No treatment-related effects were found on body weight, food consumption, food efficiency, or water consumption.  No clinical signs of toxicity were observed, and all rats survived until scheduled sacrifice.  There was a slight increase in GGT activity (6.5+-1.7 U/L vs 5.0+-0.0) in rats receiving 10,000 ppm, however, the significance of this result is obscured by the low sensitivity of the assay at the low end of the linear range.  No treatment-related effects were noted at necropsy.  The absolute liver weights of mid- and high-dose rats were statistically increased 17% and 39%, respectively, while the liver weight relative to body weight of low-, mid-, and high-dose rats were statistically increased 10%, 23%, and 48%, respectively.  In addition, the relative to body kidney weight of high-dose rats was statistically increased 8%.  While the increased absolute and relative to body liver weights were observed, no histopathology was done. The liver effect was a common observation of this chemical and was considered treatment-related.

The systemic LOAEL for male Wistar rats following dietary treat - ment for 28 days with benalaxyl-M was 3000 ppm (250.4 mg/kg bw/day) based on the increases in absolute and relative to body liver weights.  The NOAEL was 1000 ppm (80.5 mg/kg bw/day).

Dietary treatment of male rats with 1000, 3000, or 10,000 ppm benalaxyl-M technical product for 28 continuous days did not affect spleen, thymus, or mesenteric lymph node weights or decrease the anti-SRBC IgM immune response. There were no statistically significant differences in anti-SRBC IgM levels in treated groups when compare to the vehicle control group.  High inter-individual variability was noted in all the treatment groups as well as in the control group.  Evaluation of the individual animal data of this study did not show any trend or distribution that would demonstrate significant suppression of anti-SRBC antibody response. Positive control group had statistically significant decrease in the anti SRBC IgM levels. This confirmed the ability of the test system to detect immuno-suppressive effects and confirmed the validity of the study design.

The Natural Killer (NK) cells activity was not evaluated in this study.  The toxicology database for benalaxyl-M does not reveal any evidence of immunotoxicity.  The overall weight of evidence suggests that the chemical does not directly target the immune system.  Under HED guidance a NK cell activity assay is not required at this time.

The immunotoxicity NOAEL for male Wistar rats treated for 28 consecutive days with benalaxyl-M was 10,000 ppm (924.6 mg/kg bw/day).  A LOAEL was not established.

This immunotoxicity study is classified Acceptable / Guideline and satisfies the guideline requirement for an immunotoxicity study (OCSPP 870.7800) in the rat.

A.4.10	Other
	Non-guideline	Mechanistic

In a 14-day mechanistic study (MRID 49040636), benalaxyl-M (96.53% a.i.; Lot/Batch # P/10/106) was administered in feed to groups of 18 male Crl: CD-1(Icr) Br mice at dietary concentrations of 0, 200, 1200, or 7000 ppm (0, 30.9, 184.4, and 1094.1 mg/kg bw/day, respectively).  Another group of 18 male mice were administered phenobarbitone (PB) in the diet at 850 ppm (139.6 mg/kg bw/day).  Six mice/groups were sacrificed for evaluation of cell proliferation after treatment for 3 and 14 days (Allocation A and B animals, respectively).   Allocation A and B animals were implanted subcutaneously with osmotic mini-pumps containing bromodeoxyuridine (BrdU) on days 6 and 8 of acclimatization, respectively.  Six mice/group were sacrificed after treatment for 14 days for evaluation of liver microsomal enzyme activity, mRNA gene expression, and oxidative stress (Allocation C animals).

No effects were observed on mortality, clinical signs, body weight, or body weight gain, in mice administered benalaxyl-M or PB.  Absolute liver weight, liver/body weight ratio, and liver/brain weight ratio were increased 16% to 17% and 15% to 20% in mice treated with benalaxyl-M for 3 days or 14 days, respectively, and absolute and relative liver weights in mice treated with PB were increased by 32% to 36% and 33% to 41% after 3 and 14 days, respectively.  No benalaxyl-M- or PB-related macroscopic lesions were observed in this study.  Centrilobular to diffuse hepatocellular hypertrophy were observed in 0/6, 1/6, 2/6, and 4/6 mice treated with 0, 200, 1200, or 7000 ppm of the test substance, respectively, for 3 days and 0/6, 2/6, 4/6, and 3/6 mice, respectively, after 14 days.  All six mice treated with PB for 3 or 14 days had centrilobular to diffuse hypertrophy.  There was a dose-related increased severity of the lesions in mice treated with benalaxyl-M, and the lesions in PB-treated  mice was more severe than in those treated with IR6141.

Analysis of the number of BrdU-positive nuclei in hepatocytes as an indicator of cell proliferation showed that cell proliferation was increased at all doses of IR6141 after 14 days; the data was equivocal after treatment for 3 days.  PB treatment resulted in an increase in cell proliferation after 3 and 14 days.  The effect of benalaxyl-M and PB treatment was analyzed on following microsomal liver enzymes: 7-ethoxyresorufin O-dealkylase (EROD, Cyp1a1 isoenzyme), 7-methoxyresorufin O-dealkylase (MROD, Cyp1a2 isoenzyme), 7-pentoxy-resorufin O-dealkylase (PROD, Cyp2b1), testosterone 6β-hydroxylase (6β-TOH, Cyp3a), lauric acid 12-hydroxylase (LA12OH, Cyp4a1), and lauric acid 11-hydroxylase (LA11OH, Cyp2e1).  EROD, MROD, and LA12OH activities were slightly increased at 1200 and 7000 ppm; PROD, 6β-OH, and LA11OH activities were moderately increased at 7000 ppm; and PROD activity was moderately increased at 1200 ppm and 6β-OH and LA11OH activities were slightly increased at 1200 ppm.  Treatment with PB for 14 days caused moderate increases in EROD, MROD, 6-β-TOH, and LA11OH activities, a pronounced increased in PROD activity and a slight increase in LA12OH activity.  The expression of the Cyp1A-1, Cyp1A-2, Cyp2B10, and Cyp3A11 genes were increased at 7000 ppm and the expression of Cyp1A-1, CypB10, and Cyp3A11 were increased at 1200 ppm.  The expression of Cyp2B10 was increased 45.8- and 195.7-fold at 1200 and 7000 ppm, respectively, and the expression of Cyp3A11 was increased 15.58-fold.  Treatment with PB for 14 days caused increased expression of all the genes tested.  Examination of the parameters of oxidative stress, reduced glutathione (GSH) and oxidized glutathione (GSSH) in liver, and thiobarbituric acid reactive substance (TBARS) in liver and serum, showed no effect of treatment with benalaxyl-M or PB for 14 days.
This 14-day mechanistic study in the mouse is Acceptable/Non-guideline. The study provides an assessment of possible liver toxicity for use in the evaluation of the mode of action of hepatocellular tumor induction in mice by benalaxyl-M.
Appendix B. Metabolism

B.1 Metabolism Summary Table

Table B.1.  Tabular Summary of Metabolites and Degradates
           Chemical Name (other names in parenthesis) and Structure
                                    Matrix
                              Percent TRR (PPM)

                     Matrices - Major Residue (>10%TRR)
                     Matrices - Minor Residue (<10%TRR)
Benalaxyl-M

Grape - Fruit
26.4 % (0.023)
NA

Tomato - Fruit
43.5 % (0.025)
NA

Lettuce
41.5 % (0.84)
NA

Rat
NA
3% feces ♂
2% feces ♀
R5
N-(hydroxyphenylacetyl)-N-(2-hydroxymethyl-6-methylphenyl)-alanine

