[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Pages 32130-32132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2434]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 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 the information collection contained in the 
guidance for industry on formal meetings with sponsors and applicants 
for Prescription Drug User Fee Act (PDUFA) products.

DATES: Submit either electronic or written comments on the collection 
of information by September 10, 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 September 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 10, 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-2018-N-2434 for ``Guidance for Industry on Formal Meetings with 
Sponsors and Applicants for PDUFA Products.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

[[Page 32131]]


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 on Formal Meetings With Sponsors and Applicants 
for Prescription Drug User Fee Act Products

OMB Control Number 0910-0429--Extension

    This information collection supports the above captioned Agency 
guidance document. The guidance document was issued to help individuals 
with procedures on 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 FDA interprets and applies section 119(a) of the Food and Drug 
Administration Modernization Act of 2007 (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.  
[thinsp]312.47 and 312.82 (21 CFR 312.47 and 312.82)). The collection 
of information described in the guidance reflects the current and past 
practice of sponsors and applicants to submit meeting requests and 
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.  
[thinsp]312.47(b)(1)(ii) and (iv)) and a ``pre-NDA meeting'' (Sec.  
[thinsp]312.47(b)(2)). While the information collection provisions of 
Sec.  [thinsp]312.47 are currently approved under OMB control number 
0910-0014, the guidance provides additional recommendations for 
submitting information to FDA in support of a meeting request. The 
guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf.
    Request for a Meeting--Consistent with recommendations found in 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 application for the 
underlying product in accordance with our regulations (Sec. Sec.  
[thinsp]312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)). 
Information provided to the Agency as part of an investigational new 
drug application (IND), NDA, or biological license application (BLA) 
must be submitted with an appropriate cover form. Form FDA 1571 must 
accompany IND submissions, and Form FDA 356h must accompany NDA and BLA 
submissions. These Agency forms are approved under OMB control numbers 
0910-0014 and 0910-0338, respectively.
    We recommend that a request be submitted in this manner to ensure 
that each request is kept in the administrative file with the complete 
application, and to ensure that pertinent information about the request 
is entered into appropriate tracking databases. Using information from 
our tracking databases enables us to monitor progress on activities 
attendant to scheduling and holding a formal meeting and to ensure that 
appropriate steps will be taken in a timely manner.
    The guidance recommends that meeting requests include the following 
information:

 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
 suggested dates and times for the meeting

    We use the information to determine the purpose of the meeting, the 
necessary participants, the proposed agenda, and to schedule the 
meeting.
    Information Package--The guidance also recommends that a sponsor or 
applicant submitting an information package provide summary information 
relevant to the product and supplementary information pertaining to any 
issue raised by the sponsor, applicant, or FDA. Information packages 
should 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)
 a summary of preclinical data that will be discussed (as 
appropriate)
 chemistry, manufacturing, and controls information that may be 
discussed (as appropriate)

    The information package enables Agency staff to prepare for the 
meeting and allows appropriate time for reviewing relevant product 
data. Although FDA reviews similar information in the meeting request, 
the information package should provide updated data reflecting the most 
current and accurate information available to the sponsor or applicant.
    We estimate the burden of the information collection as follows:

[[Page 32132]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    Guidance recommendations         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Meeting Requests:
    CDER........................           1,319            2.31           3,058              10          30,580
    CBER........................             301            1.21             363              10           3,630
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        Subtotal................  ..............  ..............  ..............  ..............          34,210
Information Packages:
    CDER........................           1,149            2.19           2,522              18          45,396
    CBER........................             187            1.12             210              18           3,780
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        Subtotal................  ..............  ..............  ..............  ..............          49,176
                                 -------------------------------------------------------------------------------
            Total...............  ..............  ..............  ..............  ..............          83,386
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase since the previous OMB approval. We attribute this 
adjustment to an increase in the number of meeting requests and 
information packages received over the last few years.
    Based on Agency data, we estimate 1,319 sponsors and applicants 
(respondents) request 3,058 formal meetings with CDER annually, and 301 
respondents request 363 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 spends 
preparing the information to be submitted with a meeting request in 
accordance with the guidance, is estimated to be 10 hours. We expect it 
takes this amount of time to gather and copy brief statements about the 
product as well as a description of the purpose and details of the 
meeting.
    Also consistent with Agency data, we estimate 1,149 respondents 
submitted 2,522 information packages to CDER annually, and 187 
respondents submitted 210 information packages to CBER annually, prior 
to a formal meeting regarding the development and review of a PDUFA 
product. We estimate 18 hours is needed to prepare the information 
package in accordance with the guidance.

    Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14800 Filed 7-10-18; 8:45 am]
 BILLING CODE 4164-01-P


