83 FR 28234 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 117 (June 18, 2018)

Page Range		28234-28236
FR Document		2018-12968

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on formal meetings between FDA and biosimilar biological product sponsors or applicants.

Federal Register, Volume 83 Issue 117 (Monday, June 18, 2018)

[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28234-28236]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry: Formal Meetings Between the 
Food and Drug Administration and Biosimilar Biological Product Sponsors 
or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on formal meetings between FDA and biosimilar 
biological product sponsors or applicants.

DATES: Submit either electronic or written comments on the collection 
of information by August 17, 2018.

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 August 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time

[[Page 28235]]

at the end of August 17, 2018. 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-0286 for ``Guidance for Industry: Formal Meetings Between 
Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants.'' 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.thefederalregister.org/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, 
[email protected].

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, including 
each proposed extension of an existing 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.
    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.

Guidance for Industry: Formal Meetings Between the FDA and Biosimilar 
Biological Product Sponsors or Applicants

OMB Control Number 0910-0802--Extension

    The Biologics Price Competition and Innovation Act of 2009, the 
Biosimilar User Fee Act of 2012, and the recent passage of the 
Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the 
Food and Drug Administration Reauthorization Act of 2017, authorizes 
user fees for biosimilar biological products. FDA has committed to 
meeting certain performance goals in connection with the reauthorized 
biosimilar user fee program. FDA developed a guidance for industry 
entitled ``Formal Meetings Between FDA and Biosimilar Biological 
Products Sponsors or Applicants'' to provide recommendations to 
industry on formal meetings between FDA and sponsors or applicants 
relating to the development and review of biosimilar biological 
products regulated by the Center for Drug Evaluation and Research 
(CDER) or the Center for Biologics Evaluation and Research (CBER) and 
assist sponsors and applicants in generating and submitting meeting 
requests and the associated meeting packages to FDA for biosimilar 
biological products. The guidance describes FDA's current

[[Page 28236]]

thinking on how the Agency intends to interpret and apply certain 
provisions of BsUFA II and provides information on specific performance 
goals for the management of meetings associated with the development 
and review of biosimilar biological products. The guidance includes two 
types of information collections: (1) The submission of a meeting 
request containing certain information and (2) the submission of the 
information package(s) that accompany the meeting request. This 
information collection supports this Agency guidance document.

A. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting 
with CDER or CBER should submit a meeting request to the sponsor's or 
applicant's application (i.e., investigational new drug application, 
biologics license application). If there is no application, a sponsor 
or applicant should submit the request to either the appropriate CDER 
division director, with a copy sent to the division's chief of project 
management staff, or to the division director of the appropriate 
product office within CBER. However, a sponsor or applicant should only 
submit such a request after first contacting the appropriate review 
division or the Biosimilars Program staff, CDER, Office of New Drugs, 
to determine to whom the request should be directed, how it should be 
submitted, the appropriate format for the request, and to arrange for 
confirmation of receipt of the request.
    Under the guidance, FDA requests that sponsors and applicants 
incorporate certain information in the meeting request including:
    1. Product name,
    2. application number (if applicable),
    3. proposed proper name or proper name (post licensure),
    4. structure,
    5. reference product name,
    6. proposed indication(s) or context of product development,
    7. meeting type being requested (the rationale for requesting the 
meeting type should be included),
    8. a brief statement of the purpose of the meeting, including a 
brief background of the issues underlying the agenda and, as 
applicable, a brief summary of completed or planned studies and 
clinical trials or data the sponsor or applicant intends to discuss at 
the meeting, the general nature of the critical questions to be asked, 
and where the meeting fits in the overall development plans,
    9. a list of specific objectives/outcomes expected from the 
meeting,
    10. a proposed agenda, including times required for each agenda 
item,
    11. a list of questions grouped by discipline and a brief 
explanation of the context and purpose of each question,
    12. a list of all individuals with their titles and affiliations 
who will attend the requested meeting from the requestor's organization 
and consultants,
    13. a list of FDA staff, if known, or disciplines asked to 
participate in the requested meeting,
    14. suggested dates and times for the meeting, and
    15. the proposed format of the meeting (i.e., face to face meeting, 
teleconference, or videoconference).
    This information is be used by FDA to facilitate formal meetings 
with biosimilar biological product sponsors.

