80 FR 32157 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on 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 80, Issue 108 (June 5, 2015)

Page Range		32157-32160
FR Document		2015-13695
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 (the PRA).
Federal Register, Volume 80 Issue 108 (Friday, June 5, 2015)
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32157-32160]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13695]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on 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) 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 (the PRA).

DATES: Fax written comments on the collection of information by July 6, 
2015.

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 title. Also include the FDA 
docket number found in brackets in the heading of this document.

[[Page 32158]]


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 Formal Meetings Between FDA and Biosimilar 
Biological Product Sponsors or Applicants OMB Control Number 0910--NEW

    In the Federal Register of April 1, 2013 (78 FR 19492), FDA 
announced the availability of a draft guidance for industry entitled 
``Formal Meetings Between FDA and Biosimilar Biological Product 
Sponsors or Applicants.'' The guidance provided 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) and the Center for Biologics Evaluation and Research (CBER). 
This guidance assists sponsors and applicants in generating and 
submitting a meeting request and the associated meeting package to FDA 
for biosimilar biological products.
    The Biologics Price Competition and Innovation Act of 2009 amended 
the Public Health Service (PHS) Act and other statutes to create an 
abbreviated licensure pathway in section 351(k) of the PHS Act (42 
U.S.C. 262(k)) for biological products shown to be biosimilar to, or 
interchangeable with, an FDA-licensed biological product (see sections 
7001 through 7003 of the Patient Protection and Affordable Care Act 
(Pub. L. 111-148)). The Biosimilar User Fee Act of 2012 (BsUFA), 
enacted as part of the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 11 2-144), amended the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to authorize a new user fee program for 
biosimilar biological products. FDA has committed to meeting certain 
performance goals in connection with the new user fee program. The 
performance goals, which are set forth in a letter from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, include meeting management goals for formal meetings 
that occur between FDA and sponsors or applicants during the 
development phase of a biosimilar biological product. This guidance 
described the Agency's current thinking on how it intends to interpret 
and apply certain provisions of BsUFA, and also provides information on 
specific performance goals for the management of meetings associated 
with the development and review of biosimilar biological products.
    The guidance reflects a unified approach to all formal meetings 
between sponsors or applicants and FDA for biosimilar biological 
product development (BPD) programs. It is intended to assist sponsors 
and applicants in generating and submitting a meeting request and the 
associated meeting package to FDA for biosimilar biological products. 
The guidance does not apply to new drug or abbreviated new drug 
applications under section 505 of the FD&C Act or to biologics license 
applications (BLAs) under section 351(a) of the PHS Act.
    FDA expects that review staff will participate in many meetings 
with biosimilar biological product sponsors or applicants who seek 
guidance relating to the development and review of biosimilar 
biological products. Because these meetings often will represent 
critical points in the regulatory process, it is important that there 
are efficient, consistent procedures for the timely and effective 
conduct of such meetings. The good meeting management practices in this 
guidance are intended to provide consistent procedures that will 
promote well-managed meetings and to ensure that such meetings are 
scheduled within a reasonable time, conducted efficiently, and 
documented appropriately. The following five meeting types that occur 
between sponsors or applicants and FDA staff during the biosimilar BPD 
phase are described in the guidance: (1) Biosimilar Initial Advisory 
meeting; (2) BPD Type 1 meeting; (3) BPD Type 2 meeting; (4) BPD Type 3 
meeting; and (5) BPD Type 4 meeting.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance will represent the 
Agency's current thinking on formal meetings between FDA and sponsors 
or applicants regarding biosimilar biological products. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.
    The guidance on the procedures for formal meetings between FDA and 
biosimilar biological product sponsors or applicants describes 
procedures for requesting, scheduling, conducting, and documenting such 
formal meetings.
    The guidance describes two types of collections of information: (1) 
The submission of a meeting request containing certain information and 
(2) the submission of an information package that accompanies the 
meeting request. The guidance also refers to previously approved 
collections of information found in FDA regulations. The collections of 
information for 21 CFR 312.48 have been approved under OMB control 
number 0910-0014.

