[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Pages 35367-35368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Nonproprietary Naming of Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is 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: Fax written comments on the collection of information by July 5, 
2016.

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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Nonproprietary Naming of Biological Products 
OMB Control Number 0910-NEW

    The guidance entitled ``Guidance for Industry on Nonproprietary 
Naming of Biological Products'' describes FDA's 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. There is a need to clearly identify biological 
products to facilitate pharmacovigilance and, for the purposes of safe 
use, to minimize inadvertent substitution. Accordingly, for biological 
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 (42 U.S.C. 262(a) or 262(k)).
    The guidance includes information collection by requesting that 
applicants propose a suffix composed of four lowercase letters for use 
as the distinguishing identifier included in the proper name designated 
by FDA at the time of licensure 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 should submit 
up to 10 proposed suffixes, in the order of the applicant's preference. 
We also recommend including supporting analyses demonstrating that the 
proposed suffixes meet the factors described in the guidance for FDA's 
consideration.
    As indicated in table 1, we estimate that we will receive a total 
of 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 our experience with 
similar information collection requirements for applicants to create 
and submit suffix proposals to FDA and in consideration of comments 
received in response to our 60-day notice.
    In the Federal Register of August 28, 2015 (80 FR 52296), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Most comments supported our 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 
biosimilar and interchangeable 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 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.
    In response to the comments we note that our estimated annual 
reporting burden results from information that would be submitted to us 
by applicants in order to facilitate Agency 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 is an annualized figure based on the average number of 
responses per respondent and the average burden per response over a 3-
year period. We understand 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. We also recognize 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 suggesting that it will take 720 hours to complete an 
analysis

[[Page 35368]]

and submission for each suffix does not provide a basis by which the 
estimate was calculated or whether it is broadly applicable. We find 
this figure rather high and retain our original estimate of 6 hours. 
The latter figure is based on our familiarity with the average amount 
of time required by similar submissions to FDA. At the same time, the 
comment also suggested that we failed to adequately account for the 
time spent on creating proposed suffixes. In consideration, therefore, 
we have revised our estimate upward to account for burden associated 
with creating and submitting up to 10 proposed suffixes for 
designation, as reflected in table 1.
    FDA estimates the information collection burden as follows:
    Description of Respondents: Respondents to the collection are 
sponsors of biological product applications.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Information for the Proposed                  20               2              40             420          16,800
 Proper Name for Biological
 Products Submitted Under
 Section 351(a) of the PHS Act..
Information for the Proposed                   3               2               6             420           2,520
 Proper Name for Biosimilar
 Products and Interchangeable
 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.

    The guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information 
for the submission of a biologics license application (BLA) and changes 
(supplements) to an approved application under 21 CFR part 601 have 
been approved under OMB control number 0910-0338. The collections of 
information for the submission of a BLA under section 351(k) of the PHS 
Act (biosimilar products and interchangeable products) have been 
approved under OMB control number 0910-0719.

    Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12885 Filed 6-1-16; 8:45 am]
 BILLING CODE 4164-01-P