[Federal Register Volume 77, Number 99 (Tuesday, May 22, 2012)]
[Notices]
[Pages 30351-30352]
[FR Doc No: 2012-12378]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Sec. 221 Public Private Partnerships Public Meeting

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of meeting.

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SUMMARY: The FAA is conducting a public meeting on May 30 to seek
initial input from interested stakeholders about program design and
implementation of an equipage incentives program for commercial
aircraft and general aviation to equip their aircraft with Next
Generation Air Transportation (NextGen) capabilities, pursuant to the
FAA's authority in the FAA Modernization and Reform Act of 2012 (sec.
221). The statute requires that such a program be based on public-
private partnership (PPP) principles and maximize the use of private
sector capital. The purpose of this meeting is to serve as an
information sharing session. The FAA is interested in engaging
stakeholders and potential public-private partners in the process of
developing an effective public-private partnership equipage incentive
program.
    This notice is for the initial meeting. A subsequent meeting will
be planned within 90 days of the May 30 meeting after FAA has assessed
stakeholder comments and feedback and further solidified its policy on
how to implement a PPP equipage incentives program.

FOR FURTHER INFORMATION CONTACT: Ann Tedford, Office of Finance and
Management: Telephone<PHONE_NUMBER>: Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA Modernization and Reform Act of 2012 granted authority for
the Secretary of Transportation to establish an equipage incentive
program to equip US registered aircraft operating in the National
Airspace System (NAS) in the interest of achieving NextGen
capabilities. The authority states a loan guarantee program could be
established either using appropriated funds or by fees and premiums.
The FAA is working to understand what options exist for establishing
the most effective program possible even if it receives no additional
appropriations to fund the incentive. In addition, the FAA must have
the authority to enter into a loan guarantee program recognized in an
appropriations Act in accordance with the Federal Credit Reform Act of
1990.
    The goal for an equipage program would be to encourage deployment
of NextGen capable aircraft in the NAS sooner than would have occurred
otherwise. Specifically, FAA would aim to increase the speed of
adoption of base levels of NextGen equipage (equipage bundles), which
will accelerate delivery of NextGen benefits by reducing the time of
mixed equipage operations. The FAA is examining various methods of
reducing the Government's risk and determining the extent of industry
interest in the program, but we need more information for our analysis.
The May 30 meeting is therefore intended to share FAA's preliminary
thinking and seek industry feedback about what factors are beneficial
to the various stakeholders, if such a program were to be created.

Meeting Information

    Public meeting at FAA Headquarters (800 Independence Avenue SW.,
Washington, DC 20591) on May 30, 2012, from 9:00 am to 12:30 pm. The
meeting will also be available to view live on-line. RSVPs will be
required for meeting attendance as well as Web cast viewing. RSVP by
May 25 to<EMAIL_ADDRESS>Background material,
meeting agenda, and details of participation webcast for the May 30
meeting can be obtained at: http://www.faa.gov/about/initiatives/equipage_incentives/.
    As the financial authority granted to FAA in Section 221 of the FAA
Modernization and Reform Act is new, the agency believes that
stakeholder input is necessary in order to optimize the design of an
effective equipage incentives plan. Input from interested stakeholders
will help inform the direction the FAA should take and raise issues
that the agency might not have considered internally. A list of
questions FAA seeks comment on is on display at: http://www.faa.gov/about/initiatives/equipage_incentives/.
    Comments specifically addressing these questions will be accepted
through June 20 and should be submitted to<EMAIL_ADDRESS>    The FAA will also provide the opportunity for private meetings and
written responses. We recognize that some of the information we are
seeking might be considered proprietary or commercially sensitive. We
will take all steps needed to protect any information provided that is
marked proprietary or commercially sensitive.

    Issued in Washington, DC, on May 14, 2012.
Julie Oettinger,
Assistant Administrator for Policy, International Affairs and
Environment.
[FR Doc. 2012-12378 Filed 5-21-12; 8:45 am]
BILLING CODE 4910-13-P


[Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 1 of 13 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: 05/ 14/ 2002 SUBJECT: Hexazinone Acute and Chronic Dietary Exposure Assessments for the TRED.

PC Code: 107201 DP Barcode: D279898 REVIEWER: John S. Punzi, Ph. D., Chemist Reregistration Branch II Health Effects Division (7509C)

THROUGH: Richard Griffin, DESAC Reviewer Branch/ Health Effects Division (7509C)

Alan Nielsen, Branch Senior Scientist Branch/ Health Effects Division (7509C)

TO: Dirk Helder, Chemical Review Manager Reregistration Branch II Special Review and Reregistration Division (7509C)

and Carol Christensen, Risk Assessor Reregistration Branch II Health Effects Division (7509C)

Executive Summary The purpose of this memorandum is to report the results of a Tier 1 dietary exposure analysis for hexazinone. In this analysis the acute and chronic dietary exposure and risk estimates resulting from food intake were determined for the U. S. population and various population subgroups. [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 2 of 13 Acute and chronic dietary exposure assessments were performed in order to determine the exposure and risk estimates which result from the use of hexazinone on the crops included in the reregistration eligibility decision.

