Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for Comments, 35154-35157 [2018-15859]
Download as PDF
<![CDATA[
35154
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules
been estimated that approximately 200
entities will be eligible to vote in the
referendum. It will take an average of 15
minutes for each voter to read the voting
instructions and complete the
referendum ballot.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Referendum Order
[Docket No. FDA–2018–N–2689]
Hakim Fobia, Marketing Specialist,
and Heather Pichelman, Director,
Promotion and Economics Division,
Specialty Crops Program, AMS, USDA,
Stop 0244, Room 1406–S, 1400
Independence Avenue SW, Washington,
DC 20250–0244, are designated as
referendum agents for this referendum.
The referendum procedures at 7 CFR
1208.100 through 1208.108, issued
pursuant to the 1996 Act, will be used
to conduct the referendum.
The referendum agents will mail the
ballots to be cast in the referendum and
voting instructions to all known, eligible
producers and importers prior to the
first day of the voting period. Persons
who produced 20,000 pounds or more
of raspberries for processing in the
United States or imported 20,000
pounds or more of processed raspberries
into the United States during the
representative period and were subject
to assessment during that period are
eligible to vote. Persons who received
an exemption from assessments
pursuant to § 1208.53 during the entire
representative period are ineligible to
vote. Any eligible producer of
raspberries for processing or importer of
processed raspberries who does not
receive a ballot should contact a
referendum agent no later than one
week before the end of the voting
period. Mail ballots must be postmarked
by October 5. Ballots delivered via
express mail or email must show proof
of delivery by no later than 11:59 p.m.
ET on October 5, 2018, to be counted.
Facilitating Competition and
Innovation in the Biological Products
Marketplace; Public Hearing; Request
for Comments
List of Subjects in 7 CFR Part 1208
Administrative practice and
procedure, Advertising, Consumer
information, Marketing agreements,
Raspberry promotion, Reporting and
recordkeeping requirements.
daltland on DSKBBV9HB2PROD with PROPOSALS
Authority: 7 U.S.C. 7411–7425; 7 U.S.C.
7401.
Dated: July 20, 2018.
Bruce Summers,
Administrator.
[FR Doc. 2018–15894 Filed 7–24–18; 8:45 am]
BILLING CODE 3410–02–P
VerDate Sep<11>2014
16:53 Jul 24, 2018
Jkt 244001
Food and Drug Administration
21 CFR Part 15
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public hearing on FDA’s
approach to enhancing competition and
innovation in the biological products
marketplace, including by facilitating
greater availability of biosimilar and
interchangeable products.
DATES: The public hearing will be held
on Tuesday, September 4, 2018, 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 Tuesday, August 14, 2018.
Section III provides attendance and
registration information. Electronic or
written comments will be accepted after
the public hearing until Friday,
September 21, 2018.
ADDRESSES: The public hearing will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Entrance for 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.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before Friday, September 21, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of Friday, September 21,
2018. Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked, and
identified as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–2689 for ‘‘Facilitating
Competition and Innovation in the
Biological Products Marketplace; Public
Hearing; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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
E:\FR\FM\25JYP1.SGM
25JYP1
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 1314, Silver Spring,
MD 20993, 301–796–9203,
OMPTFeedback@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with PROPOSALS
I. Background
The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act)
amended the Public Health Service Act
(PHS Act) and other statutes to create an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. The BPCI Act was intended to
balance innovation and consumer
interests. The abbreviated licensure
pathway, in section 351(k) of the PHS
Act, allows an applicant (a ‘‘351(k)
applicant’’) to rely, in part, on FDA’s
previous determination of safety and
effectiveness for the reference product
for approval. The BPCI Act provides,
among other things, exclusivity periods
VerDate Sep<11>2014
16:53 Jul 24, 2018
Jkt 244001
for certain biological products licensed
in ‘‘stand alone’’ applications under
section 351(a) of the PHS Act.
As the marketplace of biological
products continues to expand and
evolve, FDA expects that increased
availability of biosimilars and
interchangeable products will result in
more competition and create savings for
patients and the healthcare system. At
the same time, we recognize that there
are challenges to the rapid growth of
this marketplace. For instance, although
FDA has approved 11 marketing
applications for biosimilars as of July 1,
2018, FDA is aware that the majority of
biosimilars licensed by FDA have not
yet been marketed and are not available
to patients.
