Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Request for Comments, 44803-44807 [2017-20521]
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Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices
that are available to FDA at the time the
classification determination is made.
FDA regularly receives questions from
medical product sponsors concerning
the classification of their products. We
believe that efficient, effective
regulation would be facilitated by
providing guidance on this topic. This
guidance discusses the request for
designation (RFD) process for obtaining
a formal determination of a product’s
classification, and provides general
concepts regarding FDA’s decision
process for making classification
determinations. While issues have
arisen relating to whether a product
should be classified as a drug, device,
biological product, or combination
product, issues most frequently arise
regarding whether a product should be
classified as either a drug or a device.
Accordingly, this guidance focuses
particularly on cases in which a product
may be classified as a drug or device.
This guidance is organized into two
substantive sections. Section II provides
information on the RFD process for
obtaining a formal determination of
whether a product is classified as a drug
or device and on obtaining other
feedback from FDA on product
classification questions. Section III
discusses general concepts and
definitions relating to FDA’s decisional
process for making classification
determinations and addresses issues
that may arise in determining whether
products should be classified as drugs
or devices.
FDA carefully considered the
comments received on the two draft
guidances in preparing this final
guidance. We have combined the two
documents into one and made other
changes for clarity and ease of reference.
For example, we have revised the
discussion of the Agency’s
interpretation and application of the
term ‘‘chemical action’’ in the definition
of device at section 201(h) of the FD&C
Act, to more clearly explain the
Agency’s approach. With regard to this
issue and others, we have also included
additional examples to illustrate the
application of the Agency’s current
thinking.
In light of comments received, we
have also reconsidered inclusion of
content on the status of prior Agency
classification determinations. FDA has
had limited experience with
reevaluating classification
determinations as the issue rarely arises
for FDA to consider. In addition, it can
raise a variety of complex scientific and
regulatory questions. Accordingly, we
have concluded that it is not
appropriate to address the topic further
in guidance at this time. We will
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continue to address the issue on a caseby-case, fact-specific basis as needed, in
a transparent manner as permitted by,
and consistent with, applicable legal
requirements. Any stakeholder who has
questions regarding the classification of
a currently marketed product or
whether that classification should be
relied upon with respect to a proposed
product is encouraged to contact the
Office of Combination Products.
II. Significance of Guidance
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 ‘‘Classification of
Products as Drugs and Devices &
Additional Product Classification
Issues.’’ 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.
III. Paperwork Reduction Act of 1995
This 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 collections of information in
21 CFR part 3 have been approved
under OMB control number 0910–0523.
IV. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.fda.gov/RegulatoryInformation/
Guidances/ucm258946.htm.
Dated: September 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20522 Filed 9–25–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5319]
Devices Proposed for a New Use With
an Approved, Marketed Drug; Public
Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments.
ACTION:
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44803
The Food and Drug
Administration (FDA or the Agency) is
announcing a public hearing on a
potential approach for device sponsors
who seek to obtain marketing
authorization for their products that are
labeled for a new use with an approved,
marketed drug when the sponsor for the
approved drug does not wish to pursue
or collaborate on the new use.
DATES: The public hearing will be held
on November 16, 2017, from 9 a.m. to
5 p.m. The public hearing may be
extended or may end early depending
on the level of public participation.
Persons seeking to attend or to present
at the public hearing must register by
October 26, 2017. Sections II and III
provides attendance and registration
information. Electronic or written
comments will be accepted after the
public hearing until January 15, 2018.
Late, untimely filed comments will not
be considered.
ADDRESSES: The public hearing will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring,
MD 20993–0002. Entrance for the public
hearing participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Working
atFDA/BuildingsandFacilities/White
OakCampusInformation/
ucm241740.htm.
SUMMARY:
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
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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–N–5319 for ‘‘Devices Referencing
Drugs; Public Hearing; Request for
Comments.’’ 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
‘‘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
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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.
John
Barlow Weiner, Associate Director for
Policy, Office of Combination Products,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
5129, Silver Spring, MD 20933, 301–
796–8930, combination@fda.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
Medical products are often intended
and labeled for use in conjunction with
other medical products marketed by
different sponsors (as used in this
document, ‘‘sponsor’’ includes an
applicant or manufacturer). In some
cases, the medical products are of
different types (such as drug and device,
biological product and device, or drug
and biological product). Typically, the
different sponsors collaborate when the
two products are to be used together for
a new intended use. In some cases,
products intended for use with one
another comprise a ‘‘combination
product’’ as the term is defined in 21
CFR 3.2(e). Regardless of whether the
products meet the definition of a
combination product, collaboration
between the sponsors can facilitate
product development and obtaining
marketing authorization for the products
for the combined use, and can, thereby,
enable access to innovative treatment
options for patients. Inclusion of the
combined use in the labeling of both
products helps ensure user
understanding, and the collaboration
can also be important to ensuring the
ongoing safety and effectiveness of the
products for the combined use.
Sometimes, however, sponsors seek
marketing authorization from FDA for a
medical product for a new use with the
approved, marketed medical product of
another sponsor (i.e., not included in
the labeling for the approved, marketed
product), and the sponsor of the
approved, marketed product does not
wish to pursue the new use or work
with the other product sponsor.
