Revisions to Ambient Air Monitoring Regulations Docket ID EPA HQ OAR 2004 0018 George Allen < gallen@ nescaum. org>

05/ 08/ 2006 12: 13 PM To Tim Hanley/ RTP/ USEPA/ US@ EPA cc Phil Lorang/ RTP/ USEPA/ US@ EPA, Dick Valentinetti < dick. valentinetti@ state. vt. us>, Eric Stevenson < EStevenson@ baaqmd. gov>, Mary Stewart Douglas < mstewartdouglas@ 4cleanair. org>, Dirk Felton < hdfelton@ gw. dec. state. ny. us>, Charlie Pietarinen < Charles. Pietarinen@ dep. state. nj. us> Subject: A followup on continuous pm coarse methods from last week's Boston Monitoring Steering Comm. Mtg Hi Tim; time didn't permit me to respond to your comment in our meeting last week that daily PM coarse will be required because we expect viable continuous methods to be available over the next 2 3 years, and that continuous pm coarse will be easier than continuous pm2.5 because there isn't much of an issue with semivolatile aerosols. The semivolatile part is mostly true, but there are other issues with PM coarse continuous methods.

I don't agree with your comment that a solid [ robust] method for continuous pm coarse will be substantially easier than for PM2.5. For non compliance use [ the majority of the pm c data use in the eastern US], continuous PM coarse may turn out to be just as complex [ and have substantial data quality issues] as PM2.5 has been over the last few years.

I won't spend time here dealing with the PM c NAAQS compliance application. Why the concern about levels well below compliance? We talked about putting this method initially at many NCORE sites in the east where we don't expect compliance issues even at mid scale sites. This means pm c levels will often be pretty low  commonly into the single digits, since means for many non megacities are under 10 ug/ m3 at the neighborhood scale and at inlet heights high enough to reflect that scale. But we still want these data to have " useful" sub daily precision for the other [ non NAAQS] uses of the data  primarily for health studies.

The problems start with those lower levels  typically 1/ 2 of what we see for PM2.5 for the eastern US situation. Right there, precision starts to suffer, especially on a sub daily basis. I'm also assuming continuous PM coarse methods will be based on the dichot approach [ difference would be truly ugly]. Virtual impactors are not perfect, and require maintenance [ cleaning]; the cleaning of the PM 10 inlet may also become more important [ relative to what is needed for the PM2.5 FRM inlet]. You are also relying on 2 continuous detectors, not 1, for a dichot method to function properly. All this adds to the complexity, maintenance needs, and failure rates. What I'd like to be sure happens is that PM coarse continuous methods are tested not just for NAAQS compliance scenarios, but also in the situations I describe above. That's critical to a successful deployment of these methods for much of the country. Otherwise, we're probably going to fall back on manual filter methods in the Northeast, and lose the sub daily time resolution that we all agree is also important.

Finally, as stated in our Nescaum docket comments, I don't think you can rationally defend requiring a daily pm coarse sample requirement and a 3rd day pm2.5 requirement. In many areas, but especially in the Northeast assuming the proposed PM NAAQS are implemented, the daily pm2.5 standard will be the controlling NAAQS, not the annual. With that situation, the difference in required sampling schedules makes no sense... Please don't use a daily sampling requirement to drive the need for continuous monitoring [ as you implied in our meeting last week]! There are better ways to get there.  George ___________________________ George Allen, NESCAUM 101 Merrimac Street  10th floor Boston, MA 02114 Tel. 617 259 2035 [ direct] gallen@ nescaum. org Fax: 617 742 9162 www. nescaum. org


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on February 5, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-16735

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of    America West Airlines, Inc.  filed  12/16/03 for:

XX  Exemption for two years under 49 U.S.C. §40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between Los Angeles, California, and Puerto Vallarta, Mexico.

Applicant rep:   Joanne W. Young<PHONE_NUMBER>    DOT Analyst:  Linda
L. Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, subject to conditions (See below).

The action above was effective when taken:  February 5, 2004,   through
February 5, 2006    .

Action taken by:   Paul L. Gretch, Director

		        Office of International Aviation

XX  Authority granted is consistent with the aviation agreement between
the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX  Holder’s certificates of public convenience and necessity

XX  Standard Exemption Conditions (attached)

------------------------------------------------------------------------
------------------------------------------------------------------------
------------

Special Conditions:  The U.S.-Mexico exemption authority granted is
subject to the dormancy notice requirements set forth in condition 7 of
Appendix A of Order 88-10-2.  Consistent with our policy, the dormancy
notice period will begin June 1, 2004, America West’s proposed startup
date for these services.  The exemption authority granted is limited to
service provided on a code-share basis only.

The code-share operations conducted under this authorization are subject
to the following conditions:  (a) the code-sharing operations conducted
under this authority must comply with 14 CFR 257 and with any amendment
to the Department’s regulations concerning code-share arrangements
that may be adopted.  Notwithstanding any provisions

														2

in the contract between the carriers, our approval here is expressly
conditioned upon the requirements that the subject

foreign air transportation be sold in the name of the carrier holding
out such service in computer reservation systems and elsewhere; that the
carrier selling such transportation (i.e., the carrier shown on the
ticket) accept responsibility for the entirety of the code-share journey
for all obligations established in its contract of carriage with the
passenger; and that the passenger liability of the operating carrier be
unaffected; and (b) the authority granted here is specifically
conditioned so that neither America West nor Mesa shall give any force
or effect to any contractual provisions between themselves that are
contrary to these conditions.

________________________________________________________________________
_____________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
 To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov/reports_aviation.asp

						APPENDIX

U.S. Carrier Standard Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

											8/2003

 America West states that it will use the requested authority pursuant
to a code-share arrangement with Mesa Airlines, Inc. (Mesa), whereby
America West will place its “HP” code on flights operated by Mesa in
the subject market.  Under the U.S.-Mexico aviation agreement, up to two
U.S. carriers may be designated to operate direct-carrier service
(own-aircraft flights), and up to four U.S. carriers may be authorized
to provide code-share services in a given city-pair market.  At the time
this application was filed, Alaska Airlines, Inc., held one of the
designations to serve the Los Angeles-Puerto Vallarta route, and the
second designation was available.  However, four carriers already held
the Los Angeles-Puerto Vallarta code-share authorizations (Continental
Airlines, Inc.; Delta Air Lines, Inc.; Northwest Airlines, Inc.; and
Hawaiian Airlines, Inc. (Hawaiian)).  Thus, there were no code-share
authorizations available for the America West/Mesa code-share proposal
here.  Subsequently, Hawaiian filed a dormancy notice for the Los
Angeles-Puerto Vallarta market, and we withdrew Hawaiian’s code-share
authorization.  As a result, both the requisite designation and
code-share authorizations were available to allow us to proceed with the
instant application.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

MEMORANDUM								June 28, 2007

SUBJECT: 	DIETARY EXPOSURE ASSESSMENT OF COPPER-8 QUINOLINOATE USE OF
INDIRECT FOOD CONTACT SURFACES

From:	A. Najm Shamim, PhD., Chemist

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

To:	Tim McMahon, PhD, Senior Toxicologist and Risk Assessor for Copper-8
Quinolinoate RED

	Risk Assessment and Science Support Branch

	Antimicrobials Division (7510P)

				And

	Kathryn Jakob, CRM for Copper-8 Quinolinoate RED

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

Thru:	Mark Hartman, Chief

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

Executive Summary:

Antimicrobials Division has assessed the exposure and risk assessment of
copper-8 quinoloate for its uses in pulp/paper and adhesives. AD does
such assessments routinely even if the label language indicates a
caution for the chemical not to be used for wrappings or exposing
adhesives to foods. These use scenarios have been addressed in the past
by AD for previous REDs. AD employs FDA methodology for indirect
migration of pesticides into foods.

