[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1504-1507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00120]


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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 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 March 9, 2021.

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 March 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 9, 2021. 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:
    <bullet> 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.
    <bullet> 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'').

[[Page 1505]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> 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.
    <bullet> 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 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, 240-402-7500.
    <bullet> 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.govinfo.gov/content/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, 240-402-7500.

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, 
<a href="/cdn-cgi/l/email-protection#4c1c1e0d1f382d2a2a0c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="e5b5b7a4b691848383a5838184cb8d8d96cb828a93">[email protected]</span></a>.

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, 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 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 onboarding 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

[[Page 1506]]

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.
    (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, 
center accounting number); (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/
trainee name; (2) operative division/division; (3) location; (4) 
telephone; (5) description of items; (6) items to be returned; (7) 
return date; (8) fellow/trainee 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, 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/trainee 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/trainee 
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/trainee 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 fellow's/trainee's 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/trainee 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) 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

[[Page 1507]]

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 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 
checklist--Participants in FDA fellowship and traineeship programs may 
be asked to complete the exit checklist to manage the exit process and 
return of FDA property. The exit checklist guides the exit process for 
the following operational 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
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................           9,605
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA published a 60-day notice for this information collection on 
November 22, 2019 (84 FR 64536). FDA is reopening the 60-day comment 
period in order to satisfy PRA requirements. No changes have been made 
to the information collection.

    Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00120 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P


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