[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68455-68459]
[FR Doc No: 2013-27186]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-N-0110]

Bruce I. Diamond; 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 Dr. Bruce I.
Diamond's request for a hearing and is issuing an order under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr.
Diamond for 10 years from providing services in any capacity to a
person who has an approved or pending drug product application. FDA
bases this order on findings that Dr. Diamond was convicted of felonies
under State 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, was convicted of felonies involving fraud,
and was a material participant in acts forming the basis of a
conviction that subjects another person to debarment. In determining
the appropriateness and length of Dr. Diamond's debarment period, FDA
has evaluated the relevant considerations listed in the FD&C Act. Dr.
Diamond has failed to file with the Agency information and analysis
sufficient to create a basis for a hearing concerning this action.

DATES: This order is effective November 14, 2013.

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

    On December 16, 1997, Dr. Diamond pled guilty to 53 State criminal
offenses, including felonies, in the Superior Court for the County of
Richmond, Georgia, and the court subsequently entered judgment against
him. The offenses in the Official Code of Georgia to which

Dr. Diamond pled guilty included 16 counts of theft by taking (section
16-8-2), 10 counts of theft of services (section 16-8-5), 2 counts of
written false statements (section 16-10-20), 8 counts of acquiring a
controlled substance by misrepresentation (section 16-13-43), 8 counts
of prescribing or ordering dangerous drugs (section 16-13-78.1), 7
counts of prescription of controlled substances (section 16-13-41(f)),
1 count of practicing medicine without a license (section 43-34-26),
and 1 count of bribery (section 16-10-2). On February 10, 1999, in a
separate proceeding, Dr. Diamond consented to disqualification from
receiving investigational new drugs under Sec.  312.70(b) (21 CFR
312.70(b)).
    Dr. Diamond, who holds a doctorate in pharmacology but not a
medical degree, was a professor on the faculty of the Medical College
of Georgia (MCG), a unit of the Board of Regents of the University
System of Georgia. Dr. Diamond collaborated with a colleague there,
Richard Borison, M.D., Ph.D., to manage clinical trials for various
drug companies. Without the knowledge or consent of MCG, Drs. Diamond
and Borison used MCG and other government-owned facilities and State
employees to conduct the clinical trials but diverted the funds paid by
the study sponsors for their own gain, without compensating the
university system. Although Dr. Diamond is not a physician, he managed
medical aspects of the clinical trials. In that capacity, he signed Dr.
Borison's name on prescriptions for controlled substances and other
drugs the State defined as dangerous. During the course of one clinical
trial, Drs. Borison and Diamond bribed an employee not to report to MCG
an attempted suicide by one of the study subjects.
    By notice dated November 26, 2002, FDA proposed to debar Dr.
Diamond for 10 years from providing services in any capacity to a
person having an approved or pending drug product application. The
notice explained that the proposal was based on three separate grounds:
(1) Dr. Diamond was convicted of felonies under State law for conduct
relating to the development or approval, including the process for
development or approval, of any drug product or otherwise relating to
the regulation of drug products under the FD&C Act, and the type of
conduct serving as the basis of his convictions undermines the process
for the regulation of drugs (section 306(b)(2)(B)(i)(I) of the FD&C Act
(21 U.S.C. 335a(b)(2)(B)(i)(I))); (2) Dr. Diamond was convicted of
felonies involving bribery, fraud, and false statement, and, on the
basis of the convictions and other information, demonstrated a pattern
of conduct sufficient to find that there is reason to believe that he
may violate requirements under the FD&C Act relating to drug products
(section 306(b)(2)(B)(ii)(I); and (3) Dr. Diamond materially
participated in acts that were the basis of Dr. Borison's conviction of
offenses subjecting Dr. Borison to debarment under section
306(b)(2)(B)(ii) and Dr. Diamond's participation, and other
information, demonstrate a pattern of conduct sufficient to find that
there is reason to believe that he may violate requirements under the
FD&C Act relating to drug products (section 306(b)(2)(B)(iii)). The
notice to Dr. Diamond also outlined findings with respect to four
factors that were considered in determining the appropriateness and
period of debarment, as provided in section 306(c)(3) of the FD&C Act:
(1) The nature and seriousness of the offense, (2) the nature and
extent of management participation in the offense, (3) the nature and
extent of voluntary steps to mitigate the impact on the public, and (4)
prior convictions under the FD&C Act or other acts involving matters
within the jurisdiction of FDA.
    By letter dated January 2, 2003, through counsel, Dr. Diamond
requested a hearing on the proposal to debar. On February 17, 2004,
after FDA granted him extensions, Dr. Diamond submitted a ``final
response'' in support of his request for a hearing on the proposal to
debar. In his response, Dr. Diamond argues: (1) That his consent
agreement for disqualification under Sec.  312.70(b) precludes his
debarment, (2) that he is innocent of the charge of bribery, (3) that
he is innocent of the charges involving drug prescribing, (4) that
assertions that he used unqualified personnel to staff clinical trials
are without justification or support, (5) that research subject safety
was not compromised under his supervision, and (6) that he did not
serve in a managerial role for the criminal conduct because Dr. Borison
exercised control over him at all times.
    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 Sec.  12.24(b)
(21 CFR 12.24(b))).
    The Chief Scientist has considered Dr. Diamond'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 his hearing request, Dr. Diamond presents six issues
that we will presume are intended to call into question whether he is
subject to debarment--and, if so, whether FDA should debar him--on the
basis of any of the three grounds, section 306(b)(2)(B)(i)(I),
(b)(2)(B)(ii)(I), and (b)(2)(B)(iii) of the FD&C Act, upon which FDA
relied. We therefore address each of his arguments as a challenge to
the grounds for debarment or to FDA's conclusions regarding the
considerations in section 306(c)(3) of the FD&C Act, as appropriate.

A. Disqualification Consent Agreement

    Dr. Diamond first argues that the consent agreement for his
disqualification from receiving investigational drugs under Sec.
312.70(b) precludes his debarment under section 306 of the FD&C Act. In
support, he contends that the consent agreement ``should have precluded
any further administrative action against [him].''
    The consent agreement states that the ``agreement closes FDA's
administrative proceedings in the present matter'' (emphasis added). A
debarment action under section 306 of the FD&C Act is an entirely
separate matter from disqualification proceedings. FDA has the
authority to disqualify a researcher from conducting clinical testing
of new drugs when it determines that the researcher has repeatedly or
deliberately not followed regulations intended to protect study
subjects and ensure data integrity. (See Sec.  312.70(a).) FDA also may
debar from the drug industry individuals involved in certain conduct.
Once an individual has been debarred, he may no longer provide services
in any capacity for anyone with a drug product application that is
approved or pending at FDA. (See section 306(a) and (b) of the FD&C
Act.)
    Furthermore, the consent agreement itself does not foreclose other
types of administrative actions, such as debarment under section 306 of
the FD&C Act. Finally, there is no statutory basis for concluding that
the Agency's decision to disqualify Dr. Diamond from receiving
investigational drugs under a separate process precludes his debarment.
Accordingly, we conclude that there is no genuine and substantial issue
of fact for resolution at a hearing and that the consent agreement
regarding Dr. Diamond's disqualification does not prevent his
debarment. (See Sec.  12.24(b)(1).)

