80 FR 26058 - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 87 (May 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 87 (May 6, 2015)
| Page Range | 26058-26059 | |
| FR Document | 2015-10479 |
[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)] [Notices] [Pages 26058-26059] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10479] ----------------------------------------------------------------------- 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Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics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 investigational new drug applications (INDs), and applicants that submit new drug applications, 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 in vivo bioavailability (BA) and/or bioequivalence (BE) studies. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 6, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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. [[Page 26059]] Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mehul Mehta, Center for Drug Evaluation and Research, 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 draft 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 and applicants who wish to request a waiver of in vivo BA and/or BE studies for IR solid oral dosage forms. These waivers are intended to apply to: (1) Subsequent in vivo BA or BE studies of formulations after the initial establishment of the in vivo BA of IR dosage forms during the IND period and (2) in vivo BE studies of IR dosage forms in ANDAs. Regulations at 21 CFR part 320 address the requirements for BA and BE data for approval of drug applications and supplemental applications. Provision for waivers of in vivo BA/BE studies (biowaivers) under certain conditions is provided at Sec. 320.22. This guidance updates 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 in August 2000, and explains when biowaivers can be requested for IR solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). This guidance includes biowaiver extension to BCS class 3 drug products and additional modifications, such as criteria for high permeability and high solubility. 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 FDA's current thinking on waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a BCS. 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. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. 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 21 CFR part 314, including Sec. Sec. 314.50 and 314.94, have been approved under OMB control number 0910-0001. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: April 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-10479 Filed 5-5-15; 8:45 am] BILLING CODE 4164-01-P
![26058 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices
601.51), and any amendments to or making regulatory submissions to FDA GuidanceCompliance
annual reports on previously submitted in electronic format for NDAs, ANDAs, RegulatoryInformation/Guidances/
DMFs or BPFs. This guidance also BLAs, INDs, master files, and default.htm, or http://
applies to submissions for drug/device advertising and promotional labeling. www.regulations.gov.
combination products filed pursuant to The information collection discussed in Dated: April 30, 2015.
section 505 of the FD&C Act or the guidance is contained in our IND Leslie Kux,
subsection (a) or (k) of section 351 of the regulations (21 CFR part 312) and
Associate Commissioner for Policy.
PHS Act. approved under OMB control number
Section Technical Specification [FR Doc. 2015–10539 Filed 5–5–15; 8:45 am]
0910–0014, our NDA regulations
Documents Incorporated by Reference: (including ANDAs) (21 CFR part 314) BILLING CODE 4164–01–P
Provides a list of documents and approved under OMB control
incorporated by reference into this number 0910–0001, and our BLA
guidance and provides a complete DEPARTMENT OF HEALTH AND
regulations (21 CFR part 601) and
listing of technical supportive files on HUMAN SERVICES
approved under OMB control number
the FDA eCTD Web page at http:// 0910–0338.
www.fda.gov/Drugs/ Food and Drug Administration
Sponsors and applicants have been
DevelopmentApprovalProcess/ submitting NDAs, ANDAs, BLAs, INDs,
FormsSubmissionRequirements/ [Docket No. FDA–2015–D–1245]
and master files electronically since
ElectronicSubmissions/ucm153574.htm. 2003, and the majority of these
We also received a comment Waiver of In Vivo Bioavailability and
submissions are already received in Bioequivalence Studies for Immediate-
concerning the implementation timeline electronic format. Under section
for the Portable Document Format (PDF) Release Solid Oral Dosage Forms
745A(a) of the FD&C Act, sponsors and Based on a Biopharmaceutics
technical specification. As discussed in applicants are required to file most of
the guidance for industry ‘‘Providing Classification System; Draft Guidance
these submissions electronically. These for Industry; Availability
Regulatory Submissions in Electronic requirements will be phased in over 2-
Format—Submissions Under Section and 3-year periods after the issuance of AGENCY: Food and Drug Administration,
745A(a) of the Federal Food, Drug, and this guidance. HHS.
