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)

Page Range		39438-39439
FR Document		2015-16773

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 This guidance finalizes the draft guidance of the same title dated April 2014.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 Issue 131 (Thursday, July 9, 2015)

[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.

-----------------------------------------------------------------------

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

39438 Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)

General Population of Internet Users ............. Screening and Consent Questionnaire .......... 50,000 1 2/60
Eligible participants, ages 18 and older in the Digital Media and Tobacco Outcomes Ques- 5,000 1 20/60
U.S. tionnaire (Wave 1).
Digital Media and Tobacco Outcomes Ques- 2,400 1 20/60
tionnaire (Wave 2).

Total

Leroy A. Richardson, DATES: Submit either electronic or availability of products for patients with
Chief, Information Collection Review Office, written comments on Agency guidances rare diseases and conditions. It is
Office of Scientific Integrity, Office of the at any time. important that these meetings be
Associate Director for Science, Office of the ADDRESSES: Submit written requests for scheduled within a reasonable time,
Director, Centers for Disease Control and conducted effectively, and documented
Prevention.
single copies of the guidance to the
Office of Orphan Products Development where appropriate. This guidance is
[FR Doc. 2015–16772 Filed 7–8–15; 8:45 am] intended to provide consistent
(OOPD), Food and Drug Administration,
BILLING CODE 4163–18–P
10903 New Hampshire Ave., Bldg. 32, procedures to promote well-managed
Rm. 5295, Silver Spring, MD 20993– meetings between OOPD and
0002. Send one self-addressed adhesive stakeholders.
DEPARTMENT OF HEALTH AND Topics addressed in this guidance
label to assist the office in processing
HUMAN SERVICES include: (1) Clarification of what
your requests. The guidance may also be
obtained by mail by calling OOPD at constitutes an ‘‘informal’’ or ‘‘formal’’
Food and Drug Administration meeting, (2) program areas within OOPD
301–796–8660. See the SUPPLEMENTARY
INFORMATION section for electronic
that may be affected by this draft
[Docket No. FDA–2014–D–0313] guidance, (3) procedures for requesting
access to the guidance document.
Submit electronic comments on the and scheduling meetings with OOPD,
Meetings With the Office of Orphan (4) description of what constitutes a
Products Development; Guidance for guidance to http://www.regulations.gov.
Submit written comments on the meeting package, and (5) procedures for
Industry, Researchers, Patient Groups, the conduct and documentation of
and Food and Drug Administration guidance to the Division of Dockets
Management (HFA–305), Food and Drug meetings with OOPD.
Staff; Availability In the Federal Register of April 9,
Administration, 5630 Fishers Lane, Rm.
2014 (79 FR 19623), FDA issued, for
AGENCY: Food and Drug Administration, 1061, Rockville, MD 20852.
public comment, ‘‘Draft Guidance for
HHS. FOR FURTHER INFORMATION CONTACT: Industry, Researchers, Patient Groups,
ACTION: Notice. James D. Bona, Office of Orphan and Food and Drug Administration Staff
Products Development (OOPD), Food on Meetings with the Office of Orphan
SUMMARY: The Food and Drug and Drug Administration, Bldg. 32, Rm. Products Development.’’ The Agency
Administration (FDA) is announcing the 5204, 10903 New Hampshire Ave., issued this draft guidance to assist
availability of a guidance for industry, Silver Spring, MD 20993, 301–796– stakeholders with requesting, preparing,
researchers, patient groups, and FDA 8673, email: james.bona@fda.hhs.gov. scheduling, conducting, and
staff entitled ‘‘Meetings with the Office SUPPLEMENTARY INFORMATION: documenting meetings with OOPD. In
of Orphan Products Development.’’ This particular, the draft guidance provided
guidance provides recommendations to I. Background
clarification on what constitutes an
industry, researchers, patient groups, FDA is announcing the availability of ‘‘informal’’ or ‘‘formal’’ meeting,
and other stakeholders (collectively a guidance for industry, researchers, program areas within OOPD that may be
referred to as ‘‘stakeholders’’) interested patient groups, and FDA staff entitled affected by the guidance, procedures for
in requesting a meeting with FDA’s ‘‘Meetings with the Office of Orphan requesting and scheduling meetings
Office of Orphan Products Development Products Development.’’ Each year, with OOPD, description of what
(OOPD) on issues related to orphan drug OOPD staff participates in meetings constitutes a meeting package, and
designation requests, humanitarian use with stakeholders who seek guidance or procedures for the conduct and
device (HUD) designation requests, rare clarification relating to orphan drug or documentation of meetings.
pediatric disease designation requests, HUD designation requests, OOPD grant We received several comments on the
funding opportunities through the programs, or other rare disease issues. draft guidance. Most comments
Orphan Products Grants Program and These meetings can be ‘‘informal’’ or appreciated the clarification and
the Pediatric Device Consortia Grants ‘‘formal’’ and help build a common explanation provided by the draft
Program, and orphan product patient- understanding on FDA’s thoughts on guidance. Some comments made
srobinson on DSK5SPTVN1PROD with NOTICES