Although such delays in the market
entry of an approved biosimilar are
outside FDA’s control, we remain
focused on FDA’s critical role in
increasing the availability of biosimilars
and interchangeable products.
Recognizing that this is a crucial time in
the emergence of the marketplace of
biosimilar and interchangeable
products, FDA recently developed a
Biosimilars Action Plan. This Plan
focuses on four key areas: (1) Improving
the efficiency of the biosimilar and
interchangeable product development
and approval process; (2) maximizing
scientific and regulatory clarity for the
biosimilar product development
community; (3) developing effective
communications to improve
understanding of biosimilars among
patients, clinicians, and payors; and (4)
supporting market competition by
reducing gaming of FDA requirements
or other attempts to unfairly delay
competition.
FDA’s Biosimilars Action Plan builds
on the Agency’s substantial progress, to
date, implementing the approval
pathway for biosimilar and
interchangeable products. For example,
FDA has issued guidance for industry
on numerous scientific and regulatory
issues related to the development of
proposed biosimilar and
interchangeable products. FDA also
created the Biosimilar Product
Development (BPD) Program to facilitate
the rapid development of biosimilar and
interchangeable products. Through
enrollment in this program, FDA
provides detailed, product-specific
advice to manufacturers. As of July 1,
2018, 68 programs were enrolled in the
BPD Program and FDA had received
meeting requests to discuss the
development of biosimilars for 31
different reference products.
FDA has also prioritized its efforts to
provide useful information about
licensed biological products to the
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
35155
public. FDA publishes the Purple Book:
Lists of Licensed Biological Products
with Reference Product Exclusivity and
Biosimilarity or Interchangeability
Evaluations 1 to provide information on
licensed biological products, including
information on exclusivity for reference
products and on whether a product has
been demonstrated to be biosimilar to,
or interchangeable with, a reference
product. Another FDA priority is the
development of educational materials
for patients, healthcare providers, and
other stakeholders to increase
knowledge about biological products,
including biosimilar and
interchangeable products. For example,
FDA launched an educational campaign
in October 2017 to promote
understanding by healthcare providers
of biosimilar and interchangeable
products and how these products can
help patients (see, https://www.fda.gov/
Drugs/DevelopmentApprovalProcess/
HowDrugsareDevelopedandApproved/
ApprovalApplications/Therapeutic
BiologicApplications/Biosimilars/
ucm580435.htm).
As FDA continues working to
implement the BPCI Act, FDA welcomes
input from the public on how the
Agency can enhance its efforts to
increase access by patients to state-ofthe-art, lifesaving treatment options by
encouraging innovation and
competition in the biological products
marketplace. FDA will hold a public
hearing on September 4, 2018, from 9
a.m. to 5 p.m., to provide an
opportunity for all interested
stakeholders to submit comments.
The format of the hearing involves
presentations from the public. The
Agency will not be inviting specific
presenters; rather, with this document,
FDA is soliciting presentations from
interested stakeholders. FDA also
invites interested persons to submit
written comments to the docket on the
topics described in section II.
II. Purpose and Scope of the Public
Hearing
FDA is soliciting input from the
public on how to facilitate greater
availability of biosimilar and
interchangeable products while
retaining the balance between
competition and innovation that
Congress intended to achieve under the
BPCI Act. FDA is holding a public
hearing to receive information and
comments from a broad group of
stakeholders, including patients,
1https://www.fda.gov/drugs/development
approvalprocess/howdrugsaredeveloped
andapproved/approvalapplications/
therapeuticbiologicapplications/biosimilars/
ucm411418.htm.
E:\FR\FM\25JYP1.SGM
25JYP1
daltland on DSKBBV9HB2PROD with PROPOSALS
35156
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules
researchers, healthcare providers,
manufacturers, interested industry,
professional organizations, and the
public. The Agency has determined that
a public hearing is the most appropriate
way to ensure public engagement.
FDA welcomes any relevant
information that stakeholders wish to
share. FDA is particularly interested in
stakeholder input on how the Agency
can achieve the following goals:
• Facilitate the efficient development
of biosimilar and interchangeable
products using state-of-the-art science;
• Develop information resources, as
well as scientific or regulatory tools, to
streamline the development of
biosimilar and interchangeable
products;
• Enhance the efficiency of FDA
review of marketing applications for
biosimilar and interchangeable
products;
• Provide additional scientific or
regulatory clarity regarding FDA’s
regulation of biological products,
including FDA’s review and approval of
marketing applications for biological
products;
• Increase healthcare provider,
patient, and payor understanding of
biological products, including
biosimilar and interchangeable
products; and
• Support market competition by
addressing attempts to game FDA
requirements or otherwise delay market
entry of competing biological products.