B. Information Package

    FDA requests that a sponsor or applicant submit a meeting package 
to the appropriate review division with the meeting request. FDA 
recommends that the information packages generally include:
    1. Product name and application number (if applicable),
    2. proposed proper name or proper name (post licensure),
    3. structure,
    4. reference product name,
    5. proposed indication(s) or context of product development,
    6. dosage form, route of administration, dosing regimen (frequency 
and duration), and presentation(s),
    7. a list of all sponsor's or applicant's attendees and consultants 
with their titles and affiliations who will attend the requested 
meeting,
    8. background that includes a brief history of the development 
program and the status of product development (e.g., chemistry, 
manufacturing, and controls; nonclinical; and clinical, including any 
development outside the United States, as applicable),
    9. a brief statement summarizing the purpose of the meeting,
    10. the proposed agenda,
    11. a list of questions for discussion grouped by discipline and 
with a brief summary for each question to explain the need or context 
for the question, and
    12. data to support discussion of the listed questions, organized 
by discipline and question.
    The purpose of the meeting package is to provide FDA staff the 
opportunity to adequately prepare for the meeting, including the review 
of relevant data concerning the product.
    Description of Respondents: A sponsor or applicant for a biosimilar 
biological product who requests a formal meeting with FDA regarding the 
development and review of a biosimilar biological product.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry: Formal
    Meetings Between FDA and         Number of       Number of     Total annual   Average burden
  Biosimilar Biological Product     respondents    responses per     responses     per response     Total hours
     Sponsors or Applicants                         respondent
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests...........              36             2.5              89              15           1,335
CBER Meeting Requests...........               2               1               2              15              30
CDER Information Packages.......              29             2.2              64              30           1,920
CBER Information Packages.......               2               2               4              30             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,405
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since the last OMB approval there has been an increase in meeting 
requests with CDER and a corresponding increase in the number of 
information packages. Accordingly, we have adjusted our estimate of 
CDER meeting requests upward by six respondents. We attribute this 
change to an increase in biosimilar product development.

    Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12968 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P

28234 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices

Compensation Program Act of 2000 (42 performed. In addition, NIOSH and the duty for DOE nuclear weapons
U.S.C. 7384–7385) was enacted. This claimant may identify incidents that production programs. After dose
Act established a federal compensation may have resulted in undocumented reconstruction, NIOSH also performs a
program for employees of the radiation exposures, characterizing brief, voluntary final interview with the
Department of Energy (DOE) and certain radiological protection and monitoring claimant to explain the results and to
of its contractors, subcontractors and practices, and identify co-workers and allow the claimant to confirm or
vendors, who have suffered cancers and other witnesses as may be necessary to question the records NIOSH has
other designated illnesses as a result of confirm undocumented information. In compiled. This will also be the final
exposures sustained in the production this process, NIOSH uses a computer opportunity for the claimant to
and testing of nuclear weapons. assisted telephone interview (CATI) supplement the dose reconstruction
Executive Order 13179, issued on system, which allows interviews to be record.
December 7, 2000, delegated authorities conducted more efficiently and quickly At the conclusion of the dose
assigned to ‘‘the President’’ under the as opposed to a paper-based interview reconstruction process, the claimant
Act to the Departments of Labor, Health instrument. Both interviews are submits a form to confirm that the
and Human Services, Energy and voluntary and failure to participate in claimant has no further information to
Justice. The Department of Health and either or both interviews will not have provide to NIOSH about the claim at
Human Services (DHHS) was delegated a negative effect on the claim, although this time. The form notifies the claimant
the responsibility of establishing voluntary participation may assist the that signing the form allows NIOSH to
methods for estimating radiation doses claimant by adding important forward a dose reconstruction report to
received by eligible claimants with information that may not be otherwise DOL and to the claimant, and closes the
cancer applying for compensation. available. record on data used for the dose
NIOSH is applying the following There are no changes to the questions reconstruction. Signing this form does
methods to estimate the radiation doses contained in the package, or the not indicate that the claimant agrees
of individuals applying for estimated burden hours. This with the outcome of the dose
compensation. Information Collection Request (ICR) is reconstruction. The dose reconstruction
In performance of its dose being submitted as a reinstatement results will be supplied to the claimant
reconstruction responsibilities, under because the previous ICR expired on and to the DOL, the agency that will
the Act, NIOSH is providing voluntary April 30, 2018 and the updated ICR was utilize them as one part of its
interview opportunities to claimants (or not submitted before the expiration determination of whether the claimant
their survivors) individually and date. NIOSH uses the data collected in is eligible for compensation under the
providing them with the opportunity to this process to complete an individual Act.
assist NIOSH in documenting the work dose reconstruction that accounts, as Total annualized burden is estimated
history of the employee by fully as possible, for the radiation dose to be 3900 hours. There is no cost to
characterizing the actual work tasks incurred by the employee in the line of respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per
Type of respondents Form name respondents per response
respondent (in hours)

