[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40574-40575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Tiotropium Bromide; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Draft 
Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.'' The draft 
guidance, when finalized, will provide product-specific recommendations 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DATES: Submit either electronic or written comments on the draft 
guidance by September 27, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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 Olodaterol Hydrochloride; 
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, 240-
402-7500.
     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.govinfo.gov/content/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, 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 [email protected].

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 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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