Hexazinone residues of concern for plants are parent plus metabolites A, B, C, D, E (see D279897, S. Kinard 02/ 05/ 2002) for structures and metabolite discussion). The tolerance values for hexazinone in/ on blueberry, pineapple, and sugarcane are based on the analytical method's limit of quantitation (LOQ) and all non detectable residues were found in residue studies (see D279899, J. Punzi, 05/ 15/ 2002). This analysis used a single residue estimate based on the reassessed tolerance for blueberry, pineapple, and sugarcane. Default processing factors and 100% crop treated were used for residue input into DEEM.

Hexazinone residues of concern in ruminant milk are hexazinone plus metabolites B, C, C 2, and F. Hexazinone residues of concern in ruminant tissue are hexazinone plus metabolites B and F. For purposes of risk assessment however, the residues of concern in livestock milk and tissue are hexazinone plus metabolites B, C, C 1, C 2, and F. The livestock feeding study indicates significant residues in milk at all feeding levels and quantifiable residues in kidney. When the residue levels are corrected for exaggerated rates the values are less than the sum of the LOQ's for the residues of concern. Based on the analytical method's LOQ the reside estimate for meats and milk are 0.24 ppm. Default processing factors and 100% crop treated were used for residue input into DEEM.

The chronic dietary risk estimates are provided for the U. S. population (total) and various population subgroups. This assessment concludes that the exposure is below HED's level of concern for all population subgroups examined. Exposures, as a percentage of the RfD, ranged from approximately 3% for females aged 13 through 50 years to 15% for children aged 1 through 6 years.

The acute dietary risk estimates are provided for the population subgroup consisting of females aged 13 through 50 years only. This assessment concludes that the exposure is below HED's level of concern for this subgroup. Exposures as a percentage of the RfD are calculated to be less than 1% at the 95 th percentile.

I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose. This dose is the highest daily dose which HED has deemed will pose no unreasonable adverse health effects and is called the population adjusted dose (PAD). The PAD is equivalent to the Reference Dose (RfD) divided by the FQPA Safety Factor. Dietary risk is expressed as a percentage of the PAD. HED's level of concern is exceeded when the dietary risk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/ pesticides web site: "Available Information on Assessing Exposure from Pesticides, A User's Guide", 6/ 21/ 2000, web link: [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 3 of 13 http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf ; or see SOP 99.6 (8/ 20/ 99).

II. Residue Information Hexazinone tolerances are established under 40 CFR §180.396 (a) and (b). The tolerance for plant and animal commodities, is currently expressed in terms of the combined residues of hexazinone and its metabolites (calculated as hexazinone).

Tolerances are currently established for; alfalfa; alfalfa hay; blueberries; cattle, goat, hog, and horse fat, meat, and meat by products; range grasses, pasture grasses, milk, pineapple and sugarcane. Current tolerances range from 0.1 ppm in/ on meats and milk to 10 ppm on grasses.

Reassessed tolerances range from 0.1 ppm to 4 ppm. Tolerances are not currently needed for livestock fat, hog meat, and hog meat by products. HED is recommending that in order to reassess the established hexazinone tolerances for milk and the fat, meat, and meat byproducts of livestock and to compute a maximum theoretical dietary burden (MTDB) of hexazinone to livestock, uses on pasture and rangland grasses must be revoked. A MTDB could not be calculated including grass and grass hay since additional residue data are required for use patterns in which significant residues are expected in/ on the RACs. HED recognizes that the estimated 100,000 acres of pasture and rangeland treated with hexazinone is relatively low. Since grass and grass hay are considered major dietary components of ruminants (up to 60% of the diet per current OPPTS GLN) a MTDB for livestock could not be developed when grasses are included in the registered uses. HED has determined that a MTDB could be constructed from other potential feed items for livestock and subsequently tolerances for meats and milk can be reassessed.

Hexazinone residues of concern for plants are parent plus metabolites A, B, C, D, E (see D279897, S. Kinard 02/ 05/ 2002, for structures and metabolite discussion). The tolerance values for hexazinone in/ on blueberry, pineapple, and sugarcane are based on the analytical method's limit of quantitation (LOQ) and all non detectable residues were found in residue studies (see D279899, J. Punzi, 05/ 05/ 2002). This analysis used a single residue estimate based on the reassessed tolerance for blueberry, pineapple, and sugarcane. Default processing factors and 100% crop treated were used for residue input into DEEM.

Hexazinone residues of concern in ruminant milk are hexazinone plus metabolites B, C, C 2, and F. Hexazinone residues of concern in ruminant tissue are hexazinone plus metabolites B and F. For purposes of risk assessment however, the residues of concern in livestock milk and tissue are hexazinone plus metabolites B, C, C 1, C 2, and F. The livestock feeding study indicates significant residues in milk at all feeding levels and quantifiable residues in kidney. When the residue levels are corrected for exaggerated rates the values are less than the sum of the LOQ's for the residues of concern. Based on the analytical method's LOQ the reside estimate for meats and milk are 0.24 ppm. Default processing factors and 100% crop treated were used for residue input into DEEM. [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 4 of 13 Residue Data used for Acute and Chronic Assessments:

This TIER 1 analysis used a single residue estimate based on the reassessed tolerance for blueberry, pineapple, and sugarcane. Default processing factors and 100% crop treated were used for residue input into DEEM. For purposes of risk assessment however, the residues of concern in livestock milk and tissue are hexazinone plus metabolites B, C, C 1, C 2, and F. The same data are being used in both acute and chronic analysis.

