Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability, 52296-52299 [2015-21383]
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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
Community Living (ACL) is announcing
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requirements relating to an existing
collection: Protection and Advocacy for
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Submit written comments on the
collection of information by September
28, 2015.
DATES:
Submit written comments
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email to OIRA_submission@
omb.eop.gov, Attn: OMB Desk Officer
for ACL.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
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SUPPLEMENTARY INFORMATION:
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
PADD SGP ......................................................................................................
57
1
16
912
Estimated Total Annual Burden
Hours: 912.
Dated: August 25, 2015.
Kathy Greenlee,
Administrator & Assistant Secretary for
Aging.
[FR Doc. 2015–21409 Filed 8–27–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1543]
Nonproprietary Naming of Biological
Products; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or the
Agency) is announcing the availability
of a draft guidance for industry entitled
‘‘Nonproprietary Naming of Biological
Products.’’ The draft guidance describes
our current thinking on the need for
biological products licensed under the
Public Health Service Act (PHS Act) to
bear a nonproprietary name that
includes an FDA-designated suffix. Our
current thinking is that shared
nonproprietary names are not
appropriate for all biological products.
There is a need to clearly identify
biological products to improve
pharmacovigilance, and, for the
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purposes of safe use, to clearly
differentiate among biological products
that have not been determined to be
interchangeable. Accordingly, for
biological products, we intend to
designate a nonproprietary name that
includes a suffix composed of four
lowercase letters. Each suffix will be
incorporated in the nonproprietary
name of the product. This naming
convention is applicable to biological
products previously licensed and newly
licensed under the PHS Act. The
nonproprietary name designated for
originator biological products, related
biological products, and biosimilars will
include a unique suffix. However, FDA
is considering whether the
nonproprietary name for an
interchangeable product should include
a unique suffix, or should share the
same suffix as its reference product.
FDA invites comment on the draft
guidance and solicits comments on
ways to improve active
pharmacovigilance systems for the
purposes of monitoring the safety of
biological products.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance, including
responses to the questions in this notice,
by October 27, 2015. Submit either
electronic or written comments on the
collection of information by October 27,
2015.
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Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sandra Benton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340,
Silver Spring, MD 20993–0002, 301–
796–1042; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28AUN1.SGM
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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Nonproprietary Naming of Biological
Products.’’ The draft guidance describes
our current thinking on the need for
biological products licensed under
section 351(a) or 351(k) of the PHS Act
(42 U.S.C. 262(a) or 262(k)), as added by
the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act),1 to
bear a nonproprietary name that
includes an FDA-designated suffix. Our
current thinking is that shared
nonproprietary names are not
appropriate for all biological products.
There is a need to clearly identify
biological products for the purpose of
pharmacovigilance, and, for the
purposes of safe use, to clearly
differentiate among biological products
that have not been determined to be
interchangeable. Accordingly, for
biological products, we intend to
designate a nonproprietary name that
includes a suffix composed of four
lowercase letters. Each suffix will be
incorporated in the nonproprietary
name of the product. This naming
convention is applicable to biological
products previously licensed and newly
licensed under sections 351(a) and
351(k) of the PHS Act. The
nonproprietary name designated for
originator biological products, related
biological products, and biosimilar
products will include a unique suffix.
However, as discussed in section IV.C.
of the guidance, FDA is seeking
comment on whether the
nonproprietary name for an
interchangeable product should include
a unique suffix, or should share the
same suffix as its reference product.
By differentiating biological products
from one another that have not been
determined by the FDA to be
interchangeable, this naming
convention is intended to help
minimize inadvertent substitution.
Inadvertent substitution may lead to
unintended alternating or switching of
biological products that have not been
determined by FDA to be
interchangeable. A naming convention
that differentiates among biological
products also could help facilitate
pharmacovigilance for all biological
products. By applying this naming
convention to all biological products,
this approach is intended to: (1)
Encourage routine use of designated
suffixes in ordering, prescribing,
dispensing, and recordkeeping practices
and (2) avoid inaccurate perceptions of
1 The BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010.
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the safety and effectiveness of biological
products based on their licensure
pathways.
