Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development; Availability, 19623-19626 [2014-07908]
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Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices
Systems for Over-the-Counter Use.’’
Submit either electronic or written
comments by May 7, 2014.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1601, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
ADDRESSES:
Patricia Bernhardt, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5654, Silver Spring,
MD 20993–0002, 301–796–6136.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 7,
2014 (79 FR 829), FDA published a
notice announcing the availability of the
draft guidance entitled ‘‘Self-Monitoring
Blood Glucose Test Systems for Overthe-Counter Use.’’ Interested persons
were invited to submit comments by
April 7, 2014. At this time the Agency
is extending the comment period until
May 7, 2014, to continue to receive
public comments. Comments submitted
to the docket will assist in identifying
issues to be addressed in the finalized
guidance document.
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
TKELLEY on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2014–07899 Filed 4–8–14; 8:45 am]
BILLING CODE 4160–01–P
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[Docket No. FDA–2014–D–0313]
Draft Guidance for Industry,
Researchers, Patient Groups, and
Food and Drug Administration Staff on
Meetings With the Office of Orphan
Products Development; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry, researchers, patient groups,
and FDA staff entitled ‘‘Meetings With
the Office of Orphan Products
Development.’’ This draft 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 patientrelated topics of concern. This draft
guidance document is intended to assist
these groups with requesting, preparing,
scheduling, conducting, and
documenting meetings with OOPD.
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 or proposed
collection of information by June 9,
2014.
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Office of Orphan Products
Development, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5271, Silver Spring,
MD 20993. Send one self-addressed
adhesive label to assist that office in
processing your requests. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
ADDRESSES:
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19623
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document. OMB recommends that
written comments be faxed to the Office
of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
James Bona, Office of Orphan Products
Development, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5271, Silver Spring,
MD 20993, 301–796–8660.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft 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 include drugs, biological
products, devices, or medical foods.
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.
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 meetings with OOPD. It does not
create or confer any rights for or on any
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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.
TKELLEY on DSK3SPTVN1PROD with NOTICES
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (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
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
comment on: (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 on respondents,
including through the use of automated
collection techniques and other forms of
information technology, when
appropriate.
Title: Draft Guidance for Industry,
Researchers, Patients Groups, and Food
and Drug Administration Staff on
Meetings With the Office of Orphan
Products Development.
Description: FDA is issuing a draft
guidance on the procedures for
requesting meetings with OOPD on
issues related to orphan drug
designation requests, 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 patientrelated topics of concern. The draft
guidance describes procedures for
requesting, scheduling, conducting, and
documenting such meetings.
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The draft guidance describes three
collections of information: (1) The
submission of a meeting request (for
informal and formal meetings), (2) the
submission of a meeting package (for
formal meetings), and (3) the
submission of draft meeting minutes (for
formal and certain informal meetings).
These collections of information will be
used by the Agency to schedule and
prepare for meetings on the issues
described previously in this document
and will provide for more productive
meetings with stakeholders. This draft
guidance refers to previously approved
collections of information found in FDA
regulations. Agency regulations at part
316 (21 CFR part 316) describe
information that should be submitted in
support of an orphan drug designation
request. The information collection
provisions of part 316 have been
approved under OMB control number
0910–0167. Agency regulations at
§ 814.102 (21 CFR 814.102) describe
information that should be submitted in
support of a HUD designation request.
The information collection provisions of
§ 814.102 have been approved under
OMB control number 0910–0332.
A. Request for a Meeting
Under the draft guidance, a
stakeholder interested in meeting with
OOPD should submit a meeting request:
• For specific designation requests or
grant applications, by emailing the
identified point of contact for the
designation request or grant application
with the subject heading ‘‘Meeting
Request’’; or
• For other issues, by emailing the
general OOPD inbox at orphan@
fda.hhs.gov with the subject heading
‘‘Meeting Request’’ or by emailing the
point of contact for each OOPD Program
Area listed in the ‘‘Contact FDA’’
section of the OOPD’s Web site (https://
www.fda.gov/orphan), again with the
subject heading ‘‘Meeting Request.’’ In
the draft guidance, FDA recommends
that the meeting request, at a minimum,
include (1) a brief statement of the
meeting purpose, (2) whether the
stakeholder prefers an informal or
formal meeting, (3) suggested dates and
times for the meeting, (4) preferred
format of the meeting, and (5) the email
address(es) to which OOPD should send
a response to the meeting request (if
different from the email address from
which the request was sent) and
telephone number for the primary
contact for the stakeholder. Before
scheduling a meeting, OOPD may ask
the stakeholder for more information
about the proposed meeting to help
determine whether an informal or
formal meeting is most appropriate and
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who from OOPD should attend. For
informal meetings, the information in
the meeting request may suffice,
although OOPD may ask for
supplemental information via email or
telephone.
