80_FR_42965 80 FR 42827 - List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period

80 FR 42827 - List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 138 (July 20, 2015)

Page Range42827-42828
FR Document2015-17729

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Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs from bulk substances, in accordance with FDA's draft guidance for industry (GIF) #230, ``Compounding Animal Drugs from Bulk Drug Substances.''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.

Federal Register, Volume 80 Issue 138 (Monday, July 20, 2015) 
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42827-42828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17729]


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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.

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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accordance with FDA's draft guidance for industry (GIF) #230, 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

Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42827 presented supports the conclusion that substances that may be used by facilities may be used by a facility registered as the conduct upon which Dr. Brancato’s registered as outsourcing facilities under an outsourcing facility under section debarment was based is unlikely to the Federal Food, Drug, and Cosmetic 503B of the FD&C Act (21 U.S.C. 353B) recur. For these reasons, the Agency Act (the FD&C Act) to compound animal to compound drugs for use in animals finds that termination of Dr. Brancato’s drugs from bulk substances, in in accordance with FDA’s draft GFI debarment serves the interest of justice accordance with FDA’s draft guidance #230, ‘‘Compounding Animal Drugs and will not pose a threat to the for industry (GIF) #230, ‘‘Compounding from Bulk Drug Substances.’’ That integrity of the drug approval process. Animal Drugs from Bulk Drug notice describes the information that Under section 306(d)(4)(D) of the Substances.’’ The FDA is taking this should be provided to the FDA in FD&C Act, the period of debarment of action in response to a request for an support of each nomination. an individual who qualifies for special extension to allow interested persons termination may be limited to less than additional time to submit nominations. FDA has received a request for a 90- permanent but to no less than 1 year. Dr. DATES: Submit either electronic or day extension of the nomination period Brancato’s period of debarment, which written nominations for the bulk drug as the requestor wanted more time to commenced on January 6, 1994, has substances list by November 16, 2015. nominate drugs to the list and to lasted more than 1 year. Accordingly, provide supporting data. FDA has ADDRESSES: You may submit the Director of the Office of Enforcement nominations by any of the following considered the request and is extending and Import Operations, under section methods: the nomination period for 90 days, until 306(d)(4) of the FD&C Act and under November 16, 2015. The FDA believes authority delegated to the Director (Staff Electronic Submissions that a 90-day extension allows adequate Manual Guide 1410.35), finds that Submit electronic nominations in the time for interested persons to submit David J. Brancato’s application for following way: nominations without significantly special termination of debarment should • Federal eRulemaking Portal: http:// delaying consideration of these be granted, and that the period of www.regulations.gov. Follow the nominations. debarment should terminate instructions for submitting comments. immediately, thereby allowing him to II. Nomination Process provide services in any capacity to a Written Submissions The process for nominations for bulk person with an approved or pending Submit written nominations in the following ways: drug substances that may be used by drug product application. The Director of Enforcement and Import Operations • Mail/Hand delivery/Courier (for facilities registered as outsourcing further finds that because the Agency is paper submissions): Division of Dockets facilities under section 503B of the granting Dr. Brancato’s application, an Management (HFA–305), Food and Drug FD&C Act to compound animal drugs informal hearing under section Administration, 5630 Fishers Lane, Rm. from bulk drug substances is described 306(d)(4)(C) of the FD&C Act is 1061, Rockville, MD 20852. in the previous notice published May unnecessary. Instructions: All submissions received 19, 2015. FDA cannot guarantee that all As a result of the foregoing findings, must include the Docket No. FDA– drugs nominated during the nomination Dr. David J. Brancato’s debarment is 2015–N–1196. All nominations received period will be considered for initial terminated effective (see DATES) (21 may be posted without change to inclusion in Appendix A at the time of U.S.C. 335a(d)(4)(C) and (d)(4)(D)). http://www.regulations.gov, including its initial publication. Nominations Dated: July 15, 2015. any personal information provided. For submitted during the nomination period additional information on submitting (ending on November 16, 2015) that are Leslie Kux, nominations, see the ‘‘Request for not evaluated and included in Associate Commissioner for Policy. Nominations’’ heading of the Appendix A at the time of its initial [FR Doc. 2015–17712 Filed 7–17–15; 8:45 am] SUPPLEMENTARY INFORMATION section of publication will receive consideration BILLING CODE 4164–01–P this document. for later addition to Appendix A. In Docket: For access to the docket to addition, individuals and organizations read background documents or may petition FDA, in accordance with DEPARTMENT OF HEALTH AND nominations received, go to http:// HUMAN SERVICES 21 CFR 10.30, to make additional www.regulations.gov and insert the amendments to Appendix A after the docket number, found in brackets in the Food and Drug Administration nomination period. heading of this document, into the [Docket No. FDA–2015–N–1196] ‘‘Search’’ box and follow the prompts III. Request for Nominations and/or go to the Division of Dockets List of Bulk Drug Substances That May Management, 5630 Fishers Lane, Rm. Interested persons may submit either Be Used by an Outsourcing Facility To 1061, Rockville, MD 20852. electronic nominations to http:// Compound Drugs for Use in Animals; FOR FURTHER INFORMATION CONTACT: Neal www.regulations.gov or written Extension of Nomination Period Bataller, Center for Veterinary Medicine, nominations to the Division of Dockets Food and Drug Administration (HFV– Management (see ADDRESSES). It is only AGENCY: Food and Drug Administration, HHS. 210), 7519 Standish Pl., Rockville, MD necessary to send one set of 20855, 240–402–5745, neal.bataller@ nominations. Identify nominations with ACTION: Notice; extension of nomination fda.hhs.gov. the docket number found in brackets in mstockstill on DSK4VPTVN1PROD with NOTICES period. SUPPLEMENTARY INFORMATION: the heading of this document. Received SUMMARY: The Food and Drug nominations may be seen in the Administration (FDA) is extending the I. Background Division of Dockets Management nomination period for the notice that In the Federal Register of May 19, between 9 a.m. and 4 p.m., Monday appeared in the Federal Register of May 2015 (80 FR 28622), FDA published a through Friday, and will be posted to 19, 2015. In the notice, FDA requested notice with a 90-day nomination period the docket at http:// nominations for a list of bulk drug for the list of bulk drug substances that www.regulations.gov. VerDate Sep<11>2014 16:30 Jul 17, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\20JYN1.SGM 20JYN1

