Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development, 8880-8881 [2018-04153]
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8880
Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
Considering all applicable factors
under 306(c)(3) of the FD&C Act, OSI
concurs with ORA’s proposal that a 5year period of debarment for each
offense is warranted. On this record,
OSI finds that the nature and
seriousness of the offenses and the
nature and extent of Meunerie
Sawyerville management’s participation
in the offenses are factors weighing
heavily in favor of debarment. For the
reasons already discussed, even
assuming Meunerie Sawyerville has
discontinued using monensin in its
operations, OSI finds that operational
change insufficient under section
306(c)(3)(D) to demonstrate correction of
the causes of these offenses and to
provide reasonable assurances that the
offenses will not recur. Further, even
after taking into account Meunerie
Sawyerville’s guilty plea under section
306(c)(3)(C), OSI finds that Meunerie
Sawyerville’s conduct related to this
consideration weighs in favor of
debarment. Although Meunerie
Sawyerville’s lack of a prior conviction
under 306(c)(3)(F) is a factor weighing
against debarment, this consideration is
substantially outweighed by the nature
and seriousness of the offenses, the
nature and extent of management’s
participation in the offenses, and the
nature and extent of voluntary steps to
mitigate the impact of the offenses on
the public. Therefore, considering all of
these factors together and the record as
a whole, OSI finds that a 5-year period
of debarment is warranted for each
offense.
Therefore, the Director of OSI, under
section 306(b)(3)(A) of the FD&C Act
and under authority delegated to him by
the Commissioner of Food and Drugs,
finds that Meunerie Sawyerville has
been convicted of a felony for conduct
relating to the importation of food into
the United States. FDA has considered
the relevant factors listed in section
306(c)(3) of the FD&C Act and
determined that a debarment of 5 years
is appropriate for each of these felony
offenses. These periods will run
concurrently under section 306(c)(2)(A).
As a result of the foregoing findings,
Meunerie Sawyerville is debarred for a
period of 5 years from importing articles
of food or offering such articles for
import into the United States,
applicable (see DATES). Under section
301(cc) of the FD&C Act, the importing
or offering for import into the United
States of an article of food by, with the
assistance of, or at the direction of
Meunerie Sawyerville is a prohibited
act.
VerDate Sep<11>2014
17:26 Feb 28, 2018
Jkt 244001
Dated: February 26, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018–04195 Filed 2–28–18; 8:45 am]
BILLING CODE 4164–01–P
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; 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.
SUMMARY:
Fax written comments on the
collection of information by April 2,
2018.
DATES:
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 0910–0787. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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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 (OOPD). Each
year, the 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 provides an
estimate of the annual reporting burden
associated with the recommendations
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 patientrelated issues. FDA anticipates that the
number of meeting requests and
stakeholders will remain the same or
will slightly increase and therefore
estimates the total number of meeting
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01MRN1
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Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
requests will be 2,383 annually (2,332
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, will remain
the same; 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
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 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 will likely remain the
same; 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 the
recommendations of the 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.
In the Federal Register of November
17, 2017 (82 FR 54357), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA therefore estimates the burden of
this collection of information as follows:
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.
amozie on DSK30RV082PROD with NOTICES
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 the
corresponding meeting requests to the
OOPD.
Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04153 Filed 2–28–18; 8:45 am]
BILLING CODE 4164–01–P
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17:26 Feb 28, 2018
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01MRN1
]]>Agencies
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8880-8881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04153]
-----------------------------------------------------------------------
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; 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 April
2, 2018.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0787.
Also include the FDA docket number found in brackets in the heading of
this document.
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,
[email protected].
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.
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 (OOPD).
Each year, the 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 provides an estimate of the annual
reporting burden associated with the recommendations 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
slightly increase and therefore estimates the total number of meeting
[[Page 8881]]
requests will be 2,383 annually (2,332 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, will remain the same; 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 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 will likely remain the same; 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 the recommendations of the
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.
In the Federal Register of November 17, 2017 (82 FR 54357), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA therefore estimates the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Meeting requests, packages and Number of responses per Total annual Average burden Total hours
minutes respondents respondent responses per 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
-------------------------------------------------------------------------------
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 the corresponding meeting requests to
the OOPD.
Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04153 Filed 2-28-18; 8:45 am]
BILLING CODE 4164-01-P