III. DEEM™ Program and Consumption Information Hexazinone acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model (DEEM™) software, Version [7.76], which incorporates consumption data from USDA's Continuing Surveys of Food Intake by Individuals (CSFII), 1989 1992. The 1989 92 data are based on the reported consumption of more than 10,000 individuals over three consecutive days, and therefore represent more than 30,000 unique "person days" of data. Foods "as consumed" (e. g., apple pie) are linked to raw agricultural commodities and their food forms (e. g., apples cooked/ canned or wheat flour) by recipe translation files internal to the DEEM software. Consumption data are averaged for the entire U. S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

For chronic exposure and risk assessment, an estimate of the residue level in each food or foodform (e. g., orange or orange juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup.

For acute exposure assessments, individual one day food consumption data are used on an individual by individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic (Tier 1 or Tier 2) exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic (Tier 3/ 4) assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i. e., those who reported eating relevant commodities/ food forms) and a per capita (i. e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

HED notes that there is a degree of uncertainty in extrapolating exposures for certain population subgroups which may not be sufficiently represented in the consumption surveys, (e. g., nursing and non nursing infants or Hispanic females). Therefore, risks estimated for these subpopulations were included in representative populations having sufficient numbers of survey [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 5 of 13 respondents (e. g., all infants, or females 13 50 years).

IV. Toxicological Information The toxicological endpoint summary table below is from the HIARC document (01/ 16/ 2002, TXR# 0050371). The FQPA SF was obtained from the committee report (05/ 15/ 2002, TXR# 0050750).

Table 1. Summary of Toxicological Doses and Endpoints for [CHEMICAL] for Use in Dietary Exposure Assessment Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF* and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary [Female 13 50] NOAEL = [400] mg/ kg/ day UF = [100] Acute RfD = [4.0] mg/ kg/ day FQPA SF = [10] aPAD =[ 0.40] mg/ kg/ day [Developmental Toxicity Rat] LOAEL = [ 900] mg/ kg/ day based on [decreased fetal weight, malformation of kidneys]

Chronic Dietary all populations NOAEL= [5] mg/ kg/ day UF = [100] Chronic RfD = [0.05] mg/ kg/ day FQPA SF = [1] cPAD =[ ]

= [0.05] mg/ kg/ day [Chronic One Year Feeding Dog] LOAEL = [ ~40] mg/ kg/ day based on [hepatotoxicity]

V. Results/ Discussion As stated above, for acute and chronic assessments, HED's level of concern is exceeded when the dietary risk exceeds 100% of the PAD. The DEEM analyses can estimate the dietary exposure of the U. S. population and 26 population subgroups. The results reported in Table 2 are for the appropriate subpopulation, females aged 13 to 50 years. The results reported in Table 3 are for the U. S. Population (total), all infants (< 1 year old), children 1 6, children 7 12, females 13 50, males 13 19, males 20+, and seniors 55+. The results for the other population subgroups are included in the appendices. They are not included in the tables because the numbers of respondents in the other subgroups were not sufficient; and therefore, the exposure estimates for these subgroups contained higher levels of uncertainty. However, the respondents in these subgroups were also part of larger subgroups which are listed in the Tables. For example, nursing and non nursing infants are included in all infants. [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 6 of 13 Results of Acute Dietary Exposure Analysis Results are reported at the 95th percentile of exposure because the assessment incorporated 100% CT. The acute dietary risk estimates are provided for the population subgroup consisting of females aged 13 through 50 years only. This assessment concludes that the exposure is below HED's level of concern for this subgroup. Exposures as a percentage of the RfD are calculated to be less than 1% at the 95 th percentile.

Table 2. Results of Acute Dietary Exposure Analysis at the 95 th Percentile of Exposure Population Subgroup aPAD (mg/ kg/ day) Exposure (mg/ kg/ day) % aPAD Females 13 50 years old 0. 40 0. 003475 <1 Results of Chronic Dietary Exposure Analysis Table 3. Results of Chronic Dietary Exposure Analysis Population Subgroup cPAD (mg/ kg/ day) Exposure (mg/ kg/ day) % cPAD U. S. Population (total) 0. 05 0. 002118 4 All Infants (< 1 year) 0. 05 0. 003629 7 Children 1 6 years 0. 05 0. 007304 15 Children 7 12 years 0. 05 0. 003899 8 Females 13 50 0.05 0.001265 3 Males 13 19 0.05 0.002315 5 Males 20+ years 0. 05 0. 001183 2 Seniors 55+ 0.05 0.001123 2 The chronic dietary risk estimates are provided for the U. S. population (total) and various population subgroups. This assessment concludes that the exposure is below HED's level of concern for all population subgroups examined. Exposures, as a percentage of the RfD, ranged from approximately 3% for females aged 13 through 50 years to 15% for children aged 1 through 6 years.

