Appendix_A_-_Draft_CDRH_Workload.xls

XLS spreadsheet 58 KB Posted Nov 20, 2013

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

About this file

From the source

Appendix A - Draft CDRH Workload

View the file

Other files for this federal contract opportunity

Other files attached to Offsite Document Control and Records Management, newest first.
File	Type	Posted
Sources_Sought_Questions_and_Answers.doc	DOC document	Dec 6, 2013
CDRH_Offsite_Real_Property_Clauses.docx	DOCX document	Dec 3, 2013
Appendix_B_-_Summary_of_Volume_Submissions.doc	DOC document	Nov 20, 2013
CDRH_Offsite_Real_Property_Clauses.docx	DOCX document	Nov 20, 2013
Draft_IDIQ_SOW.doc	DOC document	Nov 20, 2013

On GovTribe

Work with this file on GovTribe

Download the original file
Contacts named in this file
Similar government files
Ask GovTribe AI about this file

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

Footage

CDRH Work Function	Document/Scanning/Processing Room	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

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.

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
EREA	FDA Certificates 3613, 3613a, 3613c	10,291.00	10,291.00	51,142.00
	Emails received from Industry
	Exporter' s Certification Statement
	Supplementary Information attachments
	Example Certificate w/attachment pages
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

Registration and Listing Data

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												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

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