[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11991-11994]
[FR Doc No: 2015-05045]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0302]

Jeffrey L. Rockmore; 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 Dr. Jeffrey L. Rockmore, and is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
debarring Dr. Rockmore 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 Dr. Rockmore 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
Dr. Rockmore's debarment, FDA has considered the relevant factors
listed in the FD&C Act. Dr. Rockmore 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 March 5, 2015.

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: Nathan Doty, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 11, 2009, in the U.S. District Court for the Northern
District of New York, Dr. Rockmore, a physician, 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 his injection of patients seeking
treatment with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin,
distributed by Toxin Research International, Inc. 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, Dr. Rockmore's colleague in the same medical
practice, The Plastic Surgery Group (TPSG), directed a nurse to obtain
31 vials of TRI-toxin, an unapproved drug product, which was
represented by its distributor as ``Botulinum Toxin Type A''. Dr.
Rockmore then proceeded to inject approximately 26 patients, who
believed they were being injected with BOTOX, with TRI-toxin as a
substitute.
    Dr. Rockmore is subject to debarment based on a finding, under
section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)): (1) That he was convicted of a misdemeanor under
Federal law 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 notice to Dr.
Rockmore dated November 30, 2010,

FDA's Office of Regulatory Affairs (ORA) proposed to debar him for 4
years from providing services in any capacity to a person having an
approved or pending drug product application.
    In a letter dated December 30, 2010, through counsel, Dr. Rockmore
requested a hearing on the proposal. In his request for a hearing, Dr.
Rockmore acknowledges his conviction under Federal law, as alleged by
FDA. By letter dated January 28, 2011, Dr. Rockmore submitted materials
and arguments in support of his request. Dr. Rockmore acknowledges that
he was convicted of a Federal misdemeanor, as found in the proposal to
debar, but argues that he should not be debarred for reasons related to
the factual basis set forth in the proposal to debar. In particular,
with respect to the considerations for determining the appropriateness
and period of debarment under section 306(c)(3) of the FD&C Act, he
argues that there are genuine and substantial issues of fact for
resolution at a hearing, namely factual issues bearing on whether he
participated in or even knew of certain conduct that resulted in his
violation of the FD&C Act.
    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 or the action requested (see 21 CFR
12.24(b)).
    The Chief Scientist has considered Dr. Rockmore's arguments, as
well as the proposal to debar itself, and concludes that, although Dr.
Rockmore has failed to raise a genuine and substantial issue of fact
requiring a hearing, the appropriate period of debarment is 2 years.

II. Arguments

    In support of his hearing request, Dr. Rockmore first asserts that
he is not subject to debarment under section 306(b)(2)(B)(i)(I) of the
FD&C Act. He contends that he pled guilty to a misdemeanor violation of
the FD&C Act (see 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 the conviction.
Dr. Rockmore concludes, therefore, that the conduct underlying his
conviction did not undermine the process for the regulation of drugs.
    Section 306(b)(2)(B)(i)(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 themselves 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)(I). During his criminal proceedings, Dr. Rockmore 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 offering an unapproved drug, TRI-toxin, for sale as an approved drug
product, BOTOX. Dr. Rockmore'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.
As a result, Dr. Rockmore is, in fact, subject to debarment under
section 306(b)(2)(B)(i)(I) of the FD&C Act.
    Dr. Rockmore next challenges the manner in which ORA applied the
considerations under section 306(c)(3) of the FD&C Act in determining
the appropriateness and period of his debarment. In the proposal to
debar Dr. Rockmore, ORA stated that there are four applicable
considerations under section 306(c)(3) of the FD&C Act: (1) The nature
and seriousness of his offense under section 306(c)(3)(A); (2) the
nature and extent of management participation in the offense under
section 306(c)(3)(B); (3) the nature and extent of voluntary steps
taken to mitigate the impact on the public under section 306(c)(3)(C);
and (4) prior convictions involving matters within the jurisdiction of
FDA under section 306(c)(3)(F). ORA found with respect to Dr. Rockmore
that the first two considerations weigh in favor of debarment and noted
that the third and fourth considerations would be treated as favorable
factors for him. In making all of its findings under section 306(c)(3)
of the FD&C Act, ORA characterized Dr. Rockmore's conduct based on
records from his criminal proceedings.
    Under section 306(c)(3)(A) of the FD&C Act, in determining the
appropriateness and period of debarment, FDA considers ``the nature and
seriousness of the offense involved.'' In the proposal to debar, ORA
relied on the criminal information to which Dr. Rockmore pled guilty to
find that the conduct underlying his convictions:

created a risk of injury to consumers due to the use of an
unapproved drug, undermined [FDA's] oversight of an approved drug
product by representing that [he] used the approved drug while
actually substituting an unapproved drug in its place, and seriously
undermined the integrity of [FDA's] regulation of drug products.

Under section 306(c)(3)(B) of the FD&C Act, ORA also considered the
``nature and extent of [Dr. Rockmore's] management participation in the
offense'' and specifically found that he was a corporate principal who
``pleaded guilty to misbranding TRI-toxin'' and ``participated in the
[TPSG's] unlawful conduct of administering [an] unapproved drug on
multiple occasions to patients.'' ORA concluded, therefore, that the
nature and seriousness of Dr. Rockmore's offenses and the nature and
extent of management participation were unfavorable factors with
respect to him.
    Dr. Rockmore counters ORA's findings with respect to those two
considerations in section 306(c)(3) of the FD&C Act with the following
arguments: (1) That he did not admit any criminal intent or intentional
wrongdoing when he pled guilty to a misdemeanor offense under the FD&C
Act; (2) that, in fact, another physician at TPSG took unilateral
action in ordering the TRI-toxin and directing a nurse to substitute it
for BOTOX; (3) that the TRI-toxin vials that they used for injecting
patients with TRI-toxin were identical to the vials he used for BOTOX
before the substitution; and (4) that since the conviction for the
underlying misdemeanor was of an individual, that there was no
management participation and that, thus, the nature and extent of
management participation is inapplicable as a factor in determining
appropriateness and period of debarment. Dr. Rockmore concedes that he
pled guilty to the misdemeanor offense because he was, in fact, guilty
of offering TRI-toxin for sale to their patients as BOTOX. He argues,
however, that the criminal records do not establish any intent or
knowledge on his part and that thus the conduct underlying his
conviction does not warrant debarment in light of the considerations in
section 306(c)(3) of the FD&C Act.
    As noted previously, ORA relied on the records of Dr. Rockmore's
criminal proceedings for its findings in the proposal to debar. There
is nothing definitive in the criminal records before FDA to contradict
Dr. Rockmore's assertions with respect to the nature of his involvement
in the misdemeanor offense to which he pled guilty. The criminal
information to which Dr. Rockmore pled guilty alleges that TPSG, as
opposed to Dr. Rockmore, began ordering TRI-toxin for use in the
medical practice, and there are no allegations that Dr. Rockmore took
part in the ordering process. Indeed, the proposal to debar states
that, as claimed

by Dr. Rockmore, another physician in the practice, William F. DeLuca,
Jr., was responsible for authorizing a nurse to substitute TRI-toxin
for BOTOX, not Dr. Rockmore. At Dr. Rockmore's sentencing hearing, at
which six other codefendants, including DeLuca, were also sentenced,
the presiding judge also made clear that he believed DeLuca was the
physician responsible for making the ``mistake'' that led to the other
physician's offenses. In addressing DeLuca, the court stated:

And we're here because of your actions and inactions. As I said,
your mistakes were different in kind and degree from those of your
colleagues. It was you who brought this drug into the practice, and
it was your conduct and your failure to check out either the company
or the drug that you were ordering, as you should have done, your
negligence in doing that that has brought us here today in the end.

