0
1 DFR  = AR x F x (1-D)t x 4.54E8 ug/lb x 2.47E-8 acre/cm2.
[2] MOE = POD (NOAEL, 10 mg/kg/day) / Daily Dermal Dose.  Daily Dermal Dose = [DFR (ug/cm[2]) x TC x 0.001 mg/ug x 8 hrs/day x 7.2% dermal absorption]  body weight 80 kg adult).

9.2.2	Inhalation Post-application Exposure and Risk Estimates

Based on the Agency's current practices, a quantitative inhalation post-application inhalation exposure assessment was not performed at this time primarily because of the low acute inhalation toxicity (Toxicity Category IV) and low vapor pressure (4 x 10[-7] mmHg).  However, there are multiple potential sources of post-application inhalation exposure to individuals performing post-application activities in previously treated areas.  These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides.  The Agency sought expert advice and input on issues related to volatilization of pesticides from its FIFRA SAP in December 2009, and received the SAP's final report on March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).  The Agency is in the process of evaluating the SAP report as well as available post-application inhalation exposure data generated by the ARTF and may, as appropriate, develop policies and procedures, to identify the need for and, subsequently, the way to incorporate occupational post-application inhalation exposure into the Agency's risk assessments.  If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post-application inhalation exposure assessment for imidacloprid.

10.0	References

J. Alsadek, 2-AUG-2012, D403995, Usage Report Package in Support of Registration for the Insecticide Imidacloprid (129099).

M. Crowley, 6-MAR-2013, D400191, Occupational and Residential Exposure Assessment for a Proposed Use to Control Burrowing Shrimp in Oyster Beds.

J. Dawson, 14-MAR-2003, D287532, Carbaryl: Revised HED Risk Assessment - Phase 5- Public Comment Period, Error Correction Comments Incorporated.

Y. Donovan, 23-MAR-1999, D242320, PP# 8F04940. Imidacloprid - Proposal for Tolerances of Residues in/on Citrus Crop group and Processed Commodities; in/on Leafy Petiole Vegetables:
Residue Chemistry Review.

F. Griffith, 15-JUN-1993, D193027, Multiresidue Method (MRM) Validation Data For Imidacloprid (Confidor[(R)]).

F. Griffith, 18-JUN-1993, D187911, PP# 3F4169 - Imidacloprid (Confidor[(R)]) on Apples, Cottonseed, Potatoes, Meat, Milk, Poultry, and Eggs. Review of the Analytical Method and Petitioner's February 5, 1993 Letter.

F. Griffith, 25-JUN-1993, TXR# 0050886, Metabolism Committee Meeting Held on June 22, 1993:  Metabolism of Imidacloprid.

F. Griffith, 15-JUL-1993, D193005, Multiresidue Method (MRM) Validation Data for Imidacloprid (Confidor[(R)]).

F. Griffith, 20-SEP-1993, D185148, Imidacloprid (Confidor(R)) on Apples, Cottonseed, Potatoes, Meat, Milk, Poultry, and Eggs.  Review of Residue Data and Analytical Method.

F. Griffith, 1-JUN-1994, D202113, Imidacloprid (Admire(R)) on Apples, Cotton-seed, Potatoes, Meat, Milk, poultry, and Eggs. Evaluation of the Tolerance Method Validation Report.

F. Griffith, 8-JUN-1994, D200233, Imidacloprid (Admire(R)) on Apples, Potatoes, Cottonseed, Meat, Milk, Poultry, and Eggs.  Review of the March 1 and April 11, 1994, Amendments.

F. Griffith, 22-JUN-1994, D194206, Imidacloprid (Admire(R)) on the Fruiting Vegetables and Brassica (Cole) Leafy Vegetables Crop Groups, Lettuce, Grapes and Grape Processed Commodities, Tomato Processed Commodities, Meat, Milk, Poultry, and Eggs. Review of the Residue Data and Analytical Method.

F. Griffith, 16-MAY-1995, D212683, Imidacloprid (Gaucho(R)) on barley, wheat, and sugarbeets following seed treatment. Review of the January 19, March 8 and 28, 1995 Amendments.

F. Griffith, 8-JUN-1995, D213252, Imidacloprid (Admire(R)) on Citrus Fruits Crop Group and Pecans. Review of the Residue Data and Analytical Method.
F. Griffith, 18-DEC-1995, D221591, Imidacloprid (Admire(R)) in citrus fruits crop group; and apples, cottonseed and potatoes. Evaluation of the Tolerance Method Validation Report.

F. Griffith, 29-FEB-1996, D217632, Imidacloprid on Tobacco. Amended Registration Request and the February 26, 1996 Amendment.

G. Kramer et al., 16-MAR-2009, D375406, Revised Human-Health Risk Assessment for Proposed Section 3 Seed Treatment Uses on Bulb Vegetables (Crop Group 3); Cereal Grains (Crop Group 15); Root and Tuber Vegetables, Except Sugar Beet (Crop Subgroup 1B); Tuberous and Corm Vegetables (Crop Subgroup 1C); Leafy Vegetables, Except Brassica (Crop Subgroup 4A); Brassica Vegetables (Crop Group 5); Fruiting Vegetables (Crop Group 8); Cucurbit Vegetables (Crop Group 9), and Residential Crack and Crevice and Bed-Bug Uses.

K. Lowe, 17-FEB-2009, D367396, Imidacloprid: Occupational and Residential Risk Assessment for Proposed Bed Bug Use and an Assessment for a Crack and Crevice Use.

