This PDF is the current document as it appeared on Public Inspection on 12/01/2016 at 08:45 am.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Physiologically Based Pharmacokinetic Analyses—Format and Content.”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.
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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 31, 2017.
You may submit comments as follows:
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”).
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 87044practices 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.Start Signature
Dated: November 29, 2016.
Associate Commissioner for Policy.
[FR Doc. 2016-28971 Filed 12-1-16; 8:45 am]
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