In addressing one of the other three physicians who pled guilty under
circumstances similar to Dr. Rockmore's, the court further stated:
``There have been disputes on how in the past over who knew what and at
what point in time. It is clear from the facts in this case that you
had no knowledge that the substance was anything other than [BOTOX]
until your discovery of it in November of 2004.''
    In short, consistent with the proposal to debar Dr. Rockmore for 4
years, the records of his criminal proceedings establish that the
misdemeanor convictions for the physicians in TPSG other than DeLuca
were not based on any affirmative involvement in ordering the TRI-toxin
or substituting the TRI-toxin for BOTOX. Furthermore, in proposing to
debar Dr. Rockmore for 4 years, ORA did not rely on any findings with
respect to Dr. Rockmore's intent or knowledge. Rather, citing the
records of Dr. Rockmore's criminal proceedings, the proposal to debar
simply rests on Dr. Rockmore's position of authority within TPSG and
his conduct in misbranding TRI-toxin by administering it to patients
who believed they were receiving BOTOX. As a result, under Sec.
12.24(b), there is no genuine and substantial issue of fact raised by
Dr. Rockmore's arguments for resolution at a hearing.
    As set forth in the proposal to debar and summarized previously,
Dr. Rockmore pled guilty to a misdemeanor under the FD&C Act for his
role in offering a drug under the name of another. Based on the
undisputed record before the Agency, the consideration in section
306(c)(3)(A) of the FD&C Act with respect to the nature and seriousness
of the offense involved is a favorable factor. As reflected in the
records of the criminal proceedings, Dr. Rockmore's offense did not
rest on any intent or knowledge of wrongdoing on his part, nor may such
intent or knowledge be inferred from the circumstances of his offense
or the findings in the proposal to debar. Although, as a practicing
physician, Dr. Rockmore should be expected to take the appropriate
steps to avoid administering an unapproved new drug to patients or
misrepresenting the drug being administered, his failure to do so over
a 10-month period does not warrant considering the nature and
seriousness of his offense as an unfavorable factor, relative to the
range of conduct that might underlie a Federal misdemeanor conviction.
    On the other hand, because of Dr. Rockmore's position of authority
within TPSG and, thus, presumed ability to prevent the series of events
that resulted in the offense underlying his misdemeanor conviction, the
nature and extent of management participation in the offense is an
unfavorable factor, for the purposes of the consideration under
306(c)(3)(B) of the FD&C Act. Dr. Rockmore asserts that there was no
management participation, and thus, this factor is inapplicable because
the underlying conviction was of an individual. However, the criminal
information to which Dr. Rockmore pled guilty alleges that TPSG began
ordering TRI-toxin for use in the medical practice. It is undisputed
that Dr. Rockmore is a principal in TPSG, and this is the basis for
considering the nature and extent of management participation as a
factor in determining the appropriateness and period of debarment. FDA
has relied on this factor in other debarment cases where the underlying
conviction was of an individual (see 78 FR 68455 (November 14, 2013);
77 FR 27236 (May 9, 2012)).
    The limited scope of his direct actions in committing the
underlying misdemeanor offense does not mitigate the extent of his
management participation, as established during his criminal
proceedings and as set out in the proposal to debar. It is true that
nothing in the criminal proceedings or the proposal to debar reflects
any involvement by him in the decision to order the TRI-toxin and
substitute it for BOTOX, and the proposal to debar specifically finds
that another physician authorized a nurse to place that order. However,
Dr. Rockmore, as a principal of TPSG, was responsible for failing to
ensure that there were controls and procedures in place to prevent
other physicians or a nurse from ordering unapproved drugs for
administration to patients. His own admitted inaction on that front
warrants treating his management participation as an unfavorable
factor.\1\
---------------------------------------------------------------------------

    \1\ See United States v. Park, 421 U.S. 658, 673-74 (1975)
(holding that a high-level manager within a business entity bears a
responsibility to prevent and correct violations of the FD&C Act).
---------------------------------------------------------------------------

    Consistent with the proposal to debar, the record establishes that
the medical practice of which Dr. Rockmore 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).
Furthermore, it is undisputed that Dr. Rockmore had no previous
criminal convictions related to matters within the jurisdiction of FDA
(see section 306(c)(3)(F) of the FD&C Act). Therefore, these will be
treated as favorable factors. In light of the foregoing four
considerations, one of which weighs against Dr. Rockmore, debarment for
2 years is appropriate.

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, finds that Dr.
Rockmore 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 that the conduct underlying the conviction undermines 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, Dr. Rockmore 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) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved, or pending, drug product application, who
knowingly uses the services of Dr. Rockmore, in any capacity during his
period of debarment, will be subject to civil money penalties. If Dr.
Rockmore, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application he will be subject to civil money penalties. In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Dr. Rockmore during his period
of debarment.

    Any application by Dr. Rockmore for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0302 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: February 24, 2015.
Stephen Ostroff,
Director, Office of the Chief Scientist.
[FR Doc. 2015-05045 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 11, 2007 (Volume 72, Number 69)]
[Notices]
[Page 18231]
[DOCID:fr11ap07-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EG07-15-000; EG07-27-000; EG07-28-000l; EG07-30-000; EG07-
31-000; EG07-32-000; EG07-33-000; EG07-34-000; EG07-35-000]

Twin Buttes Wind LLC; Grays Harbor Energy LLC; Les Power
Partners, LLC; Whirlwind Energy, LLC; Diablo Winds, LLC; Osceola
Windpower, LLC; Airtricity Sand Bluff Wind Farm; LLC; Airtricity Forest
Creek Wind Farm, LLC; Dillion Wind LLC; Notice of Effectiveness of
Exempt Wholesale Generator or Foreign Utility Company Status

April 4, 2007.
    Take notice that during the month of March 2007, the status of the
above-captioned entities as Exempt Wholesale Generators or Foreign
Utility Companies became effective by operation of the Commission's
regulations. 18 CFR 366.7(a).

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6677 Filed 4-10-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Notices]
[Pages 46982-46983]
[FR Doc No: 2017-21727]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER11-2154-007.
    Applicants: Twin Eagle Resource Management, LLC.
    Description: Amendment to June 30, 2017 Triennial Market Power
Update for the Northeast Region of Twin Eagle Resource Management, LLC.
    Filed Date: 10/3/17.
    Accession Number: 20171003-5073.
    Comments Due: 5 p.m. ET 10/24/17.

