Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability, 60019-60021 [2017-27133]
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
(GDUFA I), beginning October 1, 2012,
FDA agreed to act on received ANDAs
within established time frames. As part
of this undertaking, the Agency
instituted the use of multiple forms of
communicating with an applicant
regarding the review of an application,
including issuance of Complete
Response Letters (CRLs) and IRs.1
Under GDUFA I, FDA issued a CRL
after completing a review of an ANDA.
The CRL described all the deficiencies
identified in the ANDA that must be
satisfactorily addressed before the
ANDA can be approved. Issuance of a
CRL also completed the ANDA’s review
cycle, with the next review cycle
beginning when the applicant amended
the ANDA by submitting a complete
response to all deficiencies listed in the
CRL.
FDA used IRs to ask for information
that would assist reviewers during the
course of the review or to convey
deficiencies identified in the
application in advance of a CRL. IRs did
not stop the review clock, did not signal
the completion of a review cycle, and
were not always used consistently
across divisions or offices.
In negotiations held as part of the
Generic Drug User Fee Amendments of
2017 (GDUFA II), it was agreed that
FDA will: (1) Issue an IR to request
further information or clarification that
is needed or would be helpful to allow
completion of a discipline review and/
or (2) issue a new type of letter for
ANDAs, known as a DRL, to convey
preliminary thoughts on possible
deficiencies found by a discipline
reviewer and/or review team for its or
their portion of the application under
review at the conclusion of a discipline
review.2
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Information Requests and
Discipline Review Letters Under
GDUFA.’’ 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.
1 Food and Drug Administration Safety and
Innovation Act of 2012 (FDASIA), Public Law 112–
144 (2012). FDASIA includes GDUFA I, and by
reference, the Generic Drug User Fee Act Program
Performance Goals and Procedures (GDUFA I
Commitment Letter).
2 FDA Reauthorization Act of 2017 (FDARA),
Public Law 115–52 (2017). FDARA includes
GDUFA II, and by reference, the GDUFA
Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2018–2022 (GDUFA II
Commitment Letter).
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II. Paperwork Reduction Act of 1995
Electronic Submissions
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 collection of
information has been approved under
OMB control number 0910–0797.
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’’).
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27124 Filed 12–15–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Written/Paper Submissions
[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.
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.
SUMMARY:
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:
DATES:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18DEN1.SGM
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daltland on DSKBBV9HB2PROD with NOTICES
60020
Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
‘‘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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
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17:53 Dec 15, 2017
Jkt 244001
‘‘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-bycase 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
PO 00000
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Fmt 4703
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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
E:\FR\FM\18DEN1.SGM
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm,
https;www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Submit either electronic or
written comments on the draft guidance
by February 16, 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:
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’’).
[Docket No. FDA–2017–D–6617]
Written/Paper Submissions
Developing Targeted Therapies in LowFrequency Molecular Subsets of a
Disease; Draft Guidance for Industry;
Availability
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–6617 for ‘‘Developing Targeted
Therapies in Low-Frequency Molecular
Subsets of a Disease.’’ 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.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Developing Targeted Therapies in
Low-Frequency Molecular Subsets of a
Disease.’’ The purpose of this guidance
is to describe the FDA’s current
recommendations on how to group
patients with different molecular
alterations for eligibility in clinical
trials; and general approaches to
evaluating the benefits and risks of
targeted therapeutics within a clinically
defined disease where some molecular
alterations may occur at low
frequencies.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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17:53 Dec 15, 2017
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• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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; or 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 draft guidance document.
E:\FR\FM\18DEN1.SGM
18DEN1
Agencies
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60019-60021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27133]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.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 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