J. Melendez, 22-JULY-2009, Tier I Estimated Environmental Concentrations of Imidacloprid for the Use in the Human Health Risk Assessment, Registration of a New Product for Seed Treatment, Sepresto 75WS, and New Use on Bulb Vegetables (Crop Group 3) for GAUCHO 550SC.

J. Tyler, 13-JAN-2003; D287400, IMIDACLOPRID; Health Effects Division (HED) Metabolism Assessment Review Committee (MARC) Decision Document.

J. Tyler, 3-DEC-2008; D353984, Imidacloprid. Human Health Assessment Scoping Document in Support of Registration Review.

J. Tyler; 7-MAR-2013; D400189, Section 3 Requests for Use on Oyster Beds.

J. Tyler; 7-MAR-2013; D400187, Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action for Use on Oyster Beds; and the Section 18 Emergency Exemption Request for Use on Sugarcane in Louisiana (LA).

J. Tyler, 7-MAR-2013; D407182, Occupational Exposure Assessment to Support a Section 18 Request for the use of Imidacloprid on Sugarcane in Louisiana.

cc: J. Tyler
RDI: risk assessment team (12/12/12); RAB1 (12/19/12); G. Kramer (12/17/12); C. Smith (12/17/13)
J. Tyler: S-10943: Potomac Yard 1 (PY1):<PHONE_NUMBER>: 7509P: RAB1
Appendix A.  Toxicology Profile and Executive Summaries.

Table A.1.  Acute Toxicity of Imidacloprid.
                                 Guideline No.
                                  Study Type
                                   MRID #(s)
                                    Results
                               Toxicity Category
                                     81-1
                                  Acute Oral
                                   42055331
                             LD50 = 424 mg/kg (M)
                            LD50 >450 mg/kg (F)
                                      II
                                     81-2
                                 Acute Dermal
                                   42055332
                              LD50 >5000 mg/kg
                                      IV
                                     81-3
                               Acute Inhalation
                                   42256317
                               LC50 >5.33 m/L
                                      IV
                                     81-4
                            Primary Eye Irritation
                                   42055334
                              Not an eye irritant
                                      IV
                                     81-5
                            Primary Skin Irritation
                                   42055335
                             Not a dermal irritant
                                      IV
                                     81-6
                             Dermal Sensitization
                                   42055336
                            Not a dermal sensitizer
                                      N/A