    Docket Numbers: ER17-2538-001.
    Applicants: AEP Generation Resources Inc.
    Description: Tariff Amendment: Reactive Supply and Voltage Control
Stuart Amendment to be effective 10/1/2017.
    Filed Date: 10/3/17.
    Accession Number: 20171003-5089.
    Comments Due: 5 p.m. ET 10/24/17.

    Docket Numbers: ER18-17-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Request for Limited Tariff Waiver Request of PJM
Interconnection, L.L.C.
    Filed Date: 10/2/17.
    Accession Number: 20171002-5338.
    Comments Due: 5 p.m. ET 10/23/17.

    Docket Numbers: ER18-18-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Navopache NITSA and NOA to
be effective 10/1/2017.
    Filed Date: 10/3/17.
    Accession Number: 20171003-5114.
    Comments Due: 5 p.m. ET 10/24/17.

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

    Docket Numbers: ES18-1-000.
    Applicants: Massachusetts Electric Company.
    Description: Application under Section 204 of the Federal Power Act
for Authorization to Issue Securities of Massachusetts Electric
Company.
    Filed Date: 10/3/17.
    Accession Number: 20171003-5072.
    Comments Due: 5 p.m. ET 10/24/17.

    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: October 3, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-21727 Filed 10-6-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58617-58618]
[FR Doc No: 2017-26790]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5925]

21st Century Cures Act: Announcing the Establishment of the
Susceptibility Test Interpretive Criteria Website

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the establishment of the Susceptibility Test Interpretive
Criteria Website. The Susceptibility Test Interpretive Criteria Website
will help to efficiently update susceptibility test interpretive
criteria for antimicrobial drugs when necessary for public health and
may allow for more efficient development and evaluation of
antimicrobial susceptibility test (AST) devices. These changes may lead
to better patient care and reduce antimicrobial resistance through
improved antibiotic stewardship. FDA is publishing this notice in
accordance with procedures established by the 21st Century Cures Act
(Cures Act).

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1182, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Antimicrobial susceptibility testing is used to determine if
certain microorganisms that are isolated from a patient with an
infection are likely to be killed or inhibited by a particular
antimicrobial drug. It is important that the in vitro susceptibility
test methods and susceptibility test interpretive criteria for systemic
antibacterial or antifungal drugs be reviewed on a regular basis and
updated to reflect the most current information. The development of new
mechanisms of resistance in bacteria or fungi may result in decreased
susceptibility to a particular drug. Decreased susceptibility may raise
efficacy or safety concerns when out-of-date susceptibility test
interpretive criteria are used in guiding the treatment of patients.
    Historically, susceptibility test interpretive criteria have been
contained in the Microbiology subsection of antimicrobial drug
labeling, and there have been significant challenges associated with
ensuring that this information is up-to-date in individual
antimicrobial drug labels. For some time, FDA and other stakeholders
have recognized that susceptibility test interpretive criteria
standards established by nationally or internationally recognized
standard development organizations (SDOs) can be useful sources of
information to identify and update susceptibility test interpretive
criteria.
    Section 511A of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360a-2), as added by section 3044 of the Cures Act
(Pub. L. 114-255), was signed into law on December 13, 2016. This
provision clarifies FDA's authority to identify and efficiently update
susceptibility test interpretive criteria, including through the
recognition by FDA of standards established by SDOs. It also clarifies
that sponsors of AST devices may rely upon listed susceptibility
interpretive criteria to support premarket authorization of their
devices, provided they meet certain conditions, which provides for a
more streamlined process for incorporating up-to-date information into
such devices.

II. Susceptibility Test Interpretive Criteria Website

    Section 511A of the FD&C Act requires FDA to establish within 1
year after the date of enactment of the Cures Act an Interpretive
Criteria Website that contains a list of FDA-recognized susceptibility
test interpretive criteria standards, as well as other susceptibility
test interpretive criteria identified by FDA. FDA is announcing the
establishment of this Interpretive Criteria Website, which can be found
here: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm.
    This website recognizes susceptibility test interpretive criteria
established by an SDO that fulfills the requirements under section
511A(b)(2)(A) of the FD&C Act; identifies when FDA does not recognize,
in whole or in part, susceptibility test interpretive criteria
established by an SDO; and lists susceptibility test interpretive
criteria identified by FDA outside the SDO process. The susceptibility
test interpretive criteria listed by FDA on the Interpretive Criteria
Website are deemed to be recognized as a standard under section
514(c)(1) of the FD&C Act (21 U.S.C. 360d(c)(1)).
    At least every 6 months after the establishment of the Interpretive
Criteria Website, FDA will publish on the Interpretive Criteria Website
a notice recognizing new or updated susceptibility test interpretive
criteria standards, or parts of standards; withdrawing recognition of
susceptibility test interpretive criteria standards, or parts of
standards; and making any other necessary updates to the lists
published on the Interpretive Criteria Website. Once a year FDA will
compile the notices from that year and publish them in the Federal
Register and provide for public comment. If comments are received, FDA
will review those comments and make any updates to the recognized
standards or susceptibility test interpretive criteria as

needed. In addition to this statutorily required annual notice, FDA
intends to publish a Federal Register notice within the next few months
to allow for public comment on the initial recognition of
susceptibility test interpretive criteria.

    Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26790 Filed 12-12-17; 8:45 am]
 BILLING CODE 4164-01-P


                             SUPPORTING STATEMENT
                        ENVIRONMENTAL PROTECTION AGENCY

1.  Identification of the Information Collection

      1(a) 	Title of the Information Collection

      Pesticide Establishment Application, Notification of Registration, and Pesticide Production Reports for Pesticide-Producing and Device-Producing Establishments (Renewal).

      EPA ICR No. 0160.12, OMB Control No. 2070-0078.

      1(b) 	Short Characterization/Abstract

      The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(a) (7 USC 136e) requires that any person who produces pesticides or active ingredients subject to the Act must register with the Administrator of EPA the establishment in which the pesticide is produced. This Section further requires that the application for registration of any establishment shall include the name and address of the establishment and of the producer who operates such an establishment. EPA Form 3540-8, Application for Registration of Pesticide-Producing and Device-Producing Establishments, is used to collect the establishment registration information required by this Section. Establishment registration information, collected on EPA Form 3540-8, is a one-time requirement for all pesticide-producing and device-producing establishments.

      FIFRA Section 7(c) requires that any producer operating an establishment registered under Section 7 report to the Administrator within 30 days after it is registered, and annually thereafter by March 1[st] for certain pesticide/device production and sales/distribution information. The producers must report which types and amounts of pesticides, active ingredients, or devices are currently being produced, were produced during the past year, and sold or distributed in the past year. The supporting regulations at 40 CFR Part 167 provides the requirements and time schedules for submitting production information. EPA Form 3540-16, Pesticide Reports for Pesticide-Producing and Device-Producing Establishments, is used to collect the pesticide production information required by Section 7(c) of FIFRA.