FDA is also interested in stakeholder
input on the following questions about
additional steps FDA can take, within
its statutory authority, related to the
Agency’s regulation of biological
products:
1. FDA is aware that many of the
biosimilar products that have been
licensed by FDA are not yet marketed
and available to patients. What can FDA
do to help biosimilars and
interchangeable products reach patients
more quickly after these products are
licensed?
2. FDA uses the Purple Book to
provide information about biological
products licensed under section 351 of
the PHS Act. What additional
information or features could be
incorporated into the Purple Book to
make it more useful to stakeholders,
including patients, healthcare providers,
pharmacists, and manufacturers?
3. FDA expects that the number of
licensed biosimilar and interchangeable
products will continue to increase in the
coming years. In many, if not most,
cases, FDA anticipates that multiple
products will be licensed as biosimilar
to, or interchangeable with, a given
reference product. What additional
VerDate Sep<11>2014
16:53 Jul 24, 2018
Jkt 244001
steps can FDA take to facilitate the
evolution of the biosimilar and
interchangeable product marketplace?
What can FDA do to ensure that
confidence in these products among
patients, healthcare providers,
pharmacists, and other stakeholders will
continue to grow?
4. Extensive analytical
characterization of the proposed
biosimilar product and the reference
product serves as the foundation for a
demonstration of biosimilarity. FDA
recognizes that obtaining and testing
multiple lots of the reference product
adds to the costs of developing a
biosimilar product. What can FDA do to
help reduce development costs arising
from analytical studies of the reference
product without compromising FDA’s
robust scientific standards for licensure
of products under section 351(k) of the
PHS Act? FDA is particularly interested
in stakeholder comments on (1) the
number of lots of each product (the
proposed biosimilar product and the
reference product) that should be used
in analytical studies submitted to
support licensure of a proposed
biosimilar product; and (2) how a 351(k)
applicant should account for and
evaluate any observed variability in
analytical attributes among lots of the
reference product or the proposed
biosimilar product.
5. A 351(k) applicant may, with
adequate scientific justification, use a
non-U.S.-licensed comparator product
in certain studies submitted to support
licensure of a proposed biosimilar
product. What additional steps can FDA
take to facilitate multinational
development programs that may include
non-U.S.-licensed comparators, to help
support development of biosimilar
products?
6. FDA expects continued innovation
in the biological product marketplace,
including innovation during the
lifecycle of reference products licensed
under section 351(a) of the PHS Act.
What can FDA do to ensure that product
changes during the lifecycle of reference
products (e.g., changes in product
presentation) are adequately
incentivized without inappropriately
deterring competition from biosimilar
and interchangeable products, with the
overall goal of balancing of innovation
and competition?
7. Patents or exclusivity may protect
one or more conditions of use (e.g.,
indications) of the reference product. As
a result, 351(k) applicants may seek
licensure of the proposed biosimilar
product for fewer than all of the
conditions of use for which the
reference product is licensed. Once a
condition of use is no longer protected
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
by patents or exclusivity, FDA
anticipates that 351(k) applicants often
will seek licensure of their product for
this condition of use. What challenges
do 351(k) applicants face in this context
and what should FDA do to achieve the
appropriate balance between innovation
and competition when one or more
conditions of use of the reference
product are protected by exclusivity or
patents?
8. The scope of exclusivity under
section 351(k)(7) of the PHS Act may
also affect biological product innovation
and market entry of biosimilars.
Accordingly, FDA seeks comment on
the potential application of ‘‘umbrella
exclusivity’’ under section 351(k)(7). If
umbrella exclusivity were to apply in
this context, a biological product that
would not be eligible for a new period
of exclusivity under section 351(k)(7)(C)
would nevertheless be protected for the
duration of the exclusivity period for a
previously approved reference product.
