Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development, 75566-75568 [2014-29612]
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75566
Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0313]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry, Researchers, Patient Groups,
and Food and Drug Administration
Staff on Meetings With the Office of
Orphan Products Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 20,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
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. All
comments should be identified with the
OMB control number 0910–NEW and
title, ‘‘Draft Guidance for Industry,
Researchers, Patient Groups, and Food
and Drug Administration Staff on
Meetings With the Office of Orphan
Products Development.’’ Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. Draft Guidance
for Industry, Researchers, Patient
Groups, and Food and Drug
Administration Staff on Meetings With
the Office of Orphan Products
Development—(OMB Control Number
0910–NEW).
FDA is issuing a draft guidance on the
procedures for requesting meetings with
the Office of Orphan Products
Development (OOPD) on issues related
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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. 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
§ 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
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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 follow-up 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
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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices
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
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 follow-up to all
formal and certain informal meetings.
In the Federal Register of April 9,
2014 (79 FR 19623), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
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Activity
Meeting
Meeting
Meeting
Meeting
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Requests (informal) ................................................
Requests (formal) ..................................................
Packages ...............................................................
Minutes ...................................................................
2120
46
46
67
1
1
1
1
2120
46
46
67
3
10
18
8
6360
460
828
536
Total ..............................................................................
........................
........................
........................
........................
8,184
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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices
Dated: December 11, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29612 Filed 12–17–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0097]
Providing Regulatory Submissions in
Electronic Format—Standardized
Study Data; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Standardized Study Data.’’ The
guidance announced in this document
is being issued in accordance with the
Food and Drug Administration Safety
and Innovation Act (FDASIA), which
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to require
that certain submissions under the
FD&C Act and Public Health Service Act
(PHS Act) be submitted in electronic
format, beginning no earlier than 24
months after issuance of final guidance
on that topic. The guidance describes
how FDA plans to implement the
requirements for the electronic
submission of standardized study data
contained in certain submissions under
new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), biologics license applications
(BLAs), and investigational new drug
applications (INDs). This finalizes the
revised draft guidance that was issued
on February 6, 2014.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the documents to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993; or
the Office of Communication, Outreach
and Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
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SUMMARY:
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assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the documents.
Submit electronic comments on the
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.
FOR FURTHER INFORMATION CONTACT: Ron
Fitzmartin, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1192, Silver Spring,
MD 20993–0002, ronald.fitzmartin@
fda.hhs.gov; or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, Bldg.
71, rm. 7301, Silver Spring, MD 20993,
stephen.ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDASIA (Pub. L. 112–144), signed by
the President on July 9, 2012, amended
the FD&C Act to add section 745A,
entitled ‘‘Electronic Format for
Submissions.’’ Section 745A(a)(1) of the
FD&C Act requires that submissions
under section 505(b), (i), or (j) of the
FD&C Act (21 U.S.C. 355(b), (i), or (j))
and submissions under sections 351(a)
or (k) of the PHS Act (42 U.S. C. 262(a)
or (k)) be submitted to FDA in electronic
format no earlier than 24 months after
FDA issues final guidance on that topic.
In accordance with section 745A(a)(1)
of the FD&C Act, FDA is issuing this
guidance, announcing its determination
that the study data contained in the
submission types identified in this
guidance must be submitted
electronically (except for submissions
that are exempted), in a format that FDA
can process, review, and archive.
Currently, the Agency can process,
review, and archive electronic
submissions of study data that use the
standards, formats, and terminologies
specified in the Data Standards Catalog 1
posted to the FDA’s Study Data
Standards Resources Web page.
In the Federal Register of February 6,
2014 (79 FR 7201), FDA announced the
availability of the revised draft guidance
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Standardized Study Data.’’ The
comment period on the revised draft
guidance ended on May 6, 2014. We
reviewed all comments received on the
draft guidance and revised several
sections of the guidance. The updates
include:
1 Available at https://www.fda.gov/forindustry/
datastandards/studydatastandards/default.htm.
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Section II.A: (1) Clarified which INDs
and BLAs are addressed in this
guidance. Specifically, a footnote was
added to clarify the meaning of
‘‘certain’’ in the context of BLAs and
INDs and states that the guidance is not
applicable to INDs for devices that are
regulated by CBER as biological
products under section 351 of the PHS
Act and to INDs that are
noncommercial. Further, the guidance is
not applicable to those devices that are
regulated by CBER as biological
products under section 351 of the PHS
Act. Examples are provided in this
regard. (2) Clarified that both clinical
and nonclinical study data are within
the scope of the guidance.
Section II.C: (1) Clarified that the
Agency may refuse to file an NDA or
BLA or refuse to receive an ANDA
containing study data that are not in
conformance with the required
standards. (2) Clarified that both the
Clinical Data Interchange Standards
Consortium (CDISC) Study Data
Tabulation Model (SDTM) and Standard
Exchange for Nonclinical Data (SEND)
are examples of study data standards for
tabulations data. (3) Clarified that some
controlled terminologies are extensible
and permit additions to existing code
lists. It is the expectation that sponsors
or applicants will use the controlled
terminologies maintained by external
organizations as the standard.
Section II.D: Clarified the waiver
process.
Section II.E: (1) Clarified that FDA
recognizes that version updates to
standards may be released in the
interval between the start of a study and
the submission of study data to the
Agency and the Data Standards Catalog
may list more than one version of a
supported standard. (2) Specified the
definition of study start date for both
clinical and nonclinical studies. (3)
Revised terminology to more clearly
state when a particular requirement
becomes required.
This guidance implements the
electronic submission requirements of
section 745A(a) of the FD&C Act by
specifying the format for electronic
submission of study data contained in
NDA, ANDA, BLA, and IND
submissions. With the publication of
this Federal Register notice of
availability, all studies with a start
date 2 24 months or later after the
2 For purposes of this guidance, the study start
date for clinical studies is the earliest date of
informed consent among any subject that enrolled
in the study. For example, see Study Start Date (also
known as the study initiation date) in the SDTM
Trial Summary Domain (TSPARMCD = SSTDTC).
For nonclinical studies, the study start date is the
date on which the study protocol or plan is
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]]>Agencies
[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Notices]
[Pages 75566-75568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29612]
[[Page 75566]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0313]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry, Researchers, Patient Groups, and Food and Drug Administration
Staff on Meetings With the Office of Orphan Products Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
20, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, 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. All
comments should be identified with the OMB control number 0910-NEW and
title, ``Draft Guidance for Industry, Researchers, Patient Groups, and
Food and Drug Administration Staff on Meetings With the Office of
Orphan Products Development.'' Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. Draft Guidance for Industry, Researchers, Patient
Groups, and Food and Drug Administration Staff on Meetings With the
Office of Orphan Products Development--(OMB Control Number 0910-NEW).
FDA is issuing a draft guidance on the procedures for requesting
meetings with the 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. 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 follow-up 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
[[Page 75567]]
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 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 follow-up to all formal and certain
informal meetings.
In the Federal Register of April 9, 2014 (79 FR 19623), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Meeting Requests (informal)..... 2120 1 2120 3 6360
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
----------------------------------------------------------------------------------------------------------------
[[Page 75568]]
Dated: December 11, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29612 Filed 12-17-14; 8:45 am]
BILLING CODE 4164-01-P