AD has determined that % aPAD and or % cPAD for copper-8 quinoloate uses
in pulp/paper (% aPAD and cPAD less than one percent for adults and
children) and adhesives (% cPAD less than one percent for adults and a
little over one percent for children) pose no dietary concerns for US
populations..

Discussion:

AD’s label reviews have shown that copper -8-quinolinoate has the
following use patterns/use sites. Some of which may require  indirect
food contact dietary exposure assessments.:  Sapstain use, wood in
contact with fruits and vegetables like mushroom trays etc.; paper
products, cardboard, adhesives, conveyor belts, Kraft paper, paperboard,
 plastics, potato. We will follow the same methodology for this RED
also.

FDA METHODOLOGY FOR DETERMINING ESTIMATED DAILY INTAKE (EDI) OF A
PESTICIDE USE IN A FOOD CONTACT PAPER .

For the determination of the amount of a pesticide migrating into food
when the food is in contact with the treated paper, FDA makes the
following assumptions:

					Table I

Parameter	Assumption/Value

1.Paper slurry, prior to entering paper manufacturing machine	1%: 99%
water, 1% pulp

2.Concentration of slurries entering driers	33% pulp, 67% water

3.Standard paper wt.	50 mg/in2

4.Finished paper	8% water, 92% pulp

5. Mass of food in contact with surface area of treated paper	10 g/in2

6. Consumption factor (CF)*	0.10

7. Daily  average food intake (adult)	3000 g

8. Daily average food intake (child)	1500 g

Notes: *FDA1,2,3 Method makes a number of assumptions for calculating
migration of active (in this case copper-8-quinolinoate)) from food
contact surfaces (paper): 1. Food contact surface (paper) can be a one
time use/day or a repeat use material; 2. Consumption factor (CF) or
fraction of daily food which comes in to contact with the packaging
surface (paper). CF represents the actual weight of food that comes into
contact with the paper to the weight of all food packaged with paper; 3.
The CF varies from one type of packaging (type of paper) to the other
(type of paper). FDA methodology of migration of active assumes a 100%
migration to the food commodities (This represents a worst case
scenario).

Note:	Label search indicates that copper-8-quinolinoate is used in pulp
and paper in more than one formulation. : 1)PQ-56 (EPA Reg#: 1022-489);
2)  PQ-57 (EPA Reg#: 1022-490); 3) Cunilate 2174-NO ( EPA Reg#:
2829-44); 4) Cunilate 2002 (EPA Reg#: 707-302); 5) Cu-8 (EPA Reg#:
10827-5). In all applications for pulp and paper maximum active is 10%
and in all application dilutions are made. The minimum dilution is 0.5%
active or 0.5 lb of active per 1000 lbs of paper. This also translates
into 1.0 lbs active per 2000 lbs.  A short ton = 2000 lbs.   We use this
rate of applications to determine the exposure of this active to food
through indirect contact with paper.

1 lb active /2000 lb of finished paper = 454 active  mg/kg of  finished
paper

 But the paper slurry is 1% ; 454 mg x 01 = 4.5  active mg/kg of
finished paper = ~ 5 ppm of active in the paper slurry= Application Rate

Application  rate x % water / % pulp = 5 ppm  = 5µg/g pulp slurry x
0.67g water/0.33.g pulp = 10 µ g of active/g pulp.

Consumption Factor (CF) = 0.10

	Likely amount of Cu-8  migrating into food:

⁄ mass of pulp x 0.92 g pulp∕ g of paper x 0.05 g ∕ in2 x 1 in2
∕ 10 g food = 0.046µ g of Cu-8 ∕ g food

Since the Consumption factor for paper, based on FDA’s methodology is
0.10

The actual amount of Cu-8 in daily diet will be:

0.046µg of Cu-8 ∕ g food x 0.10 = 0.0046 µg ∕ g food

Estimated Daily Intake (EDI) of Cu-8 for an adult:

0.0046µg of Cu-8 ∕ g food x 3000 g food =13.8µg of Cu-8/person/day

Estimated Daily Intake (EDI) of Cu-8 for a child:

0.0046µg of Cu-8 ∕ g food x 1500 g food = 6.9 µg of Cu-8 /person/
day

AD’s End Points Selection Committee (A Memo by Tim McMahon, June 13,
2006) determined that: cPAD (chronic RfD) for Copper-8 quinolinoate is
0.05 mg/kg/day.

In Table II estimations are given for % cPAD

				Table II

∕ 0.05 mg/kg/day x 100

= 0.3%

	Child: 6.9 µg 	Child: 6.9µg/70 kg/day = 0.0046 mg/kg/day	Child:
0.0046 mg/kg/day ∕ 0.05 mg/kg/day = 0.9%

The calculations of % cPAD show that there are no chronic dietary
concerns from the migration of Cu-8 form paper to food. No acute dietary
end points exist, and therefore, Agency does not have any acute exposure
from the use of Cu-8 by migration into foods.

As a matter of policy, AD has assessed adhesive use as an indirect food
use.  Since it is likely that adhesives may end up in the food packaging
materials, and this may result in the migration of the pesticide into
the food indirectly.  For the indirect food dietary assessment, AD has
adopted Food & Drug Administration (FDA) methodology.  For adhesive use,
FDA has provided guidance for dietary estimation that a maximum of 7 ppb
of a pesticide is likely to migrate from the food packaging materials
into the food. The quantity of 7 ppb can be used to calculate the
Estimated Daily Intake (EDI), Daily Dietary Dose (DDD), and using the
acute and dietary end points from toxicity data, one calculates the
overall risks to general and subgroups of populations (% aPAD, and %
cPAD).

For the present case: FDA’s assumptions are: 1) Maximum migration of
Copper-8 Quinolinoate into food from adhesive use = 7 ppb = 7µg/g; 2)
Maximum adult food intake = 3000 g; 3) Maximum food intake for a child =
1500 g.

In general, % PAD =  DDD/% a PAD or % cPAD.

Table III gives estimates of % cPAD for adhesive use of Copper-8
Quinoloate

.

.

					Table III

Use	Dietary Conc. (ppb)	Estimated Daily Intake (EDI) µg/p/day	Daily
Dietary Dose (DDD) mg/kg/day

	% aPAD	% cPAD

( cPAD) = o.05 mg/kg/day

Adhesive	7	Adult: 7µg/g x 3000g = 21 µg/p/day

Child: 7 µg/g x 1500 g = 10.5 µg/p/day	Adult: 21 µg/70 kg/day =
0.0003 mg/kg/day

Child: 10.5 µg/15kg/day = 0.0007 mg/kg/day	Adult: no data. No concerns.

Child: no data. No concerns.	Adult:  0.0003 mg/kg/day ∕ 0.05 mg/kg/day
x100 = 0.6%

Child: 0.0007 mg/kg/day ∕ 0.05 mg/kg/day x 100  = 1.4 %

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calculations assume that the adhesive use is 100% of the chemical
produced, which is not a likely scenario. The actual % cPAD is going to
be much lower than the estimated one The Agency has no chronic dietary
concerns from the use of Copper-8 Quinoloate in adhesives.

