Population Pharmacokinetics; Guidance for Industry; Availability, 6575-6577 [2022-02355]

Download as PDF Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices lotter on DSK11XQN23PROD with NOTICES1 Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993, 301–796–0855; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling—Content and Format.’’ Evaluation of a therapeutic protein product’s and certain select drug products’ immunogenicity (e.g., risk of developing anti-drug antibodies, including neutralizing antibodies) and its potential clinical impact generally plays an important role in the assessment of the product’s safety and effectiveness for each proposed indication. Because some, but not all, anti-drug antibodies have been associated with safety concerns or loss of effectiveness, FDA believes that presenting immunogenicity information in a consistent manner would enable health care practitioners to more easily differentiate products associated with anti-drug antibodies having clinical effect(s) from products with anti-drug antibodies that do not have a clinically meaningful effect on pharmacokinetics, pharmacodynamics, safety, or effectiveness. This draft guidance recommends the use of a dedicated Immunogenicity subsection (subsection 12.6) under the CLINICAL PHARMACOLOGY section. Information and statements to include in this subsection (e.g., data on antidrug antibody incidence, clinical pharmacologic effects of anti-drug antibodies) are described in the draft guidance, along with recommended content to include in other sections of the labeling (e.g., summary of anti-drug antibody-associated effects on safety and/or effectiveness in the WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and/or CLINICAL STUDIES sections, as applicable). The labeling recommendations are based on: (1) Adequacy of the methodology for detection of anti-drug antibodies, (2) sufficiency of available data to draw clinical conclusions, and (3) whether the anti-drug antibodies have clinically significant effect(s). In addition to recommendations on presentation of known immunogenicity information, this draft guidance also provides recommendations for consistently stating when such information is VerDate Sep<11>2014 18:50 Feb 03, 2022 Jkt 256001 unknown, if appropriate. The draft guidance also provides procedural information, including recommendations for updating immunogenicity information in the Prescribing Information of applicable approved products. When finalized, this guidance will supersede the immunogenicity labelingspecific recommendations from the guidance for industry entitled ‘‘Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format’’ (available at https://www.fda.gov/ media/74346/download). When finalized, this guidance will also supersede the recommendations in section IV.C.3., ADVERSE REACTIONS, Immunogenicity, of the guidance for industry entitled ‘‘Labeling for Biosimilar Products’’ (available at https://www.fda.gov/media/96894/ download), including the statement ‘‘Immunogenicity information for therapeutic protein products is usually placed in a subsection in the ADVERSE REACTIONS section entitled Immunogenicity’’ and statements recommended for inclusion as the first paragraph in the ADVERSE REACTIONS subsection that precedes the immunogenicity data. FDA has verified the website addresses as of the date this document publishes in the Federal Register, but websites are subject to change over time. 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 ‘‘Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling—Content and Format.’’ 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 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. The collections of information in 21 CFR part 600 have been approved under OMB control PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 6575 number 0910–0308. The collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. The collections of information in 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910–0572. The collections of information related to pharmacology data have been approved under OMB control number 0910–0014. The collections of information submitting biologics license applications under section 351(k) of the Public Health Service Act have been approved under OMB control number 0910–0719. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https:// www.regulations.gov. Dated: January 28, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–02348 Filed 2–3–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–2398] Population Pharmacokinetics; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Population Pharmacokinetics.’’ This guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA’s current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs), biologic license applications (BLAs), and abbreviated new drug applications (ANDAs). This guidance also provides expectations regarding the format and content of the population PK report, as well as any SUMMARY: E:\FR\FM\04FEN1.SGM 04FEN1 6576 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices labeling recommendations resulting from such analyses. This guidance finalizes the draft guidance of the same title issued on July 12, 2019. DATES: The announcement of the guidance is published in the Federal Register on February 4, 2022. 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 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’’). lotter on DSK11XQN23PROD with NOTICES1 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– 2019–D–2398 for ‘‘Population Pharmacokinetics.’’ 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 VerDate Sep<11>2014 18:50 Feb 03, 2022 Jkt 256001 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. 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 to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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. See the SUPPLEMENTARY PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 INFORMATION section for electronic access to the guidance document. Hao Zhu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3132, Silver Spring, MD 20993, 301–796–2772; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Population Pharmacokinetics.’’ Population PK analyses can quantify the impact of intrinsic and extrinsic patient factors on the exposure of a drug. In conjunction with supporting exposureresponse data, population PK data can be used to identify patient factors that result in a clinically significant change in drug exposure and inform the proper use of drugs. Since FDA announced the publication of the original population PK guidance in 1999, the number of applications relevant for population PK analysis has increased, and the sophistication and reliability of population PK analysis methods have improved. This guidance finalizes the draft guidance entitled ‘‘Population Pharmacokinetics’’ issued on July 12, 2019 (84 FR 33267). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include greater detail on the use of population PK modeling for biologics, handling of time-varying covariates, additional methods and terminology typically used for population PK analyses, and updates to format and content for submitting population PK reports. In addition, editorial changes were made to improve clarity. 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 ‘‘Population Pharmacokinetics.’’ 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 contains no new collection of information. Therefore, clearance by the Office of Management E:\FR\FM\04FEN1.SGM 04FEN1 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required. However, this guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001. The collections of information in 21 CFR parts 600 and 601 have been approved under OMB control number 0910–0338. The collections of information in 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910–0572. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// www.regulations.gov. Dated: January 31, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–02355 Filed 2–3–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1636] Assessment of Pressor Effects of Drugs; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ‘‘Assessment of Pressor Effects of Drugs.’’ This draft guidance is intended to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure is, therefore, an important consideration in risk assessment and product labeling. This draft guidance revises the draft guidance for industry ‘‘Assessment of Pressor Effects of Drugs’’ issued on May 31, 2018. lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:50 Feb 03, 2022 Jkt 256001 Submit either electronic or written comments on the draft guidance by April 5, 2022 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: DATES: 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–1636 for ‘‘Assessment of Pressor Effects of Drugs.’’ 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, 240–402–7500. • Confidential Submissions—To submit a comment with confidential PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 6577 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. 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 draft guidance document. Devi Kozeli, Center for Drug Evaluation and Research (HFD–110), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4183, Silver Spring, MD 20903, 301–796–2240. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: E:\FR\FM\04FEN1.SGM 04FEN1