Table A.2.  Toxicity Profile of Imidacloprid Technical.
                           Guideline No./ Study Type
                    MRID No. (year)/ Classification /Doses
                                    Results
870.3100
90-Day oral toxicity rodents (rats)
NA
NA
870.3150
90-Day oral toxicity (nonrodents)
NA
NA
870.3200
21/28-Day dermal toxicity
(rabbits)
42256329 (1990)
Acceptable/guideline
0 or 1000 mg/kg/day
6 hr/day, 5 d/week
NOAEL = 1000 mg/kg/day (HDT).
LOAEL = not identified.
870.3250
90-Day dermal toxicity
NA
NA
870.3465
4-Week inhalation toxicity
(rat)
42273001 (1989) Acceptable/guideline
0, 0.0055, 0.035, or 0.191 mg/L/day, 6 hr/day,
5 d/week for 4 weeks
NOAEL = 0.191 mg/L/day (HDT).
LOAEL = not identified.
870.3700a
Prenatal developmental toxicity (rats)
42256338 (1992)
Acceptable/guideline
F:  0, 10, 30, or 100 mg/kg/day
Maternal NOAEL = 10 mg/kg/day.
LOAEL = 30 mg/kg/day based on decreased body-weight gain and decreased corrected body-weight gain.
Developmental NOAEL = 30 mg/kg/day.
LOAEL = 100 mg/kg/day based on a slight increase in the incidence of wavy ribs.
870.3700b
Prenatal developmental toxicity (rabbits)
42256339 (1992)
Acceptable/guideline
F:  0, 8, 24, or 72 mg/kg/day
Maternal NOAEL = 24 mg/kg/day.
LOAEL = 72 mg/kg/day based on maternal deaths and decreased maternal absolute body weights, body-weight gains, and food consumption.
Developmental NOAEL = 24 mg/kg/day.
LOAEL = 72 mg/kg/day based on abortion, total litter resorptions, increased post-implantation loss due to increased late resorptions, decreased fetal weights, and very low incidences of skeletal alterations.
870.3800
Reproduction and fertility effects (rats)
42256340 (1990)
Acceptable/guideline
0, 100, 250, or 700 ppm
F0 (M/F): 0, 8.1/8.8, 20.1/22.1, or 56.7/62.8 mg/kg/day
F1 (M/F): 0, 6.4/7.2, 16.5/18.9, or 47.3/52.3 mg/kg/day
Parental/Systemic NOAEL = 16.5 mg/kg/day.
LOAEL = 47.3 mg/kg/day based on decreased premating weight gain by F0 males and females and F1 females and decreased gestational weight gain by F1 females.
Reproductive NOAEL = 47.3 mg/kg/day (HDT).
LOAEL = not identified.
Offspring NOAEL = 16.5 mg/kg/day.
LOAEL = 47.3 mg/kg/day based on decreased pup body weights in both litters of both generations.
870.4100a
Chronic toxicity (rodents)
NA; see 870.4300
NA
870.4100b
Chronic toxicity (dogs)
42273002 (1989)
Acceptable/guideline
0, 200, 500, or 1250/2500 ppm
M/F: 0, 6.1, 15, or 41(first 16 wks.), then 72 mg/kg/d
NOAEL = 72 mg/kg/day (HDT).
LOAEL = not identified.
870.4200a
Carcinogenicity (rats)
NA; see 870.4300
NA
870.4200b
Carcinogenicity (mice)
42256335 (1991)
Acceptable/guideline with 42256336
0, 100, 330, or 1000 ppm
M:  0, 20, 66, or 208 mg/kg/day
F:  0, 30, 104, or 274 mg/kg/day
42256336 (1991)
0 or 2000 ppm
M:  0 or 414; F: 0 or 424 mg/kg/day
NOAEL = Males:  208 mg/kg/day; Females:  274 mg/kg/day.
LOAEL = Males:  414 mg/kg/day; Females:  424 mg/kg/day based on decreased body weights, food consumption and water intake.
No evidence of carcinogenicity.
870.4300
Combined Chronic/carcinogenicity (rats)
42256331 (1989)
Acceptable/guideline with 42256332
0, 100, 300, or 900 ppm
M:  0, 5.7, 16.9, or 51.3 mg/kg/day
F:  0, 7.6, 24.9, or 73.0 mg/kg/day
42256332 (1991)
0 or 1800 ppm
M:  0 or 102.6; F: 0 or 143.7 mg/kg/day
NOAEL = Males:  5.7 mg/kg/day; Females:  7.6 mg/kg/day.
LOAEL = Males:  16.9 mg/kg/day; Females:  24.9 mg/kg/day based on thyroid toxicity (increased incidence of mineralized particles in thyroid colloid) in males.
No evidence of carcinogenicity.
870.5100
Bacterial reverse mutation
 42256341
Acceptable/guideline
Negative for inducing reverse mutation in bacteria exposed to doses up to 5000 ug/plate.
870.5100
Bacterial reverse mutation
42256343
Acceptable/guideline
Negative up to 12,500 ug/plate.
870.5100
Bacterial reverse mutation
42256363
Acceptable/guideline
Negative up to 5500 ug/plate.
870.5300
In vitro mammalian cell gene mutation
42256342
Acceptable/guideline
Negative for inducing forward mutation in Chinese Hamster Ovary (CHO) (mammalian) cells treated up to 1222 ug/mL.
870.5300
In vitro mammalian cell gene mutation
42256364
Acceptable/guideline
Negative up to 2000 ug/mL.
870.5300
In vitro mammalian cell gene mutation
42256365
Acceptable/guideline
Negative up to 2000 ug/mL.
870.5375
In vitro mammalian chromosome abberation (HL)
42256345
Acceptable/guideline
Positive at 500 ug/mL - S9 and 1300 ug/mL +S9, both cytotoxic doses.
870.5375
In vitro mammalian chromosome abberation (CHV79)
42256370
Acceptable/guideline
Negative up to 1000 ug/mL.
870.5375
In vitro mammalian chromosome abberation (CHO)
42256371
Acceptable/guideline
Negative up to 1000 ug/mL.
870.5380
Mammalian germ cell chromosome abberation (mouse)
42256348
Unacceptable/guideline
Negative, but only tested up to 80 mg/ml.
870.5385
Mammalian bone marrow chromosome aberration (chinese hamster)
42256344
Acceptable/guideline
Negative for chromosome breakage up to 2000 ug/mL.
870.5395
Mammalian micronucleus (mouse)
42256347
Unacceptable/guideline
Negative, but only tested up to 80 mg/kg.
870.5395
Mammalian micronucleus (mouse)
42256366
Acceptable/guideline
Negative up to 50 mg/kg IP, toxic dose.
870.5395
Mammalian micronucleus (mouse)
42256367
Unacceptable/guideline
Negative up to 80 mg/kg IP, a non-toxic dose.
870.5395
Mammalian micronucleus (mouse)
42256368
Unacceptable/guideline
Negative up to 100 mg/kg PO, a non-toxic dose.
870.5395
Mammalian micronucleus (mouse)
42256369
Acceptable/guideline
Negative up to 160 mg/kg PO, toxic dose.
870.5500
DNA damage/repair REC assay
41156351
Acceptable/guideline
Negative up to 5000 ug/disc, the limit of solubility, with or without activation.
870.5550
Unscheduled DNA synthesis (RPH)
42256352
Acceptable/guideline
Negative up to 750 ug/mL, a cytotoxic dose.
870.5575
Mitotic gene conversion
42256353
Acceptable/guideline
Negative for crossing-over in yeast cells exposed with/without activation to precipitating levels of test article (5,000-10,000 ug/mL).
870.5550
Unscheduled DNA synthesis (RPH)
42256372
Acceptable/guideline
Negative up to cytotoxic doses (1333 ug/mL).
870.5900
In vitro sister chromatid exchange (CHO)
42256349
Acceptable/guideline
Positive at 500 ug/mL -S9 and 2000 ug/mL +S9, both cytotoxic doses.
870.5900
In vitro sister chromatid exchange (CHO)
47256350
Acceptable/guideline
Negative at cytotoxic doses of 400 ug/mL -S9 and 1250 ug/mL +S9.
870.59.15
In vivo sister chromatid exchange (chinese hamster bone marrow)
42256346
Acceptable/guideline
Negative up to 2000 mg/kg.
870.6200a
Acute neurotoxicity screening battery
rat
43170301 (1994)
43285801 (1994)
Acceptable/guideline
0, 42, 151, or 307 mg/kg
NOAEL = not identified.
LOAEL = 42 mg/kg based on decreased motor and locomotor activities observed in females.
870.6200b
Subchronic neurotoxicity screening battery
rat
43286401 (1994)
Minimum
0, 150, 1000, or 3000 ppm
M:  0, 9.3, 63.3, or 196 mg/kg/day
F:  0, 10.5, 69.3, or 213 mg/kg/day
NOAEL = 9.3 mg/kg/day.
LOAEL = 63.3 mg/kg/day based on decreased body-weight gain.
870.6300
Developmental neurotoxicity
(rat)
45537501 (2001)
Acceptable/non-guideline
0, 100, 250, or 750 ppm
Gest.:  0, 8.0-8.3, 19.4-19.7, or 54.7-58.4 mg/kg/day
Lact.:  0, 12.8-19.5, 30.0-45.4, or 80.4-155.0 mg/kg/day
Maternal NOAEL = 20 mg/kg/day.
LOAEL = 55 mg/kg/day based on decreased food consumption and body-weight gain during lactation.
Offspring NOAEL = 20 mg/kg/day.
LOAEL = 55 mg/kg/day based on decreased body weight and body-weight gain, decreased motor activity and decreased caudate/putamen width in females.
870.7485
Metabolism and pharmacokinetics
rat
42256354 (1990)
42256356 (1987)
M&F:  1.0 or 20.0 mg/kg (labeled) as single oral dose or 1.0 mg/kg unlabeled orally followed by 1.0 mg/kg single oral dose (labeled) or 1.0 mg/kg (labeled) single dose IV.
M:  20.0 mg/kg single oral dose or 1.0 mg/kg single duodenal dose.
42256357 (1991)
M&F:  1.0 mg/kg single oral dose.
M:  1.0 or 150 mg/kg single oral dose
42256373 (1990).
M:  1.0 or 150 mg/kg single oral dose or
80.0 mg/kg single oral dose after 1 year 1800 ppm.
42256355 (1987)
M:  1.0 mg/kg single oral or IV dose.
42256358 (1990)
42256359 (1990)
Acceptable/guideline