B. Debarment Under Section 306(b)(2)(B)(i)(I) or 306(b)(2)(B)(ii)(I) of
the FD&C Act

    Dr. Diamond's next two arguments focus on the conduct underlying
his convictions for bribing an employee not to report an attempted
suicide by a study subject and unlawfully acquiring and prescribing
controlled substances and dangerous drugs. Dr. Diamond does not deny
that he was convicted of those offenses, nor does he dispute that this
type of conduct subjects him to permissive debarment under the FD&C
Act. Rather, he argues that he is innocent of the charges and that
``due to his need to reach a plea agreement with the State of Georgia
to the charges that he misappropriated money from the State, he entered
in to a complex and not wholly supported in fact plea agreement'' and
he ``accepted perhaps too much when he pled guilty.''
    Section 306(b)(2)(B)(i)(I) of the FD&C Act provides FDA with
authority to debar an individual who has been convicted of certain
State felonies, if the Agency finds that the type of conduct serving as
the basis for the conviction undermines the process for the regulation
of drugs. The relevant factual issues are whether Dr. Diamond was, in
fact, convicted of a felony under State law for conduct relating to the
development or approval of a drug product or otherwise relating to the
regulation of drug products under the FD&C Act and whether that type of
conduct undermines the process for the regulation of drugs. Dr. Diamond
does not dispute that he pled guilty to bribery and unlawful
prescriptions for controlled substances and dangerous drugs or that
this type of conduct undermines the process for the regulation of
drugs. Dr. Diamond has therefore failed to show that a genuine and
substantial factual dispute exists with respect to FDA's finding that
he is subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C
Act.
    In the alternative, section 306(b)(2)(B)(ii)(I) of the FD&C Act
provides FDA with authority to debar an individual who has been
convicted of a felony involving, among other things, bribery, false
statements, or fraud, if the Agency finds that the individual has
demonstrated a pattern of conduct sufficient to find that there is
reason to believe he may violate requirements under the FD&C Act
relating to drug products. The relevant factual issues are whether Dr.
Diamond was convicted of a felony involving bribery, false statements,
or fraud and whether he has demonstrated a pattern of conduct
sufficient to find that there is reason to believe he may violate
requirements under the FD&C Act relating to drug products. Dr. Diamond
does not dispute that he pled guilty to felonies involving bribery,
false statement, and fraud, namely theft of over $10 million from MCG
by an 8-year pattern of deception, bribing an employee, making written
false statements, acquiring controlled substances by misrepresentation,
prescribing dangerous drugs and controlled substances while not being a
registered practitioner, and practicing medicine without a license. FDA
further determined that the type of conduct underlying Dr. Diamond's
felony convictions, which were based on the 8-year conspiracy to
defraud MCG through a scheme involving clinical studies, demonstrated
``a pattern of conduct sufficient to find that there is reason to
believe [Dr. Diamond] may violate requirements relating to drug
products again.'' This determination was based on the nature of the
conduct underlying the offenses to which Dr. Diamond pled guilty. Dr.
Diamond has therefore failed to show that a genuine and substantial
factual dispute exists with respect to FDA's finding that he is subject
to debarment under section 306(b)(2)(B)(ii)(I) of the FD&C Act.
    Section 306(l) of the FD&C Act includes in its definition of a
conviction, a guilty plea. Accordingly, Dr. Diamond's arguments
regarding the factual circumstances underlying his plea fail to raise a
genuine and substantial issue of fact as to whether he was convicted of
a felony under State 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 or whether he was convicted of a felony
involving bribery, false statements, or fraud. Dr. Diamond contends
that his plea agreement was ``not wholly supported in fact.'' In his
Written Plea of Guilty, however, Dr. Diamond states that ``of my own
free will I want to plead guilty today to the offenses [enumerated] . .
. know and understand that I do not have to say, sign, or do anything
that will show or tend to show that I am guilty unless I want to . . .
My decision to plead guilty is freely and voluntarily made . . . I did
in fact commit the offenses of which I am charged. I am in fact guilty
as charged in the indictment and am in fact guilty of the charges I am
pleading guilty to.'' He also stated that he was advised by competent
counsel regarding his constitutional and due process rights. He was
examined by the court during a lengthy plea colloquy. Under these
circumstances, and in light of the court's acceptance of his guilty
plea, Dr. Diamond's allegations that he was actually innocent of the
offenses and that he signed a plea agreement that was not wholly
truthful are insufficient to create a genuine and substantial issue of
fact for resolution at a hearing. (See Sec.  12.24(b)(1) and (b)(2).)
Therefore, Dr. Diamond is subject to debarment.

C. Debarment Under Section 306(b)(2)(B)(iii) of the FD&C Act

    Finally, FDA found that Dr. Diamond is subject to debarment under
section 306(b)(2)(B)(iii) of the FD&C Act for his material
participation in the acts that resulted in another's conviction for an
offense described in section 306(b)(2)(B)(ii)(I) and that on that
basis, Dr. Diamond had demonstrated a pattern of conduct sufficient to
support a belief that he would violate requirements under the FD&C Act
relating to drug products. On September 30, 2003, FDA debarred Dr.
Diamond's co-conspirator, Dr. Borison, under section
306(b)(2)(B)(ii)(I) of the FD&C Act, for his conviction of felonies
under State law for racketeering, theft, and false statements and
representations. (See Richard L. Borison; Debarment Order, 68 FR 56298
(September 30, 2003).) Dr. Diamond does not deny his material
participation in the conduct that led to Dr. Borison's conviction. In
particular, he does not deny participating with Dr. Borison in the
theft of over $10 million from MCG via an 8-year pattern of deception
involving clinical trials. Furthermore, he does not dispute that his
behavior demonstrates a pattern of conduct sufficient to support a
finding that he would violate requirements under the FD&C Act relating
to drug products. Dr. Diamond has therefore failed to show that a
genuine and substantial factual dispute exists with respect to FDA's
finding that he is subject to debarment under section 306(b)(2)(B)(iii)
of the FD&C Act.

D. Debarment Considerations

    Next, we construe Dr. Diamond's arguments regarding his innocence
of the charges of bribery and unlawful prescriptions to be challenges
to FDA's findings with respect to the debarment considerations of
section 306(c)(3) of the FD&C Act. Dr. Diamond's arguments regarding
the training and qualifications of the staff he oversaw as part of his
criminal scheme and the safety of the subjects who participated in the
clinical studies also seem to be directed at those findings. As noted
previously, he also challenges FDA's finding that he participated as a
manager in the offenses involved because, he claims, Dr. Borison

