Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Information for Participation in the Food and Drug Administration Non-Employee Fellowship and Traineeship Programs, 64536-64539 [2019-25332]
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
producing an essential medical device.
In this initial call, the intent and goals
of the data collection effort will be
described, and the specific data request
made. Data will be collected, using least
burdensome methods, in a structured
manner to answer specific questions.
After the initial outreach, we will
request updates to the information on a
quarterly basis to keep the data current
and accurate. Additional followup
correspondence may occasionally be
needed to verify/validate data, confirm
receipt of followup correspondence(s),
and/or request additional details to
further inform FDA’s public health
response.
In the Federal Register of December
28, 2018 (83 FR 67298), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Shortages Data Collection ................
1 There
260
Total annual
responses
4
1,040
Average burden
per response
0.5 (30 minutes) ...............................
Total hours
520
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in
table 1 on past experience with direct
contact with the medical device
manufacturers and anticipated changes
in the medical device manufacturing
patterns for the specific devices being
monitored. FDA estimates that
approximately 260 manufacturers
would be contacted by telephone and/
or electronic mail 4 times per year either
to obtain primary data or to verify/
validate data. Because the requested
data represent data elements that are
monitored or tracked by manufacturers
as part of routine inventory management
activities, it is anticipated that for most
manufacturers, the estimated time
required of manufacturers to complete
the data request will not exceed 30
minutes per request cycle.
This information collection is a
reinstatement without change. There is
an increase (an adjustment) of 332 hours
in the total estimated burden compared
with that identified in the information
collection request previously approved
by OMB. This increase reflects changes
in market demands, in which
manufacturers are increasingly adopting
just-in-time production methods.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25368 Filed 11–21–19; 8:45 am]
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Number of
responses per
respondent
Number of
respondents
Activity
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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
Information for Participation in the
Food and Drug Administration NonEmployee Fellowship and Traineeship
Programs
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 ‘‘Collection of
Information for Participation in FDA
Non-Employee Fellowship and
Traineeship Programs.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 21, 2020.
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 21,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 21, 2020.
Comments received by mail/hand
SUMMARY:
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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
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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
Information for Participation in FDA
Non-Employee 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/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
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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. 3501–3521), 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.
Collection of 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 OMB a request to
review and approve a new collection of
information: Collection of Information
for Participation in FDA Non-Employee
Fellowship and Traineeship Programs.
Section 746(b) of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 379l(b))
allows FDA to conduct and support
intramural training programs through
fellowship and traineeship programs.
These mandatory collection forms
provide FDA with information from the
non-employee to: (1) Begin the program,
(2) administer the program, (3)
coordinate training, and (4) end the
program.
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(1) To begin the program, the nonemployee must submit the following
information: (A) New Non-Employee
Data Form; (B) Proof of Health
Insurance; (C) Emergency Contact
Information; (D) Unified Financial
Management System (UFMS) Supplier
and Site Information for Stipend
Payments, Financial Information; and
(E) CONCUR GOV New Traveler Profile
Form.
(A) New non-employee data form to
begin on-boarding process—The New
Non-Employee Data form collects
information that includes: (1) Name; (2)
Gender; (3) Birthplace; (4) Date of Birth;
(5) Email; (6) Home Address; (7) FDA
Center/Organization/Supervisor; (8)
Citizenship; (9) Social Security number
(SSN); (10) Start Date; (11) End Date;
(12) Contract Information; (13) Location;
and (14) Question regarding current or
previous Federal work experience.
(B) Proof of health insurance—
Participants in FDA fellowship and
traineeship programs will be asked for
certain information to demonstrate
proof of health insurance: (1) Name of
Health Insurance Plan Provider; (2)
Name/Contact Information of Primary
Member; (3) Member Identification
Number/Group Number; (4) Begin Date/
Policy Expiration Date; and (5)
Signature. The purpose of the health
insurance information is for FDA to
substantiate that participants of the
program are covered by health
insurance.