See, for example, 54 FR 28872 at 28897
(July 10, 1989) for an explanation of
how umbrella exclusivity functions
under the Hatch-Waxman scheme, a
related and potentially instructive
context (available at: https://
cdn.loc.gov/service/ll/fedreg/fr054/
fr054130/fr054130.pdf). Thus, umbrella
exclusivity could help shield certain
biological products that would
otherwise not be eligible for their own
period of exclusivity under section
351(k)(7)(C) from biosimilar
competition. What considerations
support recognition of umbrella
exclusivity under section 351(k)(7), and
what considerations disfavor
recognizing umbrella exclusivity? How
would umbrella exclusivity promote
biological product innovation, and what
effect would it have on market entry of
biosimilars? What is the relevance and
significance, if any, of the patent
scheme in considering this issue?
9. What other challenges have the
potential to disrupt the balance between
innovation and competition in the
biological product marketplace and how
can FDA or other stakeholders address
these challenges?
III. Participating in the Public Hearing
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, if appropriate, request
an oral presentation or participation in
E:\FR\FM\25JYP1.SGM
25JYP1
daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Proposed Rules
the open public hearing by sending an
email to OMPTfeedback@fda.hhs.gov by
Tuesday, August 14, 2018. Requests for
participation in the open public hearing
are accepted until 9 a.m. on Tuesday
September 4, 2018, and will be accepted
as long as time allows. The email should
contain complete contact information
for each attendee (name, title, degree(s),
affiliation, address, email address, and
telephone number). For those wishing to
present at the hearing, the email should
also include a presentation title. Those
without email access can register by
contacting Allison Hoffman at 301–796–
9203 by Tuesday, August 14, 2018 (see
FOR FURTHER INFORMATION CONTACT). An
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/
UCM610692.htm.
FDA will try to accommodate all
persons who wish to make a
presentation. Individuals wishing to
present should identify the number of
the specific 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 presenter will
depend on the number of individuals
who wish to speak. Presenters are
encouraged to submit an electronic copy
of their presentation (PowerPoint or
PDF) to OMPTfeedback@fda.hhs.gov on
or before Thursday, August 16, 2018.
Those who are not giving electronic
presentations are encouraged to submit
a single slide (PowerPoint or PDF) with
their name, affiliation, and topic.
Persons registered to make either an oral
presentation or participate as part of the
open public hearing are encouraged to
arrive at the hearing room early and
check in at the onsite registration table
to confirm their designated presentation
time. An 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/
ucm580561.htm.
If you need special accommodations
because of a disability, please contact
OMPTFeedback@fda.hhs.gov (see FOR
FURTHER INFORMATION CONTACT) no later
than Friday, August 17, 2018, at 12
noon Eastern Time.
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
VerDate Sep<11>2014
16:53 Jul 24, 2018
Jkt 244001
35157
the webcast, please go to https://
collaboration.fda.gov/biosimilarspart15.
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).
DEPARTMENT OF LABOR
IV. Notification of Hearing Under 21
CFR Part 15
Safety Improvement Technologies for
Mobile Equipment at Surface Mines,
and for Belt Conveyors at Surface and
Underground Mines
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(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, and the Center
for Biologics Evaluation and Research.
Under § 15.30(f) (21 CFR 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 can pose
questions; they can 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 21 CFR 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
notification, conflict with any
provisions set out in part 15, this
notification acts as a waiver of those
provisions as specified in § 15.30(h).
Dated: July 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15859 Filed 7–24–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
Mine Safety and Health Administration
30 CFR 56 and 75
[Docket No. MSHA–2018–0016]
RIN 1219–AB91
Mine Safety and Health
Administration, Labor.
ACTION: Announcement of public
stakeholder meetings.
AGENCY:
The Mine Safety and Health
Administration (MSHA) is announcing
the dates and locations of public
stakeholder meetings on the Agency’s
Request for Information on Safety
Improvement Technologies for Mobile
Equipment at Surface Mines, and for
Belt Conveyors at Surface and
Underground Mines.
DATES: Comments must be received or
postmarked by midnight Eastern
Standard Time on December 24, 2018.
The meeting dates and locations are
listed in the SUPPLEMENTARY
INFORMATION section of this document.
ADDRESSES: Federal Register
Publications: Access documents
electronically at https://www.msha.gov/
regsinfo.htm or https://
www.regulations.gov [Docket No.
MSHA–2018–0016].
