[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Rules and Regulations]
[Pages 53665-53666]
[FR Doc No: 2013-21174]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0677]

Drawbridge Operation Regulation; Snohomish River, Everett, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the SR 529 twin bridges across the
Snohomish, mile 3.6, near Everett, WA. The deviation is necessary to
facilitate heavy maintenance and equipment upgrades on the bridges.
This deviation allows the bridges to remain in the closed position
during maintenance activities.

DATES: This deviation is effective from 12:01 a.m. on September 3, 2013
to 11:59 p.m. on October 18, 2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0677] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Lieutenant Commander Steven M.
Fischer, Bridge Specialist, Coast Guard Thirteenth District; telephone
206-220-7277, email<EMAIL_ADDRESS>If you have questions
on viewing the docket, call Barbara Hairston, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Washington State Department of
Transportation (WSDOT) has requested that the SR 529 twin bridges
across the Snohomish River remain closed to vessel traffic to
facilitate heavy maintenance and equipment upgrades on the bridges. The
SR 529 twin bridges cross the Snohomish River at mile 3.6 and provide
38 feet of vertical clearance above mean high water elevation while in
the closed position. Vessels which do not require a bridge opening may
continue to transit beneath the bridges

during this closure period. Under normal conditions the SR 529 Bridges
crossing the Snohomish River operate in accordance with 33 CFR
117.1059(c) which requires advance notification of one-hour when a
bridge opening is needed. This deviation period is from 12:01 a.m. on 3
September 2013 to 11:59 p.m. on 18 October 2013. The deviation allows
the SR 529 Bridges crossing the Snohomish River, to remain in the
closed position and need not open for maritime traffic from 12:01 a.m.
on 3 September 2013 to 11:59 p.m. on 18 October 2013. The bridges shall
operate in accordance to 33 CFR 117.1059 at all other times. Waterway
usage on the Snohomish River includes vessels ranging from commercial
tug and barge to small pleasure craft. Mariners will be notified and
kept informed of the bridges' operational status via the construction
contractor performing the maintenance as well as via the Coast Guard
Notice to Mariners publication and Broadcast Notice to Mariners as
appropriate. The bridges will not be able to open during this
maintenance activity because the lifting mechanisms will be inoperable.
    In accordance with 33 CFR 117.35(e), the drawbridges must return to
their regular operating schedule immediately at the end of the
effective period of this temporary deviation. This deviation from the
operating regulations is authorized under 33 CFR 117.35.

    Dated: August 19, 2013.
Daryl R. Peloquin,
Acting Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2013-21174 Filed 8-29-13; 8:45 am]
BILLING CODE 9110-04-P


to the test. These containers shall be complete with ends assembled.
Should any of the containers thus tested fail, the entire lot must be
rejected. All containers constituting a lot shall be of like material,
size, design construction, finish, and quality.
    (c) Marking. By means of printing, lithographing, embossing, or
stamping, each container must be marked:
    (1) DOT-2P1.
    (2) With the name or symbol of the person making the mark. A
symbol, if used, must be registered with the Associate Administrator.

0
47. Sections 178.33d, 178.33d-1, 178.33d-2 and 178.33d-3 are added to
subpart B to read as follows:

Sec.  178.33d  Specification 2Q; inner nonrefillable metal receptacle
variations.

Sec.  178.33d-1  Compliance.

    Required in all details.

Sec.  178.33d-2  Variation 1.

    Notwithstanding the variation provided in this paragraph, each
container must otherwise conform to a DOT 2Q container in accordance
with Sec.  178.33a. The following conditions also apply under Variation
1--
    (a) Type and size. The maximum capacity of containers in this class
may not exceed 0.40 L (24.4 cubic inches). The maximum inside diameter
shall not exceed 2.1 inches.
    (b) Manufacture. Ends: The top of the container must be designed
with a pressure relief system consisting of radial scores on the top
seam(s). The bottom of the container must be designed to buckle at a
pressure greater than the pressure at which the top buckles and vents.
    (c) Wall thickness. The minimum wall thickness for any container
shall be 0.0085 inches.
    (d) Tests. (1) Two containers (one without a pressure relief system
and one with) out of each lot of 25,000 or less, successively produced
per day shall be pressure tested to destruction at gauge pressure. The
container without a pressure relief system must not burst below 320
psig. The container assembled with a pressure relief system as
described in paragraph (b) of this section must be tested to
destruction. The bottom of the container must buckle at a pressure
greater than the pressure at which the top buckles and vents.
    (2) Each such 25,000 containers or less, successively produced per
day, shall constitute a lot and if the test container(s) shall fail,
the lot shall be rejected. Otherwise, ten (10) additional pairs of
containers may be selected at random and subjected to the test under
which failure occurred. Should any of the containers thus tested fail,
the entire lot must be rejected. All containers constituting a lot
shall be of like material, size, design construction, finish, and
quality.
    (e) Marking. By means of printing, lithographing, embossing, or
stamping, each container must be marked:
    (1) DOT-2Q1.
    (2) With the name or symbol of the person making the mark. A
symbol, if used, must be registered with the Associate Administrator.

Sec.  178.33d-3  Variation 2.

    Notwithstanding the variation provided in this paragraph, each
container must otherwise conform to a DOT 2Q container in accordance
with Sec.  178.33a. The following conditions also apply under Variation
2--
    (a) Manufacture. Ends: The ends shall be designed to withstand
pressure and the container equipped with a pressure relief system
(e.g., rim-venting release or a dome expansion device) designed to
buckle prior to the burst of the container.
    (b) Tests. (1) One out of each lot of 25,000 containers or less,
successively produced per day shall be pressure tested to destruction
at gauge pressure and must not burst below 270 psig. For containers
with a pressure relief system as described in paragraph (a) of this
section and assembled, failure at a location other than the pressure
relief system will reject the lot.
    (2) Each such 25,000 containers or less, successively produced per
day, shall constitute a lot and if the test container(s) shall fail,
the lot shall be rejected. Otherwise, ten (10) additional containers of
each container design produced may be selected at random and subjected
to the test. These containers shall be complete with ends assembled.
Should any of the containers thus tested fail, the entire lot must be
rejected. All containers constituting a lot shall be of like material,
size, design construction, finish, and quality.
    (c) Marking. By means of printing, lithographing, embossing, or
stamping, each container must be marked:
    (1) DOT-2Q2.
    (2) With the name or symbol of the person making the mark. A
symbol, if used, must be registered with the Associate Administrator.

PART 180--CONTINUING QUALIFICATION AND MAINTENANCE OF PACKAGINGS

0
48. The authority citation for part 180 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.

