FDA's Calendar of Management
Reform Initiatives

 

 Budget Process | Clinger-Cohen (CCA) | CFO Act/GMRA | FDAMA | FMFIA | GPRA | OIG | PDUFA | FDA Homepage

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Major Milestones and Reporting Requirements

 (PY = Prior Year, CY = Current Year, BY = Budget Year)

January February March April May June
July August September October November December

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JANUARY

 TOP

Budget Process
Execution
  • Issue: allowance histories (CY, BY),
  • Issue allowance/sub-allowance notices thru the 2nd quarter (CY)
  • Centers/Offices Initial Financial Operating Plans (FOPs) due to OFM (CY)
Formulation
  • Transmit BY budget estimates to OMB for President's Budget (PB)
  • Prepare Congressional Justification (CJ) materials to support and explain FDA's BY budget request
CFO Act
  • OIG issues final audit report.
  • Provide comments to the DHHS Accountability Report.
  • Submits Financial Management Status Report to DHHS (PY)

FMFIA
GPRA
  • Performance Plan due for input to Congressional Justification

Clinger-Cohen (CCA)
  • OIRM revises Exhibits 53 and 300B as directed by DHHS and OMB

QWL
  • Annual Human Resources Management Index Survey
FDAMA
PDUFA

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FEBRUARY

 TOP

Budget Process

Execution
  • Review, analyze and return FOPs to Centers/Offices (CY)
  • Update allowance/sub-allowance notices as needed thru the 2nd quarter. (CY)
  • Forward quarterly obligation report to Department (CY)
  • Forward quarterly outlays report to Department (CY,BY)

Formulation
  • President forwards BY Budget request to Congress
  • Submit BY CJ to House and Senate
  • Prepare briefing books for Congressional budget hearings
  • House Appropriations Hearing on FDA's Budget (BY)
  • Review transcripts of BY testimony from House Appropriations Sub-committee
  • Receive Q&As on BY CJ from House Appropriations Sub-committee
  • Develop Priorities for DHHS Budget (BY+1)

CFO Act
  • DHHS issues Accountability Report

FMFIA

  • Distribution of final FMFIA Report

GPRA
  • Performance Plan & CJ due to Congress

Clinger-Cohen (CCA)
  • OIRM requests information to update the PDUFA II Five Year Information Management Plan

QWL
  • Report to FDA
  • To HHS

FDAMA

  • FDA hosts stakeholder feedback meetings

PDUFA

  • Center PDUFA 5 year plan is due

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MARCH

 TOP

Budget Process
Execution
  • Submission of Quarterly PDUFA Percentages (CDER and CBER only) (CY)
  • Update/Issue allowance/sub-allowance notices as needed thru the 2nd quarter (CY)

Formulation
  • Senate Appropriations Hearings on FDA's Budget (BY)
  • Receives Q & As on BY CJ are received from Senate Sub-committee
  • Process responses to House Appropriations Sub-committee Q&As
  • Review transcripts of testimony from Senate Appropriations Hearing
  • Develop Priorities for DHHS Budget (BY+1)

CFO Act
  • Issues CFO's Annual Report.

FMFIA
  • Strike Team develops initial FMFIA design/approach for current year

GPRA
  • Budget/ Performance Plan coordination meeting (OPPL/OFM)

Clinger-Cohen (CCA)
  • Subject to change pending re-engineering outcome

QWL
  • HHS survey results issued

FDAMA
PDUFA

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APRIL

 TOP

Budget Process
Execution
  • Issue allowance/sub-allowance notices thru the 3rd quarter (CY)
  • Centers/Offices 2nd quarter FOPs due to OFM (CY)
  • Request for resource utilization report from Centers (CY)

Formulation
  • Process Responses to Senate Appropriations Subcommittee:
    Q & As
  • Develop Submission to DHHS Budget (BY+1)

CFO Act

FMFIA
  • FMFIA Training (TBD)

GPRA
  • Memo from B.Byrd to Center Directors & Exec. Officers to begin planning process
  • OP/OFM meet with Center program contacts: Review FY 2000 & plan for FY 2001

