81 FR 87043 - Physiologically Based Pharmacokinetic Analyses-Format and Content; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 232 (December 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 232 (December 2, 2016)
| Page Range | 87043-87044 | |
| FR Document | 2016-28971 |
[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)] [Notices] [Pages 87043-87044] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28971] [[Page 87043]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-3969] Physiologically Based Pharmacokinetic Analyses--Format and Content; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Physiologically Based Pharmacokinetic Analyses--Format and Content.'' This guidance recommends to drug sponsors the format and content for submitting physiologically based pharmacokinetic (PBPK) analyses to FDA to enable efficient and consistent review. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 31, 2017. 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-2016-D-3969 for ``Physiologically Based Pharmacokinetic Analyses-- Format and Content; Draft Guidance for Industry; Availability.'' 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 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: http://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: Ping Zhao, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3182, Silver Spring, MD 20993-0002, 301- 796-3774. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Physiologically Based Pharmacokinetic Analyses--Format and Content.'' A PBPK analysis uses models and simulations that combine physiology, population, and drug characteristics to describe the pharmacokinetics and/or pharmacodynamics of that particular drug in humans. Throughout a drug's life cycle, PBPK analyses can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, inform dosing recommendations, and enable prescription drug labeling. Currently, the format and content of PBPK analyses that are submitted to FDA vary significantly across drug developers. Standardizing the content and format of the PBPK analyses can facilitate FDA's efficient assessment, consistent application, and timely decision making during regulatory review. This guidance recommends including the following five sections in a PBPK study report: (1) Executive Summary, (2) Materials and Methods, (3) Results, (4) Discussion, and (5) Appendices. This guidance does not address methodological considerations and best practices for the conduct of PBPK modeling and simulation, or the appropriateness of PBPK analyses for a particular drug. This draft guidance is being issued consistent with FDA's good guidance [[Page 87044]] practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the format and content of PBPK analyses. 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. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collection of information in 21 CFR 314.50(d) has been approved under OMB control number 0910-0001. Dated: November 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28971 Filed 12-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices 87043
DEPARTMENT OF HEALTH AND Written/Paper Submissions electronic and written/paper comments
HUMAN SERVICES Submit written/paper submissions as received, go to https://
follows: www.regulations.gov and insert the
Food and Drug Administration • Mail/Hand delivery/Courier (for docket number, found in brackets in the
[Docket No. FDA–2016–D–3969] written/paper submissions): Division of heading of this document, into the
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
Physiologically Based and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
Pharmacokinetic Analyses—Format Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
and Content; Draft Guidance for • For written/paper comments 1061, Rockville, MD 20852.
Industry; Availability submitted to the Division of Dockets Submit written requests for single
Management, FDA will post your copies of the draft guidance to the
AGENCY: Food and Drug Administration, Division of Drug Information, Center for
HHS. comment, as well as any attachments,
except for information submitted, Drug Evaluation and Research, Food
ACTION: Notice of availability. and Drug Administration, 10001 New
marked and identified, as confidential,
SUMMARY: The Food and Drug if submitted as detailed in Hampshire Ave., Hillandale Building,
Administration (FDA or Agency) is ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
announcing the availability of a draft Instructions: All submissions received 0002. Send one self-addressed adhesive
guidance for industry entitled must include the Docket No. FDA– label to assist that office in processing
‘‘Physiologically Based Pharmacokinetic 2016–D–3969 for ‘‘Physiologically your requests. See the SUPPLEMENTARY
Analyses—Format and Content.’’ This Based Pharmacokinetic Analyses— INFORMATION section for electronic
guidance recommends to drug sponsors Format and Content; Draft Guidance for access to the draft guidance document.
the format and content for submitting Industry; Availability.’’ Received FOR FURTHER INFORMATION CONTACT: Ping
physiologically based pharmacokinetic comments will be placed in the docket Zhao, Office of Clinical Pharmacology,
(PBPK) analyses to FDA to enable and, except for those submitted as Office of Translational Sciences, Center
efficient and consistent review. ‘‘Confidential Submissions,’’ publicly for Drug Evaluation and Research, Food
DATES: Although you can comment on viewable at https://www.regulations.gov and Drug Administration, 10903 New
any guidance at any time (see 21 CFR or at the Division of Dockets Hampshire Ave., Bldg. 51, Rm. 3182,
10.115(g)(5)), to ensure that the Agency Management between 9 a.m. and 4 p.m., Silver Spring, MD 20993–0002, 301–
considers your comment on this draft Monday through Friday. 796–3774.