Methylene-labeled imidacloprid was rapidly absorbed with approximately 90% of the administered dose being eliminated within 24 hours and 96% within 48 hours.  There were no biologically significant differences between sexes, dose levels, or route of administration.  Urinary excretion was the major route of elimination (70-80% of recovered radioactivity), with a lesser amount eliminated in feces (17-25% of recovered radioactivity).  Biliary excretion was a major contributor to fecal radioactivity (36.6% vs. 4.8% of recovered radioactivity in bile-fistulated animals).  Total tissue burden after 48 hours accounted for only approximately 0.5% of the recovered radioactivity, with major sites of accumulation being the liver, kidney, lung, skin, and plasma and minor sites being the brain and testes.  Maximum plasma concentration occurred between 1.1 and 2.5 hours, and elimination half-lives (calculated from two exponential terms) were 3 and 26-118 hours.  There were two major evident routes of biotransformation.  The first included an oxidative cleavage of the parent compound to give 6-CNA and its glycine conjugate.  Dechlorination of this metabolite formed the 6-hydroxynicotinic acid and its mercapturic acid derivative.  The second included the hydroxylation of imidazolidine followed by elimination of water of the parent compound to give NTN 35884.

In a comparison between [methylene-[14]C]imidacloprid and [imidazolidine-4,5-[14]C]imidacloprid, the rates of excretion were similar; however, the renal portion was higher with the imidazolidine-labeled test material.  The imidazolidine-labeled test material also demonstrated higher accumulation in the tissues, with the major sites of accumulation being the liver, kidney, lung, and skin, and the minor sites being brain and muscle.

In a comparison between [methylene-[14]C]imidacloprid and WAK 3839, there were no significant differences in the absorption, distribution, and excretion of the total radioactivity.  More radioactivity was found in the tissues of the animals receiving imidacloprid at the 1.0 and 150.0 dose levels.  The major sites of accumulation of WAK 3839 included lung, renal fat, liver, and kidney, with minor sites being the testis and brain.  WAK 3839 was formed during pretreatment (chronic oral dosing) of imidacloprid; however, the proposed metabolic pathways of the two compounds were different.
870.7600
Dermal penetration
NA
NA

Appendix B.  Physical/Chemical Properties.

Table B1.  Physicochemical Properties of Imidacloprid.
Parameter
                                     Value
                                   Reference
Molecular Weight
                                     255.7
                                  PP#6E7116;
          W. Cutchin, 14-May-2007; DP#s: 332757, 333517, & 334153

                             The Pesticide Manual
                            Twelfth Edition (2000)
pH
                                    5 to 11

Water solubility (g/L at 23°C)
                                     1.54

Solvent solubility (g/L at 20°C)
    Dichloromethane: 55, Isopropanol: 1.2, Toluene: 0.68, n-hexane: <0.1

Vapor pressure (mPa at 20°C)
                                  4 x 10[-7]

Octanol/water partition coefficient, log KOW (25°C)
                                 0.57 (21°C)

Henry's law constant (@20°C)
                            6.5x10[-11] atm m3/mole
                                    Cal-EPA
Soil Half-life (or other relevant information from EFED Drinking water assessment)

    R.Parker, 13-April-2007; DP#s: 334029, 334030, 332756, 333122, 333123,
                        333125, 333126, 330568, 330569

Hydrolysis half-life @ pH 7
                                    Stable

Photolysis half-life, distilled water (days)
                                      0.2

Photolysis half-life, soil (days)
                                      39

Aerobic soil half-life (days)
                                      359

Aerobic aquatic metabolism half-life (days)
                                      27