0
49. Section 180.209 is amended as follows:
0
a. In paragraph (a), Table 1 ``Requalification of Cylinders'' is
revised, and a footnote is added;
0
b. Revise paragraph (e); and
0
c. Amend the Table in paragraph (g) by adding an entry for ``DOT 4BW''
at the end of the table.
    The revision and amendments read as follows.

Sec.  180.209  Requirements for requalification of specification
cylinders.

    (a) * * *

                Table 1--Requalification of Cylinders \1\
------------------------------------------------------------------------
                                     Minimum test
    Specification under which       pressure (psig)     Requalification
        cylinder was made                 \2\           period (years)
------------------------------------------------------------------------
DOT 3...........................  3000 psig.........  5.
DOT 3A, 3AA.....................  5/3 times service   5, 10, or 12 (see
                                   pressure, except    Sec.
                                   noncorrosive        180.209(b), (e),
                                   service (see Sec.   (f), (h), and
                                     180.209(g)).      (j).
DOT 3AL.........................  5/3 times service   5, 10 or 12 (see
                                   pressure.           Sec.
                                                       180.209(e), (j)
                                                       and Sec.
                                                       180.209(m) \3\).
DOT 3AX, 3AAX...................  5/3 times service   5, 10 (see Sec.
                                   pressure.           180.209(e).
3B, 3BN.........................  2 times service     5 or 10 (see Sec.
                                   pressure (see        180.209(e),
                                   Sec.                (f)).
                                   180.209(g)).
3E..............................  Test not required.
3HT.............................  5/3 times service   3 (see Sec.  Sec.
                                   pressure.            180.209(k) and
                                                       180.213(c)).
3T..............................  5/3 times service   5.
                                   pressure.
4AA480..........................  2 times service     5 or 10 (see Sec.
                                   pressure (see        180.209(e) or
                                   Sec.                (h)).
                                   180.209(g)).
4B, 4BA, 4BW, 4B-240ET..........  2 times service     5, 10, or 12 (see
                                   pressure, except    Sec.
                                   non-corrosive       180.209(e), (f),
                                   service (see Sec.   and (j)).
                                     180.209(g)).
4D, 4DA, 4DS....................  2 times service...  5.
DOT 4E..........................  2 times service     5 or 10 (see Sec.
                                   pressure, except     180.209(e)).
                                   non-corrosive
                                   (see Sec.
                                   180.209(g)).
4L..............................  Test not required.
8, 8AL..........................  ..................  10 or 20 (see Sec.
                                                         180.209(i)).
Exemption or special permit       See current         See current
 cylinder.                         exemption or        exemption or
                                   special permit.     special permit.
Foreign cylinder (see Sec.        As marked on        5 (see Sec.  Sec.
 173.301(j) of this subchapter     cylinder, but not    180.209(l) and
 for restrictions on use).         less than 5/3 of    180.213(d)(2)).
                                   any service or
                                   working pressure
                                   marking.
------------------------------------------------------------------------
\1\ Any cylinder not exceeding 2 inches outside diameter and less than 2
  feet in length is excepted from volumetric expansion test.
\2\ For cylinders not marked with a service pressure, see Sec.
  173.301a(b) of this subchapter.
\3\ This provision does not apply to cylinders used for carbon dioxide,
  fire extinguisher or other industrial gas service.

* * * * *
    (e) Proof pressure test. A cylinder made in conformance with DOT
Specifications 4B, 4BA, 4BW, or 4E protected externally by a suitable
corrosion-resistant coating and used exclusively for non-corrosive gas
that is commercially free from corroding components may be requalified
by volumetric expansion testing or proof pressure testing every 10
years instead of every 5 years. When subjected to a proof pressure
test, the cylinder must be carefully examined under test pressure and
removed from service if a leak or defect is found.
* * * * *
    (g) * * *

----------------------------------------------------------------------------------------------------------------
               Cylinders conforming to . . .                             Used exclusively for . . .
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
DOT 4BW...................................................  Alkali metal alloys, liquid, n.o.s., Alkali metal
                                                             dispersions or Alkaline earth metal dispersions,
                                                             Potassium, Potassium Sodium alloys and Sodium that
                                                             are commercially free of corroding components.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
50. In Sec.  180.213, revise paragraph (c) introductory text to read as
follows:

Sec.  180.213  Requalification markings.

* * * * *
    (c) Requalification marking method. The depth of requalification
markings may not be greater than specified in the applicable
specification. The markings must be made by stamping, engraving,
scribing, or applying a label embedded in epoxy that will remain
legible and durable throughout the life of the cylinder, or by other
methods that produce a legible, durable mark.
* * * * *

Marie Therese Dominguez,
Administrator, Pipeline and Hazardous Materials Safety Administration.
[FR Doc. 2016-00780 Filed 1-20-16; 8:45 am]
BILLING CODE 4910-60-P


2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, including the metabolites N'-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]benzoyl}-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl] amino}carbonyl)phenyl]urea

Livestock: 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide

None
Commodity[1]
Tolerance (ppm)/Maximum Residue Limit (mg/kg)

U.S.
Canada
Mexico[2]
Codex
Cotton, gin byproducts
0.45

Cottonseed Subgroup 20C
0.20
0.03 Undelinted cotton seeds

Sunflower Subgroup 20B
1.0
1.0 Sunflower seeds

Pea, hay
17

Grain, aspirated fractions
10

Soybean, hulls
0.50

Soybean, seed
0.10
0.03

Pea and bean, dried shelled, except soybean, subgroup 6C
0.30
0.03 (includes dry soybeans)

Rapeseed Subgroup 20A
0.45

Cattle, goat, sheep, and horse; liver
2.5
0.8

Cattle, goat, sheep, and horse; meat byproducts, except liver
0.05
0.02

Completed:  M. Negussie; 11/04/2010
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts U.S. tolerances and/or Codex MRLs for its export purposes.

APPENDIX I.  Chemical Names and Structures of Saflufenacil and Metabolites.
Common name/code
Figure C.3.1  ID No.
Chemical name
Chemical structure
Saflufenacil
2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]
sulfonyl]benzamide

M800H01
N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)benzoyl]-N-isopropylsulfamide

M800H02
N'-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N-isopropyl-N-methylsulfamide

M800H03
N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)benzoyl]-N-methylsulfamide

M800H04
(2E)-3-{4-chloro-2-fluoro-5-[({[isopropyl(methyl)amino]sulfonyl}amino)
carbonyl]phenyl)amino]carbonyl(methylamino)}-4,4,4-trifluorobut-2-enoic acid

M800H05
N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)benzoyl]-sulfamide

M800H10
N'-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N-methylsulfamide

M800H11
N'-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N-isopropylsulfamide

M800H35
N-[4-chloro-2-fluoro-5-({[(isopropylamino)
sulfonyl]amino} carbonyl)phenyl]
urea

Appendix II.  Tolerance-Assessment Calculations.