2.  Need for and Use of the Collection

      2(a) 	Need/Authority for the Collection

      FIFRA Section 7 states that required pesticide production information be reported annually as required under regulations (40 CFR 167) as the Administrator may prescribe.

      2(b) 	Practical Utility/Users of the Data

      The purpose of this reporting requirement is to obtain pesticide production information. The EPA requires this information to maintain current and complete records of the locations of all pesticide-producing and device-producing establishments. This information provides an overview of establishments engaged in pesticide activities and allows the Agency to target establishments for inspections with optimal utilization of limited inspection resources. Such production information permits EPA to trace ineffective, contaminated or otherwise violative products to their source, and minimizes any adverse environmental impact that might arise from the production or distribution of violative products. If this information were not collected, the Agency would be unable to meet the statutory requirements of FIFRA.

      The Office of Compliance (OC) in the Office of Enforcement and Compliance Assurance (OECA) collects the establishment and pesticide production information for compliance purposes and risk assessment. This information is used by EPA Regional pesticide enforcement and compliance staffs, the OC, the Office of Civil Enforcement (OCE), and the Office of Pesticide Programs (OPP) within the Office of Chemical Safety & Pollution Prevention (OCSPP), as well as the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), other Federal agencies, States under Cooperative Enforcement Agreements, and the public.

      EPA Headquarters, Regions and the States use the data for targeting inspection activities, compliance and outreach, and enforcement actions. Establishment registration and production data are used to:  identify where specific pesticides are made; target inspections in response to tips or complaints of producer violations; determine where violative products found in the marketplace were produced, thus facilitating recalls of problem products; facilitate the issuance of Stop Sale, Use or Removal Orders for violative products; help locate production sites of canceled or suspended products; and assist in notifying producers of regulatory actions or requirements.

3.  Non-duplication, Consultations and Other Collection Criteria

      3(a) 	Non-duplication

      No agency besides EPA, nor any other program within EPA, requests this information. The Agency, under Section 29 of FIFRA, does collect a subset of production data for only conditionally registered pesticides. However, this production data for conditionally registered pesticides does not fulfill the requirements of Section 7 of FIFRA. Therefore, no duplication exists.

      3(b) 	Public Notice Required Prior to ICR Submission to OMB

      The Federal Register notice required by 5 CFR 1320.8(d) was published May 6, 2019 at 84 FR 19785. There were no comments received in response to the Federal Register Notice.

      3(c) 	Consultations

      With the launch of the eReporting system, EPA decided to reanalyze the burden estimates for this ICR as well as collect information on how long it took to complete EPA Form 3540-8 and EPA Form 3540-16 through the efile system separately from the traditional paper form. We consulted with nine industry representatives (listed below) of the respondent universe  --  small businesses, firms with multiple establishments, and repackagers  --  on the scope and burden covered by this ICR and to estimate the amount of time they typically spent gathering, compiling and filling out information for both forms if done via paper and electronically.

      1. Melinda Bowman  -  Compliance Services
      2. Nicole O'Loughlin  -  Pyxis
      3. Emily Tian  -  Reach24H
      4. Kimberly York  -  Syngenta
      5. Carrie Nolan  -  Wagner Reg
      6. Christina Swick  -  Lewis & Harrison
      7. Amber Duke  -  Asmark
      8. Linda Murray  -  3M
      9. Susan Asmark  -  Asmark

      The burden estimates in this ICR are based on the consultation with industry. From the surveys we learned that, generally, the information is already assembled and compiled so filling out the forms involves little burden.

      3(d) 	Effects of Less Frequent Collection

      EPA Form 3540-8 is a one-time requirement for information used to register pesticide-producing and device-producing establishments. EPA Form 3540-16 must be submitted by all establishments subject to Section 7 of FIFRA, 30 days after notification of the initial assignment of an establishment registration number, and thereafter on an annual basis. The statute dictates the time schedule in which reporting must occur. Therefore, EPA could not carry out the requirements of the statute if EPA collected such data on a less frequent reporting schedule.

      Additionally, if the information were not submitted, the EPA would be unable to fulfill its statutory responsibilities relative to the review and registration of pesticides and the protection of human health and the environment.

      3(e) 	General Guidelines

      The collection does not include or require any of the provisions requiring special explanation listed at 5 CFR 1320.5(d)(2).

      3(f) 	Confidentiality

      The information collected on EPA Form 3540-8 does not involve any confidentiality concerns or sensitive questions. However, pesticide and device producers must report certain confidential business information (CBI) on EPA Form 3540-16, including the amounts of pesticides/devices produced, sold, and distributed, under FIFRA Section 7 requirements. EPA safeguards trade secrets in accordance with FIFRA Sections 7(d) and 10. The Agency's copies of individual firms' reports are stored in secure file cabinets within CBI security areas. Confidential business information pertaining to specific data on any one firm cannot be released to the public.

      3(g) 	Sensitive questions

      No information of a sensitive nature concerning sexual behavior or attitudes, religious beliefs, or other matters usually considered private will be collected as a result of this ICR.

4.  The Respondents and the Information Requested

      4(a) 	Respondents NAICS Codes

      Establishments producing pesticide products, pesticide chemical ingredients, and devices are subject to FIFRA. The six-digit sector/sub-sector United States North American Industry Classification System (NAICS) Codes assigned to the businesses and other institutions participating in this program include primarily Manufacturing, Sectors 31-33; and Agricultural, Forestry, Fishing & Hunting, Sector 11.

      4(b) 	Information Requested

      (i) Data Items

      All data in this ICR that is recorded is required by Section 7 of FIFRA and the supporting regulations at 40 CFR 167. Under this requirement producers of pesticides and devices must report to the Agency annually the types and amounts of pesticides and devices produced, repackaged, and relabeled; the amount sold or distributed in U.S. markets; the amount sold or distributed in foreign markets; and the amount anticipated to be produced in the following year.

	(ii) Respondent Activities

 Read instructions (provided with each EPA Form)
 Plan the reporting activity
 Gather information
 Plan and review information for accuracy
 Store, file and maintain the information
 One-time CDX registration, if registering electronically

      During normal business operations, a producer would plan and maintain the information required to comply with this information collection activity, arrange for the collection and review of the information for accuracy, and arrange to maintain or store the information. The information required to be reported is information that the producer would generally maintain as prudent business practices. The Agency does not specify in the regulation how the data to be gathered must be organized; however, the Agency does supply a reporting form, which provides for the reporting of the required information in a consistent manner.

5.  The Information Collected:  Agency Activities, Collection Methodology, and Information Management

      5(a) 	Agency Activities

      In this collection the Agency will: (1) answer companies' and producers' questions; (2) review the data collected; (3) provide appropriate protection of confidential business information; and (4) store collected data both electronically and in paper file systems.

      5(b) 	Collection Methodology and Management

      Producers determine how to best comply with the requirements for record keeping under FIFRA Section 7. They may collect and store the required data electronically or by paper copy.