VII. Conclusions [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 7 of 13 The Tier 1 acute and chronic dietary risk assessments were conducted for all supported hexazinone food uses. Dietary risk estimates are provided for the U. S. population (total) and various population subgroups. This assessment concludes that for all supported registered commodities, the acute risk estimates are below the Agency's level of concern at the 95 th exposure percentile for the population subgroup consisting of females aged 13 to 50 years. The acute dietary exposure estimate for this group is <1% of the aPAD. This assessment also concludes that for all commodities, the chronic risk estimates are below the Agency's level of concern for the U. S. population (total) (4% of the cPAD) and all population subgroups. The most highly exposed population subgroup is children aged 1 to 6 years. The chronic dietary exposure estimate for the highest exposed population subgroup is 15% of the cPAD. [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 8 of 13 Apendix U. S. Environmental Protection Agency Ver. 7.76 DEEM Chronic analysis for HEXAZINONE (1989 92 data) Residue file name: C:\ deem\ hexazinone_ nopork. RS7 Adjustment factor #2 used. Analysis Date 05 15 2002/ 12: 57: 29 Residue file dated: 05 15 2002/ 12: 12: 42/ 8 Reference dose (RfD, Chronic) = .05 mg/ kg bw/ day =============================================================================== Total exposure by population subgroup

Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population (total) 0.002118 4.2%

U. S. Population (spring season) 0.002129 4.3% U. S. Population (summer season) 0.002075 4.2% U. S. Population (autumn season) 0.002208 4.4% U. S. Population (winter season) 0.002060 4.1%

Northeast region 0.002098 4.2% Midwest region 0.002360 4.7% Southern region 0.001942 3.9% Western region 0.002147 4.3%

Hispanics 0.002297 4.6% Non hispanic whites 0.002126 4.3% Non hispanic blacks 0.001914 3.8% Non hisp/ non white/ non black 0.002242 4.5%

All infants (< 1 year) 0.003629 7.3% Nursing infants 0.000963 1.9% Non nursing infants 0.004751 9.5% Children 1 6 yrs 0.007304 14.6% Children 7 12 yrs 0.003899 7.8%

Females 13 19 (not preg or nursing) 0.001791 3.6% Females 20+ (not preg or nursing) 0.001104 2.2% Females 13 50 yrs 0.001265 2.5% Females 13+ (preg/ not nursing) 0.001947 3.9% Females 13+ (nursing) 0.001973 3.9%

Males 13 19 yrs 0.002315 4.6% Males 20+ yrs 0.001183 2.4% Seniors 55+ 0.001123 2.2% Pacific Region 0.002128 4.3%

 [Hexazinone] Dietary Exposure Assessment DP Barcode: [D279898] PC Code: [107201] Page: 9 of 13 Attachment (electronic file id 107201accr. rs7).