Generally, such proposed products have
been devices proposing new uses with
approved, marketed drugs (referred to in
this notice as devices referencing drugs
or DRDs), though other scenarios have
been proposed as well, such as drugs
proposed for new uses with cleared or
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approved, marketed devices. This notice
focuses on DRDs.
In FDA’s experience, DRDs may be
proposed: (1) To enhance the safety or
effectiveness of the marketed drug for its
already approved indication; (2) for use
with the approved drug for an
indication for which the drug is not
approved; or (3) to provide some other
benefit, such as increasing user comfort
or convenience. Such new uses have
generally also involved a change in how
the drug is used or administered, such
as a change in dose, route, or rate of
administration.
FDA seeks to ensure that safe and
effective medical products can be
brought onto the market in a timely
manner. The Agency encourages
development of products that advance
public health, particularly those that
significantly improve the safety or
effectiveness of an existing treatment or
that address an unmet medical need.
DRDs have the potential to advance the
public health by offering new uses with
approved, marketed drugs that might
not otherwise be developed, because the
drug sponsor does not wish to pursue
the new use. At the same time, DRDs
raise unique public health, scientific,
regulatory, and legal issues.
FDA, in cooperation with the Drug
Information Association, held a public
meeting in 2005 on combined uses of
separately distributed products.1 That
meeting focused on the public health,
legal, regulatory, and scientific issues 2
that arise when sponsors seek to
develop or market a product of one type
(device, drug, or biological product) that
would be labeled for use with an
approved product of a different type,
where the proposed use is not included
in the labeling for the approved product.
As reflected in the notice for that
meeting and the presentations and
discussions at the meeting, devices
intended for a new combined use with
a drug raise unique public health,
scientific, regulatory and legal issues
when the sponsors for the two products
do not work together on the new
combined use of the two products.
Since that time, FDA has gained greater
experience with these issues and
believes that many of these issues for
DRDs could be addressed under the
approach described below.
FDA wishes to obtain further public
input through a more focused hearing
1 Links to the Federal Register notice for the
workshop, presentations given, and a full transcript
of the proceedings are available at: https://
www.fda.gov/combinationproducts/meetings
conferencesworkshops/ucm116623.htm.
2 Although the issues discussed at the meeting
were described as public health or legal issues, they
also included scientific and regulatory issues.
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on the Agency’s potential approach for
premarket review of proposed DRDs.
The Agency is seeking this type of
public engagement because of the
potential importance of the issue for the
public health and the need for input
across the medical product industry and
among public health stakeholders
regarding how FDA should proceed.
II. Purpose and Scope of the Public
Hearing
The purpose of the public hearing is
to obtain comment from stakeholders on
the potential approach described below,
for premarket review of DRDs. As
described above, DRDs, for purposes of
this document and hearing, are devices
that are intended for a use with an
approved, marketed drug that is not in
the labeling for the approved drug,
where the drug application is held by a
different sponsor that does not wish to
pursue or collaborate on the new use
with the device sponsor. The approach
described below might be appropriate,
for example, for drug delivery systems
seeking to be labeled for use with an
approved drug, for an indication for
which that drug has not been approved
(e.g., to administer the drug to treat a
different disease or condition or a new
patient population). We also welcome
comment on any public health,
scientific, regulatory, or legal
considerations relating to DRDs and
other medical products seeking to be
labeled for new uses with approved,
marketed medical products of a
different type where the sponsor for the
approved, marketed product does not
wish to pursue or collaborate on the
new use. The comments that FDA
receives from this public hearing may
help inform the further development of
this approach.
A. A Potential Approach for Premarket
Review of DRDs
FDA strongly recommends
collaboration between sponsors on new
combined uses of their medical
products. The Agency is prepared to
work with sponsors to facilitate such
collaboration. When sponsors work
together, they usually have an ongoing
relationship that enables them to resolve
many of the public health, scientific,
regulatory, and legal issues that may
arise as a result of two products being
the responsibility of two independent
sponsors. Such collaboration also can
provide important information to
support a regulatory decision (see
below). Where collaboration between
sponsors is not feasible, for example,
because one sponsor does not wish to
collaborate, FDA believes that the
following factors could help address
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many of the public health, scientific,
regulatory, and legal issues associated
with DRDs. In doing so, these factors
could allow for a DRD to be reviewed
and approved via a device premarket
authorization pathway 3 without
approval of conforming labeling changes
for the approved, marketed drug
through a new drug application (NDA)
or supplement to an NDA (see Section
II.B Submission Considerations for
further discussion).
B. Factors
DRD sponsors should be able to
address the following issues as
discussed below:
1. Safety and Effectiveness of the New
Use of the Drug. The DRD sponsor is
able to demonstrate the safety and
effectiveness of the new use of the drug
that is included in the DRD labeling, by
providing substantial evidence that the
drug will have the effect it purports or
is represented to have under the
conditions of use described in the
proposed DRD labeling and showing
that the drug is safe for use under the
conditions prescribed, recommended, or
suggested in the proposed DRD labeling,
as this is the standard that applies to
new uses of drugs (see 21 U.S.C. 355(c)
and (d)). If there are multiple approved
versions of the approved drug
product(s) referenced in the DRD
labeling (including generic versions),
the DRD sponsor is able to demonstrate
the generalizability of the new use with
all such versions of the drug product.
