82 FR 48823 - Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate; Draft Guidances for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 202 (October 20, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 202 (October 20, 2017)
| Page Range | 48823-48825 | |
| FR Document | 2017-22735 |
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)] [Notices] [Pages 48823-48825] From the Federal Register Online [www.thefederalregister.org] [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inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder, entitled ``Draft Guidance on Salmeteral Xinafoate'' and ``Draft Guidance on Fluticasone Propionate.''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written comments on the draft guidances by December 19, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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
![Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48823
for Food for Animals.’’ Received FOR FURTHER INFORMATION CONTACT: https://www.fda.gov/AnimalVeterinary/
comments will be placed in the docket Jeanette Murphy, Center for Veterinary GuidanceComplianceEnforcement/
and, except for those submitted as Medicine (HFV–200), Food and Drug GuidanceforIndustry/default.htm or
‘‘Confidential Submissions,’’ publicly Administration, 7519 Standish Pl., https://www.regulations.gov.
viewable at https://www.regulations.gov Rockville, MD 20855, 240–402–6246, Dated: October 16, 2017.
or at the Dockets Management Staff Jenny.Murphy@fda.hhs.gov. Anna K. Abram,
office between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION:
Deputy Commissioner for Policy, Planning,
Monday through Friday.
I. Background Legislation, and Analysis.
• Confidential Submissions—To
submit a comment with confidential [FR Doc. 2017–22730 Filed 10–19–17; 8:45 am]
In the Federal Register of August 25,
information that you do not wish to be 2016 (81 FR 58519), FDA published the BILLING CODE 4164–01–P
made publicly available, submit your notice of availability for a draft guidance
comments only as a written/paper entitled ‘‘Current Good Manufacturing
submission. You should submit two Practice Requirements for Food for DEPARTMENT OF HEALTH AND
copies total. One copy will include the Animals,’’ giving interested persons HUMAN SERVICES
information you claim to be confidential until November 23, 2016, to comment Food and Drug Administration
with a heading or cover note that states on the draft guidance. FDA received
‘‘THIS DOCUMENT CONTAINS comments on the draft guidance and [Docket No. FDA–2007–D–0369]
CONFIDENTIAL INFORMATION.’’ The those comments were considered as the
Agency will review this copy, including guidance was finalized. Changes made Product-Specific Guidances for
the claimed confidential information, in include additional explanation and Salmeterol Xinafoate and Fluticasone
its consideration of comments. The examples and the inclusion of a part 507 Propionate; Draft Guidances for
second copy, which will have the (21 CFR part 507) Current Good Industry; Availability
claimed confidential information Manufacturing Practice (CGMP) Self- AGENCY: Food and Drug Administration,
redacted/blacked out, will be available Assessment Tool in Appendix B to HHS.
for public viewing and posted on assist facilities in reviewing the
https://www.regulations.gov. Submit ACTION: Notice of availability.
implementation of CGMP requirements
both copies to the Dockets Management at their facility. Information regarding SUMMARY: The Food and Drug
Staff. If you do not wish your name and human food by-products for use as food Administration (FDA or Agency) is
contact information to be made publicly for animals was removed; this announcing the availability of three
available, you can provide this information is contained in draft GFI draft guidances for industry on generic
information on the cover sheet and not #239, entitled ‘‘Human Food By- salmeterol xinafoate inhalation powder,
in the body of your comments and you Products for Use as Animal Food’’ (81 fluticasone propionate inhalation
must identify this information as FR 58521, August 25, 2016). In addition, aerosol, and fluticasone propionate
‘‘confidential.’’ Any information marked editorial changes were made to improve inhalation powder, entitled ‘‘Draft
as ‘‘confidential’’ will not be disclosed clarity. The guidance announced in this Guidance on Salmeteral Xinafoate’’ and
except in accordance with 21 CFR 10.20 notice finalizes the draft guidance dated ‘‘Draft Guidance on Fluticasone
and other applicable disclosure law. For August 2016. Propionate.’’ The guidances, when
more information about FDA’s posting finalized, will provide product-specific
of comments to public dockets, see 80 II. Significance of Guidance
recommendations on, among other
FR 56469, September 18, 2015, or access This level 1 guidance is being issued things, the design of bioequivalence
the information at: https://www.gpo.gov/ consistent with FDA’s good guidance (BE) studies to support abbreviated new
fdsys/pkg/FR-2015-09-18/pdf/2015- practices regulation (21 CFR 10.115). drug applications (ANDAs) for
23389.pdf. The guidance represents the current salmeterol xinafoate inhalation powder,
Docket: For access to the docket to thinking of FDA on current good fluticasone propionate inhalation
read background documents or the manufacturing practice requirements for aerosol, and fluticasone propionate
electronic and written/paper comments food for animals. It does not establish inhalation powder.
