Food and Drug Administration

Food and Drug Administration ALL PURPOSE TABLE - User Fees (Dollars in Thousands)
PROGRAM	FY 2006 Actuals		FY 2006 Enacted		FY 2007 Continuing Resolution ¹		FY 2007 Pres. Budget ²		FY 2008 Request
PROGRAM	FTE	$000	FTE	$000	FTE	$000	FTE	$000	FTE	$000
Salaries and Expenses, Definite Appropriations:

Prescription Drug User Fee Act (PDUFA):
Human Drugs (PDUFA) ..........................................................	1,146	$211,190	1,132	$219,841	1,122	$211,190	1,171	$247,576	1,171	$232,358
Center .....................................................................................	1,110	205,279	1,098	213,908	1,087	205,279	1,134	240,894	1,134	226,086
Field.......................................................................................	36	5,911	34	5,933	35	5,911	37	6,682	37	6,272
Biologics (PDUFA)....................................	221	$53,492	239	$47,675	215	$53,180	231	$54,527	231	$50,389
Center.................................................................................	213	52,014	232	44,933	207	52,014	222	51,376	222	47,492
Field...................................................................................	8	1,478	7	2,742	8	1,166	9	3,151	9	2,897
Headquarters and Office of the Commissioner (PDUFA)...	114	$14,829	132	$25,116	112	$14,829	117	$25,397	117	$26,547
FDA Consolidation at White Oak......................................		$5,033		$0		$5,033				0

GSA Rental Payments (PDUFA) ..........................................		*$14,100*		*$12,700*		*$14,100*		*$17,700*		*$21,901*
Other Rent and Rent Related (PDUFA) ..........................		*$7,000*		$0		*$7,000*		*$7,000*		*$8,000*

Subtotal PDUFA ..............................................................	1,481	$305,644	1,503	$305,332	1,449	$305,332	1,519	$352,200	1,519	$339,195

Medical Device User Fee and Modernization Act (MDUFMA):
Biologics (MDUFMA) ...........................................	28	$5,699	31	$8,801	0	$0	31	$9,549	32	$10,373
Center .................................................................	26	5,452	29	8,412			29	9,127	30	9,915
Field........................................................................	2	247	2	389			2	422	2	458
Devices and Radiological Health (MDUFMA) .................	136	$20,714	158	$22,978	0	$0	144	$24,931	146	$27,083
Center .................................................................................	130	19,838	152	22,173			137	24,058	139	26,135
Field.....................................................................................	6	876	6	805			7	873	7	948
Headquarters and Office of the Commissioner (MDUFMA).....	20	$2,654	21	$4,535	0	$0	21	$4,921	22	$5,346
Other Rent and Rent Related Activities (MDUFMA) ................		765		783				1,055		1,146
GSA Rental Payments (MDUFMA) .............................................		2,237		3,203				3,270		3,552

Subtotal (MDUFMA) .................................................................	184	$32,069	210	$40,300		$0	196	$43,726	200	$47,500

Animal Drug User Fee Act (ADUFA):
Center for Veterinary Medicine..............................................	54	$8,264	60	$9,301	0	$0	54	$9,537	58	$11,523
Headquarters and Office of the Commissioner (ADUFA)......	4	$493	4	$646			4	$696	4	732

Other Rent and Rent Related Activities (ADUFA) ..................		291
GSA Rental Payments (ADUFA)..................................................		628		1,371				1,371		1,441

Subtotal (ADUFA) ....................................................................	58	$9,676	64	$11,318		$0	58	$11,604	62	$13,696

Total Definite Appropriations.............................................	1,723	$347,389	1,777	$356,950	1,449	$305,332	1,773	$407,530	1,781	$400,391

Proposed Definite Appropriations:
Generic Drug User Fee:
Human Drugs ..................................................................									34	$14,196
Center ...............................................................................									28	11,560
Field..................................................................................									6	2,636

