Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 48826-48827 [2017-22736]

Download as PDF 48826 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 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 We are now issuing draft guidance for industry on, among other things, BE recommendations for generic tiotropium bromide inhalation powder (‘‘Draft Guidance on Tiotropium Bromide’’).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 FDA is reviewing the issues raised in the petition, and will consider any comments on the draft guidance entitled ‘‘Draft Guidance on Tiotropium Bromide’’ before responding to Boehringer’s citizen petition. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on, among other things, the design of BE studies to support ANDAs for tiotropium bromide inhalation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. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Electronic Access Electronic Submissions Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. 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. 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] srobinson on DSKBC5CHB2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 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. 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 productspecific 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: SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 • 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.gpo.gov/ E:\FR\FM\20OCN1.SGM 20OCN1 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices fdsys/pkg/FR-2015-09-18/pdf/201523389.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: srobinson on DSKBC5CHB2PROD with NOTICES 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 productspecific guidances available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific 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 VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 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: 48827 TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued Lisdexamfetamine dimesylate. Mesalamine. Mycophenolate mofetil. Ofloxacin. Olopatadine hydrochloride (multiple Reference Listed Drugs). Ropinirole hydrochloride. Sucralfate. Tadalafil. TABLE 1—NEW DRAFT PRODUCT-SPEFor a complete history of previously CIFIC GUIDANCES FOR DRUG PROD- published Federal Register notices UCTS 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: 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/Guidance ComplianceRegulatoryInformation/ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG [Docket No. FDA–2015–N–1349] PRODUCTS Extension of the Timetable 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Requirement To Submit Study Data in Logical Observation Identifiers Names and Codes AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the extension of the deadline to provide Logical Observation Identifiers Names and Codes (LOINC) SUMMARY: E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48826-48827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22736]


-----------------------------------------------------------------------

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.gpo.gov/

[[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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
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
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