B. Meeting Package
If a formal meeting is scheduled, FDA
recommends that stakeholders submit a
meeting package to OOPD at least 2
weeks before the meeting. Stakeholders
are encouraged to submit the package
electronically by email to the OOPD
program contact who scheduled the
meeting. In the draft guidance, FDA
recommends that the meeting package
contain the following information: (1)
The date, time, and subject of the
meeting; (2) an explanation of the
meeting purposes; (3) basic information
about the product to be discussed (e.g.,
product name or identifier, designation
or application number (if applicable),
proposed rare disease or condition, brief
background about the product); (4)
proposed meeting agenda; (5) any data,
information, or presentation materials to
support the discussion (if needed); and
(6) a list of all individuals, with their
titles and affiliations, who are expected
to participate in the meeting on behalf
of the stakeholder.
C. Draft Meeting Minutes
Under the draft guidance, a
stakeholder should prepare a draft of
summary meeting minutes for all formal
meetings and certain informal meetings.
These draft minutes should be sent to
the OOPD program contact by email
with the subject heading ‘‘Draft Meeting
Minutes.’’ The draft minutes should
summarize the meeting discussion
points, agreements, disagreements, and
action items. OOPD will review and
provide any revisions to the draft
meeting minutes via email, and the
stakeholder will then either accept the
version as final and notify OOPD to that
effect or will followup with questions
and/or further revisions.
Description of Respondents:
Individuals from industry, researchers,
patient groups, and other stakeholders
who seek a meeting with OOPD
regarding orphan drug designation
requests, 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 patientrelated issues.
Burden estimate: Table 1 of this
document provides an estimate of the
annual reporting burden for the
preparation and submission of meeting
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requests, meeting packages, and meeting
minutes under the guidance.
Request for a meeting: Based upon
information collected from OOPD
program areas, approximately 2,120
informal and 46 formal meetings were
requested with OOPD in fiscal year (FY)
2013 regarding orphan drug designation
requests, 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 patientrelated issues. FDA anticipates that the
number of meeting requests and
stakeholders will remain the same or
will only slightly increase, and therefore
estimates the total number of meeting
requests will be 2,166 annually (2120
informal and 46 formal meetings). The
hours per response, which is the
estimated number of hours that a
stakeholder would spend preparing the
information to be submitted with a
meeting request in accordance with the
draft guidance, is estimated to be
approximately 3 hours for informal
meetings and approximately 10 hours
for formal meetings. Based on FDA’s
experience, the Agency expects that it
will take stakeholders this amount of
time to gather and copy brief statements
about the product and a description of
the purpose and details of the meeting.
Therefore, the Agency estimates that
stakeholders will spend 6,820 hours per
year (6,360 hours for informal meetings
and 460 hours for formal meetings)
preparing meeting requests to OOPD
regarding orphan drug designation
requests, 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 patientrelated issues.
Meeting package: Based upon
information collected from OOPD
program areas, OOPD held
approximately 46 formal meetings in FY
2013 regarding orphan drug designation
requests, 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 patientrelated issues. FDA anticipates that the
number of formal meetings, and
therefore meeting packages, may
increase only slightly as a result of this
guidance; thus, the Agency estimates
that the total responses will be 46
annually. As stated previously, it is
current practice for stakeholders to
submit meeting packages to the Agency
in advance of any such formal meeting.
