[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)]
[Notices]
[Pages 12822-12823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-1315 (formerly 1999-D-0296)]


Formal Meetings Between the Food and Drug Administration and 
Sponsors or Applicants of Prescription Drug User Fee Act Products; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Formal 
Meetings Between the FDA and Sponsors or Applicants of Prescription 
Drug User Fee Act (PDUFA) Products.'' This draft guidance provides 
recommendations to industry on formal meetings between FDA and sponsors 
or applicants relating to the development and review of drug or 
biological products (``products''). This draft guidance revises the 
guidance for industry entitled ``Formal Meetings Between the FDA and 
Sponsors or Applicants'' published May 19, 2009.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 9, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-
0002, or the Office of Communication, Outreach, and Development, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rachel E. Hartford, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-0319; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants 
of PDUFA Products.'' This draft guidance provides recommendations to 
industry on formal meetings between FDA and sponsors or applicants 
relating to the development and review of products regulated by the 
Center for Drug Evaluation and Research and the Center for Biologics 
Evaluation and Research. This draft guidance does not apply to 
abbreviated new drug applications, applications for biosimilar 
biological products, or submissions for medical devices. For the 
purposes of this draft guidance, ``formal meeting'' includes any 
meeting that is requested by a sponsor or applicant following the 
request procedures provided in this guidance and includes meetings 
conducted in any format (i.e., face to face, teleconference, 
videoconference, or written response).
    This draft guidance discusses the principles of good meeting 
management practices and describes standardized procedures for 
requesting, preparing for, scheduling, conducting, and documenting such 
formal meetings. The general principles in this draft guidance may be 
extended to other nonapplication-related meetings with external 
constituents, insofar as this is possible.
    This draft guidance revises the guidance for industry entitled 
``Formal Meetings Between the FDA and Sponsors or Applicants'' 
published May 19, 2009. This draft guidance is being

[[Page 12823]]

updated in accordance with the Meeting Management Goals section of the 
PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years 
2013 through 2017. Significant changes from the 2009 guidance include:

<bullet> Addition of the written response meeting format for pre-
investigational new drug application and Type C meetings
<bullet> Designation of a post-action meeting requested within 3 months 
after an FDA regulatory action other than approval as a Type A meeting
<bullet> Designation of a post-action meeting requested 3 or more 
months after an FDA regulatory action other than approval as a Type B 
meeting
<bullet> Designation of a meeting regarding risk evaluation and 
mitigation strategies or postmarketing requirements that occur outside 
the context of the review of a marketing application as a Type B 
meeting
<bullet> Inclusion of a meeting package in Type A meeting requests
<bullet> Designation of meetings to discuss the overall development 
program for products granted breakthrough therapy designation status as 
a Type B meeting

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on formal 
meetings between FDA and sponsors or applicants of PDUFA 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.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information referred to in the guidance 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants'' 
have been approved under OMB control number 0910-0429. The collections 
of information for Form FDA 1571 and end-of-phase 2 meetings have been 
approved under OMB control number 0910-0014, and collections of 
information for Form FDA 356h have been approved under OMB control 
number 0910-0338.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: March 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05523 Filed 3-10-15; 8:45 am]
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