cc: JSPunzi (RRB2), Hexazinone Reg. Std. File, Hexazinone SF, RF, LAN. 7509C: RRB2: John S. Punzi: CM2: Rm 712M: 703 305 7727: 05/ 15/ 2002. "hexazinone" 0.05 NEWD, 0.04 NOEL, 0 0 0 05 15 2002/ 12: 12: 42 999 0 7 "01009AA"," 13B", 0.3 1 1 7 "Blueberries", "" 11 Uncooked, 0.3 1 1 "" 12 Cooked: NFS, 0.3 1 1 "" 13 Baked, 0.3 1 1 "" 14 Boiled, 0.3 1 1 "" 15 Fried, 0.3 1 1 "" 31 Canned: NFS, 0.3 1 1 "" 41 Frozen: NFS, 0.3 1 1 "" 89 "06013AA"," O", 0.3 1 1 7 "Pineapples peeled fruit", "" 11 Uncooked, 0.3 1 1 "" 12 Cooked: NFS, 0.3 1 1 "" 13 Baked, 0.3 1 1 "" 14 Boiled, 0.3 1 1 "" 31 Canned: NFS, 0.3 1 1 "" 33 Canned: Baked, 0.3 1 1 "" 41 Frozen: NFS, 0.3 1 1 "" 90 "06013DA"," O", 0.3 5 1 1 "Pineapples dried", "" 18 Dried, 0.3 5 1 "" 91 "06013JA"," O", 0.3 1.7 1 5 "Pineapples juice", "" 11 Uncooked, 0.3 1.7 1 "" 12 Cooked: NFS, 0.3 1.7 1 "" 14 Boiled, 0.3 1.7 1 "" 31 Canned: NFS, 0.3 1.7 1 "" 42 Frozen: Cooked, 0.3 1.7 1 "" 283 "25003SA"," O", 0.6 1 1 0 "Sugar cane", "" 284 "25003SB"," O", 4 1 1 0 "Sugar cane/ molasses", "" 318 "50000DB"," D", 0.24 1 1 0 "Milk nonfat solids", "" 319 "50000FA"," D", 0.24 1 1 14 "Milk fat solids", "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 16 Pasteurized, 0.24 1 1 "" 18 Dried, 0.24 1 1 "" 31 Canned: NFS, 0.24 1 1 "" 32 Canned: Cooked, 0.24 1 1 "" 34 Canned: Boiled, 0.24 1 1 "" 41 Frozen: NFS, 0.24 1 1 "" 42 Frozen: Cooked, 0.24 1 1 "" 45 Frozen: Fried, 0.24 1 1 "" 51 Cured: NFS (smoked/ p, 0.24 1 1 "" 52 Cured: Cooked( smokd/, 0.24 1 1 "" 320 "50000SA"," D", 0.24 1 1 14 "Milk sugar (lactose)", "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 16 Pasteurized, 0.24 1 1 "" 18 Dried, 0.24 1 1 "" 31 Canned: NFS, 0.24 1 1 "" 32 Canned: Cooked, 0.24 1 1 "" 34 Canned: Boiled, 0.24 1 1 "" 41 Frozen: NFS, 0.24 1 1 "" 42 Frozen: Cooked, 0.24 1 1 "" 45 Frozen: Fried, 0.24 1 1 "" 51 Cured: NFS (smoked/ p, 0.24 1 1 "" 52 Cured: Cooked( smokd/, 0.24 1 1 "" 321 "53001BA"," M", 0.24 1 1 8 "Beef meat byproducts", "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 31 Canned: NFS, 0.24 1 1 "" 41 Frozen: NFS, 0.24 1 1 "" 42 Frozen: Cooked, 0.24 1 1 "" 52 Cured: Cooked( smokd/, 0.24 1 1 "" 322 "53001BB"," M", 0.24 1 1 3 "Beef other organ meats", "" 12 Cooked: NFS, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 52 Cured: Cooked( smokd/, 0.24 1 1 "" 323 "53001DA"," M", 0.24 1.92 1 0 "Beef dried", "" 325 "53001KA"," M", 0.24 1 1 2 "Beef kidney", "" 12 Cooked: NFS, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 326 "53001LA"," M", 0.24 1 1 3 "Beef liver", "" 12 Cooked: NFS, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 327 "53001MA"," M", 0.24 1 1 13 "Beef lean (fat/ free) w/ o bones", "" 11 Uncooked, 0.24 1 1 "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 31 Canned: NFS, 0.24 1 1 "" 32 Canned: Cooked, 0.24 1 1 "" 33 Canned: Baked, 0.24 1 1 "" 34 Canned: Boiled, 0.24 1 1 "" 42 Frozen: Cooked, 0.24 1 1 "" 51 Cured: NFS (smoked/ p, 0.24 1 1 "" 52 Cured: Cooked( smokd/, 0.24 1 1 "" 59 Cured: Dried (smokd/, 0.24 1 1 "" 328 "53002BA"," M", 0.24 1 1 0 "Goat meat byproducts", "" 329 "53002BB"," M", 0.24 1 1 0 "Goat other organ meats", "" 331 "53002KA"," M", 0.24 1 1 0 "Goat kidney", "" 332 "53002LA"," M", 0.24 1 1 0 "Goat liver", "" 333 "53002MA"," M", 0.24 1 1 3 "Goat lean (fat/ free) w/ o bone", "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 334 "53003AA"," M", 0.24 1 1 0 "Horsemeat", "" 336 "53005BA"," M", 0.24 1 1 2 "Sheep meat byproducts", "" 12 Cooked: NFS, 0.24 1 1 "" 31 Canned: NFS, 0.24 1 1 "" 337 "53005BB"," M", 0.24 1 1 0 "Sheep other organ meats", "" 339 "53005KA"," M", 0.24 1 1 0 "Sheep kidney", "" 340 "53005LA"," M", 0.24 1 1 0 "Sheep liver", "" 341 "53005MA"," M", 0.24 1 1 4 "Sheep lean (fat free) w/ o bone", "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 398 "50000WA"," D", 0.24 1 1 15 "Milk based water", "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 16 Pasteurized, 0.24 1 1 "" 18 Dried, 0.24 1 1 "" 31 Canned: NFS, 0.24 1 1 "" 32 Canned: Cooked, 0.24 1 1 "" 33 Canned: Baked, 0.24 1 1 "" 34 Canned: Boiled, 0.24 1 1 "" 41 Frozen: NFS, 0.24 1 1 "" 42 Frozen: Cooked, 0.24 1 1 "" 43 Frozen: Baked, 0.24 1 1 "" 45 Frozen: Fried, 0.24 1 1 "" 52 Cured: Cooked( smokd/, 0.24 1 1 "" 406 "06013JC"," O", 0.3 6.3 1 4 "Pineapples juice concentrate", "" 12 Cooked: NFS, 0.3 6.3 1 "" 31 Canned: NFS, 0.3 6.3 1 "" 33 Canned: Baked, 0.3 6.3 1 "" 41 Frozen: NFS, 0.3 6.3 1 "" 425 "56000MA"," M", 0.24 1 1 5 "Veal lean (fat free) w/ o bones", "" 12 Cooked: NFS, 0.24 1 1 "" 13 Baked, 0.24 1 1 "" 14 Boiled, 0.24 1 1 "" 15 Fried, 0.24 1 1 "" 31 Canned: NFS, 0.24 1 1 "" 426 "56000KA"," M", 0.24 1 1 0 "Veal kidney", "" 427 "56000LA"," M", 0.24 1 1 0 "Veal liver", "" 428 "56000BB"," M", 0.24 1 1 0 "Veal other organ meats", "" 429 "56000DA"," M", 0.24 1.92 1 0 "Veal dried", "" 430 "56000BA"," M", 0.24 1 1 0 "Veal meat byproducts", ""