controlled him and masterminded the entire criminal operation.
    Section 306(c)(3) of the FD&C Act requires that FDA consider,
``where applicable,'' certain factors ``[i]n determining the
appropriateness and the period of debarment'' for any permissive
debarment. The proposal to debar Dr. Diamond set forth 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).
    In its proposal to debar, FDA presented factual findings relevant
to each of the considerations. FDA determined, under section
306(c)(3)(A) of the FD&C Act, that the nature and seriousness of Dr.
Diamond's offenses weighed in favor of debarment because of the scope
of his criminal conduct, his prescription of drugs without a
practitioner's license, and his direction of inadequately trained staff
to perform medical procedures, creating a risk of injury. The Agency
found, under section 306(c)(3)(B) of the FD&C Act, that Dr. Diamond's
management participation in the offenses weighed in favor of debarment.
The Agency found that Dr. Diamond was a manager in that he ``plann[ed]
. . ., directed, and initiated the conduct underlying [his]
conviction'' and ``directed other MCG employees to recruit subjects and
participate in the conduct of the clinical studies.'' Under section
306(c)(3)(C) of the FD&C Act, the Agency determined that, although Dr.
Diamond cooperated with the authorities once they discovered his
criminal scheme, he did not ``promptly disclose to authorities all
wrongdoing'' and exhibited a wanton disregard for the public health by
bribing an employee to remain silent about a suicide attempt. This
factor also was found to weigh in favor of disbarment. Finally,
relating to section 306(c)(3)(F) of the FD&C Act, FDA noted that the
Agency is unaware of any prior convictions under the FD&C Act, a
favorable factor.
    Dr. Diamond first appears to challenge these findings by arguing
that he is actually innocent of the bribery and unlawful prescriptions
charges. As noted previously, however, his claims of actual innocence
do not create a genuine and substantial issue of fact, as they must to
justify a hearing under Sec.  12.24(b). Dr. Diamond pled guilty to
those offenses in Federal Court, and he is bound by his guilty pleas,
notwithstanding his current arguments that he pled guilty to those
offenses only for strategic reasons.
    Dr. Diamond also contests the Agency's characterization of the
conduct underlying his criminal convictions, as well as his material
participation in the offenses committed by Dr. Borison. However, in
pleading guilty to 52 criminal offenses, Dr. Diamond admitted to
certain conduct. The conduct to which he admitted during the plea
colloquy included overseeing a staff of nine employees to assist in
running the clinical trials, bribing an employee not to report an
adverse event, and prescribing controlled substances without a medical
license. The offenses to which Dr. Diamond pled guilty stemmed from an
8-year scheme to deceive a medical college and his concurrent disregard
for the protection of patients afforded by State laws.
    By contending that the employees he oversaw did, in fact, have
adequate training in drawing blood and that his conduct did not
compromise the safety of any patients, Dr. Diamond is challenging FDA's
proposed findings regarding the nature and seriousness of any offenses
involved under section 306(c)(3)(A) of the FD&C Act and the nature and
extent of voluntary steps taken to mitigate the effect on the public
under section 306(c)(3)(C). Even assuming, as Dr. Diamond now argues,
that the nine employees he oversaw had received adequate training in
drawing blood and that no patient was actually harmed by Dr. Diamond's
conduct, the 8-year scheme in which he participated still evinces both
a clear disregard for the laws designed to protect patients and the
public at large and a willingness to commit fraud in furtherance of his
own financial gain. Dr. Diamond had 8 years to voluntarily mitigate the
effects of his wrongdoing but failed even to modify his behavior to
protect the public. Furthermore, Dr. Diamond's arguments that he did
not compromise the safety of his patients are belied by his convictions
for violating numerous State criminal statutes clearly aimed at
protecting patients, such as practicing medicine without a license and
unlawfully acquiring and prescribing controlled or dangerous drugs. In
short, given the scope of Dr. Diamond's conduct, his current claims
regarding the training of his employees and the safety of his patients
are inadequate to create a genuine and substantial issue of fact with
respect to the considerations in sections 306(c)(3)(A) and (c)(3)(C)
or, more generally, the appropriateness or period of his proposed
debarment.
    Finally, Dr. Diamond challenges the Agency's findings under section
306(c)(3)(B) of the FD&C Act that he participated as a manager in his
offenses by arguing that Dr. Borison exercised control over him and
masterminded the criminal scheme. As noted previously and as outlined
in the indictment to which he pled guilty, however, Dr. Diamond served
a managerial role in the offenses. Even assuming, as Dr. Diamond now
alleges, that he was at all times second in command to Dr. Borison, Dr.
Diamond admitted during his criminal proceedings that he oversaw a
staff of a least nine employees in implementing the criminal scheme of
which he was convicted. Furthermore, he does not dispute the findings
in the proposal to debar that he, along with Dr. Borison, was involved
in planning and initiating the criminal scheme. Dr. Diamond's claim
that he was ``at all times subservient to Dr. Borison'' fails to
present a genuine and substantial issue of fact with respect to the
consideration in section 306(c)(3)(B) of the FD&C Act or, more
generally, the appropriateness or period of his proposed debarment.
    Consistent with the findings in the proposal to debar, the Chief
Scientist finds, based on the undisputed record before the Agency, that
debarment of Dr. Diamond for two consecutive terms of 5 years is
appropriate. The considerations in section 306(c)(3)(A), (c)(3)(B), and
(c)(3)(C) of the FD&C Act weigh in favor of debarring Dr. Diamond for
at least 10 years. Although Dr. Diamond appears to have no previous
criminal convictions related to matters within the jurisdiction of FDA
(see section 306(c)(3)(F) of the FD&C Act), that consideration does not
counter to a sufficient degree the remaining considerations to warrant
decreasing the periods of debarment. Of particular note are the nature
and seriousness of Dr. Diamond's offenses. As detailed previously, Dr.
Diamond pled guilty to an 8-year criminal scheme reflecting not only,
as found in the proposal to debar, ``a wanton disregard for the public
health,'' but also a willingness to defraud a government body over a
sustained period of time. Reducing the period of debarment from 10
years to some lesser amount of time based on Dr. Diamond's lack of
prior criminal convictions would be inconsistent with protecting the
public health and thus the remedial purpose of the Agency's debarment
authority under section 306 of the FD&C Act.

II. Findings and Order

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

Act, or in the alternative section 306(b)(2)(B)(ii)(I) and
(b)(2)(B)(iii) and under authority delegated to him, finds that Dr.
Diamond is subject to debarment. The Chief Scientist has considered the
relevant factors listed in section 306(c)(3) of the FD&C Act and
determined that debarment for 10 years is appropriate.
    As a result of the foregoing findings, Dr. Diamond is debarred for
10 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)
(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. Diamond, in any capacity during his
period of debarment, will be subject to civil money penalties. If Dr.
Diamond, 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. Diamond during his period of
debarment.
    Any application by Dr. Diamond for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2000-N-0110 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 4, 2013.
Jesse L. Goodman,
Chief Scientist.
[FR Doc. 2013-27186 Filed 11-13-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Rules and Regulations]
[Page 70345]
[FR Doc No: 2011-29236]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-1022]

Drawbridge Operation Regulations; Elizabeth River, Eastern
Branch, Norfolk, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Norfolk Southern 5 Railroad Bridge, mile 1.1, Norfolk, VA.
Under this temporary deviation, the drawbridge may remain in the closed
position on specific dates and times to facilitate laying new rail.

DATES: This deviation is effective from 7 a.m. to 5 p.m. on November
30, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-1022 and are available online
at www.regulations.gov, inserting USCG-2011-1022 in the ``Keyword'' box
and then clicking ``Search''. They are also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Jim Rousseau, Bridge Management Specialist, Fifth
Coast Guard District; telephone<PHONE_NUMBER>. Email_
<EMAIL_ADDRESS>If you have any questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Norfolk Southern Corporation, who owns
and operates this swing drawbridge, has requested a temporary deviation
from the current operating regulations set out in 33 CFR 117.1007(a) to
facilitate laying new rail.
    Under the current operation schedule, the draw shall remain in the
open position for navigation. The draw shall only be closed for train
crossings or periodic maintenance. The Norfolk Southern 5
Bridge, at mile 1.1, across the Elizabeth River (Eastern Branch) in
Norfolk, VA, has a vertical clearance in the closed position to vessels
of 6 feet above mean high water.
    To facilitate laying new rail, the drawbridge will be maintained in
the closed-to-navigation position from 7 a.m. to 5 p.m. on November 30,
2011. The bridge normally operates in the open position with several
vessels transiting a week. Coordination with waterway users has been
completed.
    The Coast Guard will inform the users of the waterway through our
Local and Broadcast Notices to Mariners of the opening restrictions of
the draw span to minimize transiting delays caused by the temporary
deviation. There are no alternate routes available but vessels may pass
before 7 a.m. and after 5 p.m. Mariners able to pass under the bridge
in the closed position may do so at any time and the bridge is able to
open for emergencies.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period.
    This deviation from the operating regulations is authorized under
33 CFR 117.35.