2. User Confusion and Medication
Error/Use Error. Given the potential for
user confusion or medication error/use
error, for example, due to certain
differences in the labeling for the DRD
and the approved drug that it is
referencing, the DRD sponsor is able to
demonstrate that the potential for user
confusion or error has been adequately
addressed. The DRD labeling must
provide adequate directions for the new
use with the approved, marketed drug.
3. Postmarket Change Management.
The DRD sponsor is able to demonstrate
that it is able to address safety or
effectiveness issues associated with
changes to the approved, marketed drug,
for example, by demonstrating: That the
likelihood of changes to the approved,
marketed drug is low; changes to the
drug are unlikely to raise safety or
effectiveness issues with respect to the
conditions of use with the drug as
described in the DRD labeling; and
3 FDA has not determined at this time whether
DRDs may be reviewed through other device
premarket authorization pathways besides
premarket approval applications (PMAs), but FDA
intends to consider this issue and welcomes
comment on it.
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periodic testing will be conducted and
be adequate to assure ongoing safety and
effectiveness of the combined use. It is
important that these issues be addressed
because the DRD sponsor does not have
a relationship with the sponsor for the
approved, marketed drug, and,
therefore, any changes to the two
products will not be coordinated or
communicated in advance.
4. Postmarket Safety. The DRD
sponsor is able to demonstrate that it
has a postmarket safety plan to
adequately address adverse events,
including medication errors, related to
the drug when used with the DRD. It is
important that its postmarket safety plan
allows the DRD sponsor to adequately
capture, report, and respond
appropriately to adverse events
associated with the new drug use
described in the DRD labeling, because
the DRD sponsor does not have a
relationship with the sponsor(s) of the
approved, marketed drug and because
the DRD sponsor will often be uniquely
positioned to understand and address
adverse events resulting from the new
use of the drug described in the DRD
labeling.
5. Data Reliance. The DRD sponsor is
able to provide all information needed
to evaluate the safety and effectiveness
of the new use with the approved drug
referenced in the DRD labeling, without
relying on any proprietary information
for the approved drug (e.g., by instead
relying on non-product-specific
published literature, generalizable
knowledge). The DRD sponsor may also
be able to include in its application
safety and effectiveness data and
information from the marketing
application for the drug that are
publicly available, for example, if the
approved reference listed drug has been
withdrawn from sale, provided that
FDA has determined that the approved
reference listed drug was not withdrawn
from sale for reasons of safety or
effectiveness (see 21 U.S.C. 355(l) and
21 CFR 314.161 and 314.430).
Generally, a DRD sponsor would not
have a right of reference to proprietary
information on the approved drug with
which the DRD is proposed to be used
because the DRD sponsor has no
relationship with the sponsor of the
approved drug.
C. Submission Considerations
At the investigational stage,
depending on the details of the
investigational plan, a DRD sponsor may
seek to submit an investigational new
drug application (IND) or an
investigational device exemption
application (IDE). Either way, the Center
for Drug Evaluation and Research
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(CDER) and the Center for Devices and
Radiological Health (CDRH) would
collaborate on the review. DRD sponsors
should consult with CDER and CDRH as
to which application to submit for a
particular investigation.
FDA believes that a PMA would
generally be the appropriate device
marketing application because, e.g.,
DRDs are expected to represent a new
intended use or raise different questions
of safety or effectiveness as compared to
a legally marketed predicate device.
Generally, PMAs for DRDs would be
reviewed by CDRH, and CDRH would
collaborate with CDER on the review of
the DRD. CDRH would have the lead on
device-specific issues, and CDER would
have the lead on drug-specific issues.
The Centers would identify any review
aspects where review considerations
overlap, to ensure Agency alignment on
how to address these considerations and
communicate about them to DRD
sponsors.
D. Questions for Commenters To
Address
FDA welcomes all feedback on the
potential approach and on any public
health, scientific, regulatory, and legal
issues raised by it. We seek public
comment on the factors and submission
considerations described in this notice,
and propose the following questions in
an effort to prompt substantive input
from stakeholders:
1. Are there public health, scientific,
regulatory, or legal issues that should be
considered with respect to this potential
approach for DRDs? If so, are there ways
to address those issues?
2. Is each of the factors and
submission considerations described
above appropriate? If not, why not?
What modifications would you propose
and why? Are there additional factors or
submission considerations that the
Agency should take into account? Please
provide examples to illustrate your
view.
3. Should the approach described in
this notice be limited to certain
situations, such as where the combined
use would potentially address an unmet
medical need for a serious or lifethreatening condition? If so, please
provide a detailed analysis in support of
your view, including its legal
justification.
4. With respect to the user confusion
and medication error/use error factor,
are there other issues that DRD sponsors
should address or that FDA should
consider, to ensure that the DRD
labeling provides adequate directions
for the new use with the approved,
marketed drug, without approval of
conforming labeling changes for the
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approved, marketed drug? What issues
should be considered with respect to
promotional activities by the DRD
sponsor and/or by any sponsors for the
drug being referenced?