The draft guidance provides
information to industry, the health care
community, other regulatory agencies,
and the public on our rationale for this
naming convention. The draft guidance
also is intended to assist applicants and
application holders in proposing the
suffix to be used as part of a biological
product’s nonproprietary name. The
nonproprietary name designated by
FDA in the license for a biological
product licensed under the PHS Act is
its ‘‘proper name,’’ and the term ‘‘proper
name’’ is used throughout the draft
guidance (see section 351(a)(1)(B)(i) of
the PHS Act and 21 CFR 600.3(k)).
We invite comment on the draft
guidance, including potential
approaches for designating and
incorporating suffixes retrospectively
and prospectively into the
nonproprietary names of all biological
products. We also solicit comments on
ways to improve active
pharmacovigilance systems for the
purposes of monitoring the safety of
biological products. In providing
comments, please consider the
following:
1. What are the potential benefits and
challenges of designating a suffix in the
proper name of a biological product that
is:
Æ Devoid of meaning versus
meaningful (e.g., a suffix derived from
the name of the license holder)
Æ unique to each biological product
versus unique to each license holder
and shared by each biological product
manufactured by that license holder.
In your comments, please address
how each option would impact the
following: Safe use of biological
products; pharmacovigilance; and
market acceptance and uptake for
certain products.
2. What would be the potential
benefits and challenges for an
interchangeable product 2 to share the
same suffix as designated in the proper
name of the reference product? Your
response should consider that FDA’s
publicly available electronic resource,
the Purple Book,3 will identify
2 Interchangeable product means a biological
product that has been shown to meet the standards
described in section 351(k)(4) of the PHS Act and
may be substituted for the reference product
without the intervention of the health care provider
who prescribed the reference product (see section
351(i)(3) of the PHS Act).
3 The Purple Book: Lists of Licensed Biological
Products With Reference Product Exclusivity and
Biosimilarity or Interchangeability Evaluation is
available on FDA’s Web site at https://www.fda.gov/
drugs/developmentapprovalprocess/
howdrugsaredevelopedandapproved/
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52297
biological products determined by FDA
to be biosimilar to or interchangeable
with a reference product. If an
interchangeable product does share the
same suffix as the reference product,
how would this impact your responses
to question 1, including
pharmacovigilance?
3. Would there be additional benefits
or challenges if the suffix designated in
the proper name of a biosimilar product
that is subsequently determined to be
interchangeable were changed to that of
the reference product upon a
determination of interchangeability?
Would there be benefits or challenges to
allowing the manufacturer of the
biosimilar product that is subsequently
determined to be interchangeable to
have the option of retaining its original
suffix or adopting the same suffix as the
reference product?
4. How could FDA and/or other
Federal partners improve active
pharmacovigilance systems for purposes
of monitoring the safety of biological
products? For example, because NDC
numbers are not routinely recorded in
billing and patient records in many
clinical settings in which biological
products are dispensed and
administered, are there other identifiers
besides distinguishable nonproprietary
names that are routinely accessible by
active pharmacovigilance systems and
could enable as good as or better
pharmacovigilance? How can FDA and/
or other Federal partners help ensure
that a distinguishable identifier for each
biological product would be captured at
the point of dispensing or
administration to the patient and be
routinely accessible in systems used for
pharmacovigilance?
5. What process and reasonable
timeframe should FDA use to designate
a suffix to include in the nonproprietary
name of a previously licensed biological
product?
6. What criteria should FDA use to
prioritize retrospective application of
this naming convention to previously
licensed biological products?
7. What are the expected time frames
for sponsors of previously licensed
biological products to distribute
products that conform to this naming
convention after approval of a labeling
supplement?
8. What strategies could FDA use to
enhance stakeholders’ understanding of
and education about this naming
convention?
9. FDA notes that this naming
convention (i.e., use of a suffix) has
approvalapplications/
therapeuticbiologicapplications/biosimilars/
ucm411418.htm.
