Document ID: FDA-2007-D-0369-0430
Agency: fda
Document Type: Notice
Title: Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone
Propionate; Draft Guidances for Industry; Availability
Posted Date: 2017-10-20T04:00Z

[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48823-48825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22735]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances for Salmeterol Xinafoate and 
Fluticasone Propionate; Draft Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of three draft guidances for industry on generic 
salmeterol xinafoate inhalation powder, fluticasone propionate 
inhalation aerosol, and fluticasone propionate inhalation powder, 
entitled ``Draft Guidance on Salmeteral Xinafoate'' and ``Draft 
Guidance on Fluticasone Propionate.'' The guidances, when finalized, 
will provide product-specific recommendations on, among other things, 
the design of bioequivalence (BE) studies to support abbreviated new 
drug applications (ANDAs) for salmeterol xinafoate inhalation powder, 
fluticasone propionate inhalation aerosol, and fluticasone propionate 
inhalation powder.

DATES: Submit either electronic or written comments on the draft 
guidances by December 19, 2017 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comment on this draft guidance before it begins work on the final 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 on any guidance at any time as 
follows:

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

[[Page 48824]]

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 on Salmeterol Xinafoate'' or 
``Draft Guidance on Fluticasone Propionate.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 guidances 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 documents.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 
301-796-5850.

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 Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    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 draft product-specific 
guidances for generic salmeterol xinafoate inhalation powder, 
fluticasone propionate inhalation aerosol, and fluticasone propionate 
inhalation powder.
    FDA initially approved new drug application (NDA) 020692 for 
SEREVENT DISKUS (salmeterol xinafoate inhalation powder) in September 
1997. We are now issuing a draft guidance for industry on, among other 
things, BE recommendations for generic salmeterol xinafoate inhalation 
powder (``Draft Guidance on Salmeterol Xinafoate'').
    FDA initially approved NDA 021433 for FLOVENT HFA (fluticasone 
propionate inhalation aerosol) in May 2004 and NDA 020833 for FLOVENT 
DISKUS 100 (fluticasone propionate inhalation powder) in September 
2000. We are now also issuing two draft guidances for industry on, 
among other things, BE recommendations for generic fluticasone 
propionate inhalation aerosol and fluticasone propionate inhalation 
powder (both entitled ``Draft Guidance on Fluticasone Propionate'').
    In December 2009, GlaxoSmithKline (GSK), manufacturer of the 
reference listed drugs SEREVENT DISKUS, FLOVENT HFA, and FLOVENT DISKUS 
100, submitted a citizen petition requesting that FDA withhold approval 
of any ANDA or 505(b)(2) application for generic oral inhalation 
products containing salmeterol xinafoate and/or fluticasone propionate 
unless certain conditions were satisfied, including conditions related 
to demonstrating BE (Docket No. FDA-2009-P-0597). FDA is reviewing the 
issues raised in the petition. FDA will consider any comments on 
guidances entitled, ``Draft Guidance on Salmeterol Xinafoate'' or 
``Draft Guidance on Fluticasone Propionate,'' before responding to 
GSK's citizen petition.
    The draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidances, 
when finalized, will represent the current thinking of FDA on, among 
other things, the design of BE studies to support ANDAs for salmeterol 
xinafoate inhalation powder, fluticasone propionate inhalation aerosol, 
and fluticasone propionate inhalation powder. They do not establish any 
rights for any person and are not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. These guidances are not subject to 
Executive Order 12866.

[[Page 48825]]

II. Electronic Access

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

    Dated: October 16, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22735 Filed 10-19-17; 8:45 am]
BILLING CODE 4164-01-P