Grapes - Fruit
NA
NA

Tomato - Fruit
NA
NA

Lettuce
NA
NA

Rat
22% feces ♀
3% feces ♂
R6
methyl-N-(phenylacetyl)-N-(2-carboxy-6-hydroxymethylphenyl)-alaninate

Grapes - Fruit
NA
NA

Tomato - Fruit
NA
NA

Lettuce
NA
NA

Rat
11% feces ♂
4% feces ♀
R7
(methyl-N-(hydroxyphenylacetyl)-N-(2-carboxy-6-methylphenyl)-alaninate

Grapes - Fruit
NA
NA

Tomato - Fruit
NA
NA

Lettuce
NA
NA

Rat
24% feces ♀
8% urine ♀

38% feces ♂
1% urine ♂

G10, T4, L4

Grapes - Fruit
11% (0.0093)
NA

Tomato - Fruit
NA
3.2% (0.0018)

Lettuce
11% (0.23)
NA

Rat
NA
NA

G13, [T9, T11], [L3, L5-L9, L11]

Grapes - Fruit
14% (0.012)
NA

Tomato - Fruit
NA
5.3% (0.0030)

Lettuce
10% (0.21)
NA

Rat
NA
NA
G15, T10, L10

Grapes - Fruit
11% (0.0097)
NA

Tomato - Fruit
32% (0.018)
NA

Lettuce
30% (0.61)
NA

Rat
NA
NA

B.2  Metabolic Pathways

             Proposed Metabolic Pathway of Benalaxyl-M for Grapes

The figure below was copied without alteration from MRID 49040680.

                    Proposed Metabolic Pathway for the Rat.

The figure below was copied without alteration from MRID 49040647.

Appendix C.  Physical/Chemical Properties

TABLE C.1.	Physicochemical Properties of the Technical Grade Test Compound: Benalaxyl-M.
                                   Parameter
                                     Value
                                   Reference
Melting point/range
                                   74.86 °C
                             D421271, S. Mathur,
                                  22-JUL-2014
Boiling point
                                    330 °C

pH
                                      7.1

Density
                         1.19 +- 0.022 g/ml (19.5 °C)

Water solubility (at 25°C)
                                   37.0 mg/L

Solvent solubility (g/L)
                            n-heptane - 17074 mg/L
                            xylene - >39 (%w/w)
                            acetone - >49 (%w/w)
                         ethyl acetate - >49 (%w/w)
                      1,2-dichloroethane - >50 (%w/w)
                           methanol - >50 (%w/w)

Vapor pressure at 25°C
                                6.7 x 10[-4] Pa

Dissociation constant (pKa)
                                Not applicable

Octanol/water partition coefficient Log(KOW)

                                3.54 at 20 °C

UV/visible absorption spectrum
                  202 nm - 3.4 x 10[4] ξ (dm[3]/(mol x cm))
                    254 nm - 4.6 x 10[2]               "
                    259 nm - 4.6 x 10[2]               "
                    265 nm - 6.1 x 10[2]               "
                    275 nm - 4.4 x 10[2]               "

Appendix D.  Review of Human Research

This risk assessment does not rely on data from studies in which human subjects were intentionally exposed to a pesticide or other chemicals.


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Notices]
[Page 52769]
[FR Doc No: 2017-24559]

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

 DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2017-0111]

Notice of Application for Approval To Discontinue or Modify a
Railroad Signal System

    Under part 235 of Title 49 of the Code of Federal Regulations (CFR)
and 49 U.S.C. 20502(a), this provides the public notice that on
September 20, 2017, the Union Pacific Railroad (UP) petitioned the
Federal Railroad Administration (FRA) seeking approval to discontinue
or modify a signal system. FRA assigned the petition Docket Number FRA-
2017-0111.

Applicant: Union Pacific Railroad, Mr. Kevin D. Hicks, AVP
Engineering--Design, 1400 Douglas Street, MS 0910, Omaha, NE 68179

    Union Pacific seeks to discontinue the automatic block signals
(ABS) on the Utah Service Unit, Montana Subdivision, in the cities of
Pocatello, Chubbuck, Fort Hall, Blackfoot, Firth, Shelley and Idaho
Falls in the state of Idaho.
    There are 43 active Highway-Rail Grade Crossings and 2 hot-box and
dragging equipment detectors in the area which will remain as currently
installed.
    The reason for the discontinuance of the ABS is that the condition
of the signal system would require complete replacement to avert safety
issues and FRA defects, and the amount of traffic on the subdivision
does not warrant the cost of replacement.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by December 29, 2017 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. 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 https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Safety, Chief Safety Officer.
[FR Doc. 2017-24559 Filed 11-13-17; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Rules and Regulations]
[Page 58753-58755]
[DOCID:fr17oc07-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28645; Directorate Identifier 2007-CE-059-AD;
Amendment 39-15228; AD 2007-21-10]
RIN 2120-AA64

Airworthiness Directives; EADS SOCATA Model TBM 700 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    This Airworthiness Directive (AD) results from one report about
imperfect locking on ground of the upper access door opening
interior handle which has enabled its opening without actuating
unlocking knob.
    If not corrected an inadvertent action on the handle without
actuating the unlocking knob could lead to a door opening.
    Investigations identified the unsafe condition resulting from
interference between the window trim panel and the handle locking
mechanism.

    We are issuing this AD to require actions that are intended to
address the unsafe condition described in the MCAI.

DATES: This AD becomes effective November 21, 2007.
    On November 21, 2007, the Director of the Federal Register approved
the incorporation by reference of certain publications listed in this
AD.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov
 or in person at the Docket Management Facility,

U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Albert Mercado, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on August 1, 2007 (72
FR 41968). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    This Airworthiness Directive (AD) results from one report about
imperfect locking on ground of the upper access door opening
interior handle which has enabled its opening without actuating
unlocking knob.
    If not corrected an inadvertent action on the handle without
actuating the unlocking knob could lead to a door opening.
    Investigations identified the unsafe condition resulting from
interference between the window trim panel and the handle locking
mechanism.
    Requirements of this AD are first, check for proper operation
the locking handle and secondly modification of the window trim
panel.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received.

Comment Issue: AD Differences

    EADS SOCATA commented that the proposed AD states that there are no
differences between the proposed AD and the service information, but
the proposed AD requires the installation of a placard on the
instrument panel and the service information does not require this
placard.
    The requirement for the placard was provided to ensure the
operating limitation noted in the related service information was clear
to the operator and to enforce the limitation. The only way the FAA can
legally mandate the operating limitation is through a placard or
airplane flight manual change. We do not consider that as an FAA AD
difference as the placard requirement only enforces the operating
limitation in the MCAI and service bulletins.
    We are making no changes to the final rule AD action based on this
comment.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the AD.

Costs of Compliance

    Based on the service information, we estimate that this AD would
affect about 23 products of U.S. registry. We also estimate that it
would take about 2 work-hours per product to comply with the basic
requirements of this AD. The average labor rate is $80 per work-hour.
Required parts would cost about $5 per product. Where the service
information lists required parts costs that are covered under warranty,
we have

assumed that there will be no charge for these costs. As we do not
control warranty coverage for affected parties, some parties may incur
costs higher than estimated here.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $3,795, or $165 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD Docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2007-21-10 EADS SOCATA: Amendment 39-15228; Docket No. FAA-2007-
28645; Directorate Identifier 2007-CE-059-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective November
21, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to TBM 700 airplanes, serial numbers 1
through 9, 11 through 17, 19 through 22, 25 through 27, 29 through
31, 33 and 34, 38, 46, and 49, that are:
    (1) certificated in any category;
    (2) not equipped with modification No. MOD70-019-25; and
    (3) equipped with an interior handle unlocking device through
push-button.

Subject

    (d) Air Transport Association of America (ATA) Code 52: Doors.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    This Airworthiness Directive (AD) results from one report about
imperfect locking on ground of the upper access door opening
interior handle which has enabled its opening without actuating
unlocking knob.
    If not corrected an inadvertent action on the handle without
actuating the unlocking knob could lead to a door opening.
    Investigations identified the unsafe condition resulting from
interference between the window trim panel and the handle locking
mechanism.
    Requirements of this AD are first, check for proper operation
the locking handle and secondly modification of the window trim
panel.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Before each flight after November 21, 2007 (the effective
date of this AD) until the actions of paragraph (f)(2) of this AD
have been done, check the handle locking using paragraph A of the
accomplishment instructions in EADS SOCATA Mandatory TBM Aircraft
Service Bulletin SB 70-150, dated May 2007. If any discrepancy is
found, do the following before further flight until the modification
in paragraph (f)(2) of this AD is done:
    (i) Fabricate a placard using letters at least 1/8 inches in
height with the words ``FLIGHT ALLOWED WITH ONLY THE FLIGHT DECK
SEATS OCCUPIED.''
    (ii) Install this placard on the instrument panel within clear
view of the pilot.
    (iii) The owner/operator holding at least a private pilot
certificate as authorized by section 43.7 of the Federal Aviation
Regulations (14 CFR 43.7) may do both the pre-flight checks and the
placard requirements of this AD. Make an entry in the aircraft
records showing compliance with this portion of the AD following
section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).
    (2) Within the next 12 months after November 21, 2007 (the
effective date of this AD) modify the window trim panel using
paragraph B of the accomplishment instructions in EADS SOCATA
Mandatory TBM Aircraft Service Bulletin SB 70-150, dated May 2007.
This modification terminates the requirements of paragraph (f)(1) of
this AD.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Staff, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Albert Mercado, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of

Management and Budget (OMB) has approved the information collection
requirements and has assigned OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA)
Emergency AD No: 2007-0172-E, dated June 15, 2007; and EADS SOCATA
Mandatory TBM Aircraft Service Bulletin SB 70-150, dated May 2007,
for related information.

Material Incorporated by Reference

    (i) You must use EADS SOCATA Mandatory TBM Aircraft Service
Bulletin SB 70-150, dated May 2007 to do the actions required by
this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact EADS
SOCATA--Direction des Services, 65921 Tarbes Cedex 9, France;
telephone: +33 (0)5 62 41 73 00; fax: +33 (0)5 62 41 7-54; or in the
United States contact SOCATA AIRCRAFT, INC., North Perry Airport,
7501 South Airport Rd., Pembroke Pines, FL 33023; telephone: (954)
893-1400; fax:<PHONE_NUMBER>.
    (3) You may review copies at the FAA, Central Region, Office of
the Regional Counsel, 901 Locust, Room 506, Kansas City, Missouri
64106; or at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html
.

    Issued in Kansas City, Missouri, on October 4, 2007.
David R. Showers,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-20140 Filed 10-16-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29841-29842]
[FR Doc No: 2018-13680]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, Washington, DC 20549-2736

Extension:
    Rule 15g-3, SEC File No. 270-346, OMB Control No. 3235-0392

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in Rule 15g-3--Broker
or dealer disclosure of quotations and other information relating to
the penny stock market (17 CFR 240.15g-3) under the Securities Exchange
Act of 1934 (15 U.S.C. 78a et seq.).
    Rule 15g-3 requires that brokers and dealers disclose to customers
current quotation prices or similar market information in connection
with transactions in penny stocks. The purpose of the rule is to
increase the level of disclosure to investors concerning penny stocks
generally and specific penny stock transactions.
    The Commission estimates that approximately 195 broker-dealers will
spend an average of 87 hours annually to comply with this rule. Thus,
the total compliance burden is approximately 16,965 burden-hours per
year.
    Rule 15g-3 contains record retention requirements. Compliance with
the rule is mandatory. The required records are available only to the
examination staff of the Commission and the self regulatory
organizations of which the broker-dealer is a member.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503 or by sending an email to:
[email protected]; and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange

Commission, c/o Candace Kenner, 100 F Street NE, Washington, DC 20549
or by sending an email to [email protected]. Comments must be
submitted to OMB within 30 days of this notice.

    Dated: June 21, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-13680 Filed 6-25-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: February 19, 2008 (Volume 73, Number 33)]
[Notices]
[Page 9161-9162]
[DOCID:fr19fe08-105]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

 Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of the signal system or relief from the requirements of
49 CFR Part 236, as detailed below.

[Docket Number FRA-2007-0026]

    Applicant: CSX Transportation, Incorporated, Mr. C. M. King, Chief
Engineer, Communications and Signals, 500 Water Street , SC J-350,
Jacksonville, Florida 32202.
    The CSX Transportation, Incorporated seeks approval of the proposed
discontinuance and removal of three power operated split point derails,
Number (No.) 2, No. 4, and No. 6, located within a traffic control
system in St. Joseph, Michigan, milepost CG-87; Grand Rapids
Subdivision; Chicago Division. The derails are manually controlled by
the St. Joseph Drawbridge tender under the authority of the train
dispatcher located in Jacksonville, Florida.
    The reason given for the proposed changes is that the derails are
no longer needed in present day operation.
    Any interested party desiring to protest the granting of an
application shall set forth specifically the grounds upon which the
protest is made, and include a concise statement of the interest of the
party in the proceeding. Additionally, one copy of the protest shall be
furnished to the applicant at the address listed above.
    FRA expects to be able to determine these matters without an oral
hearing. However, if a specific request for an oral hearing is
accompanied by a showing that the party is unable to adequately present
his or her position by written statements, an application may be set
for public hearing.
    All communications concerning this proceeding should be identified
by Docket Number FRA-2007-0026 and may be submitted by one of the
following methods:
    Web site: http://www.regulations.gov. Follow the instructions for

submitting comments on the DOT electronic site;
    Fax:<PHONE_NUMBER>;
    Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590; or
    Hand Delivery: Room W12-140 of the U.S. Department of
Transportation West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the

public docket are also available for inspection and copying on the
Internet at the docket facility's Web site at http://www.regulations.gov
.

    FRA wishes to inform all potential commenters that 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
.

    Issued in Washington, DC on February 12, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E8-3026 Filed 2-15-08; 8:45 am]

BILLING CODE 4910-06-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES, AND

TOXIC SUBSTANCES

PC Code:  113961

DP Barcode:  324660

Decision #: 341716

MEMORANDUM								     November 6, 2006

SUBJECT:	Prothioconazole Section 3: Revised Environmental Fate and Ecological Risk Assessment

TO:		Tony Kish, Product Manager

		Lana Coppolino, Product Manager

Registration Division (7505C)

FROM:	Christopher Salice, Biologist

		Roxolana Kashuba, Environmental Scientist

		Environmental Risk Branch IV

Environmental Fate and Effects Division (7507C)

THROUGH:	Elizabeth Behl, Branch Chief

		Thomas Steeger, Senior Biologist

		R. David Jones, Senior Agronomist

		Environmental Risk Branch IV

Environmental Fate and Effects Division (7507C)

Environmental Fate and Effects Division (EFED) has completed revisions of its ecological risk assessment for the new fungicide prothioconazole and its end-use product PROLINE® 480SC (41.0% a.i.).  The fungicide is initially proposed for use on wheat, barley, oil seed (except sunflower and safflower), dried shell pea and bean (except soybean), peanut, and rice.  A total toxic residues approach (including prothioconazole and two primary degradates: prothioconazole-desthio and prothioconazole-S-methyl) was used to estimate ecological exposure levels.  Combined residues of concern are expected to be persistent and moderately mobile.

The results of this revised screening-level assessment indicate that there is a potential for direct adverse acute effects to non-target fresh- and saltwater non-vascular plants, freshwater vascular plants, and saltwater invertebrates other than mollusks at the proposed application rates for some uses. The results also indicate a potential for adverse effects associated with chronic exposures to mammals for all proposed uses of prothioconazole.  For listed species, acute risk levels of concern were exceeded for estuarine/marine invertebrates, semi-aquatic plants, aquatic plants, and freshwater fish.  Listed species chronic risk levels of concern were exceeded for mammals.

Prothioconazole Recommended Label Language:

“Prothioconazole-desthio (a degradate of prothioconazole) is toxic to shrimp.  Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.  Do not contaminate water when disposing of equipment washwater or rinsate."

"Prothioconazole-desthio (a degradate of prothioconazole) is known to leach through soil into ground water under certain conditions as a result of label use.  Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground-water contamination."

“This product may contaminate water through drift of spray in wind.  This product has a high potential for runoff for several months or more after application.  Poorly draining soils and soils with shallow watertables are more prone to produce runoff that contains this product. A level, well maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, streams, and springs will reduce the potential for contamination of water from rainfall-runoff.  Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours.”

Status of Fate and Ecotoxicity Data for Prothioconazole:

Tables 1 and 2 list all of the available environmental fate and ecological effect studies, respectively, and the acceptability of each study.  The major uncertainties in characterizing the environmental fate of prothioconazole involve non-rigorous soil extraction procedures, lack of complete information on the fate of the 1,2,4-triazole degradate, and inability to calculate parent adsorption coefficient and bioaccumulation factor.  The major uncertainties in characterizing effects of prothioconazole and/or prothioconazole-desthio are associated with the toxicity of prothioconazole-desthio to estuarine/marine invertebrates, the lack of an acceptable sediment toxicity test, and the lack of data on the effects of the 1,2,4-triazole degradate.  However, in general, all of the studies contained sufficient information on the fate and effects of prothioconazole for EFED to complete an ecological risk assessment of the chemical.

Table 1.  Status of environmental fate data adequacy for prothioconazole.

  SEQ CHAPTER \h \r 1

Guideline	Description	MRID	Title	Substrate	Study Classification

161-1	  SEQ CHAPTER \h \r 1 835.212	Hydrolysis	46246505	Hydrolysis of [Phenyl-UL-14C] JAU6476 in Sterile Aqueous Buffer Solutions. Prothioconazole; phenyl label	Acceptable

161-1	  SEQ CHAPTER \h \r 1 835.212	Hydrolysis	46246506	SXX0665: Hydrolysis in Buffers.	Prothioconazole-desthio;    phenyl label Supplemental

161-2	  SEQ CHAPTER \h \r 1 835.224	Photolysis in Water	46246507 Photolysis of JAU6476 in Sterile Aqueous Buffer.	Prothioconazole; phenyl and triazole labels	Supplemental

161-3	  SEQ CHAPTER \h \r 1 835.241	Photolysis on Soil	46246510 Photolysis of JAU6476 on Soil Surface.	Prothioconazole; phenyl label Acceptable

161-4	  SEQ CHAPTER \h \r 1 835.237	Photolysis in Air	---	---

Not required

162-1	  SEQ CHAPTER \h \r 1 835.42	Aerobic Soil Metabolism	46246511 Proazolthion (proposed) [JAU6476]: Degradation and Metabolism of JAU6476 in Aerobic Soils.	prothioconazole	Acceptable

162-1	  SEQ CHAPTER \h \r 1 835.42	Aerobic Soil Metabolism	46246512 Aerobic Degradation of JAU6476 in Two Soils	prothioconazole	Acceptable

162-1	  SEQ CHAPTER \h \r 1 835.42	Aerobic Soil Metabolism	46246513 Degradation of JAU6476-desthio (SXX0665) in Four Soils under Aerobic Conditions.	prothioconazole-desthio	Supplemental

162-1	  SEQ CHAPTER \h \r 1 835.42	Aerobic Soil Metabolism	46246514 Degradation of JAU6476-S-methyl (WAK7861) in Four Soils Under Aerobic Conditions.	prothioconazole-S-methyl	Supplemental

162-2	  SEQ CHAPTER \h \r 1 835.42	Anaerobic Soil Metabolism	---	---

Not required

162-3	  SEQ CHAPTER \h \r 1 835.44	Anaerobic Aquatic Metabolism	46246516 Anaerobic Aquatic Metabolism of JAU6476.	prothioconazole	Acceptable

162-4	  SEQ CHAPTER \h \r 1 835.43	Aerobic Aquatic Metabolism	46246515 Aerobic Degradation and Metabolism of the Active Ingredient JAU6476 in the Water/Sediment System	prothioconazole	Supplemental

163-1	  SEQ CHAPTER \h \r 1 835.1230

835.1240	Mobility	46246450	Adsorption/Desorption of [phenyl-UL-14C] SXX0665 on Four Different Soils	prothioconazole-desthio	Acceptable

163-1	  SEQ CHAPTER \h \r 1 835.1230

835.1240	Mobility	46246501	Adsorption/Desorption of S-methyl-JAU6476 on Four Different Soils.	prothioconazole-S-methyl	Acceptable

163-1	  SEQ CHAPTER \h \r 1 835.1230

835.1240	Mobility 	46246504	Aged Soil Column Leaching of JAU6476. prothioconazole	Acceptable

163-1	  SEQ CHAPTER \h \r 1 835.1230

835.1240	Mobility	46246539	Leaching behaviour of JAU6476 formulated as 250 EC in soil (parent leaching).	prothioconazole (formulated product) Supplemental

163-2	  SEQ CHAPTER \h \r 1 835.141	Laboratory Volatility	---	---

Not required

164-1	  SEQ CHAPTER \h \r 1 835.61	Terrestrial Field Dissipation 46246517

46246518

46246519	Terrestrial Field Dissipation of JAU6476 in California Soil, 1999.

Terrestrial Field Dissipation of JAU6476 in Georgia Soil, 1999.

Terrestrial Field Dissipation of JAU6476 in New York Soil, 1999. prothioconazole (formulated product)	Supplemental

Supplemental

Supplemental

164-2	  SEQ CHAPTER \h \r 1 835.62	Aquatic Field Dissipation	46246522

46246523

46246524

	Aquatic Field Dissipation of JAU6476 in a California Rice Field, 2000.

Aquatic Field Dissipation of JAU6476 in an Arkansas Rice Field, 2000.