The hours per response, which is the
estimated number of hours that a
stakeholder would spend preparing the
meeting package in accordance with this
draft guidance, is estimated to be
approximately 18 hours. Based on
FDA’s experience, the Agency expects it
will take stakeholders this amount of
time to gather and copy brief statements
about the product, a description of
details for the anticipated meeting, and
data and information that generally
would already have been compiled for
submission to the Agency. Therefore,
the Agency estimates that stakeholders
will spend 828 hours per year
submitting meeting packages to the
Agency prior to a formal meeting
regarding orphan drug designation
requests, 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 patientrelated issues.
Draft meeting minutes: Based upon
information collected from OOPD
program areas, OOPD received
approximately 46 draft meeting minutes
for formal meetings and 21 draft
meeting minutes for informal meetings
in FY 2013 regarding orphan drug
designation requests, 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 patientrelated issues. FDA anticipates that the
number of stakeholders submitting draft
meeting minutes may remain the same
or increase only slightly; thus, the
Agency estimates that the total number
of respondents will be 67 annually. As
stated previously, it is current practice
for stakeholders to submit draft meeting
minutes to the Agency after all formal
meetings and certain informal meetings.
The hours per response, which is the
estimated number of hours that a
stakeholder would spend preparing
draft meeting minutes in accordance
with this draft guidance, is estimated to
be approximately 8 hours. Based on
FDA’s experience, the Agency expects it
will take stakeholders this amount of
time to summarize the meeting
discussion points, agreements,
disagreements, and action items.
Therefore, the Agency estimates that
stakeholders will spend 536 hours per
year submitting draft meeting minutes
to the Agency documenting the meeting
outcomes, agreements, disagreements,
and action items as followup to all
formal and certain informal meetings.
FDA invites comments on this
analysis of information collection
burdens.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
stakeholders
Meeting requests, packages, and minutes
Meeting
Meeting
Meeting
Meeting
Number of
responses per
stakeholder
Total annual
responses
Average
burden per
response
Total hours
Requests (informal) ................................................
Requests (formal) ..................................................
Packages ...............................................................
Minutes ...................................................................
2,120
46
46
67
1
1
1
1
2,120
46
46
67
3
10
18
8
6,360
460
828
536
Total ..............................................................................
........................
........................
........................
........................
8,184
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
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is necessary to send only 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.
PO 00000
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and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
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IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or at https://
www.regulations.gov.
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07908 Filed 4–8–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0252]
Watson Laboratories, Inc.; Withdrawal
of Approval of Bupropion
Hydrochloride Extended-Release
Tablets, 300 Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
drug. In a letter dated September 30,
2013, Watson requested that FDA
withdraw approval of the 300-mg
strength of Bupropion HCl ER Tablets,
approved under ANDA 77–715, under
§ 314.150(d) (21 CFR 314.150(d)). In that
letter, Watson also waived its
opportunity for a hearing. The Agency
acknowledged Watson’s requests in a
letter dated October 4, 2013.
Therefore, under section 505(e) of the
FD&C Act (21 U.S.C. 355(e)) and
§ 314.150(d), and under authority
delegated by the Commissioner to the
Director, Center for Drug Evaluation and
Research, approval of the 300-mg
strength of Bupropion HCl ExtendedRelease Tablets under ANDA 77–715 is
withdrawn (see DATES). Distribution of
this product in interstate commerce
without an approved application is
illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a) and 331(d)).
Dated: April 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07897 Filed 4–8–14; 8:45 am]
Notice.
BILLING CODE 4160–01–P
The Food and Drug
Administration (FDA) is withdrawing
approval of Bupropion Hydrochloride
(HCl) Extended-Release (ER) Tablets,
300 Milligrams (mg) (Bupropion HCl ER
Tablets, 300 mg), under abbreviated new
drug application (ANDA) 77–715, held
by Watson Laboratories, Inc. (Watson),
4955 Orange Dr., Fort Lauderdale, FL
33314. Watson has voluntarily
requested that approval for this product
be withdrawn and waived its
opportunity for a hearing.
DATES: Effective April 9, 2014.
FOR FURTHER INFORMATION CONTACT:
Carolina M. Wirth, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6282,
Silver Spring, MD 20993–0002, 301–
796–3602.
