARY: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993–0002, 301–796–8363. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDAs applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products with Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. (As requested by the applicant, FDA withdrew approval of NDA 050448 for GRIFULVIN (griseofulvin) Oral Suspension in the Federal Register of August 16, 2001 (66 FR 43017)). Application No. Drug Applicant NDA 011210 ...... NDA 012093 ...... TESSALON (benzonatate) Capsule; Oral 200 milligrams (mg) ISORDIL (isosorbide dinitrate) Tablet; Oral 10 mg, 20 mg, 30 mg. ACLOVATE (alclometasone dipropionate) Ointment; Topical 0.05%. ACLOVATE (alclometasone dipropionate) Cream; Topical 0.05%. SARAFEM (fluoxetine hydrochloride (HCl)) Capsule; Oral Equivalent to (EQ) 10 mg Base, EQ 20 mg Base. VASOCIDIN (prednisolone sodium phosphate; sulfacetamide sodium), Solution/Drops; Ophthalmic, EQ 0.23% phosphate; 10%. PRAVACHOL (pravastatin sodium) Tablet; Oral 10 mg .......... Pfizer Inc., 1 Giralda Farms, Madison, NJ 07940. Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. Do. NDA 018702 ...... NDA 018707 ...... NDA 018936 ...... NDA 018988 ...... NDA 019898 ...... NDA 020092 ...... NDA 021551 ...... NDA 021871 ...... mstockstill on DSK4VPTVN1PROD with NOTICES NDA 050448 ...... NDA 050719 ...... ANDA 040454 .... ANDA 062483 .... VerDate Sep<11>2014 DILACOR XR (diltiazem HCl) Capsule, Extended-Release; Oral 120 mg, 180 mg, 240 mg. HALFLYTELY (polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride) For Solution and bisacodyl Delayed-Release Tablets); Oral 210 grams (g); 0.74 g; 2.86 g; 5.6 g; 5 mg. LOESTRIN 24 FE (ethinyl estradiol; norethindrone acetate) Tablet; Oral 0.02 mg; 1 mg. GRIFULVIN V (griseofulvin, microcrystalline) Suspension; Oral 125 mg/5 milliliters (mL). HELIDAC (bismuth subsalicylate; metronidazole; tetracycline HCl) Tablet, Chewable, Tablet, Capsule; Oral 262.4 mg; 250 mg, 500 mg. PROMETHAZINE HYDROCHLORIDE (promethazine HCl) Injectable; Injection 25 mg/mL, 50 mg/mL. GRIFULVIN V (griseofulvin, microsize) Suspension; Oral 125 mg/5 mL. 16:30 Jul 17, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Eli Lilly and Co., Lilly Corp. Ctr., Indianapolis, IN 46285. Novartis Pharmaceuticals Corp., 105 Eisenhower Pky., 280 Corporate Center, Roseland, NJ 07068. Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543–4000. Actavis Laboratories UT, Inc., 577 Chipeta Way, Salt Lake City, UT 84108. Braintree Laboratories, Inc., 60 Columbia St., P.O. Box 850929, Braintree, MA 02185. Warner Chilcott Co. LLC, Union Street Rd. 195 KM 1.1., Fajardo, Puerto Rico 00738. Johnson & Johnson Consumer Products Co., 199 Grandview Rd., Skillman, NJ 08558. Prometheus Laboratories Inc., 9410 Carroll Park Dr., San Diego, CA 92121. Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044. Valeant Pharmaceuticals Luxembourg S.a.r.l, C/O Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. E:\FR\FM\20JYN1.SGM 20JYN1

Agencies

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42827-42828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17729]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1196]


List of Bulk Drug Substances That May Be Used by an Outsourcing 
Facility To Compound Drugs for Use in Animals; Extension of Nomination 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of nomination period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
nomination period for the notice that appeared in the Federal Register 
of May 19, 2015. In the notice, FDA requested nominations for a list of 
bulk drug substances that may be used by facilities registered as 
outsourcing facilities under the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) to compound animal drugs from bulk substances, in 
accordance with FDA's draft guidance for industry (GIF) #230, 
``Compounding Animal Drugs from Bulk Drug Substances.'' The FDA is 
taking this action in response to a request for an extension to allow 
interested persons additional time to submit nominations.

DATES: Submit either electronic or written nominations for the bulk 
drug substances list by November 16, 2015.

ADDRESSES: You may submit nominations by any of the following methods:

Electronic Submissions

    Submit electronic nominations in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written nominations in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-1196. All nominations received may be posted without change 
to http://www.regulations.gov, including any personal information 
provided. For additional information on submitting nominations, see the 
``Request for Nominations'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
nominations received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary 
Medicine, Food and Drug Administration (HFV-210), 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5745, neal.bataller@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of May 19, 2015 (80 FR 28622), FDA 
published a notice with a 90-day nomination period for the list of bulk 
drug substances that may be used by a facility registered as an 
outsourcing facility under section 503B of the FD&C Act (21 U.S.C. 
353B) to compound drugs for use in animals in accordance with FDA's 
draft GFI #230, ``Compounding Animal Drugs from Bulk Drug Substances.'' 
That notice describes the information that should be provided to the 
FDA in support of each nomination.
    FDA has received a request for a 90-day extension of the nomination 
period as the requestor wanted more time to nominate drugs to the list 
and to provide supporting data. FDA has considered the request and is 
extending the nomination period for 90 days, until November 16, 2015. 
The FDA believes that a 90-day extension allows adequate time for 
interested persons to submit nominations without significantly delaying 
consideration of these nominations.

II. Nomination Process

    The process for nominations for bulk drug substances that may be 
used by facilities registered as outsourcing facilities under section 
503B of the FD&C Act to compound animal drugs from bulk drug substances 
is described in the previous notice published May 19, 2015. FDA cannot 
guarantee that all drugs nominated during the nomination period will be 
considered for initial inclusion in Appendix A at the time of its 
initial publication. Nominations submitted during the nomination period 
(ending on November 16, 2015) that are not evaluated and included in 
Appendix A at the time of its initial publication will receive 
consideration for later addition to Appendix A. In addition, 
individuals and organizations may petition FDA, in accordance with 21 
CFR 10.30, to make additional amendments to Appendix A after the 
nomination period.

III. Request for Nominations

    Interested persons may submit either electronic nominations to 
http://www.regulations.gov or written nominations to the Division of 
Dockets Management (see ADDRESSES). It is only necessary to send one 
set of nominations. Identify nominations with the docket number found 
in brackets in the heading of this document. Received nominations may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.


[[Page 42828]]


    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17729 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P