    Dated: October 26, 2011.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2011-29236 Filed 11-10-11; 8:45 am]
BILLING CODE 9910-04-P


[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Notices]
[Page 18744-18745]
[DOCID:fr12ap06-60]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0178; FRL-7773-3]

Notice of Filing of a Pesticide Petition for Establishment of
Regulations for Residues of Pesticide Chemicals in or on Various Food
Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of
pesticide chemicals in or on various food commodities.

DATES: Comments must be received on or before May 12, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0178 and pesticide petition number PP
5E6930, by one of the following methods:
     http://www.regulations.gov. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID Number EPA-HQ-OPP-
2006-0178. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Docket Facility is<PHONE_NUMBER>. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006- 0178. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going at regulations.gov, your e-
mail address will be captured automatically and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

     Docket: All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov or in hard copy at the Public Information

and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.

    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing a summary of the pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment of regulations in 40 CFR part
180 for residues of pesticide chemicals in or on various food
commodities. EPA has determined that this pesticide petition contains
data or information regarding the elements set forth in FFDCA section
408(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
pesticide petition. Additional data may be needed before EPA rules on
this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov. To locate this information on the homepage

of EPA's Electronic Docket, select ``Quick Search'' and type the OPP
docket ID number. Once the search has located the docket, clicking on
the ``Docket ID'' will bring up a list of all documents in the docket
for the pesticide including the petition summary.

New Tolerance

    PP 5E6930. Interregional Project Number 4, 681 Highway 1 South,
North Brunswick, NJ 08902-3390, proposes to establish tolerances for
residues of the herbicide lactofen (1-(carboethoxy) ethyl 5-2-chloro-4-
(trifluoromethyl)phenoxy-2-nitrobenzoate) in or on various food
commodities vegetable, fruiting, group and okra at 0.01 parts per
million (ppm). Adequate analytical methodology is available for
detecting and measuring levels of lactofen in or on various food
commodities with a limit of detection that allows monitoring of food
with residues at or above the level of the proposed tolerances. The
method, RM-28D, has been successfully radiovalidated in conjunction
with a tomato metabolism study, has undergone a successful independent
laboratory validation trial, and was successfully validated by the EPA
Analytical Chemistry Laboratory using peanut nutmeats and cottonseed.
In general, the analytical method has a limit of detection of 0.005 ppm
and a limit of quantitation of 0.01 ppm in crops.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: April 3, 2006.
Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E6-5394 Filed 4-11-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 130 (Friday, July 6, 2018)]
[Notices]
[Page 31535]
[FR Doc No: 2018-14495]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9040-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www2.epa.gov/nepa/

Weekly receipt of Environmental Impact Statements
Filed 06/25/2018 Through 06/29/2018
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search

EIS No. 20180149, Draft, FHWA, ND, Little Missouri River Crossing,
Comment Period Ends: 08/20/2018, Contact: Gary Goff<PHONE_NUMBER>.
EIS No. 20180150, Draft, USFS, WY, Medicine Bow Landscape Vegetation
Analysis (LaVA) Project, Comment Period Ends: 08/20/2018, Contact:
Melissa Martin<PHONE_NUMBER>.
EIS No. 20180151, Draft, USACE, FL, Lake Okeechobee Watershed
Restoration Project, Comment Period Ends: 08/20/2018, Contact: Gretchen
Ehlinger<PHONE_NUMBER>.
EIS No. 20180152, Draft, USACE, CT, Byram River Flood Risk Management
Draft Integrated Feasibility Report and EIS, Comment Period Ends: 08/
20/2018, Contact: Kimberly Rightler<PHONE_NUMBER>.

Amended Notice

EIS No. 20180146, Final, USFS, WA, WITHDRAWN, LeClerc Creek Grazing
Allotment Management Planning, Comment Period Ends: 08/13/2018,
Contact: Gayne Sears<PHONE_NUMBER>.
    Officially withdrawn per request of the U.S. Forest Service.

    Dated: July 2, 2018.
Robert Tomiak,
Director, Office of Federal Activities.
[FR Doc. 2018-14495 Filed 7-5-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57217-57218]
[FR Doc No: 2020-20320]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]

Issuance of Priority Review Voucher; Rare Pediatric Disease
Product

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), authorizes FDA to award priority
review vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that TRIKAFTA (elexacaftor/tezacaftor/ivacaftor), manufactured by
Vertex Pharmaceutical, Inc., meets the criteria for a priority review
voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-
796-9856, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor),

manufactured by Vertex Pharmaceutical, Inc., meets the criteria for a
priority review voucher.
    TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) is indicated for the
treatment of patients with cystic fibrosis aged 12 years and older who
have at least one F508del mutation in the cystic fibrosis transmembrane
conductance regulator gene.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about TRIKAFTA (elexacaftor/tezacaftor/ivacaftor), go to
the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20320 Filed 9-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 12 (Thursday, January 17, 2013)]
[Rules and Regulations]
[Pages 3843-3848]
[FR Doc No: 2013-00938]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA 2013-0003]
RIN 2127-AK42

Federal Motor Vehicle Safety Standards; New Pneumatic and Certain
Specialty Tires

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: This final rule amends Federal Motor Vehicle Safety Standard
(FMVSS) No. 109, New pneumatic and certain specialty tires, to change
the test pressure for the physical dimensions test for T-type tires
(temporary use spare tires) from 52 pounds per square inch (psi) to 60
psi. This increase in test pressure for the physical dimensions test
will marginally increase the stringency of the test and will align
FMVSS No. 109 with international and voluntary consensus standards.

DATES: This final rule is effective July 16, 2013. Optional early
compliance is permitted immediately. Petitions for reconsideration: If
you wish to petition for reconsideration of this rule, your petition
must be received by March 4, 2013.

ADDRESSES: If you submit a petition for reconsideration of this rule,
you should refer in your petition to the docket number of this document
and submit your petition to: Administrator, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue SE., West Building,
Washington, DC 20590.
    The petition will be placed in the public docket. Anyone is able to
search the electronic form of all documents received into any of our
dockets by the name of the individual submitting the document (or
signing the document, 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 (Volume
65, Number 70; Pages 19477-78).

FOR FURTHER INFORMATION CONTACT: Marisol B. Medri, NHTSA Office of
Rulemaking, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>. For legal issues,
you may call David Jasinski, NHTSA Office of Chief Counsel, telephone
202-366-2992, fax<PHONE_NUMBER>. You may send mail to these officials at
the National Highway Traffic Safety Administration, 1200 New Jersey
Avenue SE., West Building, Washington, DC 20590.