related topics of concern. This guidance orphan products, which may include recommendations to improve clarity.
document is intended to assist these drugs, biological products, devices, or FDA is issuing the draft guidance in
groups with requesting, preparing, medical foods for a rare disease or final form with minor revisions to
scheduling, conducting, and condition. These meetings may improve clarity. This guidance is being
documenting meetings with OOPD. This represent critical points in the orphan issued consistent with FDA’s good
guidance finalizes the draft guidance of product development process and may guidance practices regulation (21 CFR
the same title dated April 2014. even have an impact on the eventual 10.115). The guidance represents the

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Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices 39439

Agency’s current thinking on meetings pending drug product application. FDA misbranded in that they did not bear
with OOPD. It does not create or confer bases this order on a finding that Ms. adequate directions for use and were not
any rights for or on any person and does Durr was convicted of a felony under subject to an exemption from that
not operate to bind FDA or the public. Federal law for conduct relating to the requirement, and they were
An alternative approach may be used if regulation of a drug product. Ms. Durr accompanied by non-FDA approved
such approach satisfies the was given notice of the proposed packaging and inserts.
requirements of the applicable statutes permanent debarment and an Between August 2012 and August
and regulations. opportunity to request a hearing within 2013, Ms. Durr admitted to selling more
the timeframe prescribed by regulation. than $699,000 in misbranded drugs and
II. Paperwork Reduction Act of 1995
Ms. Durr failed to request a hearing. Ms. devices to doctors and medical practices
This guidance contains information Durr’s failure to request a hearing in Massachusetts and Connecticut. She
collection provisions that are subject to constitutes a waiver of her right to a further admitted that the loss amount
review by the Office of Management and hearing concerning this action. attributable to her personal sales, under
Budget (OMB) under the Paperwork DATES: This order is effective July 9, U.S. Sentencing Guidelines, was
Reduction Act of 1995 (44 U.S.C. 3501– 2015. between $400,000 and $1,000,000.
3520). The collections of information in Between October 2010 and August
ADDRESSES: Submit applications for
this guidance were approved under 2013, Ms. Durr personally sold
OMB control numbers 0910–0167, termination of debarment to the
Division of Dockets Management (HFA– misbranded drugs to 33 distinct doctors
0910–0332, and 0910–0787. and medical practices, and generated
305), Food and Drug Administration,
III. Comments 5630 Fishers Lane, Rm. 1061, Rockville, more than $2.6 million in illegal
MD 20852. proceeds from these sales. She admitted
Interested persons may submit either
FOR FURTHER INFORMATION CONTACT:
that, as of August 2012, she became
electronic comments regarding this
Kenny Shade, Division of Enforcement, willfully blind to the illegality of
document to http://www.regulations.gov
Office of Enforcement and Import Gallant Pharma’s business. Nonetheless,
or written comments to the Division of
Operations, Office of Regulatory Affairs, she continued her sales activity with
Dockets Management (see ADDRESSES). It
Food and Drug Administration, 12420 Gallant Pharma until her arrest in
is only necessary to send one set of
Parklawn Dr. (ELEM–4144), Rockville, August 2013.
comments. Identify comments with the
docket number found in brackets in the MD 20857, 301–796–4640. As a result of her conviction, on
heading of this document. Received SUPPLEMENTARY INFORMATION:
March 9, 2015, FDA sent Ms. Durr a
comments may be seen in the Division notice by certified mail proposing to
