Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development, 54357-54359 [2017-24926]
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Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
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burden estimate to include the
methodology or reasoning used to do so.
Based on our experience with the
information collection over the past 3
years, we estimate that 55 respondents
will submit 1 premarket notification
each. We estimate that extracting and
summarizing the relevant information
from what exists in the company’s files
and presenting it in a format that meets
the requirements of § 190.6 will take
approximately 20 hours of work per
notification. We have carefully
considered the burden associated with
the premarket notification requirement
and believe that estimates greater than
20 hours are likely to include burden
associated with researching and
generating safety data for a new dietary
ingredient. We also believe that the
burden of the premarket notification
requirement on industry is minimal and
reasonable because we are requesting
only safety and identity information that
the manufacturer or distributor should
already have developed to satisfy itself
that a dietary supplement containing a
new dietary ingredient is in compliance
with the FD&C Act. Under section
413(a)(2) of the FD&C Act, a dietary
supplement that contains a new dietary
ingredient is deemed to be adulterated
unless there is a history of use or other
evidence of safety establishing that the
new dietary ingredient will reasonably
be expected to be safe under the
conditions of use recommended or
suggested in the labeling of the dietary
supplement. This requirement is
separate from and additional to the
requirement to submit a premarket
notification for the new dietary
ingredient. FDA’s regulation on new
dietary ingredient notifications,
§ 190.6(a), requires the manufacturer or
distributor of the dietary supplement or
of the new dietary ingredient to submit
to FDA the information that forms the
basis for its conclusion that a dietary
supplement containing the new dietary
ingredient will reasonably be expected
to be safe. Thus, § 190.6 only requires
the manufacturer or distributor to
extract and summarize information that
should have already been developed to
meet the safety requirement in section
413(a)(2) of the FD&C Act.
Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24925 Filed 11–16–17; 8:45 am]
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Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0313]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; 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 or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the Guidance for
Industry, Researchers, Patient Groups,
and FDA Staff on Meetings with the
Office of Orphan Products
Development.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by January 16, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 16,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 16, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
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54357
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–D–0313 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry, Researchers, Patient
Groups, and Food and Drug
Administration Staff on Meetings with
the Office of Orphan Products
Development.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
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redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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,
including each proposed extension of an
existing 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
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
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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 of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry, Researchers,
Patient Groups, and Food and Drug
Administration Staff on Meetings With
the Office of Orphan Products
Development
OMB Control Number 0910–0787—
Extension
This information collection supports
Agency guidance regarding staff
meetings with the Office of Orphan
Products Development. Each year, the
Office of Orphan Products Development
(OOPD) staff participates in meetings
with stakeholders who seek guidance or
clarification relating to orphan drug or
humanitarian use device (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.
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 guidance
provides consistent procedures to
promote well-managed meetings
between OOPD and stakeholders.
Burden estimate. Table 1 of this
document provides an estimate of the
annual reporting burden associated with
the recommendation found in the
guidance.
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Request for a meeting. Based upon
information collected from OOPD
program areas, approximately 2,332
informal and 51 formal meetings were
requested with OOPD in fiscal year (FY)
2016 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 2,383 annually (2332
informal and 51 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
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 7,506 hours per
year (6,996 hours for informal meetings
and 510 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 packages. Based upon
information collected from OOPD
program areas, OOPD held
approximately 51 formal meetings in FY
2016 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 51
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
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estimated number of hours that a
stakeholder would spend preparing the
meeting package in accordance with this
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 918 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
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 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
592 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 therefore estimates the burden of
this collection of information as follows:
Program, and orphan product patientrelated issues.
Draft meeting minutes. Based upon
information collected from OOPD
program areas, OOPD received
approximately 51 draft meeting minutes
for formal meetings and 23 draft
meeting minutes for informal meetings
in FY 2016 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 74 annually. As
stated previously, it is current practice
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Meeting requests, packages and minutes
Meeting
Meeting
Meeting
Meeting
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
requests (informal) .................................................
requests (formal) ....................................................
packages ................................................................
minutes ...................................................................
2,332
51
51
74
1
1
1
1
2,332
51
51
74
3
10
18
8
6,996
510
918
592
Total ..............................................................................
........................
........................
........................
........................
9,016
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval, we have
increased our estimate by 832 hours and
229 respondents in parallel to an
increase in overall orphan drug
designation submissions and to
correspond meeting requests to the
Office of Orphan Products
Development.
Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24926 Filed 11–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2017–N–6175]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:32 Nov 16, 2017
Jkt 244001
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on FDA recalls for
human drugs, biological products,
devices, animal drugs, food, cosmetics,
and tobacco.
DATES: Submit either electronic or
written comments on the collection of
information by January 16, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 16,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 16, 2018.
SUMMARY:
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Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
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]]>Agencies
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54357-54359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24926]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0313]
Agency Information Collection Activities; Proposed Collection;
Comment Request; 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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the Guidance for Industry, Researchers,
Patient Groups, and FDA Staff on Meetings with the Office of Orphan
Products Development.
DATES: Submit either electronic or written comments on the collection
of information by January 16, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-D-0313 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry,
Researchers, Patient Groups, and Food and Drug Administration Staff on
Meetings with the Office of Orphan Products Development.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information
[[Page 54358]]
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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, including
each proposed extension of an existing 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 comments on these topics: (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 of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry, Researchers, Patient Groups, and Food and Drug
Administration Staff on Meetings With the Office of Orphan Products
Development
OMB Control Number 0910-0787--Extension
This information collection supports Agency guidance regarding
staff meetings with the Office of Orphan Products Development. Each
year, the Office of Orphan Products Development (OOPD) staff
participates in meetings with stakeholders who seek guidance or
clarification relating to orphan drug or humanitarian use device (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.
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 guidance
provides consistent procedures to promote well-managed meetings between
OOPD and stakeholders.
Burden estimate. Table 1 of this document provides an estimate of
the annual reporting burden associated with the recommendation found in
the guidance.
Request for a meeting. Based upon information collected from OOPD
program areas, approximately 2,332 informal and 51 formal meetings were
requested with OOPD in fiscal year (FY) 2016 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 2,383 annually (2332 informal and 51 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 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 7,506 hours per year (6,996 hours for informal
meetings and 510 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 packages. Based upon information collected from OOPD
program areas, OOPD held approximately 51 formal meetings in FY 2016
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
51 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
[[Page 54359]]
estimated number of hours that a stakeholder would spend preparing the
meeting package in accordance with this 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 918 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 51 draft meeting minutes for
formal meetings and 23 draft meeting minutes for informal meetings in
FY 2016 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 74 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
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 592 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 therefore estimates the burden of this collection of
information as follows:
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 respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Meeting requests (informal)..... 2,332 1 2,332 3 6,996
Meeting requests (formal)....... 51 1 51 10 510
Meeting packages................ 51 1 51 18 918
Meeting minutes................. 74 1 74 8 592
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Total....................... .............. .............. .............. .............. 9,016
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since the last OMB approval, we have increased our estimate by 832
hours and 229 respondents in parallel to an increase in overall orphan
drug designation submissions and to correspond meeting requests to the
Office of Orphan Products Development.
Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24926 Filed 11-16-17; 8:45 am]
BILLING CODE 4164-01-P