5. With regard to the postmarket
change management factor, what would
be examples of circumstances in which
the DRD sponsor would be able to
adequately address this factor? What
types of postmarket changes to the drug
should the DRD sponsor be prepared to
identify and address? What postmarket
mechanisms, including specific testing
or monitoring, would be appropriate to
ensure ongoing safety and effectiveness
of the combined use?
6. When multiple versions of the
drug, including generics, are marketed,
what challenges exist in identifying
which versions of the drug can be used
with the DRD? How can DRD sponsors
make this information clear to health
care providers, pharmacists, and
patients?
7. What challenges exist at the
investigational application stage, and
how can those challenges be addressed?
Are there circumstances where an IND
would be the more appropriate
investigational application for a clinical
investigation of a DRD? Are there
circumstances where an IDE would be
the more appropriate investigational
application?
8. How may this approach impact
future product development?
9. Would an approach similar to the
potential approach presented in this
notice be appropriate for other types of
combined uses (e.g., drugs referencing
devices where the device sponsor does
not wish to collaborate on the new use)?
If so, how should the factors,
submission considerations, or both be
modified for other types of combined
uses? Are there additional factors that
should be considered for other types of
combined uses?
10. Are there other possible
approaches that may be used to seek
marketing authorization for combined
uses of drugs and devices where
product sponsors are unable or
unwilling to collaborate? Please provide
a detailed analysis in support of your
proposed approach, including its legal
justification.
11. Recognizing that collaboration is
preferable, what actions can FDA and
stakeholders take to encourage and
facilitate collaboration between device
sponsors and sponsors of approved,
marketed drugs to develop new
combined uses of their medical
products?
12. Would an approach similar to the
potential approach presented in this
notice be appropriate in the case where
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a drug sponsor would like to include in
the drug labeling the use of one or more
approved or cleared companion
diagnostics for its new drug in the same
class as the drugs for which the
companion diagnostic is approved or
cleared but none of the companion
diagnostic sponsors intend to add the
new drug to the device labeling? If so,
how should the factors, submission
considerations, or both be modified?
Are there additional factors that should
be considered? Are there other possible
approaches that may be used for such
circumstance? Please provide a detailed
analysis in support of your proposed
approach, including its legal
justification.
III. Registration
Registration and Requests for Oral
Presentations: The FDA Conference
Center at the White Oak location is a
Federal facility with security procedures
and limited seating. Attendance will be
free and on a first-come, first-served
basis. If you wish to attend (either in
person or by webcast (see Streaming
Webcast of the Public Hearing)) and/or
present at the hearing, please register for
the hearing and/or make a request for
oral presentations or comments at
https://www.fda.gov/NewsEvents/
MeetingsConferencesWorkshops/
ucm572528.htm by October 26, 2017
and provide complete contact
information for each attendee (i.e.,
name, title, affiliation, address, email
address, and telephone number). Those
without email access can register by
contacting John Barlow Weiner by
October 26, 2017 (see FOR FURTHER
INFORMATION CONTACT).
FDA will try to accommodate all
persons who wish to make a
presentation. Individuals wishing to
present should identify the number of
the question, or questions, they wish to
address. This will help FDA organize
the presentations. Individuals and
organizations with common interests
should consolidate or coordinate their
presentations and request time for a
joint presentation. FDA will notify
registered presenters of their scheduled
presentation times. The time allotted for
each presentation will depend on the
number of individuals who wish to
speak. Once FDA notifies registered
presenters of their scheduled times, they
are encouraged to submit an electronic
copy of their presentation to
combination@fda.gov on or before
November 2, 2017. Persons registered to
make an oral presentation are
encouraged to arrive at the hearing room
early and check in at the onsite
registration table to confirm their
designated presentation time. An
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agenda for the hearing and any other
background materials will be made
available 5 days before the hearing at
https://www.fda.gov/NewsEvents/
MeetingsConferencesWorkshops/
ucm572528.htm.
If you need special accommodations
because of a disability, please contact
the Office of Combination Products at
301–796–8930 or combination@fda.gov
at least 7 days before the hearing.
Streaming Webcast of the Public
Hearing: For those unable to attend in
person, FDA will provide a live webcast
of the hearing. To join the hearing via
the webcast, please go to https://
www.fda.gov/NewsEvents/Meetings
ConferencesWorkshops/
ucm572528.htm.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A transcript will also be
available in either hard copy or on CD–
ROM, after submission of a Freedom of
Information request. The Freedom of
Information office address is available
on the Agency’s Web site at https://
www.fda.gov.
