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)
Food and Drug Administration
Federal Register Volume 82, Issue 246 (December 26, 2017)
| Page Range | 61011-61013 | |
| FR Document | 2017-27786 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. [[Page 61013]] 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
![Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices 61011
A regulatory review period consists of 1. The date an exemption under Dated: December 20, 2017.
two periods of time: A testing phase and section 505(i) of the Federal Food, Drug, Leslie Kux,
an approval phase. For human drug and Cosmetic Act (FD&C Act) (21 U.S.C. Associate Commissioner for Policy.
products, the testing phase begins when 355(i)) became effective: November 7, [FR Doc. 2017–27745 Filed 12–22–17; 8:45 am]
the exemption to permit the clinical 2010. FDA has verified the applicants’ BILLING CODE 4164–01–P
investigations of the drug becomes claims that November 7, 2010, is the
effective and runs until the approval date the investigational new drug
phase begins. The approval phase starts application became effective. DEPARTMENT OF HEALTH AND
with the initial submission of an HUMAN SERVICES
application to market the human drug 2. The date the application was
product and continues until FDA grants initially submitted with respect to the Food and Drug Administration
permission to market the drug product. human drug product under section
505(b) of the FD&C Act: December 24, [Docket No. FDA–2015–D–1245]
Although only a portion of a regulatory
review period may count toward the 2013. FDA has verified the applicants’ Waiver of In Vivo Bioavailability and
actual amount of extension that the claims that the new drug application Bioequivalence Studies for Immediate-
Director of USPTO may award (for (NDA) for ZYKADIA (NDA 205755) was Release Solid Oral Dosage Forms
example, half the testing phase must be initially submitted on December 24, Based on a Biopharmaceutics
subtracted as well as any time that may 2013. Classification System; Guidance for
have occurred before the patent was 3. The date the application was Industry; Availability
issued), FDA’s determination of the approved: April 29, 2014. FDA has
length of a regulatory review period for AGENCY: Food and Drug Administration,
verified the applicants’ claims that NDA
a human drug product will include all HHS.
205755 was approved on April 29, 2014.
of the testing phase and approval phase ACTION: Notice of availability.
as specified in 35 U.S.C. 156(g)(1)(B). This determination of the regulatory
FDA has approved for marketing the review period establishes the maximum SUMMARY: The Food and Drug
human drug product ZYKADIA potential length of a patent extension. Administration (FDA or Agency) is
(ceritinib). ZYKADIA is indicated for However, the USPTO applies several announcing the availability of a
the treatment of patients with anaplastic statutory limitations in its calculations guidance for industry entitled ‘‘Waiver
lymphoma kinase-positive metastatic of the actual period for patent extension. of In Vivo Bioavailability and
non-small cell lung cancer who have In their applications for patent Bioequivalence Studies for Immediate-
progressed on or are intolerant to extension, these applicants seek 472 Release Solid Oral Dosage Forms Based
crizotinib. This indication is approved days of patent term extension. on a Biopharmaceutics Classification
under accelerated approval based on System.’’ This guidance finalizes
III. Petitions recommendations for sponsors of
tumor response rate and duration of
response. An improvement in survival investigational new drug applications
Anyone with knowledge that any of (INDs), and applicants who submit new
or disease-related symptoms has not the dates as published are incorrect may
been established. Continued approval drug applications (NDAs), abbreviated
submit either electronic or written new drug applications (ANDAs), and
for this indication may be contingent comments and, under 21 CFR 60.24 ask
upon verification and description of supplements to these applications for
for a redetermination (see DATES). immediate-release (IR) solid oral dosage
clinical benefit in confirmatory trials. Furthermore, as specified in § 60.30 (21
Subsequent to this approval, the USPTO forms, and who wish to request a waiver
CFR 60.30), any interested person may of an in vivo bioavailability (BA) and/
received patent term restoration petition FDA for a determination
applications for ZYKADIA (U.S. Patent or bioequivalence (BE) study
regarding whether the applicant for requirement.
Nos. 7,964,592 from Novartis AG and
extension acted with due diligence DATES: The announcement of the
and 8,377,921 from IRM LLC), and the
USPTO requested FDA’s assistance in during the regulatory review period. To guidance is published in the Federal
determining the patents’ eligibility for meet its burden, the petition comply Register on December 26, 2017.
patent term restoration. In a letter dated with all the requirements of § 60.30,
ADDRESSES: You may submit either
October 15, 2015, FDA advised the including but not limited to: must be
electronic or written comments on
USPTO that this human drug product timely (see DATES), must be filed in Agency guidances at any time as
had undergone a regulatory review accordance with § 10.20, must contain follows:
period and that the approval of sufficient facts to merit an FDA
ZYKADIA represented the first investigation, and must certify that a Electronic Submissions
permitted commercial marketing or use true and complete copy of the petition Submit electronic comments in the
of the product. Thereafter, the USPTO has been served upon the patent following way:
requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th • Federal eRulemaking Portal:
product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) https://www.regulations.gov. Follow the
Petitions should be in the format instructions for submitting comments.
