82_FR_49028 82 FR 48826 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

82 FR 48826 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 202 (October 20, 2017)

Page Range48826-48827
FR Document2017-22736

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site. The guidances identified in this notice were developed using the process described in that guidance.

Federal Register, Volume 82 Issue 202 (Friday, October 20, 2017) 
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48826-48827]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Product-Specific Guidances; Draft and Revised 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 additional draft and revised draft product-specific 
guidances. The guidances provide product-specific recommendations on, 
among other things, the design of bioequivalence (BE) studies to 
support abbreviated new drug applications (ANDAs). In the Federal 
Register of June 11, 2010, FDA announced the availability of a guidance 
for industry entitled ``Bioequivalence Recommendations for Specific 
Products'' that explained the process that would be used to make 
product-specific guidances available to the public on FDA's Web site. 
The guidances identified in this notice were developed using the 
process described in that guidance.

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 ``Product-Specific Guidances; Draft and Revised 
Draft Guidances for Industry.'' 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/

[[Page 48827]]

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'' that 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 as a means 
to develop and disseminate product-specific guidances and provide a 
meaningful opportunity for the public to consider and comment on those 
guidances. Under that process, draft guidances are posted on FDA's Web 
site and announced periodically in the Federal Register. The public is 
encouraged to submit comments on those recommendations within 60 days 
of their announcement in the Federal Register. FDA considers any 
comments received and either publishes final guidances or publishes 
revised draft guidances for comment. Guidances were last announced in 
the Federal Register on July 14, 2017 (82 FR 32556). This notice 
announces draft product-specific guidances, either new or revised, that 
are posted on FDA's Web site.

II. Drug Products for Which New Draft Product-Specific Guidances Are 
Available

    FDA is announcing the availability of new draft product-specific 
guidances for industry for drug products containing the following 
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
 
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Azelastine hydrochloride.
Azithromycin.
Barium sulfate.
Betamethasone dipropionate.
Budesonide.
Canagliflozin; Metformin hydrochloride.
Dantrolene sodium.
Dapsone.
Deflazacort (multiple Reference Listed Drugs).
Docosanol.
Empagliflozin; Metformin hydrochloride.
Epinephrine.
Erythromycin.
Everolimus.
Fluorometholone.
Hydrocortisone acetate.
Ivermectin.
Levorphanol tartrate.
Lisdexamfetamine dimesylate.
Mometasone furoate.
Nitisinone.
Olaparib.
Osimertinib mesylate.
Permethrin.
Pirfenidone.
Telotristat etiprate.
Terbutaline sulfate.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances 
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the 
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Brimonidine tartrate (multiple Reference Listed Drugs).
Bromfenac sodium.
Ciprofloxacin hydrochloride.
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate.
Dapsone.
Diclofenac sodium.
Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide
 fumarate.
Emtricitabine; Tenofovir alafenamide fumarate.
Esomeprazole magnesium.
Lisdexamfetamine dimesylate.
Mesalamine.
Mycophenolate mofetil.
Ofloxacin.
Olopatadine hydrochloride (multiple Reference Listed Drugs).
Ropinirole hydrochloride.
Sucralfate.
Tadalafil.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the current thinking of FDA on, among 
other things, the product-specific design of BE studies to support 
ANDAs. 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. 
This guidance is not subject to Executive Order 12866.