Bean, Dried Seed

The dataset used to establish a tolerance for saflufenacil and its metabolites on bean, dried seed consisted of bean field trial data representing application rates of 0.044-0.046 lb ai/A with a 2-day PHI.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate. The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II-1.

12 out of 20 of the field trial sample results were below the combined LOQ of 0.03 ppm.  However, as this action is a joint review with Canada, maximum-likelihood estimation (MLE) procedures were not used to impute censored values.

The saflufenacil bean seed dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP.  Visual inspection of the lognormal probability plot (Figure II-1) provided in the spreadsheet indicates that the dataset is not lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure II-2) confirmed that the assumption of lognormality should be rejected.

Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the California Method (μ + 3σ) estimate rounds to the value 0.30 ppm (Figure II-2).  Therefore, 0.30 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on bean, dried seed.

Table II-1.	Residue Data Used to Calculate Tolerance for Combined Total Residues of Saflufenacil in/on Bean, Dried Seed.
Chemical:
Saflufenacil
Crop:
Bean, Dried, Seed
PHI:
2 Days
App. Rate:
0.044-0.046 lb ai/A
Submitter:
BASF
MRID Citation:
MRID 48080902

                     Total Residues of Saflufenacil (ppm)

                                     0.030

                                     0.030

                                     0.030

                                     0.030

                                     0.080

                                     0.230

                                     0.030

                                     0.030

                                     0.050

                                     0.080

                                     0.030

                                     0.030

                                     0.100

                                     0.250

                                     0.030

                                     0.030

                                     0.170

                                     0.060

                                     0.030

                                     0.030

Figure II-1.  Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Bean, Dried Seed.

Figure II-2.  Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Bean, Dried Seed.

Dry Pea Vines (hay)

The dataset used to establish a tolerance for saflufenacil and its metabolites on dry pea vines (hay) consisted of pea hay field trial data representing application rates of 0.044-0.046 lb ai/A with a 2- to 4-day PHI.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate.  The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II-2.

All 18 field trial sample results were above the combined LOQ of 0.03 ppm.  Since there were no values (combined residues) reported below the LOQ, MLE procedures were not needed to impute censored values.

The saflufenacil pea hay dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP.  Visual inspection of the lognormal probability plot (Figure II-3) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure II-4) confirmed that the assumption of lognormality should not be rejected.

Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the lognormal EU Method I and the point estimate of the 99[th] percentile rounds to the value 17 ppm (Figure II-4).  Therefore, 17 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on pea hay.

Table II-2.	Residue Data Used to Calculate Tolerance for Combined Total Residues of Saflufenacil in/on Dry Pea Vines (hay).
Chemical:
Saflufenacil
Crop:
Dry Pea Vines
PHI:
2- to 4-day
App. Rate:
0.044-0.046 lb ai/A
Submitter:
BASF
MRID Citation:
MRID 48080903

                     Total Residues of Saflufenacil (ppm)

                                     1.650

                                     1.970

                                     0.460

                                     0.510

                                     2.120

                                     2.420

                                     1.930

                                     1.350

                                     0.240

                                     0.230

                                     4.880

                                     3.720

                                     4.590

                                     4.630

                                     3.780

                                     4.350

                                     1.380

                                     1.370

Figure II-3.  Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Dry Pea Vines.

Figure II-4.  Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Dry Pea Vines.

Cotton, Undelinted Seed

The dataset used to establish a tolerance for saflufenacil and its metabolites on cotton, undelinted seed consisted of pea hay field trial data representing application rates of 0.043-0.046 lb ai/A with a 5-day PHI.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate.  The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II-3.

Since all except two of the 24 field trial sample results were above the combined LOQ of 0.03 ppm, MLE procedures were not needed to impute censored values.

The saflufenacil cotton, undelinted seed dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP.  Visual inspection of the lognormal probability plot (Figure II-5) provided in the spreadsheet indicates that the dataset is not lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure II-6) confirmed that the assumption of lognormality should be rejected.

Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the California Method (μ + 3σ) estimate rounds to the value 0.20 ppm (Figure II-6).  Therefore, 0.20 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on cotton, undelinted seed.

Table II-3.	Residue Data Used to Calculate Tolerance for Combined Total Residues of Saflufenacil in/on Cotton, Undelinted Seed.
Chemical:
Saflufenacil
Crop:
Cotton, Undelinted Seed
PHI:
5-day
App. Rate:
0.043-0.046 lb ai/A
Submitter:
BASF
MRID Citation:
MRID 48080906
                     Total Residues of Saflufenacil (ppm)
                                     0.050
                                     0.030
                                     0.050
                                     0.030
                                     0.050
                                     0.040
                                     0.040
                                     0.040
                                     0.090
                                     0.050
                                     0.140
                                     0.040
                                     0.050
                                     0.090
                                     0.050
                                     0.100
                                     0.110
                                     0.040
                                     0.140
                                     0.050
                                     0.050
                                     0.050
                                     0.040
                                     0.050

Figure II-5.  Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Cotton, Undelinted Seed.

Figure II-6.  Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Cotton, Undelinted Seed.

Cotton Gin Byproducts (stripper)

The dataset used to establish a tolerance for saflufenacil and its metabolites on cotton gin byproducts (stripper) consisted of pea hay field trial data representing application rates of 0.043-0.046 lb ai/A with a 5- or 10-day PHI.  In one of the trials, residues were higher at a PHI (10 days) that is greater than the proposed PHI (5 days).  In this case, the higher values were entered into the spreadsheet.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate.  The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II-4.

All 8 field trial sample results were above the combined LOQ of 0.03 ppm.  Since there were no values (combined residues) reported below the LOQ, MLE procedures were not needed to impute censored values.

The cotton gin byproducts (stripper) dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP.  Visual inspection of the lognormal probability plot (Figure II-7) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure II-8) confirmed that the assumption of lognormality should not be rejected.

Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the lognormal EU Method I and the point estimate of the 99[th] percentile rounds to the value 0.45 ppm (Figure II-8).  Therefore, 0.45 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on cotton gin byproducts.

Table II-4.	Residue Data Used to Calculate Tolerance for Combined Total Residues of Saflufenacil in/on Cotton Gin Byproducts (stripper).
Chemical:
Saflufenacil
Crop:
Cotton Gin Byproducts (stripper)
PHI:
5- or 10-day
App. Rate:
0.043-0.046 lb ai/A
Submitter:
BASF
MRID Citation:
MRID 48080903

                     Total Residues of Saflufenacil (ppm)

                                     0.200

                                     0.280

                                     0.190

                                     0.340

                                     0.200

                                     0.260

                                     0.300

                                     0.230

Figure II-7.  Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Cotton Gin Byproducts (stripper).