Clinger-Cohen (CCA)
  • OIRM publishes revised PDUFA II Five-Year Plan

QWL
  • FDA report to HHS on survey results
FDAMA

  • Stakeholder meetings
PDUFA

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MAY

 TOP

Budget Process
Execution
  • Review, analyze, and return FOPs to Centers/Offices (CY)
  • Update allowance/sub-allowance notices as needed thru the 3rd quarter (CY)
  • Forward quarterly obligation report to Department (CY)
  • Forward quarterly outlays report to Department (CY)

Formulation
  • OP/OFM link performance plan to preliminary budget
  • Monitor progress of BY Appropriations bills through House, Senate, Conference Action, and Enactment
  • Develop Budget Submission to DHHS (BY+1)

CFO Act
  • Requests Centers to select program performance goals for next year's Annual Report.
  • Begin financial statement audit
  • Submit (CY) financial management [Five Year] plan to DHHS
  • Submit Corrective Action Plan and Status Report to OIG.
 

FMFIA
  • DMP FMFIA Team Meeting

GPRA
  • Distribute budget & performance plan guidance
  • Center performance plan submissions due to OPE

Clinger-Cohen (CCA)
  • DHHS issues data call for Exhibit 53 and 300Bs to OIRM

QWL
FDAMA
PDUFA

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JUNE

TOP 

Budget Process
Execution
  • Update allowance/sub-allowance notices as needed thru the 3rd quarter (CY)
  • Coordinate and Conduct Third Quarter Mini-closeout (CY)
  • Publish Year-end Closeout Instructions (CY)
Formulation
  • Prepare and Submit BY+1 budget submission to the Department
  • Monitor progress of BY Appropriations bills through House, Senate, Conference Action, and Enactment
CFO Act
  • Send Center selected program performance goals to the Department and to the OIG's CPA firm.
  • CPA firm conduct field work beginning with internal controls phase.

FMFIA
  • Preliminary guidance to FMFIA Liaisons 
GPRA
  • Draft Performance Plan & DHHS Budget go to printer
  • Draft Agency Performance Plan and Preliminary Budget due to DHHS
  • Distribute budget & performance plan guidance

Clinger-Cohen (CCA)
  • Centers/Offices validate Exhibit 53 and 300Bs to OIRM
  • Centers/Offices submit Draft Exhibit 53 and 300Bs to DHHS

QWL
FDAMA

  • Report on FDAMA performance goals due to OPE
PDUFA

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JULY

 TOP

Budget Process
Execution
  • Issue allowance/sub-allowance notices as needed thru the 4th quarter (CY)
  • Forward quarterly obligation report to Department (CY)
  • Forward quarterly outlays report to Department (CY)
Formulation
  • Commissioner meets with Secretary DHHS on BY+1 budget
  • Receive approved BY+1 budget levels from DHHS Budget Office
  • Prepare package to appeal cuts in DHHS passback (BY+1)
  • Monitor progress of BY Appropriations bills through House, Senate, Conference Action, and Enactment
CFO Act
  • CFO Audit continues

FMFIA
  • Official call for letter of Assurance sent to Centers, ORA, OC and OMS
GPRA
  • Adjust budget and performance plan to reflect DHHS passback

Clinger-Cohen (CCA)
  • DHHS provides feedback regarding the quality of 300B submissions

QWL
FDAMA
PDUFA

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AUGUST

 TOP

Budget Process
Execution
  • Update allowance/sub-allowance notices as needed thru the 4th quarter (CY)
  • Submit Carryover Apportionments for all Multi year Appropriations (BY)
Formulation
  • Receive final BY+1 DHHS Passback / Prepare OMB Budget
  • Monitor progress of BY Appropriations bills through House, Senate, Conference Action, and Enactment
CFO Act
  • Nothing to report.