II. Determination of Regulatory Review
Period specified in 21 CFR 10.30. Comments submitted electronically,
Submit petitions electronically to including attachments, to https://
FDA has determined that the https://www.regulations.gov at Docket www.regulations.gov will be posted to
ethrower on DSK3G9T082PROD with NOTICES
applicable regulatory review period for No. FDA–2013–S–0610. Submit written the docket unchanged. Because your
ZYKADIA is 1,271 days. Of this time, comment will be made public, you are
petitions (two copies are required) to the
1,144 days occurred during the testing solely responsible for ensuring that your
Dockets Management Staff (HFA–305),
phase of the regulatory review period, comment does not include any
while 127 days occurred during the Food and Drug Administration, 5630
confidential information that you or a
approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD third party may not wish to be posted,
were derived from the following dates: 20852. such as medical information, your or
VerDate Sep<11>2014 20:21 Dec 22, 2017 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\26DEN1.SGM 26DEN1](https://thefederalregister.org/doc/82_FR_61257/page/1.svg)
![Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices 61013
Dated: December 20, 2017. Comments submitted electronically, claimed confidential information
Leslie Kux, including attachments, to https:// redacted/blacked out, will be available
Associate Commissioner for Policy. www.regulations.gov will be posted to for public viewing and posted on
[FR Doc. 2017–27786 Filed 12–22–17; 8:45 am] the docket unchanged. Because your https://www.regulations.gov. Submit
BILLING CODE 4164–01–P
comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Staff. If you do not wish your name and
comment does not include any contact information to be made publicly
DEPARTMENT OF HEALTH AND confidential information that you or a available, you can provide this
HUMAN SERVICES third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
Food and Drug Administration anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
[Docket No. FDA–2014–N–1069]
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Agency Information Collection that if you include your name, contact except in accordance with 21 CFR 10.20
Activities; Proposed Collection; information, or other information that and other applicable disclosure law. For
Comment Request; Blood identifies you in the body of your more information about FDA’s posting
Establishment Registration and comments, that information will be of comments to public dockets, see 80
Product Listing, Form FDA 2830 posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. do not wish to be made available to the 23389.pdf.
ACTION: Notice. public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’). received, go to https://
announcing an opportunity for public www.regulations.gov and insert the
Written/Paper Submissions
comment on the proposed collection of docket number, found in brackets in the
certain information by the Agency. Submit written/paper submissions as heading of this document, into the
Under the Paperwork Reduction Act of follows: ‘‘Search’’ box and follow the prompts
1995 (PRA), Federal Agencies are • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
required to publish notice in the written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
Federal Register concerning each Management Staff (HFA–305), Food and Rockville, MD 20852.
proposed collection of information, Drug Administration, 5630 Fishers
FOR FURTHER INFORMATION CONTACT: Ila
including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments S. Mizrachi, Office of Operations, Food
existing collection of information, and and Drug Administration, Three White
to allow 60 days for public comment in submitted to the Dockets Management
Staff, FDA will post your comment, as Flint North, 10A–12M, 11601
response to the notice. This notice Landsdown St., North Bethesda, MD
solicits comments on the information well as any attachments, except for
information submitted, marked and 20852, 301–796–7726, PRAStaff@
collection requirements relating to the fda.hhs.gov.
blood establishment registration and identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
product listing requirements in the
Agency’s regulations and Form FDA Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal
2830. must include the Docket No. FDA– Agencies must obtain approval from the
2014–N–1069 for ‘‘Blood Establishment Office of Management and Budget
DATES: Submit electronic or written Registration and Product Listing, Form (OMB) for each collection of
comments on the collection of FDA 2830.’’ Received comments, those information they conduct or sponsor.
information by February 26, 2018. filed in a timely manner (see ‘‘Collection of information’’ is defined
ADDRESSES: You may submit comments ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
as follows. Please note that late, and, except for those submitted as 1320.3(c) and includes Agency requests
untimely filed comments will not be ‘‘Confidential Submissions,’’ publicly or requirements that members of the
considered. Electronic comments must viewable at https://www.regulations.gov public submit reports, keep records, or
be submitted on or before February 26, or at the Dockets Management Staff provide information to a third party.
2018. The https://www.regulations.gov between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
electronic filing system will accept through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
comments until midnight Eastern Time • Confidential Submissions—To Agencies to provide a 60-day notice in
at the end of February 26, 2018. submit a comment with confidential the Federal Register concerning each
Comments received by mail/hand information that you do not wish to be proposed collection of information,
delivery/courier (for written/paper made publicly available, submit your including each proposed extension of an
submissions) will be considered timely comments only as a written/paper existing collection of information,
if they are postmarked or the delivery submission. You should submit two before submitting the collection to OMB
service acceptance receipt is on or copies total. One copy will include the for approval. To comply with this
before that date. information you claim to be confidential requirement, FDA is publishing notice
ethrower on DSK3G9T082PROD with NOTICES
with a heading or cover note that states of the proposed collection of
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The With respect to the following
following way: Agency will review this copy, including collection of information, FDA invites
• Federal eRulemaking Portal: the claimed confidential information, in comments on these topics: (1) Whether
https://www.regulations.gov. Follow the its consideration of comments. The the proposed collection of information
instructions for submitting comments. second copy, which will have the is necessary for the proper performance
VerDate Sep<11>2014 20:21 Dec 22, 2017 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\26DEN1.SGM 26DEN1](https://thefederalregister.org/doc/82_FR_61257/page/3.svg)
Document Created: 2017-12-23 03:08:32
Document Modified: 2017-12-23 03:08:32
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on December 26, 2017. | |
| 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. | |
| FR Citation | 82 FR 61011 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR