[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Pages 26060-26062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1922]


Formal Meetings Between the Food and Drug Administration and 
Sponsors or Applicants of Biosimilar User Fee Act Products; Draft 
Guidance for Industry; Availability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 or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Formal 
Meetings Between the FDA and Sponsors or Applicants of BsUFA 
Products.'' This draft guidance provides recommendations to industry on 
formal meetings between FDA and sponsors or applicants relating to the 
development and review of biosimilar or interchangeable biological 
products regulated by the Center for Drug Evaluation and Research 
(CDER) or the Center for Biologics Evaluation and Research (CBER). The 
previous guidance for industry entitled ``Formal Meetings Between the 
FDA and Biosimilar Biological Product Sponsors or Applicants,'' issued 
on November 18, 2015, has been withdrawn.

DATES: Submit either electronic or written comments on the draft 
guidance by September 4, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 26061]]

information submitted, marked and identified, as confidential, if 
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1922 for ``Formal Meetings Between the Food and Drug 
Administration and Sponsors or Applicants of Biosimilar User Fee Act 
Products; Draft Guidance for Industry; Availability.'' 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 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: Neel Patel, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 6468, Silver Spring, MD 20993-0002, 301-796-0970; 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants 
of BsUFA Products.'' This draft guidance provides recommendations to 
industry on formal meetings between FDA and sponsors or applicants 
relating to the development and review of biosimilar or interchangeable 
biological products regulated by CDER or CBER. This draft guidance does 
not apply to meetings associated with the development of products 
intended for submission in, or review of, new drug applications or 
abbreviated new drug applications under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), biologics license applications 
under section 351(a) of the Public Health Service Act, or submissions 
for devices under the FD&C Act. For the purposes of this draft 
guidance, formal meeting includes any meeting that is requested by a 
sponsor or applicant following the procedures provided in this draft 
guidance and includes meetings conducted in any format (i.e., face to 
face, teleconference/videoconference, written response only).
    The Biosimilar User Fee Act of 2012 (BsUFA I) added sections 744G 
and 744H to the FD&C Act, authorizing FDA to collect user fees for a 5-
year period for biosimilar biological products. BsUFA was reauthorized 
for a 5-year period in 2017 under Title IV of the FDA Reauthorization 
Act of 2017 (BsUFA II), enacted on August 18, 2017. In conjunction with 
that reauthorization, FDA agreed to specific performance goals and 
procedures described in the document, ``Biosimilar Biological Product 
Reauthorization Performance Goals and Procedures Fiscal Years 2018 
Through 2022'' (BsUFA II goals letter available at https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf). The BsUFA II goals letter includes meeting management 
goals for formal meetings that occur between the FDA and sponsors or 
applicants.
    In the BsUFA II goals letter, FDA committed to issuing this draft 
guidance. This draft guidance discusses the principles of good meeting 
management practices and describes standardized procedures for 
requesting, preparing, scheduling, conducting, and documenting formal 
meetings between FDA and sponsors or applicants of BsUFA products.
    The previous guidance for industry entitled ``Formal Meetings 
Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants,'' issued on November 18, 2015, has been withdrawn.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on formal 
meetings between the FDA and sponsors or applicants of BsUFA 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.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information 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). The collections of information referred to in the guidance for 
industry entitled ``Formal Meetings Between the FDA and Biosimilar 
Biological Product Sponsors or Applicants'' have been approved under 
OMB control number 0910-0802. The collections of information in 21 CFR 
part 312 have been approved under OMB control number 0910-0014 and 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

[[Page 26062]]

III. Electronic Access

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

    Dated: May 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12027 Filed 6-4-18; 8:45 am]
 BILLING CODE 4164-01-P


