82 FR 61011 - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 246 (December 26, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.

[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61011-61013]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1245]


Waiver of In Vivo Bioavailability and Bioequivalence Studies for 
Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics 
Classification System; Guidance 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 a guidance for industry entitled ``Waiver of In 
Vivo Bioavailability and Bioequivalence Studies for Immediate-Release 
Solid Oral Dosage Forms Based on a Biopharmaceutics Classification 
System.'' This guidance finalizes recommendations for sponsors of 
investigational new drug applications (INDs), and applicants who submit 
new drug applications (NDAs), abbreviated new drug applications 
(ANDAs), and supplements to these applications for immediate-release 
(IR) solid oral dosage forms, and who wish to request a waiver of an in 
vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.

DATES: The announcement of the guidance is published in the Federal 
Register on December 26, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 61012]]

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-2015-D-1245 for ``Waiver of In Vivo Bioavailability and 
Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms 
Based on a Biopharmaceutics Classification System.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Mehul Mehta, Center for Drug 
Evaluation and Research (HFD-860), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 301-796-1573.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies 
for Immediate-Release Solid Oral Dosage Forms Based on a 
Biopharmaceutics Classification System.'' This guidance provides 
recommendations for sponsors of INDs, and applicants who submit NDAs, 
ANDAs, and supplements to these applications for IR solid oral dosage 
forms, and who wish to request a waiver of an in vivo BA and/or BE 
study requirement. These recommendations are intended to apply to 
waivers requested during the IND period and the NDA stage or for ANDAs, 
i.e.: (1) Subsequent in vivo BA or BE studies of formulations after the 
initial establishment of the in vivo BA of IR solid oral dosage forms 
during the IND period, and (2) in vivo BE studies of IR solid oral 
dosage forms in NDAs, ANDAs, and supplements to these applications.
    This guidance finalizes the guidance for industry on Waiver of In 
Vivo Bioavailability and Bioequivalence Studies for Immediate-Release 
Solid Oral Dosage Forms Based on a Biopharmaceutics Classification 
System, published on May 6, 2015 (80 FR 26058), and explains when 
biowaivers can be requested for IR solid oral dosage forms based on an 
approach termed the Biopharmaceutics Classification System (BCS). While 
many positive comments were received on the published draft guidance, 
several requests were made for additional clarification regarding the 
biowaivers for BCS class 3 drug substances, and specific issues 
pertaining to dissolution and permeability categories. In response, 
this guidance includes biowaiver extension to BCS class 3 drug 
products, and additional modifications, such as criteria for high 
permeability and high solubility.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Waiver of In Vivo Bioavailability and 
Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms 
Based on a Biopharmaceutics Classification System. 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in part 314 (21 CFR part 314), 
including Sec. Sec.  314.50 and 314.94, have been approved under OMB 
control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.


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    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27786 Filed 12-22-17; 8:45 am]
 BILLING CODE 4164-01-P