[Federal Register Volume 84, Number 46 (Friday, March 8, 2019)]
[Notices]
[Pages 8534-8536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04242]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1543]


Nonproprietary Naming of Biological Products: Update; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Nonproprietary Naming of Biological Products: Update.'' This draft 
guidance describes FDA's current thinking on nonproprietary names of 
biological products licensed under the Public Health Service Act (PHS 
Act) that do not include an FDA-designated suffix. Specifically, the 
nonproprietary names of these products need not be revised to 
accomplish the objectives of the naming convention described in the 
final guidance for industry, ``Nonproprietary Naming of Biological 
Products,'' dated January 2017. Similarly, FDA does not intend to apply 
the naming convention described in the final guidance for industry, 
``Nonproprietary Naming of Biological Products,'' to biological 
products that are the subject of an approved application under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, 
when such an application is deemed to be a biologics license 
application (BLA) under the PHS Act (transition biological products). 
FDA is also reconsidering whether vaccines should be within the scope 
of the naming convention. In addition, the draft guidance describes 
FDA's current thinking on the appropriate suffix format for the 
nonproprietary name of an interchangeable biological product licensed 
under the PHS Act. Based on the comments received in the docket, we 
intend to revise the final guidance, ``Nonproprietary Naming of 
Biological Products,'' dated January 2017 and to amend sections in that 
document regarding the subjects addressed in this draft guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by May 7, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the revisions 
of the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1543 for ``Nonproprietary Naming of Biological Products: 
Update.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993-0002, 301-
796-1042; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903

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New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Nonproprietary Naming of Biological Products: Update.'' This 
draft guidance describes FDA's current thinking on nonproprietary names 
of biological products licensed under section 351 of the PHS Act (42 
U.S.C. 262) that do not include an FDA-designated suffix. Specifically, 
the nonproprietary names of these products need not be revised in order 
to accomplish the objectives of the naming convention described in the 
final guidance for industry, ``Nonproprietary Naming of Biological 
Products'' (Naming Guidance). Similarly, FDA does not intend to apply 
the naming convention described in the Naming Guidance to biological 
products that are the subject of an approved application under section 
505 of the FD&C Act (21 U.S.C. 355) as of March 23, 2020, when such an 
application is deemed to be a BLA under section 351 of the PHS Act 
(section 7002(e)(4) of the Biologics Price Competition and Innovation 
Act of 2009) (transition biological products). FDA is also 
reconsidering whether vaccines should be within the scope of the naming 
convention.
    In addition, this draft guidance describes FDA's current thinking 
on the appropriate suffix format for the nonproprietary name of an 
interchangeable biological product licensed under section 351(k) of the 
PHS Act. For each interchangeable product, FDA intends to designate a 
nonproprietary name that is a combination of the core name and a 
distinguishing suffix that is devoid of meaning and composed of four 
lowercase letters.
    In the Federal Register of August 28, 2015 (80 FR 52296), FDA 
announced the availability of a draft guidance, ``Nonproprietary Naming 
of Biological Products,'' dated August 2015. In this notice, FDA 
solicited comments on several issues, including questions related to 
the application of the naming convention to previously licensed 
biological products (that is, biological products that are licensed 
without an FDA-designated suffix in their proper names); and the format 
of the suffix assigned to interchangeable products. The 2015 draft 
guidance specifically sought comment on whether the nonproprietary name 
for an interchangeable product should include a unique, distinguishing 
suffix, or should share the same suffix as its reference product.
    FDA announced the availability of the final guidance dated January 
2017 in the Federal Register of January 13, 2017 (82 FR 4345). The 
final guidance explained that the Agency was still considering the 
process to implement this naming convention for previously licensed 
biological products and for transition biological products, as well as 
the appropriate suffix format for interchangeable products.
    FDA reviewed the comments received for both the draft and final 
versions of the guidance. FDA received comments indicating that 
revising the nonproprietary names of a large number of products 
licensed without an FDA-designated suffix in their proper names would 
create a substantial burden for healthcare systems, could cause 
disruption for product inventory, and could cause confusion for 
healthcare providers and patients, as the nonproprietary names of drugs 
seldom change postapproval. FDA considered these and other comments 
and, for reasons including those just described, does not intend to 
apply the naming convention to biological products licensed under the 
PHS Act without an FDA-designated suffix in their proper names. For 
similar reasons, FDA does not intend to apply the naming convention to 
transition biological products.
    FDA's current thinking is that the objectives of the naming 
convention described in the Naming Guidance can be accomplished without 
revising the nonproprietary names of: (1) Biological products licensed 
under section 351 of the PHS Act without an FDA-designated suffix in 
their proper names or (2) transition biological products. In addition, 
only applying the naming convention prospectively is expected to reduce 
burden. Commenters have expressed concerns that modifications to 
patient recordkeeping systems, inventory systems, and other databases 
would be necessary to accommodate changes to the nonproprietary names 
of previously licensed products. Not applying the naming convention to 
biological products that were licensed without an FDA-designated suffix 
in their proper names nor to transition biological products avoids the 
potential burden on various stakeholders of changing the proper names 
of a large number of biological products.
    Vaccines are currently within the scope of the naming convention 
described in the Naming Guidance. However, as stated in the draft 
guidance, FDA is reconsidering that approach and is evaluating whether 
the currently available identification systems associated with the 
administration of vaccines are sufficiently robust to ensure safe 
dispensing practices and optimal pharmacovigilance without requiring 
distinguishable proper names.
    In addition, this draft guidance explains FDA's current thinking on 
the appropriate format of the suffix included in the nonproprietary 
name of interchangeable products. FDA's current thinking is that a 
suffix included in the nonproprietary name of an interchangeable 
product should, as with other biological products within the scope of 
the guidance, be a unique, distinguishing suffix. FDA believes a 
unique, distinguishing suffix is necessary to achieve adequate 
pharmacovigilance for interchangeable products.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). Based on the comments 
received in the docket, we intend to revise the final guidance for 
industry, ``Nonproprietary Naming of Biological Products'' dated 
January 2017, and to amend sections, such as sections IV.D and V.B, in 
that document regarding the subjects addressed in this draft guidance. 
This draft guidance is not intended to be finalized as a separate 
guidance document. When revised, the guidance will represent the 
current thinking of FDA on ``Nonproprietary Naming of Biological 
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. 
This guidance is not subject to Executive Order 12866.
    FDA invites comments on the draft guidance, as well as general 
comments on how the Agency may implement the naming convention 
described in the Naming Guidance in a manner that is fair and 
consistent while also promoting the specific objectives described in 
the Naming Guidance and avoiding unnecessary burden. For example, FDA 
invites comments regarding the implications of providing the same or a 
different suffix for the same drug substance that is submitted by the 
same sponsor for multiple strengths, dosage forms, or presentations in 
the same BLA, in a supplement to an approved BLA, or in a different 
BLA. FDA also invites comments on the application of the naming 
convention to vaccine products.

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II. Paperwork Reduction Act of 1995

    This draft guidance describes information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In 
particular, the draft guidance refers to a new collection of 
information described in the final guidance, ``Nonproprietary Naming of 
Biological Products,'' recommending that applicants 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. FDA is soliciting public comment, in a 
separate document published elsewhere in this issue of the Federal 
Register (see ``Agency Information Collection Activities; Proposed 
Collection; Comment Request; Proposed Suffix for the Proper Name of a 
Biological Product'') on the information collection associated with the 
guidance, ``Nonproprietary Naming of Biological Products.'' FDA will 
also seek OMB approval for the information collection.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04242 Filed 3-7-19; 8:45 am]
 BILLING CODE 4164-01-P