Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability, 39672-39673 [2016-14351]

Download as PDF 39672 Dated: June 13, 2016. Leslie Kux, Associate Commissioner for Policy. 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before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2016. [FR Doc. 2016–14380 Filed 6–16–16; 8:45 am] BILLING CODE 4164–01–C ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions 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. 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 productspecific 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 productspecific 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 sradovich on DSK3TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 You may submit comments as follows: 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): Division of Dockets Management (HFA–305), Food PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 https://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 https:// 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 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.023</GPH> Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 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.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 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 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: sradovich on DSK3TPTVN1PROD 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 BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific 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 VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 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. 39673 TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS—Continued 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 II. Drug Products for Which New Draft recommendations, go to https:// Product-Specific BE Recommendations www.regulations.gov and enter Docket Are Available No. FDA–2007–D–0369. These draft guidances are being FDA is announcing the availability of issued consistent with FDA’s good a new draft guidance for industry on guidance practices regulation (21 CFR product-specific BE recommendations 10.115). These draft guidances, when for drug products containing the finalized, will represent the current following active ingredients: thinking of FDA on the product-specific TABLE 1—NEW DRAFT PRODUCT-SPE- design of BE studies to support ANDAs. CIFIC BE RECOMMENDATIONS FOR They do not establish any rights for any person and are not binding on FDA or DRUG PRODUCTS the public. You can use an alternative approach if it satisfies the requirements Amcinonide of the applicable statutes and Cariprazine hydrochloride regulations. 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 IV. Electronic Access 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. 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 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 PRODUCTSPECIFIC 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1490] Quality Attribute Considerations for Chewable Tablets; Draft Guidance 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 a draft guidance for industry entitled ‘‘Quality Attribute Considerations for Chewable Tablets.’’ This guidance describes the SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39672-39673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14351]


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

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.

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

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: 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): 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 https://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 https://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: https://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 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 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 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 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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
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 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 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
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