Chapter IV edits: Conservative Baseline & NSR Conservative Baseline [ Excerpt from Chp IV. Integration with Existing CAA Requirements]

p. 21 | For non EGU sources that do not have Part 75 monitoring data to use as a baseline, a historical baseline must be established that estimates actual emissions in a way that matches or approaches as closely as possible the certainty provided by the Part 75 measured data for EGUs. In the absence of Part 75 measured data, EPA proposes that States be required to estimate historical baseline emissions using assumptions that conservatively use best engineering judgement to | quantify a source's or | source category's actual emissions; source specific data is preferred when it is available. In this case, a conservative estimate would need to err on the side of underestimating baseline emissions. Because the substitute emissions reductions are estimated by subtracting controlled emissions from a projected baseline, if the historical baseline overestimates actual emissions, the estimated reductions could be higher than the actual reductions achieved. To achieve a conservative baseline, States must use conservative emission factors ( e. g., emission factors at the low end of a range when EPA guidance presents a range) or the State must provide additional information that shows with reasonable confidence that another value is more appropriate for estimating actual emissions. Other monitoring or stack testing data can be considered but care 22 p. 22 must be taken not to overestimate baselines. If a production or utilization factor is part of the historical baseline emissions calculation, again, a low ( i. e., conservative) number must be used, or additional data must be provided. Similarly, if a control efficiency factor and/ or rule effectiveness factor enters into the estimate of historical baseline emissions, it must be realistic and supported by facts or analysis. For these factors, a high value ( closer to 100% control and effectiveness) is conservative. Once the historical baseline is established for SO2 and/ or NOx emissions from the substitute sources, the second step is to project, or grow, these emissions to conditions expected in 2010 and 2015. This step results in the 2010 and 2015 baseline emissions estimates. This step should be done with state of the art methods for projecting the source or source category's economic output. To the degree available, economic forecasts should be specific to the State and county where the source is located. Where changes in production method, materials, fuels, or efficiency are expected to occur between the baseline year and 2010 or 2015, these must be accounted for in the projected 2010 and 2015 baseline emissions. The projection must also account for any adopted regulations that will affect source 23 New Source Review

Add a new section " E" at the end of Chapter IV ( Integration with Existing Clean Air Act Requirements)

E. Changes in New Source Review applicability For any EGU in a state with a SIP revision approved pursuant to this IAQR, the term " modification" is defined as follows:

The term ` modification' means any physical change in, or change in the method of operation of, an affected unit that increases the maximum hourly emissions of any pollutant regulated under this Act above the maximum hourly emissions achievable at that unit during the five years prior to the change or that results in the emission of any pollutant regulated under this Act and not previously emitted, provided that the source is in compliance with all emission and permit requirements.


[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73663-73665]
[FR Doc No: 2012-29782]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0304]

Susan F. Knott; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a request
for a hearing submitted by Susan F. Knott and is issuing an order under
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Knott
for 2 years from providing services in any capacity to a person that
has an approved or pending drug product application. FDA bases this
order on a finding that Knott was convicted of a misdemeanor under
Federal law for conduct relating to the regulation of a drug product
under the FD&C Act and that the type of conduct underlying the
conviction undermines the process for the regulation of drugs. In
determining the appropriateness and period of Knott's debarment, FDA
has considered the relevant factors listed in the FD&C Act. Knott has
failed to file with the Agency information and analyses sufficient to
create a basis for a hearing concerning this action.

DATES: The order is effective December 11, 2012.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: G. Matthew Warren, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under

Federal law for conduct relating to the regulation of drug products
under the FD&C Act, and if FDA finds that the type of conduct that
served as the basis for the conviction undermines the process for the
regulation of drugs.
    On August 11, 2009, in the U.S. district court for the northern
district of New York, Knott pled guilty to a misdemeanor under the FD&C
Act, namely misbranding a drug in violation of sections 301(k),
502(i)(3) and 303(a)(1) of the FD&C Act (21 U.S.C. 331(k), 352(i)(3),
333(a)(1)) and 18 U.S.C. 2. The basis for this conviction was conduct
surrounding her role in the injection of patients seeking treatment
with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin,
distributed by Toxic Research International, Inc. (TRI). BOTOX is a
biological product derived from botulinum toxin type A that is
manufactured by Allergan, Inc., and was approved by FDA for use on
humans for the treatment of facial wrinkles in 1991.
    According to the records of the criminal proceedings, Knott, in
following a physician's instructions, ordered at least 31 vials of TRI-
toxin, an unapproved drug product, which was represented by its
distributor as ``Botulinum Toxin Type A.'' Knott, a supervisory nurse
in the medical practice, then instructed other nurses on how to dilute
the TRI-toxin for injection into patients in accordance with orders
from one or more physicians.
    Knott is subject to debarment based on a finding, under section
306(b)(2)(B)(i) of the FD&C Act: (1) That she was convicted of a
misdemeanor under Federal law for conduct relating to the regulation of
a drug product under the FD&C Act and (2) that the type of conduct
underlying the conviction undermines the process for the regulation of
drugs. By letter dated November 30, 2010, FDA notified Knott of its
proposal to debar her for 2 years from providing services in any
capacity to a person having an approved or pending drug product
application. In a letter dated February 3, 2011, through counsel, Knott
requested a hearing on the proposal. In her request for a hearing,
Knott acknowledges her conviction under Federal law, as alleged by FDA.
However, she argues that she should not be debarred for several
reasons, including several related to the factual basis set forth in
the proposal to debar.
    We reviewed Knott's request for a hearing and find that Knott has
not created a sufficient basis for a hearing. Hearings are granted only
if there is a genuine and substantial issue of fact. Hearings will not
be granted on issues of policy or law, on mere allegations, denials, or
general descriptions of positions and contentions, or on data and
information insufficient to justify the factual determination urged
(see 21 CFR 12.24(b)).
    The Chief Scientist has considered Knott's arguments and concludes
that they are unpersuasive and fail to raise a genuine and substantial
issue of fact requiring a hearing.