(C) Emergency contact information—
Participants in FDA fellowship and
traineeship programs will be asked for
certain information about emergency
contact demographics: (1) Name of
Fellow/Trainee; (2) Center; (3) Name of
Emergency Contact; (4) Telephone
Number of Emergency Contact; and (5)
Relationship to Contact. The purpose of
emergency contact information of
Fellows/Trainees is to ensure there is a
primary contact should emergencies
arise.
(D) UFMS supplier and site
information for stipend payments,
financial information—Participants in
FDA fellowship and traineeship
programs will be asked for their
financial institution routing number and
account information for direct deposit of
stipend payments: (1) Name; (2)
Taxpayer ID or SSN; (3) Classification/
Vendor type; (4) Payment Options
(Electronic Payment Only); (5) Mailing
Address; (6) Bank/Financial Institution
Information (Name, Routing Number,
Account Number, Account type); and
(7) Signature. The purpose of the
financial information is for FDA to
process a direct deposit transaction for
a monthly stipend payment.
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(E) CONCUR GOV new traveler
profile form—Participants in FDA’s
Non-Employee Scientist programs may
be asked to travel and will need to
complete an online profile for the
Concur Government Edition (CGE)
System, which requires the following
information: (1) Personal Information
(Name, Agency, Office/Operating
Division, Residence City, Residence
State, Signatures); (2) Agency
Information (ID #, Title, CAN); (3)
Business Contact Information; (4) Email
Addresses; Emergency Contact; (5)
Travel Preferences (Preferred Airline,
Hotel, Airline Seats, Frequent Flyer
Number); (6) Credit Card Number; (7)
Banking Account for Reimbursement;
and (8) Approving Signatures. The CGE
Profile provides assistance to travel
preparers who are booking travel for
FDA program participants.
(2) To administer the program, nonemployee scientists must submit
information for: (A) Absence Recording
Form, (B) Personal Custody Property
Record, (C) FDA Health Summary, and
(D) Discovery and Invention.
(A) Absence recording form—
Participants in FDA fellowship and
traineeship programs will be asked for
certain information about tracking
attendance and absences: (1) Name of
Fellow/Trainee; (2) Office/Division of
Placement; (3) Mentor/Sponsor Name;
(4) Type of Absence; (5) Dates of
Absence; (6) Reason for Absence; and
(7) Mentor/Sponsor Approval. The
purpose of tracking attendance and
absences for Fellows/Trainees is to
determine the monthly stipend payment
and potential modifications to purchase
orders for extended absences.
(B) Personal custody property
record—Participants in FDA fellowship
and traineeship programs will be
required to sign the property request,
acknowledging personal responsibility
for government property. The plan
collects the following information: (1)
Fellow Name; (2) Operative Division/
Division; (3) Location; (4) Telephone; (5)
Description of Items; (6) Items to be
Returned; (7) Return Date; (8) Fellow
Signature; (9) Custodial Officer
Signature; and (10) Issuing Office. The
purpose of this record is to acknowledge
that an individual has received
government property and accepts
personal responsibility for items issued
to perform their roles.
(C) FDA health summary—
Participants in FDA fellowship and
traineeship programs will be asked for
information about health for laboratory
activities. The FDA Occupational Health
Services Health Summary form collects
information that includes: (1) Name; (2)
Program; (3) Email; (4) Work Phone; (5)
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FDA Mentor; (6) Center/Office Division;
(7) Location; (8) Date; (9) Primary Care
Physician and Contact Information; (10)
Immunizations; (11) Social History; (12)
Relationship History; (13) Allergies; and
(14) Medical History.
(D) Discovery and invention—
Participants in FDA fellowship and
traineeship programs will be asked for
information about discoveries and
inventions at FDA. The Discovery and
Invention Report collects information
that includes: (1) Title of Discovery; (2)
Description of Discovery; (3)
Identification of collaborators,
Cooperative Research and Development
Agreement (CRADA), and human
materials or subjects; (4) Publications;
(5) Technology Stage; (6) Commercial
Potential; and (7) Competition, Potential
Users, and Manufacturers.