Soil leaching (KOC, mL/g)
                                 178 (132-256)


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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Agency Information Collection Activities; Proposed Collection;
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detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2009-N-0505 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping and Reporting
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing Material From Cattle.'' 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 Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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: http://www.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB

for approval. To comply with this requirement, FDA is publishing notice
of the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle--21 CFR 189.5 and 700.27

OMB Control Number 0910-0623--Extension

    FDA's regulations in Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 and
700.27) set forth bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA-regulated human food and cosmetics. The
regulations designate certain materials from cattle as ``prohibited
cattle materials,'' including specified risk materials (SRMs), the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, and mechanically separated (MS) beef. Sections 189.5(c) and
700.27(c) set forth the requirements for recordkeeping and records
access for FDA-regulated human food, including dietary supplements, and
cosmetics manufactured from, processed with, or otherwise containing
material derived from cattle. The FDA issued these recordkeeping
regulations under the adulteration provisions in sections 402(a)(2)(C),
(a)(3), (a)(4), (a)(5), 601(c), and 701(a) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3),
(a)(4), (a)(5), 361(c), and 371(a)). Under section 701(a) of the FD&C
Act, the FDA is authorized to issue regulations for the FD&C Act's
efficient enforcement. With regard to records concerning imported human
food and cosmetics, the FDA relied on its authority under sections
701(b) and 801(a) of the FD&C Act (21 U.S.C. 371(b) and 381(a)).
Section 801(a) of the FD&C Act provides requirements with regard to
imported human food and cosmetics and provides for refusal of admission
of human food and cosmetics that appear to be adulterated into the
United States. Section 701(b) of the FD&C Act authorizes the
Secretaries of Treasury and Health and Human Services to jointly
prescribe regulations for the efficient enforcement of section 801 of
the FD&C Act.
    These requirements are necessary because once materials are
separated from an animal it may not be possible, without records, to
know the following: (1) Whether cattle material may contain SRMs
(brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae and the wings of the sacrum), and dorsal
root ganglia from animals 30 months and older and tonsils and distal
ileum of the small intestine from all animals of all ages); (2) whether
the source animal for cattle material was inspected and passed; (3)
whether the source animal for cattle material was nonambulatory
disabled or MS beef; and (4) whether tallow in human food or cosmetics
contain less than 0.15 percent insoluble impurities.
    FDA's regulations in Sec. Sec.  189.5(c) and 700.27(c) require
manufacturers and processors of human food and cosmetics manufactured
from, processed with, or otherwise containing material from cattle
establish and maintain records sufficient to demonstrate that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contains prohibited cattle materials. These records must be
retained for 2 years at the manufacturing or processing establishment
or at a reasonably accessible location. Maintenance of electronic
records is acceptable, and electronic records are considered to be
reasonably accessible if they are accessible from an onsite location.
Records required by these sections and existing records relevant to
compliance with these sections must be available to FDA for inspection
and copying. Existing records may be used if they contain all of the
required information and are retained for the required time period.
    Because FDA does not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec.  189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection, the importer of record of human
food or cosmetics manufactured from, processed with, or otherwise
containing cattle material must affirm that the human food or cosmetics
were manufactured from, processed with, or otherwise containing-cattle
material and must affirm that the human food or cosmetics were
manufactured in accordance with the applicable requirements of
Sec. Sec.  189.5 or 700.27. In addition, if human food or cosmetics
were manufactured from, processed with, or otherwise containing-cattle
material, the importer of record must provide within 5 business days
records sufficient to demonstrate that the human food or cosmetics were
not manufactured from, processed with, or otherwise contains prohibited
cattle material, if requested.
    Under FDA's regulations, FDA may designate a country from which
cattle materials inspected and passed for human consumption are not
considered prohibited cattle materials, and their use does not render
human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e)
provide that a country seeking to be designated must send a written
request to the Director of the Center for Food Safety and Applied
Nutrition (CFSAN Director). The information the country is required to
submit includes information about a country's BSE case history, risk
factors, measures to prevent the introduction and transmission of BSE,
and any other information relevant to determining whether SRMs, the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, or MS beef from the country seeking designation should be
considered prohibited cattle materials. FDA uses the information to
determine whether to grant a request for designation and to impose
conditions if a request is granted.
    Sections 189.5 and 700.27 further state that countries designated
under Sec. Sec.  189.5(e) and 700.27(e) will be subject to future
review by FDA to determine whether their designations remain
appropriate. As part of this process, FDA may ask designated countries
to confirm their BSE situation and the information submitted by them,
in support of their original application, has remained unchanged. FDA
may revoke a country's designation if FDA determines that it is no
longer appropriate. Therefore, designated countries may respond to
periodic FDA requests by submitting information to confirm their
designations remain appropriate. FDA uses the information to ensure
their designations remain appropriate.
    Description of Respondents: Respondents to this information