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 (e.g., investigational new drug application, 
BLA) through the controlled document system. If there is no 
application, the request should be submitted 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. Before submitting any meeting request by 
fax or email when there is no application, the sponsor or applicant 
should contact the appropriate review division or the Biosimilars 
Program staff, CDER, Office of New Drugs, to determine to whom the 
request should be directed, how the request should be submitted, and 
the appropriate format for the request, and to arrange for confirmation 
of receipt of the request.
    FDA recommends that a request be submitted in this manner to 
prevent the possibility of faxed or emailed requests being overlooked 
because of the volume of emails received daily by FDA staff. Faxed or 
emailed requests should be sent during official business hours (8 a.m. 
to 4:30 p.m. EST/EDT) Monday through Friday (except Federal government 
holidays). Processing and receipt may be delayed for requests where 
confirmation of receipt has not been prearranged.
    Under the guidance, FDA requests that sponsors and applicants 
include in meeting requests certain information about the proposed 
meeting. This information includes:
    1. Product Name.
    2. Application Number (if applicable).
    3. Proposed Proper Name (or proper name if post-licensure).
    4. Structure (if applicable).
    5. Reference Product Name.
    6. Proposed Indication(s) or Context of Product Development.

[[Page 32159]]

    7. Meeting Type Being Requested (i.e., Biosimilar Initial Advisory 
meeting, BPD Type 1, 2, 3, or 4 meeting). The rationale for requesting 
the meeting type should be included.
    8. A Brief Statement of the Purpose of the Meeting. This statement 
should include a brief background of the issues underlying the agenda. 
It also can include a brief summary of completed or planned studies and 
clinical trials or data that 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 overall development plans. 
Although the statement need not provide detailed documentation of trial 
designs or completed studies and clinical trials, it should provide 
enough information to facilitate understanding of the issues, such as a 
small table that summarizes major results.
    9. A List of the Specific Objectives/Outcomes the Requester Expects 
from the Meeting.
    10. A Proposed Agenda, Including Estimated Times Needed for Each 
Agenda Item.
    11. A List of Questions, Grouped by Discipline. For each question 
there should be a brief explanation of the context and purpose of the 
question.
    12. A List of All Individuals with Their Titles and Affiliations 
Who Will Attend the Requested Meeting from the Sponsor's or Applicant'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 (e.g., morning or afternoon) for the 
Meeting Which are Within or Beyond the Appropriate Time Frame of the 
Meeting Type Being Requested.
    15. The Proposed Format of the Meeting (i.e., face-to-face meeting, 
teleconference, or videoconference).
    This information will be used by FDA to determine the utility of 
the meeting, to identify FDA staff necessary to discuss proposed agenda 
items, and to schedule the meeting.

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 information packages generally include:
    1. Product Name and Application Number (if applicable).
    2. Proposed Proper Name (or proper name if postlicensure).
    3. Structure (if applicable).
    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 Sponsor or Applicant Attendees, Affiliations, and 
Titles.
    8. A Background Section that Includes the Following:
    a. A brief history of the development program.
    b. 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. A 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.
    12. Data to Support Discussion Organized by Discipline and 
Question. The level of detail of the data should be appropriate to the 
meeting type requested and the product development stage.
    The purpose of the information 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.
    Burden Estimate: Provided below is an estimate of the annual 
reporting burden for the submission of meeting requests and information 
packages under the guidance.
    The estimated number of respondents submitting meeting requests and 
information packages is based on the current workload and development 
expectations for biosimilar biological products. The burden hour 
estimate includes any time that may be needed by sponsors or applicants 
for rescheduling and canceling meetings, for premeetings and other 
communications with FDA about the meetings, and for resolution of 
disputes about meeting minutes.
    Based on the current workload and development expectations, FDA 
estimates that approximately 15 sponsors and applicants (respondents) 
may request approximately a total of 30 formal meetings, and submit 
approximately 30 information packages, with CDER annually, and 
approximately 1 respondent may request approximately 2 formal meetings, 
and submit approximately 2 information packages, with CBER annually.
    For a meeting request, the hours per response, which is the 
estimated number of hours that a respondent would spend preparing the 
information to be submitted with a meeting request in accordance with 
the guidance, is estimated to be approximately 15 hours. Based on FDA's 
experience, we expect it will take respondents this amount of time to 
gather and copy brief statements about the product and a description of 
the purpose and details of the meeting.
    For an information package, the hours per response, which is the 
estimated number of hours that a respondent would spend preparing the 
information package in accordance with the guidance, is estimated to be 
approximately 30 hours. Based on FDA's experience, we expect it will 
take respondents this amount of time to gather and copy brief 
statements about the product, a description of the details for the 
anticipated meeting, and data and information that generally would 
already have been compiled for submission to FDA. In total, we expect 
sponsors to spend 480 hours preparing meeting requests and 960 hours 
preparing information packages each year.
    In the Federal Register of April 1, 2013 (78 FR 19492), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. None of the comments pertained to the 
information collection provisions in the draft guidance.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
 Guidance for industry on 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                        (hours)
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................              15               2              30              15             450

[[Page 32160]]

 
    CBER........................               1               2               2              15              30
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             480
----------------------------------------------------------------------------------------------------------------
Information Packages:
    CDER........................              15               2              30              30             900
    CBER........................               1               2               2              30              60
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             960
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           1,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

C. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but we are not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

    1. See http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13695 Filed 6-4-15; 8:45 am]
 BILLING CODE 4164-01-P
32158 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices

FOR FURTHER INFORMATION CONTACT: FDA sponsors or applicants during the biosimilar biological product sponsors
PRA Staff, Office of Operations, Food development phase of a biosimilar or applicants describes procedures for
and Drug Administration, 8455 biological product. This guidance requesting, scheduling, conducting, and
Colesville Rd., COLE–14526, Silver described the Agency’s current thinking documenting such formal meetings.
Spring, MD 20993–0002, PRAStaff@ on how it intends to interpret and apply The guidance describes two types of
fda.hhs.gov. certain provisions of BsUFA, and also collections of information: (1) The
SUPPLEMENTARY INFORMATION: In provides information on specific submission of a meeting request
compliance with 44 U.S.C. 3507, FDA performance goals for the management containing certain information and (2)
has submitted the following proposed of meetings associated with the the submission of an information
development and review of biosimilar package that accompanies the meeting
collection of information to OMB for
biological products. request. The guidance also refers to
review and clearance.
The guidance reflects a unified previously approved collections of
Guidance for Industry on Formal approach to all formal meetings between information found in FDA regulations.
Meetings Between FDA and Biosimilar sponsors or applicants and FDA for The collections of information for 21
Biological Product Sponsors or biosimilar biological product CFR 312.48 have been approved under
Applicants OMB Control Number development (BPD) programs. It is OMB control number 0910–0014.
0910—NEW intended to assist sponsors and
applicants in generating and submitting A. Request for a Meeting
In the Federal Register of April 1,
a meeting request and the associated Under the guidance, a sponsor or
2013 (78 FR 19492), FDA announced the
meeting package to FDA for biosimilar applicant interested in meeting with
availability of a draft guidance for
biological products. The guidance does CDER or CBER should submit a meeting
industry entitled ‘‘Formal Meetings
not apply to new drug or abbreviated request to the sponsor’s or applicant’s
Between FDA and Biosimilar Biological
new drug applications under section application (e.g., investigational new
Product Sponsors or Applicants.’’ The
505 of the FD&C Act or to biologics drug application, BLA) through the
guidance provided recommendations to
license applications (BLAs) under controlled document system. If there is
industry on formal meetings between section 351(a) of the PHS Act. no application, the request should be
FDA and sponsors or applicants relating FDA expects that review staff will submitted to either the appropriate
to the development and review of participate in many meetings with CDER division director with a copy sent
biosimilar biological products regulated biosimilar biological product sponsors to the division’s chief of project
by the Center for Drug Evaluation and or applicants who seek guidance management staff or to the division
Research (CDER) and the Center for relating to the development and review director of the appropriate product
Biologics Evaluation and Research of biosimilar biological products. office within CBER. Before submitting
(CBER). This guidance assists sponsors Because these meetings often will any meeting request by fax or email
and applicants in generating and represent critical points in the when there is no application, the
submitting a meeting request and the regulatory process, it is important that sponsor or applicant should contact the
associated meeting package to FDA for there are efficient, consistent procedures appropriate review division or the
biosimilar biological products. for the timely and effective conduct of
The Biologics Price Competition and Biosimilars Program staff, CDER, Office
such meetings. The good meeting of New Drugs, to determine to whom the
Innovation Act of 2009 amended the management practices in this guidance
Public Health Service (PHS) Act and request should be directed, how the
are intended to provide consistent request should be submitted, and the
other statutes to create an abbreviated procedures that will promote well-
licensure pathway in section 351(k) of appropriate format for the request, and
managed meetings and to ensure that to arrange for confirmation of receipt of
the PHS Act (42 U.S.C. 262(k)) for such meetings are scheduled within a
biological products shown to be the request.
reasonable time, conducted efficiently, FDA recommends that a request be
biosimilar to, or interchangeable with, and documented appropriately. The submitted in this manner to prevent the
an FDA-licensed biological product (see following five meeting types that occur possibility of faxed or emailed requests
sections 7001 through 7003 of the between sponsors or applicants and being overlooked because of the volume
Patient Protection and Affordable Care FDA staff during the biosimilar BPD of emails received daily by FDA staff.
Act (Pub. L. 111–148)). The Biosimilar phase are described in the guidance: (1) Faxed or emailed requests should be
User Fee Act of 2012 (BsUFA), enacted Biosimilar Initial Advisory meeting; (2) sent during official business hours (8
as part of the Food and Drug BPD Type 1 meeting; (3) BPD Type 2 a.m. to 4:30 p.m. EST/EDT) Monday
Administration Safety and Innovation meeting; (4) BPD Type 3 meeting; and through Friday (except Federal
Act (Pub. L. 11 2–144), amended the (5) BPD Type 4 meeting. government holidays). Processing and
Federal Food, Drug, and Cosmetic Act This guidance is being issued receipt may be delayed for requests
(the FD&C Act) to authorize a new user consistent with FDA’s good guidance where confirmation of receipt has not
fee program for biosimilar biological practices regulation (21 CFR 10.115). been prearranged.
products. FDA has committed to The guidance will represent the Under the guidance, FDA requests
meeting certain performance goals in Agency’s current thinking on formal that sponsors and applicants include in
connection with the new user fee meetings between FDA and sponsors or meeting requests certain information
program. The performance goals, which applicants regarding biosimilar about the proposed meeting. This
are set forth in a letter from the biological products. It does not create or
asabaliauskas on DSK5VPTVN1PROD with NOTICES

information includes:
Secretary of Health and Human Services confer any rights for or on any person 1. Product Name.
to the Chairman of the Committee on and does not operate to bind FDA or the 2. Application Number (if applicable).
Health, Education, Labor, and Pensions public. An alternative approach may be 3. Proposed Proper Name (or proper
of the Senate and the Chairman of the used if such approach satisfies the name if post-licensure).
Committee on Energy and Commerce of requirements of the applicable statutes 4. Structure (if applicable).
the House of Representatives, include and regulations. 5. Reference Product Name.
meeting management goals for formal The guidance on the procedures for 6. Proposed Indication(s) or Context
meetings that occur between FDA and formal meetings between FDA and of Product Development.

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Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32159

7. Meeting Type Being Requested (i.e., meeting request. FDA recommends that products. The burden hour estimate
Biosimilar Initial Advisory meeting, information packages generally include: includes any time that may be needed
BPD Type 1, 2, 3, or 4 meeting). The 1. Product Name and Application by sponsors or applicants for
rationale for requesting the meeting type Number (if applicable). rescheduling and canceling meetings,
should be included. 2. Proposed Proper Name (or proper for premeetings and other
8. A Brief Statement of the Purpose of name if postlicensure). communications with FDA about the
the Meeting. This statement should 3. Structure (if applicable). meetings, and for resolution of disputes
include a brief background of the issues 4. Reference Product Name. about meeting minutes.
underlying the agenda. It also can 5. Proposed Indication(s) or Context Based on the current workload and
include a brief summary of completed of Product Development. development expectations, FDA
or planned studies and clinical trials or 6. Dosage Form, Route of estimates that approximately 15
data that the sponsor or applicant Administration, Dosing Regimen sponsors and applicants (respondents)
intends to discuss at the meeting, the (frequency and duration), and may request approximately a total of 30
general nature of the critical questions Presentation(s). formal meetings, and submit
to be asked, and where the meeting fits 7. A List of Sponsor or Applicant approximately 30 information packages,
in overall development plans. Although Attendees, Affiliations, and Titles. with CDER annually, and approximately
the statement need not provide detailed 8. A Background Section that Includes 1 respondent may request
documentation of trial designs or the Following: approximately 2 formal meetings, and
completed studies and clinical trials, it a. A brief history of the development submit approximately 2 information
should provide enough information to program. packages, with CBER annually.
facilitate understanding of the issues, b. The status of product development
For a meeting request, the hours per
such as a small table that summarizes (e.g., chemistry, manufacturing, and
response, which is the estimated
major results. controls; nonclinical; and clinical,
number of hours that a respondent
9. A List of the Specific Objectives/ including any development outside the
would spend preparing the information
Outcomes the Requester Expects from United States, as applicable).
to be submitted with a meeting request
the Meeting. 9. A Brief Statement Summarizing the
in accordance with the guidance, is
10. A Proposed Agenda, Including Purpose of the Meeting.
10. A Proposed Agenda. estimated to be approximately 15 hours.
Estimated Times Needed for Each Based on FDA’s experience, we expect
Agenda Item. 11. A List of Questions for Discussion
Grouped by Discipline and with a Brief it will take respondents this amount of
11. A List of Questions, Grouped by time to gather and copy brief statements
Discipline. For each question there Summary for Each Question to Explain
the Need or Context for the Question. about the product and a description of
should be a brief explanation of the the purpose and details of the meeting.
context and purpose of the question. 12. Data to Support Discussion
12. A List of All Individuals with Organized by Discipline and Question. For an information package, the hours
Their Titles and Affiliations Who Will The level of detail of the data should be per response, which is the estimated
Attend the Requested Meeting from the appropriate to the meeting type number of hours that a respondent
Sponsor’s or Applicant’s Organization requested and the product development would spend preparing the information
and Consultants. stage. package in accordance with the
13. A List of FDA Staff, if Known, or The purpose of the information guidance, is estimated to be
Disciplines, Asked to Participate in the package is to provide FDA staff the approximately 30 hours. Based on
Requested Meeting. opportunity to adequately prepare for FDA’s experience, we expect it will take
14. Suggested Dates and Times (e.g., the meeting, including the review of respondents this amount of time to
morning or afternoon) for the Meeting relevant data concerning the product. gather and copy brief statements about
Which are Within or Beyond the Description of Respondents: A the product, a description of the details
Appropriate Time Frame of the Meeting sponsor or applicant for a biosimilar for the anticipated meeting, and data
Type Being Requested. biological product who requests a and information that generally would
15. The Proposed Format of the formal meeting with FDA regarding the already have been compiled for
Meeting (i.e., face-to-face meeting, development and review of a biosimilar submission to FDA. In total, we expect
teleconference, or videoconference). biological product. sponsors to spend 480 hours preparing
This information will be used by FDA Burden Estimate: Provided below is meeting requests and 960 hours
to determine the utility of the meeting, an estimate of the annual reporting preparing information packages each
to identify FDA staff necessary to burden for the submission of meeting year.
discuss proposed agenda items, and to requests and information packages In the Federal Register of April 1,
schedule the meeting. under the guidance. 2013 (78 FR 19492), FDA published a
The estimated number of respondents 60-day notice requesting public
B. Information Package submitting meeting requests and comment on the proposed collection of
FDA requests that a sponsor or information packages is based on the information. None of the comments
applicant submit a meeting package to current workload and development pertained to the information collection
the appropriate review division with the expectations for biosimilar biological provisions in the draft guidance.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Guidance for industry on formal meetings between FDA Number of Total annual burden per Total
responses per
and biosimilar biological product sponsors or applicants respondents responses response hours
respondent (hours)

Meeting Requests:
CDER ............................................................................ 15 2 30 15 450

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32160 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Average
Number of
Guidance for industry on formal meetings between FDA Number of Total annual burden per Total
responses per
and biosimilar biological product sponsors or applicants respondents responses response hours
respondent (hours)

CBER ............................................................................ 1 2 2 15 30

Total ....................................................................... ........................ ........................ ........................ ........................ 480

Information Packages:
CDER ............................................................................ 15 2 30 30 900
CBER ............................................................................ 1 2 2 30 60

Total ....................................................................... ........................ ........................ ........................ ........................ 960

