Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability, 4890-4892 [2017-00795]
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
two be combined by creating a
Protection and Advocacy Annual
Program Performance Report and
Statement of Goals and Priorities form.
By combining the forms, P&As will have
a reduced burden because they will only
have to submit one annual report. The
combined form will also allow federal
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The annual PPR and SGP are
reviewed by federal staff for compliance
and outcomes. Information in the PPRs
and SGPs is analyzed to create a
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accomplishments against goals and to
formulate areas of technical assistance
related to compliance with Federal
requirements and program performance.
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report will inform AIDD of trends in
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federally-funded entities, and identify
best practices for efficient use of federal
funds.
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A notice was published in the Federal
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remains the same, with the addition of
more quantitative measures to support
the qualitative data that the grantees
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more quantitative measures will provide
a fuller picture of how the programs are
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Reduction Act of 1995, the
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soliciting public comment on the
burden related to the information
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Programs/AIDD/Program_Resource_
Search/Results_PA.aspx.
Estimated Burden: The average
burden for the 57 Protection and
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based on consultations with selected
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SUPPLEMENTARY INFORMATION:
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Protection and Advocacy Annual Program Performance Report and Statement of Goals and Priorities ........................................................................
57
1
75
4,275
Dated: January 10, 2017.
Edwin L. Walker,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2017–00880 Filed 1–13–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4412]
Comparative Analyses and Related
Comparative Use Human Factors
Studies for a Drug-Device Combination
Product Submitted in an Abbreviated
New Drug Application; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
sradovich on DSK3GMQ082PROD with NOTICES
HHS.
ACTION:
‘‘Comparative Analyses and Related
Comparative Use Human Factors
Studies for a Drug-Device Combination
Product Submitted in an ANDA.’’ This
draft guidance is intended to assist
potential applicants who plan to
develop and submit an abbreviated new
drug application (ANDA) to seek
approval of a generic combination
product that includes both a drug
constituent part and a delivery device
constituent part.
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 March 20, 2017.
ADDRESSES: You may submit comments
as follows:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
SUMMARY:
Electronic Submissions
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’’).
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
Estimated Total Annual Burden
Hours: 4,275.
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
i This number includes the 50 States, District of
Columbia, Puerto Rico and three Outlying Areas.
VerDate Sep<11>2014
18:21 Jan 13, 2017
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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
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–
2016–D–4412 for ‘‘Comparative
Analyses and Related Comparative Use
Human Factors Studies for a DrugDevice Combination Product Submitted
in an ANDA.’’ 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
VerDate Sep<11>2014
18:21 Jan 13, 2017
Jkt 241001
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
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:
Andrew LeBoeuf, Office of Generic
Drugs, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240–
402–0503, Andrew.LeBoeuf@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Comparative Analyses and Related
Comparative Use Human Factors
Studies for a Drug-Device Combination
Product Submitted in an ANDA.’’
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) (the Hatch-Waxman
Amendments) created, among other
things, section 505(j) of the Federal
Food, Drug and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355(j)). Under section
505(j) of the FD&C Act, an ANDA
applicant can rely on FDA’s previous
finding that the reference listed drug
(RLD) is safe and effective so long as the
ANDA applicant demonstrates that the
proposed drug product and the RLD are
the same with respect to active
ingredient(s), dosage form, route of
administration, strength, and, with
certain exceptions, labeling. An ANDA
must also include sufficient information
to demonstrate that the proposed
product is bioequivalent to the RLD, and
that the ANDA meets the approval
requirements relating to chemistry,
manufacturing, and controls. An ANDA
generally is not required to be the same
as the listed drug it references in certain
respects. For example, a generic drug
generally can differ from its RLD in
certain respects with regard to the
device or with respect to inactive
ingredients.
Drug products that meet the approval
requirements under section 505(j) of the
FD&C Act are generally considered by
FDA to be therapeutically equivalent to
their RLD. Products classified as
therapeutically equivalent can be
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4891
substituted with the full expectation
that the generic product will produce
the same clinical effect and safety
profile as the RLD under the conditions
specified in the labeling.
These general principles apply to
products submitted in ANDAs,
including drug-device combination
products. A generic drug-device
combination product classified as
therapeutically equivalent to the RLD
can be expected to produce the same
clinical effect and safety profile as the
RLD under the conditions specified in
labeling. This does not mean, however,
that the proposed generic drug-device
combination product and its RLD need
to be identical in all respects. FDA
recognizes that an identical design may
not always be feasible and, in certain
instances, differences in the design of
the user interface for a generic drugdevice combination product as
compared to the RLD may exist without
precluding approval of the generic
combination drug-device product under
an ANDA. In some instances in which
differences exist, certain additional
information and/or data relating to the
user-interface of the proposed generic
drug-device combination product, such
as data from comparative use human
factors studies, may be appropriate to
support approval of the proposed
product in an ANDA. The extent to
which differences between the proposed
product and the RLD affect the
approvability of the proposed ANDA
product will be evaluated on a case-bycase basis.
This draft guidance provides general
principles, including recommendations
on threshold analyses, which are
intended to assist potential applicants
in the identification and the assessment
of differences in the design of the user
interface of a proposed generic drugdevice combination product when
compared to the user interface for its
RLD.
This draft guidance also provides
recommendations on the design and
conduct of comparative use human
factors studies that may help applicants
determine whether design differences
identified between the proposed generic
drug-device combination product and
its RLD would preclude approval as an
ANDA under the FD&C Act.
