Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate; Draft Guidances for Industry; Availability, 48823-48825 [2017-22735]

Download as PDF srobinson on DSKBC5CHB2PROD with NOTICES Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices for Food for Animals.’’ 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 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/201523389.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 guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary Medicine (HFV–200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6246, Jenny.Murphy@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 25, 2016 (81 FR 58519), FDA published the notice of availability for a draft guidance entitled ‘‘Current Good Manufacturing Practice Requirements for Food for Animals,’’ giving interested persons until November 23, 2016, to comment on the draft guidance. FDA received comments on the draft guidance and those comments were considered as the guidance was finalized. Changes made include additional explanation and examples and the inclusion of a part 507 (21 CFR part 507) Current Good Manufacturing Practice (CGMP) SelfAssessment Tool in Appendix B to assist facilities in reviewing the implementation of CGMP requirements at their facility. Information regarding human food by-products for use as food for animals was removed; this information is contained in draft GFI #239, entitled ‘‘Human Food ByProducts for Use as Animal Food’’ (81 FR 58521, August 25, 2016). In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated August 2016. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on current good manufacturing practice requirements for food for animals. 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. This guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in part 507 have been approved under OMB control number 0910–0789. IV. Electronic Access Persons with access to the internet may obtain the guidance at either PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 48823 https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: October 16, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–22730 Filed 10–19–17; 8:45 am] BILLING CODE 4164–01–P 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. 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: SUMMARY: 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 E:\FR\FM\20OCN1.SGM 20OCN1 48824 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices srobinson on DSKBC5CHB2PROD with NOTICES 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 VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 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/201523389.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 productspecific guidances available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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. E:\FR\FM\20OCN1.SGM 20OCN1 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices II. Electronic Access Persons with access to the internet may obtain the draft guidances at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled ‘‘Draft Guidance on Tiotropium Bromide.’’ The draft guidance, 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 tiotropium bromide inhalation powder. DATES: Submit either electronic or written comments on the draft guidance 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: srobinson on DSKBC5CHB2PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 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 Tiotropium Bromide.’’ 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 48825 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/201523389.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 document. 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 productspecific guidances available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ 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 a draft product-specific guidance for generic tiotropium bromide inhalation powder. FDA initially approved new drug application 21395 for SPIRIVA E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.