(3) For the coordination of training,
non-employee scientists must complete
information for the: (A) Training
Development Plan; (B) Final Project
Report; (C) Training Request; (D) Travel
Request; (E) Learning Management
System (LMS) Request; (F) Standard
Operating Procedures (SOP)
Verification; and (G) Program
Evaluation.
(A) Training development plan—
Participants in FDA fellowship and
traineeship programs will be required to
develop the individual plan in
partnership with their Mentor. The plan
collects the following information: (1)
Fellow Name; (2) Mentor(s)/Preceptor(s)
Name; (3) Sign-On Date; (4) Year 1
Goals, Courses/Training, Regulatory
Activities, and Completion Date; (5)
Year 2 Goals, Courses/Trainings,
Regulatory Activities, and Completion
Date; (6) Fellow Signature; and (7)
Mentor(s)/Preceptor(s) Signature. The
purpose of this individual development/
training plan is to have a record of
mandatory training and specific goals
and tasks for the contributions and/or
completion of a project.
(B) Final project report—Participants
in FDA fellowship and traineeship
programs will be required to complete
the final report in partnership with their
Mentor. The plan collects the following
information: (1) Fellow Name; (2)
Mentor/Preceptor Name; (3) Goals; (4)
Objectives; (5) Alignment with Center or
FDA Goals; (6) Project Summary/
Abstract; (7) Accomplishments; and (8)
Impact on Public Health. The purpose of
this report is to acknowledge the
contributions to the overall project and
identify performance successes or
challenges. The collection of
information is mandatory to participate
in FDA’s fellowship and traineeship
programs.
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(C) Training request—Participants in
FDA fellowship and traineeship
programs will be asked to identify the
following for external training requests:
(1) Name of Fellow/Trainee; (2)
Operating Office/Staff Division; (3) Title
and Topic of Training; (4) Name of
Hosting Agency/Organization; (5)
Purpose/Justification for External
Training; (6) Dates; (7) Location; and (8)
Approving Signatures. The purpose of
the External Training Request is to
provide justification substantiating the
benefits to the Operating Office/Staff
Division and/or benefits to the Fellows/
Trainee professional development and
training. The collection of information
is mandatory to participate in FDA’s
fellowship and traineeship programs.
(D) Travel request—Participants in
FDA fellowship and traineeship
programs will be asked for certain
information about travel requests and
authorizations/approvals: (1) Office/
Division; (2) Research Project Title; (3)
Mentor/Sponsor Name; (4) Mentor/
Sponsor Email and Telephone; (5)
Fellow’s Name; (6) Appointment Period;
(7) Funding Source and Fiscal Year; (8)
Brief Description of Travel; (9)
Anticipated Travel Dates; and (10)
Travel Justification and Relation to
Project. The purpose of authorization for
travel of Fellows/Trainees is to
determine if the travel has been
approved by the Sponsor/Mentor and if
the travel is a mission-related activity to
the Fellow/Trainee training plan or
appointment/assignment. The collection
of information is mandatory to
participate in FDA’s fellowship and
traineeship programs.
(E) Learning Management System
(LMS) access—Participants in FDA
fellowship and traineeship programs
will be asked for information to obtain
access to the LMS: (1) Name, (2)
Location, (3) Organizational Unit, and
(4) Email Address. The purpose of LMS
Access Request is to obtain information
of Non-Employee Scientists to ensure
they have access to receive training and
educational opportunities offered in the
Health and Human Services LMS
System.
(F) SOP verification—Participants in
FDA fellowship and traineeship
programs will be asked for certain
information to verify that they have read
and received instructional training on
the SOPs for said program. The form
collects the following: (1) Name; (2)
Signature; (3) Date; and (4) Center.