FOR FURTHER INFORMATION CONTACT:
Sheila A. McConnell, Director, Office of
Standards, Regulations, and Variances,
MSHA, at mcconnell.sheila.a@dol.gov
(email), 202–693–9440 (voice), or 202–
693–9441 (fax). These are not toll-free
numbers.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Stakeholder Meetings
MSHA will hold six public
stakeholder meetings and one webinar
on the Agency’s Request for Information
(RFI) addressing Safety Improvement
Technologies for Mobile Equipment at
Surface Mines, and for Belt Conveyors
at Surface and Underground Mines. The
meetings will be conducted in an
informal manner. Presenters and
attendees may provide written
information to the court reporter for
inclusion in the record. MSHA will
make transcripts of the meetings
available at https://www.regulations.gov
and on MSHA’s website at: https://
arlweb.msha.gov/currentcomments.asp.
Interested parties may attend these
stakeholder meetings either in-person or
E:\FR\FM\25JYP1.SGM
25JYP1
]]>Agencies
[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Proposed Rules]
[Pages 35154-35157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15859]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2018-N-2689]
Facilitating Competition and Innovation in the Biological
Products Marketplace; 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 FDA's approach to enhancing competition
and innovation in the biological products marketplace, including by
facilitating greater availability of biosimilar and interchangeable
products.
DATES: The public hearing will be held on Tuesday, September 4, 2018,
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 Tuesday,
August 14, 2018. Section III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until Friday, September 21, 2018.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for 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.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before Friday, September 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of Friday, September 21, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-2689 for ``Facilitating Competition and Innovation in the
Biological Products Marketplace; Public Hearing; Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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
[[Page 35155]]
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: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1314, Silver
Spring, MD 20993, 301-796-9203, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) amended the Public Health Service Act (PHS Act) and other statutes
to create an abbreviated licensure pathway for biological products
shown to be biosimilar to, or interchangeable with, an FDA-licensed
biological reference product. The BPCI Act was intended to balance
innovation and consumer interests. The abbreviated licensure pathway,
in section 351(k) of the PHS Act, allows an applicant (a ``351(k)
applicant'') to rely, in part, on FDA's previous determination of
safety and effectiveness for the reference product for approval. The
BPCI Act provides, among other things, exclusivity periods for certain
biological products licensed in ``stand alone'' applications under
section 351(a) of the PHS Act.
As the marketplace of biological products continues to expand and
evolve, FDA expects that increased availability of biosimilars and
interchangeable products will result in more competition and create
savings for patients and the healthcare system. At the same time, we
recognize that there are challenges to the rapid growth of this
marketplace. For instance, although FDA has approved 11 marketing
applications for biosimilars as of July 1, 2018, FDA is aware that the
majority of biosimilars licensed by FDA have not yet been marketed and
are not available to patients.
Although such delays in the market entry of an approved biosimilar
are outside FDA's control, we remain focused on FDA's critical role in
increasing the availability of biosimilars and interchangeable
products. Recognizing that this is a crucial time in the emergence of
the marketplace of biosimilar and interchangeable products, FDA
recently developed a Biosimilars Action Plan. This Plan focuses on four
key areas: (1) Improving the efficiency of the biosimilar and
interchangeable product development and approval process; (2)
maximizing scientific and regulatory clarity for the biosimilar product
development community; (3) developing effective communications to
improve understanding of biosimilars among patients, clinicians, and
payors; and (4) supporting market competition by reducing gaming of FDA
requirements or other attempts to unfairly delay competition.
FDA's Biosimilars Action Plan builds on the Agency's substantial
progress, to date, implementing the approval pathway for biosimilar and
interchangeable products. For example, FDA has issued guidance for
industry on numerous scientific and regulatory issues related to the
development of proposed biosimilar and interchangeable products. FDA
also created the Biosimilar Product Development (BPD) Program to
facilitate the rapid development of biosimilar and interchangeable
products. Through enrollment in this program, FDA provides detailed,
product-specific advice to manufacturers. As of July 1, 2018, 68
programs were enrolled in the BPD Program and FDA had received meeting
requests to discuss the development of biosimilars for 31 different
reference products.
FDA has also prioritized its efforts to provide useful information
about licensed biological products to the public. FDA publishes the
Purple Book: Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evaluations
\1\ to provide information on licensed biological products, including
information on exclusivity for reference products and on whether a
product has been demonstrated to be biosimilar to, or interchangeable
with, a reference product. Another FDA priority is the development of
educational materials for patients, healthcare providers, and other
stakeholders to increase knowledge about biological products, including
biosimilar and interchangeable products. For example, FDA launched an
educational campaign in October 2017 to promote understanding by
healthcare providers of biosimilar and interchangeable products and how
these products can help patients (see, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580435.htm).