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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
some similarities to the World Health
Organization (WHO) proposal,
‘‘Biological Qualifier—An INN
Proposal.’’ At the time of publication of
this draft guidance, WHO was still
evaluating the comments received on its
proposal. If WHO adopts a Biological
Qualifier proposal, how should the
biological qualifiers generated by WHO
be considered in the determination of
FDA-designated proper names for the
biological products within the scope of
this guidance?
We are continuing to consider the
transition provisions of section
7002(e)(2) through (e)(4) of the BPCI Act
that apply to biological products
submitted or approved under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), including how those
provisions may impact the
nonproprietary naming of products to
which those provisions apply. We invite
comment from all stakeholders on the
application of this naming convention
to biological products approved under
the FD&C Act.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on nonproprietary naming of biological
products, including biosimilar products
and interchangeable products. 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.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
The draft guidance proposes a new
collection of information by requesting
information from applicants and
application holders to propose a suffix
composed of four lowercase letters to be
included in the ‘‘proper name.’’ The
‘‘proper name’’ is designated by FDA at
the time of licensure for biological
products submitted under section 351(a)
of the PHS Act and for biosimilar
products and interchangeable products
submitted under section 351(k) of the
PHS Act. The applicant should also
include information that the proposed
suffix meets the factors described in the
draft guidance. For the prospective
application of this naming convention,
our evaluation will generally occur
during the investigational new drug
application phase and will also be
incorporated into the review of the
marketing application.
The draft guidance also refers to a
previously approved collection of
information found in FDA regulations
that is expected to change as a result of
the draft guidance and the retrospective
application of the naming convention.
The collection of information is related
to the following: The submission of a
biologics license application (BLA) and
changes to an approved application,
which is covered under part 601 (21
CFR part 601) and approved under OMB
control number 0910–0338. As a result
of the draft guidance, the estimated
number of additional responses for the
annual burden for changes to an
approved application under § 601.12
would be increased by approximately 25
responses.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations
that are not expected to change as a
result of the draft guidance. The
collection of information is related to
the following: The submission of a BLA
under section 351(k) of the PHS Act
(biosimilar products and
interchangeable products), which is
approved under OMB control number
0910–0719.
FDA estimates the burden of this
collection of information for the
prospective application of the naming
convention as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Information for the Proposed Proper Name for Biological
Products Submitted Under Section 351(a) of the PHS
Act ....................................................................................
Information for the Proposed Proper Name for Biosimilar
Products and Interchangeable Products Submitted
Under Section 351(k) of the PHS Act ..............................
20
2
40
6
240
3
2
6
6
36
Total ..............................................................................
........................
........................
........................
........................
276
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
As indicated in table 1, we estimate
that we will receive a total of
approximately 40 requests annually for
the proposed ‘‘proper name’’ for
biological products submitted under
section 351(a) of the PHS Act and 6
requests annually for the proposed
‘‘proper name’’ for biosimilar products
and interchangeable products submitted
under section 351(k) of the PHS Act.
The average burden per response
(hours) is based on the Agency’s
experience with similar information
collection requirements.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: August 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–21383 Filed 8–27–15; 8:45 am]
BILLING CODE 4164–01–P
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Document Control
Center, Bldg. 71, Rm. G335, Silver
Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
guidance may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Colleen Maschal, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993, 1–877–287–1373,
CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0404]
Determination of the Period Covered
by a No-Tobacco-Sale Order and
Compliance With an Order; Guidance
for Tobacco Retailers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for tobacco
retailers entitled ‘‘Determination of the
Period Covered by a No-Tobacco-Sale
Order and Compliance With an Order.’’
The guidance represents FDA’s current
thinking with respect to imposing notobacco-sale orders (NTSOs) on retailers
who have committed repeated
violations of certain restrictions on the
sale and distribution of tobacco
products. This guidance discusses,
among other things, the period of time
covered by an NTSO and a retailer’s
compliance with an NTSO.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
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SUMMARY:
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FDA is announcing the availability of
a guidance for tobacco retailers entitled
‘‘Determination of the Period Covered
by a No-Tobacco-Sale Order and
Compliance With an Order.’’ On June
22, 2009, President Obama signed the
Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111–31) into law. The
Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to give FDA authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect public health generally and to
reduce tobacco use by minors. Section
906(d) of the FD&C Act (21 U.S.C.
