
[Federal Register Volume 84, Number 46 (Friday, March 8, 2019)]
[Notices]
[Pages 8532-8533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Proposed Suffix for the Proper Name of a Biological 
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on Proposed Suffix for the Proper Name of a 
Biological Product.

DATES: Submit either electronic or written comments on the collection 
of information by May 7, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 7, 2019. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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 ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Proposed Suffix for the Proper 
Name of a Biological Product.'' Received comments, those filed in a 
timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 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.

[[Page 8533]]

    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.

Proposed Suffix for the Proper Name of a Biological Product

OMB Control Number 0910--New

    The final guidance for industry, ``Nonproprietary Naming of 
Biological Products,'' proposes a new collection of information by 
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 Public Health Service 
Act (PHS Act) (42 U.S.C. 262(a)) and for biosimilar products and 
interchangeable products submitted under section 351(k) of the PHS Act. 
The guidance recommends an applicant submit up to 10 proposed suffixes 
and include any analyses of how the proposed suffixes meet the factors 
described in the final guidance for industry. FDA's evaluation will 
generally occur during the investigational new drug application phase 
and will also be incorporated into the review of the marketing 
application.
    FDA previously published a 60-day notice in the Federal Register of 
August 28, 2015 (80 FR 52296), and a 30-day notice in the Federal 
Register of January 13, 2017 (82 FR 4345), on this proposed collection 
of information. OMB did not reach a decision on this collection of 
information, withdrawing it on July 3, 2018. Consistent with the 
revisions proposed in the draft guidance, entitled ``Nonproprietary 
Naming of Biological Products--Update,'' FDA is re-initiating the 
notice and comment process for this collection of information, 
beginning with this 60-day notice.
    Published elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of a draft guidance for industry entitled 
``Nonproprietary Naming of Biological Products: Update.'' This draft 
guidance proposes to amend the final guidance, ``Nonproprietary Naming 
of Biological Products.'' The draft guidance describes, among other 
things, FDA's current thinking on nonproprietary (proper) names of 
biological products licensed under section 351 of the PHS Act that do 
not include an FDA-designated suffix. Specifically, the proper 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, '' dated 
January 2017. This draft guidance is not intended to be finalized. 
Based on the comments received on this draft guidance, FDA intends to 
revise the final guidance, ``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.
    Consistent with the Draft Guidance, FDA proposes to gather the same 
type of information contemplated by the withdrawn information 
collection request (80 FR 52269 and 82 FR 4345). Due to the revisions 
proposed in the draft guidance, however, FDA anticipates that the 
number of respondents will be reduced, and FDA has re-estimated the 
burden of the collection of information accordingly. The proposed 
collection of information described in this notice is a new collection 
of information only and does not include a modification of an existing 
collection of information as previously recommended as part of the 60-
day (80 FR 52296) and 30-day (82 FR 4345) notices of the Federal 
Register.
    FDA estimates the burden of this collection of information as 
follows:

                                 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                  15               1              15             420           6,300
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(a) of the PHS
 Act............................
Information for the Proposed                   9               1               9             420           3,780
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(k) of the PHS
 Act............................
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    Total.......................  ..............  ..............  ..............  ..............          10,080
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    As indicated in table 1 above, we estimate that we will receive a 
total of approximately 15 requests annually for the proposed ``proper 
name'' for biological products submitted under section 351(a) of the 
PHS Act and 9 requests annually for the proposed ``proper name'' for 
biosimilar products and interchangeable products submitted under 
section 351(k) of the PHS Act. The estimated total annual responses are 
based on data from user fee rates for fiscal year 2019. The number of 
responses per respondent has been updated to reflect FDA's most recent 
information on the number of applications that are expected to be 
submitted under 351 of the PHS Act to the Agency annually. The average 
burden per response (hours) is based on FDA's consideration of comments 
received in response to the 60-day and 30-day notices requesting public 
comment on the withdrawn information collection request associated with 
the final guidance (80 FR 52269 and 82 FR 4345).

    Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04241 Filed 3-7-19; 8:45 am]
BILLING CODE 4164-01-P