---------------------------------------------------------------------------
\1\https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm.
---------------------------------------------------------------------------
As FDA continues working to implement the BPCI Act, FDA welcomes
input from the public on how the Agency can enhance its efforts to
increase access by patients to state-of-the-art, lifesaving treatment
options by encouraging innovation and competition in the biological
products marketplace. FDA will hold a public hearing on September 4,
2018, from 9 a.m. to 5 p.m., to provide an opportunity for all
interested stakeholders to submit comments.
The format of the hearing involves presentations from the public.
The Agency will not be inviting specific presenters; rather, with this
document, FDA is soliciting presentations from interested stakeholders.
FDA also invites interested persons to submit written comments to the
docket on the topics described in section II.
II. Purpose and Scope of the Public Hearing
FDA is soliciting input from the public on how to facilitate
greater availability of biosimilar and interchangeable products while
retaining the balance between competition and innovation that Congress
intended to achieve under the BPCI Act. FDA is holding a public hearing
to receive information and comments from a broad group of stakeholders,
including patients,
[[Page 35156]]
researchers, healthcare providers, manufacturers, interested industry,
professional organizations, and the public. The Agency has determined
that a public hearing is the most appropriate way to ensure public
engagement.
FDA welcomes any relevant information that stakeholders wish to
share. FDA is particularly interested in stakeholder input on how the
Agency can achieve the following goals:
Facilitate the efficient development of biosimilar and
interchangeable products using state-of-the-art science;
Develop information resources, as well as scientific or
regulatory tools, to streamline the development of biosimilar and
interchangeable products;
Enhance the efficiency of FDA review of marketing
applications for biosimilar and interchangeable products;
Provide additional scientific or regulatory clarity
regarding FDA's regulation of biological products, including FDA's
review and approval of marketing applications for biological products;
Increase healthcare provider, patient, and payor
understanding of biological products, including biosimilar and
interchangeable products; and
Support market competition by addressing attempts to game
FDA requirements or otherwise delay market entry of competing
biological products.
FDA is also interested in stakeholder input on the following
questions about additional steps FDA can take, within its statutory
authority, related to the Agency's regulation of biological products:
1. FDA is aware that many of the biosimilar products that have been
licensed by FDA are not yet marketed and available to patients. What
can FDA do to help biosimilars and interchangeable products reach
patients more quickly after these products are licensed?
2. FDA uses the Purple Book to provide information about biological
products licensed under section 351 of the PHS Act. What additional
information or features could be incorporated into the Purple Book to
make it more useful to stakeholders, including patients, healthcare
providers, pharmacists, and manufacturers?
3. FDA expects that the number of licensed biosimilar and
interchangeable products will continue to increase in the coming years.
In many, if not most, cases, FDA anticipates that multiple products
will be licensed as biosimilar to, or interchangeable with, a given
reference product. What additional steps can FDA take to facilitate the
evolution of the biosimilar and interchangeable product marketplace?
What can FDA do to ensure that confidence in these products among
patients, healthcare providers, pharmacists, and other stakeholders
will continue to grow?
4. Extensive analytical characterization of the proposed biosimilar
product and the reference product serves as the foundation for a
demonstration of biosimilarity. FDA recognizes that obtaining and
testing multiple lots of the reference product adds to the costs of
developing a biosimilar product. What can FDA do to help reduce
development costs arising from analytical studies of the reference
product without compromising FDA's robust scientific standards for
licensure of products under section 351(k) of the PHS Act? FDA is
particularly interested in stakeholder comments on (1) the number of
lots of each product (the proposed biosimilar product and the reference
product) that should be used in analytical studies submitted to support
licensure of a proposed biosimilar product; and (2) how a 351(k)
applicant should account for and evaluate any observed variability in
analytical attributes among lots of the reference product or the
proposed biosimilar product.
5. A 351(k) applicant may, with adequate scientific justification,
use a non-U.S.-licensed comparator product in certain studies submitted
to support licensure of a proposed biosimilar product. What additional
steps can FDA take to facilitate multinational development programs
that may include non-U.S.-licensed comparators, to help support
development of biosimilar products?
