Uniform Guidance, Standard Forms, Code of Fed Regulations Flashcards
Uniform Guidance
Streamlines and supersedes guidance that was previously contained in eight different OMB Circulars (Chapter 2 CFR, Part 200)
Uniform Guidance Subpart A
Acronyms & Definitions
Uniform Guidance Subpart B
General Provisions
Uniform Guidance Subpart C
Pre-Federal Award Requirements and Contents of Federal Awards
Uniform Guidance Subpart D
Standards for Financial and Program Management
Uniform Guidance Subpart E
Cost Principles
Uniform Guidance Subpart F
Audit Requirements
UG Areas on Performance and Financial Monitoring and Reporting
- 327 - Financial Reporting
- 328 - Monitoring and Reporting Performance
- 329 - Fixed Amount Subawards
UG Areas on Record Retention and Access
- 333 - Record Retention and Access
- 334 - Requests for Transfer of Records
- 335 - Methods of Collection, Transmission and Storage of Info
- 336 - Access to Records
- 337 - Restrictions to Public Access of Records
Paperwork Reduction Act of 1980
The Paperwork Reduction Act of 1980 is a United States federal law enacted in 1980 designed to reduce the total amount of paperwork burden the federal government imposes on private businesses and citizens. The Act imposes procedural requirements on agencies that wish to collect information from the public.
SF 270
Request for Advance or Reimbursement
SF 271
Outlay Report and Request for Reimbursement for Construction Programs
SF 425
Federal Financial Report
SF 425A
Federal Financial Report Attachment
SF 428
Tangible Personal Property Report
SF 429
Real Property Status Report
PPR
Performance Progress Report
RPPR
Research Performance Progress Report
SF SAC
Data collection form for single audits
SF 425 Reporting Deadlines
Quarterly or Semiannual Reports - deadline is 30 days after the close of the reporting period
Annual Reports - deadline is due within 90 days of close. NIH changed this to 120 days, but not all agencies did.
Federal Cash Transactions Report
- Cash Reconciliation due quarterly
- Must be submitted each quarter 30 days after end of quarter (Jan - March, due April 30th)
Uniform Guidance Subpart B (2 CFR 200.100)
General Provisions
Requires federal awarding agencies to use OMB-approved application standard information collections to solicit applications
UG 200.206 Standard Application Requirements
UG 200.204
Agency review of merit proposals
1991
45CFR Part 46
A rule of ethics regarding biomedical and behavioral research involving human subs in the U.S. The basic DHHS policy for the protection of human subjects.
- Requirement for assuring compliance by research institution
- Requirements for obtaining and documenting informed consent
- Requirements for IRB membership, function, operations, review of research, and record keeping
Adopted by 15 fed departments and agencies
The Common Rule
For competitive grants or cooperative agreements, fed awarding agencies must design and execute a merit review process for applications.
Process must be described or incorporated by reference in funding opportunity.
UG 200.204 Federal Awarding Agency Review of Merit Proposals
Streamlines and supersedes guidance that was previously contained in eight different OMB Circulars (chapter 2 CFR, Part 200)
The Uniform Guidance
CFR Title 21
Food & Drugs regulations
UG Subpart A
Subpart A contains acronyms and definitions used throughout the Guidance.
UG Subpart B
Subpart B discusses general provisions including the purpose of the Guidance, its applicability, and effective date.
UG Subpart C
Subpart C covers administrative requirements directed primarily at federal agencies including pre-award activities and requirements for the contents of federal awards.
UG Subpart D
Subpart D includes many of the administrative requirements that will be areas of focus for your clients including procurement, internal control, and subrecipient monitoring.
UG Subpart E
Subpart E includes reforms to the Cost Principles previously found in Circulars A-21, A-87, and A-122; and
UG Subpart F
Subpart F includes the reforms to single audit requirements which were previously found in Circulars A-133 and A-50.
45 CFR Part 46
Common Rule
Common Rule Subpart A
Federal policy
Common Rule Subpart B
Additional protections for pregnant women, human fetuses, and neonates
Common Rule Subpart C
Additional protections for prisoners
Common Rule Subpart D
additional protections for children
UG Subparts
Subpart A - contains acronyms and definitions used throughout the Guidance. (200.0-200.99)
Subpart B - discusses general provisions including the purpose of the Guidance, its applicability, and effective date. (200.100 - 200.199)
Subpart C - covers administrative requirements directed primarily at federal agencies including pre-award activities and requirements for the contents of federal awards. (200 - 299)
Subpart D - includes many of the administrative requirements that will be areas of focus for your clients including procurement, internal control, and subrecipient monitoring. (300-399)
Subpart E - includes reforms to the Cost Principles previously found in Circulars A-21, A-87, and A-122 (400-499)
Subpart F - includes the reforms to single audit requirements which were previously found in Circulars A-133 and A-50. (500-599)
FWA
- federal wide assurance
- institutional commitment to HHS that it will comply w common rule (45 CFR 46)
OMB
- office of management and budget
- oversees and coordinates federal procurement policy, performance, personnel management, IT, financial management
4 Subparts of 45 CFR 46 (common rule)
A - federal policy (basic IRB provisions, informed consent requirements, compliance assurances)
B - additional protections for pregnant women
C - additional protections for prisoners
D - additional protections for children
Federal acquisition regulations (FAR)
1) what does it govern?
2) where is it codified?
1) governs federal contracts
2) codified in title 48 of code if federal regulations (CFR)
purpose of Federal Acquisition Regulations (FAR)
> cost - reduce admin costs and price of services
quality - improve quality of gov contracts
efficiency - expedite process to reduce admin burden and save tax payer dollars
establish uniform acquisition procedures
promote competition between contractors
Standard form 33
- what is it?
- when does it apply?
- it is how a gov contract is issued
- form on which fed gov solicits, offers and awards a federal contract
CFR
- code of federal regulations
- codification of general and permanent rules published in fed register by exec depts and agencies of fed gov
- 50 titles further broken down into chapters, parts, sections, paragraphs
- included in UG subpart D
- Requires NFEs to:
1) est. and maintain effective internal control over award to provide reasonable assuarance that award is being managed in compliance with fed statues, regs, terms and conditions of award.
2) evaluate and monitor compliance
3) take prompt action on noncompliance and audit findings
4) safeguard protected PII
Internal Controls
UG at a glance - dictionary
A
0-99
UG at a glance - housekeeping
B
100s
UG at a glance - pre-award
C
200s
UG at a glance - post-award
D
300s
UG at a glance - coat principles
E
400s
UG at a glance - audit
F
500s
Revised Common Rule (2018-2019)
What were 4 changes?
1) changed definition of human sub - expanded to include both identifiable data and identifiable specimens
2) provides explicit definition of clinical trials
3) changes to IRB exemption categories
4) mandates single IRB for federally funded multi-site studies
