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CRA > Uniform Guidance, Standard Forms, Code of Fed Regulations > Flashcards

Uniform Guidance, Standard Forms, Code of Fed Regulations Flashcards

1
Q

Uniform Guidance

A

Streamlines and supersedes guidance that was previously contained in eight different OMB Circulars (Chapter 2 CFR, Part 200)

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2
Q

Uniform Guidance Subpart A

A

Acronyms & Definitions

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3
Q

Uniform Guidance Subpart B

A

General Provisions

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4
Q

Uniform Guidance Subpart C

A

Pre-Federal Award Requirements and Contents of Federal Awards

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5
Q

Uniform Guidance Subpart D

A

Standards for Financial and Program Management

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6
Q

Uniform Guidance Subpart E

A

Cost Principles

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7
Q

Uniform Guidance Subpart F

A

Audit Requirements

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8
Q

UG Areas on Performance and Financial Monitoring and Reporting

A
  1. 327 - Financial Reporting
  2. 328 - Monitoring and Reporting Performance
  3. 329 - Fixed Amount Subawards
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9
Q

UG Areas on Record Retention and Access

A
  1. 333 - Record Retention and Access
  2. 334 - Requests for Transfer of Records
  3. 335 - Methods of Collection, Transmission and Storage of Info
  4. 336 - Access to Records
  5. 337 - Restrictions to Public Access of Records
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10
Q

Paperwork Reduction Act of 1980

A

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.

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11
Q

SF 270

A

Request for Advance or Reimbursement

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12
Q

SF 271

A

Outlay Report and Request for Reimbursement for Construction Programs

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13
Q

SF 425

A

Federal Financial Report

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14
Q

SF 425A

A

Federal Financial Report Attachment

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15
Q

SF 428

A

Tangible Personal Property Report

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16
Q

SF 429

A

Real Property Status Report

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17
Q

PPR

A

Performance Progress Report

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18
Q

RPPR

A

Research Performance Progress Report

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19
Q

SF SAC

A

Data collection form for single audits

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20
Q

SF 425 Reporting Deadlines

A

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.

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21
Q

Federal Cash Transactions Report

A
  • Cash Reconciliation due quarterly

- Must be submitted each quarter 30 days after end of quarter (Jan - March, due April 30th)

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22
Q

Uniform Guidance Subpart B (2 CFR 200.100)

A

General Provisions

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23
Q

Requires federal awarding agencies to use OMB-approved application standard information collections to solicit applications

A

UG 200.206 Standard Application Requirements

24
Q

UG 200.204

A

Agency review of merit proposals

25
Q

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

A

The Common Rule

26
Q

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.

A

UG 200.204 Federal Awarding Agency Review of Merit Proposals

27
Q

Streamlines and supersedes guidance that was previously contained in eight different OMB Circulars (chapter 2 CFR, Part 200)

A

The Uniform Guidance

28
Q

CFR Title 21

A

Food & Drugs regulations

29
Q

UG Subpart A

A

Subpart A contains acronyms and definitions used throughout the Guidance.

30
Q

UG Subpart B

A

Subpart B discusses general provisions including the purpose of the Guidance, its applicability, and effective date.

31
Q

UG Subpart C

A

Subpart C covers administrative requirements directed primarily at federal agencies including pre-award activities and requirements for the contents of federal awards.

32
Q

UG Subpart D

A

Subpart D includes many of the administrative requirements that will be areas of focus for your clients including procurement, internal control, and subrecipient monitoring.

33
Q

UG Subpart E

A

Subpart E includes reforms to the Cost Principles previously found in Circulars A-21, A-87, and A-122; and

34
Q

UG Subpart F

A

Subpart F includes the reforms to single audit requirements which were previously found in Circulars A-133 and A-50.

35
Q

45 CFR Part 46

A

Common Rule

36
Q

Common Rule Subpart A

A

Federal policy

37
Q

Common Rule Subpart B

A

Additional protections for pregnant women, human fetuses, and neonates

38
Q

Common Rule Subpart C

A

Additional protections for prisoners

39
Q

Common Rule Subpart D

A

additional protections for children

40
Q

UG Subparts

A

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)

41
Q

FWA

A
  • federal wide assurance

- institutional commitment to HHS that it will comply w common rule (45 CFR 46)

42
Q

OMB

A
  • office of management and budget

- oversees and coordinates federal procurement policy, performance, personnel management, IT, financial management

43
Q

4 Subparts of 45 CFR 46 (common rule)

A

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

44
Q

Federal acquisition regulations (FAR)

1) what does it govern?
2) where is it codified?

A

1) governs federal contracts

2) codified in title 48 of code if federal regulations (CFR)

45
Q

purpose of Federal Acquisition Regulations (FAR)

A

> 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

46
Q

Standard form 33

  • what is it?
  • when does it apply?
A
  • it is how a gov contract is issued

- form on which fed gov solicits, offers and awards a federal contract

47
Q

CFR

A
  • 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
48
Q
  • 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
A

Internal Controls

49
Q

UG at a glance - dictionary

A

A

0-99

50
Q

UG at a glance - housekeeping

A

B

100s

51
Q

UG at a glance - pre-award

A

C

200s

52
Q

UG at a glance - post-award

A

D

300s

53
Q

UG at a glance - coat principles

A

E

400s

54
Q

UG at a glance - audit

A

F

500s

55
Q

Revised Common Rule (2018-2019)

What were 4 changes?

A

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

CRA (21 decks)

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