387f(d)) authorizes FDA to issue
regulations that restrict the sale and
distribution of tobacco products if FDA
determines such regulations would be
appropriate for the protection of the
public health. Section 303(f)(8) of the
FD&C Act (21 U.S.C. 333(f)(8))
authorizes FDA to impose an NTSO
against a person found to have
committed repeated violations, at a
particular retail outlet, of restrictions on
the sale and distribution of tobacco
products issued under section 906(d) of
the FD&C Act, such as FDA’s
‘‘Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and
Adolescents’’ (21 CFR part 1140). The
term ‘‘no-tobacco-sale order’’ refers to
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52299
an order prohibiting the sale of tobacco
products at a retail outlet indefinitely or
for a specified period of time under
section 303(f)(8) of the FD&C Act. A
‘‘repeated violation’’ means ‘‘at least 5
violations of particular requirements
over a 36-month period at a particular
retail outlet that constitute a repeated
violation . . .’’ (section 103(q)(1)(A) of
the Tobacco Control Act).
FDA conducts inspections of retail
outlets to evaluate compliance with the
requirements of the FD&C Act and its
implementing regulations. This
guidance discusses the period of time to
be covered by an NTSO where there is
evidence of ‘‘repeated violations’’ at a
particular retail outlet. It also discusses
a retailer’s compliance with an NTSO.
This guidance is meant to supplement
FDA’s guidances entitled ‘‘Civil Money
Penalties and No-Tobacco-Sale Orders
for Tobacco Retailers’’ and ‘‘Civil
Money Penalties for Tobacco Retailers
and No-Tobacco-Sale Orders: Responses
to Frequently Asked Questions.’’
In the Federal Register of May 13,
2015 (80 FR 27318), FDA announced the
availability of the draft guidance of the
same title. FDA received comments on
the draft guidance and those comments
were considered as the guidance was
finalized.
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 with respect to the
period of time to be covered by NTSOs
and retailers’ compliance with NTSOs.
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.
III. Comments
A. General Information About
Submitting Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES).
It is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document.
B. Public Availability of Comments
Received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to
the docket at https://
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]]>Agencies
[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52296-52299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21383]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1543]
Nonproprietary Naming of Biological Products; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Nonproprietary Naming of Biological Products.'' The draft guidance
describes our current thinking on the need for biological products
licensed under the Public Health Service Act (PHS Act) to bear a
nonproprietary name that includes an FDA-designated suffix. Our current
thinking is that shared nonproprietary names are not appropriate for
all biological products. There is a need to clearly identify biological
products to improve pharmacovigilance, and, for the purposes of safe
use, to clearly differentiate among biological products that have not
been determined to be interchangeable. Accordingly, for biological
products, we intend to designate a nonproprietary name that includes a
suffix composed of four lowercase letters. Each suffix will be
incorporated in the nonproprietary name of the product. This naming
convention is applicable to biological products previously licensed and
newly licensed under the PHS Act. The nonproprietary name designated
for originator biological products, related biological products, and
biosimilars will include a unique suffix. However, FDA is considering
whether the nonproprietary name for an interchangeable product should
include a unique suffix, or should share the same suffix as its
reference product. FDA invites comment on the draft guidance and
solicits comments on ways to improve active pharmacovigilance systems
for the purposes of monitoring the safety of biological products.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance, including responses to the questions in this notice, by
October 27, 2015. Submit either electronic or written comments on the
collection of information by October 27, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
[[Page 52297]]
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Nonproprietary Naming of Biological Products.'' The draft
guidance describes our current thinking on the need for biological
products licensed under section 351(a) or 351(k) of the PHS Act (42
U.S.C. 262(a) or 262(k)), as added by the Biologics Price Competition
and Innovation Act of 2009 (BPCI Act),\1\ to bear a nonproprietary name
that includes an FDA-designated suffix. Our current thinking is that
shared nonproprietary names are not appropriate for all biological
products. There is a need to clearly identify biological products for
the purpose of pharmacovigilance, and, for the purposes of safe use, to
clearly differentiate among biological products that have not been
determined to be interchangeable. Accordingly, for biological products,
we intend to designate a nonproprietary name that includes a suffix
composed of four lowercase letters. Each suffix will be incorporated in
the nonproprietary name of the product. This naming convention is
applicable to biological products previously licensed and newly
licensed under sections 351(a) and 351(k) of the PHS Act. The
nonproprietary name designated for originator biological products,
related biological products, and biosimilar products will include a
unique suffix. However, as discussed in section IV.C. of the guidance,
FDA is seeking comment on whether the nonproprietary name for an
interchangeable product should include a unique suffix, or should share
the same suffix as its reference product.