[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3406-3408]
[FR Doc No: 2023-00940]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0756; FRL-10116-01-OCSPP]

Availability of New Approach Methodologies in the Endocrine
Disruptor Screening Program; Notice of Availability and Opportunity for
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on a draft White Paper
entitled ``Availability of New Approach Methodologies (NAMs) in the
Endocrine Disruptor Screening Program (EDSP).'' This draft White Paper
was developed pursuant to the Federal, Food, Drug and Cosmetic Act
(FFDCA), which requires EPA to develop a screening program, to
determine whether certain substances may have an effect in humans that
is similar to an effect produced by a naturally occurring estrogen, or
other endocrine effects. This draft White Paper announces that certain
NAMs have been validated and may now be accepted by the EPA as
alternatives for certain EDSP Tier 1 assays while others are useful for
prioritization purposes and for use as other scientifically relevant
information, where appropriate, in weight of evidence evaluations.

DATES: Comments must be received on or before March 20, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2021-0756, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Natalie Bray, Pesticide Reregistration
Division (7508M), Office of Pesticide Programs, Environmental
Protection Agency; telephone number:<PHONE_NUMBER>; email address:
bra[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions

regarding the applicability of this action to a particular entity,
contact the person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. In addition to one complete
version of the comment that includes information claimed as CBI, a copy
of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
    2. Multimedia submissions. Multimedia submissions (audio, video,
etc.) must be accompanied by a written comment. The written comment is
considered the official comment and should include discussion of all
points you wish to make. The EPA will generally not consider comments
or comment contents located outside of the primary submission (i.e., on
the web, cloud, or other file sharing system).
    3. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html. Please note that once submitted, comments cannot be
edited or removed from the docket. The EPA may publish any comment
received to its public docket.

II. Executive Summary

A. What is the Agency's authority for taking this action?

    Section 408(p)(1) of the Federal, Food, Drug and Cosmetic Act
(FFDCA), 21 U.S.C. 408, requires EPA to ``develop a screening program,
using appropriate validated test systems and other scientifically
relevant information, to determine whether certain substances may have
an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or such other endocrine effects as [EPA]
may designate.''

B. What action is the Agency taking?

    The Agency is releasing the draft document entitled ``Availability
of New Approach Methodologies (NAMs) in the Endocrine Disruptor
Screening Program (EDSP)'' [herein called the draft ``White Paper''].
This draft White Paper announces that certain NAMs have been validated
and may now be accepted by the EPA as alternatives for certain EDSP
Tier 1 assays while others are useful for prioritization purposes and
for use as other scientifically relevant information, where
appropriate, in weight of evidence evaluations. The draft White Paper
provides further details concerning when specified NAMs may be used.
    In 1998, pursuant to FFDCA section 408(p)(1), EPA introduced the
EDSP including the use of a two-tiered screening framework consisting
of a battery of in vitro and in vivo assays (63 FR 42852, August 11,
1998 (FRL-6021-3) and 63 FR 71542, December 28, 1998 (FRL-6052-9)). The
purpose of Tier 1 screening is to identify chemicals that have
potential biological activity (``bioactivity'') in the estrogen,
androgen or thyroid hormone pathways using a battery of assays. For
more than a decade at the EPA, research efforts have focused on the
development and evaluation of high-throughput in vitro assays and in
silico methods as NAMs, including databases and computational models,
for use as alternatives to the current suite of assays in the EDSP Tier
1 battery to accelerate the pace of screening, add efficiencies,
decrease costs, and reduce animal testing.
    EPA has determined that the Estrogen Receptor (ER) pathway model
based on the full 18-assay ToxCast/Tox21 battery may be used as an
alternative to performing certain EDSP Tier 1 screening assays: ER
binding in vitro assay (OCSPP 890.1250), ER transcriptional activation
in vitro assay (ERTA; OCSPP 890.1300), and the in vivo Uterotrophic
assay (rat) (OCSPP 890.1600). EPA has further determined that the
Androgen Receptor (AR) pathway model based on the full 11-assay
ToxCast/Tox21 battery may be used as an alternative for the AR binding
in vitro assay (OCSPP 890.1150). The data from these NAMs will be
evaluated on a chemical-by-chemical basis (each assay evaluated
independently).
    The following models and assays are not yet accepted by the EDSP as
alternatives per se for Tier 1 screening assays, but may be used for
priority setting for EDSP Tier 1 screening or for consideration for use
as other scientifically relevant information, where appropriate in
weight of evidence evaluations:
    (1) ER and AR pathway models using assay subsets (also referred to
as reduced or minimal assay data sets); (2) In Silico Qualitative
Structure Activity Relationship Consensus Models for ER and AR (https://ntp.niehs.nih.gov/whatwestudy/niceatm/comptox/ct-opera/opera.html);
(3) Integration of Bioactivity and Exposure (Integrated Bioactivity
Exposure Ratio), which compares an estimated external dose threshold
for a biological effect, based on an internal dose (i.e., plasma
concentration) derived from bioactivity data (e.g., ER and AR pathway
model outputs), with estimates of exposure; and, (4) The Sequence
Alignment to Predict Across Species Susceptibility (SeqAPASS) tool for
interspecies extrapolation.
    EPA requests the public provide comment on the clarity and
completeness of the draft document. Given the strengths and
uncertainties of these methods, EPA also requests the public provide
comment on the draft conclusions that certain NAMs have been validated
and may now be accepted by the EPA as alternatives for certain EDSP
Tier 1 assays while others are useful for prioritization purposes and
for consideration for use as other scientifically relevant information.
    Included in the docket for this action are two documents that
respond to comments on related subject matter. One document responds to
comments received in response to a notice issued in the Federal
Register of June 19, 2015 (80 FR 35350 (FRL-9928-69), see also docket
ID No. EPA-HQ-OPPT-2015-0305) requesting comment on EPA's document
titled ``Endocrine Disruptor Screening Program: Use of High Throughput
Assays and Computational Tools.'' The other document contains EPA's
responses to comments regarding the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) Meeting from
November 28-30, 2017 (82 FR 26097, June 6, 2017 (FRL-9962-79) and 82 FR
36137, August 3, 2017 (FRL-9965-61), see also docket ID No. EPA-HQ-OPP-
2017-0214). EPA is including these documents in the docket for this
action because they provide useful context on past public input on the
EDSP which EPA considered when developing the draft White Paper. EPA is
not requesting public comment on these response to comments documents.