SUPPLEMENTARY INFORMATION: FDA
approved ANDA 77–715 for Bupropion
HCl ER Tablets, 300 mg on June 13,
2007, under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(j)). Bupropion
HCl ER Tablets, 300 mg was indicated
for the treatment of major depressive
disorder. On September 24, 2013, FDA
requested that Watson voluntarily
withdraw its Bupropion HCl ER Tablets,
300 mg from the market after results of
a bioequivalence study conducted by
Watson showed that the firm’s
Bupropion HCl ER Tablets, 300 mg are
not therapeutically equivalent to the
300-mg strength of the reference listed
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SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Organization, Functions, and
Delegations of Authority
Part GFJ
Indian Health Service
Navajo Area Office
Part GFJ, of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (HHS), as amended at 52 FR
47053–67, December 11, 1987, as
amended at 60 FR 56606, November 9,
1995, as amended at 61 FR 67048,
December 19, 1996, as amended at 69
FR 41825, July 12, 2004, as amended at
70 FR 24087, May 6, 2005 70 FR 60350,
October 17, 2005, and most recently
amended at 71 FR 69570, December 1,
2006, is hereby amended to reflect a
reorganization of the Navajo Area Indian
Health Service (IHS). The purpose of
this re-organization proposal is to
update the current approved Navajo
Area IHS organization structure due to
the decrease in Area shares from Federal
facilities transitioning to Public Law 93–
638 Indian Self-Determination and
Education Assistance Act facilities.
Delete the functional statements for the
Navajo Area IHS in their entirety and
replace with the following:
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Organizations and Functions
Department of Health and Human
Services
Indian Health Service (G)
Navajo Area Indian Health Service (GFJ)
Office of the Area Director (GFJ1)
(1) Plans, develops and directs the
Area Program within the framework of
Indian Health Service (IHS) policy in
pursuit of the IHS mission; (2) delivers
and ensures the delivery of high quality
comprehensive health services; (3)
coordinates the IHS activities and
resources internally and externally with
those of other governmental and
nongovernmental programs; (4)
promotes optimum utilization of health
care services through management and
delivery of services to American Indians
and Alaska Natives; (5) encourages the
full application of the principles of
Indian preference and Equal
Employment Opportunity (EEO); and (6)
provides Indian Tribes and other Indian
community groups with optional ways
of participating in the Indian health
programs including an opportunity to
participate in developing the mission,
values and goals for the Navajo Area
Indian Health Service (NAIHS).
Branch of Planning (GFJ1A)
Provides advice on program planning
and evaluation activities to include:
(1) Strategic planning coordination at
the Area level, including planning,
implementing, and monitoring progress
on the achievement of the Area Strategic
Plan; (2) facilities planning, including
the development of program
justification documents, program of
requirements, quarters justifications,
and other required facilities planning
and construction documents; (3) staffing
requirements and projections for Service
Units, facilities projects, and other
needs; (4) statistical and
epidemiological reporting, analysis, and
monitoring, reporting, and including
monitoring health status, morbidity,
mortality, patient care, health services,
health systems, population,
demographic, and other health related
data for the Area, Service Units, Tribes,
States, health programs, universities,
researchers, and the general public; (5)
developing and implementing data
quality improvements and strategies; (6)
ensuring resource allocation
methodologies are current by updating
and providing technical support for
resource allocation to the Office of the
Area Director (OAD) and the Navajo
Area Management Council; (7)
providing other program planning and
health systems planning activities and
technical support to the OAD by
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]]>Agencies
[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19623-19626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07908]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0313]
Draft Guidance for Industry, Researchers, Patient Groups, and
Food and Drug Administration Staff on Meetings With the Office of
Orphan Products Development; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry, researchers, patient
groups, and FDA staff entitled ``Meetings With the Office of Orphan
Products Development.'' This draft 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 draft guidance document
is intended to assist these groups with requesting, preparing,
scheduling, conducting, and documenting meetings with OOPD.
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 or proposed collection of information by June 9, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Orphan Products Development, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5271, Silver
Spring, MD 20993. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the draft guidance
document.
Submit electronic comments on the draft guidance to https://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. Identify comments with the docket number
found in brackets in the heading of this document. OMB recommends that
written comments be faxed to the Office of Information and Regulatory
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
oira_submission@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT: James Bona, Office of Orphan Products
Development, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5271, Silver Spring, MD 20993, 301-796-8660.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft 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 include drugs, biological
products, devices, or medical foods. 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.