      The Agency, in turn, annually provides forms for pesticide-producing and device-producing establishments to report their collected and stored information. On January 2, 2016, EPA launched an electronic reporting option.

      EPA's Office of Enforcement and Compliance Assurance, Office of Pesticide Programs, and Office of Environmental Information partnered to deploy electronic reporting (eReporting) of establishment registration information (EPA Form 3540-8) and pesticide production information (EPA Form 3540-16) into the Section Seven Tracking System (SSTS). eReporting allows producers who operate pesticide-producing or device-producing establishments to electronically enter and submit their establishment registration information and pesticide production information by way of EPA's CDX. CDX provides a suite of services to support data collection and exchange with external partners and stakeholders such as states, tribes, localities, industry, federal agencies and other organizations or countries. This process is voluntary, it is not mandatory. This process has a one-time registration requirement.

      5(c) 	Small Entity Flexibility

      The information collected under this ICR does not significantly impact small businesses, since the information being reported would be considered as "customary and usual business activities." Even though the record keeping and reporting requirements are the same for small and large businesses, the Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses.

      5(d) 	Collection Schedule

      The collection schedule established in the regulations at 40 CFR 167.85(d) requires that each producer report pesticide and device production information within 30 days of receipt of the notification of assignment of their establishment number from the Agency; thereafter, each producer is required annually to report their pesticide production information by March 1. Each December, the Agency will remind producers of the March 1 reporting deadline and providing them with the link where they can obtain the forms online.

6.  Estimating the Burden and Cost of the Collection

      6(a) 	Estimating Respondent Burden

      With the launch of the eReporting system, EPA decided to reanalyze the burden estimates for this ICR as well as collect information on how long it takes to complete EPA Forms 3540-8 and 3540-16 through the efile system separately from the traditional paper form. We asked nine industry representatives of the respondent universe  --  small businesses, firms with multiple establishments, and repackagers  --  to estimate the amount of time they typically spent gathering, compiling and filling out information for both forms if done via paper and electronically.

      The estimates for EPA Form 3540-8 are based on these surveys with industry. The one-time submission of information is of such a nature as to demand no research of company records or calculations; it is easily completed by technical personnel; and reviewed and signed by a company officer. The completion of the application rarely exceeds the estimated hourly rate. See Table 1 for respondent burden estimates.

      Burden estimates for EPA Form 3540-16 are based on the results of the surveys as well. From the surveys, we learned that, generally, the information is already assembled and compiled so filling out the form involves little burden. See Table 2 for the respondent burden estimates for EPA Form 3540-16.

      6(b) 	Estimating Respondent Costs

      (i) Estimating Labor Costs

      This ICR uses estimates of labor rates and associated costs based on Department of Commerce Bureau of Labor Statistics estimates. Specifically, this ICR uses the May 2018 National Industry-Specific Occupational Employment and Wage Estimates for the industry NAICS code 325300 (Pesticide, Fertilizer and other Agricultural Chemical Manufacturing), which is presumed to dominate this sector. The mean hourly wage rates for NAICS code 325300 were: management, $65.52; technical (engineering), $48.25; and clerical (administrative), $21.85. A factor of 1.6 was added to adjust for benefit costs, resulting in respective total labor costs of $104.83, $77.20, and $34.96.

Application for Registration of Pesticide-Producing and Device-Producing Establishments (EPA Form 3540-8):

      Public reporting burden for this collection of information using the paper form is estimated to average 0.98 hours (58.8 minutes) per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and completing the review and collection of information. The burden for those pesticide establishments completing the electronic version of EPA Form 3540-8 is 1.25 hours (75 minutes), which includes a one-time CDX registration, estimated to take 30 minutes per respondent.

Pesticide Report for Pesticide-Producing Establishments (EPA Form 3540-16)

      Public reporting burden for this collection of information for those respondents using the paper version of EPA Form 3540-16 is estimated to average 2.1 hours (2 hours and 6 minutes) per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing the review and collection of information. The burden for any establishment using the eReporting system to complete EPA Form 3540-16 is estimated to average 1.45 hours (1 hour and 27 minutes). Some respondents will have an estimated additional 30 minutes to complete a one-time CDX registration.

      See Tables 1 and 2 for the respondent cost estimates for EPA Forms 3540-8 and 3540-16, respectively.

      (ii) Estimating Capital and Operations and Maintenance Costs

      The only type of industry costs associated with the ICR activity in the standards is labor costs. There are no capital/start-up or O&M costs.

      6(c) 	Estimate of Agency Burden and Costs

      The cost to the Government for the Application for Registration of Pesticide-Producing and Device-Producing Establishments (EPA Form 3540-8) is based on one work-year to review and process applications. Other direct costs are limited to review of the data, mailing costs, etc. The number of respondents (815) are estimated based on the average annual number of applicants registering establishments over the past four-year period. See Table 3 for Agency burden and cost estimates.

      The cost to the Government for the Pesticide Report for Pesticide-Producing and Device-Producing Establishments (EPA Form 3540-16) is based on one work-year to review and process production reports. The number of respondents is the number of active pesticide-producing and device-producing establishments registered with EPA (14,248) as well as 815 initial reports from newly registered establishments. See Table 4 for Agency burden and cost estimates.

      This ICR consolidated all government labor costs to that of a GS-13 step 1, as the bulk of the work is performed at this level. The minor shares of burden carried by management and clerical staff have been judged approximately equal and thus balance out if the entire burden is estimated at the GS-13/1 level.

      EPA estimates that 10 percent of paper and 5 percent of electronic submissions are missing information or contain an error that requires the Agency to follow up with respondents. For purposes of this ICR, EPA used these assumptions in its calculations.

      The estimates for Agency costs for EPA Forms 3540-8 and 3540-16 are shown in Tables 3 and 4, respectively.

      6(d) 	Estimating the Respondents Universe and Total Burden and Costs

      As of October 2019, there were 14,248 active pesticide-producing and device-producing establishments registered with EPA. While the actual number of registered establishments fluctuates somewhat, the average over the past three-year period has appeared to stabilize at the present level. For purposes of this ICR, EPA assumes that the number of newly registered establishments in any period of time will be approximately equal to the number of currently registered establishments going out of business. Currently, 55 percent of respondents submit EPA Form 3540-8 through eReporting. Approximately 61 percent of pesticide establishments submit EPA Forms 3540-16 through eReporting. For purposes of this ICR, EPA used these percentages in its calculations. The total annual respondent burden is 27,135.26 hours (919.66 + 26,215.6) and the total annual labor costs are $1,955,029.67 ($71,180.70 + $1,883,848.97).

      For those utilizing paper forms, the total annual respondent burden is 12,697.16 hours and the total annual labor costs are $883,471.33.  For respondents using eReporting, the total annual respondent burden is 14,438.10 hours and the total annual labor costs are $1,071,558.34.

      Details upon which these estimates are based appear in Table 1: Respondent Burden Hours and Costs for Application for Registration of Pesticide-Producing Establishments (EPA Form 3540-8) and Table 2: Respondent Burden Hours and Costs for Pesticide Report for Pesticide-Producing Establishments (EPA Form 3540-16).