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with 21 CFR
part 15. The hearing will be conducted
by a presiding officer, who will be
accompanied by FDA senior
management from the Office of the
Commissioner, the Center for Drug
Evaluation and Research, the Center for
Devices and Radiological Health, and
the Center for Biologics Evaluation and
Research. Under § 15.30(f), the hearing
is informal and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may pose questions; they may
question any person during or at the
conclusion of each presentation. Public
hearings under part 15 are subject to
FDA’s policy and procedures for
electronic media coverage of FDA’s
public administrative proceedings (21
CFR part 10, subpart C). Under § 10.205,
representatives of the media may be
permitted, subject to certain limitations,
to videotape, film, or otherwise record
FDA’s public administrative
proceedings, including presentations by
participants. The hearing will be
transcribed as stipulated in § 15.30(b)
(see Transcripts). To the extent that the
conditions for the hearing, as described
in this notice, conflict with any
provisions set out in part 15, this notice
VerDate Sep<11>2014
18:28 Sep 25, 2017
Jkt 241001
acts as a waiver of those provisions as
specified in § 15.30(h).
Dated: September 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20521 Filed 9–25–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
COMPETES Reauthorization Act
Challenge Competition
Health Resources and Services
Administration, Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration’s (HRSA’s)
Maternal and Child Health Bureau
(MCHB) announces a prize competition
to support the development and testing
of low-cost, scalable technology-based
innovations to meet the needs of
families and health care providers of
children with special health care needs
(CSHCN), particularly children with
medical complexity (CMC), to improve
the quality of care, patient
empowerment, and family experiences
while saving costs to the health care
system.
FOR FURTHER INFORMATION CONTACT:
James Resnick, Office of the Associate
Administrator, MCHB, JResnick@
hrsa.gov, (301) 443–3222, or Marie
Mann, Division of Services for Children
with Special Health Needs, MCHB,
MMann@hrsa.gov, (301) 443–4925.
SUPPLEMENTARY INFORMATION: On
January 4, 2011, the America
COMPETES Reauthorization Act of 2010
was signed into law allowing the use of
challenges and prize competitions
increasing agencies’ ability to promote
and harness innovation. Competitions
run by the federal government result in
a number of benefits to the public,
including the following:
(a) Increasing the number and
diversity of the individuals, teams, and
organizations that are addressing a
particular problem or challenge of
national significance;
(b) Improving the skills of the
participants in the competition; and
(c) Directing attention to new market
opportunities and stimulating private
sector investment.
This challenge structured in three
phases, reach a diverse population of
innovators and solvers, including
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
44807
coders, public health experts,
individuals affiliated with academic
institutions, research and development
communities in the private sector, and
others. All submissions will be
evaluated and separate prizes will be
awarded for each of the three phases
below.
Phase 1: Design
Phase 2: Development and Small Scale
Testing
Phase 3: Scaling
Estimated dates for each phase are as
follows:
Phase 1: Effective on January 22, 2018
Phase 1 Submission Period Ends: April
20, 2018, 11:59 p.m. ET
Phase 1 Judging Period: April 21–May
18, 2018
Phase 1 Winners Announced: May 25,
2018
Phase 2 Begins: May 29, 2018
Phase 2 Submission Period Ends:
October 26, 2018
Phase 2 Judging Period: October 29–
November 20, 2018
Phase 2 Winners Announced: December
4, 2018
Phase 3 Begins: December 7, 2018
Phase 3 Submission Period Ends: May
10, 2019
Phase 3 Winner Announced: May 30,
2019
Subject of Challenge Competition
MCHB is sponsoring the Making
Technology Work for Care Planning and
Coordination for Children with Special
Health Care Needs Challenge. CSHCN,
particularly CMC, often rely on multiple
systems, services, and health
professionals to maintain health and
optimize well-being. Care coordination
and care planning centered on the
comprehensive needs of the child and
family can lead to improved quality and
experience of care, as well as more costeffective care. Even with the presence of
care coordinators and the development
of shared care plans, communication
and collaboration gaps remain because
care coordinators and the shared care
plans often are specific to providers
and/or systems. Families have
expressed frustration about working
with the multiple systems and the lack
of communication and coordination
between them. They try to address the
gap by assuming responsibility for their
children’s 24/7 care and care
coordination. However, they often
encounter numerous obstacles and
barriers to fulfilling this role, including
difficulty obtaining needed information
or guidance from health professionals.
They desire resources like electronic
and informational tools to allow easy
aggregation of information and sharing
E:\FR\FM\26SEN1.SGM
26SEN1
Agencies
[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44803-44807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20521]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5319]
Devices Proposed for a New Use With an Approved, Marketed Drug;
Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing on a potential approach for device sponsors
who seek to obtain marketing authorization for their products that are
labeled for a new use with an approved, marketed drug when the sponsor
for the approved drug does not wish to pursue or collaborate on the new
use.
DATES: The public hearing will be held on November 16, 2017, from 9
a.m. to 5 p.m. The public hearing may be extended or may end early
depending on the level of public participation. Persons seeking to
attend or to present at the public hearing must register by October 26,
2017. Sections II and III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until January 15, 2018. Late, untimely filed comments
will not be considered.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the
public hearing participants (non-FDA employees) is through Building 1,
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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
[[Page 44804]]
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-N-5319 for ``Devices Referencing Drugs; Public Hearing;
Request for Comments.'' 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
``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.
FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Associate Director
for Policy, Office of Combination Products, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20933, 301-796-8930, combination@fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Medical products are often intended and labeled for use in
conjunction with other medical products marketed by different sponsors
(as used in this document, ``sponsor'' includes an applicant or
manufacturer). In some cases, the medical products are of different
types (such as drug and device, biological product and device, or drug
and biological product). Typically, the different sponsors collaborate
when the two products are to be used together for a new intended use.