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 meetings
with OOPD. It does not create or confer any rights for or on any
[[Page 19624]]
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
Under the Paperwork Reduction Act of 1995 (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 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 comment on: (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 on respondents, including through the use of automated
collection techniques and other forms of information technology, when
appropriate.
Title: Draft Guidance for Industry, Researchers, Patients Groups,
and Food and Drug Administration Staff on Meetings With the Office of
Orphan Products Development.
Description: FDA is issuing a draft guidance on the procedures for
requesting meetings with OOPD on issues related to orphan drug
designation requests, 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. The draft guidance
describes procedures for requesting, scheduling, conducting, and
documenting such meetings.
The draft guidance describes three collections of information: (1)
The submission of a meeting request (for informal and formal meetings),
(2) the submission of a meeting package (for formal meetings), and (3)
the submission of draft meeting minutes (for formal and certain
informal meetings). These collections of information will be used by
the Agency to schedule and prepare for meetings on the issues described
previously in this document and will provide for more productive
meetings with stakeholders. This draft guidance refers to previously
approved collections of information found in FDA regulations. Agency
regulations at part 316 (21 CFR part 316) describe information that
should be submitted in support of an orphan drug designation request.
The information collection provisions of part 316 have been approved
under OMB control number 0910-0167. Agency regulations at Sec. 814.102
(21 CFR 814.102) describe information that should be submitted in
support of a HUD designation request. The information collection
provisions of Sec. 814.102 have been approved under OMB control number
0910-0332.
A. Request for a Meeting
Under the draft guidance, a stakeholder interested in meeting with
OOPD should submit a meeting request:
For specific designation requests or grant applications,
by emailing the identified point of contact for the designation request
or grant application with the subject heading ``Meeting Request''; or
For other issues, by emailing the general OOPD inbox at
orphan@fda.hhs.gov with the subject heading ``Meeting Request'' or by
emailing the point of contact for each OOPD Program Area listed in the
``Contact FDA'' section of the OOPD's Web site (https://www.fda.gov/orphan), again with the subject heading ``Meeting Request.'' In the
draft guidance, FDA recommends that the meeting request, at a minimum,
include (1) a brief statement of the meeting purpose, (2) whether the
stakeholder prefers an informal or formal meeting, (3) suggested dates
and times for the meeting, (4) preferred format of the meeting, and (5)
the email address(es) to which OOPD should send a response to the
meeting request (if different from the email address from which the
request was sent) and telephone number for the primary contact for the
stakeholder. Before scheduling a meeting, OOPD may ask the stakeholder
for more information about the proposed meeting to help determine
whether an informal or formal meeting is most appropriate and who from
OOPD should attend. For informal meetings, the information in the
meeting request may suffice, although OOPD may ask for supplemental
information via email or telephone.
B. Meeting Package
If a formal meeting is scheduled, FDA recommends that stakeholders
submit a meeting package to OOPD at least 2 weeks before the meeting.
Stakeholders are encouraged to submit the package electronically by
email to the OOPD program contact who scheduled the meeting. In the
draft guidance, FDA recommends that the meeting package contain the
following information: (1) The date, time, and subject of the meeting;
(2) an explanation of the meeting purposes; (3) basic information about
the product to be discussed (e.g., product name or identifier,
designation or application number (if applicable), proposed rare
disease or condition, brief background about the product); (4) proposed
meeting agenda; (5) any data, information, or presentation materials to
support the discussion (if needed); and (6) a list of all individuals,
with their titles and affiliations, who are expected to participate in
the meeting on behalf of the stakeholder.
C. Draft Meeting Minutes
Under the draft guidance, a stakeholder should prepare a draft of
summary meeting minutes for all formal meetings and certain informal
meetings. These draft minutes should be sent to the OOPD program
contact by email with the subject heading ``Draft Meeting Minutes.''
The draft minutes should summarize the meeting discussion points,
agreements, disagreements, and action items. OOPD will review and
provide any revisions to the draft meeting minutes via email, and the
stakeholder will then either accept the version as final and notify
OOPD to that effect or will followup with questions and/or further
revisions.