Another scenario which may likely pose some concerns is the use of
copper-8 treated wooden trays which are used to store or transfer foods.
No data, laboratory or monitoring, were submitted. It is therefore a
data gap for the dietary risk assessment for copper-8.

					BIBLIOGRAPHY

Food and Drug Administration (FDA), 2003, “Guidance for Industry:
Preparation of food Contact Notifications and food Additive Petitions
for Food contact Substances: Chemistry Recommendations, Final
Guidance”

FDA, 2003,   HYPERLINK "http://www.cfsan.fda.gov/~opa2pmmne.html"
http://www.cfsan.fda.gov/~opa2pmmne.html

FDA, 2003, “Sanitizing solutions: Chemistry Guidelines for Food
Additive Petitions, January 1993.   HYPERLINK "http://www"  http://www .
Cfsan.fda.gov/~dms/opa-cg3a.html.

AD’s End Point Selection Memo by  Tim McMahon, June 13, 2006

 PAGE

 PAGE   1


[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Pages 24340-24341]
[FR Doc No: 2017-10819]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-85-000.
    Applicants: Entergy New Orleans, Inc.
    Description: Supplement to February 24, 2017 Application for
Approval under Sec.  203 of the Federal Power Act of Entergy New
Orleans, Inc.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5058.
    Comments Due: 5 p.m. ET 5/30/17.

    Docket Numbers: EC17-119-000.
    Applicants: Drift Sand Wind Project, LLC.
    Description: Application for Authorization under Sec.  203 of the
Federal Power Act, Request for Shortened Notice Period, Expedited
Consideration and Confidential Treatment of Drift Sand Wind Project,
LLC.
    Filed Date: 5/18/17.
    Accession Number: 20170518-5183.
    Comments Due: 5 p.m. ET 6/8/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-1629-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Section 205(d) Rate Filing: OATT 6.17 Schedule 17 re:
Western New York Facilities Charge to be effective 7/18/2017.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5007.
    Comments Due: 5 p.m. ET 6/9/17.

    Docket Numbers: ER17-1630-000.
    Applicants: Duke Energy Progress, LLC, Duke Energy Florida, LLC,
Duke Energy Carolinas, LLC.
    Description: Section 205(d) Rate Filing: OATT Attachment C-2
Amendment Filing to be effective 7/19/2017.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5052.
    Comments Due: 5 p.m. ET 6/9/17.

    Docket Numbers: ER17-1631-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Amendment to Service
Agreement No. 4604; Queue Nos. U4-028/U4-029 to be effective 12/19/
2016.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5054.
    Comments Due: 5 p.m. ET 6/9/17.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES17-19-000.
    Applicants: ITC Great Plains, LLC.
    Description: Amendment to April 27, 2017 Application of ITC Great
Plains, LLC under Sec.  204 of the Federal Power Act and part 34 of the
Commission's Regulations.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5009.
    Comments Due: 5 p.m. ET 5/30/17.

    Docket Numbers: ES17-20-000.
    Applicants: ITC Midwest LLC.
    Description: Amendment to April 27, 2017 Application of Midwest LLC
under Sec.  204 of the Federal Power Act and part 34 of the
Commission's Regulations.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5010.
    Comments Due: 5 p.m. ET 5/30/17.

    Docket Numbers: ES17-21-000.
    Applicants: International Transmission Company.
    Description: Amendment to April 27, 2017 Application of
International Transmission Company under Sec.  204 of the Federal Power
Act and part 34 of the Commission's Regulations.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5011.
    Comments Due: 5 p.m. ET 5/30/17.

    Docket Numbers: ES17-22-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Amendment to April 27, 2017 Application of Michigan
Electric Transmission Company, LLC under Sec.  204 of the Federal Power
Act and part 34 of the Commission's Regulations.
    Filed Date: 5/19/17.
    Accession Number: 20170519-5012.
    Comments Due: 5 p.m. ET 5/30/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern

time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 19, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-10819 Filed 5-25-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45831-45838]
[FR Doc No: 2011-19332]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0559]

Prescription Drug User Fee Rates for Fiscal Year 2012

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2012. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and
Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV),
authorizes FDA to collect user fees for certain applications for
approval of drug and biological products, on establishments where the
products are made, and on such products. Base revenue amounts to be
generated from PDUFA fees were established by PDUFA IV, with provisions
for certain adjustments. Fee revenue amounts for applications,
establishments, and products are to be established each year by FDA so
that one-third of the PDUFA fee revenues FDA collects each year will be
generated from each of these categories. This document establishes fee
rates for FY 2012 for application fees for an application requiring
clinical data ($1,841,500), for an application not requiring clinical
data or a supplement requiring clinical data ($920,750), for
establishment fees ($520,100), and for product fees ($98,970). These
fees are effective on October 1, 2011, and will remain in effect
through September 30, 2012. For applications and supplements that are
submitted on or after October 1, 2011, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2012 will be
issued in August 2011, using the new fee schedule.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 1350 Picard Dr.,
PI50, Rm. 210J, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively), establish three different kinds of user fees. Fees are
assessed on the following: (1) Certain types of applications and
supplements for approval of drug and biological products, (2) certain
establishments where such products are made, and (3) certain products
(section 736(a) of the FD&C Act). When certain conditions are met, FDA
may waive or reduce fees (section 736(d) of the FD&C Act).
    For FY 2008 through FY 2012, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA IV. The base
revenue amount for FY 2008 is to be adjusted for workload, and that
adjusted amount becomes the base amount for the remaining 4 FYs. That
adjusted base revenue amount is increased for drug safety enhancements
by $10,000,000 in each of the subsequent 4 FYs, and the increased total
is further adjusted each year for inflation and workload. Fees for

applications, establishments, and products are to be established each
year by FDA so that revenues from each category will provide one-third
of the total revenue to be collected each year.
    This document uses the fee base revenue amount for FY 2008
published in the Federal Register of October 12, 2007 (72 FR 58103)
(the October 2007 notice); adjusts it for the FY 2009, FY 2010, FY
2011, and FY 2012 drug safety increases (see section 736(b)(4) of the
FD&C Act), for inflation, and for workload, for excess collections
through FY 2011, and for a final year adjustment; and then establishes
the application, establishment, and product fees for FY 2012. These
fees are effective on October 1, 2011, and will remain in effect
through September 30, 2012.

II. Fee Revenue Amount for FY 2012

    The total fee revenue amount for FY 2012 is $702,172,000, based on
the fee revenue amount specified in the statute, including additional
fee funding for drug safety and adjustments for inflation, changes in
workload, offset for excess collections and the final year adjustment.
The statutory amount and a one-time base adjustment are described in
sections II.A and II.B of this document. The adjustment for inflation
is described in section II.C of this document, and the adjustment for
changes in workload in section II.D of this document. The adjustment
for estimated excess collections through FY 2012 is described in
section III of this document, and the final year adjustment is
described in section IV of this document.

A. FY 2012 Statutory Fee Revenue Amounts Before Adjustments

    PDUFA IV specifies that the fee revenue amount before adjustments
for FY 2012 for all fees is $457,783,000 ($392,783,000 specified in
section 736(b)(1) of the FD&C Act plus an additional $65,000,000 for
drug safety in FY 2012 specified in section 736(b)(4)).

B. Base Adjustment to Statutory Fee Revenue Amount

    The statute also specifies that $354,893,000 of the base amount is
to be further adjusted for workload increases through FY 2007 (see
section 736(b)(1)(B) of the FD&C Act). The workload adjustment on this
amount is to be made in accordance with the workload adjustment
provisions that were in effect for FY 2007, except that the adjustment
for investigational new drug (IND) workload is based on the number of
INDs with a submission in the previous 12 months rather than on the
number of new commercial INDs submitted in the same 12-month period.
This adjustment was explained in detail in the October 2007 notice.
Increasing the statutorily specified amount of $354,893,000 by the
specified workload adjuster (11.73 percent) results in an increase of
$41,629,000, rounded to the nearest thousand. Adding this amount to the
$457,783,000 statutorily specified amount from section II.A of this
document, results in a total adjusted PDUFA IV base revenue amount of
$499,412,000, before further adjustment for inflation and changes in
workload after FY 2007.

C. Inflation Adjustment to FY 2012 Fee Revenue Amount

    PDUFA IV provides that fee revenue amounts for each FY after FY
2008 shall be adjusted for inflation. The adjustment must reflect the
greater of the following amounts: (1) The total percentage change that
occurred in the Consumer Price Index (CPI) (all items; U.S. city
average) during the 12-month period ending June 30 preceding the FY for
which fees are being set; (2) the total percentage pay change for the
previous FY for Federal employees stationed in the Washington, DC
metropolitan area; or (3) the average annual change in cost, per FDA
full time equivalent (FTE), of all personnel compensation and benefits
paid for the first 5 of the previous 6 FYs. PDUFA IV provides for this
annual adjustment to be cumulative and compounded annually after FY
2008 (see section 736(c)(1) of the FD&C Act).
    The first factor is the CPI increase for the 12-month period ending
in June 2011. The CPI for June 2011 was 225.722 and the CPI for June
2010 was 217.965. (These CPI figures are available on the Bureau of
Labor Statistics (BLS) Web site at http://data.bls.gov/cgi-bin/surveymost?bls by checking the first box under ``Price Indexes'' and
then clicking ``Retrieve Data'' at the bottom of the page. FDA has
verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.) The CPI for June 2011 is 3.559 percent higher than
the CPI for the previous 12-month period.
    The second factor is the increase in pay for the previous FY (FY
2011 in this case) for Federal employees stationed in the Washington,
DC metropolitan area. This figure is published by the Office of
Personnel Management (OPM), and found on their Web site at http://www.opm.gov/oca/11tables/html/dcb.asp above the salary table. (FDA has
verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.) For FY 2011 it was 0.00 percent.
    The third factor is the average change in FDA cost for compensation
and benefits per FTE over the previous 5 of the most recent 6 FYs (FY
2006 through FY 2010). The data on total compensation paid and numbers
of FTE paid, from which the average cost per FTE can be derived, are
published in FDA's Justification of Estimates for Appropriations
Committees. Table 1 of this document summarizes that actual cost and
FTE use data for the specified FYs, and provides the percent change
from the previous FY and the average percent change over the most 5
recent FYs, which is 3.72 percent.

                                  Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual average
                                                   FY2006            FY2007            FY2008            FY2009            FY2010         increase for
                                                                                latest 5 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B..................................    $1,114,704,000    $1,144,369,000    $1,215,627,000    $1,464,445,000    $1,634,108,000  ................
Total FTE...................................             9,698             9,569             9,811            11,413            12,256  ................
PC&B per FTE................................          $114,942          $119,591          $123,905          $128,314          $130,457  ................
Percent Change from Previous Year...........              5.70              4.05              3.61              3.56              1.67              3.72
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The inflation increase for FY 2012 is 3.72 percent. This is the
greater of the CPI change during the 12-month period ending June 30
preceding the FY for which fees are being set (3.559 percent), the
increase in pay for the previous FY (FY 2011 in this case) for Federal
employees stationed in the Washington, DC metropolitan area (0.00
percent), and

the average annual change in cost, per FDA FTE, of all personnel
compensation and benefits paid for the first 5 of the previous 6 FYs
(3.72 percent). Because the average change in pay per FTE (3.72
percent) is the highest of the three factors, it becomes the inflation
adjustment for total fee revenue for FY 2012.
    The inflation adjustment for FY 2009 was 5.64 percent. This is the
greater of the CPI increase during the 12-month period ending June 30
preceding the FY for which fees were being set (June 30, 2008, which
was 5.05 percent), the increase in pay for FY 2008 for Federal
employees stationed in Washington, DC (4.49 percent), or the average
annual change in cost, per FDA FTE, of all personnel compensation and
benefits paid for the first 5 of the previous 6 FYs (5.64 percent).
    The inflation adjustment for FY 2010 was 5.54 percent. This is the
greater of the CPI increase during the 12-month period ending June 30
preceding the FY for which fees were being set (June 30, 2009)
(negative 1.43 percent), the increase in pay for FY 2009 for Federal
employees stationed in Washington, DC (4.78 percent), or the average
annual change in cost, per FDA FTE, of all personnel compensation and
benefits paid for the first 5 of the previous 6 FYs (5.54 percent).
    The inflation adjustment for FY 2011 was 4.53 percent. This is the
greater of the CPI increase during the 12-month period ending June 30
preceding the FY for which fees were being set (June 30, 2010) (1.053
percent), the increase in pay for FY 2010 for Federal employees
stationed in Washington, DC (2.42 percent), or the average annual
change in cost, per FDA FTE, of all personnel compensation and benefits
paid for the first 5 of the previous 6 FYs (4.53 percent).
    PDUFA IV provides for this inflation adjustment to be cumulative
and compounded annually after FY 2008 (see section 736(c)(1) of the
FD&C Act). This factor for FY 2012 (3.72 percent) is compounded by
adding one to it and then multiplying it by one plus the inflation
adjustment factor for FY 2011 (4.53 percent) and by one plus the
inflation adjustment factor for FY 2010 (5.54 percent) and by one plus
the inflation adjustment factor for FY 2009 (5.64 percent). The result
of this multiplication of the inflation factors for the 4 years since
FY 2008 (1.0372 times 1.0453 times 1.0554 times 1.0564 percent) becomes
the inflation adjustment for FY 2012. This inflation adjustment for FY
2012 is 20.88 percent.
    Increasing the FY 2012 fee revenue base of $499,412,000, by 20.88
percent yields an inflation-adjusted fee revenue amount for FY 2012 of
$603,689,000, rounded to the nearest thousand dollars, before the
application of the FY 2012 workload adjustment.

D. Workload Adjustment to the FY 2012 Inflation Adjusted Fee Revenue
Amount

    PDUFA IV does not allow FDA to adjust the total revenue amount for
workload beginning in FY 2010, unless an independent accounting firm
study is complete (see section 736(c)(2)(C) of the FD&C Act). That
study, conducted by Deloitte Touche, LLP, was completed on March 31,
2009, and is available online at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm164339.htm. The study found that
the adjustment methodology used by FDA reasonably captures changes in
workload for reviewing human drug applications under PDUFA IV.
Accordingly, FDA continues to use the workload adjustment methodology
prescribed in PDUFA IV.
    For each fiscal year beginning in FY 2009, PDUFA IV provides that
fee revenue amounts, after they have been adjusted for inflation, shall
be further adjusted to reflect changes in workload for the process for
the review of human drug applications (see section 736(c)(2) of the
FD&C Act). PDUFA IV continues the Prescription Drug User Fee Amendments
of 2002 (PDUFA III) workload adjustment with modifications, and
provides for a new additional adjustment for changes in review
activity.
    FDA calculated the average number of each of the four types of
applications specified in the workload adjustment provision: (1) Human
drug applications, (2) active commercial INDs (applications that have
at least one submission during the previous 12 months), (3) efficacy
supplements, and (4) manufacturing supplements received over the 5-year
period that ended on June 30, 2007 (base years), and the average number
of each of these types of applications over the most recent 5-year
period that ended June 30, 2011.
    The calculations are summarized in table 2 of this document. The 5-
year averages for each application category are provided in Column 1
(``5-Year Average Base Years 2002-2007'') and Column 2a (``5-Year
Average 2007-2011'').
    PDUFA IV specifies that FDA make additional adjustments for changes
in review activities to human drug applications and active commercial
INDs. These adjustments, specified under PDUFA IV, are summarized in
columns 2b and 2c in table 2 of this document. The number in the new
drug applications/biologics license applications (NDAs/BLAs) line of
column 2b of table 2 of this document is the percent by which the
average workload for meetings, annual reports, and labeling supplements
for NDAs and BLAs has changed from the 5-year period 2002 through 2007,
to the 5-year period 2007 through 2011. Likewise, the number in the
``Active commercial INDs'' line of column 2b of table 2 of this
document is the percent by which the workload for meetings and special
protocol assessments for active commercial INDs has changed from the 5-
year period 2002 through 2007, to the 5-year period 2007 through 2011.
There is no entry in the last two lines of column 2b because the
adjustment for changes in review workload does not apply to the
workload for efficacy supplements and manufacturing supplements.
    Column 3 of table 2 of this document reflects the percent change in
workload from column 1 to column 2c. Column 4 of table 2 of this
document shows the weighting factor for each type of application,
estimating how much of the total FDA drug review workload was accounted
for by each type of application in the table during the most recent 5
years. Column 5 of table 2 of this document is the weighted percent
change in each category of workload. This was derived by multiplying
the weighting factor in each line in column 4 by the percent change
from the base years in column 3. At the bottom right of table 2 of this
document is the sum of the values in column 5 that are added,
reflecting an increase in workload of 8.12 percent for FY 2012 when
compared to the base years.

                                                   Table 2--Workload Adjuster Calculation for FY 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Column 3
                                                            Column 1  5-  Column 2a  5-  Column 2b     Column 2c     Percent                   Column 5
                                                           year  average      year       Adjustment   (Column 2a      change      Column 4     Weighted
                     Application type                        base years      average    for changes  increased by   (column 1    Weighting     percent
                                                             2002-2007      2007-2011    in review    column 2b)    to column      factor       change
                                                                                activity                     2c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs................................................         123.8          130.8       -0.01%         130.8         5.6%        35.3%        1.99%
Active commercial INDs...................................       5,528.2         6520.6        -2.41        6363.2         15.1         42.4         6.40
Efficacy supplements.....................................         163.4          157.4           NA         157.4         -3.7          9.9        -0.36
Manufacturing supplements................................        2589.2         2606.8           NA        2606.8          0.7         12.4         0.08
                                                          ----------------------------------------------------------------------------------------------
    FY 2012 Workload Adjuster............................  .............  ............  ...........  ............  ...........  ...........         8.12
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The FY 2012 workload adjuster reflected in the calculations in
table 3 of this document is 8.12 percent. Therefore the inflation-
adjusted revenue amount of $603,689,000 from section II.C of this
document will be increased by the FY 2012 workload adjuster of 8.12
percent, resulting in a total adjusted revenue amount in FY 2012 of
$652,709,000, rounded to the nearest thousand dollars.

E. Rent and Rent-Related Adjustment to the FY 2011 Adjusted Fee Revenue
Amount

    PDUFA specifies that for FY 2010 and each subsequent FY, the
revenue amount will be decreased if the actual cost paid for rent and
rent-related expenses for preceding FYs are less than estimates made
for such FYs in FY 2006 (see section 736(c)(3) of the FD&C Act). Table
3 of this document shows the estimates of rent and rent-related costs
for FY 2008 through FY 2010 made in 2006 and the actual costs for these
3 FYs, the only FYs for which complete data are available at this time.

  Table 3--Comparison of Actual and Estimated Rent and Rent-Related Expenses for the Center for Drug Evaluation and Research (CDER) and the Center for
                                                        Biologics Evaluation and Research (CBER)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Estimates made in 2006                                      Actual amounts paid
                                     -------------------------------------------------------------------------------------------------------------------
                                         FY 2008       FY 2009       FY 2010         Total         FY 2008       FY 2009       FY 2010         Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER................................   $46,732,000   $40,415,000   $41,589,000    $128,736,000   $51,619,000   $64,687,250   $58,049,000    $174,355,250
CBER................................    22,295,000    23,067,000    25,652,000      71,014,000    26,715,000    26,966,750    27,815,000      81,496,750
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................    69,027,000    63,482,000    67,241,000     199,750,000    78,334,000    91,654,000    85,864,000     255,852,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Because FY 2008 through FY 2010 costs for rent and rent-related
items in total ($255,852,000) exceeded the estimates of these costs
made in FY 2006 ($199,750,000), no decrease in the FY 2012 estimated
PDUFA revenues is required under this provision of PDUFA.

III. Offset for Excess Collections Through FY 2011

    Under the provisions of PDUFA III, which applies to user fees
collected for FY 2002 through FY 2007, if the amount of fees collected
for a FY exceeds the amount of fees specified in appropriation acts for
that FY, the excess amount shall be credited to FDA's appropriation
account and shall be subtracted from the amount of fees that would
otherwise be authorized to be collected in a subsequent FY (See 21
U.S.C. 379h(g)(4) as amended by PDUFA III). In setting PDUFA fees for
FY 2007 in August of 2006, some offsets were made under these
provisions, but some offsets still need to be made based on final
collection data for that period. Table 4 shows the amount of fees
specified in FDA's annual appropriation for each year from FY 2003
through FY 2007; the amounts FDA has collected for each year; the
amount of offset previously taken; and the cumulative difference. FDA
will take this difference as an offset against FY 2012 fee collections.

                       Table 4--Offsets Remaining To Be Taken for PDUFA III, FY 2003-2007
----------------------------------------------------------------------------------------------------------------
                                                                                Excess
                                                                                collections
                                                                                offset under      Remaining
                                                       Fees                           section         excess
                   Fiscal year                     appropriated   Fees collected   736(g)(4) of     collections
                                                                                the FD&C Act    to be offset
                                                                                when 2007 fees
                                                                                were set
----------------------------------------------------------------------------------------------------------------
2003............................................    $222,900,000    $218,302,684  ..............  ..............
2004............................................     249,825,000     258,333,700      $7,230,906      $1,277,794
2005............................................     284,394,000     287,178,231  ..............       2,784,231
2006............................................     305,332,000     313,514,278  ..............       8,209,278
2007............................................     352,200,000     370,934,966  ..............      18,734,966
                                                 ---------------------------------------------------------------
    Cumulative difference to be offset against    ..............  ..............  ..............      30,974,959
     FY 2012 collections........................
----------------------------------------------------------------------------------------------------------------

    In addition, under the provisions of PDUFA, as amended by PDUFA IV,
if the sum of the cumulative amount of the fees collected for FY 2008
through 2010, and the amount of fees estimated to be collected under
this section III of the document for FY 2011, exceeds the cumulative
amount appropriated for fees for FYs 2008 through 2011, the excess will
be credited to FDA's appropriation account and subtracted from the
amount of fees that FDA would otherwise be authorized to collect for FY
2012 under the FD&C Act (21 U.S.C. 379h(g)(4) as amended by PDUFA IV).
    Table 5 of this document shows the amounts specified in
appropriation acts for each year from FY 2008 through FY 2011, and the
amounts FDA has collected for FYs 2008, 2009, and 2010 as of March 31,
2011, and the amount that FDA estimated it would collect in FY 2011
when it published the notice of FY 2011 fees in the Federal Register on
August 4, 2010 (75 FR 46956). In FY 2011, application fee revenues to
date are less than anticipated when fees were set in August 2010. The
bottom line of table 5 of this document shows the estimated cumulative
difference between fee amounts specified in appropriation acts for FY
2008 through FY 2011 and PDUFA fee amounts collected.