In some cases, products intended for use with one another comprise a
``combination product'' as the term is defined in 21 CFR 3.2(e).
Regardless of whether the products meet the definition of a combination
product, collaboration between the sponsors can facilitate product
development and obtaining marketing authorization for the products for
the combined use, and can, thereby, enable access to innovative
treatment options for patients. Inclusion of the combined use in the
labeling of both products helps ensure user understanding, and the
collaboration can also be important to ensuring the ongoing safety and
effectiveness of the products for the combined use.
Sometimes, however, sponsors seek marketing authorization from FDA
for a medical product for a new use with the approved, marketed medical
product of another sponsor (i.e., not included in the labeling for the
approved, marketed product), and the sponsor of the approved, marketed
product does not wish to pursue the new use or work with the other
product sponsor. Generally, such proposed products have been devices
proposing new uses with approved, marketed drugs (referred to in this
notice as devices referencing drugs or DRDs), though other scenarios
have been proposed as well, such as drugs proposed for new uses with
cleared or approved, marketed devices. This notice focuses on DRDs.
In FDA's experience, DRDs may be proposed: (1) To enhance the
safety or effectiveness of the marketed drug for its already approved
indication; (2) for use with the approved drug for an indication for
which the drug is not approved; or (3) to provide some other benefit,
such as increasing user comfort or convenience. Such new uses have
generally also involved a change in how the drug is used or
administered, such as a change in dose, route, or rate of
administration.
FDA seeks to ensure that safe and effective medical products can be
brought onto the market in a timely manner. The Agency encourages
development of products that advance public health, particularly those
that significantly improve the safety or effectiveness of an existing
treatment or that address an unmet medical need. DRDs have the
potential to advance the public health by offering new uses with
approved, marketed drugs that might not otherwise be developed, because
the drug sponsor does not wish to pursue the new use. At the same time,
DRDs raise unique public health, scientific, regulatory, and legal
issues.
FDA, in cooperation with the Drug Information Association, held a
public meeting in 2005 on combined uses of separately distributed
products.\1\ That meeting focused on the public health, legal,
regulatory, and scientific issues \2\ that arise when sponsors seek to
develop or market a product of one type (device, drug, or biological
product) that would be labeled for use with an approved product of a
different type, where the proposed use is not included in the labeling
for the approved product.
---------------------------------------------------------------------------
\1\ Links to the Federal Register notice for the workshop,
presentations given, and a full transcript of the proceedings are
available at: https://www.fda.gov/combinationproducts/meetingsconferencesworkshops/ucm116623.htm.
\2\ Although the issues discussed at the meeting were described
as public health or legal issues, they also included scientific and
regulatory issues.
---------------------------------------------------------------------------
As reflected in the notice for that meeting and the presentations
and discussions at the meeting, devices intended for a new combined use
with a drug raise unique public health, scientific, regulatory and
legal issues when the sponsors for the two products do not work
together on the new combined use of the two products. Since that time,
FDA has gained greater experience with these issues and believes that
many of these issues for DRDs could be addressed under the approach
described below.
FDA wishes to obtain further public input through a more focused
hearing
[[Page 44805]]
on the Agency's potential approach for premarket review of proposed
DRDs. The Agency is seeking this type of public engagement because of
the potential importance of the issue for the public health and the
need for input across the medical product industry and among public
health stakeholders regarding how FDA should proceed.
II. Purpose and Scope of the Public Hearing
The purpose of the public hearing is to obtain comment from
stakeholders on the potential approach described below, for premarket
review of DRDs. As described above, DRDs, for purposes of this document
and hearing, are devices that are intended for a use with an approved,
marketed drug that is not in the labeling for the approved drug, where
the drug application is held by a different sponsor that does not wish
to pursue or collaborate on the new use with the device sponsor. The
approach described below might be appropriate, for example, for drug
delivery systems seeking to be labeled for use with an approved drug,
for an indication for which that drug has not been approved (e.g., to
administer the drug to treat a different disease or condition or a new
patient population). We also welcome comment on any public health,
scientific, regulatory, or legal considerations relating to DRDs and
other medical products seeking to be labeled for new uses with
approved, marketed medical products of a different type where the
sponsor for the approved, marketed product does not wish to pursue or
collaborate on the new use. The comments that FDA receives from this
public hearing may help inform the further development of this
approach.
A. A Potential Approach for Premarket Review of DRDs
FDA strongly recommends collaboration between sponsors on new
combined uses of their medical products. The Agency is prepared to work
with sponsors to facilitate such collaboration. When sponsors work
together, they usually have an ongoing relationship that enables them
to resolve many of the public health, scientific, regulatory, and legal
issues that may arise as a result of two products being the
responsibility of two independent sponsors. Such collaboration also can
provide important information to support a regulatory decision (see
below). Where collaboration between sponsors is not feasible, for
example, because one sponsor does not wish to collaborate, FDA believes
that the following factors could help address many of the public
health, scientific, regulatory, and legal issues associated with DRDs.
In doing so, these factors could allow for a DRD to be reviewed and
approved via a device premarket authorization pathway \3\ without
approval of conforming labeling changes for the approved, marketed drug
through a new drug application (NDA) or supplement to an NDA (see
Section II.B Submission Considerations for further discussion).
---------------------------------------------------------------------------
\3\ FDA has not determined at this time whether DRDs may be
reviewed through other device premarket authorization pathways
besides premarket approval applications (PMAs), but FDA intends to
consider this issue and welcomes comment on it.
---------------------------------------------------------------------------
B. Factors
DRD sponsors should be able to address the following issues as
discussed below:
1. Safety and Effectiveness of the New Use of the Drug. The DRD
sponsor is able to demonstrate the safety and effectiveness of the new
use of the drug that is included in the DRD labeling, by providing
substantial evidence that the drug will have the effect it purports or
is represented to have under the conditions of use described in the
proposed DRD labeling and showing that the drug is safe for use under
the conditions prescribed, recommended, or suggested in the proposed
DRD labeling, as this is the standard that applies to new uses of drugs
(see 21 U.S.C. 355(c) and (d)). If there are multiple approved versions
of the approved drug product(s) referenced in the DRD labeling
(including generic versions), the DRD sponsor is able to demonstrate
the generalizability of the new use with all such versions of the drug
product.
2. User Confusion and Medication Error/Use Error. Given the
potential for user confusion or medication error/use error, for
example, due to certain differences in the labeling for the DRD and the
approved drug that it is referencing, the DRD sponsor is able to
demonstrate that the potential for user confusion or error has been
adequately addressed. The DRD labeling must provide adequate directions
for the new use with the approved, marketed drug.
3. Postmarket Change Management. The DRD sponsor is able to
demonstrate that it is able to address safety or effectiveness issues
associated with changes to the approved, marketed drug, for example, by
demonstrating: That the likelihood of changes to the approved, marketed
drug is low; changes to the drug are unlikely to raise safety or
effectiveness issues with respect to the conditions of use with the
drug as described in the DRD labeling; and periodic testing will be
conducted and be adequate to assure ongoing safety and effectiveness of
the combined use. It is important that these issues be addressed
because the DRD sponsor does not have a relationship with the sponsor
for the approved, marketed drug, and, therefore, any changes to the two
products will not be coordinated or communicated in advance.
4. Postmarket Safety. The DRD sponsor is able to demonstrate that
it has a postmarket safety plan to adequately address adverse events,
including medication errors, related to the drug when used with the
DRD. It is important that its postmarket safety plan allows the DRD
sponsor to adequately capture, report, and respond appropriately to
adverse events associated with the new drug use described in the DRD
labeling, because the DRD sponsor does not have a relationship with the
sponsor(s) of the approved, marketed drug and because the DRD sponsor
will often be uniquely positioned to understand and address adverse
events resulting from the new use of the drug described in the DRD
labeling.
5. Data Reliance. The DRD sponsor is able to provide all
information needed to evaluate the safety and effectiveness of the new
use with the approved drug referenced in the DRD labeling, without
relying on any proprietary information for the approved drug (e.g., by
instead relying on non-product-specific published literature,
generalizable knowledge). The DRD sponsor may also be able to include
in its application safety and effectiveness data and information from
the marketing application for the drug that are publicly available, for
example, if the approved reference listed drug has been withdrawn from
sale, provided that FDA has determined that the approved reference
listed drug was not withdrawn from sale for reasons of safety or
effectiveness (see 21 U.S.C. 355(l) and 21 CFR 314.161 and 314.430).
Generally, a DRD sponsor would not have a right of reference to
proprietary information on the approved drug with which the DRD is
proposed to be used because the DRD sponsor has no relationship with
the sponsor of the approved drug.
C. Submission Considerations
At the investigational stage, depending on the details of the
investigational plan, a DRD sponsor may seek to submit an
investigational new drug application (IND) or an investigational device
exemption application (IDE). Either way, the Center for Drug Evaluation
and Research
[[Page 44806]]
(CDER) and the Center for Devices and Radiological Health (CDRH) would
collaborate on the review. DRD sponsors should consult with CDER and
CDRH as to which application to submit for a particular investigation.
FDA believes that a PMA would generally be the appropriate device
marketing application because, e.g., DRDs are expected to represent a
new intended use or raise different questions of safety or
effectiveness as compared to a legally marketed predicate device.
Generally, PMAs for DRDs would be reviewed by CDRH, and CDRH would
collaborate with CDER on the review of the DRD. CDRH would have the
lead on device-specific issues, and CDER would have the lead on drug-
specific issues. The Centers would identify any review aspects where
review considerations overlap, to ensure Agency alignment on how to
address these considerations and communicate about them to DRD
sponsors.
D. Questions for Commenters To Address
FDA welcomes all feedback on the potential approach and on any
public health, scientific, regulatory, and legal issues raised by it.
We seek public comment on the factors and submission considerations
described in this notice, and propose the following questions in an
effort to prompt substantive input from stakeholders:
1. Are there public health, scientific, regulatory, or legal issues
that should be considered with respect to this potential approach for
DRDs? If so, are there ways to address those issues?