Agencies

[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6575-6577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02355]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2398]


Population Pharmacokinetics; 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 final guidance for industry entitled ``Population 
Pharmacokinetics.'' This guidance assists sponsors in the application 
of population pharmacokinetics (population PK) during the drug 
development process to inform drug use and includes FDA's current 
thinking on the data and model requirements for population PK analyses 
submitted as part of new drug applications (NDAs), biologic license 
applications (BLAs), and abbreviated new drug applications (ANDAs). 
This guidance also provides expectations regarding the format and 
content of the population PK report, as well as any

[[Page 6576]]

labeling recommendations resulting from such analyses. This guidance 
finalizes the draft guidance of the same title issued on July 12, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on February 4, 2022.

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 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-2019-D-2398 for ``Population Pharmacokinetics.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Hao Zhu, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3132, Silver Spring, MD 20993, 301-796-2772; or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Population Pharmacokinetics.'' Population PK analyses can 
quantify the impact of intrinsic and extrinsic patient factors on the 
exposure of a drug. In conjunction with supporting exposure-response 
data, population PK data can be used to identify patient factors that 
result in a clinically significant change in drug exposure and inform 
the proper use of drugs. Since FDA announced the publication of the 
original population PK guidance in 1999, the number of applications 
relevant for population PK analysis has increased, and the 
sophistication and reliability of population PK analysis methods have 
improved.
    This guidance finalizes the draft guidance entitled ``Population 
Pharmacokinetics'' issued on July 12, 2019 (84 FR 33267). FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include greater 
detail on the use of population PK modeling for biologics, handling of 
time-varying covariates, additional methods and terminology typically 
used for population PK analyses, and updates to format and content for 
submitting population PK reports. In addition, editorial changes were 
made to improve clarity.
    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 ``Population Pharmacokinetics.'' 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 contains no new collection of information. Therefore, 
clearance by the Office of Management

[[Page 6577]]

and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 
U.S.C. 3501-3521) is not required.
    However, this guidance refers to previously approved FDA 
collections of information. These collections of information are 
subject to review by OMB under the PRA. The collections of information 
in 21 CFR parts 312 and 314 have been approved under OMB control 
numbers 0910-0014 and 0910-0001. The collections of information in 21 
CFR parts 600 and 601 have been approved under OMB control number 0910-
0338. The collections of information in 21 CFR 201.56 and 201.57 have 
been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: January 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02355 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P
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