Headquarters and Office of the Commissioner (Generic Drug).....									0	$518
GSA Rental Payments (Generic Drug) ...........................................										$987
Other Rent and Rent Related (Generic Drug) .............................										$0

Subtotal (Generic Drug) ....................................................									34	$15,701

Total Definite and Proposed Definite Appropriations.......									1,815	$416,092

Indefinite Appropriations:
Mammography Quality and Standards Act (MQSA):
Devices and Radiological Healthâ.....................................	34	$13,764	34	$16,961	34	$17,306	34	$17,306	34	$18,171
Center ....................................................................................	26	4,784	26	5,337	26	5,445	26	5,445	26	5,717
Field Activities.........................................................................	8	8,980	8	11,624	8	11,861	8	11,861	8	12,454
Headquarters and Office of the Commissioner (MQSA).......	2	$234	1	$212	1	$216	2	$216	2	$227

Subtotal (MQSA) .............................................................	36	$13,998	35	$17,173	35	$17,522	36	$17,522	36	$18,398

Export Certification.....................................................	13	$2,033	11	$1,639	14	$2,300	16	$2,300	17	$2,500

Color Certification Fund............................................	33	$5,694	30	$6,001	31	$6,181	34	$6,181	34	$7,000

Total Indefinite Appropriations...............................	82	$21,725	76	$24,813	80	$26,003	86	$26,003	87	$27,898

Total User Fees	1,805	$369,114	1,853	$381,763	1,529	$331,335	1,859	$433,533	1,902	$443,990

*Mandatory Proposed User Fees -- Non-Add:*

*Reinspection User Fee:*
*Office of Regulatory Affairs...................................*	-	-	-	-	-	-	*102*	*$12,300*	*102*	*$13,014*
Foods Program Estimate...........................................	-	-	-	-	-	-	44	5,215	44	5,517
Human Drugs Program Estimate...............................	-	-	-	-	-	-	16	2,009	16	2,126
Biologics Program Estimate.....................................	-	-	-	-	-	-	3	410	3	434
Animal Drugs and Feeds Program Estimate...........	-	-	-	-	-	-	17	2,050	17	2,169
Devices and Radiological Health Program Estimate.............	-	-	-	-	-	-	22	2,616	22	2,768
*Headquarters and Office of the Commissioner ..............*	-	-	-	-	-	-	16	*$7,100*	16	*$7,512*
*Other Rent Related Activities.........................................*	-	-	-	-	-	-		*$800*		*$846*
*GSA Rental Payments....................................................*	-	-	-	-	-	-		*$1,800*		*$1,904*
FDA Consolidation at White Oak................................

*Subtotal Reinspection User Fee*	-	-	-	-	-	-	*118*	*$22,000*	*118*	*$23,276*

*Food and Animal Feed Export Certification Fee:*
*Foods..........................................................................*							23	*$3,473*	23	*$3,674*
Center.......................................................................	-	-	-	-	-	-	6	906	6	958
Field Activities............................................................							17	2,567	17	2,716
*Animal Feeds and Drugs.........................................*
Center......................................................................	-	-	-	-	-	-	0	63	0	67

*Subtotal Food and Animal Feed Export Certification Fee.*							23	*$3,536*	23	*$3,741*

Total Proposed New Mandatory User Fees.................	-	$0	-	$0	-	$0	141	$25,536	141	$27,017

¹ Under the continuing resolution funding level, FDA cannot meet the statutory triggers for the Medical Device and Animal Drug User Fee Programs. The zero FTE for these two user fee programs reflects the requirement to terminate these programs. To pay program termination costs, FDA will spend available user fee carryover balances from prior fiscal years. FDA will also have to spend BA resources to pay some program termination costs. Finally, FDA will furlough the Medical Device and Animal Drug program staff for the remainder of FY 2007. In FY 2008, FDA will resume these two user fee programs.
²The PDUFA amounts include a one time increase in collections of $31.6 M for the Final Year adjustment under the PDUFA III statute.