Figure II-8.  Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Cotton Gin Byproducts (stripper).

Canola Seed

The dataset used to establish a tolerance for saflufenacil and its metabolites on canola seed consisted of pea hay field trial data representing application rates of 0.041-0.046 lb ai/A with a 2- to 7-day PHI.  In one of the trials, residues were higher at a PHI (7 days) that is greater than the proposed PHI (3 days).  In this case, the higher values were entered into the spreadsheet.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate.  The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II-5.

Since all except two of the 32 field trial sample results were above the combined LOQ of 0.03 ppm, MLE procedures were not needed to impute censored values.

The saflufenacil canola seed dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP.  Visual inspection of the lognormal probability plot (Figure II-9) provided in the spreadsheet indicates that the dataset is not lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure II-10) confirmed that the assumption of lognormality should be rejected.

Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the California Method (μ + 3σ) estimate rounds to the value 0.45 ppm (Figure II-10).  Therefore, 0.45 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on canola seed.

Table II-5.	Residue Data Used to Calculate Tolerance for Combined Total Residues of Saflufenacil in/on Canola Seed.
Chemical:
Saflufenacil
Crop:
Canola Seed
PHI:
2- to 7-day
App. Rate:
0.043-0.046 lb ai/A
Submitter:
BASF
MRID Citation:
MRID 48135201
                     Total Residues of Saflufenacil (ppm)
                                     0.070
                                     0.140
                                     0.060
                                     0.140
                                     0.070
                                     0.070
                                     0.060
                                     0.110
                                     0.030
                                     0.100
                                     0.040
                                     0.080
                                     0.550
                                     0.070
                                     0.430
                                     0.090
                                     0.200
                                     0.040
                                     0.170
                                     0.040
                                     0.030
                                     0.090
                                     0.130
                                     0.090
                                     0.110
                                     0.070
                                     0.130
                                     0.080
                                     0.090
                                     0.060
                                     0.070
                                     0.060

Figure II-9.  Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Canola Seed.

Figure II-10.  Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Canola Seed.


[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Page 13050]
[FR Doc No: 2013-04322]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP10-1410-006.
    Applicants: Kern River Gas Transmission Company.
    Description: to be effective 12/1/2010.
    Filed Date: 2/19/13.
    Accession Number: 20130219-5076.
    Comments Due: 5 p.m. ET 3/4/13.

    Docket Numbers: RP13-573-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 02/19/13 Negotiated Rates--Occidental Energy Mrktg--
(RTS)--6060-08 & 09 to be effective 3/1/2013.
    Filed Date: 2/19/13.
    Accession Number: 20130219-5066.
    Comments Due: 5 p.m. ET 3/4/13.

    Docket Numbers: RP13-574-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: to be effective 3/21/2013.
    Filed Date: 2/19/13.
    Accession Number: 20130219-5179.
    Comments Due: 5 p.m. ET 3/4/13.

    Docket Numbers: RP13-575-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: EOG Resources Negotiated Rate to be effective 4/1/
2013.
    Filed Date: 2/20/13.
    Accession Number: 20130220-5065.
    Comments Due: 5 p.m. ET 3/4/13.

    Docket Numbers: RP13-576-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Nicor Gas Neg Rate to be effective 4/1/2013.
    Filed Date: 2/20/13.
    Accession Number: 20130220-5069.
    Comments Due: 5 p.m. ET 3/4/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

    Dated: February 20, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-04322 Filed 2-25-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Rules and Regulations]
[Pages 20836-20838]
[FR Doc No: 2020-06584]

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

40 CFR Part 52

[EPA-R04-OAR-2019-0503; FRL-10007-45-Region 4]

Air Plan Approvals; GA and NC; Prevention of Significant
Deterioration Infrastructure Requirements for the 2015 Ozone NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is conditionally
approving portions of the Georgia and North Carolina infrastructure
State Implementation Plan (SIP) submissions for the 2015 8-hour ozone
National Ambient Air Quality Standards (NAAQS) provided to EPA on
September 24, 2018, and September 27, 2018, respectively. Whenever EPA
promulgates a new or revised NAAQS, the Clean Air Act (CAA or Act)
requires that each state adopt and submit a SIP submission to establish
that the state's SIP meets infrastructure requirements for the
implementation, maintenance, and enforcement of each such NAAQS.
Specifically, EPA is taking final action to conditionally approve the
portions of the Georgia and North Carolina infrastructure SIP
submissions related to the prevention of significant deterioration
(PSD) infrastructure elements for the 2015 8-hour ozone NAAQS.

DATES: This rule will be effective May 15, 2020.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2019-0503. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Ward can be reached
by telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background and Overview

    On October 1, 2015, EPA promulgated revised primary and secondary
NAAQS for ozone, revising the 8-hour ozone standards from 0.075 parts
per million (ppm) to a new more protective level of 0.070 ppm. See 80
FR 65292 (October 26, 2015). Pursuant to section 110(a)(1) of the CAA,
states are required to submit SIP revisions meeting the applicable
requirements of section 110(a)(2) within three years after promulgation
of a new or revised NAAQS or within such shorter period as EPA may
prescribe. Section 110(a)(2) requires states to address basic SIP
elements such as requirements for monitoring, basic program
requirements, and legal authority that are designed to assure
attainment and maintenance of the NAAQS. This particular type of SIP is
commonly referred to as an ``infrastructure SIP.'' States were required
to submit such SIP revisions for the 2015 8-hour ozone NAAQS to EPA no
later than October 1, 2018.\1\
---------------------------------------------------------------------------

    \1\ In infrastructure SIP submissions, states generally certify
evidence of compliance with sections 110(a)(1) and (2) of the CAA
through a combination of state regulations and statutes, some of
which have been incorporated into the SIP. In addition, certain
federally-approved, non-SIP regulations may also be appropriate for
demonstrating compliance with sections 110(a)(1) and (2).
---------------------------------------------------------------------------