(G) Program Evaluation—Participants
in FDA fellowship and traineeship
programs will be asked to complete an
evaluation providing program data that
will be synthesized into program reports
on the overall effectiveness of the
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program. The evaluation collects the
following information: (1) Demographic
Data; (2) Expectations of Fellowship or
Training Program; (3) Administration
Processes and Support to Fellow or
Trainee; (4) FDA Retention and Plans of
Fellow or Trainee; (5) Training and
Education Completed; and (6)
Professional/Research Goals. The
purpose of this evaluation is to assess
the effectiveness of the program and
feedback from participants to improve
the quality of the experience.
(4) To end the program, a nonemployee must submit the Exit Check
List—Participants in FDA fellowship
and traineeship programs may be asked
to complete the exit check list to
manage the exit process and return of
FDA property. The Exit Checklist guides
the exit process for the following
operations components: (1) Access Key/
Pass; (2) Accountable Property; (3)
System Applications inactive; (4)
Library Materials; (5) Government
Issued Documents (i.e., passports); (6)
Personal Identity Verification Card/
Badge; (7) Borrowed Records; (8)
Employee Records; and (9) Information
Technology Accounts.
All exit information will be entered to
terminate access to any FDA
information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average burden
per response
1,220
600
1,220
600
1
1
1
1
1
1
1
1
0.25
0.25
0.25
0.25
......
......
......
......
305
150
305
150
620
1,220
1,220
1,220
1,220
1,220
1,220
610
610
1,220
1,220
1,220
1,220
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0.25 (15 minutes) ......
0.25 (15 minutes) ......
0.25 (15 minutes) ......
1 ................................
1 ................................
1 ................................
1 ................................
0.5 (30 minutes) ........
0.5 (30 minutes) ........
0.25 (15 minutes) ......
0.25 (15 minutes) ......
0.5 (30 minutes) ........
1 ................................
155
305
305
1,220
1,220
1,220
1,220
305
305
305
305
610
1,220
Total ..................................................................
........................
........................
........................
....................................
9,605
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
information collection associated with
certain Freedom of Information Act and
Privacy Act requests.
Food and Drug Administration
DATES:
[FR Doc. 2019–25332 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
Submit either electronic or
written comments on the collection of
information by January 21, 2020.
[Docket No. FDA–2016–N–2066]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Certification of
Identity for Freedom of Information Act
and Privacy Act Requests
Food and Drug Administration,
HHS.
ACTION:
minutes)
minutes)
minutes)
minutes)
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
AGENCY:
(15
(15
(15
(15
Total hours
New Non-Employee Data Form ...............................
Proof of Health Insurance ........................................
Emergency Contact Information ..............................
UFMS Supplier and Site Information for Stipend
Payments, Financial Information.
CONCUR GOV New Traveler Profile ......................
Absence Recording Form ........................................
Personal Custody Property Record .........................
FDA Health Summary ..............................................
Discovery and Invention Form .................................
Training Development Plan .....................................
Final Project Report .................................................
Training Request ......................................................
Travel Request .........................................................
LMS Access .............................................................
SOP Verification .......................................................
Program Evaluation .................................................
Exit Checklist ...........................................................
1 There
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Number of
responses per
respondent
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
SUMMARY:
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16:57 Nov 21, 2019
Jkt 250001
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 21,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 21, 2020.
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:
PO 00000
Frm 00087
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Sfmt 4703
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
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]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64536-64539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25332]
-----------------------------------------------------------------------
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 Information for Participation in the
Food and Drug Administration Non-Employee Fellowship and Traineeship
Programs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 ``Collection of Information for
Participation in FDA Non-Employee Fellowship and Traineeship
Programs.''
DATES: Submit either electronic or written comments on the collection
of information by January 21, 2020.
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 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 21, 2020. 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
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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 Information for Participation in
FDA Non-Employee 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]a.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Collection of 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 OMB a request
to review and approve a new collection of information: Collection of
Information for Participation in FDA Non-Employee Fellowship and
Traineeship Programs. Section 746(b) of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 379l(b)) allows FDA to conduct and support
intramural training programs through fellowship and traineeship
programs. These mandatory collection forms provide FDA with information
from the non-employee to: (1) Begin the program, (2) administer the
program, (3) coordinate training, and (4) end the program.
