RFP-Performance Table Rev A.pdf

RFP SOW

Section#

Description Standard

D.1 Central Document Room D.1.7.4 Mail Distribution, Sort, and Prioritization 99% - accuracy for priority Documents D.1.7.4.1 New IND processing 99% - accuracy, processed within 3-working days upon receipt by CDER D.1.7.4.4 New NDA processing 99% - accuracy, processed within 3-working days upon receipt by CDER D.1.7.4.7 Electronic Submissions 99% - accuracy, processed and delivered to EDR staff within 1-working days D.3 Office of New Drugs (OND) D.3.3.2 Identification and Validation 99% - processing accuracy Identification & Validation of Priority

Documents D.3.3.2.3 OND Data Entry 99% - processing accuracy Data Abstraction & Entry D.3.3.2.4 NDA Data Entry into COMIS & ECH 99% - processing accuracy Data Abstraction & Entry into COMIS and ECH D.3.3.2.7 IND Data Entry into DARRTS 99% - processing accuracy Data Abstraction & Entry into

DARRTS

D.3.3.2.8 BLA Data Entry into RMS-BLA 99% - processing accuracy Data Abstraction & Entry into RMS-

BLA

D.3.4 Labeling and Barcoding 99% - processing accuracy D.3.10 IND, NDA, BLA Review Material Distribution to

CDER's Program Managers 99% - processing accuracy Review Material Distribution within: 2-days for Priority Documents / 3-days for Non-Priority Documents

D.3.11 Turnover Material Processing 99% - processing accuracy within 1-working day of sign-off by CDER's PM

Critical Processing Time Constraints

RFP SOW

Section#

Description Standard

D.4 DDMAC

D.4.2 DDMAC Mail Processing 99% - mail processing accuracy; Identify & Route "priority" mail within 1-working day / Distribute all "non-priority" within 2-working days

D.5 Office of Generic Drugs (OGD) D.5.4.1.5 Processing Electronic Data for an ANDA 99% - processing accuracy; process Electronic media within 24-hours upon receipt D.6 Drug Master Files (DMF) D.6.11 DMF Requests 99% - processing accuracy; Contractor shall respond to DMF requests within 1-working day D.9 Electronic Document Room (EDR) D.9.3 Acceptable Quality Levels (AQL) 99% overall performance quality level process electronic document within 48-hours, respond to CDER reviewer requests within 1-working day

D.9.4.2 Misdirected Mail 99% - processing accuracy; forward misdirected mail to appropriate CDER Review Div. within 1-working day

D.9.6.2.1 Receipt of Gateway Submissions 99% - processing accuracy; complete processing within 24-hours upon receipt of the e-mail notification

D.9.7 EDR Tracking/Logging/Reporting 99% - processing accuracy; operation shall take no longer than 2-working days

D.9.8 Daily Workload Report All submissions pending for more than 2-working days are listed separately with all receipt and problem information and tracked daily for progress.