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 ‘‘Comparative Analyses and Related
Comparative Use Human Factors
Studies for a Drug-Device Combination
Product Submitted in an ANDA.’’ It
does not establish any rights for any
E:\FR\FM\17JAN1.SGM
17JAN1
4892
Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
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. 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: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00795 Filed 1–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0121]
Compliance Policy for Required
Warning Statements on SmallPackaged Cigars; 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 draft guidance for
industry entitled ‘‘Compliance Policy
for Required Warning Statements on
Small-Packaged Cigars.’’ The draft
guidance, when finalized, is intended to
assist any person who manufacturers,
packages, sells, offers to sell, distributes,
or imports cigars in small packages, in
complying with the warning statement
requirements in FDA’s regulations
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to Chapter IX of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act). The draft guidance
describes FDA’s compliance policy for
cigars in packaging that is too small or
otherwise unable to accommodate a
label with sufficient space to bear the
required warning statements. The draft
guidance explains that FDA does not
intend to take enforcement action with
respect to cigars that do not comply
with the size and placement
requirements in the regulation when the
information and specifications required
under the regulation appear on the
carton or other outer container or
wrapper that could accommodate the
required warning statements, or on a tag
otherwise firmly and permanently
affixed to the cigar package.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:21 Jan 13, 2017
Jkt 241001
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 February 16,
2017.
ADDRESSES: You may submit comments
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’’).
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–
2017–D–0121 for ‘‘Compliance Policy
for Required Warning Statements on
Small-Packaged Cigars.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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 this guidance to the Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the guidance
document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT:
Deirdre Jurand, Center for Tobacco
E:\FR\FM\17JAN1.SGM
17JAN1
]]>Agencies
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4890-4892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-4412]
Comparative Analyses and Related Comparative Use Human Factors
Studies for a Drug-Device Combination Product Submitted in an
Abbreviated New Drug Application; 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
``Comparative Analyses and Related Comparative Use Human Factors
Studies for a Drug-Device Combination Product Submitted in an ANDA.''
This draft guidance is intended to assist potential applicants who plan
to develop and submit an abbreviated new drug application (ANDA) to
seek approval of a generic combination product that includes both a
drug constituent part and a delivery device constituent part.
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 March 20, 2017.
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
[[Page 4891]]
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-2016-D-4412 for ``Comparative Analyses and Related Comparative Use
Human Factors Studies for a Drug-Device Combination Product Submitted
in an ANDA.'' 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 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: Andrew LeBoeuf, Office of Generic
Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
402-0503, Andrew.LeBoeuf@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Comparative Analyses and Related Comparative Use Human
Factors Studies for a Drug-Device Combination Product Submitted in an
ANDA.''
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) (the Hatch-Waxman Amendments) created, among other
things, section 505(j) of the Federal Food, Drug and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(j)). Under section 505(j) of the FD&C Act, an
ANDA applicant can rely on FDA's previous finding that the reference
listed drug (RLD) is safe and effective so long as the ANDA applicant
demonstrates that the proposed drug product and the RLD are the same
with respect to active ingredient(s), dosage form, route of
administration, strength, and, with certain exceptions, labeling. An
ANDA must also include sufficient information to demonstrate that the
proposed product is bioequivalent to the RLD, and that the ANDA meets
the approval requirements relating to chemistry, manufacturing, and
controls. An ANDA generally is not required to be the same as the
listed drug it references in certain respects. For example, a generic
drug generally can differ from its RLD in certain respects with regard
to the device or with respect to inactive ingredients.
Drug products that meet the approval requirements under section
505(j) of the FD&C Act are generally considered by FDA to be
therapeutically equivalent to their RLD. Products classified as
therapeutically equivalent can be substituted with the full expectation
that the generic product will produce the same clinical effect and
safety profile as the RLD under the conditions specified in the
labeling.
These general principles apply to products submitted in ANDAs,
including drug-device combination products. A generic drug-device
combination product classified as therapeutically equivalent to the RLD
can be expected to produce the same clinical effect and safety profile
as the RLD under the conditions specified in labeling. This does not
mean, however, that the proposed generic drug-device combination
product and its RLD need to be identical in all respects. FDA
recognizes that an identical design may not always be feasible and, in
certain instances, differences in the design of the user interface for
a generic drug-device combination product as compared to the RLD may
exist without precluding approval of the generic combination drug-
device product under an ANDA. In some instances in which differences
exist, certain additional information and/or data relating to the user-
interface of the proposed generic drug-device combination product, such
as data from comparative use human factors studies, may be appropriate
to support approval of the proposed product in an ANDA. The extent to
which differences between the proposed product and the RLD affect the
approvability of the proposed ANDA product will be evaluated on a case-
by-case basis.
This draft guidance provides general principles, including
recommendations on threshold analyses, which are intended to assist
potential applicants in the identification and the assessment of
differences in the design of the user interface of a proposed generic
drug-device combination product when compared to the user interface for
its RLD.
This draft guidance also provides recommendations on the design and
conduct of comparative use human factors studies that may help
applicants determine whether design differences identified between the
proposed generic drug-device combination product and its RLD would
preclude approval as an ANDA under the FD&C Act.
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 ``Comparative
Analyses and Related Comparative Use Human Factors Studies for a Drug-
Device Combination Product Submitted in an ANDA.'' It does not
establish any rights for any
[[Page 4892]]
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. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00795 Filed 1-13-17; 8:45 am]
BILLING CODE 4164-01-P