    As explained in a notice of proposed rulemaking (NPRM) published on
February 11, 2020 (85 FR 7695), Georgia and North Carolina cite to
several regulations 2 3 to demonstrate that their

respective SIPs meet the PSD-related requirements of sections
110(a)(2)(C), 110(a)(2)(D)(i)(II) (Prong 3),\4\ and 110(a)(2)(J). Each
of these requirements are met if the state's implementation plan
includes a PSD program that meets current Federal requirements,
however, Georgia's and North Carolina's SIP-approved PSD programs do
not contain or reference the most recent version of 40 CFR part 51,
appendix W, Guideline on Air Quality Models.\5\ Therefore, on November
14, 2019, and December 16, 2019, GA EPD and NC DEQ, respectively,
submitted commitment letters to EPA requesting conditional approval of
the PSD-related requirements of sections 110(a)(2)(C),
110(a)(2)(D)(i)(II) (Prong 3), and 110(a)(2)(J) of the aforementioned
infrastructure SIP revisions. In these letters, Georgia and North
Carolina commit to satisfying the PSD program requirements of sections
110(a)(2)(C), 110(a)(2)(D)(i)(II) (Prong 3), and 110(a)(2)(J) for the
2015 8-hour ozone NAAQS by revising their PSD regulations to reflect
the most recent version of appendix W and submitting SIP revisions
containing these revised rules within one year of final conditional
approval.
---------------------------------------------------------------------------

    \2\ Georgia's September 24, 2018, infrastructure SIP submission
cites the following rules to meet the PSD program requirements of
110(a)(2)(C): Georgia Rules for Air Quality Control 391-3-1-.02--
``Provisions. Amended,'' including PSD requirements under Rule 391-
3-1-.02(7)--``Prevention of Significant Deterioration,'' 391-3-
1-.03--``Permits. Amended,'' including 391-3-1-.03(1)--
``Construction (SIP) Permit,'' and 391-3-1-.03--``Permits.
Amended,'' including 391-3-1-.03(2)--``Operating (SIP) Permit.'' For
the PSD program requirements of 110(a)(2)(D)(i)(II)--prong 3 and
110(a)(2)(J), Georgia cites Rule 391-3-1-.02(7)--``Prevention of
Significant Deterioration.''
    \3\ North Carolina's September 27, 2018, infrastructure SIP
submission cites the following rules to meet the PSD program
requirements of 110(a)(2)(C): 15A North Carolina Administrative Code
(NCAC) 2D .0500--``Emission Control Standards'' and 15A NCAC 2D
.0530--``Prevention of Significant Deterioration.'' For the PSD
program requirements of 110(a)(2)(D)(i)(II)--prong 3 and
110(a)(2)(J), North Carolina cites 15A NCAC 2D .0530--``Prevention
of Significant Deterioration.''
    \4\ Section 110(a)(2)(D)(i)(II) contains a provision that
prohibits emissions activity in one state from interfering with
measures required to prevent significant deterioration of air
quality in another state, which is commonly referred to as ``prong
3.''
    \5\ EPA approved the most recent version of appendix W on
January 17, 2017, at 82 FR 5182.
---------------------------------------------------------------------------

    If Georgia and North Carolina meet their respective commitments
within one year of the final conditional approval, the PSD-related
program requirements of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II)
(Prong 3), and 110(a)(2)(J) of the conditionally approved
infrastructure SIP submissions will remain a part of the SIP until EPA
takes final action approving or disapproving the new SIP revision(s).
However, if Georgia or North Carolina fails to submit these revisions
within the one-year timeframe, the conditional approval will
automatically become a disapproval one year from EPA's final
conditional approval and EPA will provide notification of the
disapproval of these requirements. If the conditional approval is
converted to a disapproval, the final disapproval triggers the FIP
requirement under CAA section 110(c).
    In the NPRM published on February 11, 2020, EPA proposed to
conditionally approve Georgia and North Carolina's SIP submissions
provided on September 24, 2018, and September 27, 2018, for the
applicable infrastructure SIP requirements of the 2015 8-hour ozone
NAAQS. The NPRM provides additional detail regarding the background and
rationale for EPA's action. Comments on the NPRM were due on or before
March 12, 2020. EPA received one comment in support of this action and
did not receive any adverse comments.

II. Final Action

    EPA is taking final action to conditionally approve the portions of
Georgia's and North Carolina's September 24, 2018, and September 27,
2018, 2015 8-hour ozone infrastructure SIP submission, respectively,
that address the PSD-related requirements of CAA sections 110(a)(2)(C),
110(a)(2)(D)(i)(II) (Prong 3), and 110(a)(2)(J). All other outstanding
applicable infrastructure requirements for this SIP submission have
been or will be addressed in separate rulemakings.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. These actions merely
approve state law as meeting Federal requirements and do not impose
additional requirements beyond those imposed by state law. For that
reason, these actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Are not Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory actions because SIP approvals are exempted under
Executive Order 12866;
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Do not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not an economically significant regulatory actions
based on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIPs subject to these actions are not approved to apply on any
Indian reservation land or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 15, 2020. Filing a

petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: March 17, 2020.
Mary S. Walker,
Regional Administrator, Region 4.

    Title 40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart L--Georgia

0
2. Add Sec.  52.569 to read as follows:

Sec.  52.569  Conditional approval.

    Georgia submitted a letter to EPA on November 14, 2019, with a
commitment to address the State Implementation Plan deficiencies
regarding the PSD-related requirements of CAA sections 110(a)(2)(C),
110(a)(2)(D)(i)(II) (Prong 3), and 110(a)(2)(J) for the 2015 8-hour
ozone NAAQS. EPA conditionally approved these portions of Georgia's
September 24, 2018 infrastructure SIP submission in an action published
in the Federal Register on April 15, 2020. If Georgia fails to meet its
commitment by April 15, 2021, the conditional approval will become a
disapproval on that date and EPA will issue a notification to that
effect.

Subpart II-- North Carolina

0
3. Add Sec.  52.1769 to read as follows:

Sec.  52.1769  Conditional approval.

    North Carolina submitted a letter to EPA on December 16, 2019, with
a commitment to address the State Implementation Plan deficiencies
regarding the PSD-related requirements of CAA sections 110(a)(2)(C),
110(a)(2)(D)(i)(II) (Prong 3), and 110(a)(2)(J) for the 2015 8-hour
ozone NAAQS. EPA conditionally approved these portions of North
Carolina's September 27, 2018 infrastructure SIP submission in an
action published in the Federal Register on April 15, 2020. If North
Carolina fails to meet its commitment by April 15, 2021, the
conditional approval will become a disapproval on that date and EPA
will issue a notification to that effect.

[FR Doc. 2020-06584 Filed 4-14-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Rules and Regulations]
[Pages 33669-33673]
[FR Doc No: 2014-13663]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2014-0248; Special Conditions No. 25-553-SC]

Special Conditions: Gulfstream Model GVI Airplanes; Airbag-
Equipped Shoulder Belt

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Gulfstream Model
GVI airplane. This airplane, as modified by Gulfstream, will have a
novel or unusual design feature associated with airbag-equipped
shoulder belts. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: The effective date of these special conditions is June 12, 2014.
We must receive your comments by July 28, 2014.

