81_FR_39789 81 FR 39672 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

81 FR 39672 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 117 (June 17, 2016)

Page Range39672-39673
FR Document2016-14351

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of 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 BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

Federal Register, Volume 81 Issue 117 (Friday, June 17, 2016) 
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39672-39673]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14351]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Product-Specific Bioequivalence Recommendations; Draft and 
Revised Draft Guidances 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 additional draft and revised draft product-specific 
bioequivalence (BE) recommendations. The recommendations provide 
product-specific guidance on the design of 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 BE recommendations available to the public on FDA's 
Web site. The BE recommendations identified in this notice were 
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 Bioequivalence Recommendations; 
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 http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover

[[Page 39673]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 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 BE 
recommendations available to the public on FDA's Web site at http://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 BE recommendations and 
provide a meaningful opportunity for the public to consider and comment 
on those recommendations. Under that process, draft recommendations 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 recommendations or publishes revised draft recommendations for 
comment. Recommendations were last announced in the Federal Register on 
April 15, 2016 (81 FR 22283). This notice announces draft product-
specific recommendations, either new or revised, that are posted on 
FDA's Web site.

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

    FDA is announcing the availability of a new draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
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Amcinonide
Cariprazine hydrochloride
Cobimetinib fumarate
Empagliflozin; Metformin hydrochloride
Erythromycin ethylsuccinate
Everolimus
Flibanserin
Fluocinonide (multiple reference listed drugs)
Hydrocortisone
Lesinurad
Meloxicam
Methylergonovine maleate
Ombitasvir; paritaprevir; ritonavir
Prednicarbate
Propofol
Pseudoephedrine hydrochloride
Selexipag
Tacrolimus
------------------------------------------------------------------------

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

    FDA is announcing the availability of a revised draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Acetaminophen; hydrocodone bitartrate
Albuterol sulfate
Azelastine hydrochloride; Fluticasone propionate
Benzoyl peroxide; Clindamycin phosphate
Dexamethasone; Tobramycin (multiple reference listed drugs)
Lansoprazole
Loteprednol Etabonate
Loteprednol Etabonate; Tobramycin Ophthalmic
Mesalamine (multiple reference listed drugs)
Methylphenidate
Morphine sulfate
Paroxetine hydrochloride
Pomalidomide
Prednisolone Acetate
Rimexolone
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices related to product-specific BE recommendations, go to http://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 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14351 Filed 6-16-16; 8:45 am]
BILLING CODE 4164-01-P