42828 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices Dated: July 15, 2015. meet relevant legal and regulatory which is generally known as the Leslie Kux, requirements. ‘‘Orange Book.’’ Under FDA regulations, Associate Commissioner for Policy. a drug is removed from the list if the FOR FURTHER INFORMATION CONTACT: [FR Doc. 2015–17729 Filed 7–17–15; 8:45 am] Agency withdraws or suspends Stacy Kane, Center for Drug Evaluation BILLING CODE 4164–01–P approval of the drug’s NDA or ANDA and Research, Food and Drug for reasons of safety or effectiveness, or Administration, 10903 New Hampshire if FDA determines that the listed drug Ave., Bldg. 51, Rm. 6207, Silver Spring, DEPARTMENT OF HEALTH AND was withdrawn from sale for reasons of MD 20993–0002, 301–796–8363. HUMAN SERVICES safety or effectiveness (21 CFR 314.162). SUPPLEMENTARY INFORMATION: In 1984, Under § 314.161(a) (21 CFR Food and Drug Administration Congress enacted the Drug Price 314.161(a)), the Agency must determine Competition and Patent Term whether a listed drug was withdrawn [Docket No. FDA–2015–N–2412] Restoration Act of 1984 (Pub. L. 98–417) from sale for reasons of safety or (the 1984 amendments), which effectiveness: (1) Before an ANDA that Determination That TESSALON authorized the approval of duplicate refers to that listed drug may be (Benzonatate) Capsules and Other versions of drug products approved approved, (2) whenever a listed drug is Drug Products Were Not Withdrawn under an ANDA procedure. ANDA voluntarily withdrawn from sale and From Sale for Reasons of Safety or sponsors must, with certain exceptions, ANDAs that refer to the listed drug have Effectiveness show that the drug for which they are been approved, and (3) when a person seeking approval contains the same petitions for such a determination under AGENCY: Food and Drug Administration, active ingredient in the same strength 21 CFR 10.25(a) and 10.30. Section HHS. and dosage form as the ‘‘listed drug,’’ 314.161(d) provides that if FDA ACTION: Notice. which is a version of the drug that was determines that a listed drug was previously approved. ANDAs applicants withdrawn from sale for safety or SUMMARY: The Food and Drug do not have to repeat the extensive effectiveness reasons, the Agency will Administration (FDA) has determined clinical testing otherwise necessary to initiate proceedings that could result in that the drug products listed in this gain approval of a new drug application the withdrawal of approval of the document were not withdrawn from (NDA). ANDAs that refer to the listed drug. sale for reasons of safety or The 1984 amendments include what FDA has become aware that the drug effectiveness. This determination means is now section 505(j)(7) of the Federal products listed in the table are no longer that FDA will not begin procedures to Food, Drug, and Cosmetic Act (21 U.S.C. being marketed. (As requested by the withdraw approval of abbreviated new 355(j)(7)), which requires FDA to applicant, FDA withdrew approval of drug applications (ANDAs) that refer to publish a list of all approved drugs. NDA 050448 for GRIFULVIN these drug products, and it will allow FDA publishes this list as part of the (griseofulvin) Oral Suspension in the FDA to continue to approve ANDAs that ‘‘Approved Drug Products with Federal Register of August 16, 2001 (66 