Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs, 53257-53259 [2018-22960]
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53257
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
gear that may not be protective against
all hazards is being used by fire fighters.
Intuitively, the use conditions to
which turnout gear would be exposed to
when used by a large or medium
metropolitan fire department would be
very different than those of a smaller
department. However, the absence of
scientific data to link performance to
use conditions (e.g., number and type of
washings, number of fire-related calls)
provides a barrier to transitioning to an
alternative approach to retirement.
This study will obtain a statistically
meaningful sample of turnout gear from
three fire departments. The use
conditions for the sampled turnout gear
will be determined, and the gear will be
subjected to established performance
requirements. For each set of gear, its
performance will be directly linked to
its use condition history. This combined
lab and field data will help determine
if there is a relationship between
turnout gear use conditions and the
ability for turnout gear to effectively
protect the user.
The use conditions for each set of
sampled gear will be determined by:
(1) Reviewing fire department records,
practices, and policies;
(2) surveying the fire fighters assigned
to each set of sampled gear to obtain
one-month of retrospective information
about the use conditions to which it was
likely exposed; and
(3) a 6-month prospective data
collection where the fire fighters
assigned to each set of sampled gear
provide information about their shiftspecific exposures.
The estimated annualized Burden
Hours for this information collection is
1,050. There is no cost to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Individual Fire Fighter .............
Turnout Gear Safety Survey—Retrospective Exposures for
past month.
Turnout Gear Safety Survey—Prospective Exposures for six
months.
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
[FR Doc. 2018–22939 Filed 10–19–18; 8:45 am]
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4163–18–P
[FR Doc. 2018–22942 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2018–N–3305]
[Docket No. FDA–2018–N–3728]
Allergenic Products Advisory
Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the Allergenic
Products Advisory Committee
scheduled for November 7, 2018, is
cancelled. This meeting was announced
in the Federal Register of September 26,
2018.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6338, Silver Spring, MD 20993–0002,
240–402–5771, serina.hunter-thomas@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:12 Oct 19, 2018
Jkt 247001
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Collection of
Conflict of Interest Information for
Participation in Food and Drug
Administration Non-Employee
Fellowship and Traineeship Programs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Average
burden per
response
(in hours)
100
1
30/60
100
60
10/60
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the ‘‘Collection of
Conflict of Interest Information for
Participation in FDA Non-Employee
Fellowship and Traineeship Programs.’’
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 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 December 21,
2018]. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 21, 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
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
SUMMARY:
PO 00000
Number of
responses per
respondent
Frm 00052
Fmt 4703
Sfmt 4703
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
E:\FR\FM\22OCN1.SGM
22OCN1
53258
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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–
2018–N–3728 for ‘‘Collection of Conflict
of Interest Information for Participation
in FDA Fellowship and Traineeship
Programs.’’ 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
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
VerDate Sep<11>2014
18:12 Oct 19, 2018
Jkt 247001
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
the information will have practical
utility; (2) the accuracy of FDA’s
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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.
Collection of Conflict of Interest
Information for Participation in FDA
Non-Employee Fellowship and
Traineeship Programs; OMB Control
Number 0910—NEW
In compliance with 44 U.S.C. 3507,
FDA will submit to the Office of
Management and Budget a request to
review and approve a new collection of
information: ‘‘Collection of Conflict of
Interest Information for Participation in
FDA Non-Employee Fellowship and
Traineeship Programs.’’ Section 742 (b)
of the Food, Drug and Cosmetic Act (21
U.S.C. 379l) allows FDA to conduct and
support intramural training programs
through fellowship and traineeship
programs. These new forms provide the
FDA with information about financial
investments and relationships from nonemployee scientists who participate in
FDA fellowship and traineeship
programs. Participants in FDA
fellowship and traineeship programs
will be asked for certain information
about financial interests and current
relationships: (1) Description of the
financial interest; (2) the type of
financial interest (e.g. stocks, bonds,
stock options); (3) if the financial
interest is an employee benefit from
prior employment; (4) value of financial
interest; (5) who owns the financial
interest (e.g. self, spouse minor
children); (6) employment relationship
with an FDA significantly regulated
organization (SRO); (7) and service as a
consultant to an FDA SRO, and/or
proprietary interest(s) in one of more
product(s) regulated by FDA, including
patent, trademark, copyright, or
licensing agreement. The purpose of the
financial information is for FDA to
determine if there is a conflict of
interest between the Fellow’s or
Trainee’s financial and relationship
interests and their activities at FDA. The
collection of information is mandatory
to participate in FDA’s fellowship and
traineeship programs.