Table 5--Offsets To Be Taken for the PDUFA IV Period, FY 2008-2011 for FY 2008-2010, Fees Collected Through 3/31/
                                   2011; for FY 2011, Estimate as of 3/31/2011
----------------------------------------------------------------------------------------------------------------
                                                                       Fees
                           Fiscal year                             appropriated   Fees collected    Difference
----------------------------------------------------------------------------------------------------------------
2008............................................................    $459,412,000    $479,582,086     $20,170,086
2009............................................................     510,665,000     521,496,042      10,831,042
2010............................................................     578,162,000     567,877,548    (10,284,452)
2011 estimate...................................................     667,057,000     619,070,000    (47,987,000)
                                                                 -----------------------------------------------
    Cumulative difference.......................................  ..............  ..............    (27,270,324)
----------------------------------------------------------------------------------------------------------------

    The cumulative fees collected for FYs 2008 through 2011 are
estimated to be more than $27 million less than the cumulative fee
amounts specified in appropriation acts during this same period. Under
section 736(g)(4) of the FD&C Act, an offset is only made if the
cumulative fees collected exceed cumulative fee appropriations for this
period. Accordingly, there will be no offset of fees attributable to
the PDUFA IV period of FYs 2008 through 2012. The only offset will be
for the $30,974,959 for the PDUFA III period. Reducing the inflation
and workload adjusted estimate of total revenue of $652,709,000 by the
PDUFA III offset of $30,975,000 (rounded to the nearest thousand
dollars) results in a revenue estimate of $621,734,000, before the
final year adjustment.

IV. Final Year Adjustment

    Under the provisions of PDUFA, as amended, the Secretary of Health
and Human Services may, in addition to the inflation and workload
adjustments, further increase the fees and fee revenues if such an
adjustment is necessary to provide for not more than 3 months of
operating reserves of carryover user fees for the process for the
review of human drug applications for the first 3 months of FY 2013.
The rationale for the amount of this increase shall be contained in the
annual notice establishing fee revenues and fees for FY 2012 (see 21
U.S.C. 379h(c)(4)).

    Table 6--Estimated Carryover Balance at the End of FY 2012, After
           Deduction of Estimated FY 2011-2012 Operating Costs
------------------------------------------------------------------------

------------------------------------------------------------------------
Total carryover balance end of FY 2010..................    $150,611,598
Used for offset in 2012.................................      30,975,000
Used for additional 53 FTE (FDAAA drug safety), FY 2011-      29,771,000
 2012...................................................
Reserve for refunds.....................................       2,500,000
Used for CBER move to White Oak.........................      37,896,000
Used to cover 2011 estimated revenue shortfalls.........       8,382,000
Used to cover 2012 estimated revenue shortfalls.........       8,694,000
Estimated 2012 end of FY carryover balance..............      32,393,598
------------------------------------------------------------------------

    As of September 30, 2010, FDA had cash carryover balances of
$150,611,598. However, of this amount, a total of $30,975,000 will be
used to cover the cost of the reduction in fee revenue that will result
from the offset in fees for excess collections during PDUFA III. A
total of $29,771,000 will be used in FY 2011 and FY 2012 to cover the
cost of additional FTEs allocated in FY 2009 to address increased PDUFA
workload associated with new drug safety provisions under FDAAA. A
total of $2,500,000 is not available to FDA to obligate because it
represents the minimum amount FDA will need to keep in reserve for
refunds that will need to be made. A total of $37,896,000 is expected
to be used for the CBER move to the White Oak campus in FY 2012-2014.
Based on FDA's experience in FY 2010 when about 17 fewer paid full
application fees were received by FDA than expected, causing a revenue
shortfall, FDA is assuming that about 5.5 fewer full applications will
be received in both FY 2011 and FY 2012, resulting in shortfalls of
over $8,382,000 and $8,694,000 each year, respectively, that will have
to be covered from the carryover balances. Thus the amount of carry-
over balance FDA expects to be available for obligation at the end of
FY 2012 is $32,393,598, as shown in the last line of table 6 of this
document.

 Table 7--Estimated Fee Revenue Needed To Sustain FY 2012 Operations for
                      the First 3 Months of FY 2013
------------------------------------------------------------------------

------------------------------------------------------------------------
Estimated total spending from fees in FY 2012...........    $652,709,000
Estimated FY 2013 inflation costs at 3.72%..............      24,280,775
Estimated FY 2013 funds to sustain FY 2012 operations...     676,989,755
Estimated fees needed for 3 months in FY 2013...........     169,247,444
Estimated end-of-FY 2012 carryover balance..............      32,393,598
Additional revenue needed for 3 months in FY 2013.......     136,854,000
------------------------------------------------------------------------

    In FY 2012, FDA expects to spend a total of $652,709,000, as noted
at the end of section III of this document. To sustain current
operations in FY 2012, with an anticipated inflation rate of 3.72
percent, FDA expects to obligate a total of $676,989,775 in FY 2013--or
a total of about $169,247,444 during the first 3 months of FY 2013. The
available

carryover balance at the beginning of FY 2013 is estimated at
$32,393,598. Thus FDA would need an additional $136,854,000
($169,247,444 minus $32,393,598, rounded to the nearest thousand
dollars) as the final year adjustment to assure sufficient operating
reserves for the first 3 months of FY 2013.
    FDA recognizes that adding $136,854,000 to the fee revenue costs in
FY 2012 poses a substantial burden on the regulated industry at a time
when it is undergoing significant financial strain. In light of this,
and in light of the fact that the legislative language authorizing the
final year adjustment allows FDA discretion in whether to make this
adjustment for a full 3 months of operating reserves or for a shorter
period, FDA has decided to balance its own risks with the amount of
burden the final year adjustment will place on the industry. In making
this decision, FDA has decided to assume more risk, making the final
year adjustment to allow for only 2 months of operating reserves
instead of for 3 months of operating reserves. Accordingly FDA will
make the final year adjustment for a lesser amount, as derived in table
8 of this document.