39672 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Dated: June 13, 2016. guidance before it begins work on the and Drug Administration, 5630 Fishers Leslie Kux, final version of the guidance, submit Lane, Rm. 1061, Rockville, MD 20852. Associate Commissioner for Policy. either electronic or written comments • For written/paper comments [FR Doc. 2016–14380 Filed 6–16–16; 8:45 am] on the draft guidance by August 16, submitted to the Division of Dockets BILLING CODE 4164–01–C 2016. Management, FDA will post your comment, as well as any attachments, ADDRESSES: You may submit comments except for information submitted, as follows: marked and identified, as confidential, DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions if submitted as detailed in ‘‘Instructions.’’ Food and Drug Administration Submit electronic comments in the Instructions: All submissions received following way: must include the Docket No. FDA– [Docket No. FDA–2007–D–0369] • Federal eRulemaking Portal: http:// 2007–D–0369 for ‘‘Product-Specific www.regulations.gov. Follow the Bioequivalence Recommendations; Draft Product-Specific Bioequivalence instructions for submitting comments. Recommendations; Draft and Revised and Revised Draft Guidances for Comments submitted electronically, Industry.’’ Received comments will be Draft Guidances for Industry; including attachments, to http:// Availability placed in the docket and, except for www.regulations.gov will be posted to those submitted as ‘‘Confidential AGENCY: Food and Drug Administration, the docket unchanged. Because your Submissions,’’ publicly viewable at HHS. comment will be made public, you are http://www.regulations.gov or at the ACTION: Notice of availability. solely responsible for ensuring that your Division of Dockets Management comment does not include any between 9 a.m. and 4 p.m., Monday SUMMARY: The Food and Drug confidential information that you or a through Friday. Administration (FDA or Agency) is third party may not wish to be posted, • Confidential Submissions—To announcing the availability of such as medical information, your or submit a comment with confidential additional draft and revised draft anyone else’s Social Security number, or information that you do not wish to be product-specific bioequivalence (BE) confidential business information, such made publicly available, submit your recommendations. The as a manufacturing process. Please note comments only as a written/paper recommendations provide product- that if you include your name, contact submission. You should submit two specific guidance on the design of BE information, or other information that copies total. One copy will include the studies to support abbreviated new drug identifies you in the body of your information you claim to be confidential applications (ANDAs). In the Federal comments, that information will be with a heading or cover note that states Register of June 11, 2010, FDA posted on http://www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS announced the availability of a guidance • If you want to submit a comment CONFIDENTIAL INFORMATION.’’ The for industry entitled ‘‘Bioequivalence with confidential information that you Agency will review this copy, including Recommendations for Specific do not wish to be made available to the the claimed confidential information, in Products’’ that explained the process public, submit the comment as a its consideration of comments. The that would be used to make product- written/paper submission and in the second copy, which will have the specific BE recommendations available manner detailed (see ‘‘Written/Paper claimed confidential information to the public on FDA’s Web site. The BE Submissions’’ and ‘‘Instructions’’). redacted/blacked out, will be available sradovich on DSK3TPTVN1PROD with NOTICES recommendations identified in this for public viewing and posted on http:// notice were developed using the process Written/Paper Submissions www.regulations.gov. Submit both described in that guidance. Submit written/paper submissions as copies to the Division of Dockets DATES: Although you can comment on follows: Management. If you do not wish your any guidance at any time (see 21 CFR • Mail/Hand delivery/Courier (for name and contact information to be 10.115(g)(5)), to ensure that the Agency written/paper submissions): Division of made publicly available, you can considers your comment on this draft Dockets Management (HFA–305), Food provide this information on the cover EN17JN16.023</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39673 sheet and not in the body of your announced periodically in the Federal TABLE 2—REVISED DRAFT PRODUCT- comments and you must identify this Register. The public is encouraged to SPECIFIC BE RECOMMENDATIONS information as ‘‘confidential.’’ Any submit comments on those FOR DRUG PRODUCTS—Continued information marked as ‘‘confidential’’ recommendations within 60 days of will not be disclosed except in their announcement in the Federal Loteprednol Etabonate accordance with 21 CFR 10.20 and other Register. FDA considers any comments Loteprednol Etabonate; Tobramycin Oph- applicable disclosure law. For more received and either publishes final thalmic Mesalamine (multiple reference listed drugs) information about FDA’s posting of recommendations or publishes revised Methylphenidate comments to public dockets, see 80 FR draft recommendations for comment. Morphine sulfate 56469, September 18, 2015, or access Recommendations were last announced Paroxetine hydrochloride the information at: http://www.fda.gov/ in the Federal Register on April 15, Pomalidomide regulatoryinformation/dockets/ 2016 (81 FR 22283). This notice Prednisolone Acetate default.htm. announces draft product-specific Rimexolone Docket: For access to the docket to recommendations, either new or read background documents or the revised, that are posted on FDA’s Web For a complete history of previously electronic and written/paper comments site. published Federal Register notices received, go to http:// related to product-specific BE II. Drug Products for Which New Draft recommendations, go to http:// www.regulations.gov and insert the Product-Specific BE Recommendations www.regulations.gov and enter Docket docket number, found in brackets in the Are Available No. FDA–2007–D–0369. heading of this document, into the ‘‘Search’’ box and follow the prompts FDA is announcing the availability of These draft guidances are being and/or go to the Division of Dockets a new draft guidance for industry on issued consistent with FDA’s good Management, 5630 Fishers Lane, Rm. product-specific BE recommendations guidance practices regulation (21 CFR 1061, Rockville, MD 20852. for drug products containing the 10.115). These draft guidances, when Submit written requests for single following active ingredients: finalized, will represent the current copies of the draft guidance to the thinking of FDA on the product-specific Division of Drug Information, Center for TABLE 1—NEW DRAFT PRODUCT-SPE- design of BE studies to support ANDAs. Drug Evaluation and Research, Food CIFIC BE RECOMMENDATIONS FOR They do not establish any rights for any and Drug Administration, 10001 New DRUG PRODUCTS person and are not binding on FDA or Hampshire Ave., Hillandale Building, the public. You can use an alternative 4th Floor, Silver Spring, MD 20993– Amcinonide approach if it satisfies the requirements 0002. Send one self-addressed adhesive Cariprazine hydrochloride of the applicable statutes and label to assist that office in processing Cobimetinib fumarate regulations. your requests. See the SUPPLEMENTARY Empagliflozin; Metformin hydrochloride Erythromycin ethylsuccinate IV. Electronic Access INFORMATION section for electronic Everolimus Persons with access to the Internet access to the draft guidance document. Flibanserin may obtain the draft guidance at either FOR FURTHER INFORMATION CONTACT: Fluocinonide (multiple reference listed drugs) http://www.fda.gov/Drugs/ Xiaoqiu Tang, Center for Drug Hydrocortisone GuidanceCompliance Evaluation and Research, Food and Lesinurad RegulatoryInformation/Guidances/ Drug Administration, 10903 New Meloxicam Methylergonovine maleate default.htm or http:// Hampshire Ave., Bldg. 75, Rm. 4730, www.regulations.gov. Silver Spring, MD 20993–0002, 301– Ombitasvir; paritaprevir; ritonavir Prednicarbate Dated: June 13, 2016. 796–5850. Propofol Leslie Kux, SUPPLEMENTARY INFORMATION: Pseudoephedrine hydrochloride Associate Commissioner for Policy. Selexipag I. Background Tacrolimus [FR Doc. 2016–14351 Filed 6–16–16; 8:45 am] In the Federal Register of June 11, BILLING CODE 4164–01–P 2010 (75 FR 33311), FDA announced the III. Drug Products for Which Revised availability of a guidance for industry Draft Product-Specific BE entitled ‘‘Bioequivalence Recommendations Are Available DEPARTMENT OF HEALTH AND Recommendations for Specific HUMAN SERVICES FDA is announcing the availability of Products’’ that explained the process a revised draft guidance for industry on Food and Drug Administration that would be used to make product- product-specific BE recommendations specific BE recommendations available [Docket No. FDA–2016–D–1490] for drug products containing the to the public on FDA’s Web site at following active ingredients: http://www.fda.gov/Drugs/ Quality Attribute Considerations for GuidanceCompliance Chewable Tablets; Draft Guidance for TABLE 2—REVISED DRAFT PRODUCT- Industry; Availability RegulatoryInformation/Guidances/ default.htm. SPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS AGENCY: Food and Drug Administration, As described in that guidance, FDA HHS. adopted this process as a means to sradovich on DSK3TPTVN1PROD with NOTICES Acetaminophen; hydrocodone bitartrate ACTION: Notice of availability. develop and disseminate product- Albuterol sulfate specific BE recommendations and SUMMARY: The Food and Drug Azelastine hydrochloride; Fluticasone propio- provide a meaningful opportunity for nate Administration (FDA or Agency) is the public to consider and comment on Benzoyl peroxide; Clindamycin phosphate announcing the availability of a draft those recommendations. Under that Dexamethasone; Tobramycin (multiple ref- guidance for industry entitled ‘‘Quality process, draft recommendations are erence listed drugs) Attribute Considerations for Chewable posted on FDA’s Web site and Lansoprazole Tablets.’’ This guidance describes the VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1


Document Created: 2016-06-17 01:05:12
Document Modified: 2016-06-17 01:05:12
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.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2016.
ContactXiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850.
FR Citation81 FR 39672 
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