FDA estimates the burden of this
collection of information as follows:
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53259
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Collection Form—Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA
Oak Ridge Institute for Science and Education Fellowship
Traineeship Program ...........................................................
Reagan-Udall Fellowship at FDA ........................................
500
500
50
1
1
1
500
500
50
1
1
1
500
500
50
Total ..............................................................................
........................
........................
........................
........................
1,050
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 21, 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.
[FR Doc. 2018–22960 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–3916]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TECENTRIQ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TECENTRIQ and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 21, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 22, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 December 21,
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:12 Oct 19, 2018
Jkt 247001
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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–
2016–E–3916 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; TECENTRIQ.’’
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
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 § 10.20 (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
E:\FR\FM\22OCN1.SGM
22OCN1
]]>Agencies
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53257-53259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22960]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3728]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Collection of Conflict of Interest Information for
Participation in Food and Drug Administration Non-Employee Fellowship
and Traineeship Programs
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 ``Collection of Conflict of Interest
Information for Participation in FDA Non-Employee Fellowship and
Traineeship Programs.''
DATES: Submit either electronic or written comments on the collection
of information by December 21, 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 December 21, 2018]. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 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
[[Page 53258]]
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-2018-N-3728 for ``Collection of Conflict of Interest Information
for Participation in FDA Fellowship and Traineeship Programs.''
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 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,
[email protected].
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.
Collection of Conflict of Interest Information for Participation in FDA
Non-Employee Fellowship and Traineeship Programs; OMB Control Number
0910--NEW
In compliance with 44 U.S.C. 3507, FDA will submit to the Office of
Management and Budget a request to review and approve a new collection
of information: ``Collection of Conflict of Interest Information for
Participation in FDA Non-Employee Fellowship and Traineeship
Programs.'' Section 742 (b) of the Food, Drug and Cosmetic Act (21
U.S.C. 379l) allows FDA to conduct and support intramural training
programs through fellowship and traineeship programs. These new forms
provide the FDA with information about financial investments and
relationships from non-employee scientists who participate in FDA
fellowship and traineeship programs. Participants in FDA fellowship and
traineeship programs will be asked for certain information about
financial interests and current relationships: (1) Description of the
financial interest; (2) the type of financial interest (e.g. stocks,
bonds, stock options); (3) if the financial interest is an employee
benefit from prior employment; (4) value of financial interest; (5) who
owns the financial interest (e.g. self, spouse minor children); (6)
employment relationship with an FDA significantly regulated
organization (SRO); (7) and service as a consultant to an FDA SRO, and/
or proprietary interest(s) in one of more product(s) regulated by FDA,
including patent, trademark, copyright, or licensing agreement. The
purpose of the financial information is for FDA to determine if there
is a conflict of interest between the Fellow's or Trainee's financial
and relationship interests and their activities at FDA. The collection
of information is mandatory to participate in FDA's fellowship and
traineeship programs.
FDA estimates the burden of this collection of information as
follows:
[[Page 53259]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Collection Form--Report of Financial Interests and Other Relationships for Non-Employee Scientists at FDA
----------------------------------------------------------------------------------------------------------------
Oak Ridge Institute for Science 500 1 500 1 500
and Education Fellowship.......
Traineeship Program............. 500 1 500 1 500
Reagan-Udall Fellowship at FDA.. 50 1 50 1 50
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22960 Filed 10-19-18; 8:45 am]
BILLING CODE 4164-01-P