SUPPLEMENTARY INFORMATION:

I. Background

a. T-Type Spare Tires

    NHTSA regulates ``T-type'' spare tires under FMVSS No. 109, New
pneumatic and certain specialty tires. A ``T-type'' spare tire refers
to a type of spare tire that is manufactured to be used as a temporary
substitute by the consumer for a conventional tire that failed. For T-
type spare tires, FMVSS No. 109 specifies tire dimensions and
laboratory test requirements for bead unseating resistance, strength,
endurance, and high speed performance. The standard also defines tire
load ratings and specifies labeling requirements for the tires.
    NHTSA amended FMVSS No. 109 to permit the manufacture of T-type
(then known as ``60-psi'') spare tires in 1977, describing them as
``differ[ing] substantially in specification and construction from
conventional tires. * * * [with] a higher inflation pressure (60 psi),
different dimensions, and a shorter treadwear life than conventional

tires.'' \1\ The agency also adopted endurance and high-speed
performance tests, strength requirements, a resistance to bead
unseating test, and a physical dimensions test, which were appropriate
for the temporary use tires.
---------------------------------------------------------------------------

    \1\ 42 FR 12869, 12870 (March 7, 1977).
---------------------------------------------------------------------------

b. Physical Dimensions Test

    The purpose of the physical dimensions test is to measure the
tire's growth under inflated conditions and to determine if it is
within allowable growth limits. If a tire exceeds allowable growth
limits in the physical dimensions test, that indicates that there could
be a safety risk from that tire's not matching well with its rim, or
not fitting well with the vehicle to which it is attached. Either of
these mismatches could present safety risks.
    All T-type tires must comply with growth limits as specified by
S<IP_ADDRESS> of FMVSS No. 109, which states that the tire's actual section
width and overall width may not exceed the specified section width \2\
by more than 7 percent or 10 millimeters (0.4 inches), whichever is
greater. The ``section width'' of a tire is defined in S3 of FMVSS No.
109 as ``the linear distance between the exteriors of the sidewalls of
an inflated tire, excluding elevations due to labeling, decoration, or
protective bands.''
---------------------------------------------------------------------------

    \2\ S<IP_ADDRESS> states that the measured section width ``shall not
exceed the section width specified in a submission made by an
individual manufacturer, pursuant to S4.4.1(a) or in one of the
publications described in S4.4.1(b) for its size designation and
type * * *.'' (Emphasis added.) The ``publications described in
S4.4.1(b)'' refer to the year books published by various tire
manufacturer associations, such as T&RA. As a practical matter,
individual tire manufacturers generally submit section width
information to associations like T&RA for inclusion in the year
books, rather than submitting such information directly to NHTSA,
although FMVSS No. 109 allows the latter option.
---------------------------------------------------------------------------

    The test procedure for the physical dimensions test is specified in
S5.1 of FMVSS No. 109. That section states that the tire is mounted on
the appropriate test rim and inflated to the pressure listed in Table
II of the standard, which for 60-psi tires is 52 psi. The tire is then
conditioned at ambient temperature for 24 hours, at which point the
inflation is checked and adjusted back to 52 psi if necessary, and then
the tire is measured.

c. Test Pressure

    NHTSA requires tire manufacturers to specify both a ``recommended''
pressure and a ``maximum permissible inflation pressure.'' The
recommended inflation pressure is the operational inflation pressure
needed to support the weight of the vehicle when loaded to its gross
vehicle weight rating. The maximum permissible inflation pressure,
which is required to be molded on the tire's sidewall, is the maximum
pressure beyond which the tire should not be inflated. Usually, a
manufacturer's recommended inflation pressure is lower than the tire's
maximum pressure labeled on the tire sidewall.
    Since most tires have a recommended inflation pressure that is
lower than the specified maximum pressure for the tire, the test
pressure that NHTSA uses to test tires dynamically on a test wheel is
generally lower than the maximum pressure labeled on the sidewall.
Further, tires may be operated at some level of under-inflation during
normal service. To reflect this real-world use, FMVSS No. 109's dynamic
test procedures generally specify under-inflating a tire when testing
the tire on the road-wheel. Moreover, dynamic tests are more stringent
when the tire is tested at an inflation pressure lower than the
pressure required to support the given test load. Under-inflating a
tire eventually results in greater heat build-up due to over-deflection
of a tire's sidewall, which increases the likelihood of tire failure.
    Consistent with this approach, in the 1977 final rule, NHTSA
determined that T-type (60 psi) tires should be tested in all of the
FMVSS No. 109 tests at a test pressure lower than the tire's maximum
permissible inflation pressure of 60 psi. For the physical dimensions
test, the agency determined that a 52-psi value reflects an operational
inflation pressure appropriate for use in the test. The 52-psi maximum
permissible inflation pressure adopted in 1977 has not been changed
since that final rule.

d. Tire & Rim Association Petition

    In a July 13, 2007 petition, the Tire & Rim Association (T&RA) \3\
requested that the agency make a ``technical correction'' \4\ to Table
II of FMVSS No. 109 regarding T-type tires. Specifically, T&RA
requested that ``the inflation pressure for the measurement of physical
dimensions in Table II be changed from 52 psi to 60 psi.'' T&RA stated
that ``There is only one application inflation pressure for T-type
tires, 60 psi,'' and that therefore ``this is the appropriate pressure
for the subject measurement.'' The petitioner also stated that the
inflation pressure for the bead unseating, tire strength, and tire
endurance test should remain at 52 psi.
---------------------------------------------------------------------------

    \3\ T&RA is a technical standardizing body of the tire, rim,
valve, and allied part manufacturers in the United States.
    \4\ The agency believes that the petition should be addressed by
this notice and comment rulemaking rather than by way of a technical
correction.
---------------------------------------------------------------------------

II. Summary of the NPRM

    In a notice of proposed rulemaking (NPRM) published on October 30,
2009,\5\ NHTSA proposed to grant T&RA's petition and increase the test
pressure used for the physical dimensions test from 52 psi to 60 psi.
Although we agreed that raising the inflation pressure for the physical
dimensions test was appropriate, we did not agree with T&RA's
reasoning. Instead, we proposed to raise the inflation pressure for two
other reasons. First, we tentatively concluded that raising the
inflation pressure makes engineering sense because doing so would raise
the stringency of the test under conditions that are within the realm
of real world use, since it was conceivable that the tires would be
operated at 60 psi (which is the pressure assigned the tire by the tire
manufacturer). Second, we tentatively concluded that raising the test
pressure will align FMVSS No. 109 with the European and Japanese
regulations that cover T-type tires. The European and Japanese
regulations both specify an inflation pressure of 4.2 bar or 420 kPa
(which is the metric equivalent of 60 psi) \6\ for the physical
dimensions test.\7\
---------------------------------------------------------------------------

    \5\ 74 FR 56166 (Docket No. NHTSA-2009-0117).
    \6\ More precisely, 420 kPa is equal to 60.9 psi. However, when
adopting metric conversions in 1998, NHTSA generally favored
equivalent conversions over exact ones and favored conversions that
were already consistent with established tire industry, European, or
other international standards. See 63 FR 28912, 28913 (May 27,
1998).
    \7\ See ECE Regulation No. 30, Annex 6, para. 1.2.5, available
at http://live.unece.org/fileadmin/DAM/trans/main/wp29/wp29regs/r030r3e.pdf; Automobile Type Approval Handbook for Japanese
Certification, Safety Regulations for Road Vehicles, Technical
Standards For Pneumatic Tyres For Passenger-Use Motor Vehicles,
Annex, 1-2-5.
---------------------------------------------------------------------------

    We believed that existing 60-psi T-type spare tires would be able
to pass the amended physical dimensions test. Further, because the
request to raise the test pressure for the physical dimensions test
came from a tire manufacturer trade association, we believed that the
amended test would be practical.
    The October 2009 NPRM also proposed other minor changes to FMVSS
No. 109:
     The agency proposed deleting references to CT tires.
     The agency proposed revising S4.4.1(b) to update the list
of tire industry organizations to make the list consistent with that
established in the upgrade of FMVSS No. 139, New pneumatic radial tires
for light vehicles.
     The agency proposed to redesignate ``Appendix A'' as
``Appendix'' and move it to the end of the standard. The

agency also proposed removing references to tables that were no longer
set forth in the appendix and updating the address of NHTSA.