Claimant .......................................................... Initial Interview ............................................... 3,600 1 1
Claimant .......................................................... Conclusion form OCAS–1 .............................. 3,600 1 5/60

Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND Under the Paperwork Reduction Act of
Acting Chief, Information Collection Review HUMAN SERVICES 1995 (PRA), Federal Agencies are
Office, Office of Scientific Integrity, Office required to publish notice in the
of the Associate Director for Science, Office Food and Drug Administration Federal Register concerning each
of the Director, Centers for Disease Control proposed collection of information,
and Prevention. [Docket No. FDA–2013–D–0286] including each proposed extension of an
[FR Doc. 2018–12972 Filed 6–15–18; 8:45 am] existing collection of information, and
Agency Information Collection to allow 60 days for public comment in
BILLING CODE 4163–18–P
Activities; Proposed Collection; response to the notice. This notice
Comment Request; Guidance for solicits comments on formal meetings
Industry: Formal Meetings Between the between FDA and biosimilar biological
Food and Drug Administration and product sponsors or applicants.
Biosimilar Biological Product DATES: Submit either electronic or
Sponsors or Applicants written comments on the collection of
AGENCY: Food and Drug Administration, information by August 17, 2018.
HHS. ADDRESSES: You may submit comments
amozie on DSK3GDR082PROD with NOTICES1

ACTION: Notice. as follows. Please note that late,
untimely filed comments will not be
SUMMARY: The Food and Drug considered. Electronic comments must
Administration (FDA or Agency) is be submitted on or before August 17,
announcing an opportunity for public 2018. The https://www.regulations.gov
comment on the proposed collection of electronic filing system will accept
certain information by the Agency. comments until midnight Eastern Time

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28236 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices

thinking on how the Agency intends to 3. proposed proper name or proper the information packages generally
interpret and apply certain provisions of name (post licensure), include:
BsUFA II and provides information on 4. structure, 1. Product name and application
specific performance goals for the 5. reference product name, number (if applicable),
management of meetings associated 6. proposed indication(s) or context of 2. proposed proper name or proper
with the development and review of product development, name (post licensure),
biosimilar biological products. The 7. meeting type being requested (the 3. structure,
guidance includes two types of rationale for requesting the meeting type 4. reference product name,
information collections: (1) The should be included), 5. proposed indication(s) or context of
submission of a meeting request 8. a brief statement of the purpose of product development,
containing certain information and (2) the meeting, including a brief 6. dosage form, route of
the submission of the information background of the issues underlying the administration, dosing regimen
package(s) that accompany the meeting agenda and, as applicable, a brief (frequency and duration), and
request. This information collection summary of completed or planned presentation(s),
supports this Agency guidance studies and clinical trials or data the 7. a list of all sponsor’s or applicant’s
document. sponsor or applicant intends to discuss attendees and consultants with their
at the meeting, the general nature of the titles and affiliations who will attend
A. Request for a Meeting critical questions to be asked, and where the requested meeting,
the meeting fits in the overall 8. background that includes a brief
Under the guidance, a sponsor or
development plans, history of the development program and
applicant interested in meeting with 9. a list of specific objectives/
CDER or CBER should submit a meeting the status of product development (e.g.,
outcomes expected from the meeting, chemistry, manufacturing, and controls;
request to the sponsor’s or applicant’s 10. a proposed agenda, including
application (i.e., investigational new nonclinical; and clinical, including any
times required for each agenda item,
drug application, biologics license development outside the United States,
11. a list of questions grouped by
application). If there is no application, as applicable),
discipline and a brief explanation of the
a sponsor or applicant should submit 9. a brief statement summarizing the
context and purpose of each question,
the request to either the appropriate 12. a list of all individuals with their purpose of the meeting,
CDER division director, with a copy titles and affiliations who will attend 10. the proposed agenda,
sent to the division’s chief of project the requested meeting from the 11. a list of questions for discussion
management staff, or to the division requestor’s organization and grouped by discipline and with a brief
director of the appropriate product consultants, summary for each question to explain
office within CBER. However, a sponsor 13. a list of FDA staff, if known, or the need or context for the question, and
or applicant should only submit such a disciplines asked to participate in the 12. data to support discussion of the
request after first contacting the requested meeting, listed questions, organized by discipline
appropriate review division or the 14. suggested dates and times for the and question.
Biosimilars Program staff, CDER, Office meeting, and The purpose of the meeting package is
of New Drugs, to determine to whom the 15. the proposed format of the to provide FDA staff the opportunity to
request should be directed, how it meeting (i.e., face to face meeting, adequately prepare for the meeting,
should be submitted, the appropriate teleconference, or videoconference). including the review of relevant data
format for the request, and to arrange for This information is be used by FDA concerning the product.
confirmation of receipt of the request. to facilitate formal meetings with Description of Respondents: A
biosimilar biological product sponsors. sponsor or applicant for a biosimilar
Under the guidance, FDA requests
biological product who requests a
that sponsors and applicants B. Information Package formal meeting with FDA regarding the
incorporate certain information in the
FDA requests that a sponsor or development and review of a biosimilar
meeting request including:
applicant submit a meeting package to biological product.
1. Product name, the appropriate review division with the FDA estimates the burden of this
2. application number (if applicable), meeting request. FDA recommends that collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Guidance for Industry: Formal Meetings Between FDA and Number of Total annual
responses per burden per Total hours
Biosimilar Biological Product Sponsors or Applicants respondents responses
respondent response

CDER Meeting Requests ..................................................... 36 2.5 89 15 1,335
CBER Meeting Requests ..................................................... 2 1 2 15 30
CDER Information Packages ............................................... 29 2.2 64 30 1,920
CBER Information Packages ............................................... 2 2 4 30 120

Total .............................................................................. ........................ ........................ ........................ ........................ 3,405
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
amozie on DSK3GDR082PROD with NOTICES1

Since the last OMB approval there has adjusted our estimate of CDER meeting Dated: June 13, 2018.
been an increase in meeting requests requests upward by six respondents. We Leslie Kux,
with CDER and a corresponding attribute this change to an increase in Associate Commissioner for Policy.
increase in the number of information biosimilar product development. [FR Doc. 2018–12968 Filed 6–15–18; 8:45 am]
packages. Accordingly, we have BILLING CODE 4164–01–P

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Document Created: 2018-06-18 15:49:52
Document Modified: 2018-06-18 15:49:52

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 17, 2018.
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, [email protected]
FR Citation		83 FR 28234

83 FR 28234 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 117 (June 18, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration