[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60913-60915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0247]


Agency Information Collection Activities; Proposed Collection; 
Submission for Office of Management and Budget Review; Guidance for 
Industry on Formal Meetings With Sponsors and Applicants for 
Prescription Drug User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 9, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2012-N-0247 for ``Agency Information Collection Activities; 
Proposed Collection; Submission for Office of Management and Budget 
Review; Guidance for Industry on Formal Meetings With Sponsors and 
Applicants for PDUFA Products.''
    Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
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

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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 http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    To ensure that comments on the information collection are received, 
OMB recommends that written comments be faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 
202-395-7285, or emailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0429.

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 With Sponsors and Applicants 
for PDUFA Products--OMB Control Number 0910-0429--Extension

    This information collection approval request is for FDA guidance on 
the procedures for formal meetings between FDA and sponsors or 
applicants regarding the development and review of PDUFA products. The 
guidance describes procedures for requesting, scheduling, conducting, 
and documenting such formal meetings. The guidance provides information 
on how the Agency will interpret and apply section 119(a) of the Food 
and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115), 
specific PDUFA goals for the management of meetings associated with the 
review of human drug applications for PDUFA products, and provisions of 
existing regulations describing certain meetings (Sec. Sec.  312.47 and 
312.82 (21 CFR 312.47 and 312.82)).
    The guidance describes two collections of information: The 
submission of a meeting request containing certain information and the 
submission of an information package in advance of the formal meeting. 
Agency regulations at Sec. Sec.  312.47(b)(1)(ii), (1)(iv), and (2) 
describe information that should be submitted in support of a request 
for an end-of-phase 2 meeting and a pre-NDA meeting. The information 
collection provisions of Sec.  312.47 have been approved by OMB control 
number 0910-0014. However, the guidance provides additional 
recommendations for submitting information to FDA in support of a 
meeting request. As a result, FDA is submitting additional estimates 
for OMB approval.

I. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting 
with the Center for Drug Evaluation and Research (CDER) or the Center 
for Biologics Evaluation and Research (CBER) should submit a meeting 
request to the appropriate FDA component as an amendment to the 
underlying application. FDA regulations (Sec. Sec.  312.23, 314.50, and 
601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information 
provided to the Agency as part of an investigational new drug 
application (IND), new drug application (NDA), or biological license 
application (BLA) must be submitted with an appropriate cover form. 
Form FDA 1571 must accompany submissions under INDs and Form FDA 356h 
must accompany submissions under NDAs and BLAs. Both forms have valid 
OMB control numbers as follows: Form FDA 1571--OMB control number 0910-
0014 and Form FDA 356h--OMB control number 0910-0338.
    In the guidance document, CDER and CBER ask that a request for a 
formal meeting be submitted as an amendment to the application for the 
underlying product under the requirements of Sec. Sec.  312.23, 314.50, 
and 601.2; therefore, requests should be submitted to the Agency with 
the appropriate form attached, either Form FDA 1571 or Form FDA 356h. 
The Agency recommends that a request be submitted in this manner for 
two reasons: (1) To ensure that each request is kept in the 
administrative file with the entire underlying application, and (2) to 
ensure that pertinent information about the request is entered into the 
appropriate tracking databases. Use of the information in the Agency's 
tracking databases enables the Agency to monitor progress on the 
activities attendant to scheduling and holding a formal meeting and to 
ensure that appropriate steps will be taken in a timely manner.
    Under the guidance, the Agency requests that sponsors and 
applicants include in meeting requests certain information about the 
proposed meeting. Such information includes:
     Information identifying and describing the product;
     the type of meeting being requested;
     a brief statement of the purpose of the meeting;
     a list of objectives and expected outcomes from the 
meeting;
     a preliminary proposed agenda;
     a draft list of questions to be raised at the meeting;
     a list of individuals who will represent the sponsor or 
applicant at the meeting;
     a list of Agency staff requested to be in attendance;
     the approximate date that the information package will be 
sent to the Agency; and
     suggested dates and times for the meeting.
    This information will be used by the Agency to determine the 
utility of the meeting, to identify Agency staff necessary to discuss 
proposed agenda items, and to schedule the meeting.