Cosmetic Act,’’ certain technical For some sponsors and applicants, ACTION: Notice.
specifications are required no earlier there may be new costs, including
than 2 years after the final guidance is capital costs or operating and SUMMARY: The Food and Drug
published. maintenance costs, which would result Administration (FDA) is announcing the
This guidance implements the from the requirements under FDASIA availability of a draft guidance for
electronic submission requirements of and this guidance, because some industry entitled ‘‘Waiver of In Vivo
section 745A(a) of the FD&C Act by sponsors and applicants may have to Bioavailability and Bioequivalence
specifying the format for electronic upgrade eCTD specifications and/or Studies for Immediate-Release Solid
submissions. All submissions submitted change their method of submitting Oral Dosage Forms Based on a
24 months after the publication of this information to FDA. FDA estimates that, Biopharmaceutics Classification
guidance must use the appropriate FDA- for some sponsors and applicants, the System.’’ This guidance provides
supported eCTD specifications for NDA, costs may be as follows: recommendations for sponsors of
ANDA, and certain BLA submissions. • eCTD Publishing Software: $25,000 investigational new drug applications
Certain IND submissions must use the to $150,000 (INDs), and applicants that submit new
FDA-supported eCTD specifications for • Publishing Operations Support: drug applications, abbreviated new drug
electronic submissions submitted 36 $50,000 to $1 million applications (ANDAs), and supplements
months after publication of this • Training: $5,000 to $50,000 to these applications for immediate-
guidance. release (IR) solid oral dosage forms, and
In section 745A(a) of the FD&C Act, III. Comments
who wish to request a waiver of in vivo
Congress granted explicit authorization Interested persons may submit either bioavailability (BA) and/or
to FDA to implement the statutory electronic comments to http:// bioequivalence (BE) studies.
electronic submission requirements by www.regulations.gov or written
DATES: Although you can comment on
specifying the format for such comments regarding this document to
submissions in guidance. Because this the Division of Dockets Management any guidance at any time (see 21 CFR
guidance provides such requirements (see ADDRESSES). It is only necessary to 10.115(g)(5)), to ensure that the Agency
under section 745A(a) of the FD&C Act, send one set of comments. Identify considers your comment on this draft
indicated by the use of the words must comments with the docket number guidance before it begins work on the
or required, it is not subject to the usual found in brackets in the heading of this final version of the guidance, submit
restrictions in FDA’s good guidance document. Received comments may be either electronic or written comments
practice regulations, such as the seen in the Division of Dockets on the draft guidance by July 6, 2015.
requirement that guidances not establish Management between 9 a.m. and 4 p.m., ADDRESSES: Submit written requests for
legally enforceable responsibilities. See Monday through Friday, and will be single copies of the draft guidance to the
21 CFR 10.115(d). posted to the docket at http:// Division of Drug Information, Center for
www.regulations.gov. Drug Evaluation and Research, Food
II. Paperwork Reduction Act of 1995 and Drug Administration, 10001 New
IV. Electronic Access
tkelley on DSK3SPTVN1PROD with NOTICES
This guidance refers to previously Hampshire Ave., Hillandale Building,
approved collections of information that Persons with access to the Internet 4th Floor, Silver Spring, MD 20993–
are subject to review by the Office of may obtain the document at http:// 0002. Send one self-addressed adhesive
Management and Budget (OMB) under www.fda.gov/Drugs/Guidance label to assist that office in processing
the Paperwork Reduction Act of 1995 ComplianceRegulatoryInformation/ your requests. See the SUPPLEMENTARY
(44 U.S.C. 3501–3520). The guidance Guidances/default.htm, http:// INFORMATION section for electronic
pertains to sponsors and applicants www.fda.gov/BiologicsBloodVaccines/ access to the draft guidance document.
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![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices 26059
Submit electronic comments on the requirements of the applicable statutes DATES: Although you can comment on
draft guidance to http:// and regulations. any guidance at any time (see 21 CFR
www.regulations.gov. Submit written 10.115(g)(5)), if you wish to submit
II. Comments
comments to the Division of Dockets comments on a specific withdrawal
Management (HFA–305), Food and Drug Interested persons may submit either action in this notice, submit either
Administration, 5630 Fishers Lane, Rm. electronic comments regarding this electronic or written comments by June
1061, Rockville, MD 20852. document to http://www.regulations.gov 5, 2015.
FOR FURTHER INFORMATION CONTACT: or written comments to the Division of ADDRESSES: You may submit comments
Mehul Mehta, Center for Drug Dockets Management (see ADDRESSES). It by any of the following methods:
Evaluation and Research, Food and is only necessary to send one set of
comments. Identify comments with the Electronic Submissions
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD docket number found in brackets in the Submit electronic comments in the
20993, 301–796–1573. heading of this document. Received following way:
SUPPLEMENTARY INFORMATION:
comments may be seen in the Division • Federal eRulemaking Portal: http://
of Dockets Management between 9 a.m. www.regulations.gov. Follow the
I. Background and 4 p.m., Monday through Friday, and instructions for submitting comments.
FDA is announcing the availability of will be posted to the docket at http://
www.regulations.gov. Written Submissions
a draft guidance for industry entitled
‘‘Waiver of In Vivo Bioavailability and III. Paperwork Reduction Act of 1995 Submit written submissions in the
Bioequivalence Studies for Immediate- following ways:
Release Solid Oral Dosage Forms Based This guidance refers to previously • Mail/Hand delivery/Courier (for
on a Biopharmaceutics Classification approved collections of information that paper submissions): Division of Dockets
System.’’ This guidance provides are subject to review by the Office of Management (HFA–305), Food and Drug
recommendations for sponsors and Management and Budget (OMB) under Administration, 5630 Fishers Lane, Rm.