received, go to https:// any rights for any person and is not
www.regulations.gov and insert the DATES: Submit either electronic or
binding on FDA or the public. You can
docket number, found in brackets in the written comments on the draft
use an alternative approach if it satisfies
heading of this document, into the guidances by December 19, 2017 to
the requirements of the applicable
‘‘Search’’ box and follow the prompts ensure that the Agency considers your
statutes and regulations. This guidance
and/or go to the Dockets Management comment on this draft guidance before
is not subject to Executive Order 12866.
Staff, 5630 Fishers Lane, Rm. 1061, it begins work on the final version of the
Rockville, MD 20852. III. Paperwork Reduction Act of 1995 guidance.
You may submit comments on any This guidance refers to previously ADDRESSES: You may submit comments
guidance at any time (see 21 CFR approved collections of information on any guidance at any time as follows:
10.115(g)(5)). found in FDA regulations. These
Submit written requests for single Electronic Submissions
collections of information are subject to
copies of the guidance to the Policy and review by the Office of Management and Submit electronic comments in the
Regulations Staff (HFV–6), Center for Budget (OMB) under the Paperwork following way:
Veterinary Medicine, Food and Drug • Federal eRulemaking Portal:
srobinson on DSKBC5CHB2PROD with NOTICES
Reduction Act of 1995 (44 U.S.C. 3501–
Administration, 7500 Standish Pl., 3520). The collections of information in https://www.regulations.gov. Follow the
Rockville, MD 20855. Send one self- part 507 have been approved under instructions for submitting comments.
addressed adhesive label to assist that OMB control number 0910–0789. Comments submitted electronically,
office in processing your requests. See including attachments, to https://
the SUPPLEMENTARY INFORMATION section IV. Electronic Access www.regulations.gov will be posted to
for electronic access to the guidance Persons with access to the internet the docket unchanged. Because your
document. may obtain the guidance at either comment will be made public, you are
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![Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48825
II. Electronic Access confidential business information, such except in accordance with 21 CFR 10.20
Persons with access to the internet as a manufacturing process. Please note and other applicable disclosure law. For
may obtain the draft guidances at either that if you include your name, contact more information about FDA’s posting
https://www.fda.gov/Drugs/Guidance information, or other information that of comments to public dockets, see 80
ComplianceRegulatoryInformation/ identifies you in the body of your FR 56469, September 18, 2015, or access
Guidances/default.htm or https:// comments, that information will be the information at: https://www.gpo.gov/
www.regulations.gov. posted on https://www.regulations.gov. fdsys/pkg/FR-2015-09-18/pdf/2015-
• If you want to submit a comment 23389.pdf.
Dated: October 16, 2017. with confidential information that you Docket: For access to the docket to
Anna K. Abram, do not wish to be made available to the read background documents or the
Deputy Commissioner for Policy, Planning, public, submit the comment as a electronic and written/paper comments
Legislation, and Analysis. written/paper submission and in the received, go to https://
[FR Doc. 2017–22735 Filed 10–19–17; 8:45 am] manner detailed (see ‘‘Written/Paper www.regulations.gov and insert the
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). docket number, found in brackets in the
Written/Paper Submissions heading of this document, into the
‘‘Search’’ box and follow the prompts
DEPARTMENT OF HEALTH AND Submit written/paper submissions as and/or go to the Dockets Management
HUMAN SERVICES follows: Staff, 5630 Fishers Lane, Rm. 1061,
• Mail/Hand delivery/Courier (for
Rockville, MD 20852.
Food and Drug Administration written/paper submissions): Dockets
You may submit comments on any
Management Staff (HFA–305), Food and
[Docket No. FDA–2007–D–0369] guidance at any time (see 21 CFR
Drug Administration, 5630 Fishers
10.115(g)(5)).