collection include manufacturers, processors, and importers of FDA
regulated human food, including dietary supplements, and cosmetics
manufactured from, processed with, or otherwise containing material
derived from cattle, as well as, with regard to Sec. Sec.  189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 700.27(c)(6)................          54,825               1          54,825  .033 (2 minutes)..........................           1,809
189.5(e) and 700.27(e); request for                        1               1               1  80........................................              80
 designation.
189.5(e) and 700.27(e); response to request                1               1               1  26........................................              26
 for review by FDA.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           1,915
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of      records per    Total annual         Average burden per recordkeeper         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic facilities.........................             697              52          36,244  .25 (15 minutes)..........................           9,061
Foreign facilities..........................             916              52          47,632  .25 (15 minutes)..........................          11,908
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          20,969
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Except where otherwise noted, this estimate is based on FDA's
estimate of the number of facilities affected by the final rule
entitled, ``Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle'' published in the Federal Register of October 11, 2006 (71
FR 59653).
    Reporting: FDA's regulations in Sec. Sec.  189.5(c)(6) and
700.27(c)(6) impose a reporting burden on importers of human food and
cosmetics manufactured from, processed with, or otherwise containing
cattle material. Importers of these products must affirm that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contain prohibited cattle materials and must affirm that the
human food or cosmetics were manufactured in accordance with the
applicable requirements of Sec. Sec.  189.5 or 700.27. The affirmation
is made by the importer of record to the FDA through FDA's Operational
and Administrative System for Import Support. Affirmation by importers
is expected to take approximately 2 minutes per entry line. Table 2
shows 54,825 lines of human food and cosmetics likely to contain cattle
materials are imported annually. The reporting burden of affirming
whether import entry lines contain cattle-derived materials is
estimated to take 1,809 hours annually (54,825 lines x 2 minutes per
line).
    FDA's estimate of the reporting burden for designation under
Sec. Sec.  189.5 and 700.27 is based on its experience and the average
number of requests for designation received in the past 3 years. In the
last 3 years, FDA has not received any requests for designation. Thus,
FDA estimates that one or fewer will be received annually in the
future. Based on this experience, FDA estimates the annual number of
new requests for designation will be one. FDA estimates that preparing
the information required by Sec. Sec.  189.5 and 700.27 and submitting
it to FDA in the form of a written request to the CFSAN Director will
require a burden of approximately 80 hours per request. Thus, the
burden for new requests for designation is estimated to be 80 hours
annually, as shown in table 1, row 2.
    Under Sec. Sec.  189.5(e) and 700.27(e), designated countries are
subject to future review by FDA and may respond to periodic FDA
requests by submitting information to confirm their designations remain
appropriate. In the last 3 years, FDA has not requested any reviews.
Thus, FDA estimates that one or fewer will occur annually in the
future. FDA estimates that the designated country undergoing a review
in the future will need one-third of the time it took preparing its
request for designation to respond to FDA's request for review, or 26
hours (80 hours x 0.33 = 26.4 hours, rounded to 26). The annual burden
for reviews is estimated to be 26 hours, as shown in table 1, row 3.
The total reporting burden for this information collection is estimated
to be 1,915 hours annually.
    Recordkeeping: FDA estimates that there are 697 domestic facility
relationships and 916 foreign facility relationships consisting of the
following facilities: An input supplier of cattle-derived materials
that requires records (the upstream facility) and a purchaser of
cattle-derived materials requiring documentation (this may be a human
food or cosmetics manufacturer or processor). The recordkeeping burden
of FDA's regulations in Sec. Sec.  189.5(c) and 700.27(c) is the burden
of sending, verifying, and storing documents regarding shipments of
cattle material that is to be used in human food and cosmetics.
    In this estimate of the recordkeeping burden, FDA treats these
recordkeeping activities as shared activities between the upstream and
downstream facilities. It is in the best interests of both facilities
in the relationship to share the burden necessary to comply with the
regulations; therefore, FDA estimates the time burden of developing
these records as a joint task between the two facilities. Thus, FDA
estimates that this recordkeeping burden will be about 15 minutes per
week, or 13 hours per year, and FDA assumes that the recordkeeping
burden will be shared between 2 entities (i.e., the ingredient supplier
and the manufacturer of

finished products). Therefore, the total recordkeeping burden for
domestic facilities is estimated to be 9,061 hours (13 hours x 697),
and the total recordkeeping burden for foreign facilities is estimated
to be 11,908 hours (13 hours x 916), as shown in table 2.

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12448 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Rules and Regulations]
[Pages 55683-55685]
[FR Doc No: 2022-19467]

========================================================================
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.

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

Federal Register / Vol. 87, No. 175 / Monday, September 12, 2022 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0774; Airspace Docket No. 22-AGL-26]
RIN 2120-AA66

Amendment of Class D and Class E Airspace and Revocation of Class
E Airspace; La Crosse, WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class D and Class E airspace and
revokes Class E airspace at La Crosse, WI. This action due to an
airspace review conducted as part of the decommissioning of the La
Crosse very high frequency (VHF) omnidirectional range (VOR) as part of
the VOR Minimal Operational Network (MON) Program.