IV. 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. 2017-22736 Filed 10-19-17; 8:45 am]
 BILLING CODE 4164-01-P

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

Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48827 fdsys/pkg/FR-2015-09-18/pdf/2015- on July 14, 2017 (82 FR 32556). This TABLE 2—REVISED DRAFT PRODUCT- 23389.pdf. notice announces draft product-specific SPECIFIC GUIDANCES FOR DRUG Docket: For access to the docket to guidances, either new or revised, that PRODUCTS—Continued read background documents or the are posted on FDA’s Web site. electronic and written/paper comments Lisdexamfetamine dimesylate. II. Drug Products for Which New Draft Mesalamine. received, go to https:// Product-Specific Guidances Are Mycophenolate mofetil. www.regulations.gov and insert the Available Ofloxacin. docket number, found in brackets in the Olopatadine hydrochloride (multiple Ref- heading of this document, into the FDA is announcing the availability of erence Listed Drugs). ‘‘Search’’ box and follow the prompts new draft product-specific guidances for Ropinirole hydrochloride. and/or go to the Dockets Management industry for drug products containing Sucralfate. Staff, 5630 Fishers Lane, Rm. 1061, the following active ingredients: Tadalafil. Rockville, MD 20852. You may submit comments on any TABLE 1—NEW DRAFT PRODUCT-SPE- For a complete history of previously guidance at any time (see 21 CFR CIFIC GUIDANCES FOR DRUG PROD- published Federal Register notices 10.115(g)(5)). UCTS related to product-specific guidances, go Submit written requests for single to https://www.regulations.gov and copies of the draft guidances to the Azelastine hydrochloride. enter Docket No. FDA–2007–D–0369. Division of Drug Information, Center for Azithromycin. These draft guidances are being Drug Evaluation and Research, Food Barium sulfate. issued consistent with FDA’s good and Drug Administration, 10001 New Betamethasone dipropionate. guidance practices regulation (21 CFR Budesonide. 10.115). These draft guidances, when Hampshire Ave., Hillandale Building, Canagliflozin; Metformin hydrochloride. 4th Floor, Silver Spring, MD 20993– finalized, will represent the current Dantrolene sodium. 0002. Send one self-addressed adhesive Dapsone. thinking of FDA on, among other things, label to assist that office in processing Deflazacort (multiple Reference Listed the product-specific design of BE your requests. See the SUPPLEMENTARY Drugs). studies to support ANDAs. They do not INFORMATION section for electronic Docosanol. establish any rights for any person and access to the draft guidance documents. Empagliflozin; Metformin hydrochloride. are not binding on FDA or the public. Epinephrine. You can use an alternative approach if FOR FURTHER INFORMATION CONTACT: Erythromycin. Xiaoqiu Tang, Center for Drug it satisfies the requirements of the Everolimus. Evaluation and Research (HFD–600), Fluorometholone. applicable statutes and regulations. This Food and Drug Administration, 10903 Hydrocortisone acetate. guidance is not subject to Executive New Hampshire Ave., Bldg. 75, Rm. Ivermectin. Order 12866. 4730, Silver Spring, MD 20993–0002, Levorphanol tartrate. IV. Electronic Access 301–796–5850. Lisdexamfetamine dimesylate. Mometasone furoate. Persons with access to the internet SUPPLEMENTARY INFORMATION: Nitisinone. may obtain the draft guidances at either Olaparib. https://www.fda.gov/Drugs/Guidance I. Background Osimertinib mesylate. ComplianceRegulatoryInformation/ In the Federal Register of June 11, Permethrin. Guidances/default.htm or https:// 2010 (75 FR 33311), FDA announced the Pirfenidone. Telotristat etiprate. www.regulations.gov. availability of a guidance for industry entitled ‘‘Bioequivalence Terbutaline sulfate. Dated: October 16, 2017. Recommendations for Specific Anna K. Abram, Products’’ that explained the process III. Drug Products for Which Revised Deputy Commissioner for Policy, Planning, that would be used to make product- Draft Product-Specific Guidances Are Legislation, and Analysis. specific guidances available to the Available [FR Doc. 2017–22736 Filed 10–19–17; 8:45 am] public on FDA’s Web site at https:// FDA is announcing the availability of BILLING CODE 4164–01–P www.fda.gov/Drugs/Guidance revised draft product-specific guidances ComplianceRegulatoryInformation/ for industry for drug products Guidances/default.htm. containing the following active DEPARTMENT OF HEALTH AND As described in that guidance, FDA ingredients: HUMAN SERVICES adopted this process as a means to Food and Drug Administration develop and disseminate product- TABLE 2—REVISED DRAFT PRODUCT- specific guidances and provide a SPECIFIC GUIDANCES FOR DRUG [Docket No. FDA–2015–N–1349] meaningful opportunity for the public to PRODUCTS consider and comment on those Extension of the Timetable guidances. Under that process, draft Requirement To Submit Study Data in Brimonidine tartrate (multiple Reference List- guidances are posted on FDA’s Web site ed Drugs). Logical Observation Identifiers Names and announced periodically in the Bromfenac sodium. and Codes Federal Register. The public is Ciprofloxacin hydrochloride. AGENCY: Food and Drug Administration, encouraged to submit comments on Cobicistat; Elvitegravir; Emtricitabine; srobinson on DSKBC5CHB2PROD with NOTICES HHS. those recommendations within 60 days Tenofovir alafenamide fumarate. Dapsone. ACTION: Notice. of their announcement in the Federal Diclofenac sodium. Register. FDA considers any comments Emtricitabine; Rilpivirine hydrochloride; SUMMARY: The Food and Drug received and either publishes final Tenofovir alafenamide fumarate. Administration (FDA or the Agency) is guidances or publishes revised draft Emtricitabine; Tenofovir alafenamide fuma- announcing the extension of the guidances for comment. Guidances were rate. deadline to provide Logical Observation last announced in the Federal Register Esomeprazole magnesium. Identifiers Names and Codes (LOINC) VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1


Document Created: 2017-10-20 00:06:35
Document Modified: 2017-10-20 00:06:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit 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.
ContactXiaoqiu 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 Citation82 FR 48826 
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