ADDRESSES: Send comments identified by docket number FAA-2014-0248
using any of the following methods:
    Federal eRegulations Portal: Go to http://www.regulations.gov/ and
follow the online instructions for sending your comments
electronically.
    Mail: Send comments to Docket Operations, M-30, U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
    Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except federal holidays.
    Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: Dan Jacquet, Airframe and Cabin
Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification
Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
425-227-2676; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA has determined that notice of, and
opportunity for prior public comment on, these special conditions are

impracticable because these procedures would significantly delay
issuance of the design approval and thus delivery of the affected
airplane. In addition, the substance of these special conditions has
been subject to the public-comment process in several prior instances
with no substantive comments received. The FAA therefore finds that
good cause exists for making these special conditions effective upon
publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On October 23, 2012, Gulfstream applied for a supplemental type
certificate for airbag-equipped shoulder belts in the Gulfstream Model
GVI airplane. The Gulfstream Model GVI is a two-engine jet transport
airplane with an executive cabin interior. The maximum takeoff weight
is 99,600 pounds, with a maximum passenger capacity of 19.

Type Certification Basis

    Under the provisions of Sec.  21.101 Gulfstream must show that the
GVI, as changed, continues to meet the applicable provisions of the
regulations incorporated by reference in type certificate no. T00015AT
or the applicable regulations in effect on the date of application for
the change. The regulations incorporated by reference in the type
certificate are commonly referred to as the ``original type
certification basis.'' The regulations incorporated by reference in
T00015AT are as follows:
    The certification basis is 14 CFR part 25, Airworthiness Standards:
Transport Category Airplanes, effective February 1, 1965, including
Amendments 25-1 through 25-120 and 25-122, 25-124, and 25-132.
    Amendment 25-118 was not published and therefore does not apply.
    Optional Design Regulations:
     The Model GVI has been shown to comply with the
requirements for ditching: Sec.  25.801, 25.563, 25.807(e), and
25.1585(a). When the operating rules require emergency-ditching
equipment, compliance with Sec. Sec.  25.1411 and 25.1415 must be
shown. Gulfstream Report GVI-GER-1709, titled ``Design Requirements
Document for Ditching Equipment,'' provides an acceptable means for
showing compliance with Sec. Sec.  25.1411 and 25.1415.
     The Model GVI is approved for flight into known icing
conditions and has demonstrated compliance to Sec.  25.1419.
    Exemption No. 9761, Sec. Sec.  25.562(a) and 25.785(b) for side-
facing divans also applies.
    The certification basis includes certain special conditions,
exemptions, and equivalent-safety findings that are not relevant to
these proposed special conditions.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the GVI because of a novel or unusual
design feature, special conditions are prescribed under the provisions
of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same novel or unusual design feature,
the special conditions would also apply to the other model.
    In addition to the applicable airworthiness regulations and special
conditions, the GVI must comply with the fuel-vent and exhaust-emission
requirements of 14 CFR part 34 and the noise-certification requirements
of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Gulfstream model GVI will incorporate the following novel or
unusual design feature:
    Gulfstream Aerospace Corporation is proposing to install inflatable
shoulder straps on side-facing divans to reduce the potential for head
injury in the event of an accident. The inflatable shoulder strap works
similarly to an automotive airbag except that the airbag is integrated
with the shoulder strap of the restraint system.
    Part 25 states the performance criteria for head injury protection
in objective terms. However, none of these criteria are adequate to
address the specific issues raised concerning seats with inflatable
shoulder straps. The FAA has therefore determined that, in addition to
the requirements of part 25, special conditions are needed to address
requirements particular to installation of seats with inflatable
shoulder straps.
    Accordingly, in addition to the passenger-injury criteria specified
in Sec.  25.785, these special conditions are adopted for Gulfstream
GVI airplanes equipped with inflatable shoulder straps.

Discussion

    From the standpoint of a passenger-safety system, the inflatable
shoulder belt is unique in that it is both an active and entirely
autonomous device. While the automotive industry has good experience
with airbags, the conditions of use and reliance on the inflatable
shoulder belt as the sole means of injury protection are quite
different. In automobile installations, the airbag is a supplemental
system and works in conjunction with an upper torso restraint. In
addition, the crash event is more definable and of typically shorter
duration, which can simplify the activation logic. The airplane
operating environment is also quite different from automobiles, and
includes the potential for greater wear and tear and unanticipated
abuse conditions (due to galley loading, passenger baggage, etc.).
Airplanes also operate where exposure to high-intensity electromagnetic
fields could affect the activation system.
    The inflatable shoulder belt has two potential advantages over
other means of head-impact protection. First, it can provide
significantly greater protection than would be expected with energy-
absorbing pads, and second, it can provide essentially equivalent
protection for occupants of all stature. These are significant
advantages from a safety standpoint, because such devices will likely
provide a level of safety that exceeds the minimum standards of the
federal aviation regulations. Conversely, inflatable shoulder belts in
general are active systems and must be relied upon to activate properly
when needed, as opposed to an energy-absorbing pad or upper-torso
restraint that is passive and always available. Therefore, the
potential advantages must be balanced against this and other potential
disadvantages in developing standards for this design feature.
    The FAA has considered the installation of inflatable shoulder
belts to have two primary safety concerns: First, that they perform
properly under foreseeable operating conditions, and second, that they
do not perform in a manner or at such times as would constitute a
hazard to the airplane or occupants. This latter point has the
potential to be the more rigorous of the

