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, 1504-1507 [2021-00120]
Download as PDF
<![CDATA[
1504
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
March 9, 2021.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
tkelley on DSKBCP9HB2PROD with NOTICES
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Creditable
Coverage Disclosure to CMS On-Line
Form and Instructions; Use: Most
entities that currently provide
prescription drug benefits to any
Medicare Part D eligible individual
must disclose whether their prescription
drug benefit is creditable (expected to
pay at least as much, on average, as the
standard prescription drug plan under
Medicare). The disclosure must be
provided annually and upon any change
that affects whether the coverage is
creditable prescription drug coverage.
Form Number: CMS–10198; Frequency:
Annually; Affected Public: Individuals
and Households, State, Local, or Tribal
Governments, Federal Government;
Number of Respondents: 110,217;
Number of Responses: 110,217; Total
Annual Hours: 9,185. (For questions
regarding this collection, contact
Tammie Hill at (410) 786–3317.)
Dated: January 4, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–00074 Filed 1–7–21; 8:45 am]
BILLING CODE 4120–01–P
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10198—Creditable Coverage
Disclosure to CMS On-Line Form and
Instructions
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.
The term ‘‘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
VerDate Sep<11>2014
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
21:23 Jan 07, 2021
Jkt 253001
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:
PO 00000
Notice.
Frm 00030
Fmt 4703
Sfmt 4703
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.
SUMMARY:
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’’).
E:\FR\FM\08JAN1.SGM
08JAN1
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
tkelley on DSKBCP9HB2PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3728 for ‘‘Collection of
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.
• 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-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
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, 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,
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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
1505
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 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 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
E:\FR\FM\08JAN1.SGM
08JAN1
tkelley on DSKBCP9HB2PROD with NOTICES
1506
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
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, 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/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
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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
E:\FR\FM\08JAN1.SGM
08JAN1
1507
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
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 nonemployee 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
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
(15
(15
(15
(15
minutes)
minutes)
minutes)
minutes)
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 ...........................................................
1,220
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
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0417]
Request for Nominations on the
National Mammography Quality
Assurance Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
BILLING CODE 4164–01–P
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on the National Mammography
Quality Assurance Advisory Committee
in the Center for Devices and
Radiological Health notify FDA in
writing. FDA is also requesting
nominations for nonvoting industry
representatives to serve on the National
SUMMARY:
tkelley on DSKBCP9HB2PROD with NOTICES
Average burden per
response
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Mammography Quality Assurance
Advisory Committee. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
Any industry organization
interested in participating in the
selection of appropriate nonvoting
members to represent industry interests
must send a letter stating that interest to
FDA by February 8, 2021 (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by February 8,
2021.
DATES:
All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
ADDRESSES:
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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'').
[[Page 1505]]
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3728 for ``Collection of 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.
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,
[email protected].
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
