[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Pages 14642-14643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0093]


Liposome Drug Products: Chemistry, Manufacturing, and Controls; 
Human Pharmacokinetics and Bioavailability; and Labeling Documentation; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Liposome Drug 
Products: Chemistry, Manufacturing, and Controls; Human 
Pharmacokinetics and Bioavailability; and Labeling Documentation.'' 
This guidance document finalizes the revised draft of the same name 
that published on October 30, 2015. This guidance provides 
recommendations to applicants on the chemistry, manufacturing, and 
controls (CMC); pharmacokinetics and bioavailability; and labeling 
documentation for liposome drug products submitted in new drug 
applications (NDAs) and abbreviated new drug applications (ANDAs), 
reviewed by the Center for Drug Evaluation and Research (CDER).

DATES: The announcement of the guidance is published in the Federal 
Register on April 5, 2018.

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-2002-D-0093 (formerly 2002D-0337) for ``Liposome Drug Products: 
Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and 
Bioavailability; and Labeling Documentation.'' 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

[[Page 14643]]

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.gpo.gov/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: Richard T. Lostritto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993-0002, 301-
796-1697.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Liposome Drug Products: Chemistry, Manufacturing, and 
Controls; Human Pharmacokinetics and Bioavailability; and Labeling 
Documentation.'' This guidance provides recommendations to applicants 
on the CMC, human pharmacokinetics and bioavailability, and labeling 
documentation for liposome drug products submitted in NDAs and ANDAs 
reviewed by CDER. Although this guidance does not intend to provide 
recommendations specific to liposome drug products to be marketed under 
biologics license applications (BLAs), many scientific principles 
described in this guidance may also apply to these products.
    In the Federal Register of August 21, 2002 (67 FR 54220), FDA 
announced the availability of a draft version of this guidance. FDA 
published a revised draft guidance on October 30, 2015 (80 FR 66906), 
because of the need to address changes in technology since the draft 
was first published in 2002, and to add ANDAs to the scope. Most of the 
changes to the 2015 revised draft guidance were made to clarify 
statements in the 2002 draft guidance. FDA received comments in 
response to the draft and revised draft guidance, and this guidance 
reflects FDA's careful consideration of those comments.
    The guidance does not provide recommendations on clinical efficacy 
and safety studies, nonclinical pharmacology and/or toxicology studies, 
liposome formulations of vaccine adjuvants or biologics, or drug-lipid 
complexes.
    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 ``Liposome Drug Products: Chemistry, 
Manufacturing, and Controls; Human Pharmacokinetics and 
Bioavailability; and Labeling Documentation.'' 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. The 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 21 CFR part 314 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.

    Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06926 Filed 4-4-18; 8:45 am]
 BILLING CODE 4164-01-P