Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability, 66906-66907 [2015-27744]

Download as PDF 66906 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices Estimated Total Annual Burden Hours: 275. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–27666 Filed 10–29–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2002–D–0093 (Formerly Docket ID 2002D–0337)] Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ‘‘Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.’’ This revised draft guidance document replaces the draft of the same name that published on August 21, 2002. This revised draft guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 liposome drug products submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) reviewed by the Center for Drug Evaluation and Research (CDER). 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 December 29, 2015. 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– PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 2002–D–0093 (formerly docket ID 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 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: https://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 E:\FR\FM\30OCN1.SGM 30OCN1 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. II. The Paperwork Reduction Act of 1995 Richard T. Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993–0002, 301– 796–1697. This revised draft 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. SUPPLEMENTARY INFORMATION: III. Electronic Access I. Background Persons with access to the Internet may obtain the revised draft guidance at either https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. tkelley on DSK3SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: The FDA is announcing the availability of a revised draft guidance for industry entitled ‘‘Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.’’ This revised draft guidance provides recommendations to applicants on the CMC, human pharmacokinetics and bioavailability, and labeling documentation for liposome drug products submitted in NDAs, ANDAs, and BLAs reviewed by CDER. This revision adds BLAs and ANDAs. It also updates the discussions on liposome technology. In the Federal Register of August 21, 2002 (67 FR 54220), FDA announced the availability of a draft version of this guidance. FDA received comments in response to the draft guidance, and this revised guidance reflects FDA’s careful consideration of these comments. Most of the changes to the revised draft guidance were made to clarify statements in the 2002 draft guidance. In addition, FDA decided to publish a revised draft guidance because of changes in technology since the draft was first published in 2002, the addition of BLAs reviewed by CDER as a result of a CDER and Center for Biologics Evaluation and Research reorganization in 2003, and the addition of ANDAs. The revised draft 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 druglipid complexes. This revised draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This revised draft guidance, when finalized, will represent the Agency’s current thinking on liposome drug products. 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. VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27744 Filed 10–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 66907 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’’). [Docket No. FDA–2010–D–0503] Written/Paper Submissions Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance 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– 2010–D–0503 for ‘‘Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance.’’ 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice of administrative stay of action. The Food and Drug Administration (FDA or we) is announcing a stay of portions of the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled ‘‘Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an IND.’’ We are republishing the guidance with the portions that are being stayed clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to this stay. DATES: This stay is effective October 30, 2015 Submit either electronic or written comments on FDA guidances at any time. SUMMARY: ADDRESSES: You may submit comments as follows: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1

Agencies

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Pages 66906-66907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27744]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0093 (Formerly Docket ID 2002D-0337)]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry entitled
``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human
Pharmacokinetics and Bioavailability; and Labeling Documentation.''
This revised draft guidance document replaces the draft of the same
name that published on August 21, 2002. This revised draft 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), abbreviated new drug applications (ANDAs), and
biologics license applications (BLAs) reviewed by the Center for Drug
Evaluation and Research (CDER).

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 December 29, 2015.

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-2002-D-0093 (formerly docket ID 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 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: https://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

[[Page 66907]]

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: Richard T. Lostritto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301-
796-1697.

SUPPLEMENTARY INFORMATION:

I. Background

The FDA is announcing the availability of a revised draft guidance
for industry entitled ``Liposome Drug Products: Chemistry,
Manufacturing, and Controls; Human Pharmacokinetics and
Bioavailability; and Labeling Documentation.'' This revised draft
guidance provides recommendations to applicants on the CMC, human
pharmacokinetics and bioavailability, and labeling documentation for
liposome drug products submitted in NDAs, ANDAs, and BLAs reviewed by
CDER. This revision adds BLAs and ANDAs. It also updates the
discussions on liposome technology.
In the Federal Register of August 21, 2002 (67 FR 54220), FDA
announced the availability of a draft version of this guidance. FDA
received comments in response to the draft guidance, and this revised
guidance reflects FDA's careful consideration of these comments. Most
of the changes to the revised draft guidance were made to clarify
statements in the 2002 draft guidance. In addition, FDA decided to
publish a revised draft guidance because of changes in technology since
the draft was first published in 2002, the addition of BLAs reviewed by
CDER as a result of a CDER and Center for Biologics Evaluation and
Research reorganization in 2003, and the addition of ANDAs.
The revised draft 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 revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). This revised draft
guidance, when finalized, will represent the Agency's current thinking
on liposome drug products. 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. The Paperwork Reduction Act of 1995

This revised draft 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 revised draft
guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27744 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P

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