requirements, owing to the active nature of the system.
    The inflatable shoulder belt will rely on electronic sensors for
signaling, and a stored gas canister for inflation. These same devices
could be susceptible to inadvertent activation, causing deployment in a
potentially unsafe manner. The consequence of inadvertent deployment,
as well as failure to deploy, must be considered in establishing the
reliability of the system. Gulfstream Aerospace Corporation must
substantiate that the effects of an inadvertent deployment in flight
either would not cause injuries to occupants, or that such
deployment(s) meet the requirement of Sec.  25.1309(b). The effect of
an inadvertent deployment on a passenger or crewmember that might be
positioned close to the inflatable shoulder belt should also be
considered. The person could be either standing or sitting. A minimum
reliability level must be established for this case, depending upon the
consequences, even if the effect on the airplane is negligible.
    The potential for an inadvertent deployment could be increased as a
result of condition in service. The installation must take into account
wear and tear so that the likelihood of an inadvertent deployment is
not increased to an unacceptable level. In this context, an appropriate
inspection interval and self-test capability are considered necessary.
Other outside influences are lightning and high-intensity radiated
fields (HIRF). Existing HIRF special conditions for the model GVI are
applicable.
    Additionally, the inflatable shoulder-belt installation should be
protected from the effects of fire, so that an additional hazard is not
created by, for example, a rupture of the pyrotechnic squib.
    To be an effective safety system, the inflatable shoulder belt must
function properly and must not introduce any additional hazards to
occupants as a result of its functioning. In several ways, the
inflatable shoulder belt differs from traditional occupant-protection
systems and requires special conditions to ensure adequate performance.
    Because the inflatable shoulder belt is essentially a single-use
device, this potentially could deploy under crash conditions that are
not sufficiently so severe as to require head-injury protection from
the inflatable shoulder belt. Because an actual crash is frequently
composed of a series of impacts before the airplane comes to rest, this
could render the inflatable shoulder belt useless if a larger impact
follows the initial impact. The situation does not exist with energy-
absorbing pads or upper-torso restraints, which tend to provide
continuous protection regardless of severity or number of impacts in a
crash event. Therefore, the inflatable shoulder-belt installation
should provide protection, when it is required, by not expending its
protection during a less-severe impact. It is also possible to have
several large impact events during the course of a crash, but we will
not require the inflatable shoulder belt to provide protection for
multiple impacts.
    Because each occupant's restraint system provides protection for
that occupant only, the installation must address seats that are
unoccupied. It will be necessary to show that the required protection
is provided for each occupant regardless of the number of occupied
seats, and considering that unoccupied seats may have shoulder belts
that are active.
    The inflatable shoulder belts should be effective for a wide range
of occupants. The FAA has historically considered the range from the
5th-percentile female to the 95th-percentile male as the range of
occupants that must be taken into account. In this case, the FAA is
proposing consideration of a broader range of occupants, due to the
nature of shoulder-belt installation and their close proximity to the
occupant. In a similar vein, these persons could have assumed the brace
position for those accidents where an impact is anticipated. Test data
indicate that occupants in the brace position do not require
supplemental protection, so it would not be necessary to show that the
inflatable shoulder belts will enhance the brace position. However, the
inflatable shoulder belts must not introduce a hazard in the case of
deploying into the seated, braced occupant.
    Another area of concern is the use of seats, so equipped, by
children, whether lap-held, in approved child safety seats, or
occupying the seat directly. Similarly, if the seat is occupied by a
pregnant woman, the installation should address such usage either by
demonstrating that it will function properly, or by adding appropriate
limitation on usage.
    Because the inflatable shoulder belt will be electrically powered,
there is the possibility that the system could fail due to a separation
in the fuselage. And because this system is intended as a crash/post-
crash protection means, failure to deploy due to fuselage separation is
not acceptable. As with emergency lighting, the system should function
properly if such a separation occurs at any point in the fuselage. As
required by Sec.  25.1353(a), operation of the existing airplane
electrical equipment should not adversely impact the function of the
inflatable lapbelt under all foreseeable conditions.
    The inflatable lapbelt is likely to have a large volume
displacement. Likewise, the inflated bag could potentially impede
egress of passengers. The bag deflates to absorb energy, so it is
likely that an inflatable lapbelt would be deflated at the time that
persons would be trying to leave their seats. Nonetheless, we consider
it appropriate to specify a time interval after which the inflatable
lapbelt may not impede rapid exit (egress) from the airplane. Ten
seconds has been deemed to be a reasonable time, as this corresponds to
the maximum time allowed for an exit to be openable (Sec.  25.809).
    In actuality, it is unlikely that an exit would be prepared this
quickly in an accident severe enough to warrant deployment of the
inflatable lapbelt, and the inflatable lapbelt will likely deflate much
sooner than ten seconds.
    This potential impediment to rapid egress is even more critical at
the seats installed in the emergency-exit rows. Section 25.813 requires
passenger access to the exit, from the main aisle, in the form of an
unobstructed passageway, with no interference in opening the exit. The
restraint system must not create an impediment to the access to, and
the opening of, the exit. In some cases, the passenger, rather than a
flightcrew member, opens an exit such as a Type III overwing hatch.
These lap belts should be evaluated in the exit row under existing
regulations (Sec. Sec.  25.809 and 25.813) and guidance material. The
inflatable lap belts must also be evaluated in post-crash conditions,
and should be evaluated using representative restraint systems in the
bag-deployed condition.
    This evaluation would include reviewing the access to, and opening
of, the exit, specifically for obstructions in the egress path, and any
interference in opening the exit. Each unique interior configuration
must be considered.
    If the restraint creates any obstruction or interference, it is
likely that it could impede the rapid egress from the airplane.
Project-specific guidance is likely necessary if these restraint
systems are installed at exit-door rows.
    Part I of appendix F to part 25 specifies the flammability
requirements for interior materials and components. Appendix F has no
reference to inflatable restraint systems because such devices did not
exist at the time the flammability requirements were written. The
existing requirements are based on both material types and use, and
have been specified in light of the state-of-

the-art materials available to perform a given function. In the absence
of a specific reference, the default requirement would be for the type
of material used in constructing the inflatable restraint, which is a
fabric in this case. However, in writing special conditions, the FAA
must also consider the use of the material, and whether the default
requirement is appropriate. In this case, the specialized function of
the inflatable shoulder belt means that highly specialized materials
are needed. The standard normally applied to fabrics is a 12-second
vertical ignition test. However, materials that meet this standard do
not perform adequately as inflatable shoulder belts. Because the safety
benefit of the inflatable shoulder belt is significant, the
flammability standard appropriate for these devices should not screen
out suitable materials, thereby effectively eliminating use of the
inflatable shoulder belt based on its flammability performance. At this
time, the 2.5-inch-per-minute horizontal test is considered to provide
that balance. As the technology in materials progresses (which is
expected), the FAA may change this standard in subsequent special
conditions to account for improved materials.
    The following special conditions can be characterized as addressing
either the safety performance of the system or the system's integrity
against inadvertent activation. Because a crash requiring use of the
inflatable shoulder belt is a relatively rare event, and because the
consequences of an inadvertent activation are potentially quite severe,
these later requirements are probably more rigorous from a design
standpoint.
    Note that, although these special conditions are applicable to the
inflatable shoulder belts as installed, compliance with these special
conditions is not an installation approval. While these special
conditions relate to each such system installed, the overall
installation approval is a separate finding and must consider the
combined effects of all such systems installed.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Gulfstream Model GVI airplane. Should Gulfstream apply at a later date
for a supplemental type certificate to modify any other model included
on type certificate no. T00015AT to incorporate the same novel or
unusual design feature, the special conditions would apply to that
model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of airplane. It is not a rule of general applicability and
affects only the applicant who applied to the FAA for approval of these
features on the airplane.
    The substance of these special conditions has been subjected to the
notice-and-comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, because a delay would
significantly affect the certification of the airplane, which is
imminent, the FAA has determined that prior public notice and comment
are unnecessary and impracticable, and good cause exists for adopting
these special conditions upon publication in the Federal Register. The
FAA is requesting comments to allow interested persons to submit views
that may not have been submitted in response to the prior opportunities
for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Gulfstream Model GVI airplanes
modified by Gulfstream.
    In addition to the requirements specified in exemption no. 9761,
the following special conditions are proposed as part of the type
certification basis for Gulfstream Model GVI airplanes equipped with an
airbag system in the shoulder belt.
    1. For seats with an airbag system in the shoulder belt, show that
the airbag system in the shoulder belt will deploy and provide
protection under crash conditions where it is necessary to prevent
serious injury. The means of protection must take into consideration a
range of stature from a 2-year-old child to a 95th-percentile male. The
airbag system in the shoulder belt must provide a consistent approach
to energy absorption throughout that range of occupants. When the seat
system includes an airbag system, that system must be included in each
of the certification tests as it would be installed in the airplane. In
addition, the following situations must be considered, wherein the seat
occupant is:

