2019-26971. Product-Specific Guidance for Cocaine Hydrochloride; Nasal Solution; New Draft Guidance for Industry; Availability  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a new draft guidance for industry, entitled “Draft Guidance for Cocaine Hydrochloride.” The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for a cocaine hydrochloride nasal solution.

    DATES:

    Submit either electronic or written comments on the draft guidance by February 14, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments as follows:Start Printed Page 68464

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2007-D-0369 for “Draft Guidance for Cocaine Hydrochloride.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” will be publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

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    FOR FURTHER INFORMATION CONTACT:

    Mara Miller, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993-0002, 301-796-0683.

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    SUPPLEMENTARY INFORMATION:

    I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” which explained the process that would be used to make product-specific guidances available to the public on FDA's website at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs.

    As described in that guidance, FDA adopted this process to develop and disseminate product-specific guidances and to provide a meaningful opportunity for the public to consider and comment on the guidances. This notice announces the availability of a new draft guidance on a generic cocaine hydrochloride nasal solution.

    FDA initially approved new drug application 209963 GOPRELTO (cocaine hydrochloride) nasal solution in December 2017. We are now issuing a new draft guidance for industry on a generic cocaine hydrochloride nasal solution (“Draft Guidance on Cocaine Hydrochloride”).

    The new draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The new draft guidance, when finalized, will represent the current thinking of FDA on the information and data to demonstrate BE to support ANDAs for cocaine hydrochloride nasal solution. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov.

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    Dated: December 6, 2019.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

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    [FR Doc. 2019-26971 Filed 12-13-19; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
12/16/2019
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Notice
Action:
Notice of availability.
Document Number:
2019-26971
Dates:
Submit either electronic or written comments on the draft guidance by February 14, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Pages:
68463-68464 (2 pages)
Docket Numbers:
Docket No. FDA-2007-D-0369
SectionNoes:
PDF File:
2019-26971.pdf
Supporting Documents:
» Supplemental Comment from GlaxoSmithKline
» Attachment A Suggested Guidance Redlined re Comment from Celgene Corporation and Abraxis BioScience LLC
» Attachment A Suggested Guidance Clean Draft Guidance on Paclitaxel re Comment from Celgene Corporation and Abraxis BioScience LLC
» Draft Guidance on Sevelamer Hydrochloride re comment from Vifor Pharma, Ltd.
» Response from FDA CDER to Bristol-Myers Squibb Co Denial of Petition re comment from Vifor Pharma, Ltd.
» Response from FDA / CDER to Shire Development Partial Approval and Denial of Petition re comment from Vifor Pharma, Ltd.
» Levothyroxine Sodium Products Joint Public Meeting Transcript May 2005 re Comment from Vifor Pharma, Ltd
» Draft Guidance on Lanthanum Carbonate (Nov 2013) re Comment from Vifor Pharma, Ltd
» Draft Guidance on Colestipol Hydrochloride re Comment from Vifor Pharma, Ltd
» Draft Guidance on Colesevelam Hydrochloride (Tablet Nov 2013) re Comment from Vifor Pharma, Ltd