(e) 	Bottom Line Burden Hours and Cost Tables

Table 1: Respondent Burden Hours and Costs for Application for Registration of Pesticide-Producing Establishments (EPA Form 3540-8)

                                  ACTIVITIES
                              ANNUAL BURDEN HOURS
                                  TOTAL HOURS
                                 TOTAL COSTS $

                             Management Paper Form
                             Technical Paper Form
                              Clerical Paper Form
                             Management eReporting
                             Technical eReporting
                              Clerical eReporting

                                    $104.83
                                    $77.20
                                    $34.96
                                    $104.83
                                    $77.20
                                    $34.96

a.  Read or Hear Any Instructions
                        ($104.83 x 36.7) = $3,847.33
                          ($77.20 x 37) = $2,833.24
                         ($34.96 x 36.7) = $1,283.03
                         ($104.83 x 44.8) = $4,696.47
                          ($77.20 x 44.8) = $3,458.56
                          ($34.96 x 44.8) = $1,566.21
                                     244.5
                                  $17,684.85
b. Process, Compile, and Review the Information
                                      0
                         ($77.20 x 121.11) = $9,349.69
                                       0
                                       0
                          ($77.20 x 44.8) = $3458.56
                                       0
                                    165.91
                                  $12,808.25
c. Complete Form(s)
                                       0
                          ($77.20 x 73.4) = $5,666.48
                                       0
                                       0
                          ($77.20 x 44.8) = $3458.56
                                       0
                                     118.2
                                   $9,125.04
d. Record, Disclose, Display, or Report the Information
                                       0
                           ($77.20 x 37) = $2,833.24
                                       0
                                       0
                          ($77.20 x 44.8) = $3,458.56
                                       0
                                     81.5
                                   $6,291.80
e. Store, File, or Maintain the Information
                                       0
                                       0
                          ($34.96 x 18.35) = $641.52
                                       0
                          ($77.20 x 44.8) = $3,458.56
                           ($34.96 x 22.4) = $783.10
                                     85.55
                                   $4,883.18
f. One-time CDX Registration
                                       0
                                       0
                                       0
                         ($104.83 x 112) = $11,741.18
                          ($77.20 x 112) = $8,646.40
                                       0
                                      224
                                  $20,387.58

      Annual Burden Hour Total = 919.66* Annual Cost Total = $71,180.70*
     * assumes 815 responses annually, 55% by eReporting and 45% by paper

    ***NOTE:  Numbers in the Tables (1-4) may vary slightly due to rounding

Table 2: Respondent Burden Hours and Costs for Pesticide Report for Pesticide-Producing Establishments (EPA Form 3540-16)

                                  ACTIVITIES
                              ANNUAL BURDEN HOURS
                                  TOTAL HOURS
                                 TOTAL COSTS $

                             Management Paper Form
                             Technical Paper Form
                              Clerical Paper Form
                             Management eReporting
                             Technical eReporting
                              Clerical eReporting

                                    $104.83
                                    $77.20
                                    $34.96
                                    $104.83
                                    $77.20
                                    $34.96

a.  Read or Hear Any Instructions
                         ($104.83 x 587.5 = $61,588.80
                       ($77.20 x 1468.75) = $113,387.50
                        ($34.96 x 587.5) = $20,539.00
                        ($104.83 x 918.8) = $96,319.64
                         ($77.20 x 2297) = $177,328.40
                         ($34.96 x 918.8) = $32,121.25
                                   6,778.35
                                  $501,284.59
b. Process, Compile, and Review the Information
                                      0
                        ($77.20 x 2937.5) = $226,775.00
                                       0
                                       0
                         ($77.20 x 4594) = $354,656.80
                                       0
                                    7,531.5
                                  $581,431.80
c. Complete Form(s)
                                       0
                        ($77.20 x 2937.5) = $226,775.00
                                       0
                                       0
                        ($77.20 x 1837.66 = $141,862.72
                                       0
                                    4,775.1
                                  $368,637.72
d. Record, Disclose, Display, or Report the Information
                                       0
                         ($77.20 x 1175) = $90,710.00
                        ($34.96 x 1175) = $41,078.00
                                       0
                         ($77.20 x 918.0) = $70,931.36
                                       0
                                    3,268.8
                                  $202,719.36
e. Store, File, or Maintain the Information
                                       0
                         ($77.20 x 587.5) = $45,355.00
                       ($34.96 x 881.25) = $30,808.50
                                       0
                         ($77.20 x 918.0) = $70,931.36
                         ($34.96 x 918.8) = $32,121.25
                                   3,306.35
                                  $179,216.11
f. One-time CDX Registration
                                       0
                                       0
                                       0
                        ($104.83 x 277.75) = $29,117.09
                        ($77.20 x 277.75) = $21,442.30
                                       0
                                     555.5
                                  $50,559.39

                     Annual Burden Hour total = 26,215.6*
                      Annual Cost total = $1,883,848.97*

* assumes 15,063 responses annually, and one-time CDX registration for an estimated 1111 respondents (20 percent of respondents who previous used paper)

***NOTE:  Numbers in the Tables (1-4) may vary slightly because of a rounding factor.

Table 3: Annual Agency Burden/Cost Estimates for Application and Notification for Pesticide-Producing Establishments (EPA Form 3540-8)

[2019 GS- 13/1 hourly rate is $36.75 x (1.6 benefits cost) = $58.80]

                                  ACTIVITIES
                        ANNUAL BURDEN HOURS PAPER FORM
                        ANNUAL BURDEN HOURS eREPORTING
                                  TOTAL COSTS
                                       $
a. Respond to Inquiries
                               ($58.80 x 121.11)
                                   $7,121.27
                               ($58.80 x 147.84)
                                   $8,692.99
                                  $15,814.26

b. Review Information for Accuracy
                                ($58.80 x 163)
                                   $9,584.40
                                ($58.80 x 44.8)
                                   $2,634.24
                                  $12,218.64

c. Record Form Submission and Assign Establishment Number
                                ($58.80 x 163)
                                   $9,584.40
                                ($58.80 x 44.8)
                                   $2,634.24
                                  $12,218.64

d. Follow Up on Submissions with Errors
                               ($58.80 x 18.35)
                                   $1,078.98
                                ($58.80 x 5.6)
                                    $329.28
                                   $1,408.26

e. Store and Maintain Data
                                ($58.80 x 163)
                                   $9,584.40
                                ($58.80 x 22.4)
                                  $1,3717.12
                                  $10,901.52

f. Prepare Notification
                               ($58.80 x 110.1)
                                   $6,473.88
                                ($58.80 x 22.4)
                                  $1,3717.12
                                   $7,791.00

                                                                          TOTAL
                                 738.56 hours/
                                  $43,427.33
                                 287.84 hours/
                                  $16,924.99
                           1,026.4 hours/ $60,352.32