II. Arguments

    In support of her hearing request, Knott first asserts that section
306(b)(2)(B)(i) of the FD&C Act does not apply to her because she was
never involved in the approval or regulation of drug products, nor was
the underlying conduct of her conviction related to those activities.
During her criminal proceedings, however, Knott pled guilty to
misbranding and causing the misbranding of a drug in violation of
sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act by causing
TRI-toxin, a drug not approved for use, to be offered for sale as an
approved drug product, BOTOX. This conduct clearly relates to the
regulation of drugs under the FD&C Act because it was in direct
violation of the FD&C Act. The conduct also undermined the process for
the regulation of drugs in that it permitted an unapproved drug to be
substituted for an approved drug without the knowledge of the patient.
As a result, Knott is subject to debarment under section
306(b)(2)(B)(i).
    Knott next contends that she pled guilty to a misdemeanor violation
under section 303(a)(1) of the FD&C Act, which is a strict liability
offense, and that thus there was no demonstration or admission of
criminal intent or knowledge underlying her conviction. She argues
that, because she was not aware her conduct violated the FD&C Act, the
conduct underlying her conviction could not undermine the process for
regulation of drugs and she should not be debarred.
    With respect to Knott's assertion that her offense was strict
liability, section 306(b)(2)(B)(i) of the FD&C Act specifically
provides for the debarment of individuals convicted of Federal
misdemeanors related to the regulation of drug products under the FD&C
Act. Given that misdemeanor violations of the FD&C Act itself are
strict liability offenses, it stands to reason that criminal intent is
not a critical component to debar an individual under section
306(b)(2)(B)(i). The charge to which Knott pled guilty did not hinge on
supervisory liability or a technical violation of the FD&C Act. The
charge in the information to which she pled guilty alleged that she
caused a drug to be misbranded by offering it for sale under the name
of another drug, BOTOX. The criminal information further establishes
that, over the course of 9 months, she took the affirmative steps of
ordering the drug and assisting in the formulation of the drug for
injection to at least 150 patients. That the charge did not require a
showing of intent has little to no bearing on whether Knott should be
debarred. An individual need not have criminal intent for his or her
conduct to undermine the process for the regulation of drugs. Knott's
conduct undermined the process for the regulation of drugs in that it
permitted an unapproved drug to be substituted for an approved drug
without the knowledge of the patient. Knott has not presented any
genuine and substantial issues of fact with respect to whether the
conduct underlying her conviction undermines the process for the
regulation of drugs.
    Finally, Knott argues that the considerations under section
306(c)(3) of the FD&C Act weigh against imposing debarment of any
length or debarment beyond a minimal period and that FDA should
exercise discretion and decline to debar her for that reason. As set
forth in the proposal and summarized in this document, Knott pled
guilty to a misdemeanor under the FD&C Act for her role in offering a
drug under the name of another. Consistent with the proposal to debar,
therefore, we find that the consideration in section 306(c)(3)(A) of
the FD&C Act with respect to the nature and seriousness of the offense
involved weighs in favor of debarring Knott for some period of time.
    The record establishes that the medical practice of which Knott was
a part ultimately took voluntary steps to mitigate the effect on the
public health from its unlawful conduct (see section 306(c)(3)(C) of
the FD&C Act). Moreover, the record reflects that she was merely
following a physician's orders and that thus she did not serve a
managerial role in the offense (see section 306(c)(3)(B) of the FD&C
Act). Finally, it is undisputed that she had no previous criminal
convictions related to matters within the jurisdiction of FDA (see
section 306(c)(3)(F) of the FD&C Act). These considerations
counterbalance the nature and seriousness of her offense sufficiently
to warrant decreasing the period of debarment from 5 years to 2 years,
as recommended in the proposal to debar.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of
the FD&C

Act and under authority delegated to him by the Commissioner of Food
and Drugs, finds: (1) That Knott has been convicted of a misdemeanor
under Federal law for conduct relating to the development or approval
of a drug product or otherwise relating to the regulation of a drug
product under the FD&C Act and (2) that the conduct underlying the
conviction undermines the process for the regulation of drugs. FDA has
considered the relevant factors listed in section 306(c)(3) of the FD&C
Act and determined that a debarment of 2 years is appropriate.
    As a result of the foregoing findings, Knott is debarred for 2
years from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see 21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd)). Any person
with an approved or pending drug product application, who knowingly
uses the services of Knott, in any capacity during her period of
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Knott, during her period of
debarment, provides services in any capacity to a person with an
approved or pending drug product application, she will be subject to
civil money penalties (section 307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Knott during her period of
debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Knott for termination of debarment under section
306(d) of the FD&C Act should be identified with Docket No. FDA-2010-N-
0304 and sent to the Division of Dockets Management (see ADDRESSES).
All such submissions are to be filed in four copies. The public
availability of information in these submissions is governed by 21 CFR
10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain documents in the Docket
at http://www.regulations.gov/.

    Dated: November 29, 2012.
Jesse L. Goodman,
Chief Scientist.
[FR Doc. 2012-29782 Filed 12-10-12; 8:45 am]
BILLING CODE 4160-01-P