[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4345-4348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00694]


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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; 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 or Agency) is announcing 
the availability of a guidance for industry entitled ``Nonproprietary 
Naming of Biological Products.'' The guidance describes our current 
thinking on the need for biological products previously and newly 
licensed under the Public Health Service Act (PHS Act) to bear 
nonproprietary names that include FDA-designated suffixes. Accordingly, 
we intend to designate nonproprietary names for originator biological 
products, related biological products, or biosimilar products which 
will include a core name and a distinguishing suffix that is devoid of 
meaning and composed of four lowercase letters. This guidance finalizes 
the draft guidance issued on August 28, 2015.
    FDA is also announcing that a proposed collection of information 
has been submitted to the Office of Management and Budget (OMB) for 
review and clearance under the Paperwork Reduction Act of 1995.

DATES: Submit either electronic or written comments on Agency guidances 
at any time. Submit written comments on the collection of information 
by February 13, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--New and 
title ``Nonproprietary Naming of Biological Products.'' Also include 
the FDA docket number found in brackets in the heading of this 
document.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1543 for ``Nonproprietary Naming of Biological Products.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential

[[Page 4346]]

with a heading or cover note that states ``THIS DOCUMENT CONTAINS 
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including 
the claimed confidential information, in its consideration of comments. 
The second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
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 (CBER), 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: 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. 
Regarding the information collection: FDA PRA Staff, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Nonproprietary Naming of Biological Products.'' The guidance 
describes our current thinking on the need for biological products 
licensed under section 351(a) and (k) of the PHS Act (42 U.S.C. 262(a) 
and (k)) to bear a nonproprietary name that includes an FDA-designated 
suffix. Under this naming convention, the nonproprietary name 
designated for each originator biological product, related biological 
product, and biosimilar product will be a proper name that is a 
combination of the core name and a distinguishing suffix that is devoid 
of meaning and composed of four lowercase letters. The suffix format 
described in this guidance is applicable to originator biological 
products, related biological products, and biosimilar products 
previously licensed and newly licensed under section 351(a) or 351(k) 
of the PHS Act. FDA is continuing to consider the appropriate suffix 
format for interchangeable biological products.
    This naming convention will facilitate pharmacovigilance for 
originator biological products, related biological products, and 
biosimilar products containing related drug substances when other means 
to track a specific dispensed product are not readily accessible or 
available. Distinguishable nonproprietary names will also facilitate 
accurate identification of these biological products by health care 
practitioners and patients. Further, distinguishing suffixes should 
help minimize inadvertent substitution of any such products that have 
not been determined to be interchangeable. Application of the naming 
convention to biological products licensed under the PHS Act should (1) 
encourage routine use of designated suffixes in ordering, prescribing, 
dispensing, recordkeeping, and pharmacovigilance practices and (2) 
avoid inaccurate perceptions of the safety and effectiveness of 
biological products based on their licensure pathway, as described in 
detail in the guidance.
    The guidance provides information to industry, the health care 
community, other regulatory agencies, and the public on FDA's rationale 
for this naming convention. The guidance is also intended to assist 
applicants and application holders in proposing the suffix to be 
incorporated into an originator biological product, related biological 
product, or biosimilar product's nonproprietary name.
    In the Federal Register of August 28, 2015 (80 FR 52296), FDA 
announced the availability of the draft guidance of the same title. FDA 
received numerous comments on the draft guidance, and those comments 
were considered as the guidance was finalized. In the notice announcing 
the draft guidance, FDA asked about the benefits and challenges of 
designating (1) a suffix that is devoid of meaning versus meaningful 
(e.g., derived from the name of the license holder) and (2) a suffix 
that is unique to each biological product versus shared by each 
biological product manufactured by that license holder. FDA determined 
that the suffix format that best achieves the goals described in the 
guidance is a suffix that is devoid of meaning and not shared by each 
biological product manufactured by that license holder.
    FDA intends to apply a naming convention to interchangeable 
products that will feature a core name and a suffix included in the 
proper name; however, FDA is continuing to consider the appropriate 
format of the suffix for these products.
    This guidance also will apply to those biological products that are 
approved under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
on or before March 23, 2020, when such products are deemed to be 
licensed under section 351 of the PHS Act on March 23, 2020 (section 
7002(e)(2) through (e)(4) of the Biologics Price Competition and 
Innovation Act of 2009 (BPCI Act)). FDA intends to provide additional 
guidance regarding administrative issues associated with the transition 
(including the process for implementing the naming convention described 
in this guidance).
    For the purposes of the guidance, unless otherwise specified, 
references to biological products include biological products licensed 
under the PHS Act, such as therapeutic protein products, vaccines, 
allergenic products, and blood derivatives, and do not include certain 
biological products that also meet the definition of a device in 
section 201(h) of the FD&C Act (21 U.S.C. 321(h)), such as in vitro 
reagents (e.g., antibody to hepatitis B surface antigen, blood grouping 
reagents, hepatitis C virus encoded antigen) and blood donor screening 
tests (e.g., HIV and hepatitis C). Also, for the purposes of the

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guidance, unless otherwise specified, references to biological products 
do not include products for which a proper name is provided in the 
regulations (e.g., 21 CFR part 640) or to certain categories of 
biological products for which there are well-established, robust 
identification and tracking systems to ensure safe dispensing practices 
and optimal pharmacovigilance (e.g., ISBT 128 for cord blood products 
and blood components).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on 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.
    In compliance with 44 U.S.C. 3507, FDA has submitted the following 
proposed collection of information to OMB for review and clearance.