 Table 8--Estimated Fee Revenue Needed To Sustain FY 2012 Operations for
                      the First 2 Months of FY 2013
------------------------------------------------------------------------

------------------------------------------------------------------------
Estimated total spending from fees in FY 2012........       $652,709,000
Estimated FY 2013 inflation costs at 3.72%...........         24,280,775
Estimated 2013 funds to sustain 2012 operations......        676,989,775
Estimated fees needed for 2 months in FY 2013........        112,831,629
Estimated 2012 end of FY carryover balance...........         32,393,598
Additional revenue needed for 2 months in 2013.......         80,438,031
------------------------------------------------------------------------

    Rounding this amount to the nearest thousand dollars results in a
final year adjustment of $80,438,000. Adding this amount to the total
of $621,743,000, the total after the offset adjustment at the end of
section III of this document, results in a total revenue target of
$702,172,000, rounded to the nearest thousand dollars, for FY 2012.
    PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the FD&C Act).
Accordingly, one-third of the total revenue amount (rounded to the
nearest thousand dollars), or a total of $234,057,000 is the total
amount of fee revenue that will be derived from each of these fee
categories: Application Fees, Establishment Fees, and Product Fees.
    While the fee revenue amount anticipated in FY 2012 is
$702,172,000, as the previous paragraph shows, FDA assumes that the fee
appropriation for FY 2012 will be 5 percent higher, or $737,281,000,
rounded to the nearest thousand dollars. The PDUFA IV 5-Year Financial
Plan, (which can be found at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm153456.htm) states in Assumption 14 (Fee
Revenue and Annual Appropriation Amount) that the PDUFA workload
adjuster is a lagging adjustment dampened by averages over five years,
and will not help FDA keep up with workload if there are sudden
increases in the number of applications to be reviewed in the current
fiscal year. Appropriated amounts for PDUFA fee revenue each year are
estimated at 5 percent higher than estimated fee revenues for each
year, to provide FDA with the ability to cope with surges in
application review workload should that occur. If FDA collects less
than the fee estimate at the beginning of the year and less than the
fee appropriation, then collections rather than appropriations set the
upper limit on how much FDA may actually keep and spend. If, however,
FDA collects more than fee estimates at the beginning of the year, due
to a workload surge, a slightly higher fee appropriation will permit
FDA to keep and spend the higher collections in order to respond to a
real surge in review workload that caused the increased collections--an
unexpected increase in the number of applications that FDA must review
in accordance with PDUFA goals. For this reason, in most FY since 1993,
actual appropriations have slightly exceeded PDUFA fee revenue
estimates made each year.

V. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate one-third of the total fee
revenue amount, or $234,057,000, in FY 2012, as calculated previously
in this document.

B. Estimate of the Number of Fee-Paying Applications and the
Establishment of Application Fees

    For FY 2008 through FY 2012, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next FY by averaging the number of fee-paying FAEs received in the
5 most recent fiscal years. Using a rolling average of the 5 most
recent fiscal years is the same method that has been applied for the
last 8 years.
    In estimating the number of fee-paying FAEs that FDA will receive
in FY 2012, the 5-year rolling average for the most recent 5 years will
be based on actual counts of fee-paying FAEs received for FY 2007
through FY 2011. For FY 2011, FDA is estimating the number of fee-
paying FAEs for the full year based on the actual count for the first 9
months and estimating the number for the final 3 months, as we have
done for the past 8 years.
    Table 9 of this document shows, in column 1, the total number of
each type of FAE received in the first 9 months of FY 2011, whether
fees were paid or not. Column 2 shows the number of FAEs for which fees
were waived or exempted during this period, and column 3 shows the
number of fee-paying FAEs received through June 30, 2011. Column 4
estimates the 12-month total fee-paying FAEs for FY 2011 based on the
applications received through June 30, 2011. All of the counts are in
FAEs. A full application requiring clinical data counts as one FAE. An
application not requiring clinical data counts as one-half an FAE, as
does a supplement requiring clinical data. An application that is
withdrawn, or refused for filing, counts as one-fourth of an FAE if the
applicant initially paid a full application fee, or one-eighth of an
FAE if the applicant initially paid one-half of the full application
fee amount.

  Table 9--FY 2011 Full Application Equivalents Received Through June 30, 2011, and Projected Through September
                                                    30, 2011
----------------------------------------------------------------------------------------------------------------
                                                                             Column 2
                                                                Column 1       Fees       Column 3     Column 4
                                                                 Total     exempted or   Total fee     12-Month
                                                                received      waived       paying     fee paying
                                                              through  6/  through  6/  through  6/   projection
                                                                30/2011      30/2011      30/2011
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data........................       55            18          37            49.33
Applications not requiring clinical data....................        9.5           5.5         4             5.33
Supplements requiring clinical data.........................       44.5           9          35.5          47.88
Withdrawn or refused to file................................        1.625         1.25         .375          .5
                                                             ---------------------------------------------------
    Total...................................................      110.625        33.75       76.875       102.5
----------------------------------------------------------------------------------------------------------------

    In the first 9 months of FY 2011, FDA received 110.625 FAEs, of
which 76.875 were fee-paying. Based on data from the last 10 FYs, on
average, 25 percent of the applications submitted each year come in the
final 3 months. Dividing 76.875 by 3 and multiplying by 4 extrapolates
the amount to the full 12 months of the FY and projects the number of
fee-paying FAEs in FY 2011 at 102.5.
    As table 10 of this document shows, the average number of fee-
paying FAEs received annually in the most recent 5-year period, and
including our estimate for FY 2011, is 127.1 FAEs. FDA will set fees
for FY 2011 based on this estimate as the number of full application
equivalents that will pay fees.

                                     Table 10--Fee-Paying FAE 5-Year Average
----------------------------------------------------------------------------------------------------------------
                                                                                2011         5-Year
         Fiscal year              2007          2008          2009          2010        estimate       average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs.............        134.4         140.0         140.3         118.4         102.5         127.1
----------------------------------------------------------------------------------------------------------------

    The FY 2012 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 5 years,
127.1, into the fee revenue amount to be derived from application fees
in FY 2012, $234,057,000. The result, rounded to the nearest $100, is a
fee of $1,841,500 per full application requiring clinical data, and
$920,750 per application not requiring clinical data or per supplement
requiring clinical data.

VI. Fee Calculations for Establishment and Product Fees

A. Establishment Fees

    At the beginning of FY 2011, the establishment fee was based on an
estimate that 415 establishments would be subject to, and would pay,
fees. By the end of FY 2011, FDA estimates that 475 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. FDA estimates that a total
of 10 establishment fee waivers or reductions will be made for FY 2011.
In addition, FDA estimates that another 15 full establishment fees will
be exempted this year based on the orphan drug exemption in FDAAA (see
section 736(k) of the FD&C Act). Subtracting 25 establishments (10
waivers, plus the estimated 15 establishments under the orphan
exemption) from 450 leaves a net of 415 fee-paying establishments. FDA
will use 450 for its FY 2012 estimate of establishments paying fees,
after taking waivers and reductions into account. The fee per
establishment is determined by dividing the adjusted total fee revenue
to be derived from establishments ($234,057,000) by the estimated 450
establishments, for an establishment fee rate for FY 2012 of $520,100
(rounded to the nearest $100).

B. Product Fees

    At the beginning of FY 2011, the product fee was based on an
estimate that 2,385 products would be subject to and would pay product
fees. By the end of FY 2011, FDA estimates that 2,450 products will
have been billed for product fees, before all decisions on requests for
waivers, reductions, or exemptions are made. FDA assumes that there
will be 55 waivers and reductions granted. In addition, FDA estimates
that another 30 product fees will be exempted this year based on the
orphan drug exemption in FDAAA (see section 736(k) of the FD&C Act).
FDA estimates that 2,365 products will qualify for product fees in FY
2011, after allowing for waivers and reductions, including the orphan
drug products eligible under the FDAAA exemption, and will use this
number for its FY 2012 estimate. The FY 2012 product fee rate is
determined by dividing the adjusted total fee revenue to be derived
from product fees ($234,057,000) by the estimated 2,365 products for a
FY 2012 product fee of $98,970 (rounded to the nearest $10).

VII. Fee Schedule for FY 2012

    The fee rates for FY 2012 are set out in table 11 of this document.