refer to the products as long as they Therapeutic Equivalence Evaluations,’’ FR 43017)). Application No. Drug Applicant NDA 011210 ...... TESSALON (benzonatate) Capsule; Oral 200 milligrams (mg) Pfizer Inc., 1 Giralda Farms, Madison, NJ 07940. NDA 012093 ...... ISORDIL (isosorbide dinitrate) Tablet; Oral 10 mg, 20 mg, 30 Valeant Pharmaceuticals North America, LLC, 400 Somerset mg. Corporate Blvd., Bridgewater, NJ 08807. NDA 018702 ...... ACLOVATE (alclometasone dipropionate) Ointment; Topical Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006, 0.05%. Melville, NY 11747. NDA 018707 ...... ACLOVATE (alclometasone dipropionate) Cream; Topical Do. 0.05%. NDA 018936 ...... SARAFEM (fluoxetine hydrochloride (HCl)) Capsule; Oral Eli Lilly and Co., Lilly Corp. Ctr., Indianapolis, IN 46285. Equivalent to (EQ) 10 mg Base, EQ 20 mg Base. NDA 018988 ...... VASOCIDIN (prednisolone sodium phosphate; sulfacetamide Novartis Pharmaceuticals Corp., 105 Eisenhower Pky., 280 sodium), Solution/Drops; Ophthalmic, EQ 0.23% phos- Corporate Center, Roseland, NJ 07068. phate; 10%. NDA 019898 ...... PRAVACHOL (pravastatin sodium) Tablet; Oral 10 mg .......... Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543–4000. NDA 020092 ...... DILACOR XR (diltiazem HCl) Capsule, Extended-Release; Actavis Laboratories UT, Inc., 577 Chipeta Way, Salt Lake Oral 120 mg, 180 mg, 240 mg. City, UT 84108. NDA 021551 ...... HALFLYTELY (polyethylene glycol 3350; potassium chloride; Braintree Laboratories, Inc., 60 Columbia St., P.O. Box sodium bicarbonate; sodium chloride) For Solution and 850929, Braintree, MA 02185. bisacodyl Delayed-Release Tablets); Oral 210 grams (g); 0.74 g; 2.86 g; 5.6 g; 5 mg. NDA 021871 ...... LOESTRIN 24 FE (ethinyl estradiol; norethindrone acetate) Warner Chilcott Co. LLC, Union Street Rd. 195 KM 1.1., Tablet; Oral 0.02 mg; 1 mg. Fajardo, Puerto Rico 00738. NDA 050448 ...... GRIFULVIN V (griseofulvin, microcrystalline) Suspension; Johnson & Johnson Consumer Products Co., 199 Grandview Oral 125 mg/5 milliliters (mL). Rd., Skillman, NJ 08558. mstockstill on DSK4VPTVN1PROD with NOTICES NDA 050719 ...... HELIDAC (bismuth subsalicylate; metronidazole; tetracycline Prometheus Laboratories Inc., 9410 Carroll Park Dr., San HCl) Tablet, Chewable, Tablet, Capsule; Oral 262.4 mg; Diego, CA 92121. 250 mg, 500 mg. ANDA 040454 .... PROMETHAZINE HYDROCHLORIDE (promethazine HCl) Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA Injectable; Injection 25 mg/mL, 50 mg/mL. 19044. ANDA 062483 .... GRIFULVIN V (griseofulvin, microsize) Suspension; Oral 125 Valeant Pharmaceuticals Luxembourg S.a.r.l, C/O Valeant mg/5 mL. Pharmaceuticals North America LLC, 400 Somerset Cor- porate Blvd., Bridgewater, NJ 08807. VerDate Sep<11>2014 16:30 Jul 17, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\20JYN1.SGM 20JYN1


Document Created: 2015-12-15 12:58:23
Document Modified: 2015-12-15 12:58:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; extension of nomination period.
DatesSubmit either electronic or written nominations for the bulk drug substances list by November 16, 2015.
ContactNeal Bataller, Center for Veterinary Medicine, Food and Drug Administration (HFV-210), 7519 Standish Pl., Rockville, MD 20855, 240-402-5745, [email protected]
FR Citation80 FR 42827 
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