[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the draft guidance issued on August 28, 2015.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
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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............................
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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