Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows, 50145-50147 [2017-23515]
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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Sergio de del Castillo, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1538,
Silver Spring, MD 20993–0002, 301–
796–6419; and Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
301–240–402–7911.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
The automatic class III designation for
devices of a new type occurs by
operation of law and without any action
by FDA, regardless of the level of risk
posed. Any device that is of a new type
that was not in commercial distribution
before May 28, 1976, is automatically
classified as, and remains within, class
III and requires premarket approval
unless and until FDA takes an action to
classify or reclassify the device section
513(f)(1) of the FD&C Act (21 U.S.C.
360c(f)(1)). We refer to these devices as
‘‘postamendments devices’’ because
they were not in commercial
distribution prior to the date of
enactment of the Medical Device
Amendments of 1976.
FDA may classify a device through
the De Novo classification process,
which is the pathway authorized under
section 513(f)(2) of the FD&C Act (21
U.S.C. 360c(f)(2)). A person may submit
a De Novo request after submitting a
premarket notification under section
510(k) of the FD&C Act and receiving a
not substantially equivalent (NSE)
determination (section 513(f)(2)(A)(i) of
the FD&C Act). A person may also
submit a De Novo request without first
submitting a premarket notification
under section 510(k), if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence (section 513(f)(2)(A)(ii) of
the FD&C Act).
Upon receipt of a De Novo request,
FDA is required to classify the device by
written order (section 513(f)(2)(A)(iii) of
the FD&C Act). The classification will
be according to the criteria under
section 513(a)(1) of the FD&C Act (21
U.S.C. 360c(a)(1)). Per section
513(f)(2)(B)(i) of the FD&C Act, the
classification is the initial classification
of the device for the purposes of section
513(f)(1) of the FD&C Act.
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We believe De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo classification process, the
device can serve as a predicate for
future devices of that type, including for
510(k)s (section 513(f)(2)(B)(i)). As a
result, other device sponsors do not
have to submit a De Novo request or
PMA in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i),
defining ‘‘substantial equivalence’’).
Instead, sponsors can use the lessburdensome 510(k) process, when
applicable, as a pathway to market their
device.
FDA is issuing this document to
provide guidance on the process for the
submission and review of a De Novo
request under section 513(f)(2) of the
FD&C Act, also known as the De Novo
classification process. This guidance
also provides updated recommendations
for interactions with FDA related to the
De Novo classification process,
including what information to submit
when seeking a path to market via the
De Novo classification process. This
guidance will provide clarity regarding
the Agency’s review process and
expectations for information to be
submitted in a De Novo request and
ensures predictability and consistency
for sponsors.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register (79 FR 47651) of
August 14, 2014. FDA revised the
guidance as appropriate in response to
the comments. This document
supersedes ‘‘New Section 513(f)(2)—
Evaluation of Automatic Class III
Designation, Guidance for Industry and
CDRH Staff’’ dated February 19, 1998.
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation)’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1760 to identify the guidance
you are requesting.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the De Novo
Classification Process (Evaluation of
Automatic Class III Designation). It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
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IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
the guidance ‘‘De Novo Classification
Process (Evaluation of Automatic Class
III Designation)’’ have been approved
under OMB control number 0910–0844.
The collections of information in the
guidance document ‘‘Requests for
Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ have been
approved under OMB control number
0910–0756. The collections of
information in 21 CFR part 807, subpart
E have been approved under OMB
control number 0910–0120; the
collections of information in 21 CFR
part 814 have been approved under
OMB control number 0910–0231; and
the collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485.
[FR Doc. 2017–23492 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5975]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Survey of Alumni
Commissioner’s Fellowship Program
Fellows
AGENCY:
Food and Drug Administration,
HHS.
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50146
ACTION:
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
Written/Paper 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 and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the Survey of
Alumni Commissioner’s Fellowship
Program Fellows.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by December 29, 2017.
DATES:
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 29,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 29, 2017.
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.
ADDRESSES:
sradovich on DSK3GMQ082PROD with NOTICES
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’’).
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17:59 Oct 27, 2017
Jkt 244001
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–
2017–N–5975 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Survey of
Alumni Commissioner’s Fellowship
Program Fellows.’’ 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/201523389.pdf.
Docket: For access to the docket to
read background documents or the
PO 00000
Frm 00031
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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
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.
