80 FR 39438 - Meetings With the Office of Orphan Products Development; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 131 (July 9, 2015)

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 This guidance finalizes the draft guidance of the same title dated April 2014.

[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39438-39439]
From the Federal Register Online  [www.thefederalregister.org]
[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]
 BILLING CODE 4164-01-P