II. Paperwork Reduction Act of 1995, Nonproprietary Naming of 
Biological Products, OMB Control Number 0910--New

    The guidance describes FDA's current thinking on the need for 
biological products licensed under the PHS Act to bear a nonproprietary 
name that includes an FDA-designated suffix. There is a need to clearly 
identify biological products to facilitate pharmacovigilance and safe 
use. Accordingly, for originator biological products, related 
biological products, or biosimilar products licensed under the PHS Act, 
FDA intends to designate a nonproprietary name that includes a core 
name and a distinguishing suffix. This naming convention is applicable 
to biological products previously licensed and newly licensed under 
section 351(a) or 351(k) of the PHS Act.
    The final guidance proposes a new collection of information by 
requesting that applicants and application holders propose a suffix 
composed of four lowercase letters for use as the suffix included in 
the proper name. The proper name is designated by FDA in the license 
for biological products licensed under the PHS Act. The suffix will be 
incorporated in the nonproprietary name of the product. The guidance 
recommends that applicants and application holders submit up to 10 
proposed suffixes, in the order of the applicant's preference. FDA also 
recommends including supporting analyses demonstrating that the 
proposed suffixes meet the factors described in the final guidance for 
FDA's consideration.
    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 
six requests annually for the proposed proper name for biological 
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 for applicants to create 
and submit suffix proposals to FDA.
    As noted, in the Federal Register of August 28, 2015, FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. Most comments supported FDA's proposal to designate a 
suffix. Many comments suggested that a meaningful, distinguishable 
suffix may help to improve pharmacovigilance, enhance safety, and 
facilitate identification between biological products. Some comments 
supported use of a random suffix to avoid creating an unfair advantage 
for specific manufacturers. Several comments stated that the current 
practices of FDA and non-FDA entities for identifying products is 
sufficient for the purpose of pharmacovigilance, and designation of a 
suffix is not needed. One comment stated that FDA's estimate of 6 hours 
to submit proposed suffixes is based only on the time needed to prepare 
the submission itself after the multiple suffixes have been selected. 
The comment further stated that because FDA suggests that each 
respondent submit three suggested suffixes for Agency consideration, 
the time needed to do an analysis of each suffix would exceed 720 hours 
per suffix (based on their own company experience) or 2,160 hours total 
for the three suffixes. The commenter subsequently submitted additional 
information to clarify how the estimates were calculated.
    Response: FDA's estimate of the annual reporting burden results 
from information that would be submitted to FDA by applicants in order 
to facilitate FDA's designation of a suffix as part of the proper name 
of a biological product. We estimated that sponsors would spend 2 hours 
completing the submission for each of the three suffixes, resulting in 
6 hours as the average burden. This estimate for submission of the 
requested information is based on the average number of responses per 
respondent and the average burden per response over a 3-year period. 
FDA understands that there is a certain amount of research and other 
costs that an applicant might encounter in analyzing any proposed name 
for a biological product. FDA also recognizes that the burden may be 
higher for some applicants and lower for other applicants based on a 
variety of factors specific to the applicant.
    The comment suggests that it will take 720 hours to complete an 
analysis and submission for each suffix. We have considered the 
information provided in support of this estimate and believe the 
estimate is likely too high. Our original estimate of 6 hours was based 
on the Agency's familiarity with the time it would take to make similar 
submissions to FDA. However, as identified by the comment, FDA's 
original estimate failed to adequately account for the time spent on 
creating proposed suffixes. We have reconsidered our original estimate 
as a result of the comment, and we have revised our estimate to account 
for the burden to create and submit up to 10 proposed suffixes to FDA 
for designation. As indicated in table 1, we estimate an average burden 
of approximately 420 hours to account for creating and submitting 
multiple proposed suffixes.
    FDA estimates the information collection burden as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Information for the Proposed                  20               2              40             420          16,800
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(a) of the PHS
 Act............................

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Information for the Proposed                   3               2               6             420           2,520
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(k) of the PHS
 Act............................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          19,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This guidance also refers to previously approved collections of 
information found in FDA regulations. The collection of information 
related to the submission of a BLA under section 351(k) of the PHS Act 
(biosimilar products and interchangeable products) has been approved 
under OMB control number 0910-0719. The guidance also refers to a 
previously approved collection of information found in FDA regulations 
that is expected to change as a result of the guidance and the 
retrospective application of the naming convention. The collections of 
information in 21 CFR part 601 related to the submission of a biologics 
license application (BLA) and changes to an approved application have 
been approved under OMB control number 0910-0338. As a result of the 
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.
    FDA is issuing this final guidance subject to OMB approval of the 
collections of information. Before implementing the information 
collection provisions of the guidance, FDA will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the collections of information, including OMB control 
number(s) for newly approved collections.

III. Electronic Access

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

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00694 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P