(1) To begin the program, the non-employee must submit the
following information: (A) New Non-Employee Data Form; (B) Proof of
Health Insurance; (C) Emergency Contact Information; (D) Unified
Financial Management System (UFMS) Supplier and Site Information for
Stipend Payments, Financial Information; and (E) CONCUR GOV New
Traveler Profile Form.
(A) New non-employee data form to begin on-boarding process--The
New Non-Employee Data form collects information that includes: (1)
Name; (2) Gender; (3) Birthplace; (4) Date of Birth; (5) Email; (6)
Home Address; (7) FDA Center/Organization/Supervisor; (8) Citizenship;
(9) Social Security number (SSN); (10) Start Date; (11) End Date; (12)
Contract Information; (13) Location; and (14) Question regarding
current or previous Federal work experience.
(B) Proof of health insurance--Participants in FDA fellowship and
traineeship programs will be asked for certain information to
demonstrate proof of health insurance: (1) Name of Health Insurance
Plan Provider; (2) Name/Contact Information of Primary Member; (3)
Member Identification Number/Group Number; (4) Begin Date/Policy
Expiration Date; and (5) Signature. The purpose of the health insurance
information is for FDA to substantiate that participants of the program
are covered by health insurance.
(C) Emergency contact information--Participants in FDA fellowship
and traineeship programs will be asked for certain information about
emergency contact demographics: (1) Name of Fellow/Trainee; (2) Center;
(3) Name of Emergency Contact; (4) Telephone Number of Emergency
Contact; and (5) Relationship to Contact. The purpose of emergency
contact information of Fellows/Trainees is to ensure there is a primary
contact should emergencies arise.
(D) UFMS supplier and site information for stipend payments,
financial information--Participants in FDA fellowship and traineeship
programs will be asked for their financial institution routing number
and account information for direct deposit of stipend payments: (1)
Name; (2) Taxpayer ID or SSN; (3) Classification/Vendor type; (4)
Payment Options (Electronic Payment Only); (5) Mailing Address; (6)
Bank/Financial Institution Information (Name, Routing Number, Account
Number, Account type); and (7) Signature. The purpose of the financial
information is for FDA to process a direct deposit transaction for a
monthly stipend payment.
[[Page 64538]]
(E) CONCUR GOV new traveler profile form--Participants in FDA's
Non-Employee Scientist programs may be asked to travel and will need to
complete an online profile for the Concur Government Edition (CGE)
System, which requires the following information: (1) Personal
Information (Name, Agency, Office/Operating Division, Residence City,
Residence State, Signatures); (2) Agency Information (ID #, Title,
CAN); (3) Business Contact Information; (4) Email Addresses; Emergency
Contact; (5) Travel Preferences (Preferred Airline, Hotel, Airline
Seats, Frequent Flyer Number); (6) Credit Card Number; (7) Banking
Account for Reimbursement; and (8) Approving Signatures. The CGE
Profile provides assistance to travel preparers who are booking travel
for FDA program participants.
(2) To administer the program, non-employee scientists must submit
information for: (A) Absence Recording Form, (B) Personal Custody
Property Record, (C) FDA Health Summary, and (D) Discovery and
Invention.
(A) Absence recording form--Participants in FDA fellowship and
traineeship programs will be asked for certain information about
tracking attendance and absences: (1) Name of Fellow/Trainee; (2)
Office/Division of Placement; (3) Mentor/Sponsor Name; (4) Type of
Absence; (5) Dates of Absence; (6) Reason for Absence; and (7) Mentor/
Sponsor Approval. The purpose of tracking attendance and absences for
Fellows/Trainees is to determine the monthly stipend payment and
potential modifications to purchase orders for extended absences.