guidance before it begins work on the • Confidential Submissions—To SUPPLEMENTARY INFORMATION:
final version of the guidance, submit submit a comment with confidential
either electronic or written comments information that you do not wish to be I. Background
on the draft guidance by January 31, made publicly available, submit your FDA is announcing the availability of
2017. comments only as a written/paper a draft guidance for industry entitled
ADDRESSES: You may submit comments submission. You should submit two ‘‘Physiologically Based Pharmacokinetic
as follows: copies total. One copy will include the Analyses—Format and Content.’’ A
information you claim to be confidential PBPK analysis uses models and
Electronic Submissions with a heading or cover note that states simulations that combine physiology,
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS population, and drug characteristics to
following way: CONFIDENTIAL INFORMATION.’’ The describe the pharmacokinetics and/or
• Federal eRulemaking Portal: Agency will review this copy, including pharmacodynamics of that particular
https://www.regulations.gov. Follow the the claimed confidential information, in drug in humans. Throughout a drug’s
instructions for submitting comments. its consideration of comments. The life cycle, PBPK analyses can be used to
Comments submitted electronically, second copy, which will have the support decisions on whether, when,
including attachments, to https:// claimed confidential information and how to conduct certain clinical
www.regulations.gov will be posted to redacted/blacked out, will be available pharmacology studies, inform dosing
the docket unchanged. Because your for public viewing and posted on recommendations, and enable
comment will be made public, you are https://www.regulations.gov. Submit prescription drug labeling. Currently,
solely responsible for ensuring that your both copies to the Division of Dockets the format and content of PBPK analyses
comment does not include any Management. If you do not wish your that are submitted to FDA vary
confidential information that you or a name and contact information to be significantly across drug developers.
third party may not wish to be posted, made publicly available, you can Standardizing the content and format of
such as medical information, your or provide this information on the cover the PBPK analyses can facilitate FDA’s
anyone else’s Social Security number, or sheet and not in the body of your efficient assessment, consistent
confidential business information, such comments and you must identify this application, and timely decision making
as a manufacturing process. Please note information as ‘‘confidential.’’ Any during regulatory review. This guidance
that if you include your name, contact information marked as ‘‘confidential’’ recommends including the following
information, or other information that will not be disclosed except in five sections in a PBPK study report: (1)
identifies you in the body of your accordance with 21 CFR 10.20 and other Executive Summary, (2) Materials and
comments, that information will be applicable disclosure law. For more Methods, (3) Results, (4) Discussion,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
posted on https://www.regulations.gov. information about FDA’s posting of and (5) Appendices. This guidance does
• If you want to submit a comment comments to public dockets, see 80 FR not address methodological
with confidential information that you 56469, September 18, 2015, or access considerations and best practices for the
do not wish to be made available to the the information at: http://www.fda.gov/ conduct of PBPK modeling and
public, submit the comment as a regulatoryinformation/dockets/ simulation, or the appropriateness of
written/paper submission and in the default.htm. PBPK analyses for a particular drug.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to This draft guidance is being issued
Submissions’’ and ‘‘Instructions’’). read background documents or the consistent with FDA’s good guidance
VerDate Sep<11>2014 17:55 Dec 01, 2016 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1](https://thefederalregister.org/doc/81_FR_87275/page/1.svg)
![87044 Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices
practices regulation (21 CFR 10.115). or written comments and ask for a viewable at https://www.regulations.gov
The draft guidance, when finalized, will redetermination by January 31, 2017. or at the Division of Dockets
represent the current thinking of FDA Furthermore, any interested person may Management between 9 a.m. and 4 p.m.,
on the format and content of PBPK petition FDA for a determination Monday through Friday.