DATES: Effective 0901 UTC, December 29, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class D airspace, Class E surface airspace, and Class
E airspace extending upward from 700 feet above the surface and removes
the Class E airspace designated as an extension to Class D and Class E
surface airspace at La Crosse Regional Airport, La Crosse, WI, to
support instrument flight rule operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (87 FR 36421; June 17, 2022) for Docket No. FAA-2022-0774 to
amend the Class D and Class E airspace and revoke Class E airspace at
La Crosse, WI. Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. No comments were received.
    Class D and E airspace designations are published in paragraphs
5000, 6002, 6004, and 6005, respectively, of FAA Order JO 7400.11F,
dated August 10, 2021, and effective September 15, 2021, which is
incorporated by reference in 14 CFR 71.1. The Class D and E airspace
designations listed in this document will be published subsequently in
FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71:
    Amends the Class D airspace at La Crosse Regional Airport, La
Crosse, WI, by adding an extension 1 mile each side of the 359[deg]
bearing from the La Crosse Regional: RWY 18-LOC extending from the 4.4-
mile radius of the airport to 5.3 miles north of the airport; adds an
extension 1 mile each side of the 359[deg] bearing from the airport
extending from the 4.4-mile radius to 5.3 miles north of the airport;
adds an extension 1 mile each side of the 036[deg] bearing from the
airport extending from the 4.4-mile radius of the airport to 6.2 miles
northeast of the airport; adds an extension 1 mile each side of the
119[deg] bearing from the airport extending from the 4.4-mile radius of
the airport to 5.7 miles southeast of the airport; adds an extension 1
mile each side of the 216[deg] bearing from the airport extending from
the 4.4-mile radius of the airport to 5.6 miles southwest of the
airport; and replaces the outdated term ``Notice to Airmen'' with
``Notice to Air Missions'';
    Amends the Class E surface airspace at La Crosse Regional Airport
by adding an extension 1 mile each side of the 359[deg] bearing from
the La Crosse Regional: RWY 18-LOC extending from the 4.4-mile radius
of the airport to 5.3 miles north of the airport; adds an extension 1
mile each side of the 359[deg] bearing from the airport extending from
the 4.4-mile radius to 5.3 miles north of the airport; adds an
extension 1 mile each side of the 036[deg] bearing from the airport
extending from the 4.4-mile radius of the airport to 6.2 miles
northeast of the airport; adds an extension 1 mile each side of the
119[deg] bearing from the airport extending from the 4.4-mile radius of
the airport to 5.7 miles southeast of the airport; adds an extension 1
mile each side of the 216[deg] bearing from the airport extending from
the 4.4-mile radius of the airport to 5.6 miles southwest of the
airport; removes the 3,200 feet MSL restriction as it is not required;
and replaces the outdated term ``Notice to Airmen'' with ``Notice to
Air Missions'';
    Removes the Class E airspace designated as an extension to Class D
and Class E surface areas at La Crosse Regional Airport as these
extensions have been incorporated into the Class D

airspace and Class E surface airspace and this airspace is no longer
required;
    And amends the Class E airspace extending upward from 700 feet
above the surface at La Crosse Regional Airport by adding an extension
1 mile each side of the 359[deg] bearing from the La Crosse Regional:
RWY 18-LOC extending from the 6.9-mile radius of the airport to 7.2
miles north of the airport.
    This action is due to an airspace review conducted as part of the
decommissioning of the La Crosse VOR, which provided navigation
information for the instrument procedures at these airports, as part of
the VOR MON Program.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (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) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AGL WI D La Crosse, WI [Amended]

La Crosse Regional Airport, WI
    (Lat. 43[deg]52'45'' N, long. 91[deg]15'24'' W)
La Crosse Regional: RWY 18-LOC
    (Lat. 43[deg]52'01'' N, long. 91[deg]15'31'' W)

    That airspace extending upward from the surface to and including
3,200 feet MSL within a 4.4-mile radius of La Crosse Regional
Airport; and within 1 mile each side of the 359[deg] bearing from
the La Crosse Regional: RWY 18-LOC extending from the 4.4-mile
radius of the La Crosse Regional Airport to 5.3 miles north of the
airport; and within 1 mile each side of the 359[deg] bearing from
the La Crosse Regional Airport extending from the 4.4-mile radius of
the airport to 5.3 miles north of the airport; and within 1 mile
each side of the 036[deg] bearing from the La Crosse Regional
Airport extending from the 4.4-mile radius of the airport to 6.2
miles northeast of the airport; and within 1 mile each side of the
119[deg] bearing from the La Crosse Regional Airport extending from
the 4.4-mile radius of the airport to 5.7 miles southeast of the
airport; and within 1 mile each side of the 216[deg] bearing from
the La Crosse Regional Airport extending from the 4.4-mile radius of
the airport to 5.6 miles southwest of the airport. This Class D
airspace area is effective during the specific dates and times
established in advance by a Notice to Air Missions. The effective
dates and times will thereafter be continuously published in the
Chart Supplement.

Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.

* * * * *

AGL WI E2 La Crosse, WI [Amended]

La Crosse Regional Airport, WI
    (Lat. 43[deg]52'45'' N, long. 91[deg]15'24'' W)
La Crosse Regional: RWY 18-LOC
    (Lat. 43[deg]52'01'' N, long. 91[deg]15'31'' W)

    That airspace extending upward from the surface within a 4.4-
mile radius of La Crosse Regional Airport; and within 1 mile each
side of the 359[deg] bearing from the La Crosse Regional: RWY 18-LOC
extending from the 4.4-mile radius of the La Crosse Regional Airport
to 5.3 miles north of the airport; and within 1 mile each side of
the 359[deg] bearing from the La Crosse Regional Airport extending
from the 4.4-mile radius of the airport to 5.3 miles north of the
airport; and within 1 mile each side of the 036[deg] bearing from
the La Crosse Regional Airport extending from the 4.4-mile radius of
the airport to 6.2 miles northeast of the airport; and within 1 mile
each side of the 119[deg] bearing from the La Crosse Regional
Airport extending from the 4.4-mile radius of the airport to 5.7
miles southeast of the airport; and within 1 mile each side of the
216[deg] bearing from the La Crosse Regional Airport extending from
the 4.4-mile radius of the airport to 5.6 miles southwest of the
airport. This Class E airspace area is effective during the specific
dates and times established in advance by a Notice to Air Missions.
The effective dates and times will thereafter be continuously
published in the Chart Supplement.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

AGL WI E4 La Crosse, WI [Remove]

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
feet or More Above the Surface of the Earth.

