[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39438-39439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16773]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0313]
Meetings With the Office of Orphan Products Development; Guidance
for Industry, Researchers, Patient Groups, and Food and Drug
Administration Staff; 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 guidance for industry, researchers, patient groups,
and FDA staff entitled ``Meetings with the Office of Orphan Products
Development.'' This guidance provides recommendations to industry,
researchers, patient groups, and other stakeholders (collectively
referred to as ``stakeholders'') interested in requesting a meeting
with FDA's Office of Orphan Products Development (OOPD) on issues
related to orphan drug designation requests, humanitarian use device
(HUD) designation requests, rare pediatric disease designation
requests, funding opportunities through the Orphan Products Grants
Program and the Pediatric Device Consortia Grants Program, and orphan
product patient-related topics of concern. This guidance document is
intended to assist these groups with requesting, preparing, scheduling,
conducting, and documenting meetings with OOPD. This guidance finalizes
the draft guidance of the same title dated April 2014.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Orphan Products Development (OOPD), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The guidance may also be
obtained by mail by calling OOPD at 301-796-8660. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: James D. Bona, Office of Orphan
Products Development (OOPD), Food and Drug Administration, Bldg. 32,
Rm. 5204, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-
8673, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry,
researchers, patient groups, and FDA staff entitled ``Meetings with the
Office of Orphan Products Development.'' Each year, OOPD staff
participates in meetings with stakeholders who seek guidance or
clarification relating to orphan drug or HUD designation requests, OOPD
grant programs, or other rare disease issues. These meetings can be
``informal'' or ``formal'' and help build a common understanding on
FDA's thoughts on orphan products, which may include drugs, biological
products, devices, or medical foods for a rare disease or condition.
These meetings may represent critical points in the orphan product
development process and may even have an impact on the eventual
availability of products for patients with rare diseases and
conditions. It is important that these meetings be scheduled within a
reasonable time, conducted effectively, and documented where
appropriate. This guidance is intended to provide consistent procedures
to promote well-managed meetings between OOPD and stakeholders.
Topics addressed in this guidance include: (1) Clarification of
what constitutes an ``informal'' or ``formal'' meeting, (2) program
areas within OOPD that may be affected by this draft guidance, (3)
procedures for requesting and scheduling meetings with OOPD, (4)
description of what constitutes a meeting package, and (5) procedures
for the conduct and documentation of meetings with OOPD.
In the Federal Register of April 9, 2014 (79 FR 19623), FDA issued,
for public comment, ``Draft Guidance for Industry, Researchers, Patient
Groups, and Food and Drug Administration Staff on Meetings with the
Office of Orphan Products Development.'' The Agency issued this draft
guidance to assist stakeholders with requesting, preparing, scheduling,
conducting, and documenting meetings with OOPD. In particular, the
draft guidance provided clarification on what constitutes an
``informal'' or ``formal'' meeting, program areas within OOPD that may
be affected by the guidance, procedures for requesting and scheduling
meetings with OOPD, description of what constitutes a meeting package,
and procedures for the conduct and documentation of meetings.
We received several comments on the draft guidance. Most comments
appreciated the clarification and explanation provided by the draft
guidance. Some comments made recommendations to improve clarity.
FDA is issuing the draft guidance in final form with minor
revisions to improve clarity. This guidance is being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). The
guidance represents the
[[Page 39439]]
Agency's current thinking on meetings with OOPD. 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. Paperwork Reduction Act of 1995
This guidance contains information collection provisions 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 in this guidance were approved under OMB
control numbers 0910-0167, 0910-0332, and 0910-0787.
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
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or at http://www.regulations.gov.
Dated: July 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16773 Filed 7-8-15; 8:45 am]
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