                   Table 11--Fee Schedule for FY 2012
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2012
------------------------------------------------------------------------
Applications............................................  ..............
    Requiring clinical data.............................      $1,841,500
    Not requiring clinical data.........................         920,750
    Supplements requiring clinical data.................         920,750
Establishments..........................................         520,100
Products................................................          98,970
------------------------------------------------------------------------

IX. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2011. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee

identification (ID) number on your check, bank draft, or postal money
order. Your payment can be mailed to: Food and Drug Administration,
P.O. Box 979107, St. Louis, MO 63197-9000.
    If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: U.S. Bank, Attention:
Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for courier delivery only.)
    Please make sure that the FDA post office box number (P.O. Box
979107) is written on the check, bank draft, or postal money order.
    Wire transfer payment may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution may charge a wire transfer fee
between $15.00 and $35.00. Please ask your financial institution about
the fee and include it with your payment to ensure that your fee is
fully paid. The account information is as follows: New York Federal
Reserve Bank, U.S. Dept of Treasury, TREAS NYC, 33 Liberty St., New
York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD, 20850.
    Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
    The tax identification number of the Food and Drug Administration
is 53-0196965.

B. Establishment and Product Fees

    FDA will issue invoices for establishment and product fees for FY
2012 under the new fee schedule in August 2011. Payment will be due on
October 1, 2011. FDA will issue invoices in November 2012 for any
products and establishments subject to fees for FY 2012 that qualify
for fee assessments after the August 2011 billing.

    Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19332 Filed 7-29-11; 8:45 am]
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[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71576-71577]
[FR Doc No: 2011-29837]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0410]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Premarket Notification for a New
Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Premarket Notification for a New
Dietary Ingredient'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-

400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On August 25, 2011, the Agency submitted a
proposed collection of information entitled ``Premarket Notification
for a New Dietary Ingredient'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0330.
The approval expires on November 30, 2013. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29837 Filed 11-17-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4400-4401]
[FR Doc No: 2011-1435]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63731; File No. SR-BX-2010-083]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order
Approving a Proposed Rule Change Relating to the Price Improvement
Period To Permit an Initiating Participant To Designate a PIP Surrender
Quantity

January 19, 2011.
    On November 24, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission''), pursuant
to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'')
\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to the Rules
of the Boston Options Exchange Group, LLC (``BOX'') to permit an
Options Participant initiating a Price Improvement Period (``PIP'') to
designate a PIP Surrender Quantity. Notice of the proposed rule change
was published for comment in the Federal Register on December 8,
2010.\3\ The Commission received no comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 63416 (December 2,
2010), 75 FR 76503.
---------------------------------------------------------------------------

    Currently, the BOX rules that govern the PIP (``PIP Rules'') \4\
generally allow an Options Participant initiating a PIP (``Initiating
Participant'') to retain priority and trade allocation privileges for
forty percent (40%) of the size of a PIP Order upon conclusion of the
PIP auction.\5\ This proposed rule change will permit an Initiating
Participant, when starting a PIP auction, to submit the Primary
Improvement Order to BOX with a designation to specify a quantity of
contracts that it is willing to ``surrender'' from the number of
contracts to which it is entitled to other Options Participants (``PIP
Surrender Quantity'').\6\ By designating a PIP Surrender Quantity, the
Initiating Participant could potentially be allocated less than the
forty percent (40%) to which it may be entitled under BOX Rules.\7\
---------------------------------------------------------------------------

    \4\ See Chapter V, Section 18 of the Rules of the Boston Options
Exchange Group, LLC (``BOX Rules'').
    \5\ See id., paragraphs f(i)-f(ii).
    \6\ The Initiating Participant would specify the PIP Surrender
Quantity as a number of contracts, not as a percentage of the total
PIP Order. Telephone conversation between Michael Burbach, Vice
President of Legal Affairs, BOX and Ira Brandriss, Special Counsel,
Division of Trading and Markets, Commission, January 13, 2011.
    \7\ The Primary Improvement Order would also still yield
priority to certain competing orders in certain circumstances. See
PIP Rules, supra note 4, paragraph (f)(iii). In the case of a Max
Improvement Primary Improvement Order, see subsection (e)(ii) of the
PIP Rules, the Surrender Quantity would be deducted from the number
of contracts, if any, remaining for the Initiating Participant at
the last level of allocation--i.e., from the 40% share to which the
Initiating Participant is entitled at that level--and ceded to any
other Options Participants at that level. Thus it is possible, under
the proposed rule change, that if the Surrender Quantity is greater
than the number of contracts remaining for the Initiating
Participant at the last level of allocation, the Initiating
Participant will receive no contracts at that level. Telephone
conversation between Michael Burbach, Vice President of Legal
Affairs, BOX, and Ira Brandriss, Special Counsel and Nicholas
Shwayri, Attorney-Advisor, Division of Trading and Markets,
Commission, January 19, 2011.
---------------------------------------------------------------------------

    The proposed rule change further makes clear that in no case shall
the Initiating Participant's use of the Surrender Quantity function
result in an allocation to the Initiating Participant that would be
greater than the maximum allowable allocation the Initiating
Participant would otherwise receive in accordance with the allocation
procedures set forth in the PIP Rules.\8\ The proposal specifies that
the PIP Surrender Quantity shall not be effective for an amount that is
lesser than or equal to sixty percent (60%) of the size of the PIP
Order.
---------------------------------------------------------------------------

    \8\ See, generally id., paragraph (f).
---------------------------------------------------------------------------

    Additionally, the proposed rule change will modify the BOX Trading
Host's trade allocation at the conclusion of the PIP auction to account
for the PIP Surrender Quantity. The proposal specifies that when the
BOX Trading Host determines the priority and trade allocation amounts
for the Initiating Participant upon the conclusion of the PIP auction,
the Trading Host will automatically adjust the trade allocations to the
other PIP Participants according to the priority set forth generally in
the PIP Rules,\9\ providing a total amount to the other PIP
Participants up to the PIP Surrender Quantity. Under the proposal, the
Primary Improvement Order is allocated the remaining size of the PIP
Order, if any. If the aggregate size of other PIP Participants' contra
orders is not equal to or greater than the PIP Surrender Quantity, then
the remaining PIP Surrender Quantity shall be left unfilled by those
participants and the Primary Improvement Order shall be allocated the
remaining size of the PIP Order as set forth in the PIP Rules.\10\ The
Exchange has stated that it will provide Options Participants with
three (3) business days notice, via Information Circular, about the
implementation date of the PIP Surrender Quantity prior to

its implementation in the BOX trading system.
---------------------------------------------------------------------------

    \9\ See id., paragraph (e).
    \10\ See id., paragraph (f).
---------------------------------------------------------------------------

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\11\ In particular, the Commission finds that the proposed
rule change is consistent with the requirements of Section 6(b)(5) of
the Act,\12\ which requires, among other things, that the rules of a
national securities exchange be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
for a free and open market and a national market system and, in
general, to protect investors and the public interest. The Commission
believes that Initiating Participant's use of the Surrender Quantity
function could benefit investors by allowing an Initiating Participant
the flexibility to designate a lower amount than the forty percent
(40%) of the PIP Order to which the Initiating Participant is entitled,
thereby providing the other PIP Participants with the opportunity to
receive increased trade allocations.
---------------------------------------------------------------------------

    \11\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-BX-2010-083), be and hereby is
approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-1435 Filed 1-24-11; 8:45 am]
BILLING CODE 8011-01-P