---------------------------------------------------------------------------
\1\ The BPCI Act was enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
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By differentiating biological products from one another that have
not been determined by the FDA to be interchangeable, this naming
convention is intended to help minimize inadvertent substitution.
Inadvertent substitution may lead to unintended alternating or
switching of biological products that have not been determined by FDA
to be interchangeable. A naming convention that differentiates among
biological products also could help facilitate pharmacovigilance for
all biological products. By applying this naming convention to all
biological products, this approach is intended to: (1) Encourage
routine use of designated suffixes in ordering, prescribing,
dispensing, and recordkeeping practices and (2) avoid inaccurate
perceptions of the safety and effectiveness of biological products
based on their licensure pathways.
The draft guidance provides information to industry, the health
care community, other regulatory agencies, and the public on our
rationale for this naming convention. The draft guidance also is
intended to assist applicants and application holders in proposing the
suffix to be used as part of a biological product's nonproprietary
name. The nonproprietary name designated by FDA in the license for a
biological product licensed under the PHS Act is its ``proper name,''
and the term ``proper name'' is used throughout the draft guidance (see
section 351(a)(1)(B)(i) of the PHS Act and 21 CFR 600.3(k)).
We invite comment on the draft guidance, including potential
approaches for designating and incorporating suffixes retrospectively
and prospectively into the nonproprietary names of all biological
products. We also solicit comments on ways to improve active
pharmacovigilance systems for the purposes of monitoring the safety of
biological products. In providing comments, please consider the
following:
1. What are the potential benefits and challenges of designating a
suffix in the proper name of a biological product that is:
[cir] Devoid of meaning versus meaningful (e.g., a suffix derived
from the name of the license holder)
[cir] unique to each biological product versus unique to each
license holder and shared by each biological product manufactured by
that license holder.
In your comments, please address how each option would impact the
following: Safe use of biological products; pharmacovigilance; and
market acceptance and uptake for certain products.
2. What would be the potential benefits and challenges for an
interchangeable product \2\ to share the same suffix as designated in
the proper name of the reference product? Your response should consider
that FDA's publicly available electronic resource, the Purple Book,\3\
will identify biological products determined by FDA to be biosimilar to
or interchangeable with a reference product. If an interchangeable
product does share the same suffix as the reference product, how would
this impact your responses to question 1, including pharmacovigilance?
---------------------------------------------------------------------------
\2\ Interchangeable product means a biological product that has
been shown to meet the standards described in section 351(k)(4) of
the PHS Act and may be substituted for the reference product without
the intervention of the health care provider who prescribed the
reference product (see section 351(i)(3) of the PHS Act).
\3\ The Purple Book: Lists of Licensed Biological Products With
Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluation is available on FDA's Web site at
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm.
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3. Would there be additional benefits or challenges if the suffix
designated in the proper name of a biosimilar product that is
subsequently determined to be interchangeable were changed to that of
the reference product upon a determination of interchangeability? Would
there be benefits or challenges to allowing the manufacturer of the
biosimilar product that is subsequently determined to be
interchangeable to have the option of retaining its original suffix or
adopting the same suffix as the reference product?