III. Do guidance documents contain binding requirements?

    As guidance, the draft White Paper is not binding on the Agency or
any outside parties, and the Agency may depart from it where
circumstances warrant and without prior notice. While EPA has made
every effort to ensure the accuracy of the discussion in the guidance,
the obligations of EPA and the regulated community are determined by
statutes, regulations, or other legally binding documents. In the event
of a conflict between the discussion in the guidance documents and any
statute,

regulation, or other legally binding document, the guidance documents
will not be controlling.
    Authority: 21 U.S.C. 408.

    Dated: January 13, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-00940 Filed 1-18-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17212-17214]
[FR Doc No: 2014-06758]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71764; File No. SR-CBOE-2014-003]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Granting Approval of Proposed Rule Change To List
and Trade CBOE Short-Term Volatility Index Options

March 21, 2014.

I. Introduction

    On January 27, 2014, the Chicago Board Options Exchange,
Incorporated (``Exchange'' or ``CBOE'') filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to list options on the CBOE
Short-Term Volatility Index (``VXST''). The proposed rule change was
published for comment in the Federal Register on February 6, 2014.\3\
The Commission received no comments on the proposed rule change. This
order grants approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 71458 (January 31,
2014), 79 FR 7239 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The Exchange proposes to list and trade A.M. cash-settled,
European-style options on the VXST, which will expire every week.
According to the Exchange, VXST is designed to measure investors'
consensus view of future (nine day) expected stock market volatility,
and VXST options will trade alongside the existing CBOE Volatility
Index (``VIX'') options (which expire on a monthly basis and measure a
30 day period of implied volatility).\4\ The Exchange states that the
calculation of VXST is based on the VIX methodology as applied to
option series on the S&P 500 index that expire on every Friday.\5\ The
constituent S&P 500 index options that expire on a Friday (i.e., nine
days from the VXST option expiration date, which is typically a
Wednesday in the preceding week) may include the following types of
options on the S&P 500 index: Standard monthly options, End-of-Week
(``EOW'') expirations, and Quarterly Index (``QIX'') expirations.
According to the Exchange, because some of the constituent options used
to calculate VXST are A.M.-settled and some are P.M.-settled, the
amount of time covered by a specific contract will vary slightly
depending on the type of series used for any given A.M.-settled VXST
option.\6\
---------------------------------------------------------------------------

    \4\ According to the Exchange, the VXST index was introduced by
CBOE on October 1, 2013 and has been disseminated at least once a
day on every trading day since that time. See Notice, supra note 3,
at 7239-40.
    \5\ The Exchange states that VXST is calculated in the same
manner as other volatility indexes (e.g., VIX). A more detailed
explanation of the method used to calculate the VIX may be found on
the CBOE's Web site at http://www.cboe.com/micro/vix/vixwhite.pdf.
See Notice, supra note 3, at 7240.
    \6\ For a VXST option contract calculated using A.M.-settled
standard S&P 500 index options, the period of implied volatility
covered by the contract will be exactly nine days. For a VXST option
contract calculated using P.M.-settled EOW or QIX on the S&P 500
index, the period of implied volatility covered by the contract will
be nine days, plus 390 minutes. See Notice, supra note 3, at 7240.
---------------------------------------------------------------------------

    Similar to VIX and VIX options, the cash (spot) VXST value will be
calculated using premium quotations and the exercise settlement value
for VXST options will be calculated using the actual opening premium
prices of the constituent S&P 500 index options on the expiration day
of the VXST option.\7\ The Exchange will compute values for VXST on a
real-time basis throughout each trading day, from approximately 8:30
a.m. (Chicago time) until approximately 3:15 p.m. (Chicago time).\8\
VXST levels will be calculated by CBOE and generally disseminated at
15-second intervals to major market data vendors.\9\ The trading hours
for VXST options will be from 8:30 a.m. to 3:15 p.m. (Chicago
time).\10\
---------------------------------------------------------------------------