***NOTE:  Numbers in the Tables (1-4) may vary slightly because of a rounding factor.

Table 4: Annual Agency Burden Cost Estimates for Pesticide Report for Pesticide-Producing Establishments (EPA Form 3540-16)

[2019 GS-13/1 hourly rate is $36.75 x 1.6 benefits cost) = $58.80]

                                  ACTIVITIES
                        ANNUAL BURDEN HOURS PAPER FORM
                        ANNUAL BURDEN HOURS eREPORTING
                                 ANNUAL COSTS
a. Preparation of Notification
                                 ($58.80 x 12)
                                    $705.60
                                       0
                                                                        $705.60

b. Respond to Inquiries
                              ($58.80 x 1938.75)
                                  $113,998.50
                              ($58.80 x 3032.04)
                                  $178,283.95
                                                                    $292,282.45

c. Review Information for Accuracy
                              ($58.80 x 1938.75)
                                  $113,998.50
                               ($58.80 x 918.8)
                                  $54,025.44
                                                                    $168,023.94

d. Follow Up on Submissions with Errors
                               ($58.80 x 293.75)
                                  $17,272.50
                               ($58.80 x 114.85)
                                   $6,753.18
                                                                     $24,025.68

e. Record and Enter Data into Electronic Database
                              ($58.80 x 1938.75)
                                 $113,998.50
                               ($58.80 x 918.8)
                                  $54,025.44
                                                                    $168,023.94

f. Store and Maintain Data
                              ($58.80 x 1468.75)
                                  $86,362.50
                               ($58.80 x 918.8)
                                  $54,025.44
                                                                    $140,387.94

TOTAL
                          7590.75 hours/ $446,336.10
                          5903.29 hours/ $347,113.45
                                                   13,494.04 hours/ $793,449.55

1026.4 hours (Table #3) + 13,484.04 hours (Table #4) = 14,520.44

$60,352.32 (Table #3) + $793,449.55 (Table #4) = $853,801.87

COMBINED AGENCY BURDEN COSTS FOR THIS ICR = $853,801.87

***NOTE:	Numbers in the Tables (1-4) may vary slightly due to rounding.

      6(f) 	Program Changes and Adjustments to Burden

      There is an increase of 3,057 hours in burden due to our wholesale reassessment of the burden covered by this ICR based on the option of electronic submission, which began in 2016. Some adjustments also resulted from corrections of clerical or computational errors in the previous ICR renewal supporting statement. All other adjustments to the burden estimates resulted from (1) adjustments in the salary computation for industry to reflect current wage scales, (2) adjustments in the salary computation for Agency personnel to reflect current wage scales and average grade level, (3) adjustments for inflation, (4) adjustment to the number of respondents, and (5) adjustments based on differences in submitting information through the paper form or the eReporting system.

      6(g) 	Burden Statement

      The annual public reporting and recordkeeping burden for this collection of information averages 3.08 hours per response using the paper forms. For respondents using the eReporting system, the estimated average is 3 hours which includes 30 minutes for registering for CDX. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

 	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. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2011-0824, which is available for online viewing at www.regulations.gov, or in person viewing at the Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Enforcement and Compliance Docket is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select "search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention:  Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-OECA-2011-0824 and OMB Control Number 2070-0078 in any correspondence.


[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49594-49595]
[FR Doc No: 2021-19079]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0089]

Agency Information Collection Activities; Renewal Information
Collection Request: National Consumer Complaint Database

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Renewal Information Collection Request
(ICR) described below to the Office of Management and Budget (OMB) for
its review and approval and invites public comment. This renewal
collection of information is for the National Consumer Complaint
Database (NCCDB), which is an online interface allowing consumers,
drivers and others to file complaints against unsafe and unscrupulous
companies and/or their employees, including shippers, receivers and
transportation intermediaries, depending on the type of complaint.
These complaints cover a wide range of activities, including but not
limited to driver harassment, coercion, movement of household goods,
financial responsibility instruments for brokers and freight
forwarders, Americans with Disability Act (ADA), Electronic Log Device
(ELD), Medical Review Officer (MRO), and Substance Abuse Practitioner
(SAP) complaints. FMCSA requests approval to renew the ICR titled
``National Consumer Complaint Database'' covered by OMB Control Number
2126-0067 in order to continue to collect consumer complaint
information so FMCSA can use complaint data to take enforcement action,
better inform FMCSA policies for safer motor carrier operations, and
improve consumer protection.

DATES: We must receive your comments on or November 2, 2021.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2021-0089 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Services; U.S. Department of Transportation,
1200 New Jersey Avenue SE, West Building, Ground Floor, Room W12-140,
Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m.
and 5 p.m. E.T., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments, see
the Public Participation heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, visit http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal website. If you want us to notify you
that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket and will be
considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Ms. Donnice Wagoner, Department of
Transportation, Federal Motor Carrier Safety Administration, Commercial
Enforcement and Investigations Division/MC-ECC, West Building 6th
Floor, 1200 New Jersey Avenue SE, Washington, DC 20590. Telephone: 202-
366-8045. email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FMCSA maintains online information and resources to assist
drivers, others in the motor carrier industry, and members of the
general public in filing safety complaints regarding household goods
(HHG) carriers, hazardous material (HM) carriers, property carriers,
cargo tank facilities, passenger carriers, electronic log devices
(ELD), and Medical Review Officers (MRO) and Substance Abuse
Professionals (SAP) reporting to the Agency's Drug and Alcohol
Clearinghouse. There is also information pertaining to the filing of
consumer complaints, particularly regarding HHG transportation and ADA
compliance.\1\

This online interface is known as the National Consumer Complaint
Database (NCCDB). The NCCDB has contributed to safer motor carrier
operations on our nation's highways by identifying carriers for
investigations and improved consumer protection by ensuring moving
companies use fair business practices. FMCSA uses the information
collected in the NCCDB to monitor and induce non-compliant regulated
entities to achieve and maintain compliance.
---------------------------------------------------------------------------

    \1\ The U.S. Department of Transportation (DOT) maintains
reporting and other requirements for over-the-road buses (OTRBs)
under its Americans with Disabilities Act (ADA) regulations. (For a
complete listing of the DOT's ADA regulations, see 49 CFR parts 37
and 38.)
---------------------------------------------------------------------------

