82 FR 48825 - Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability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 | 48825-48826 | |
| FR Document | 2017-22734 |
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)] [Notices] [Pages 48825-48826] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22734] ----------------------------------------------------------------------- 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SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled ``Draft Guidance on Tiotropium Bromide.'' The draft guidance, when finalized, will provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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 DATES: Submit either electronic or written comments on the draft guidance by December 19, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: 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 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 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 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 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 a draft product-specific guidance for generic tiotropium bromide inhalation powder. FDA initially approved new drug application 21395 for SPIRIVA [[Page 48826]] HANDIHALER (tiotropium bromide inhalation powder) in January 2004. We are now issuing draft guidance for industry on, among other things, BE recommendations for generic tiotropium bromide inhalation powder (``Draft Guidance on Tiotropium Bromide''). In October 2012, Boehringer Ingelheim, manufacturer of the reference listed drug SPIRIVA HANDIHALER, submitted a citizen petition requesting, among other things, that FDA adopt and apply certain requirements that ensure the safety and efficacy of any proposed generic and follow-on versions of SPIRIVA HANDIHALER 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). FDA is reviewing the issues raised in the petition, and will consider any comments on the draft guidance entitled ``Draft Guidance on Tiotropium Bromide'' before responding to Boehringer's citizen petition. This 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, among other things, the design of BE studies to support ANDAs for tiotropium bromide inhalation powder. 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. II. Electronic Access Persons with access to the internet may obtain the draft guidance 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. 2017-22734 Filed 10-19-17; 8:45 am] BILLING CODE 4164-01-P
![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
VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1](https://thefederalregister.org/doc/82_FR_49027/page/1.svg)
![48826 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices
HANDIHALER (tiotropium bromide DEPARTMENT OF HEALTH AND • If you want to submit a comment
inhalation powder) in January 2004. We HUMAN SERVICES with confidential information that you
are now issuing draft guidance for do not wish to be made available to the
industry on, among other things, BE Food and Drug Administration public, submit the comment as a
recommendations for generic tiotropium written/paper submission and in the
[Docket No. FDA–2007–D–0369] manner detailed (see ‘‘Written/Paper
bromide inhalation powder (‘‘Draft
Guidance on Tiotropium Bromide’’). Product-Specific Guidances; Draft and Submissions’’ and ‘‘Instructions’’).
In October 2012, Boehringer Revised Draft Guidances for Industry; Written/Paper Submissions
Ingelheim, manufacturer of the Availability Submit written/paper submissions as
reference listed drug SPIRIVA AGENCY: Food and Drug Administration, follows:
HANDIHALER, submitted a citizen HHS. • Mail/Hand delivery/Courier (for
petition requesting, among other things, written/paper submissions): Dockets
ACTION: Notice of availability.
that FDA adopt and apply certain Management Staff (HFA–305), Food and
requirements that ensure the safety and SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
efficacy of any proposed generic and Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
follow-on versions of SPIRIVA announcing the availability of • For written/paper comments
HANDIHALER under section 505(j) and additional draft and revised draft submitted to the Dockets Management
product-specific guidances. The Staff, FDA will post your comment, as
(b)(2), respectively, of the Federal Food,
guidances provide product-specific well as any attachments, except for
Drug, and Cosmetic Act (21 U.S.C. 355(j)
recommendations on, among other information submitted, marked and
and (b)(2)) (Docket No. FDA–2012–P– identified, as confidential, if submitted
1072). FDA is reviewing the issues things, the design of bioequivalence
(BE) studies to support abbreviated new as detailed in ‘‘Instructions.’’
raised in the petition, and will consider Instructions: All submissions received
any comments on the draft guidance drug applications (ANDAs). In the
must include the Docket No. FDA–
entitled ‘‘Draft Guidance on Tiotropium Federal Register of June 11, 2010, FDA
2007–D–0369 for ‘‘Product-Specific
Bromide’’ before responding to announced the availability of a guidance
Guidances; Draft and Revised Draft
Boehringer’s citizen petition. for industry entitled ‘‘Bioequivalence Guidances for Industry.’’ Received
Recommendations for Specific comments will be placed in the docket
This draft guidance is being issued Products’’ that explained the process
consistent with FDA’s good guidance and, except for those submitted as
that would be used to make product- ‘‘Confidential Submissions,’’ publicly
practices regulation (21 CFR 10.115). specific guidances available to the
The draft guidance, when finalized, will viewable at https://www.regulations.gov
public on FDA’s Web site. The or at the Dockets Management Staff
represent the current thinking of FDA guidances identified in this notice were between 9 a.m. and 4 p.m., Monday
on, among other things, the design of BE developed using the process described through Friday.
studies to support ANDAs for in that guidance. • Confidential Submissions—To
tiotropium bromide inhalation powder. DATES: Submit either electronic or submit a comment with confidential
It does not establish any rights for any written comments on the draft guidance information that you do not wish to be
person and is not binding on FDA or the by December 19, 2017 to ensure that the made publicly available, submit your
public. You can use an alternative Agency considers your comment on this comments only as a written/paper
approach if it satisfies the requirements draft guidance before it begins work on submission. You should submit two
of the applicable statutes and the final version of the guidance. copies total. One copy will include the
regulations. This guidance is not subject ADDRESSES: You may submit comments information you claim to be confidential
to Executive Order 12866. on any guidance at any time as follows: with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
II. Electronic Access Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Persons with access to the internet Submit electronic comments in the Agency will review this copy, including
may obtain the draft guidance at either following way: the claimed confidential information, in
https://www.fda.gov/Drugs/ • Federal eRulemaking Portal: its consideration of comments. The
GuidanceCompliance https://www.regulations.gov. Follow the second copy, which will have the
RegulatoryInformation/Guidances/ instructions for submitting comments. claimed confidential information
Comments submitted electronically, redacted/blacked out, will be available
default.htm or https://
including attachments, to https:// for public viewing and posted on
www.regulations.gov.
www.regulations.gov will be posted to https://www.regulations.gov. Submit
Dated: October 16, 2017. the docket unchanged. Because your both copies to the Dockets Management
Anna K. Abram, comment will be made public, you are Staff. If you do not wish your name and
Deputy Commissioner for Policy, Planning, solely responsible for ensuring that your contact information to be made publicly
Legislation, and Analysis. comment does not include any available, you can provide this
[FR Doc. 2017–22734 Filed 10–19–17; 8:45 am] confidential information that you or a information on the cover sheet and not
third party may not wish to be posted, in the body of your comments and you
BILLING CODE 4164–01–P
such as medical information, your or must identify this information as
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
srobinson on DSKBC5CHB2PROD with NOTICES
confidential business information, such as ‘‘confidential’’ will not be disclosed
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
that if you include your name, contact and other applicable disclosure law. For
information, or other information that more information about FDA’s posting
identifies you in the body of your of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1](https://thefederalregister.org/doc/82_FR_49027/page/2.svg)
Document Created: 2017-10-20 00:06:26
Document Modified: 2017-10-20 00:06:26
| 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 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. | |
| 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 48825 |
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