applicants who wish to request a waiver the Paperwork Reduction Act of 1995 1061, Rockville, MD 20852.
of in vivo BA and/or BE studies for IR (44 U.S.C. 3501–3520). The collections Instructions: All submissions received
solid oral dosage forms. These waivers of information in 21 CFR part 314, must include the Docket No. FDA–
are intended to apply to: (1) Subsequent including §§ 314.50 and 314.94, have 2015–N–1419 for this action. All
in vivo BA or BE studies of formulations been approved under OMB control comments received may be posted
after the initial establishment of the in number 0910–0001. without change to http://
vivo BA of IR dosage forms during the IV. Electronic Access www.regulations.gov, including any
IND period and (2) in vivo BE studies personal information provided.
Persons with access to the Internet Docket: For access to the docket to
of IR dosage forms in ANDAs.
may obtain the document at either read background documents or
Regulations at 21 CFR part 320
http://www.fda.gov/Drugs/Guidance comments received, go to http://
address the requirements for BA and BE
ComplianceRegulatoryInformation/ www.regulations.gov and insert the
data for approval of drug applications
Guidances/default.htm or http:// docket number(s), found in brackets in
and supplemental applications.
www.regulations.gov. the heading of this document, into the
Provision for waivers of in vivo BA/BE
studies (biowaivers) under certain Dated: April 29, 2015. ‘‘Search’’ box and follow the prompts
conditions is provided at § 320.22. This Leslie Kux, and/or go to the Division of Dockets
guidance updates the guidance for Associate Commissioner for Policy. Management, 5630 Fishers Lane, Rm.
industry on ‘‘Waiver of In Vivo [FR Doc. 2015–10479 Filed 5–5–15; 8:45 am]
1061, Rockville, MD 20852.
Bioavailability and Bioequivalence BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: Lisa
Studies for Immediate-Release Solid M. Helmanis, Regulations Policy and
Oral Dosage Forms Based on a Management Staff, Office of the
Biopharmaceutics Classification DEPARTMENT OF HEALTH AND Commissioner, Food and Drug
System,’’ published in August 2000, and HUMAN SERVICES Administration, 10903 New Hampshire
explains when biowaivers can be Ave., Bldg. 32, Rm. 3326, Silver Spring,
requested for IR solid oral dosage forms Food and Drug Administration MD 20993–0002, 301–796–9135, email:
based on an approach termed the Lisa.Helmanis.@fda.hhs.gov.
Biopharmaceutics Classification System [Docket No. FDA–2015–N–1419]
SUPPLEMENTARY INFORMATION:
(BCS). This guidance includes
Withdrawal of Draft Guidance I. Background
biowaiver extension to BCS class 3 drug
Documents Published Before
products and additional modifications, In September 2000, FDA codified its
December 31, 2013
such as criteria for high permeability good guidance practices (GGPs). GGPs
and high solubility. AGENCY: Food and Drug Administration, are FDA’s policies and procedures for
This draft guidance is being issued HHS. the development, issuance, and use of
consistent with FDA’s good guidance ACTION: Notice. guidance documents. Level I guidance
practices regulation (21 CFR 10.115). documents set forth initial
The draft guidance, when finalized, will SUMMARY: The Food and Drug interpretations of statutory or regulatory
represent FDA’s current thinking on Administration (FDA) is announcing the requirements, explain changes in
tkelley on DSK3SPTVN1PROD with NOTICES
waiver of in vivo bioavailability and withdrawal of 47 draft guidance interpretation of policies, or discuss
bioequivalence studies for immediate- documents that published before complex scientific issues or highly
release solid oral dosage forms based on December 31, 2013, and have never controversial issues. The GGPs,
a BCS. It does not establish any rights been finalized. FDA is taking this action generally, require that such guidances
for any person and is not binding on to improve the efficiency and be issued in draft for public comment
FDA or the public. You can use an transparency of the guidance before they are finalized. FDA’s
alternative approach if it satisfies the development process. guidance documents do not create
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Document Created: 2015-12-16 07:41:15
Document Modified: 2015-12-16 07:41:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 July 6, 2015. | |
| Contact | Mehul Mehta, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-1573. | |
| FR Citation | 80 FR 26058 |
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