analyses. It does not establish any rights regarding whether the applicant for • Confidential Submissions—To
for any person and is not binding on extension acted with due diligence submit a comment with confidential
FDA or the public. You can use an during the regulatory review period by information that you do not wish to be
alternative approach if it satisfies the May 31, 2017. See ‘‘Petitions’’ in the made publicly available, submit your
requirements of the applicable statutes SUPPLEMENTARY INFORMATION section for comments only as a written/paper
and regulations. more information. submission. You should submit two
ADDRESSES: You may submit comments copies total. One copy will include the
II. Electronic Access
as follows: information you claim to be confidential
Persons with access to the Internet with a heading or cover note that states
may obtain the draft guidance at either Electronic Submissions
‘‘THIS DOCUMENT CONTAINS
http://www.fda.gov/Drugs/ Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
GuidanceComplianceRegulatory following way: Agency will review this copy, including
Information/Guidances/default.htm or • Federal eRulemaking Portal: the claimed confidential information, in
https://www.regulations.gov. https://www.regulations.gov. Follow the its consideration of comments. The
instructions for submitting comments. second copy, which will have the
III. Paperwork Reduction Act of 1995 Comments submitted electronically, claimed confidential information
This draft guidance refers to including attachments, to https:// redacted/blacked out, will be available
previously approved collections of www.regulations.gov will be posted to for public viewing and posted on
information found in FDA regulations. the docket unchanged. Because your https://www.regulations.gov. Submit
These collections of information are comment will be made public, you are both copies to the Division of Dockets
subject to review by the Office of solely responsible for ensuring that your Management. If you do not wish your
Management and Budget (OMB) under comment does not include any name and contact information to be
the Paperwork Reduction Act of 1995 confidential information that you or a made publicly available, you can
(44 U.S.C. 3501–3520). The collection of third party may not wish to be posted, provide this information on the cover
information in 21 CFR 314.50(d) has such as medical information, your or sheet and not in the body of your
been approved under OMB control anyone else’s Social Security number, or comments and you must identify this
number 0910–0001. confidential business information, such information as ‘‘confidential.’’ Any
Dated: November 29, 2016. as a manufacturing process. Please note information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
Leslie Kux,
information, or other information that accordance with 21 CFR 10.20 and other
Associate Commissioner for Policy.
identifies you in the body of your applicable disclosure law. For more
[FR Doc. 2016–28971 Filed 12–1–16; 8:45 am] comments, that information will be information about FDA’s posting of
BILLING CODE 4164–01–P posted on https://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND do not wish to be made available to the
HUMAN SERVICES regulatoryinformation/dockets/
public, submit the comment as a default.htm.
written/paper submission and in the Docket: For access to the docket to
Food and Drug Administration
manner detailed (see ‘‘Written/Paper read background documents or the
[Docket No. FDA–2016–E–0616] Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Written/Paper Submissions received, go to https://
Determination of Regulatory Review
www.regulations.gov and insert the
Period for Purposes of Patent Submit written/paper submissions as
docket number, found in brackets in the
Extension; OPDIVO follows:
• Mail/Hand delivery/Courier (for heading of this document, into the
AGENCY: Food and Drug Administration, written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
HHS. Dockets Management (HFA–305), Food and/or go to the Division of Dockets
ACTION: Notice. and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments FOR FURTHER INFORMATION CONTACT:
Administration (FDA) has determined submitted to the Division of Dockets Beverly Friedman, Office of Regulatory
the regulatory review period for Management, FDA will post your Policy, Food and Drug Administration,
OPDIVO and is publishing this notice of comment, as well as any attachments, 10903 New Hampshire Ave., Bldg. 51,
that determination as required by law. except for information submitted, Rm. 6250, Silver Spring, MD 20993,
FDA has made the determination marked and identified, as confidential, 301–796–3600.
because of the submission of an if submitted as detailed in SUPPLEMENTARY INFORMATION:
application to the Director of the U.S. ‘‘Instructions.’’
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Patent and Trademark Office (USPTO), Instructions: All submissions received I. Background
Department of Commerce, for the must include the Docket No. FDA– The Drug Price Competition and
extension of a patent which claims that 2016–E–0616 for ‘‘Determination of Patent Term Restoration Act of 1984
human biological product. Regulatory Review Period for Purposes (Pub. L. 98–417) and the Generic
DATES: Anyone with knowledge that any of Patent Extension; OPDIVO.’’ Received Animal Drug and Patent Term
of the dates as published (see the comments will be placed in the docket Restoration Act (Pub. L. 100–670)
SUPPLEMENTARY INFORMATION section) are and, except for those submitted as generally provide that a patent may be
incorrect may submit either electronic ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years
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Document Created: 2018-02-14 09:02:04
Document Modified: 2018-02-14 09:02:04
| 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 | 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 January 31, 2017. | |
| Contact | Ping Zhao, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3182, Silver Spring, MD 20993-0002, 301- 796-3774. | |
| FR Citation | 81 FR 87043 |
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