I. Background permanently debar her from providing
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and Section 306(a)(2)(B) of the FD&C Act services in any capacity to a person that
will be posted to the docket at http:// (21 U.S.C. 335a(a)(2)(B)) requires has an approved or pending drug
www.regulations.gov. debarment of an individual if FDA finds product application. The proposal was
that the individual has been convicted based on the finding, under section
IV. Electronic Access of a felony under Federal law for 306(a)(2)(B) of the FD&C Act, that Ms.
Persons with access to the Internet conduct relating to the regulation of any Durr was convicted of a felony under
may obtain the document at either drug product under the FD&C Act. Federal law for conduct related to the
http://www.fda.gov/ On April 2, 2014, the U.S. District regulation of a drug product. FDA
RegulatoryInformation/Guidances/ Court for the Eastern District of Virginia determined that Ms. Durr’s felony
default.htm or at http:// entered judgment against Ms. Durr for conviction was related to the regulation
www.regulations.gov. one count of introducing misbranded of drug products because the conduct
drugs into interstate commerce with underlying her conviction undermined
Dated: July 2, 2015.
intent to defraud or mislead, in FDA’s regulatory oversight over drug
Leslie Kux, products marketed in the United States
violation of sections 301(a) and
Associate Commissioner for Policy. by intentionally introducing into
303(a)(2) of the FD&C Act (21 U.S.C.
[FR Doc. 2015–16773 Filed 7–8–15; 8:45 am] interstate commerce drug products that
331(a) and 333(a)(2)).
BILLING CODE 4164–01–P FDA’s finding that debarment is did not bear adequate directions for use
appropriate is based on the felony and were not subject to an exemption
conviction referenced herein. The from that requirement, and which,
DEPARTMENT OF HEALTH AND factual basis for this conviction is as among other things, were accompanied
HUMAN SERVICES follows: Ms. Durr was a sales by non-FDA approved packaging and
representative for Gallant Pharma inserts. The proposal also offered Ms.
Food and Drug Administration
International Inc. (Gallant Pharma) Durr an opportunity to request a
[Docket No. FDA–2014–N–2100] between October 2010 and August 2013, hearing, providing her 30 days from the
and was responsible for selling date of receipt of the letter in which to
Patricia Durr: Debarment Order injectable cosmetic drugs and devices, file the request, and advised her that
AGENCY: Food and Drug Administration, and intravenous chemotherapy drugs, to failure to request a hearing constituted
HHS. doctors and hospitals in Massachusetts a waiver of the opportunity for a hearing
ACTION: Notice. and Connecticut. Some of the drugs Ms. and of any contentions concerning this
Durr facilitated the sale of were action. The proposal was received on
srobinson on DSK5SPTVN1PROD with NOTICES

SUMMARY: The U.S. Food and Drug misbranded within the meaning of the March 24, 2015. Ms. Durr failed to
Administration (FDA) is issuing an FD&C Act. respond within the timeframe
order under the Federal Food, Drug, and Ms. Durr admitted that she sold drugs prescribed by regulation and has,
Cosmetic Act (the FD&C Act) which were not approved by the FDA therefore, waived her opportunity for a
permanently debarring Patricia Durr for use on patients in the United States. hearing and has waived any contentions
from providing services in any capacity She further admitted that the drugs she concerning her debarment (21 CFR part
to a person that has an approved or sold on behalf of Gallant Pharma were 12).

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Document Created: 2018-02-23 09:13:55
Document Modified: 2018-02-23 09:13:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on Agency guidances at any time.
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]
FR Citation		80 FR 39438

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration