Appendix_5_-_CDRH_Work_Functions.xls

XLS spreadsheet 88 KB Posted May 23, 2014

Attached to: Fully Integrated Records Facility (Offsite Document Control Center) Federal contract opportunity
Solicitation number: FDA-Off-Site-RIM-000141
Issued by: Department of Health and Human Services Food and Drug Administration

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Appendice 5

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Other files for this federal contract opportunity

Other files attached to Fully Integrated Records Facility (Offsite Document Control Center), newest first.
File	Type	Posted
Revised_Solicitation.pdf	PDF	Jul 14, 2014
Amendment_7_to_Solicitation.pdf	PDF	Jul 14, 2014
Revised_Attachment_3_-_Labor_Category_Descriptions.pdf	PDF	Jul 14, 2014
Revised_Attachment_5_-_IDIQ_Pricing_Worksheet.xls	XLS spreadsheet	Jul 8, 2014
IMG-20140612-00033.jpg	JPG image	Jul 8, 2014
IMG-20140612-00031.jpg	JPG image	Jul 8, 2014
IMG-20140612-00030.jpg	JPG image	Jul 8, 2014
Amendment_5_to_Solicitation.pdf	PDF	Jul 8, 2014
IMG-20140612-00035.jpg	JPG image	Jul 8, 2014
IMG-20140612-00036.jpg	JPG image	Jul 8, 2014
Revised_Solicitation.pdf	PDF	Jul 8, 2014
Appendix_8_-_Estimate_of_Monthly_Scanning_Amounts.pdf	PDF	Jun 25, 2014
Revised_Appendix_3_-_Summary_of_Volume_of_Submissions_by_Center.pdf	PDF	Jun 25, 2014
Amendment_4_to_Solicitation.pdf	PDF	Jun 25, 2014
Revised_Attachment_3_-_Labor_Category_Descriptions.pdf	PDF	Jun 25, 2014
Revised_Standard_Form_1449.pdf	PDF	Jun 25, 2014
Revised_Solicitation.pdf	PDF	Jun 25, 2014
Attachment_11_-_Form_3514.pdf	PDF	Jun 25, 2014
Revised_Attachment_5_-_IDIQ_Pricing_Worksheet.xls	XLS spreadsheet	Jun 23, 2014
Revised_Attachment_1_-_IDIQ_Statement_of_Work.pdf	PDF	Jun 23, 2014
Revised_Attachment_6_-_Task_Order_1_PricingWorksheet.xls	XLS spreadsheet	Jun 23, 2014
Revised_Attachment_2_-_Task_Order_1_Performance_Work_Statement.pdf	PDF	Jun 23, 2014
Appendix_2A_-_Addendum_to_Physical_Security_Requirements_Specifications_For_FDA_Facilities.pdf	PDF	Jun 23, 2014
Amendment_3_to_Solicitation.pdf	PDF	Jun 23, 2014
Amendment_1_to_Solicitation.pdf	PDF	Jun 3, 2014
Site_Visit_Registrants.pdf	PDF	Jun 3, 2014
Site_Visit_Attendees.pdf	PDF	Jun 3, 2014
Site_Visit_Presentation.pdf	PDF	Jun 3, 2014
Appendix_3_-_Summary_of_Volume_of_Submissions_by_Center.pdf	PDF	May 23, 2014
Appendix_6C_-_Basic_RP_LAN_room_layout.pdf	PDF	May 23, 2014
Attachment_2_-_Task_Order_1_Statement_of_Work.pdf	PDF	May 23, 2014
Attachment_3_-_Labor_Category_Descriptions.pdf	PDF	May 23, 2014
Appendix_4_-_FDA_Document_Control_Facilities.xls	XLS spreadsheet	May 23, 2014
Appendix_6B_-_Large_Computer_Room_General_Specifications_with__Electrical_Requirements.pdf	PDF	May 23, 2014
Appendix_6D_-_Electrical_BTU_Loading_Worksheet_.xls	XLS spreadsheet	May 23, 2014
Appendix_6E_-_ground-bus.pdf	PDF	May 23, 2014
Appendix_7_-_Glossary_of_Terms.pdf	PDF	May 23, 2014
Attachment_5_-_IDIQ_Pricing_Worksheet.xls	XLS spreadsheet	May 23, 2014
Attachment_10_-_Offeror_Represenatations_and_Certifications.doc	DOC document	May 23, 2014
Attachment_9_-_Template_for_Questions.xls	XLS spreadsheet	May 23, 2014
Attachment_7_-_Past_Performance_Questionnaire.doc	DOC document	May 23, 2014
Appendix_2_-_FDA_Physical_Security_Requirements Specifications_for_FDA_Facilities.pdf	PDF	May 23, 2014
Attachment_8_-_Form_3398.pdf	PDF	May 23, 2014
Attachment_6_-_Task_Order_1_PricingWorksheet.xls	XLS spreadsheet	May 23, 2014
Attachment_4_-_Wage_Determination.pdf	PDF	May 23, 2014
Attachment_1_-_IDIQ_Statement_of_Work.pdf	PDF	May 23, 2014
Appendix_1_-_FDA_IT_Facilities_Requirements.pdf	PDF	May 23, 2014
Standard_Form_1449.pdf	PDF	May 23, 2014
Solicitation.pdf	PDF	May 23, 2014
Appendix_6A-_Small_Computer_Room_or_LAN_Closets_Electrical_Requirements.pdf	PDF	May 23, 2014

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Footage

CDRH Work Function	Address	Linear Footage	Square Footage	% of Box Shelving	% of Loose Files
DCC	10903 New Hampshire Ave, Silver Spring, MD 20993	12,000	7,500	4 Shelving Units	75%
Registration and Listing	5630 Fishers Lane, Rockville, MD 20857		300 square feet
Export Applications and Certificates	10903 New Hampshire Ave, Silver Spring, MD 20993		336 square feet	7 cabinets/ 5 drawers each	100%- CFG's, C802, C801 , NCR
Adverse Event Reporting	16071 Industrial Drive, Gaithersburg, Maryland 20877-1462	N/A	7,500 square feet	All CDRH	MedWatch 3500 and 3500A Forms
Radilogical Health	10903 New Hampshire Ave, Silver Spring, MD 20993	3,000	2,100

2012 Submissions and File Maint

2012 CDRH Application, Submissions, and File Maintenance
CDRH Work Function	Document Types	# of Submissions Submitted	Electronic Submission (future state)	# of Amendments	Electronic Submission (future state)
			% reduction on current workload		% reduction on current workload
DCC	PMA Originals & Panel Track Sups.	40	no change from current state	400	no change from current state
	Real Time PMA/PDP Supplements	300		175
	30 Day Notices & 135-Day PMA/PDP Sup	1600		330
	180 Day PMA/PDP sup. (user fee)	400		500
	PMA/PDP Reports	1000		700
	PMA Modules	60		40
	PMA Module Supplements	5
	HDE Originals	10		50
	HDE Supplements	110		50
	HDE Reports	75		40
	510(k) Originals	4000		1300
	510(k) Supplements	4000
	510(k) Add-to-Files	1500
	De Novo Requests	25
	513(g)	5
	IDE Originals	300		500
	IDE Supplements	3000		500
	Q-Submissions (Pre-Submission/Pre-IDE) Originals	1100		1100
	Q-Submissions (Pre-Submission/Pre-IDE) Supps.	1000		1000
	CLIA Documents	50		50
	Reclassifications Petitions	25		25
	515(i)	50		50
	Master Files	50		50
		18705		6685
R&L	*See Registration and Listing Data Tab
EREA (current state)	Certificates	60+ per day
MDR	Manufacturer Initial Reports	467689
	Supplemental Reports	271232
	Five-Day Manufacturer Reports	7
	Importer Reports	429
	User Facility Initial Reports	1674
	User Facility Annual Reports	240
	MedSun User Facility Reports	4588
	MedWatch Voluntary Reports	4785
	Voluntary Phone Reports	250
Rad Health	EPRC Recall	32
	Medical Device Recalls	258
	Accidental Radiation Occurrence	60
	EPRC Establishment Inspection Report	87
	Medical Device Establishment Inspection Report	24
	Field Test	2
	Import Issues, Detention/Refusal	1
	Inquiry	6
	Lab Sample	63
	Laser Light Show Correspondence, Other	0
	Laser Light Show Notification	447
	Manufacturer Application for Alternate Test Procedures	- 0
	Manufacturer Request for Alternate Labeling	1
	Manufacturer Special Exemption from Reporting/Recordkeeping	5
	Other	30
	Request Exemption of Products for Gov't Use from a Standard	1
	Request Exemption of Products for Gov't Use from Reporting/Recordkeeping	1
	Request for Regulatory or Safety Information	2
	Response to FDA Activity or Communication	80
	Response to Program Disapproval	- 0
	EPRC Complaint	18
	Medical Device Complaint	27
	US Designated Agent	9
	Total Regulatory Correspondence	1,154
	Abbreviated Report	133
	Annual Report	1,615
	Common Aspects Report	4
	Initial Product Report	1,011
	Laser OEM Registration and Listing	148
	Model Change Product Report	10
	Product Report	1,522
	Variance Request	248
	Total Radiation Safety Reports	4,691
	Medical Reports of Assembly	23571
	Dental Reports of Assembly	325
	Veterinary Reports of Assembly	10
	Total Reports of Assembly	23,906
*In most cases documents have both incoming and outgoing processing involved. Each document may have multiple transactions (i.e., cycles of tracking processing).
Therefore the number of transactions will be substantially greater than the number of unique documents.

2013 Submissions and File Maint

2013 CDRH Application, Submissions, and File Maintenance
CDRH Work Function	Document Types	# of Submissions Submitted	Electronic Submission (future state)	# of Amendments	Electronic Submission (future state)
			% reduction on current workload		% reduction on current workload
DCC	PMA Originals & Panel Track Sups.
	Real Time PMA/PDP Supplements
	30 Day Notices & 135-Day PMA/PDP Sup
	180 Day PMA/PDP sup. (user fee)
	PMA/PDP Reports
	PMA Modules
	PMA Module Supplements
	HDE Originals
	HDE Supplements
	HDE Reports
	510(k) Originals
	510(k) Supplements
	510(k) Add-to-Files
	De Novo Requests
	513(g)
	IDE Originals
	IDE Supplements
	Q-Submissions (Pre-Submission/Pre-IDE) Originals
	Q-Submissions (Pre-Submission/Pre-IDE) Supps.
	CLIA Documents
	Reclassifications Petitions
	515(i)
	Master Files
R&L	*See Registration and Listing Data Tab
EREA (current state)	Certificates	60+ per day
MDR	Manufacturer Initial Reports	632,562
	Supplemental Reports	304,923
	Five-Day Manufacturer Reports	15
	Importer Reports	2,442
	User Facility Initial Reports	1,060
	User Facility Annual Reports	184
	MedSun User Facility Reports	4,320
	MedWatch Voluntary Reports	5,239
	Voluntary Phone Reports	269
Rad Health	EPRC Recall	22
	Medical Device Recalls	242
	Accidental Radiation Occurrence	119
	EPRC Establishment Inspection Report	69
	Medical Device Establishment Inspection Report	22
	Field Test	0
	Import Issues, Detention/Refusal	7
	Inquiry	3
	Lab Sample	62
	Laser Light Show Correspondence, Other	2
	Laser Light Show Notification	125
	Manufacturer Application for Alternate Test Procedures	1
	Manufacturer Request for Alternate Labeling	2
	Manufacturer Special Exemption from Reporting/Recordkeeping	- 0
	Other	15
	Request Exemption of Products for Gov't Use from a Standard	2
	Request Exemption of Products for Gov't Use from Reporting/Recordkeeping	- 0
	Reporting/Recordkeeping	4
	Request for Regulatory or Safety Information	- 0
	Response to FDA Activity or Communication	136
	Response to Program Disapproval	1
	EPRC Complaint	52
	Medical Device Complaint	30
	US Designated Agent	9
	Total Regulatory Correspondence	925
	Abbreviated Report	137
	Annual Report	1,829
	Common Aspects Report	7
	Initial Product Report	1,169
	Laser OEM Registration and Listing	138
	Model Change Product Report	1
	Product Report	1,711
	Variance Request	342
	Total Radiation Safety Reports	5,334
	Medical Reports of Assembly	23571
	Dental Reports of Assembly	325
	Veterinary Reports of Assembly	6
	Total Reports of Assembly	23,902
*In most cases documents have both incoming and outgoing processing involved. Each document may have multiple transactions (i.e., cycles of tracking processing).
Therefore the number of transactions will be substantially greater than the number of unique documents.

2012 Imaging and eCopy Loading

2012 CDRH Document Imaging and eCopy Loading
CDRH Work Function	Document Types	# of Request received	# of Request reviewed	# of Certificates Issued	# of Pages scanned/imaged	# of Pages scanned	# of Pages Uploaded	Electronic Submission (future state)	# of E-Copies	# Received	# of E-Copies	# eSubmissions Loaded	Electronic Submission (future state)	# Forms Entered	Electronic Submission (future state)	# of Documents	Electronic Submission (future state)
						% reduction on current workload		% reduction on current workload			% reduction on current workload		% reduction on current workload		% reduction on current workload		% reduction on current workload
DCC	E-Copy
	HDE				9,199	75% reduction by 5th year	42,216	5% increase by 5th year	140		5% increase by 5th year
	IDE				51,699		379,479		1,226
	Master Files				178,852		9536		47
	PDD				3,420		361		10
	PID				8,995		29,475		292
	PMA				171,295		1,047,190		3,437
	PMN				2,097,675		938,343		2,758
	PMR				3,562		84,883		75
					2,524,697		2,531,483		7,985
R&L	*See Registration and Listing Data Tab
MDR	Manufacturer Initial Reports				510970		510970
	Supplemental Reports				280642		280642
	Five-Day Manufacturer Reports				42		42
	Importer Reports				1000		1000
	User Facility Initial Reports				2100		2100
	User Facility Annual Reports				36		36
	MedSun User Facility Reports				1900		1900
	MedWatch Voluntary Reports				23925		23925
	Voluntary Phone Reports				500		500
Rad Health	Radiation Safety Reports				400,000							1,000				5,000
	Regulatory Correspondence				5,250											1,050
	Reports of Assembly													14,000		24,000

2013 Imaging and eCopy Loading

2013 CDRH Document Imaging and eCopy Loading

CDRH Work Function

Document Types

# of Request received

# of Request reviewed

# of Certificates Issued

# of Pages scanned/imaged

# of Pages scanned

# of Pages Uploaded

Electronic Submission (future state)

# of E-Copies

# Received

# of E-Copies

# eSubmissions Loaded

Electronic Submission (future state)

# Forms Entered

Electronic Submission (future state)

# of Documents

Electronic Submission (future state)

% reduction on current workload

DCC

eCopy

20,000

IDE

7,000

PMA Submission

5,000

510(k) Submissions

10,500

All other ODE Documents

1,000

R&L

*See Registration and Listing Data Tab

MDR

Manufacturer Initial Reports

541,206

Supplemental Reports

206,469

Five-Day Manufacturer Reports

Importer Reports

7,263

User Facility Initial Reports

1,416

User Facility Annual Reports

MedSun User Facility Reports

645

MedWatch Voluntary Reports

15,246

Voluntary Phone Reports

538

Rad Health

Radiation Safety Reports

5,334

Regulatory Correspondence

925

Reports of Assembly

23902

Registration & Listing 2012

Registration and Listing Data 2012
ACTIVITY	JANUARY	FEBRUARY	MARCH	APRIL	MAY	JUNE	JULY	AUGUST	SEPTEMBER	OCTOBER	NOVEMBER	DECEMBER	YEAR TOTAL
Emails answered	2138	1490	1242	869	915	833	783	1194	1249	2813	3323	2988	19837
Voicemails answered	488	338	243	153	169	188	213	272	251	715	749	736	4515
Letters answered		29	10					1					40
Foreign FEIs assigned	87		114	448	332	119	46	182	174	15	6	28	1551
Domestic FEIs assigned	199	134	143			17	45	33	42	46	181	104	944
Registration # assignment emails (TASK 6)	286	134	257	386	327	136	91	215	216	61	187	132	2433
Registration confirmation emails (TASK 4)	2200	706	842	531	438	394	491	600	222	2269	4976	4421	18090
Registration reminder emails	4793												4793
Failed to reregister emails (TASK 29)										23472	1201	13356	38029
Final registration notice emails			2228										2228
Extension of registration deadline emails - 2012												21394	21394
Duplicate registration records corrected	22	24	25	24	18	13	25	15	17	13	43	53	292
Delayed response emails (TASK 11)	1657	491											2148
Untitled Letter emails (TASK 16)		3173											3173
Untitled Letter secondary attempt emails		103											103
Untitled Letters sent by postal mail		244											244
Province info corrected for foreign establishments					65	42	130		56				293
Unused PIN/PCN emails			479										479
FURLS access change emails		551	91	63									705
Invalid device listing emails				27									27
Account ID emails (TASK 27)									25919				25919
R&L newsletter emails				22924		18069							40993
Invalid pending listings cancelled (REQNP cleanup)				101		31	2						134
Registration records reassociated with active FURLS accounts					51								51

Registration & Listing 2013

Registration and Listing Data 2013
ACTIVITY	JANUARY	FEBRUARY	MARCH	APRIL	MAY	JUNE	JULY	AUGUST	SEPTEMBER	OCTOBER	NOVEMBER	DECEMBER	YEAR TOTAL
Emails answered	3549	2534	2535	1690	1115	948	972	1335	1175	1411	2290	3378	22,932
Voicemails answered	949	763	732	367	342	248	291	322	430	352	448	845	6,089
Foreign FEIs assigned	6	53	16	128	261	110	153	207	415	122	52	50	1,573
Registration # assignment emails (TASK 6)	182	136	176	206	261	107	95	184	304	149	58	173	2,031
Registration confirmation emails (TASK 4)	4790	2329	1186	704	553	469	341	340	183	2142	5328	10057	28,422
Failed to reregister emails (TASK 29)										14066	13580	11425	39,071
Duplicates report generated and reviewed	4	4	4	4	4	4	4	4	4	2	4	4	46
Duplicate registration records corrected	39	40	23	24	14	20	15	15	14	5	21	12	242
Untitled Letter emails (TASK 16)			6809										6,809
Untitled Letter secondary attempt emails			1266										1,266
Untitled Letters sent by postal mail			299										299
List of non reregistered Class 3 device facilities (TASK 14)	1				1					1			3
District Lists (all registered & unregistered facilities)				20	2								22
Province info corrected for foreign establishments									58				58
Unused PIN/PCN emails							121	383					504
Email addresses corrected				55	7	4	4			6			76
Email regarding missing proprietary names on device listings								1832					1,832
Account ID emails (TASK 27)									16585				16,585
R&L newsletter emails						14281							14,281
Pending listings updated				4									4

File details come from the government source that posted it. Updated Nov 14, 2017.