Aquatic Field Dissipation of JAU6476 in a cropped Arkansas Rice Field, 2000.

prothioconazole (formulated product)	Supplemental

Supplemental

Supplemental

165-4	  SEQ CHAPTER \h \r 1 850.173	Accumulation in Laboratory Fish 46246034	(Carbon 14)-JAU6476-Bioconcentration and Biotransformation in Bluegill (Lepomis macrochirus) Under Flow-Through Conditions. prothioconazole 	Supplemental

165-4	  SEQ CHAPTER \h \r 1 850.173	Accumulation in Laboratory Fish 46246035	(Carbon 14)-JAU6476-Desthio - Bioconcentration and Biotransformation in Bluegill (Lepomis macrochirus) Under Flow-Through Conditions.	prothioconazole-desthio 	Acceptable

Table 2.  Status of ecological effects data adequacy for prothioconazole.

Guideline	Description	MRID	Title	Substrate	Study Classification

71-1

850.2100	Avian acute oral	462460-36

462460-37	Acute oral toxicity study with the Bobwhite	TGAI.

SXX0665.  	Acceptable

Acceptable

71-2	OECD 205	Avian acute dietary	462460-38

462460-39	A dietary LC50 study with the Northern Bobwhite	TGAI.

Desthio..	Acceptable

71-2	OECD 205	Avian acute dietary	462460-40	A dietary LC50 study with the Mallard	TGAI. 	Acceptable

71-4a	--	Avian repro 	462460-42

462460-43	Avian reproduction study in Northern Bobwhite 	TGAI.

Desthio.  No. 	Acceptable

Acceptable

71-4b	--	Avian repro	462460-44

462460-45	Avian reproduction study in Mallard	TGAI.  No.

Desthio.  No.	Acceptable

Supplemental

72-1

Freshwater fish acute	462460-18

462460-19

462460-20

462460-21	An acute toxicity study with the Rainbow trout	TGAI.  No.

480SC

SXX0665.  No.

S-methyl.  	Acceptable

Acceptable

Acceptable

Acceptable

72-1

Freshwater fish acute	462460-22

462460-23	Acute toxicity to Bluegill sunfish	TGAI.

480SC 	Acceptable

Acceptable

Non-guideline	Non-guideline	Freshwater fish acute	462460-25	Acute toxicity to common carp	TGAI. No.	Supplemental

72-1a

Freshwater fish acute	462460-26	Acute toxicity to Fathead minnow Desthio.  	Acceptable

72-1a

Freshwater fish acute	462460-24	Acute toxicity to Golden orfe	SXX0665.   Invalid

72-2	OECD 202	Freshwater invertebrate acute	462460-09

462460-10

462460-11

462460-12	An acute toxicity study with the daphnid	TGAI.  No.

480SC.

SXX0665.

S-methyl.  	Acceptable

Acceptable

Supplemental

Acceptable

Non-guideline	Non-guideline

462460-13	Acute toxicity study with crayfish	Desthio.  No	Invalid

72-3a

Estuarine/ marine fish acute	462460-27	Acute toxicity study with the Sheepshead minnow	TGAI	Acceptable

72-3b

Oyster shell deposition	462460-14	Acute toxicity to Eastern Oyster	TGAI Acceptable

72-3c

Estuarine/ marine invertebrate acute	462460-16

462460-17	Acute toxicity to Mysids

	TGAI.  No.

Desthio.  No.	Acceptable

Acceptable

72-4a

Fish early life stage	462460-31

462460-32	Toxicity to the early life stages of the Rainbow trout	TGAI

Desthio

	Invalid

Invalid

72-4b

Freshwater invertebrate life cycle	462460-28

462460-29	21-d chronic toxicity with the Daphnid	TGAI

Desthio	Acceptable

Acceptable

72-4c

Estuarine/ marine invertebrate life cycle	462460-30	Life cycle toxicity test with the Mysid	Desthio. No. 	Acceptable

72-5

Estuarine/ marine fish life cycle	462460-33	Life-cycle toxicity test with the Fathead minnow	Desthio	Supplemental

122-1

Non-target plants seedling emergence/vegetative vigor	462460-49	Tier I seedling emergence/vegetative vigor	480SC 	Acceptable

123-2a

Non-target plants, Tier II seedling emergence	462460-50	Tier II seedling emergence	480SC 	Acceptable

123-2

Non-target plants; aquatic vascular plant toxicity test	462461-01

462461-02

462461-04	Toxicity to duckweed	TGAI

480SC.

Desthio 	Acceptable

Acceptable

Acceptable

123-2

Non-target plants; freshwater non-vascular plant toxicity test	462461-09 Acute toxicity to the freshwater diatom	TGAI	Acceptable

123-2

Non-target plants; marine non-vascular plant toxicity test	462461-10 Growth inhibition test with the marine diatom	TGAI	Acceptable

123-2

Non-target plants; freshwater non-vascular plant toxicity test	462461-05

462461-07

462461-08	Growth inhibition test with freshwater blue-green alga	TGAI

S-methyl.

SXX0665. No.	Acceptable

Supplemental

Acceptable

123-3

Non-target plants; freshwater non-vascular plant toxicity test	462461-03

462461-06	Toxicity to the freshwater green alga	TGAI

480SC 	Acceptable

Acceptable

141-1

Non-target insect contact toxicity test	462460-46

462460-48	Acute oral and contact toxicity tests with the honeybee	480SC

TGAI	Acceptable

Acceptable

N/A

Sediment-dwelling invertebrate toxicity test	462461-31

462461-32	Development and emergence of Chironomus larvae	TGAI

SXX0665 	Supplemental

Supplemental

-  PAGE  1  of    NUMPAGES 6 -


[Federal Register: May 9, 2006 (Volume 71, Number 89)]
[Notices]
[Page 26943]
[DOCID:fr09my06-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-324-000]

Maritimes & Northeast Pipeline, L.L.C.; Notice of Proposed
Changes in FERC Gas Tariff

May 2, 2006.
    Take notice that on April 26, 2006, Maritimes & Northeast Pipeline,
L.L.C. (Maritimes) tendered for filing as part of its FERC Gas Tariff,
First Revised Volume No. 1, Third Revised Sheet No. 283 proposed to be
effective May 27, 2006.
    Maritimes states that copies of its filing have been mailed to all
affected customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-6969 Filed 5-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Pages 34021-34022]
[FR Doc No: E9-16612]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0212]

Draft Guidance for Industry on ``Incorporation of Physical-
Chemical Identifiers into Solid Oral Dosage Form Drug Products for
Anticounterfeiting,'' Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Incorporation
of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug
Products for Anticounterfeiting.'' This draft guidance provides
recommendations to pharmaceutical manufacturers on design
considerations for incorporating physical-chemical identifiers (PCIDs)
into solid oral dosage forms (SODFs), supporting documentation to be
submitted in new drug applications (NDAs) and abbreviated new drug
applications (ANDAs) to address the proposed incorporation of PCIDs in
SODFs, supporting documentation to be submitted in postapproval
submissions to report or request approval to incorporate PCIDs into
SODFs, and procedures for reporting or requesting approval to
incorporate PCIDs into SODFs as a postapproval change. This draft
guidance also provides our recommendations regarding evaluation of
toxicological and other concerns for PCIDs that are incorporated into
packaging and labeling and procedures for reporting or requesting
approval to add PCIDs to packaging and containers as a postapproval
change.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 13, 2009.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT:  John L. Smith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10993 New
Hampshire Ave., Building 21, rm. 2619, Rockville, MD 20857, 301-796-
1757.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Incorporation of Physical-Chemical Identifiers into Solid
Oral Dosage Form Drug Products for Anticounterfeiting.'' Pharmaceutical
manufacturers aiming to thwart drug product counterfeiting have been
investigating readily available technologies to make drug products more
difficult to duplicate. One approach that pharmaceutical manufacturers
appear to be considering involves adding a trace amount of an inactive
ingredient(s) to an existing section of the dosage form. A unique
physical-chemical characteristic of that ingredient makes it possible
to detect and authenticate legitimate dosage forms and identify
counterfeits.
    This draft guidance provides recommendations to pharmaceutical
manufacturers on the following topics: (1) Design considerations for
incorporating PCIDS into SODFs, (2) supporting documentation to be
submitted with NDAs and ANDAs to address the proposed incorporation of
PCIDs in SODFs, (3) supporting documentation to be submitted in
postapproval submissions to report or request approval to incorporate
PCIDs into SODFs, and (4) procedures for reporting or requesting
approval to incorporate PCIDs into SODFs as a postapproval change. This
draft guidance also provides our recommendations regarding: (1)
Evaluation of toxicological and other concerns for PCIDs that are
incorporated into packaging and labeling and (2) procedures for
reporting or requesting approval to add PCIDs to packaging and
containers as a postapproval change.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on
``Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage
Form Drug Products for Anticounterfeiting.'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The documentation in premarketing regulatory submissions
recommended for applicants incorporating PCIDs into SODFs would be
covered under 21 CFR 314.50 and 314.94, and the documentation in
postapproval regulatory submissions would be covered under 21 CFR
314.70. This information collection is approved by OMB under OMB
control number 0910-0001.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: July 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16612 Filed 7-13-09; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Pages 70954-70955]
[FR Doc No: 2013-28391]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1424]

Transport Format for the Submission of Regulatory Study Data;
Notice of Pilot Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) in the Food and
Drug Administration (FDA) are announcing a pilot project to evaluate
the Clinical Data Interchange Standard Consortium (CDISC) Submission
Data Standards (SDS) Extensible Markup Language (XML) transport format
for the submission of regulatory study data. The current study data
transport format supported by FDA is the SAS Transport (XPORT) version
5 file format. Although XPORT has been a reliable exchange format for
many years, it is not an extensible modern technology. SDS XML is an
extension of the CDISC Operational Data Model, which is a vendor
neutral, platform-independent format for the exchange and archive of
study data. FDA is announcing an invitation to sponsors to participate
in this pilot project to evaluate the SDS XML transport format.

DATES: Submit either electric or written requests for participation in
the pilot project by January 27, 2014.

ADDRESSES: Submit electronic requests to participate in the pilot and
comments regarding this pilot project to http://www.regulations.gov.
Summit written requests and comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1062, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 1160, Silver Spring, MD 20993, 301-796-
5333<EMAIL_ADDRESS>or Stephen Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N Rockville, MD 20852,
301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In the 1999 ``Guidance to Industry: Providing Regulatory
Submissions in Electronic Format'' FDA recommended that regulatory
submissions of clinical data to FDA utilize SAS Institute's open
transport called XPORT version 5 format (XPORT). The XPORT format was
developed in the late 1980s and there have been no version updates
since 1999. XPORT is now considered by many to be an outdated transport
technology for transferring data across different hardware and
operating systems.
    Following a Federal Register Notice, FDA held a public meeting on
November 5, 2012, entitled ``Regulatory New Drug Review: Solutions for
Study Data Exchange Standards.'' The purpose of the public meeting was
to solicit input from industry, technology vendors, and other members
of the public regarding the advantages and disadvantages of current and
emerging open, consensus-based standards for the exchange of regulated
study data. FDA indicated, in the Notice and at the meeting, based on
feedback received at the public meeting and other information sources,
it would undertake further requirements analysis in support of expected
evaluation projects.

II. Project Participation

    FDA envisions several pilot projects conducted to evaluate new
transport formats. The purpose of this pilot project is to obtain
additional experience with CDISC SDS XML format. A successful pilot may
allow CDER and CBER to routinely receive study data that employ CDISC
SDS XML format as the transport format once an alternatives analysis is
completed. As part of this pilot, FDA would like to have sponsors
participate in the preparation and submission of previously submitted
study datasets using the SDS XML transport format. Participation in
this evaluation will be outside of the regulatory pathway and, as such,
will not be used to make regulatory decisions.
    FDA expects that the pilot will assess the technical capability of
SDS XML to exchange and archive regulatory study data in
investigational new drug applications, new drug applications, and
biologics licensing applications.

III. Requests for Participation

    Requests to participate in the SDS XML pilot project are to be
identified with the docket number found in brackets in the heading of
this document. Interested persons should include the following
information in the request: Contact name, contact phone number, email
address, name of the sponsor, address, and license number. Once
requests for participation are received, FDA will contact interested
sponsors to discuss the pilot project. FDA is seeking a limited number
of sponsors (approximately three to five, but no more than six) to
participate in this project. The elapsed time duration of the pilot is
expected to be approximately 12 months but may be extended as needed.
Participants should be willing to provide previously submitted study
data using both the SAS XPORT version 5 format and the CDISC SDS XML
format.

    Dated: November 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28391 Filed 11-26-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Notices]
[Pages 1493-1495]
[FR Doc No: 2011-245]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0413]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of Applications for exemptions; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 16 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. If granted, the exemptions would enable these
individuals to qualify as drivers of commercial motor vehicles (CMVs)
in interstate commerce without meeting the Federal vision standard.

DATES: Comments must be received on or before February 9, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2010-0413 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line 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: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. 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
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to, or greater than, the level that would be
achieved absent such exemption.'' FMCSA can renew exemptions at the end
of each 2-year period. The 16 individuals listed in this notice have
each requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

Michael L. Ballantyne

    Mr. Ballantyne, age 55, has had refractive amblyopia in his right
eye since birth. The best corrected visual acuity in his right eye is
20/200 and in his left eye, 20/20. Following an examination in 2010,
his optometrist noted, ``In my medical opinion has

sufficient vision to operate commercial vehicle.'' Mr. Ballantyne
reported that he has driven straight trucks for 30 years, accumulating
750,000 miles. He holds a Class B Commercial Driver's License (CDL)
from Missouri. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

Terry Brown

    Mr. Brown, 47, has had amblyopia in his left eye due to an injury
sustained in 1996. The best corrected visual acuity in his right eye is
20/20 and in his left eye, 20/400. Following an examination in 2010,
his optometrist noted, ``The vision is more than adequate in his right
eye to perform his duties as a commercial truck driver.'' Mr. Brown
reported that he has driven straight trucks for 2 years, accumulating
20,000 miles and tractor-trailer combinations for 20 years accumulating
1.4 million miles. He holds a Class D operator's license from South
Carolina. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Delbert M. Carson

    Mr. Carson, 65, has had histoplasmosis in his right eye since
birth. The best corrected visual acuity in his right eye is 20/800 and
in his left eye, 20/25. Following an examination in 2010, his
optometrist noted, ``In my medical opinion, Mr. Delbert Carson has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Carson reported that he has driven tractor-
trailer combinations for 43 years, accumulating 430 million miles. He
holds a Class F operator's license from South Carolina. His driving
record for the last 3 years shows no crashes and one conviction for a
moving violation in a CMV. He exceeded the speed limit by 13 mph.