III. Comments and Analysis

    The agency received three comments in response to the October 2009
NPRM. The comments were submitted by the Alliance of Automobile
Manufacturers (Alliance),\8\ Advocates for Highway and Auto Safety
(Advocates), and a private citizen (Jonathan David Korhonen).
---------------------------------------------------------------------------

    \8\ The Alliance is a trade association of 11 automobile
manufacturers: BMW Group, Chrysler Group LLC, Ford Motor Company,
General Motors Company, Jaguar Land Rover, Mazda, Mercedes-Benz USA,
Mitsubishi Motors, Porsche, Toyota, and Volkswagen.
---------------------------------------------------------------------------

    The Alliance concurred with the proposals in the NPRM to increase
the test pressure of T-type tires from 52 psi to 60 psi for the
physical dimensions test, the deletion of references to CT type tires,
the revisions to update the list of tire industry organizations, and
the redesignation of ``Appendix A'' as ``Appendix'' and its relocation
to the end of the standard. The Alliance also concurred with the
proposed effective date.
    Advocates stated that it supports NHTSA's proposal to raise the
inflation pressure from 52 psi to 60 psi for the physical dimensions
test on T-type tires. Advocates asserted that this will result in a
more demanding test that could lead to increased tire quality and
integrity during real-world use. Advocates also supported the continued
use of a 52 psi inflation pressure for the bead unseating, tire
strength, and tire endurance tests because those test pressures
represented real-world conditions in which T-type tires would be used
while underinflated.
    However, Advocates recommended that NHTSA reconsider its continued
use of a 58 psi inflation pressure for the high speed performance test.
Advocates stated that T-type tires are often stored for long periods of
time until an unexpected event leads to their use. Advocates also
asserted that, although owners' manuals for passenger motor vehicles
advise frequent checking and re-inflation of T-type tires, this is
rarely performed, leading to the majority of T-type tires mounted on
vehicles being in an underinflated condition. Advocates argued that
this problem is further compounded by the majority of motorists who do
not carry air pumps to inflate T-type tires to the recommended
operating pressure or tire gauges to check the inflation of tired.
Further, Advocates noted that the absence of a requirement that T-type
tires be equipped with tire pressure monitoring systems (TPMS) further
prevents drivers from being notified of underinflated tires. Advocates
stated that, by lowering the inflation pressure for the high speed
performance test, NHTSA could ensure that T-type tires were better able
to withstand higher speeds while underinflated.
    NHTSA is making no changes to the proposal in response to
Advocates' comment. The agency considers the issues related to the
inflation pressure of T-type tires for the high speed performance test
to be outside the scope of this rulemaking action.
    The agency also addressed the issue of TPMS on spare tires during
the rulemaking establishing FMVSS No. 138, Tire pressure monitoring
systems.\9\ NHTSA decided not to require TPMS on spare tires (either T-
type or full-sized) for two reasons. First, most drivers know that
temporary tires are not intended for extended use. Second, T-type tires
pose operational problems for both direct and indirect TPMS because the
recommended inflation pressure for these tires is considerably
different than the pressure for tires used in normal service. The
agency also believed a TPMS requirement for spare tires would be a
potential disincentive for a vehicle manufacturer to supply a spare
tire.
---------------------------------------------------------------------------

    \9\ See 70 FR 18136, 18160 (Apr. 8, 2005); 70 FR 53079, 53088
(Sep. 7, 2005).
---------------------------------------------------------------------------

    The agency also received a comment from a private citizen, Jonathan
David Korhonen. Mr. Korhonen questioned how the NPRM would affect the
overall cost to manufacture vehicles. He recommended keeping the
proposed changes as suggestions and concluded that the changes should
not take the place of education for drivers.
    In response to Mr. Korhonen's comment, the agency believes that the
costs of implementing the proposed changes in the NPRM are near zero.
We believe that existing T-type tires are likely to pass the upgraded
physical dimensions test.
    After careful consideration of all comments received and all issues
relevant to the NPRM, the agency has decided to adopt the NPRM as
proposed.\10\ Raising the test pressure for the physical dimensions
test will raise the stringency of the test under conditions that are
within the realm of real world use. Further, raising the test pressure
is consistent with international harmonization. We believe that
existing tires will be able to pass the amended physical dimensions
test and that the new test will be practicable. We are also adopting
the minor changes to FMVSS No. 109 discussed in the NPRM.
---------------------------------------------------------------------------

    \10\ The only change made to the NPRM was the correction of a
misspelled word in the Appendix to Sec.  571.109.
---------------------------------------------------------------------------

    Finally, for consistency, we are making three changes to the
regulatory text of FMVSS No. 109 that were not included in the NPRM.
The agency finds that good cause exists for these amendments to be
included in this final rule notwithstanding the fact that they were not
included in the October 2009 NPRM because advance public notice would
be unnecessary. The specific changes and the basis for the good cause
finding are discussed below.
    First, we are amending S<IP_ADDRESS>(b) to eliminate maximum tire
pressures that were used only for the physical dimensions test for CT
tires. This is consistent with the proposed amendments, which we are
adopting today, to eliminate pressures used for CT tires in S4.2.1(b),
S4.3.4, Table I-C, and Table II.
    Second, we are further amending S<IP_ADDRESS>(b) to correct an error.
Although 340 kPa is listed in the maximum tire pressures that are used
for conducting the physical dimensions test in Table II, the pressure
was inadvertently removed from the list of tire pressures in
S<IP_ADDRESS>(b) in a prior rulemaking action.\11\ The inclusion of the 340
kPa maximum tire pressure in Table II and other similar sections that
list the permissible maximum tire pressures shows that this omission
was unintentional. Thus, advance notice of this correction is
unnecessary.
---------------------------------------------------------------------------

    \11\ An August 1, 1994 final rule adding the 350 kPa maximum
pressure for tires other than CT tires removed the 340 kPa test
pressure from S<IP_ADDRESS>(b). See 59 FR 38938, 38941. This omission was
not discussed in the preamble of the final rule. See 59 FR 38938-40.
The 340 kPa pressure was included in S<IP_ADDRESS>(b) of FMVSS No. 109
prior to the August 1, 1994 amendment. See 49 CFR 571.109,
S<IP_ADDRESS>(b) (1993). Furthermore, the 340 kPa was not omitted from
S<IP_ADDRESS>(b) in the November 8, 1993 NPRM that preceded the
amendment. See 58 FR 59226, 59228.
---------------------------------------------------------------------------

    Third, we are updating NHTSA's address in S4.4.1(a) to be
consistent with the correction to NHTSA's address in Appendix A. This
is a procedural amendment that will ensure that documents sent to the
agency will be delivered to the agency.