6. FDA expects continued innovation in the biological product
marketplace, including innovation during the lifecycle of reference
products licensed under section 351(a) of the PHS Act. What can FDA do
to ensure that product changes during the lifecycle of reference
products (e.g., changes in product presentation) are adequately
incentivized without inappropriately deterring competition from
biosimilar and interchangeable products, with the overall goal of
balancing of innovation and competition?
7. Patents or exclusivity may protect one or more conditions of use
(e.g., indications) of the reference product. As a result, 351(k)
applicants may seek licensure of the proposed biosimilar product for
fewer than all of the conditions of use for which the reference product
is licensed. Once a condition of use is no longer protected by patents
or exclusivity, FDA anticipates that 351(k) applicants often will seek
licensure of their product for this condition of use. What challenges
do 351(k) applicants face in this context and what should FDA do to
achieve the appropriate balance between innovation and competition when
one or more conditions of use of the reference product are protected by
exclusivity or patents?
8. The scope of exclusivity under section 351(k)(7) of the PHS Act
may also affect biological product innovation and market entry of
biosimilars. Accordingly, FDA seeks comment on the potential
application of ``umbrella exclusivity'' under section 351(k)(7). If
umbrella exclusivity were to apply in this context, a biological
product that would not be eligible for a new period of exclusivity
under section 351(k)(7)(C) would nevertheless be protected for the
duration of the exclusivity period for a previously approved reference
product. See, for example, 54 FR 28872 at 28897 (July 10, 1989) for an
explanation of how umbrella exclusivity functions under the Hatch-
Waxman scheme, a related and potentially instructive context (available
at: https://cdn.loc.gov/service/ll/fedreg/fr054/fr054130/fr054130.pdf).
Thus, umbrella exclusivity could help shield certain biological
products that would otherwise not be eligible for their own period of
exclusivity under section 351(k)(7)(C) from biosimilar competition.
What considerations support recognition of umbrella exclusivity under
section 351(k)(7), and what considerations disfavor recognizing
umbrella exclusivity? How would umbrella exclusivity promote biological
product innovation, and what effect would it have on market entry of
biosimilars? What is the relevance and significance, if any, of the
patent scheme in considering this issue?
9. What other challenges have the potential to disrupt the balance
between innovation and competition in the biological product
marketplace and how can FDA or other stakeholders address these
challenges?
III. Participating in the Public Hearing
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, if
appropriate, request an oral presentation or participation in
[[Page 35157]]
the open public hearing by sending an email to [email protected]
by Tuesday, August 14, 2018. Requests for participation in the open
public hearing are accepted until 9 a.m. on Tuesday September 4, 2018,
and will be accepted as long as time allows. The email should contain
complete contact information for each attendee (name, title, degree(s),
affiliation, address, email address, and telephone number). For those
wishing to present at the hearing, the email should also include a
presentation title. Those without email access can register by
contacting Allison Hoffman at 301-796-9203 by Tuesday, August 14, 2018
(see FOR FURTHER INFORMATION CONTACT). An 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/UCM610692.htm.
FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the specific 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 presenter will depend on the number of individuals who wish to
speak. Presenters are encouraged to submit an electronic copy of their
presentation (PowerPoint or PDF) to [email protected] on or
before Thursday, August 16, 2018. Those who are not giving electronic
presentations are encouraged to submit a single slide (PowerPoint or
PDF) with their name, affiliation, and topic. Persons registered to
make either an oral presentation or participate as part of the open
public hearing are encouraged to arrive at the hearing room early and
check in at the onsite registration table to confirm their designated
presentation time. An 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/ucm580561.htm.
If you need special accommodations because of a disability, please
contact [email protected] (see FOR FURTHER INFORMATION CONTACT)
no later than Friday, August 17, 2018, at 12 noon Eastern Time.
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://collaboration.fda.gov/biosimilarspart15.
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).
IV. Notification 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 part 15 (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, and the
Center for Biologics Evaluation and Research. Under Sec. 15.30(f) (21
CFR 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 can pose
questions; they can 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 21 CFR
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 notification, conflict with any
provisions set out in part 15, this notification acts as a waiver of
those provisions as specified in Sec. 15.30(h).
Dated: July 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15859 Filed 7-24-18; 8:45 am]
BILLING CODE 4164-01-P