Wingson Chang

    Mr. Chang, 39, has had refractive amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/20
and in his left eye, 20/60. Following an examination in 2010, his
optometrist noted, ``In my medical opinion, Mr. Chang has sufficient
vision with both eyes working together to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Chang reported that he
has driven straight trucks for 21 years, accumulating 7.6 million
miles. He holds a Class B CDL from New Jersey. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Richard C. Dickinson

    Mr. Dickinson, 55, has had amblyopia in his right eye since birth.
The best corrected visual acuity in his right eye is 20/50 and in his
left eye, 20/20. Following an examination in 2010, his optometrist
noted, ``This is to certify that, in my opinion, Richard C. Dickinson
has sufficient vision to perform driving tasks required to operate a
commercial vehicle.'' Mr. Dickinson reported that he has driven
straight trucks for 6 years, accumulating 30,000 miles and tractor-
trailer combinations for 6 years accumulating 30,000 miles. He holds a
Class B CDL from Georgia. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Richard A. Guthrie

    Mr. Guthrie, 52, has had a prosthetic left eye since childhood. The
best corrected visual acuity in his right eye is 20/20. Following an
examination in 2010, his optometrist noted, ``In my opinion, Richard
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Guthrie reported that he has driven
straight trucks for 15 years, accumulating 300,000 miles and tractor-
trailer combinations for 20 years accumulating 700,000 miles. He holds
a Class D operator's license from Montana. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Kenneth L. Handy

    Mr. Handy, 68, has had nuclear sclerosis cataract and amblyopia in
his right eye since childhood. The best corrected visual acuity in his
right eye is 20/250 and in his left eye, 20/20. Following an
examination in 2010, his ophthalmologist noted, ``I believe he has
sufficient vision to perform driving tasks required to operate a
commercial vehicle.'' Mr. Handy reported that he has driven straight
trucks for 8 years, accumulating 200,000 miles. He holds a Class B CDL
from Iowa. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Thomas J. Ivins

    Mr. Ivins, 53, has had central serous retinopathy in his left eye
since 2004. The best corrected visual acuity in his right eye is 20/20
and in his left eye, 20/100. Following an examination in 2010, his
optometrist noted, ``In my opinion, Mr. Ivins has sufficient vision to
perform the tasks required to safely operate a commercial vehicle.''
Mr. Ivins reported that he has driven straight trucks for 5 years,
accumulating 312,500 miles and tractor-trailer combinations for 28
years accumulating 5 million miles. He holds a Class A CDL from
Florida. His driving record for the last 3 years shows no crashes and
one conviction for a moving violation in a CMV. He exceeded the speed
limit by 9 mph.

Byron K. Lavender

    Mr. Lavender, 44, has had ambloypia in his right eye since
childhood. The best corrected visual acuity in his right eye is 20/100
and in his left eye, 20/15. Following an examination in 2010, his
optometrist noted, ``In my opinion, Bryon has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Lavender reported that he has driven straight trucks for 20 years,
accumulating 800,000 miles. He holds a Class B CDL from Ohio. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Victor M. McCants

    Mr. McCants, 43, has had macular drusen in his right eye since
1997. The visual acuity in his right eye is 20/50 and in his left eye,
20/20. Following an examination in 2010, his optometrist noted, ``With
20/20 vision obtained without any glasses and 140 degrees peripheral
vision, I feel he should not have any trouble driving a commercial
vehicle.'' Mr. McCants reported that he has driven tractor-trailer
combinations for 17 years, accumulating 816,000 miles. He holds a Class
A CDL from Alabama. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

William K. Otwell

    Mr. Otwell, 47, has had complete loss of vision in his right eye
since childhood. The best corrected visual acuity in his right eye is
light perception and in his left eye, 20/20. Following an examination
in 2010, his optometrist noted, ``I feel that his vision is adequate to
operate a commercial vehicle.'' Mr. Otwell reported that he has driven
straight trucks for 16 years, accumulating 720,000 miles. He holds a
Class B CDL from Louisiana. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Donald R. Pointer

    Mr. Pointer, 32, has had a prosthetic left eye since childhood. The
visual acuity in his right eye is 20/20.

Following an examination in 2010, his optometrist noted, ``It is my
medical opinion that Mr. Pointer has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Pointer
reported that he has driven straight trucks for 5 years, accumulating
13,000 miles. He holds a Class A CDL from Colorado. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Steve A. Reece

    Mr. Reece, 48, has had a retinal detachment in his left eye due to
an injury sustained in 1991. The best corrected visual acuity in his
right eye is 20/20 and in his left eye, 20/200. Following an
examination in 2010, his ophthalmologist noted, ``I feel that his
vision should be sufficient to perform the driving tasks he has been
doing for the past 19 years.'' Mr. Reece reported that he has driven
straight trucks for 25 years, accumulating 200,000 miles and tractor-
trailer combinations for 21 years accumulating 1 million miles. He
holds a Class A CDL from Missouri. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Thomas S. Roth

    Mr. Roth, 50, has had a prosthetic right eye since childhood. The
visual acuity in his right eye is hand motion and in his left eye, 20/
20. Following an examination in 2010, his optometrist noted, ``In my
medical opinion and the guidelines set by the State of Pennsylvania,
Mr. Roth has sufficient vision to perform the drivers tasks required to
operate a commercial vehicle.'' Mr. Roth reported that he has driven
straight trucks for 27 years, accumulating 405,000 miles and tractor-
trailer combinations for 24 years accumulating 120,000 miles. He holds
a Class A CDL from Delaware. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Mark A. Steckmyer

    Mr. Steckmyer, 47, has had optic atrophy secondary to optic
neuritis in his left eye since 1984. The visual acuity in his right eye
is 20/20 and in his left eye, count- finger vision. Following an
examination in 2010, his optometrist noted, ``He has sufficient vision
to perform driving tasks required to operate a commercial vehicle due
to the stable and longstanding nature of his injury.'' Mr. Steckmyer
reported that he has driven straight trucks for 8 years, accumulating
70,200 miles. He holds a Class B CDL from Kentucky. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

James M. Tennyson

    Mr. Tennyson, 60, has had Kerataconus and a failed corneal graft in
his left eye since birth. The best corrected visual acuity in his right
eye is 20/25 and in his left eye, hand motion. Following an examination
in 2010, his ophthalmologist noted, ``I feel in my professional opinion
that with his visual acuity he will be able to operate a commercial
vehicle.'' Mr. Tennyson reported that he has driven straight trucks for
44 years, accumulating 528,000 miles. He holds a Class C operator's
license from Maryland. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business February 9, 2011. Comments will
be available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: December 29, 2010.
Larry W. Minor,
Associate Administration, Office of Policy.
[FR Doc. 2011-245 Filed 1-7-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: September 11, 2007 (Volume 72, Number 175)]
[Proposed Rules]
[Page 51722-51725]
[DOCID:fr11se07-13]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29171; Directorate Identifier 2007-NM-154-AD]
RIN 2120-AA64

Airworthiness Directives; Saab Model SAAB 2000 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, * * * Special Federal Aviation
Regulation 88 (SFAR88) * * * required a safety review of the
aircraft Fuel Tank System * * *, * * * Fuel Airworthiness
Limitations are items arising from a systems safety analysis that
have been shown to have failure mode(s) associated with an `unsafe
condition' * * *. These are identified in Failure Conditions for
which an unacceptable probability of ignition risk could exist if
specific tasks and/or practices are not performed in accordance with
the manufacturers' requirements.

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by October 11,
2007.