II. Information Package

    A sponsor or applicant submitting an information package to the 
Agency in advance of a formal meeting should provide summary 
information relevant to the product and supplementary information 
pertaining to any issue raised by the sponsor, applicant, or Agency. 
The Agency recommends that information packages generally include:
     Identifying information about the underlying product;
     a brief statement of the purpose of the meeting;
     a list of objectives and expected outcomes of the meeting;
     a proposed agenda for the meeting;
     a list of specific questions to be addressed at the 
meeting;
     a summary of clinical data that will be discussed (as 
appropriate);

[[Page 60915]]

     a summary of preclinical data that will be discussed (as 
appropriate); and
     chemistry, manufacturing, and controls information that 
may be discussed (as appropriate).
    The purpose of the information package is to provide Agency staff 
the opportunity to adequately prepare for the meeting, including the 
review of relevant data concerning the product. Although FDA reviews 
similar information in the meeting request, the information package 
should provide updated data that reflect the most current and accurate 
information available to the sponsor or applicant. The Agency finds 
that reviewing such information is critical to achieving a productive 
meeting.
    The collection of information described in the guidance reflects 
the current and past practice of sponsors and applicants to submit 
meeting requests as amendments to INDs, NDAs, and BLAs and to submit 
background information prior to a scheduled meeting. Agency regulations 
currently permit such requests and recommend the submission of an 
information package before an end-of-phase 2 meeting (Sec. Sec.  
312.47(b)(1)(ii) and (iv)) and a pre-NDA meeting (Sec.  312.47(b)(2)).
    Description of Respondents: A sponsor or applicant for a drug or 
biological product who requests a formal meeting with the Agency 
regarding the development and review of a PDUFA product.
    Burden Estimate: Provided in this document is an estimate of the 
annual reporting burden for the submission of meeting requests and 
information packages under the guidance.

III. Request for a Formal Meeting

    Based on data collected from the review divisions and offices 
within CDER and CBER, FDA estimates that approximately 1,099 sponsors 
and applicants (respondents) request approximately 2,366 formal 
meetings with CDER annually and approximately 175 respondents request 
approximately 264 formal meetings with CBER annually regarding the 
development and review of a PDUFA product. 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 10 
hours. Based on FDA's experience, the Agency expects 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.

IV. Information Package

    Based on data collected from the review divisions and offices 
within CDER and CBER, FDA estimates that approximately 959 respondents 
submitted approximately 1,901 information packages to CDER annually and 
approximately 142 respondents submitted approximately 193 information 
packages to CBER annually prior to a formal meeting regarding the 
development and review of a PDUFA product. 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 18 hours. Based on FDA's experience, the 
Agency expects 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 the 
Agency.
    In the Federal Register of May 20, 2015 (80 FR 29010), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    As stated earlier, the guidance provides information on how the 
Agency will interpret and apply section 119(a) of FDAMA, specific PDUFA 
goals for the management of meetings associated with the review of 
human drug applications for PDUFA products, and provisions of existing 
regulations describing certain meetings (Sec. Sec.  312.47 and 312.82). 
The information collection provisions in Sec.  312.47 concerning end-
of-phase 2 meetings and pre-NDA meetings have been approved by OMB 
control number 0910-0014. However, the guidance provides additional 
recommendations for submitting information to FDA in support of a 
meeting request. As a result, FDA is submitting for OMB approval these 
additional estimates.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
Meeting requests and information     Number of     responses per   Total annual   Average burden    Total hours
            packages                respondents     respondent       responses     per response
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Meeting Requests:
    CDER........................           1,099            2.15           2,366              10          23,660
    CBER........................             175            1.51             264              10           2,640
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        Total...................  ..............  ..............  ..............  ..............          26,300
Information Packages:
    CDER........................             959            1.99           1,901              18          34,218
    CBER........................             142            1.36             193              18           3,474
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        Total...................  ..............  ..............  ..............  ..............          37,692
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            Grand Total.........  ..............  ..............  ..............  ..............          63,992
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25624 Filed 10-7-15; 8:45 am]
 BILLING CODE 4164-01-P