82 FR 60019 - Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 241 (December 18, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug Products, Including Biological Products, that Contain Nanomaterials.'' This draft guidance has been developed to provide industry with the Agency's current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials. The draft guidance also includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products.

[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60019-60021]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27133]


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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Nanomaterials; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Drug 
Products, Including Biological Products, that Contain Nanomaterials.'' 
This draft guidance has been developed to provide industry with the 
Agency's current thinking for the development of human drug products, 
including those that are biological products, that contain 
nanomaterials. The draft guidance also includes recommendations for 
applicants and sponsors of investigational, premarket, and postmarket 
submissions for these products.

DATES: Submit either electronic or written comments on the draft 
guidance by March 19, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

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-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 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

[[Page 60020]]

``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.thefederalregister.org/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 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.

FOR FURTHER INFORMATION CONTACT: Katherine Tyner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4146, Silver Spring, MD 20993-0002, 301-
796-0085; 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 draft 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 draft guidance discusses 
both general principles and specific considerations for the development 
of drug products containing nanomaterials, including considerations for 
establishing the equivalence of such products with other drugs. 
Considerations for quality, nonclinical, and clinical studies are 
discussed as they relate to drug products containing nanomaterials 
throughout product development and production.
    This draft guidance does not limit or classify the types of 
nanomaterials that can be used in drug products. Rather, it is focused 
on the deliberate and purposeful manipulation and control of dimensions 
to produce specific physicochemical properties which may warrant 
further evaluation with regards to safety, effectiveness, performance, 
and quality. This guidance does not address, or presuppose, what 
ultimate regulatory outcome, if any, will result for a particular drug 
product that contains nanomaterials. Issues such as the safety, 
effectiveness, public health impact, or the regulatory status of drug 
products that contains nanomaterials are currently addressed on a case-
by-case basis using FDA's existing review processes. Current CDER and 
CBER guidance documents and requirements for the evaluation and 
maintenance of quality, safety, and efficacy, apply to drug product 
containing nanomaterials that otherwise fall within their scopes. In 
addition, the Agency may continue to develop guidance addressing 
certain specific commonly-used types of nanomaterials, e.g., some 
liposomes, to better address the challenges in evaluating and 
characterizing the quality and performance of drug products that 
incorporate them.
    This draft guidance is one of several FDA guidance documents 
related to FDA-regulated products that may involve the use of 
nanotechnology. FDA has not established regulatory definitions of 
``nanotechnology,'' ``nanomaterial,'' ``nanoscale,'' or other related 
terms. In Guidance for Industry,'' Considering Whether an FDA-Regulated 
Product Involves the Application of Nanotechnology,'' issued in 2014, 
FDA described certain considerations for determining whether FDA-
regulated products involve the application of nanotechnology. FDA will 
apply these considerations broadly to all FDA-regulated products, 
including drug products within the scope of this draft guidance. The 
use of the term ``nanomaterial'' in this draft guidance, as in other 
FDA guidance documents, does not constitute the establishment of a 
regulatory definition. Rather, we use this term for ease of reference 
only. See section II of the draft guidance for additional information.
    FDA requests comment on the draft guidance. We also seek comment on 
the terminology, including the term ``nanomaterial'', as used in the 
draft guidance.
    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 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. This guidance 
is not subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes recommendations related to collections 
of information that are subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 
U.S.C. 3501-3520). The collections of information that are related to 
the burden of submitting investigational new drug applications are 
covered under 21 CFR part 312 and have been approved under OMB control 
number 0910-0014. The collections of information related to the burden 
of submitting new drug applications, including supplemental 
applications, are covered under 21 CFR part 314 and have been approved 
under OMB control number 0910-0001. The collections of information 
related to the burden of submitting section 351(k) biosimilar 
applications have been approved under OMB control number 0910-0719. The 
collections of information related to the burden of complying with the 
current good manufacturing process recordkeeping requirements under 21 
CFR part 211 have been approved under OMB control number 0910-0139. The 
collections of information related to the burden of complying with the 
environmental impact requirements under 21 CFR part 25 have been 
approved under OMB control number 0910-0322. The design and testing of 
prescription drug labeling required under 21 CFR 201.56 and 201.57 is 
approved under OMB control number

[[Page 60021]]

0910-0572. Concerning the immediate container label and outer container 
or package, in the Federal Register of December 18, 2014 (79 FR 75506), 
we published a proposed rule on the electronic distribution of 
prescribing information for human prescription drugs, including 
biological products. In Section VII, Paperwork Reduction Act of 1995, 
we estimated the burden to design (including revisions), test, and 
produce the label for a drug's immediate container and outer container 
or package, as set forth in 21 CFR part 201 and other sections in 
subpart A and subpart B.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, 
https;www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27133 Filed 12-15-17; 8:45 am]
 BILLING CODE 4164-01-P