(B) Personal custody property record--Participants in FDA
fellowship and traineeship programs will be required to sign the
property request, acknowledging personal responsibility for government
property. The plan collects the following information: (1) Fellow Name;
(2) Operative Division/Division; (3) Location; (4) Telephone; (5)
Description of Items; (6) Items to be Returned; (7) Return Date; (8)
Fellow Signature; (9) Custodial Officer Signature; and (10) Issuing
Office. The purpose of this record is to acknowledge that an individual
has received government property and accepts personal responsibility
for items issued to perform their roles.
(C) FDA health summary--Participants in FDA fellowship and
traineeship programs will be asked for information about health for
laboratory activities. The FDA Occupational Health Services Health
Summary form collects information that includes: (1) Name; (2) Program;
(3) Email; (4) Work Phone; (5) FDA Mentor; (6) Center/Office Division;
(7) Location; (8) Date; (9) Primary Care Physician and Contact
Information; (10) Immunizations; (11) Social History; (12) Relationship
History; (13) Allergies; and (14) Medical History.
(D) Discovery and invention--Participants in FDA fellowship and
traineeship programs will be asked for information about discoveries
and inventions at FDA. The Discovery and Invention Report collects
information that includes: (1) Title of Discovery; (2) Description of
Discovery; (3) Identification of collaborators, Cooperative Research
and Development Agreement (CRADA), and human materials or subjects; (4)
Publications; (5) Technology Stage; (6) Commercial Potential; and (7)
Competition, Potential Users, and Manufacturers.
(3) For the coordination of training, non-employee scientists must
complete information for the: (A) Training Development Plan; (B) Final
Project Report; (C) Training Request; (D) Travel Request; (E) Learning
Management System (LMS) Request; (F) Standard Operating Procedures
(SOP) Verification; and (G) Program Evaluation.
(A) Training development plan--Participants in FDA fellowship and
traineeship programs will be required to develop the individual plan in
partnership with their Mentor. The plan collects the following
information: (1) Fellow Name; (2) Mentor(s)/Preceptor(s) Name; (3)
Sign-On Date; (4) Year 1 Goals, Courses/Training, Regulatory
Activities, and Completion Date; (5) Year 2 Goals, Courses/Trainings,
Regulatory Activities, and Completion Date; (6) Fellow Signature; and
(7) Mentor(s)/Preceptor(s) Signature. The purpose of this individual
development/training plan is to have a record of mandatory training and
specific goals and tasks for the contributions and/or completion of a
project.
(B) Final project report--Participants in FDA fellowship and
traineeship programs will be required to complete the final report in
partnership with their Mentor. The plan collects the following
information: (1) Fellow Name; (2) Mentor/Preceptor Name; (3) Goals; (4)
Objectives; (5) Alignment with Center or FDA Goals; (6) Project
Summary/Abstract; (7) Accomplishments; and (8) Impact on Public Health.
The purpose of this report is to acknowledge the contributions to the
overall project and identify performance successes or challenges. The
collection of information is mandatory to participate in FDA's
fellowship and traineeship programs.
(C) Training request--Participants in FDA fellowship and
traineeship programs will be asked to identify the following for
external training requests: (1) Name of Fellow/Trainee; (2) Operating
Office/Staff Division; (3) Title and Topic of Training; (4) Name of
Hosting Agency/Organization; (5) Purpose/Justification for External
Training; (6) Dates; (7) Location; and (8) Approving Signatures. The
purpose of the External Training Request is to provide justification
substantiating the benefits to the Operating Office/Staff Division and/
or benefits to the Fellows/Trainee professional development and
training. The collection of information is mandatory to participate in
FDA's fellowship and traineeship programs.
(D) Travel request--Participants in FDA fellowship and traineeship
programs will be asked for certain information about travel requests
and authorizations/approvals: (1) Office/Division; (2) Research Project
Title; (3) Mentor/Sponsor Name; (4) Mentor/Sponsor Email and Telephone;
(5) Fellow's Name; (6) Appointment Period; (7) Funding Source and
Fiscal Year; (8) Brief Description of Travel; (9) Anticipated Travel
Dates; and (10) Travel Justification and Relation to Project. The
purpose of authorization for travel of Fellows/Trainees is to determine
if the travel has been approved by the Sponsor/Mentor and if the travel
is a mission-related activity to the Fellow/Trainee training plan or
appointment/assignment. The collection of information is mandatory to
participate in FDA's fellowship and traineeship programs.
(E) Learning Management System (LMS) access--Participants in FDA
fellowship and traineeship programs will be asked for information to
obtain access to the LMS: (1) Name, (2) Location, (3) Organizational
Unit, and (4) Email Address. The purpose of LMS Access Request is to
obtain information of Non-Employee Scientists to ensure they have
access to receive training and educational opportunities offered in the
Health and Human Services LMS System.
(F) SOP verification--Participants in FDA fellowship and
traineeship programs will be asked for certain information to verify
that they have read and received instructional training on the SOPs for
said program. The form collects the following: (1) Name; (2) Signature;
(3) Date; and (4) Center.
(G) Program Evaluation--Participants in FDA fellowship and
traineeship programs will be asked to complete an evaluation providing
program data that will be synthesized into program reports on the
overall effectiveness of the
[[Page 64539]]
program. The evaluation collects the following information: (1)
Demographic Data; (2) Expectations of Fellowship or Training Program;
(3) Administration Processes and Support to Fellow or Trainee; (4) FDA
Retention and Plans of Fellow or Trainee; (5) Training and Education
Completed; and (6) Professional/Research Goals. The purpose of this
evaluation is to assess the effectiveness of the program and feedback
from participants to improve the quality of the experience.
(4) To end the program, a non-employee must submit the Exit Check
List--Participants in FDA fellowship and traineeship programs may be
asked to complete the exit check list to manage the exit process and
return of FDA property. The Exit Checklist guides the exit process for
the following operations components: (1) Access Key/Pass; (2)
Accountable Property; (3) System Applications inactive; (4) Library
Materials; (5) Government Issued Documents (i.e., passports); (6)
Personal Identity Verification Card/Badge; (7) Borrowed Records; (8)
Employee Records; and (9) Information Technology Accounts.
All exit information will be entered to terminate access to any FDA
information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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New Non-Employee Data Form.................. 1,220 1 1 0.25 (15 minutes)......................... 305
Proof of Health Insurance................... 600 1 1 0.25 (15 minutes)......................... 150
Emergency Contact Information............... 1,220 1 1 0.25 (15 minutes)......................... 305
UFMS Supplier and Site Information for 600 1 1 0.25 (15 minutes)......................... 150
Stipend Payments, Financial Information.
CONCUR GOV New Traveler Profile............. 620 1 1 0.25 (15 minutes)......................... 155
Absence Recording Form...................... 1,220 1 1 0.25 (15 minutes)......................... 305
Personal Custody Property Record............ 1,220 1 1 0.25 (15 minutes)......................... 305
FDA Health Summary.......................... 1,220 1 1 1......................................... 1,220
Discovery and Invention Form................ 1,220 1 1 1......................................... 1,220
Training Development Plan................... 1,220 1 1 1......................................... 1,220
Final Project Report........................ 1,220 1 1 1......................................... 1,220
Training Request............................ 610 1 1 0.5 (30 minutes).......................... 305
Travel Request.............................. 610 1 1 0.5 (30 minutes).......................... 305
LMS Access.................................. 1,220 1 1 0.25 (15 minutes)......................... 305
SOP Verification............................ 1,220 1 1 0.25 (15 minutes)......................... 305
Program Evaluation.......................... 1,220 1 1 0.5 (30 minutes).......................... 610
Exit Checklist.............................. 1,220 1 1 1......................................... 1,220
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Total................................... .............. .............. .............. .......................................... 9,605
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25332 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P