Product-Specific Guidance for Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Submit written requests for single
Tiotropium Bromide; Draft Guidance copies of the draft guidance to the
for Industry; Availability submitted to the Dockets Management
Staff, FDA will post your comment, as Division of Drug Information, Center for
AGENCY: Food and Drug Administration, well as any attachments, except for Drug Evaluation and Research, Food
HHS. information submitted, marked and and Drug Administration, 10001 New
identified, as confidential, if submitted Hampshire Ave., Hillandale Building,
ACTION: Notice of availability.
as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
SUMMARY: The Food and Drug Instructions: All submissions received 0002. Send one self-addressed adhesive
Administration (FDA or Agency) is must include the Docket No. FDA– label to assist that office in processing
announcing the availability of a draft 2007–D–0369 for ‘‘Draft Guidance on your requests. See the SUPPLEMENTARY
guidance for industry on generic Tiotropium Bromide.’’ Received INFORMATION section for electronic
tiotropium bromide inhalation powder comments will be placed in the docket access to the draft guidance document.
entitled ‘‘Draft Guidance on Tiotropium and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
Bromide.’’ The draft guidance, when ‘‘Confidential Submissions,’’ publicly Xiaoqiu Tang, Center for Drug
finalized, will provide product-specific viewable at https://www.regulations.gov Evaluation and Research (HFD–600),
recommendations on, among other or at the Dockets Management Staff Food and Drug Administration, 10903
things, the design of bioequivalence between 9 a.m. and 4 p.m., Monday New Hampshire Ave., Bldg. 75, Rm.
(BE) studies to support abbreviated new through Friday. 4730, Silver Spring, MD 20993–0002,
drug applications (ANDAs) for • Confidential Submissions—To 301–796–5850.
tiotropium bromide inhalation powder. submit a comment with confidential SUPPLEMENTARY INFORMATION:
DATES: Submit either electronic or information that you do not wish to be
written comments on the draft guidance made publicly available, submit your I. Background
by December 19, 2017 to ensure that the comments only as a written/paper In the Federal Register of June 11,
Agency considers your comment on this submission. You should submit two 2010 (75 FR 33311), FDA announced the
draft guidance before it begins work on copies total. One copy will include the availability of a guidance for industry
the final version of the guidance. information you claim to be confidential entitled ‘‘Bioequivalence
ADDRESSES: You may submit comments with a heading or cover note that states Recommendations for Specific
on any guidance at any time as follows: ‘‘THIS DOCUMENT CONTAINS Products,’’ which explained the process
CONFIDENTIAL INFORMATION.’’ The that would be used to make product-
Electronic Submissions Agency will review this copy, including specific guidances available to the
Submit electronic comments in the the claimed confidential information, in public on FDA’s Web site at https://
following way: its consideration of comments. The www.fda.gov/Drugs/Guidance
• Federal eRulemaking Portal: second copy, which will have the ComplianceRegulatoryInformation/
https://www.regulations.gov. Follow the claimed confidential information Guidances/default.htm.
instructions for submitting comments. redacted/blacked out, will be available As described in that guidance, FDA
Comments submitted electronically, for public viewing and posted on adopted this process to develop and
including attachments, to https:// https://www.regulations.gov. Submit disseminate product-specific guidances
www.regulations.gov will be posted to both copies to the Dockets Management and to provide a meaningful
the docket unchanged. Because your Staff. If you do not wish your name and
srobinson on DSKBC5CHB2PROD with NOTICES
opportunity for the public to consider
comment will be made public, you are contact information to be made publicly and comment on the guidances. This
solely responsible for ensuring that your available, you can provide this notice announces the availability of a
comment does not include any information on the cover sheet and not draft product-specific guidance for
confidential information that you or a in the body of your comments and you generic tiotropium bromide inhalation
third party may not wish to be posted, must identify this information as powder.
such as medical information, your or ‘‘confidential.’’ Any information marked FDA initially approved new drug
anyone else’s Social Security number, or as ‘‘confidential’’ will not be disclosed application 21395 for SPIRIVA
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Document Created: 2017-10-20 00:06:19
Document Modified: 2017-10-20 00:06:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 48823 |
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