2. Is each of the factors and submission considerations described
above appropriate? If not, why not? What modifications would you
propose and why? Are there additional factors or submission
considerations that the Agency should take into account? Please provide
examples to illustrate your view.
3. Should the approach described in this notice be limited to
certain situations, such as where the combined use would potentially
address an unmet medical need for a serious or life-threatening
condition? If so, please provide a detailed analysis in support of your
view, including its legal justification.
4. With respect to the user confusion and medication error/use
error factor, are there other issues that DRD sponsors should address
or that FDA should consider, to ensure that the DRD labeling provides
adequate directions for the new use with the approved, marketed drug,
without approval of conforming labeling changes for the approved,
marketed drug? What issues should be considered with respect to
promotional activities by the DRD sponsor and/or by any sponsors for
the drug being referenced?
5. With regard to the postmarket change management factor, what
would be examples of circumstances in which the DRD sponsor would be
able to adequately address this factor? What types of postmarket
changes to the drug should the DRD sponsor be prepared to identify and
address? What postmarket mechanisms, including specific testing or
monitoring, would be appropriate to ensure ongoing safety and
effectiveness of the combined use?
6. When multiple versions of the drug, including generics, are
marketed, what challenges exist in identifying which versions of the
drug can be used with the DRD? How can DRD sponsors make this
information clear to health care providers, pharmacists, and patients?
7. What challenges exist at the investigational application stage,
and how can those challenges be addressed? Are there circumstances
where an IND would be the more appropriate investigational application
for a clinical investigation of a DRD? Are there circumstances where an
IDE would be the more appropriate investigational application?
8. How may this approach impact future product development?
9. Would an approach similar to the potential approach presented in
this notice be appropriate for other types of combined uses (e.g.,
drugs referencing devices where the device sponsor does not wish to
collaborate on the new use)? If so, how should the factors, submission
considerations, or both be modified for other types of combined uses?
Are there additional factors that should be considered for other types
of combined uses?
10. Are there other possible approaches that may be used to seek
marketing authorization for combined uses of drugs and devices where
product sponsors are unable or unwilling to collaborate? Please provide
a detailed analysis in support of your proposed approach, including its
legal justification.
11. Recognizing that collaboration is preferable, what actions can
FDA and stakeholders take to encourage and facilitate collaboration
between device sponsors and sponsors of approved, marketed drugs to
develop new combined uses of their medical products?
12. Would an approach similar to the potential approach presented
in this notice be appropriate in the case where a drug sponsor would
like to include in the drug labeling the use of one or more approved or
cleared companion diagnostics for its new drug in the same class as the
drugs for which the companion diagnostic is approved or cleared but
none of the companion diagnostic sponsors intend to add the new drug to
the device labeling? If so, how should the factors, submission
considerations, or both be modified? Are there additional factors that
should be considered? Are there other possible approaches that may be
used for such circumstance? Please provide a detailed analysis in
support of your proposed approach, including its legal justification.
III. Registration
Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. If you wish to attend (either in
person or by webcast (see Streaming Webcast of the Public Hearing))
and/or present at the hearing, please register for the hearing and/or
make a request for oral presentations or comments at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm by
October 26, 2017 and provide complete contact information for each
attendee (i.e., name, title, affiliation, address, email address, and
telephone number). Those without email access can register by
contacting John Barlow Weiner by October 26, 2017 (see FOR FURTHER
INFORMATION CONTACT).
FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the question, or questions, they wish to address. This will help FDA
organize the presentations. Individuals and organizations with common
interests should consolidate or coordinate their presentations and
request time for a joint presentation. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Once FDA notifies registered presenters of their scheduled
times, they are encouraged to submit an electronic copy of their
presentation to combination@fda.gov on or before November 2, 2017.
Persons registered to make an oral presentation are encouraged to
arrive at the hearing room early and check in at the onsite
registration table to confirm their designated presentation time. An
[[Page 44807]]
agenda for the hearing and any other background materials will be made
available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm.
If you need special accommodations because of a disability, please
contact the Office of Combination Products at 301-796-8930 or
combination@fda.gov at least 7 days before the hearing.
Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see ADDRESSES). A transcript
will also be available in either hard copy or on CD-ROM, after
submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
https://www.fda.gov.
IV. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner, the Center
for Drug Evaluation and Research, the Center for Devices and
Radiological Health, and the Center for Biologics Evaluation and
Research. Under Sec. 15.30(f), the hearing is informal and the rules
of evidence do not apply. No participant may interrupt the presentation
of another participant. Only the presiding officer and panel members
may pose questions; they may question any person during or at the
conclusion of each presentation. Public hearings under part 15 are
subject to FDA's policy and procedures for electronic media coverage of
FDA's public administrative proceedings (21 CFR part 10, subpart C).
Under Sec. 10.205, representatives of the media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see Transcripts). To the extent that the conditions for the
hearing, as described in this notice, conflict with any provisions set
out in part 15, this notice acts as a waiver of those provisions as
specified in Sec. 15.30(h).
Dated: September 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20521 Filed 9-25-17; 8:45 am]
BILLING CODE 4164-01-P