* * * * *

AGL WI E5 La Crosse, WI [Amended]

La Crosse Regional Airport, WI
    (Lat. 43[deg]52'45'' N, long. 91[deg]15'24'' W)
La Crosse Regional: RWY 18-LOC
    (Lat. 43[deg]52'01'' N, long. 91[deg]15'31'' W)
Mayo Clinic Health System-Franciscan Healthcare, WI, Point In Space
Coordinates
    (Lat. 43[deg]47'39'' N, long. 91[deg]14'00'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of La Crosse Regional Airport; and within 1
mile each side of the 359[deg] bearing from the La Crosse Regional:
RWY 18-LOC extending from the 6.9-mile radius of the La Crosse
Regional Airport to 7.2 miles north of the airport; and within 1
mile each side of the 359[deg] bearing from the La Crosse Regional
Airport extending from the 6.9-mile radius of the airport to 7.1
miles north of the airport; and within 2.9 miles each side of the
036[deg] bearing from the La Crosse Regional Airport extending from
the 6.9-mile radius of the airport to 9.6 mile northeast of the
airport; and within 1 mile each side of the 119[deg] bearing from
the La Crosse Regional Airport extending from the 6.9-mile radius of
the airport to 7.4 mile southeast of the airport; and within 2 miles
each side of the 216[deg] bearing from the La Crosse Regional
Airport extending from the 6.9-mile radius of the airport to 11.3
miles southwest of the airport; and within a 6-mile radius of the
point in space serving Mayo Clinic Health System-Franciscan
Healthcare.

    Issued in Fort Worth, Texas, on September 6, 2022.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2022-19467 Filed 9-9-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 19, 2006 (Volume 71, Number 243)]
[Notices]
[Page 75963-75964]
[DOCID:fr19de06-60]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0978; FRL-8258-5]

Board of Scientific Counselors Human Health Mid-Cycle
Subcommittee Meetings--January 2007

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of two meetings.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the Environmental Protection Agency, Office of Research and
Development (ORD), gives notice of two meetings of the Board of
Scientific Counselors (BOSC) Human Health Mid-Cycle Subcommittee.

DATES: The first meeting (a teleconference call) will be held on
Tuesday, January 9, 2007, from 1 p.m. to 3 p.m. The second meeting
(face-to-face meeting) will be held on Wednesday, January 24, 2007,
from 10 a.m. to 3 p.m. All times noted are eastern time. The meetings
may adjourn early if all business is finished. Requests for the draft
agendas or for making oral presentations at the meetings will be
accepted up to 1 business day before each meeting.

ADDRESSES: The first meeting will be by teleconference only--meeting
rooms will not be used. Members of the public may obtain the call-in
number and access code for the teleconference meeting from Virginia
Houk, whose contact information is listed under the FOR FURTHER
INFORMATION CONTACT section of this notice. The second meeting will be
held at the Crowne Plaza Washington National Airport hotel, 1480
Crystal Drive, Arlington, Virginia 22202. Submit your comments,

identified by Docket ID No. EPA-HQ-ORD-2006-0978, by one of the
following methods:
     http://www.regulations.gov: Follow the online instructions for

submitting comments.
     E-mail: Send comments by electronic mail (e-mail) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2006-0978.

     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2006-0978.
     Mail: Send comments by mail to: Board of Scientific
Counselors, Human Health Mid-Cycle Subcommittee Meeting--January 2007
Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC,
20460, Attention Docket ID No. EPA-HQ-ORD-2006-0978.
     Hand Delivery or Courier. Deliver comments to: EPA Docket
Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC, Attention Docket ID No. EPA-HQ-ORD-2006-
0978.

    Note: this is not a mailing address. Such deliveries are only
accepted during the docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-0978. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index.

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

Room B102, 1301 Constitution Ave., NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the ORD
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Virginia Houk, Mail Code B305-02, National Health and
Environmental Effects Research Laboratory, Office of Research and
Development, Environmental Protection Agency, 109 TW Alexander Drive,
Research Triangle Park, NC 27711; via phone/voice mail at: (919) 541-
2815; via fax at:<PHONE_NUMBER>; or via e-ail at:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

General Information

    Any member of the public interested in receiving a draft BOSC
agenda or making a presentation at the meetings may contact Virginia
Houk, the Designated Federal Officer, via any of the contact methods
listed in the ``FOR FURTHER INFORMATION CONTACT'' section above. In
general, each individual making an oral presentation will be limited to
a total of three minutes.
    Proposed agenda items for the first meeting (teleconference)
include, but are not limited to: the objectives of the review, an
overview of the Human Health Research Program (HHRP), a summary of
major changes in the HHRP since 2005, an update on the Human Health
Multi-Year Plan, and research to evaluate the effectiveness of risk
management decisions. Proposed agenda items for the second meeting
(face-to-face) include, but are not limited to: the HHRP's response to
recommendations from its 2005 BOSC review, the revised Human Health
Multi-Year Plan, the development of performance metrics, and
accountability and risk management decisions. The meetings are open to
the public.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Virginia Houk at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability, please

contact Virginia Houk, preferably at least 10 days prior to the
meeting, to give EPA as much time as possible to process your request.

    Dated: December 13, 2006.
Jeff Morris,
Acting Director, Office of Science Policy.
 [FR Doc. E6-21597 Filed 12-18-06; 8:45 am]

BILLING CODE 6560-50-P