Description of Respondents: Individuals from industry, researchers,
patient groups, and other stakeholders who seek a meeting with OOPD
regarding orphan drug designation requests, 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 issues.
Burden estimate: Table 1 of this document provides an estimate of
the annual reporting burden for the preparation and submission of
meeting
[[Page 19625]]
requests, meeting packages, and meeting minutes under the guidance.
Request for a meeting: Based upon information collected from OOPD
program areas, approximately 2,120 informal and 46 formal meetings were
requested with OOPD in fiscal year (FY) 2013 regarding orphan drug
designation requests, 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 issues. FDA anticipates that the number
of meeting requests and stakeholders will remain the same or will only
slightly increase, and therefore estimates the total number of meeting
requests will be 2,166 annually (2120 informal and 46 formal meetings).
The hours per response, which is the estimated number of hours that a
stakeholder would spend preparing the information to be submitted with
a meeting request in accordance with the draft guidance, is estimated
to be approximately 3 hours for informal meetings and approximately 10
hours for formal meetings. Based on FDA's experience, the Agency
expects that it will take stakeholders this amount of time to gather
and copy brief statements about the product and a description of the
purpose and details of the meeting. Therefore, the Agency estimates
that stakeholders will spend 6,820 hours per year (6,360 hours for
informal meetings and 460 hours for formal meetings) preparing meeting
requests to OOPD regarding orphan drug designation requests, 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 issues.
Meeting package: Based upon information collected from OOPD program
areas, OOPD held approximately 46 formal meetings in FY 2013 regarding
orphan drug designation requests, 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 issues. FDA
anticipates that the number of formal meetings, and therefore meeting
packages, may increase only slightly as a result of this guidance;
thus, the Agency estimates that the total responses will be 46
annually. As stated previously, it is current practice for stakeholders
to submit meeting packages to the Agency in advance of any such formal
meeting. The hours per response, which is the estimated number of hours
that a stakeholder would spend preparing the meeting package in
accordance with this draft guidance, is estimated to be approximately
18 hours. Based on FDA's experience, the Agency expects it will take
stakeholders this amount of time to gather and copy brief statements
about the product, a description of details for the anticipated
meeting, and data and information that generally would already have
been compiled for submission to the Agency. Therefore, the Agency
estimates that stakeholders will spend 828 hours per year submitting
meeting packages to the Agency prior to a formal meeting regarding
orphan drug designation requests, 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 issues.
Draft meeting minutes: Based upon information collected from OOPD
program areas, OOPD received approximately 46 draft meeting minutes for
formal meetings and 21 draft meeting minutes for informal meetings in
FY 2013 regarding orphan drug designation requests, 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 issues. FDA anticipates that the number of stakeholders
submitting draft meeting minutes may remain the same or increase only
slightly; thus, the Agency estimates that the total number of
respondents will be 67 annually. As stated previously, it is current
practice for stakeholders to submit draft meeting minutes to the Agency
after all formal meetings and certain informal meetings. The hours per
response, which is the estimated number of hours that a stakeholder
would spend preparing draft meeting minutes in accordance with this
draft guidance, is estimated to be approximately 8 hours. Based on
FDA's experience, the Agency expects it will take stakeholders this
amount of time to summarize the meeting discussion points, agreements,
disagreements, and action items. Therefore, the Agency estimates that
stakeholders will spend 536 hours per year submitting draft meeting
minutes to the Agency documenting the meeting outcomes, agreements,
disagreements, and action items as followup to all formal and certain
informal meetings.
FDA invites comments on this analysis of information collection
burdens.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Meeting requests, packages, and Number of responses per Total annual burden per Total hours
minutes stakeholders stakeholder responses response
----------------------------------------------------------------------------------------------------------------
Meeting Requests (informal)..... 2,120 1 2,120 3 6,360
Meeting Requests (formal)....... 46 1 46 10 460
Meeting Packages................ 46 1 46 18 828
Meeting Minutes................. 67 1 67 8 536
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 8,184
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is necessary to send
only 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 https://www.regulations.gov.
[[Page 19626]]
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or at https://www.regulations.gov.
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07908 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P
