83 FR 54107 - Biopharmaceutics Classification System-Based Biowaivers; International Council for Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 208 (October 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 208 (October 26, 2018)
| Page Range | 54107-54108 | |
| FR Document | 2018-23425 |
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)] [Notices] [Pages 54107-54108] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23425] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3614] Biopharmaceutics Classification System-Based Biowaivers; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Biopharmaceutics Classification System-Based Biowaivers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance will provide recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of in vivo bioequivalence (BE) studies for drug products. In vivo BE studies are needed to demonstrate lack of impact of significant formulation changes on a drug's bioavailability during its development, for post-approval line extensions, and when developing a generic product. Utilizing the critical properties of the drug substance and the drug product, and applying the BCS framework, assurance of in vivo BE findings can be obtained using extensive in vitro studies. The draft guidance is intended to avoid unnecessary human BE trials based on extensive in vitro characterization of the drug substance and drug product properties. DATES: Submit either electronic or written comments on the draft guidance by January 24, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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 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-2018-D-3614 for ``Biopharmaceutics Classification System-Based Biowaivers.'' 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. [[Page 54108]] 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, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Mehul Mehta, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 2178, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1573. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548. SUPPLEMENTARY INFORMATION: I. Background In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization, and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory Agencies. ICH was established to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance. In May 2018, the ICH Assembly endorsed the draft guideline entitled ``Biopharmaceutics Classification System-Based Biowaivers'' and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Multidisciplinary M9 Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Multidisciplinary M9 Expert Working Group. The draft guidance provides guidance on the biopharmaceutics classification of drug substances and the BCS-based waiver of in vivo BE studies for drug products. 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 the current thinking of FDA on ``Biopharmaceutics Classification System-Based Biowaivers.'' 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.regulations.gov, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: October 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23425 Filed 10-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices 54107
available for inspection at the offices of the biopharmaceutics classification of Drug Administration, 5630 Fishers
the Board of Governors. Interested drug substances and the Lane, Rm. 1061, Rockville, MD 20852.
persons may express their views in Biopharmaceutics Classification System • For written/paper comments
writing on the standards enumerated in (BCS)-based waiver of in vivo submitted to the Dockets Management
the BHC Act (12 U.S.C. 1842(c)). If the bioequivalence (BE) studies for drug Staff, FDA will post your comment, as
proposal also involves the acquisition of products. In vivo BE studies are needed well as any attachments, except for
a nonbanking company, the review also to demonstrate lack of impact of information submitted, marked and
includes whether the acquisition of the significant formulation changes on a identified, as confidential, if submitted
nonbanking company complies with the drug’s bioavailability during its as detailed in ‘‘Instructions.’’
standards in section 4 of the BHC Act development, for post-approval line Instructions: All submissions received
(12 U.S.C. 1843). Unless otherwise extensions, and when developing a must include the Docket No. FDA–
noted, nonbanking activities will be generic product. Utilizing the critical 2018–D–3614 for ‘‘Biopharmaceutics
conducted throughout the United States. properties of the drug substance and the Classification System-Based
Unless otherwise noted, comments drug product, and applying the BCS Biowaivers.’’ Received comments will
regarding each of these applications framework, assurance of in vivo BE be placed in the docket and, except for
must be received at the Reserve Bank findings can be obtained using extensive those submitted as ‘‘Confidential
indicated or the offices of the Board of in vitro studies. The draft guidance is Submissions,’’ publicly viewable at
Governors not later than November 23, intended to avoid unnecessary human https://www.regulations.gov or at the
2018. BE trials based on extensive in vitro Dockets Management Staff between 9
A. Federal Reserve Bank of Boston characterization of the drug substance a.m. and 4 p.m., Monday through
(Prabal Chakrabarti, Senior Vice and drug product properties. Friday.
President) 600 Atlantic Avenue, Boston, DATES: Submit either electronic or • Confidential Submissions—To
Massachusetts 02210–2204. Comments written comments on the draft guidance submit a comment with confidential
can also be sent electronically to by January 24, 2019 to ensure that the information that you do not wish to be
BOS.SRC.Applications.Comments@ Agency considers your comment on this made publicly available, submit your
bos.frb.org: draft guidance before it begins work on comments only as a written/paper
1. Hometown Financial Group, MHC the final version of the guidance. submission. You should submit two
and Hometown Financial Group, Inc., ADDRESSES: You may submit comments copies total. One copy will include the
both of Easthampton, Massachusetts; to on any guidance at any time as follows: information you claim to be confidential
merge with Pilgrim Bancshares, Inc., with a heading or cover note that states
and thereby acquire Pilgrim Bank, both Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
of Cohasset, Massachusetts. Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Board of Governors of the Federal Reserve following way: Agency will review this copy, including
System, October 23, 2018. • Federal eRulemaking Portal: the claimed confidential information, in
Yao-Chin Chao, https://www.regulations.gov. Follow the its consideration of comments. The
Assistant Secretary of the Board. instructions for submitting comments. second copy, which will have the
[FR Doc. 2018–23449 Filed 10–25–18; 8:45 am] Comments submitted electronically, claimed confidential information
BILLING CODE P including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Dockets Management
DEPARTMENT OF HEALTH AND
solely responsible for ensuring that your Staff. If you do not wish your name and
HUMAN SERVICES
comment does not include any contact information to be made publicly
Food and Drug Administration confidential information that you or a available, you can provide this
third party may not wish to be posted, information on the cover sheet and not
[Docket No. FDA–2018–D–3614] such as medical information, your or in the body of your comments and you
anyone else’s Social Security number, or must identify this information as
Biopharmaceutics Classification ‘‘confidential.’’ Any information marked
System-Based Biowaivers; confidential business information, such
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
International Council for except in accordance with 21 CFR 10.20
Harmonisation; Draft Guidance for that if you include your name, contact
information, or other information that and other applicable disclosure law. For
Industry; Availability more information about FDA’s posting
identifies you in the body of your
AGENCY: Food and Drug Administration, comments, that information will be of comments to public dockets, see 80
HHS. posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
ACTION: Notice of availability. • If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
SUMMARY: The Food and Drug do not wish to be made available to the 23389.pdf.
Administration (FDA or Agency) is public, submit the comment as a Docket: For access to the docket to
announcing the availability of a draft written/paper submission and in the read background documents or the
guidance for industry entitled manner detailed (see ‘‘Written/Paper electronic and written/paper comments
‘‘Biopharmaceutics Classification received, go to https://
khammond on DSK30JT082PROD with NOTICES
Submissions’’ and ‘‘Instructions’’).
System-Based Biowaivers.’’ The draft www.regulations.gov and insert the
guidance was prepared under the Written/Paper Submissions docket number, found in brackets in the
auspices of the International Council for Submit written/paper submissions as heading of this document, into the
Harmonisation (ICH), formerly the follows: ‘‘Search’’ box and follow the prompts
International Conference on • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
Harmonisation. The draft guidance will written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
provide recommendations to support Management Staff (HFA–305), Food and Rockville, MD 20852.
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![54108 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
You may submit comments on any European Commission; the European RegulatoryInformation/Guidances/
guidance at any time (see 21 CFR Federation of Pharmaceutical Industries default.htm.
10.115(g)(5)). Associations; FDA; the Japanese Dated: October 22, 2018.
Submit written requests for single Ministry of Health, Labour, and Welfare; Leslie Kux,
copies of this guidance to the Division the Japanese Pharmaceutical
Associate Commissioner for Policy.
of Drug Information, Center for Drug Manufacturers Association; and the
[FR Doc. 2018–23425 Filed 10–25–18; 8:45 am]
Evaluation and Research, Food and Pharmaceutical Research and
BILLING CODE 4164–01–P
Drug Administration, 10001 New Manufacturers of America. The
Hampshire Ave., Hillandale Building, Standing Members of the ICH
4th Floor, Silver Spring, MD 20993– Association include Health Canada and
DEPARTMENT OF HEALTH AND
0002, or the Office of Communication, Swissmedic. Any party eligible as a
HUMAN SERVICES
Outreach and Development, Center for Member in accordance with the ICH
Biologics Evaluation and Research Articles of Association can apply for Food and Drug Administration
(CBER), Food and Drug Administration, membership in writing to the ICH
10903 New Hampshire Ave., Bldg. 71, Secretariat. The ICH Secretariat, which [Docket Nos. FDA–2017–E–4274; FDA–
coordinates the preparation of 2016–E–3887]
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive documentation, operates as an
Determination of Regulatory Review
label to assist that office in processing international nonprofit organization and
Period for Purposes of Patent
your requests. The guidance may also be is funded by the Members of the ICH
Extension; TALTZ
obtained by mail by calling CBER at 1– Association.