ADDRESSES: You may send comments by any of the following methods:
     DOT Docket Web Site: Go to http://dms.dot.gov and follow

the instructions for sending your comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: Room W12-140 on the ground floor of the
West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://dms.dot.gov
; or in person at the Docket Operations office between 9

a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this proposed AD, the regulatory evaluation, any
comments received, and other information. The street address for the
Docket Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Mike Borfitz, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2677; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-
29171; Directorate Identifier 2007-NM-154-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://dms.dot.gov
, including any personal information you provide. We will

also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2006-0199, dated July 11, 2006 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, the FAA published Special Federal
Aviation Regulation 88 (SFAR 88) in June 2001. SFAR 88 required a
safety review of the aircraft Fuel Tank System to determine that the
design meets the requirements of FAR (Federal Aviation Regulation)
Sec.  25.901 and Sec.  25.981(a) and (b).
    A similar regulation has been recommended by the JAA (Joint
Aviation Authorities) to the European National Aviation Authorities
in JAA letter 04/00/02/07/03-L024 of 3 February 2003. The review was
requested to be mandated by NAA's (National Aviation Authorities)
using JAR (Joint Aviation Regulation) Sec.  25.901(c), Sec.
25.1309.
    In August 2005, EASA published a policy statement on the process
for developing instructions for maintenance and inspection of Fuel
Tank System ignition source prevention (EASA D 2005/CPRO, http://www.easa.eu.int/home/cert_policy_statements_en.html
) that also

included the EASA expectations with regard to compliance times of
the corrective actions on the unsafe and the not unsafe part of the
harmonised design review results. On a global scale the TC (type
certificate) holders committed themselves to the EASA published
compliance dates (see EASA policy statement). The EASA policy
statement has been revised in March 2006: The date of 31-12-2005 for
the unsafe related actions has now been set at 01-07-2006.
    Fuel Airworthiness Limitations are items arising from a systems
safety analysis that have been shown to have failure mode(s)
associated with an `unsafe condition' as defined in FAA's memo 2003-
112-15 `SFAR 88--Mandatory Action Decision Criteria'. These are
identified in Failure Conditions for which an unacceptable
probability of ignition risk could exist if specific tasks and/or
practices are not performed in accordance with the manufacturers'
requirements.
    This EASA Airworthiness Directive mandates the Fuel System
Airworthiness Limitations (comprising maintenance/inspection tasks
and Critical Design Configuration Control Limitations (CDCCL)) for
the type of aircraft, that resulted from the design reviews and the
JAA recommendation and EASA policy statement mentioned above.

The corrective action is revising the Airworthiness Limitations Section
of the Instructions for Continued Airworthiness to incorporate new
limitations for fuel tank systems. You may obtain further information
by examining the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88. (The JAA is an associated body of the European
Civil Aviation Conference (ECAC) representing the civil aviation
regulatory authorities of a number of European States who have agreed
to co-operate in developing and implementing common safety regulatory
standards and procedures.) Under this regulation, the JAA stated that
all members of the ECAC that hold type certificates for transport
category airplanes are required to conduct a design review against
explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Saab has issued Fuel Airworthiness Limitations 2000 LKS 009032,
dated February 14, 2006. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 7 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $560, or $80 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII,

Part A, Subpart III, Section 44701: General requirements.'' Under that
section, Congress charges the FAA with promoting safe flight of civil
aircraft in air commerce by prescribing regulations for practices,
methods, and procedures the Administrator finds necessary for safety in
air commerce. This regulation is within the scope of that authority
because it addresses an unsafe condition that is likely to exist or
develop on products identified in this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

SAAB Aircraft AB: Docket No. FAA-2007-29171; Directorate Identifier
2007-NM-154-AD.

Comments Due Date

    (a) We must receive comments by October 11, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Saab Model SAAB 2000 airplanes,
certificated in any category, all serial numbers.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (g) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, the FAA published Special Federal
Aviation Regulation 88 (SFAR 88) in June 2001. SFAR 88 required a
safety review of the aircraft Fuel Tank System to determine that the
design meets the requirements of FAR (Federal Aviation Regulation)
Sec.  25.901 and Sec.  25.981(a) and (b).
    A similar regulation has been recommended by the JAA (Joint
Aviation Authorities) to the European National Aviation Authorities
in JAA letter 04/00/02/07/03-L024 of 3 February 2003. The review was
requested to be mandated by NAA's (National Aviation Authorities)
using JAR (Joint Aviation Regulation) Sec.  25.901(c), Sec.
25.1309.
    In August 2005 EASA (European Aviation Safety Agency) published
a policy statement on the process for developing instructions for
maintenance and inspection of Fuel Tank System ignition source
prevention (EASA D 2005/CPRO, http://www.easa.eu.int/home/cert_policy_statements_en.html
) that also included the EASA

expectations with regard to compliance times of the corrective
actions on the unsafe and the not unsafe part of the harmonised
design review results. On a global scale the TC (type certificate)
holders committed themselves to the EASA published compliance dates
(see EASA policy statement). The EASA policy statement has been
revised in March 2006: the date of 31-12-2005 for the unsafe related
actions has now been set at 01-07-2006.
    Fuel Airworthiness Limitations are items arising from a systems
safety analysis that have been shown to have failure mode(s)
associated with an `unsafe condition' as defined in FAA's memo 2003-
112-15 `SFAR 88--Mandatory Action Decision Criteria'. These are
identified in Failure Conditions for which an unacceptable
probability of ignition risk could exist if specific tasks and/or
practices are not performed in accordance with the manufacturers'
requirements.
    This EASA Airworthiness Directive mandates the Fuel System
Airworthiness Limitations (comprising maintenance/inspection tasks
and Critical Design Configuration Control Limitations (CDCCL)) for
the type of aircraft, that resulted from the design reviews and the
JAA recommendation and EASA policy statement mentioned above.

The corrective action is revising the Airworthiness Limitations
Section of the Instructions for Continued Airworthiness to
incorporate new limitations for fuel tank systems.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 3 months after the effective date of this AD, revise
the Airworthiness Limitations Section (ALS) of the Instructions for
Continued Airworthiness to incorporate the maintenance and
inspection instructions in Part 1 of Saab Fuel Airworthiness
Limitations 2000 LKS 009032, dated February 14, 2006. For all tasks
identified in Part 1 of Saab Fuel Airworthiness Limitations 2000 LKS
009032, dated February 14, 2006, the initial compliance times start
from the effective date of this AD, and the repetitive inspections
must be accomplished thereafter at the interval specified in Part 1
of Saab Fuel Airworthiness Limitations 2000 LKS 009032, dated
February 14, 2006.
    (2) Within 12 months after the effective date of this AD, revise
the ALS of the Instructions for Continued Airworthiness to
incorporate the CDCCLs as defined in Part 2 of Saab Fuel
Airworthiness Limitations 2000 LKS 009032, dated February 14, 2006.
    (3) Except as provided by paragraph (g) of this AD: After
accomplishing the actions specified in paragraphs (f)(1) and (f)(2)
of this AD, no alternative inspection, inspection intervals, or
CDCCLs may be used.
    (4) Where Saab Fuel Airworthiness Limitations 2000 LKS 009032,
dated February 14, 2006, allows for exceptional short-term
extensions, an exception is acceptable to the FAA if it is approved
by the appropriate principal inspector in the FAA Flight Standards
Certificate Holding District Office.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Mike
Borfitz, Aerospace Engineer, International Branch, ANM-116, FAA,
Transport Airplane Directorate, FAA, 1601 Lind, Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before

using any approved AMOC on any airplane to which the AMOC applies,
notify your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2006-0199, dated July 11, 2006, and Saab
Fuel Airworthiness Limitations 2000 LKS 009032, dated February 14,
2006, for related information.

    Issued in Renton, Washington, on September 4, 2007.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E7-17832 Filed 9-10-07; 8:45 am]

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