a. Holding an infant
b. a pregnant woman
c. a child in a child-restraint device
d. a child not using a child-restraint device

    2. The airbag system in the shoulder belt must provide adequate
protection for each occupant regardless of the number of occupants of
the seat assembly, considering that unoccupied seats may have an active
airbag system in the shoulder belt.
    3. The design must prevent the airbag system in the shoulder belt
from being either incorrectly buckled or incorrectly installed, such
that the airbag system in the shoulder belt would not properly deploy.
Alternatively, it must be shown that such deployment is not hazardous
to the occupant, and will provide the required injury protection.
    4. It must be shown that the airbag system in the shoulder belt is
not susceptible to inadvertent deployment as a result of wear and tear,
or inertial loads resulting from in-flight or ground maneuvers
(including gusts and hard landings), and other operating and
environmental conditions (vibrations, moisture, etc.) likely to occur
in service.
    5. Deployment of the airbag system in the shoulder belt must not
injure the seated occupant, including injuries that could impede rapid
egress. This assessment should include an occupant whose belt is
loosely fastened.
    6. It must be shown that inadvertent deployment of the airbag
system in the shoulder belt, during the most critical part of the
flight, will either meet the requirement of Sec.  25.1309(b) or not
cause a hazard to the airplane or its occupants.
    7. It must be shown that the airbag system in the shoulder belt
will not impede rapid egress of occupants 10 seconds after airbag
deployment.
    8. The airbag system must be protected from lightning and high-
intensity radiated fields (HIRF). The threats to the airplane specified
in existing regulations regarding lighting, Sec.  25.1316, and HIRF,
Sec.  25.1317, are incorporated by reference for the purpose of
measuring lightning and HIRF protection.
    9. The airbag system in the shoulder belt must function properly
after loss of normal airplane electrical power, and after a transverse
separation of the fuselage at the most critical location. A separation
at the location of the airbag

system in the shoulder belt does not have to be considered.
    10. It must be shown that the airbag system in the shoulder belt
will not release hazardous quantities of gas or particulate matter into
the cabin.
    11. The airbag system in the shoulder-belt installation must be
protected from the effects of fire such that no hazard to occupants
will result.
    12. A means must be available for a crewmember to verify the
integrity of the airbag system in the shoulder-belt activation system
prior to each flight, or it must be demonstrated to reliably operate
between inspection intervals. The FAA considers that the loss of the
airbag-system deployment function alone (i.e., independent of the
conditional event that requires the airbag-system deployment) is a
major-failure condition.
    13. The inflatable material may not have an average burn rate of
greater than 2.5 inches per minute when tested, using the horizontal
flammability test defined in part 25, appendix F, part I, paragraph
(b)(5).
    14. The airbag system in the shoulder belt, once deployed, must not
adversely affect the emergency-lighting system (i.e., block floor
proximity lights to the extent that the lights no longer meet their
intended function).

    Issued in Renton, Washington, on May 12, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-13663 Filed 6-11-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6575-6577]
[FR Doc No: 2022-02355]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2398]

Population Pharmacokinetics; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Population
Pharmacokinetics.'' This guidance assists sponsors in the application
of population pharmacokinetics (population PK) during the drug
development process to inform drug use and includes FDA's current
thinking on the data and model requirements for population PK analyses
submitted as part of new drug applications (NDAs), biologic license
applications (BLAs), and abbreviated new drug applications (ANDAs).
This guidance also provides expectations regarding the format and
content of the population PK report, as well as any

labeling recommendations resulting from such analyses. This guidance
finalizes the draft guidance of the same title issued on July 12, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on February 4, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-2398 for ``Population Pharmacokinetics.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Hao Zhu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3132, Silver Spring, MD 20993,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Population Pharmacokinetics.'' Population PK analyses can
quantify the impact of intrinsic and extrinsic patient factors on the
exposure of a drug. In conjunction with supporting exposure-response
data, population PK data can be used to identify patient factors that
result in a clinically significant change in drug exposure and inform
the proper use of drugs. Since FDA announced the publication of the
original population PK guidance in 1999, the number of applications
relevant for population PK analysis has increased, and the
sophistication and reliability of population PK analysis methods have
improved.
    This guidance finalizes the draft guidance entitled ``Population
Pharmacokinetics'' issued on July 12, 2019 (84 FR 33267). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include greater
detail on the use of population PK modeling for biologics, handling of
time-varying covariates, additional methods and terminology typically
used for population PK analyses, and updates to format and content for
submitting population PK reports. In addition, editorial changes were
made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Population Pharmacokinetics.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no new collection of information. Therefore,
clearance by the Office of Management

and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44
U.S.C. 3501-3521) is not required.
    However, this guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR parts 312 and 314 have been approved under OMB control
numbers 0910-0014 and 0910-0001. The collections of information in 21
CFR parts 600 and 601 have been approved under OMB control number 0910-
0338. The collections of information in 21 CFR 201.56 and 201.57 have
been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: January 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02355 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 10, 2009 (Volume 74, Number 45)]
[Notices]
[Page 10340]
[DOCID:fr10mr09-121]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
    Time and Date: April 2, 2009, from 12 noon until 3 p.m. Eastern
Daylight Time.
    Place: This meeting will take place telephonically. Any interested
person may call Mr. Avelino Gutierrez at<PHONE_NUMBER> to receive the
toll free number and pass code needed to participate in this meeting by
telephone.
    Status: Open to the public.
    Matters to be Considered: The Unified Carrier Registration Plan
Board of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Plan Board of Directors at<PHONE_NUMBER>.

    Dated: March 5, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-5265 Filed 3-6-09; 4:15 pm]

BILLING CODE 4910-EX-P