IV. Effective Date

    Section 30111(d) of title 49, United States Code, provides that a
Federal motor vehicle safety standard may not become effective before
the 180th day after the standard is prescribed or later than one year
after it is prescribed except when a different effective date is, for
good cause shown, in the public interest. This final rule is effective
180 days after publication of this final rule in the Federal Register.
However, we

will permit optional early compliance immediately.

V. Rulemaking Analyses and Notices

Executive Orders 12866 and 13563 and DOT Regulatory Policies and
Procedures

    The agency has considered the impact of this rulemaking action
under Executive Orders 12866 and 13563 and the DOT's regulatory
policies and procedures. This action was not reviewed by the Office of
Management and Budget under Executive Order 12866. The agency has
considered the impact of this action under the Department of
Transportation's regulatory policies and procedures (44 FR 11034;
February 26, 1979), and has determined that it is not ``significant''
under them.
    This final rule increases slightly the stringency of an existing
test applicable to T-type spare tires for passenger vehicles. The
rulemaking will not affect the current costs of testing T-type tires to
FMVSS No. 109's performance requirements. The minimal impacts of
today's amendment do not warrant preparation of a regulatory
evaluation.

Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) of 1996), whenever an agency is required, except as provided
below, to publish a notice of rulemaking for any proposed or final
rule, it must prepare and make available for public comment a
regulatory flexibility analysis that describes the effect of the rule
on small entities (i.e., small businesses, small organizations, and
small governmental jurisdictions). The Small Business Administration's
regulations at 13 CFR part 121 define a small business, in part, as a
business entity ``which operates primarily within the United States.''
(13 CFR 121.105(a)).
    No regulatory flexibility analysis is required if the head of an
agency certifies the rule will not have a significant economic impact
on a substantial number of small entities. SBREFA amended the
Regulatory Flexibility Act to require Federal agencies to provide a
statement of the factual basis for certifying that a rule will not have
a significant economic impact on a substantial number of small
entities.
    NHTSA has considered the effects of this final rule under the
Regulatory Flexibility Act. I certify that this final rule will not
have a significant economic impact on a substantial number of small
entities. The final rule will affect tire manufacturers who manufacture
T-type tires, none of which, according to the agency's knowledge, are
small businesses. Even if there were a substantial number of small
businesses manufacturing T-type tires, these entities would not be
significantly affected by this final rule since, to the agency's
knowledge, all currently manufactured T-type tires meet the new
requirement. The rulemaking does not affect costs of testing T-type
tires to FMVSS No. 109's performance requirements.

Executive Order 13609 (Promoting International Regulatory Cooperation)

    The policy statement in section 1 of Executive Order 13609
provides, in part:

    The regulatory approaches taken by foreign governments may
differ from those taken by U.S. regulatory agencies to address
similar issues. In some cases, the differences between the
regulatory approaches of U.S. agencies and those of their foreign
counterparts might not be necessary and might impair the ability of
American businesses to export and compete internationally. In
meeting shared challenges involving health, safety, labor, security,
environmental, and other issues, international regulatory
cooperation can identify approaches that are at least as protective
as those that are or would be adopted in the absence of such
cooperation. International regulatory cooperation can also reduce,
eliminate, or prevent unnecessary differences in regulatory
requirements.

    This final rule would harmonize the inflation pressure NHTSA uses
for the physical dimensions test with European and Japanese regulations
covering T-type tires.

Executive Order 13132 (Federalism)

    NHTSA has examined today's final rule pursuant to Executive Order
13132 (64 FR 43255, August 10, 1999) and concluded that no additional
consultation with States, local governments, or their representatives
is mandated beyond the rulemaking process. The agency has concluded
that the rule does not have sufficient federalism implications to
warrant either consultation with State and local officials or
preparation of a federalism summary impact statement. The rule does not
have ``substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and the responsibilities among the various levels of
government.''
    Further, no consultation is needed to discuss the issue of
preemption in connection with today's final rule. The issue of
preemption can arise in connection with NHTSA rules in two ways.
    First, the National Traffic and Motor Vehicle Safety Act contains
an express preemption provision: ``When a motor vehicle safety standard
is in effect under this chapter, a State or a political subdivision of
a State may prescribe or continue in effect a standard applicable to
the same aspect of performance of a motor vehicle or motor vehicle
equipment only if the standard is identical to the standard prescribed
under this chapter.'' 49 U.S.C. 30103(b)(1). It is this statutory
command that unavoidably preempts State legislative and administrative
law, not today's rulemaking, so consultation is unnecessary.
    Second, the Supreme Court has recognized the possibility of implied
preemption: In some instances, State requirements imposed on motor
vehicle manufacturers, including sanctions imposed by State tort law,
can stand as an obstacle to the accomplishment and execution of some of
the NHTSA safety standards. When such a conflict is discerned, the
Supremacy Clause of the Constitution makes the State requirements
unenforceable. See Geier v. American Honda Motor Co., 529 U.S. 861
(2000).
    NHTSA has considered the nature (e.g., the language and structure
of the regulatory text) and purpose of today's final rule and does not
foresee any potential State requirements that might conflict with it.
Without any conflict, there could not be any implied preemption of
state law, including state tort law.

National Environmental Policy Act

    NHTSA has analyzed this rulemaking action for the purposes of the
National Environmental Policy Act. The agency has determined that
implementation of this action will not have any significant impact on
the quality of the human environment.

Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA), a person is not
required to respond to a collection of information by a Federal agency
unless the collection displays a valid OMB control number. There is no
information collection requirement associated with this final rule.

National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, (15 U.S.C. 272) directs the
agency to evaluate and use voluntary consensus standards in its
regulatory activities unless doing so would be inconsistent

with applicable law or is otherwise impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, and business practices) that are
developed or adopted by voluntary consensus standards bodies, such as
the Society of Automotive Engineers. The NTTAA directs us to provide
Congress (through OMB) with explanations when we decide not to use
available and applicable voluntary consensus standards.
    This final rule harmonizes FMVSS No. 109 with several voluntary
consensus standards, including the T&RA 2008 Year Book standard,\12\
the ETRTO standard,\13\ and the JATMA standard,\14\ all of which
specify 60 psi or 420 kPa (or 4.2 bar) as the inflation pressure for
measuring T-type tire dimensions. This final rule also harmonizes FMVSS
No. 109 with ECE Regulation 30 and Japanese Safety Regulations, which
currently require the physical dimensions test for T-type tires to be
conducted at the tire's maximum permissible inflation pressure, 4.2 bar
(420 kPa or 60 psi).
---------------------------------------------------------------------------

    \12\ The Tire & Rim Association, Inc., (T&RA), Year Book, 2008,
Measuring Procedure for New Tires, at XIII.
    \13\ European Tyre and Rim Technical Organization (ETRTO),
Standards Manual, 2005. Table 11.2, Temporary Use Spare Tyres--T
type, at P.22.
    \14\ The Japan Automobile Tyre Manufacturers Association, Inc.
(JATMA), Year Book (Tyre Standards), 2008. Section G-5, ``Measuring
Procedure for Tyres,'' Note 1, at 0-4.
---------------------------------------------------------------------------

Executive Order 12988 (Civil Justice Reform)

    With respect to the review of the promulgation of a new regulation,
section 3(b) of Executive Order 12988, ``Civil Justice Reform'' (61 FR
4729, February 7, 1996) requires that Executive agencies make every
reasonable effort to ensure that the regulation: (1) Clearly specifies
the preemptive effect; (2) clearly specifies the effect on existing
Federal law or regulation; (3) provides a clear legal standard for
affected conduct, while promoting simplification and burden reduction;
(4) clearly specifies the retroactive effect, if any; (5) adequately
defines key terms; and (6) addresses other important issues affecting
clarity and general draftsmanship under any guidelines issued by the
Attorney General. This document is consistent with that requirement.
    Pursuant to this Order, NHTSA notes as follows. The issue of
preemption is discussed above. NHTSA notes further that there is no
requirement that individuals submit a petition for reconsideration or
pursue other administrative proceeding before they may file suit in
court.

Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires federal agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of more
than $100 million annually (adjusted for inflation with base year of
1995). Before promulgating a NHTSA rule for which a written statement
is needed, section 205 of the UMRA generally requires the agency to
identify and consider a reasonable number of regulatory alternatives
and adopt the least costly, most cost-effective, or least burdensome
alternative that achieves the objectives of the rule. The provisions of
section 205 do not apply when they are inconsistent with applicable
law. Moreover, section 205 allows the agency to adopt an alternative
other than the least costly, most cost-effective, or least burdensome
alternative if the agency publishes with the final rule an explanation
of why that alternative was not adopted.
    This final rule will not result in any expenditure by State, local,
or tribal governments or the private sector. Thus, this final rule is
not subject to the requirements of sections 202 and 205 of the UMRA.

Protection of Children From Environmental Health and Safety Risks

    Executive Order 13045, ``Protection of Children from Environmental
Health and Safety Risks'' (62 FR 19855, April 23, 1997), applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental,
health, or safety risk that the agency has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the agency must evaluate the environmental health or
safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the agency.
    This final rule is not an economically significant regulatory
action under Executive Order 12866. Consequently, no further analysis
is required under Executive Order 13045.

Regulatory Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading at the beginning of this document
to find this action in the Unified Agenda.

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 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.regulations.gov.

List of Subjects in 49 CFR Part 571

    Imports, Motor vehicle safety, Motor vehicles, Rubber and rubber
products, and Tires.

    In consideration of the foregoing, NHTSA hereby amends 49 CFR part
571 as follows:

PART 571--FEDERAL MOTOR VEHICLE SAFETY STANDARDS

0
1. The authority citation for part 571 of Title 49 continues to read as
follows:

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166;
delegation of authority at 49 CFR 1.95.

0
2. Section 571.109 is amended by
0
a. Removing the definition of CT in S3;
0
b. Revising S4.2.1(b), S<IP_ADDRESS>(b), the introductory text of S4.3.4,
S4.4.1(a), and S4.4.1(b);
0
c. Redesignating Appendix A as ``Appendix to Sec.  571.109,'' moving
the appendix to the end of Sec.  571.109 (following the tables to Sec.
571.109), and revising the appendix; and
0
d. Revising Table I-C and Table II.
    The revised and redesignated text, tables, and appendix read as
follows:

Sec.  571.109  Standard No. 109; New pneumatic and certain specialty
tires.

* * * * *
    S4.2.1 * * *
    (b) Its maximum permissible inflation pressure shall be either 32,
36, 40, or 60 psi, or 240, 280, 300, 340, or 350 kPa.
* * * * *
    S<IP_ADDRESS> * * *
    (b) (For tires with a maximum permissible inflation pressure of
240,

280, 300, 340 or 350 kPa, or 60 psi) 7 percent or 10 mm (0.4 inches),
whichever is larger.
* * * * *
    S4.3.4 If the maximum inflation pressure of a tire is 240, 280,
300, 340, or 350 kPa, then:
* * * * *
    S4.4.1 * * *
    (a) Listed by manufacturer name or brand name in a document
furnished to dealers of the manufacturer's tires, to any person upon
request, and in duplicate to the Docket Section (No: NHTSA-2009-0117),
National Highway Traffic Safety Administration, West Building, 1200 New
Jersey Ave SE., Washington, DC 20590; or
    (b) Contained in publications, current at the date of manufacture
of the tire or any later date, of at least one of the following
organizations:

Tire and Rim Association
The European Tyre and Rim Technical Organization
Japan Automobile Tyre Manufacturers Association, Inc.
Tyre and Rim Association of Australia
Associacao Latino Americana de Pneus e Aros (Brazil)
South African Bureau of Standards
* * * * *

                                         Table I-C--For Radial Ply Tires
----------------------------------------------------------------------------------------------------------------
                                                               Maximum permissible inflation
                                         -----------------------------------------------------------------------
            Size designation                         PSI                                 kPa
                                         -----------------------------------------------------------------------
                                             32       36       40      240      280      300      340      350
----------------------------------------------------------------------------------------------------------------
Below 160 mm:
    (in-lbs)............................    1,950    2,925    3,900    1,950    3,900    1,950    3,900    1,950
    (joules)............................      220      330      441      220      441      220      441      220
160 mm or above:
    (in-lbs)............................    2,600    3,900    5,200    2,600    5,200    2,600    5,200    2,600
    (joules)............................      294      441      588      294      588      294      588      294
----------------------------------------------------------------------------------------------------------------

* * * * *

                                       Table II--Test Inflation Pressures
                   [Maximum permissible inflation pressure to be used for the following test]
----------------------------------------------------------------------------------------------------------------
                                                 psi                                     kPa
           Test type            --------------------------------------------------------------------------------
                                    32       36       40       60      240      280      300      340      350
----------------------------------------------------------------------------------------------------------------
Physical dimensions............       24       28       32       60      180      220      180      220      180
Bead unseating, tire strength,        24       28       32       52      180      220      180      220      180
 and tire endurance............
High speed performance.........       30       34       38       58      220      260      220      260      220
----------------------------------------------------------------------------------------------------------------

* * * * *

Appendix to Sec.  571.109

    Persons requesting the addition of new tire sizes not included
in S4.4.1(b) organizations may, upon approval, submit five (5)
copies of information and data supporting the request to the Vehicle
Dynamics Division, Office of Crash Avoidance Standards, National
Highway Traffic Safety Administration, West Building, 1200 New
Jersey Ave. SE., Washington, DC 20590.
    The information should contain the following:
    1. The tire size designation, and a statement either that the
tire is an addition to a category of tires listed in the tables or
that it is in a new category for which a table has not been
developed.
    2. The tire dimensions, including aspect ratio, size factor,
section width, overall width, and test rim size.
    3. The load-inflation schedule of the tire.
    4. A statement as to whether the tire size designation and load
inflation schedule has been coordinated with the Tire and Rim
Association, the European Tyre and Rim Technical Organization, the
Japan Automobile Tyre Manufacturers Association, Inc., the Tyre and
Rim Association of Australia, the Associacao Latino Americana de
Pneus e Aros (Brazil), or the South African Bureau of Standards.
    5. Copies of test data sheets showing test conditions, results
and conclusions obtained for individual tests specified in Sec.
571.109.
    6. Justification for the additional tire sizes.

    Issued on: January 4, 2013.
David L. Strickland,
Administrator.
[FR Doc. 2013-00938 Filed 1-16-13; 8:45 am]
BILLING CODE 4910-59-P