    The NCCDB grew out of a telephone hotline known as the Safety
Violation Hotline Service. Congress mandated this hotline in Section
4017 of the ``Transportation Equity Act of the 21st Century,'' Public
Law 105-178, 112 Stat. 107, June 9, 1998. The Motor Carrier Safety
Improvement Act of 1999, Pubic Law 106-159, 113 Stat. 1748, December 9,
1999, created the Federal Motor Carrier Safety Administration and
section 213 of the Act expanded the Safety Violation Hotline Service to
include a 24-hour operation. On August 10, 2005, Congress enacted the
Safe, Accountable, Flexible, and Efficient Transportation Equity Act: A
Legacy for Users, (SAFETEA-LU), Public Law 109-59, 119 Stat. 1144.
Section 4214 of SAFETEA-LU requires DOT to create a system to record
and log aggregate complaint information regarding violations of the
Federal Motor Carrier Safety Regulations.
    The NCCDB fulfills the requirements of these mandates. Complaints
are accepted through the NCCDB in connection with other statutory
mandates, including, but not limited to, protection of drivers against
harassment and coercion under sections 32301(b) and 32911,
respectively, of the Moving Ahead for Progress in the 21st Century Act,
Public Law 112-141, 126 Stat. 405. The NCCDB also accepts complaints
from interested parties regarding third party intermediaries (brokers
and freight forwarders) and their associated financial responsibility
instruments.
    Title: National Consumer Complaint Database.
    OMB Control Number: 2126-0067.
    Type of Request: Information collection request renewal.
    Respondents: Consumers, Drivers, and Other Participants in the
Motor Carrier Industry.
    Estimated Number of Respondents: 18,546 respondents.
    Estimated Time per Response: 15 minutes.
    Expiration Date: February 28, 2022.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 4,638 hours [18,546 respondents x 1
response per respondent x 15 minutes per response = 4,638]. Note that
estimates may not match exactly due to rounding.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the agency to perform its mission; (2) the
accuracy of the estimated burden; (3) ways for the FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize or include your
comments in the request for OMB's clearance of this information
collection.

    Issued under the authority of 49 CFR 1.87.
Thomas P. Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2021-19079 Filed 9-2-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38442-38443]
[FR Doc No: 2013-15280]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0032; Notice 1]

 Notice of Receipt of Petition for Decision That Nonconforming
2005-2006 Mercedes Benz SLR Passenger Cars Manufactured Before
September 1, 2006 Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Receipt of petition.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
nonconforming 2005-2006 Mercedes Benz SLR passenger cars manufactured
before September 1, 2006 that were not originally manufactured to
comply with all applicable Federal Motor Vehicle Safety Standards
(FMVSS), are eligible for importation into the United States because
they are substantially similar to vehicles that were originally
manufactured for sale in the United States and that were certified by
their manufacturer as complying with the safety standards (the U.S.-
certified version of 2005-2006 Mercedes Benz SLR passenger cars) and
they are capable of being readily altered to conform to the standards.

DATE: The closing date for comments on the petition is July 26, 2013.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured

for importation into and sale in the United States, certified under 49
U.S.C. 30115, and of the same model year as the model of the motor
vehicle to be compared, and is capable of being readily altered to
conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    J.K. Technologies, LLC. of Baltimore, Maryland (``J.K.'')
(Registered Importer 90-006) has petitioned NHTSA to decide whether
nonconforming 2005-2006 Mercedes Benz SLR passenger cars manufactured
before September 1, 2006 are eligible for importation into the United
States. The vehicles which J.K. believes are substantially similar are
2005-2006 Mercedes Benz SLR passenger cars that were manufactured for
sale in the United States and certified by their manufacturer as
conforming to all applicable FMVSS.
    The petitioner claims that it compared non-U.S. certified 2005-2006
Mercedes Benz SLR passenger cars manufactured before September 1, 2006
to their U.S.-certified counterparts, and found the vehicles to be
substantially similar with respect to compliance with most FMVSS.
    J.K. submitted information with its petition intended to
demonstrate that non-U.S. certified 2005-2006 Mercedes Benz SLR
passenger cars manufactured before September 1, 2006, as originally
manufactured, conform to many FMVSS in the same manner as their U.S.
certified counterparts, or are capable of being readily altered to
conform to those standards. Specifically, the petitioner claims that
non-U.S. certified 2005-2006 Mercedes Benz SLR passenger cars
manufactured before September 1, 2006 are identical to their U.S.
certified counterparts with respect to compliance with Standard Nos.
102 Transmission Shift Lever Sequence, Starter Interlock, and
Transmission Braking Effect, 103 Windshield Defrosting and Defogging
Systems, 104 Windshield Wiping and Washing Systems, 106 Brake Hoses,
109 New Pneumatic Tires, 110 Tire Selection and Rims, 113 Hood Latch
System, 116 Motor Vehicle Brake Fluids, 124 Accelerator Control
Systems, 135 Light Vehicle Brake Systems, 201 Occupant Protection in
Interior Impact, 202 Head Restraints, 204 Steering Control Rearward
Displacement, 205 Glazing Materials, 206 Door Locks and Door Retention
Components, 207 Seating Systems, 209 Seat belt Assemblies, 210 Seat
Belt Assembly Anchorages, 212 Windshield Mounting, 214 Side Impact
Protection, 216 Roof Crush Resistance, 219 Windshield Zone Intrusion,
and 302 Flammability of Interior Materials.
    The petitioner also contends that the vehicles are capable of being
readily altered to meet the following standards, in the manner
indicated:
    Standard No. 101 Controls and Displays: Replacement of the
instrument cluster with a U.S.-model component and reprogramming the
vehicle computer to operate the necessary safety systems.
    Standard No. 108 Lamps, Reflective Devices, and Associated
Equipment: Replacement of the headlamps, side marker lamps, tail lamps
(which incorporate side marker lamps), and high mounted stop lamps with
U.S.-model components and installing the U.S.-model high-mounted stop
lamp assembly.
    Standard No. 110 Tire Selection and Rims for Motor Vehicles With a
GVWR of 4,536 kilograms (10,000 pounds) or Less: Installation of a tire
information placard.
    Standard No. 111 Rearview Mirrors: Replacement of the passenger
side rearview mirror with a U.S.-model component or inscription of the
required warning statement on the face of that mirror.
    Standard No. 114 Theft Protection and Rollaway Prevention:
Reprogramming the vehicle computer to activate the systems.
    Standard No. 118 Power-operated Window, Partition, And Roof Panel
Systems: Reprogramming the vehicle computer to conform to the standard
if the vehicle does not already conform.
    Standard No. 208 Occupant Crash Protection: Reprogramming the
vehicle computer to activate the audible warning system. J.K. states
that these vehicles are otherwise identical to the U.S.-market vehicles
with respect to this standard.
    Standard No. 301 Fuel System Integrity: Installation of a U.S.-
model evaporative system with rollover and check valve.
    Standard No. 401 Interior Trunk Release: Installation of U.S.-model
interior trunk release components.
    The petitioner additionally states that a vehicle identification
plate must be affixed to the vehicle near the left windshield post to
meet the requirements of 49 CFR Part 565.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

    Issued on: June 20, 2013.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2013-15280 Filed 6-25-13; 8:45 am]
BILLING CODE 4910-59-P


APPENDIX C

AREA SOURCES

Bureau of Air Quality

Department of Environmental Protection

This page blank for copying purposes.


             Janet
             McDonald/RTP/USE
             PA/US                                                   To
<EMAIL_ADDRESS>
             04/16/2007 06:29<EMAIL_ADDRESS>
             PM                                                      cc

                                                                Subject
                                      EGU FRN

See revised language on pg. 10.

(See attached file: EGU FRN 4-16.doc)

 EGU FRN 4-16.doc