Survey of Alumni Commissioner’s
Fellowship Program Fellows—OMB
Control Number 0910—NEW
FDA is requesting approval from OMB
to gather information from Alumni
Commissioner’s Fellowship Program
(CFP) Fellows. The information from
Alumni CFP Fellows will allow FDA’s
Office of the Commissioner (OC) to
E:\FR\FM\30OCN1.SGM
30OCN1
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
easily and efficiently elicit and review
program feedback. The online voluntary
survey will assist the Agency in
promoting and protecting the public
health by encouraging outside persons
to share their experience with the FDA
while a Commissioner’s Fellow. The
process will reduce the time and cost of
submitting written documentation to the
Agency and lessen the likelihood of
surveys being misrouted within the
Agency mail system. The information
gathered by the survey will be used to
gain insights into, and to document,
impacts that the CFP has had and is
having on former CFP fellows and
contributions and impacts that the
former fellows are making in their
current work. The voluntary surveys
include questions to assess the
50147
following measures: Post-fellowship
employment (e.g., employment type);
number of awards; number of
contributions while a CFP fellow (e.g.,
number of publications, guidance
documents authored or co-authored);
and contributions in their field (e.g., list
of publications).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Fellowship Program Survey .................................................
35
1
35
* 0.50
17.5
1 There
are no capital costs or operating maintenance costs associated with this collection of information.
* 30 minutes.
FDA based these estimates on the
number of fellows who have graduated
and left the Agency over the past 5
years.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4180]
Voluntary Medical Device
Manufacturing and Product Quality
Program; Public Workshop; Request
for Comments; Reopening of Comment
Period
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period provided
in the notice entitled ‘‘Voluntary
Medical Device Manufacturing and
Product Quality Program; Public
Workshop; Request for Comments,’’
published in the Federal Register of
July 25, 2017 (82 FR 34531). That notice
announced the public workshop to be
held on October 10, 2017, and requested
comments by October 18, 2017. The
Agency is taking this action to allow
interested parties additional time to
submit comments.
DATES: FDA is reopening the comment
period for the public workshop
‘‘Voluntary Medical Device
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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18:51 Oct 27, 2017
Jkt 244001
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 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 14, 2017.
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.
ADDRESSES:
[FR Doc. 2017–23515 Filed 10–27–17; 8:45 am]
AGENCY:
Manufacturing and Product Quality
Program; Public Workshop; Request for
Comments’’ published on July 25, 2017
(82 FR 34531). Submit either electronic
or written comments on this public
workshop by December 14, 2017.
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.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
• 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–
2017–N–4180 for ‘‘Voluntary Medical
Device Manufacturing and Product
Quality Program; Public Workshop;
Request for Comments; Reopening of
Comment Period.’’ 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
E:\FR\FM\30OCN1.SGM
30OCN1
]]>Agencies
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50145-50147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5975]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Survey of Alumni Commissioner's Fellowship Program
Fellows
AGENCY: Food and Drug Administration, HHS.
[[Page 50146]]
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 and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the Survey of Alumni Commissioner's Fellowship
Program Fellows.
DATES: Submit either electronic or written comments on the collection
of information by December 29, 2017.
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 29, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 29, 2017. 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-2017-N-5975 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Survey of Alumni Commissioner's
Fellowship Program Fellows.'' 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 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.
Survey of Alumni Commissioner's Fellowship Program Fellows--OMB Control
Number 0910--NEW
FDA is requesting approval from OMB to gather information from
Alumni Commissioner's Fellowship Program (CFP) Fellows. The information
from Alumni CFP Fellows will allow FDA's Office of the Commissioner
(OC) to
[[Page 50147]]
easily and efficiently elicit and review program feedback. The online
voluntary survey will assist the Agency in promoting and protecting the
public health by encouraging outside persons to share their experience
with the FDA while a Commissioner's Fellow. The process will reduce the
time and cost of submitting written documentation to the Agency and
lessen the likelihood of surveys being misrouted within the Agency mail
system. The information gathered by the survey will be used to gain
insights into, and to document, impacts that the CFP has had and is
having on former CFP fellows and contributions and impacts that the
former fellows are making in their current work. The voluntary surveys
include questions to assess the following measures: Post-fellowship
employment (e.g., employment type); number of awards; number of
contributions while a CFP fellow (e.g., number of publications,
guidance documents authored or co-authored); and contributions in their
field (e.g., list of publications).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fellowship Program Survey.......................................... 35 1 35 * 0.50 17.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating maintenance costs associated with this collection of information.
* 30 minutes.
FDA based these estimates on the number of fellows who have
graduated and left the Agency over the past 5 years.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23515 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P