4. How could FDA and/or other Federal partners improve active
pharmacovigilance systems for purposes of monitoring the safety of
biological products? For example, because NDC numbers are not routinely
recorded in billing and patient records in many clinical settings in
which biological products are dispensed and administered, are there
other identifiers besides distinguishable nonproprietary names that are
routinely accessible by active pharmacovigilance systems and could
enable as good as or better pharmacovigilance? How can FDA and/or other
Federal partners help ensure that a distinguishable identifier for each
biological product would be captured at the point of dispensing or
administration to the patient and be routinely accessible in systems
used for pharmacovigilance?
5. What process and reasonable timeframe should FDA use to
designate a suffix to include in the nonproprietary name of a
previously licensed biological product?
6. What criteria should FDA use to prioritize retrospective
application of this naming convention to previously licensed biological
products?
7. What are the expected time frames for sponsors of previously
licensed biological products to distribute products that conform to
this naming convention after approval of a labeling supplement?
8. What strategies could FDA use to enhance stakeholders'
understanding of and education about this naming convention?
9. FDA notes that this naming convention (i.e., use of a suffix)
has
[[Page 52298]]
some similarities to the World Health Organization (WHO) proposal,
``Biological Qualifier--An INN Proposal.'' At the time of publication
of this draft guidance, WHO was still evaluating the comments received
on its proposal. If WHO adopts a Biological Qualifier proposal, how
should the biological qualifiers generated by WHO be considered in the
determination of FDA-designated proper names for the biological
products within the scope of this guidance?
We are continuing to consider the transition provisions of section
7002(e)(2) through (e)(4) of the BPCI Act that apply to biological
products submitted or approved under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), including how those provisions may impact the
nonproprietary naming of products to which those provisions apply. We
invite comment from all stakeholders on the application of this naming
convention to biological products approved under the FD&C Act.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on nonproprietary
naming of biological products, including biosimilar products and
interchangeable products. 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.
II. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
The draft guidance proposes a new collection of information by
requesting information from applicants and application holders to
propose a suffix composed of four lowercase letters to be included in
the ``proper name.'' The ``proper name'' is designated by FDA at the
time of licensure for biological products submitted under section
351(a) of the PHS Act and for biosimilar products and interchangeable
products submitted under section 351(k) of the PHS Act. The applicant
should also include information that the proposed suffix meets the
factors described in the draft guidance. For the prospective
application of this naming convention, our evaluation will generally
occur during the investigational new drug application phase and will
also be incorporated into the review of the marketing application.
The draft guidance also refers to a previously approved collection
of information found in FDA regulations that is expected to change as a
result of the draft guidance and the retrospective application of the
naming convention. The collection of information is related to the
following: The submission of a biologics license application (BLA) and
changes to an approved application, which is covered under part 601 (21
CFR part 601) and approved under OMB control number 0910-0338. As a
result of the draft guidance, the estimated number of additional
responses for the annual burden for changes to an approved application
under Sec. 601.12 would be increased by approximately 25 responses.
The draft guidance also refers to previously approved collections
of information found in FDA regulations that are not expected to change
as a result of the draft guidance. The collection of information is
related to the following: The submission of a BLA under section 351(k)
of the PHS Act (biosimilar products and interchangeable products),
which is approved under OMB control number 0910-0719.
FDA estimates the burden of this collection of information for the
prospective application of the naming convention as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Information for the Proposed 20 2 40 6 240
Proper Name for Biological
Products Submitted Under
Section 351(a) of the PHS Act..
Information for the Proposed 3 2 6 6 36
Proper Name for Biosimilar
Products and Interchangeable
Products Submitted Under
Section 351(k) of the PHS Act..
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Total....................... .............. .............. .............. .............. 276
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 52299]]
As indicated in table 1, we estimate that we will receive a total
of approximately 40 requests annually for the proposed ``proper name''
for biological products submitted under section 351(a) of the PHS Act
and 6 requests annually for the proposed ``proper name'' for biosimilar
products and interchangeable products submitted under section 351(k) of
the PHS Act. The average burden per response (hours) is based on the
Agency's experience with similar information collection requirements.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: August 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21383 Filed 8-27-15; 8:45 am]
BILLING CODE 4164-01-P
