Supplemental Information for the SF-424 Application Instruction Redlined

Instructions for U.S. Department of Education
Supplemental Information for the SF-424 Application for Federal Assistance
1. Project Director and Applicable Entity Identification Numbers. Name, address, telephone and fax numbers, and e-mail and alternate
email addresses of the Project Director to be contacted on matters involving this application. Enter Project Director’s level of effort (the
percentage of time devoted to the grant). Items marked with an asterisk (*) are mandatory. If applicable, you must enter any of the following
identification numbers that apply: Office of Postsecondary Education Identification (OPE ID(s)); National Center for Education Statistics
Schools Identification (NCES School ID(s)); National Center for Education Statistics Local Education Agency/School District Identification
(NCES LEA/School District ID(s)). Provide the relevant number or numbers that are applicable for the institution(s), LEA(s), and school(s) that
will be served by the proposed project. If you are providing multiple numbers, enter them separated by commas or semicolons. If you are
applying on behalf of the entire LEA/School District, you do not need to provide the NCES School ID for each school within the LEA/School
District. Search for the OPE ID code at: College Navigator - National Center for Education Statistics at https://nces.ed.gov/collegenavigator/;
the NCES School ID at: https://nces.ed.gov/globallocator/; and the NCES LEA/School District ID at: https://nces.ed.gov/ccd/districtsearch/. If
not applicable, enter “n/a” in the relevant field(s).
2. Select compliance with the assurance related to section 427 of the General Education Provisions Act and provide the relevant page
number(s) from the application.
3. New Potential Grantee or Novice Applicant. Select N/A if this item is not applicable because the program competition’s notice inviting
applications (NIA) does not include a definition of either “New Potential Grantee” or “Novice Applicant.” This item is not applicable when the
program competition’s NIA does not include either definition. If this item is applicable, for (a), check “Yes” if you meet the definition for new
potential grantees or novice applicants specified in the program competition’s NIA and included on the attached page entitled “Definitions for
U.S. Department of Education Supplemental Information for the SF-424.”. By checking “Yes” the applicant certifies that it meets the new
potential grantee or novice applicant requirements. Check “No” if you do not meet the definition for new potential grantees or novice
applicants. For (b), if the program competition NIA is giving competitive preference points for new potential grantees or novice applicants,
indicate how many points you are claiming for your application. The NIA will indicate how many are available depending on the design of the
competition. Some competitions may provide more than one category of new potential grantees with differing levels of points.
4. Human Subjects Research. (See I. A. “Definitions” in attached page entitled “Definitions for U.S. Department of Education Supplemental
Information for the SF-424 form.”)
4a. If Not Human Subjects Research. Check “No” if research activities involving human subjects are not planned at any time during the
proposed project period. The remaining parts of Item 3 are then not applicable.
43a. If Human Subjects Research. Check “Yes” if research activities involving human subjects are planned at any time during the proposed
project period, either at the applicant organization or at any other performance site or collaborating institution. Check “Yes” even if the
research is exempt from the regulations for the protection of human subjects. (See I. B. “Exemptions” in attached page entitled “Definitions for
U.S. Department of Education Supplemental Information for the SF-424 Application for Federal Assistance.”)
43b. If Human Subjects Research is Exempt from the Human Subjects Regulations. Check “Yes” if all the research activities proposed
are designated to be exempt from the regulations. Check the exemption number(s) corresponding to one or more of the eight exemption
categories (Regulation revised in 2018 and became effective in 2019) listed in I. B. “Exemptions.” In addition, follow the instructions in II. A.
“Exempt Research Narrative” in the attached page entitled “Definitions for U.S. Department of Education Supplemental Information for the SF424 Application for Federal Assistance.”
43b. If Human Subjects Research is Not Exempt from Human Subjects Regulations. Check “No” if some or all of the planned research
activities are covered (not exempt). In addition, follow the instructions in II. B. “Nonexempt Research Narrative” in the attached page entitled
“Definitions for U.S. Department of Education Supplemental Information for the SF-424 Application for Federal Assistance.”
43b. Federal Wide Assurance Number. If the applicant has an approved Federal Wide Assurance (FWA) on file with the Office for Human
Research Protections (OHRP), U.S. Department of Health and Human Services, that covers the specific activity, insert the number in the space
provided. (A list of current FWAs is available at: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc.) If the applicant does not have an
approved assurance on file with OHRP, enter “None.” In this case, the applicant, by signature on the SF-424, is declaring that it will comply
with 34 CFR part 97 and proceed to obtain the human subjects assurance upon request by the designated ED official. If the application is
recommended/selected for funding, the designated ED official will request that the applicant obtain the assurance within 30 days after the
specific formal request.
43c. If applicable, please attach your “Exempt Research” or “Nonexempt Research” narrative to your submission of the U.S. Department of
Education Supplemental Information for the SF-424 form as instructed in item II, “Instructions for Exempt and Nonexempt Human Subjects
Research Narratives” in the attached page entitled “Definitions for U.S. Department of Education Supplemental Information for the SF-424
Application for Federal Assistance.”
Note about Institutional Review Board Approval. ED does not require certification of Institutional Review Board approval with the
application. However, if an application that involves non-exempt human subjects research is recommended/selected for funding, the designated
ED official will request that the applicant obtain and send the certification to ED within 30 days after the formal request.
No covered human subjects research can be conducted until the study has ED clearance for protection of human subjects in research.

5. Infrastructure Programs. In accordance with section 70914 of the Infrastructure Investment and Jobs Act, the Build America Buy America
Act (BABAA) requires that grantees funded under the U.S. Department of Education programs that allow funds to be used for infrastructure
projects, i.e., construction, remodeling, and broadband infrastructure, may not use their grant funds for these infrastructure projects or activities
unless they comply with the following BABAA domestic sourcing requirements:
1.All iron and steel used in the infrastructure project or activity are produced in the United States.
2.All manufactured products used in the infrastructure project or activity are produced in the United States.
3.All construction materials are manufactured in the United States.
If the NIA in section III. 4. “Other” reflects that the program under which an application is submitted is subject to the BABAA domestic
sourcing requirements, select the item that applies.
Note: The BABAA domestic sourcing requirements only apply to those activities in each application grant proposal related to infrastructure
(specifically, only construction, remodeling, or broadband infrastructure activities). No other projects or costs associated with other proposed
grant activities are subject to the BABAA domestic sourcing requirements.
For applications with proposed infrastructure projects and activities that are subject to the BABAA domestic sourcing requirements, select the
type of infrastructure activity (i.e., construction, remodeling, and/or broadband infrastructure), and identify the page numbers from within the
application narrative where the infrastructure projects or activities are addressed.
Public Burden Statement:
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless such collection
displays a valid OMB control number. Public reporting burden for this collection of information is estimated to average 20 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information. The obligation to respond to this collection is required to obtain or retain benefit (20 USC 3474
General Education Provisions Act). Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to the U.S. Department of Education, 400 Maryland Ave., SW, Washington, DC 20210-4537 or
email ICDocketMgr@ed.gov and reference the OMB Control Number 1894-0007. Note: Please do not return the completed ED SF 424
Supplemental Form to this address.

Definitions for U.S. Department of Education
Supplemental Information for the SF-424 Application for Federal Assistance
Definitions:

—Human Subject

NEW POTENTIAL GRANTEE OR NOVICE APPLICANT

The regulations define human subject as “a living individual
about whom an investigator (whether professional or student)
conducting research obtains (i) information or biospecimens
through intervention or interaction with the individual and uses,
studies, or analyzes the information or biospecimens, or (ii )
obtains, uses, studies, analyzes, or generate identifiable private
information or identifiable biospecimens.”

New Potential Grantee: The definition of New Potential Grantee
is set in the program competition’s Notice Inviting Applications
(NIA). The New Potential Grantee priority is from 34 CFR
75.225 of the Education Department General Administrative
Regulationsthe Department’s Administrative Priorities for
Discretionary Grant Programs published in the Federal
Register March 9, 2020 (85 FR 13640).
Novice Applicant: For discretionary grant programs, novice
applicant means any applicant for a grant from ED that—


Has never received a grant or subgrant under the program
from which it seeks funding;



Has never been a member of a group application, submitted
in accordance with 34 CFR 75.127-75.129, that received a
grant under the program from which it seeks funding; and



Has not had an active discretionary grant from the Federal
government in the five years before the deadline date for
applications under the program. For the purposes of this
requirement, a grant is active until the end of the grant’s
project or funding period, including any extensions of those
periods that extend the grantee’s authority to obligate funds.

In the case of a group application submitted in accordance with
34 CFR 75.127-75.129, a group includes only parties that meet
the requirements listed above. The Novice Applicant priority is
from 34 CFR 75.225, and it must be included in the program
competition NIA to be claimed on the form.
PROTECTION OF HUMAN SUBJECTS IN RESEARCH
I. Definitions and Exemptions
A. Definitions.
A research activity involves human subjects if the activity is
research, as defined in the Department’s regulations, and the
research activity will involve use of human subjects, as defined
in the regulations.
—Research
The ED Regulations for the Protection of Human Subjects, Title
34, Code of Federal Regulations, Part 97, define research as “a
systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to
generalizable knowledge. Activities which meet this definition
constitute research whether or not they are conducted or
supported under a program that is considered research for other
purposes. For example, some demonstration and service
programs may include research activities.”

If an activity involves obtaining information about a living
person by manipulating that person or that person’s
environment, as might occur when a new instructional technique
is tested, or by communicating or interacting with the
individual, as occurs with surveys and interviews, the definition
of human subject is met. If an activity involves obtaining private
information about a living person in such a way that the
information can be directly or indirectly linked to that
individual, the definition of human subject is met.
Private information includes information about behavior that
occurs in a context in which an individual can reasonably expect
that no observation or recording is taking place, and information
which has been provided for specific purposes by an individual
and which the individual can reasonably expect will not be
made public (for example, a school health record).
B. Exemptions.
Research activities in which the only involvement of human
subjects will be in one or more of the following eight categories
of exemptions are not covered by the regulations:
(1) Research conducted in established or commonly accepted
educational settings, that specifically involves normal
educational practices that are not likely to adversely impact
students’ opportunity to learn required educational content or
the assessment of educators who provide instruction. This
includes most research on regular and special education
instructional strategies, and research on the effectiveness of or
the comparison among instructional techniques, curricula, or
classroom management methods. If an educational practice is
being introduced to the site and is not widely used for similar
populations, it is not covered by this exemption.
(2) Research that only includes interactions involving
educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of
public behavior (including visual or auditory recordings) if at
least one of the following criteria is met: (i) the information
obtained is recorded by the investigator in such a manner that
the identity of the human subjects cannot readily be ascertained,
directly or through identifiers linked to the subjects; (ii) Any
disclosure of the human subjects’ responses outside the research
would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects’ financial standing,
employability, educational advancement or reputation; or (iii)

the information obtained is recorded by the investigator in such
a manner that the identity of the human subjects can readily be
ascertained, directly or through identifiers linked to the subjects,
and an Institutional Review Board (IRB) conducts a “limited
IRB review” to make the determinations required by 34 CFR
97.111(a)(7).
If the subjects are children, exemption 2 applies only to
research involving educational tests and observations of public
behavior when the investigator(s) do not participate in the
activities being observed.
Exemption 2 does not apply if children are surveyed or
interviewed or if the research involves observation of public
behavior and the investigator(s) participate in the activities
being observed. Children are defined as persons who have not
attained the legal age for consent to treatments or procedures
involved in the research, under the applicable law or jurisdiction
in which the research will be conducted.
(3) Research involving benign behavioral interventions in
conjunction with the collection of information from an adult
subject through verbal or written responses (including data
entry) or audiovisual recording if the subject prospectively
agrees to the intervention and information collection and at least
one of the following criteria is met: (A) The information
obtained is recorded by the investigator in such a manner that
the identity of the human subjects cannot readily be ascertained
directly or through identifiers linked to the subjects; (B) Any
disclosure of the human subjects’ responses outside the research
would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subject’ financial standing,
employability, educational advancement or reputation; or (C)
The information obtained is recorded by the investigator in such
a manner that the identity of the human subjects can readily be
ascertained, directly or through identifiers linked to the subjects,
and an IRB conducts a limited IRB review to make the
determination required by 34 CFR 97.111(a)(7).
For the purpose of this provision, benign behavioral
interventions are brief in duration, harmless, painless, not
physically invasive, not likely to have a significant adverse
lasting impact on the subjects, and the investigator has no reason
to think the subjects will find the interventions offensive or
embarrassing. Provided all such criteria are met, examples of
such benign behavioral interventions would include having the
subject play an online game, having them solve puzzles under
various noise conditions, or having them decide how to allocate
a nominal amount of received cash between themselves and
someone else.
If the research involves deceiving the subjects regarding the
nature or purposes of the research, this exemption is not
applicable unless the subject authorizes the deception through a
prospective agreement to participate in research in
circumstances in which the subject is informed that he or she
will be unaware of or misled regarding the nature or purposes of
the research.
(4) Secondary Research for which Consent is not required.
Secondary research uses of identifiable private information or

identifiable biospecimens, if at least one of the following criteria
is men: (i) The identifiable private information or identifiable
biospecimens are publicly available; (ii) Information, which
may include information about biospecimens, is recorded by the
investigator in such a manner that the identity of the human
subjects cannot readily be ascertained directly or through
identifiers linked to the subjects, the investigator does not
contact the subjects, and the investigator will not re-identify
subjects; (iii) the research involves only information collection
and analysis involving the investigators’ use of identifiable
health information when that use is regulated under 45 CFR
parts 160 and 164, subparts A and E, for the purposes of “health
care operations” or “research” as those terms are defined at 45
CFR 164.501 or for “public health activities and purposes” as
described under 45 CFR 164.512 (b); or (iv) The research is
conducted by, or on behalf of, a Federal department or agency
using government-generated or government-collected
information obtained for nonresearch activities, if the research
generates identifiable private information that is or will be
maintained on information technology that is subject to and in
compliance with section 208(b) of the E-Government Act of
2002, 44 USC 3501 note, if all of the identifiable private
information collected, used or generated as part of the activity
will be maintained in systems of records subject to the Privacy
Act of 1974, 5 USC 552a, and, if applicable, the information
used in the research was collected subject to the Paperwork
Reduction Act of 1995, 44 USC 3501 et seq.
(5) Research and demonstration projects that are conducted or
supported by a Federal department or agency, or otherwise
subject to the approval of department or agency heads (or the
approval of the heads of bureaus or other subordinate agencies
that have been delegated authority to conduct the research and
demonstration projects), and that are designed to study,
evaluate, improve, or otherwise examine public benefit or
service programs, including procedures for obtaining benefits or
services under those programs, possible changes in or
alternative to those programs or procedures, or possible changes
in methods or levels of payment for benefits or services under
those programs. Such projects include, but are not limited to,
internal studies by Federal employees, and studies under
contracts or consulting arrangements, cooperative agreements,
or grants. Exempt projects also include waivers of otherwise
mandatory requirements using authorities such as sections 1115
and 1115A of the Social Security Act as amended.
Each Federal department or agency conducting or supporting
the research and demonstration projects must establish, on a
publicly accessible Federal website or in such other manner as
the department or agency head may determine, a list of the
research and demonstration projects that the Federal department
or agency conducts or supports under this provision. The
research or demonstration project must be published on this list
prior to commencing the research involving human subjects.
(6) Taste and food quality evaluation and consumer acceptance
studies, (a) if wholesome foods without additives are consumed
or (b) if a food is consumed that contains a food ingredient at or
below the level and for a use found to be safe, or agricultural
chemical or environmental contaminant at or below the level
found to be safe, by the Food and Drug Administration or
approved by the Environmental Protection Agency or the Food

Safety and Inspection Service of the U.S. Department of
Agriculture.
(7) Storage or Maintenance for Secondary Research for which
Broad Consent is required. Storage or maintenance of
identifiable private information or identifiable biospecimens for
potential secondary research use if an IRB conducts a limited
IRB review and makes the determinations requires by 34 CFR
97.111(a)(8).
(8) Secondary Research for which Broad Consent is Required.
Research involving the use of identifiable private information or
identifiable biospecimens for secondary research use if the
following criteria are met: (i) Broad Consent for the storage,
maintenance and secondary research use of the identifiable
private information or identifiable biospecimens was obtained in
accordance with 34 CFR 97.116(a) (1)-(4), (a) (6) and (d); (ii)
Documentation of informed consent or waiver of documentation
of consent was obtained in accordance with 34 CFR 97.117.
(iii) an IRB conducts a limited IRB review and makes the
determination that the research to be conducted is within the
scope of the broad consent referenced in paragraph (d)(8)(i) of
this section; and (iv) The investigator does not prevent an
investigator from abiding by any legal requirements to return
individual research results.
II. Instructions for Exempt and Nonexempt Human
Subjects Research Narratives
If the applicant marked “Yes” for Item 43.b. of the U.S.
Department of Education Supplemental Information for the SF424 form, the applicant must attach a human subjects “exempt
research” or “nonexempt research” narrative to the U.S.
Department of Education Supplemental Information for the SF424 form. If you have multiple projects, include information
about each, labeling the responses as to the project they address.
For applications that include multiple research projects this can
be done in a single narrative or in more than one narrative as
appropriate.
A. Exempt Research Narrative.
If you marked “Yes” for item 43.b. and designated exemption
numbers(s), attach the “exempt research” narrative to the U.S.
Department of Education Supplemental Information for the SF424 form. The narrative must contain sufficient information
about the involvement of human subjects in the proposed
research to allow a determination by ED that the designated
exemption(s) are appropriate. The narrative must be succinct.
B. Nonexempt Research Narrative.
If you marked “No” for item 43.b. you must attach the
“nonexempt research” narrative to the U.S. Department of
Education Supplemental Information for the SF-424 form. The
narrative must address the following seven points. Although no
specific page limitation applies to this section of the application,
be succinct.
(1) Human Subjects Involvement and Characteristics:
Provide a detailed description of the proposed involvement of
human subjects. Describe the characteristics of the subject
population, including their anticipated number, age range, and

health status. Identify the criteria for inclusion or exclusion of
any subpopulation. Explain the rationale for the involvement of
special classes of subjects, such as children, children with
disabilities, adults with disabilities, persons with mental
disabilities, pregnant women, prisoners, institutionalized
individuals, or others who are likely to be vulnerable
(2) Sources of Materials: Identify the sources of research
material obtained from individually identifiable living human
subjects in the form of specimens, records, or data. Indicate
whether the material or data will be obtained specifically for
research purposes or whether use will be made of existing
specimens, records, or data.
(3) Recruitment and Informed Consent: Describe plans for
the recruitment of subjects and the consent procedures to be
followed. Include the circumstances under which consent will
be sought and obtained, who will seek it, the nature of the
information to be provided to prospective subjects, and the
method of documenting consent. State if the IRB has authorized
a modification or waiver of the elements of consent or the
requirement for documentation of consent.
(4) Potential Risks: Describe potential risks (physical,
psychological, social, legal, or other) and assess their likelihood
and seriousness. Where appropriate, describe alternative
treatments and procedures that might be advantageous to the
subjects.
(5) Protection Against Risk: Describe the procedures for
protecting against or minimizing potential risks, including risks
to confidentiality, and assess their likely effectiveness. Where
appropriate, discuss provisions for ensuring necessary medical
or professional intervention in the event of adverse effects to the
subjects. Also, where appropriate, describe the provisions for
monitoring the data collected to ensure the safety of the
subjects.
(6) Importance of the Knowledge to be Gained: Discuss the
importance of the knowledge gained or to be gained as a result
of the proposed research. Discuss why the risks to subjects are
reasonable in relation to the anticipated benefits to subjects and
in relation to the importance of the knowledge that may
reasonably be expected to result.
(7) Collaborating Site(s): If research involving human subjects
will take place at collaborating site(s) or other performance
site(s), name the sites and briefly describe their involvement or
role in the research.
Copies of the Department of Education’s Regulations for the
Protection of Human Subjects, 34 CFR part 97 and other
pertinent materials on the protection of human subjects in
research are available from the Office of the Chief Financial
Officer, U.S. Department of Education, Washington, D.C.
20202-4331, telephone: (202) 245-8090, and on the U.S.
Department of Education’s Protection of Human Subjects in
Research Web Site:
https://www2.ed.gov/about/offices/list/ocfo/humansub.html

NOTE: The State Applicant Identifier on the SF-424 form is
for State Use only. Please complete it on the SF-424 form in the
upper right corner of the form (if applicable).