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Notice2022-08572

Drug Products, Including Biological Products, That Contain Nanomaterials; Guidance for Industry; Availability

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Published
April 22, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Drug Products, Including Biological Products, That Contain Nanomaterials." This guidance finalizes the draft guidance issued December 18, 2017, developed to provide industry with the Agency's current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance also includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products.

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<title>Federal Register, Volume 87 Issue 78 (Friday, April 22, 2022)</title>
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[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24169-24170]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0759]


Drug Products, Including Biological Products, That Contain 
Nanomaterials; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Drug 
Products, Including Biological Products, That Contain Nanomaterials.'' 
This guidance finalizes the draft guidance issued December 18, 2017, 
developed to provide industry with the Agency's current thinking for 
the development of human drug products, including those that are 
biological products, in which a nanomaterial is present in the finished 
dosage form. The guidance also includes recommendations for applicants 
and sponsors of investigational, premarket, and postmarket submissions 
for these products.

DATES: The announcement of the guidance is published in the Federal 
Register on April 22, 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:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2017-D-0759 for ``Drug Products, Including Biological Products, 
That Contain Nanomaterials.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
    <bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
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

[[Page 24170]]

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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Kavita Vyas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4154, Silver Spring, MD, 20993-0002, 301-
796-4787; or Stephen Ripley, Center for Biologics Evaluation and 
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, 
MD, 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Drug Products, Including Biological Products, That Contain 
Nanomaterials.'' This guidance applies to human drug products, 
including those that are biological products, in which a nanomaterial 
is present in the finished dosage form. This guidance discusses both 
general principles and specific considerations for developing drug 
products containing nanomaterials through abbreviated pathways. 
Considerations for quality, nonclinical, and clinical studies are 
discussed as they relate to drug products containing nanomaterials 
throughout product development and production.
    This guidance finalizes the draft guidance issued December 18, 2017 
(82 FR 60019). There were two noteworthy changes made from the draft 
version to final guidance in response to stakeholder comments. First, 
the final guidance provides a glossary of terminology to assist in 
understanding how important terms are used in the document. Second, 
several revisions were made to reflect FDA's current thinking with 
respect to abbreviated applications, including abbreviated new drug 
applications (ANDAs), for products containing nanomaterials. In 
addition to changes in response to comments, the final guidance 
document's discussion regarding over-the-counter (OTC) monograph drugs 
has been updated for consistency with the enactment of OTC reform 
provisions of the Coronavirus Aid, Relief, and Economic Security Act 
(Pub. L. 116-136).
    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 ``Drug Products, Including Biological 
Products, That Contain Nanomaterials.'' 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 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, related to investigational new drug applications, in 21 
CFR part 312 have been approved under OMB control number 0910-0014. The 
collections of information, related to new drug applications and ANDAs, 
including supplemental applications, in 21 CFR part 314 have been 
approved under OMB control number 0910-0001. The collections of 
information in section 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)), regarding biosimilar applications, have been approved 
under OMB control number 0910-0718. The collections of information, 
related to biologics license applications, in 21 CFR part 601 have been 
approved under OMB control number 0910-0338. The collections of 
information, related current good manufacturing process requirements, 
in 21 CFR part 211 have been approved under OMB control number 0910-
0139. The collections of information, related to environmental impact 
requirements, in 21 CFR part 25 have been approved under OMB control 
number 0910-0322. The collections of information related to controlled 
correspondence regarding generic drug development have been approved 
under OMB control number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
<a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

    Dated: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08572 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P


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