Total ....................................................................... ........................ ........................ ........................ ........................ 1,440
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

C. Reference Earliest Anticipated Start Date: Purpose
The following reference has been September 30, 2015. The purpose of this IHS grant program
placed on display in the Division of Signed Tribal Resolutions Due Date: is to combine existing resources and
Dockets Management (see ADDRESSES) August 3, 2015. infrastructure with IHS Headquarters
and may be seen by interested persons Proof of Non-Profit Status Due Date: (HQ) and IHS area resources in order to
between 9 a.m. and 4 p.m., Monday August 3, 2015. address the broad challenges and
through Friday, and is available opportunities associated with IHS
electronically at http:// I. Funding Opportunity Description preventive and clinical dental programs.
www.regulations.gov. (FDA has verified In accordance with the recently stated
Statutory Authority
the Web site address in this reference priorities of the Department of Health
section, but we are not responsible for The Indian Health Service (IHS) is and Human Services (HHS) Secretary on
any subsequent changes to the Web site accepting competitive grant applications the need to achieve ‘‘higher value’’
after this document publishes in the for the Dental Preventive and Clinical health care services, the dental support
Federal Register.) Support Centers Program. This program centers will address two priority goals:
is authorized under the authority of 25 (1) Provide support, guidance, training,
1. See http://www.fda.gov/downloads/
U.S.C. 13, Snyder Act; 42 U.S.C. 2001, and enhancement of I/T/U dental
Drugs/DevelopmentApprovalProcess/
HowDrugsareDevelopedandApproved/ Transfer Act; Indian Health Care programs within their area; and (2)
ApprovalApplications/ Improvement Act (IHCIA), amended ensure that the services of the support
TherapeuticBiologicApplications/ 2010. This program is described in the centers and the I/T/U/dental programs
Biosimilars/UCM281991.pdf. Catalog of Federal Domestic Assistance result in measurable improvements in
Dated: May 29, 2015. under 93.933. the oral health status of the American
Indian/Alaska Native (AI/AN) patients
Leslie Kux,
Background served. In order to address these two
Associate Commissioner for Policy. goals, a strong collaborative working
[FR Doc. 2015–13695 Filed 6–4–15; 8:45 am] The primary customers of a support relation with the IHS HQ Division of
BILLING CODE 4164–01–P center are IHS, Tribal, and urban dental Oral Health (DOH) and the Area Dental
programs and personnel throughout an Director or Area Dental Officer should
IHS area or broad geographic region. be maintained. In short, support centers
DEPARTMENT OF HEALTH AND The primary customers are not dental will empower the dental programs they
HUMAN SERVICES patients or Tribes. The primary function serve and impact oral health outcomes
of a support center is not the direct through the guidance and services they
Indian Health Service provision of clinical care. Well-designed provide. Improvements to oral health
support centers will impact upon must be documented.
Dental Preventive and Clinical Support patients’ oral health, and document
Centers Program; Office of Clinical and positive oral health outcomes for II. Award Information
Preventive Services, Division of Oral patients, primarily by providing
Health Type of Award
guidance to field programs and
Grant.
Announcement Type: New and addressing the assessed and perceived
Competing Continuation. needs of dental personnel and IHS/ Estimated Funds Available
Funding Announcement Number: Tribal/urban (I/T/U) dental programs. The total amount of funding
HHS–2015–IHS–TDCP–0001. Proposed programs focused at one identified for the current fiscal year (FY)
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Catalog of Federal Domestic locale or on clinical or preventive care 2015 is approximately $1,000,000.
Assistance Numbers: 93.933. alone, with no concomitant focus on a Individual award amounts are
regional or area support-oriented anticipated to be $250,000. The amount
Key Dates:
component for the dental program, of funding available for competing and
Application Deadline Date: August 3, while well-intentioned and of potential continuation awards issued under this
2015. value, are not responsive to this announcement are subject to the
Anticipated Review Dates: August 6–7, announcement or to the support center availability of appropriations and
2015. project. budgetary priorities of the Agency. The

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Document Created: 2015-12-15 15:20:02
Document Modified: 2015-12-15 15:20:02
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		Fax written comments on the collection of information by July 6, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 32157
80 FR 32157 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on 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 80, Issue 108 (June 5, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