FMFIA

  • Follow up call for letter of Assurance to Centers, ORA, OC and OMS for update on the individual Letter of Assurance

GPRA

Clinger-Cohen (CCA)
  • TRB assesses investments requesting Strategic Systems funding
  • ITIRB meets to assess Strategic System proposals for BY
  • OIRM submits revised 300Bs to DHHS

QWL
FDAMA
PDUFA

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SEPTEMBER

 TOP

Budget Process
Execution
  • Update allowance/sub-allowance notices as needed thru the 4th quarter (CY)
  • Coordinate and conduct year-end closeout (CY)
Formulation
  • Revised Performance Plan & Budget to OMB thru DHHS (BY+1)
  • Monitor progress of BY Appropriations bills through House, Senate, Conference Action, and Enactment
CFO Act
  • Auditors conduct field work compliance testing
  • Centers update their chapters contained in the annual report.

FMFIA

  • Early September Individual Components' assurance statement due to DMP

    		•
    GPRA
    • Preliminary budget, performance plan and results due to OMB

    Clinger-Cohen (CCA)
    • Centers/Offices provide CY IT Business Plan information to OIRM 

    QWL
    FDAMA
    PDUFA

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    OCTOBER

     TOP

    Budget Process
    Execution
    • Complete year-end closeout and prepare year-end reports (PY)
    • Develop apportionment for all Appropriations and submit to OMB (CY)
    • Issue Initial allowance/sub-allowance notices as needed thru the 1st quarter (CY) )
    Formulation
    • Support Commissioner's Hearing with OMB (BY)
    CFO Act
    • CPA firm field work - compliance testing phase begins
    • OFM closes the general ledger for the FY just completed.
    • OFM clears proposed program chapters
     

    FMFIA

    • Early October forward FDA's Letter of Assurance to the Acting Senior Associate Commissioner for signature through the commissioner (OMS) 
    GPRA

    Clinger-Cohen (CCA)
    • OIRM publishes CY IT Business Plan

    QWL
    FDAMA
    PDUFA

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    NOVEMBER

    TOP 

    Budget Process
    Execution
    • Develop draft CY full-year allocation and present to FDA management
    Formulation
    • OMB passback received/coordinated with Centers (BY)
    • Prepare package to appeal cuts in OMB passback through DHHS (BY)
    CFO Act
    • CPA firm field work - tests year-end balances (PY)
    • Draft Commissioner and Chief Financial Officer's Letters
    • Clear revised program chapters with the Center (PY)
    • OFM submits draft CFO report to DHHS and to CPA firm

    FMFIA

    • Early November Forward FDA's annual Assurance Letter submitted by the Commissioner to the Secretary of HHS 
    GPRA
    • OMB passback received

    Clinger-Cohen (CCA)
    • TRB assesses investments not requesting Strategic Systems funding
    • ITIRB recommends BY Execution funding recommendations for Strategic Systems

    QWL
    FDAMA

    • Report due to Congress
    PDUFA

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    DECEMBER

     TOP

    Budget Process
    Execution
    • Update/Issue allowance/sub-allowance notices as needed thru the1st quarter (CY)
    • Issue full-year allocations as decided by FDA Management (CY)
    • Submit technical data for inclusion in President's Budget Appendix.

    Formulation
    • Receive final approved BY budget levels from OMB.
    • Start BY CJ
    • Prepare PY accomplishments (Blue Pages) for inclusion in BY CJ
    • Submit technical data for inclusion in President's Budget Appendix.

    CFO Act
    • CPA firm field work ends.
    • OFM submits Final Draft CFO's Annual Report to DHHS and the CPA firm.
    • OFM provides comments on the draft audit report
    • OFM records remaining financial statement adjustments and issues final financial statements.

    FMFIA
    • 12/31 Department's submits its Annual Report  to the President and  Congress

    GPRA
    • Obtain modified performance results and goals for Congressional Justification

    Clinger-Cohen (CCA)
    • OIRM Submits final Exhibit 53 and 300Bs to DHHS

    QWL
    • FDA Annual QWL Report planning meeting
    FDAMA
    PDUFA

    • Issue Center call for PDUFA 5 year plan

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    Updated 05/2/02
    LJC