800–835–4709 or 240–402–8010. See The ICH Assembly is the overarching AGENCY: Food and Drug Administration,
the SUPPLEMENTARY INFORMATION section body of the Association and includes HHS.
for electronic access to the guidance representatives from each of the ICH ACTION: Notice.
document. members and observers. The Assembly
is responsible for the endorsement of SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: Administration (FDA or the Agency) has
draft guidelines and adoption of final
Regarding the guidance: Mehul guidelines. FDA publishes ICH determined the regulatory review period
Mehta, Center for Drug Evaluation and guidelines as FDA guidance. for TALTZ and is publishing this notice
Research, Food and Drug In May 2018, the ICH Assembly of that determination as required by
Administration, Bldg. 51, Rm. 2178, endorsed the draft guideline entitled law. FDA has made the determination
10903 New Hampshire Ave., Silver ‘‘Biopharmaceutics Classification because of the submission of
Spring, MD 20993–0002, 301–796–1573. System-Based Biowaivers’’ and agreed applications to the Director of the U.S.
Regarding the ICH: Amanda Roache, that the guideline should be made Patent and Trademark Office (USPTO),
Center for Drug Evaluation and available for public comment. The draft Department of Commerce, for the
Research, Food and Drug guideline is the product of the extension of a patent which claims that
Administration, 10903 New Hampshire Multidisciplinary M9 Expert Working human biological product.
Ave., Bldg. 51, Rm. 1176, Silver Spring, Group of the ICH. Comments about this DATES: Anyone with knowledge that any
MD 20993–0002, 301–796–4548. draft will be considered by FDA and the of the dates as published (in the
SUPPLEMENTARY INFORMATION: Multidisciplinary M9 Expert Working SUPPLEMENTARY INFORMATION section) are
I. Background Group. incorrect may submit either electronic
The draft guidance provides guidance or written comments and ask for a
In recent years, regulatory authorities on the biopharmaceutics classification redetermination by December 26, 2018.
and industry associations from around of drug substances and the BCS-based Furthermore, any interested person may
the world have participated in many waiver of in vivo BE studies for drug petition FDA for a determination
important initiatives to promote products. regarding whether the applicant for
international harmonization of This draft guidance is being issued extension acted with due diligence
regulatory requirements under the ICH. consistent with FDA’s good guidance during the regulatory review period by
FDA has participated in several ICH practices regulation (21 CFR 10.115). April 24, 2019. See ‘‘Petitions’’ in the
meetings designed to enhance The draft guidance, when finalized, will SUPPLEMENTARY INFORMATION section for
harmonization, and FDA is committed represent the current thinking of FDA more information.
to seeking scientifically based on ‘‘Biopharmaceutics Classification ADDRESSES: You may submit comments
harmonized technical procedures for System-Based Biowaivers.’’ It does not as follows. Please note that late,
pharmaceutical development. One of establish any rights for any person and untimely filed comments will not be
the goals of harmonization is to identify is not binding on FDA or the public. considered. Electronic comments must
and reduce differences in technical You can use an alternative approach if be submitted on or before December 26,
requirements for drug development it satisfies the requirements of the 2018. The https://www.regulations.gov
among regulatory Agencies. applicable statutes and regulations. This electronic filing system will accept
ICH was established to provide an guidance is not subject to Executive comments until 11:59 p.m. Eastern Time
opportunity for harmonization Order 12866. at the end of December 26, 2018.
initiatives to be developed with input Comments received by mail/hand
from both regulatory and industry II. Electronic Access
delivery/courier (for written/paper
representatives. FDA also seeks input Persons with access to the internet
khammond on DSK30JT082PROD with NOTICES
submissions) will be considered timely
from consumer representatives and may obtain the draft guidance at https:// if they are postmarked or the delivery
others. ICH is concerned with www.fda.gov/Drugs/ service acceptance receipt is on or
harmonization of technical GuidanceComplianceRegulatory before that date.
requirements for the registration of Information/Guidances/default.htm,
pharmaceutical products for human use https://www.regulations.gov, or https:// Electronic Submissions
among regulators around the world. The www.fda.gov/BiologicsBloodVaccines/ Submit electronic comments in the
six founding members of the ICH are the GuidanceCompliance following way:
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Document Created: 2018-10-26 02:29:11
Document Modified: 2018-10-26 02:29:11
| 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 | Submit either electronic or written comments on the draft guidance by January 24, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Regarding the guidance: Mehul Mehta, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 2178, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1573. | |
| FR Citation | 83 FR 54107 |
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