Notice2021-16046
Product-Specific Guidance for Olodaterol Hydrochloride; Tiotropium Bromide; Draft Guidance for Industry; Availability
Primary source
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Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to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 olodaterol hydrochloride; tiotropium bromide inhalation spray.
Full Text
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40574-40575]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16046]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidance for Olodaterol Hydrochloride;
Tiotropium Bromide; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Draft
Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.'' The draft
guidance, when finalized, will provide product-specific recommendations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 olodaterol hydrochloride; tiotropium bromide inhalation
spray.
DATES: Submit either electronic or written comments on the draft
guidance by September 27, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 Olodaterol Hydrochloride;
Tiotropium Bromide.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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.
[[Page 40575]]
FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398 and/or <a href="/cdn-cgi/l/email-protection#92c2c1d5bfc3e7f7e1e6fbfdfce1d2f4f6f3bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="e1b1b2a6ccb094849295888e8f92a1878580cf898992cf868e97">[email protected]</span></a>.
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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>.
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 guidance on a generic
olodaterol hydrochloride; tiotropium bromide inhalation spray.
FDA initially approved new drug application (NDA) 206756 for
STIOLTO RESPIMAT (olodaterol hydrochloride; tiotropium bromide
inhalation spray) in May 2015. We are now issuing draft guidance for
industry on BE recommendations for generic olodaterol hydrochloride;
tiotropium bromide inhalation spray (``Draft Guidance for Olodaterol
Hydrochloride; Tiotropium Bromide'').
In October 2012, Boehringer Ingelheim, manufacturer of the
reference listed drug SPIRIVA HANDIHALER, NDA 21395, submitted a
citizen petition requesting, among other things, that FDA adopt and
apply certain requirements in its review of any proposed generic and
follow-on versions of SPIRIVA HANDIHALER or any other Boehringer
Ingelheim oral inhalation product containing the active ingredient
tiotropium bromide under section 505(j) and (b)(2), respectively, of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j) and (b)(2))
(Docket No. FDA-2012-P-1072). Boehringer Ingelheim submitted a
supplement to the citizen petition in January 2021 further expanding on
its initial petition requests. FDA is reviewing the issues raised in
the petition and supplement and will consider any comments on the draft
guidance entitled ``Draft Guidance for Olodaterol Hydrochloride;
Tiotropium Bromide'' before responding to Boehringer's citizen
petition.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
information and data to demonstrate BE to support ANDAs for tiotropium
bromide inhalation spray. 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. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16046 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
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