    \7\ See id.
    \8\ See id.
    \9\ According to the Exchange, when VIX options and VXST options
expire on the same day, as the calculator of volatility indexes,
CBOE would not begin disseminating the spot (cash) values for any
volatility index that CBOE calculates until the S&P 500 index option
series that CBOE will use to calculate the exercise settlement value
for VIX options have opened. On all other VXST option expiration
days, as the calculator of volatility indexes, CBOE would not begin
disseminating the spot (cash) values for any volatility index that
CBOE calculates until the S&P 500 index option series that CBOE will
use to calculate the exercise settlement value for VXST options have
opened. See id., at n. 8.
    \10\ See id., at 7241.
---------------------------------------------------------------------------

    The Exchange proposes to list up to 12 near-term VXST option
expiration weeks, and that new series will be permitted to be added up
to and including on the last day of trading for an expiring VXST option
contract.\11\
---------------------------------------------------------------------------

    \11\ See CBOE Rules 24.9(a)(2) and 24.9.01(c).
---------------------------------------------------------------------------

    As proposed, the exercise settlement value for a VXST option will
be calculated on the specific date (usually a Wednesday) identified in
the option symbol for the series.\12\ If that

Wednesday or the Friday in the business week following that Wednesday
(i.e., nine days away) is an Exchange holiday, the exercise settlement
value will be calculated on the business day immediately preceding the
Wednesday.\13\ According to the Exchange, on the day the exercise
settlement value is calculated for VXST options, modified Hybrid
Opening System (``HOSS'') opening procedures will be used to calculate
the exercise settlement value.\14\ The exercise settlement value of a
VXST option will be calculated by the Exchange as a Special Opening
Quotation (``SOQ'') of VXST using the sequence of opening prices of the
options that comprise the VXST index.\15\ The opening price for any
series in which there is no trade will be the average of that option's
bid price and ask price as determined at the opening of trading.\16\
The ``time to expiration'' used to calculate the SOQ will account for
the actual number of days and minutes until expiration for the
constituent option series.\17\
---------------------------------------------------------------------------

    \12\ See CBOE Rule 24.9(a)(6). According to the Exchange, option
symbols are constructed as follows: Symbol + Expiration Date (Year,
Month, Day) + Call or Put + Strike Price (in dollars to three
decimal places). See Notice, supra note 3, at n. 14.
    \13\ See CBOE Rule 24.9(a)(6).
    \14\ See CBOE Rules 6.2B.01 and 6.2B.08. The Exchange states
that the main feature of the modified HOSS opening procedures is the
strategy order cut-off time for the constituent option series that
will be used to calculate the exercise settlement value of a
volatility index. See Notice, supra note 3, at n. 15.
    \15\ See CBOE Rule 24.9(a)(6).
    \16\ See id.
    \17\ See id.
---------------------------------------------------------------------------

    The expiration date of a VXST option will be on the same day that
the exercise settlement value of the VXST option is calculated.\18\ The
last trading day for a VXST option will be the business day immediately
preceding the expiration date of the VXST option (typically a
Tuesday).\19\ When the last trading day is moved because of an Exchange
holiday, the last trading day for an expiring VXST option contract will
be the day immediately preceding the last regularly scheduled trading
day.\20\ Exercise will result in delivery of cash on the business day
following expiration. The exercise-settlement amount will be equal to
the difference between the exercise-settlement value and the exercise
price of the option, multiplied by $100.
---------------------------------------------------------------------------

    \18\ See id.
    \19\ See id.
    \20\ See id.
---------------------------------------------------------------------------

    As proposed, VXST options will be quoted in index points and
fractions and one point will equal $100.\21\ The Exchange proposes that
the minimum tick size for series trading below $3 will be 0.05 ($5.00)
and above $3 will be 0.10 ($10.00).\22\ The Exchange proposes to permit
$0.50 (or greater) strike price intervals for VXST options where the
strike price is less than $75. The Exchange also proposes to permit $1
(or greater) strike price intervals for VXST options where the strike
price is $200 or less. Further, the Exchange proposes to permit $5 (or
greater) strike price intervals for VXST options where the strike price
is greater than $200.\23\
---------------------------------------------------------------------------

    \21\ See Notice, supra note 3, at 7240.
    \22\ See id., at 7240-41.
    \23\ See CBOE Rules 5.5.23 and 24.9.01(i). The Exchange also
proposes to make a technical change to CBOE Rule 24.9.12, which
permits $0.50 and $1 strike price intervals for index options used
to calculate volatility indexes. Specifically, the Exchange notes
that it proposes to add ``and $150'' to the rule text as those two
words were inadvertently omitted from the proposed rule text changes
to Rule 24.9.12 contained in original rule filing, but were
described in detail in the purpose section. See Notice, supra note
3, at 7241 and n. 13.
---------------------------------------------------------------------------

    The Exchange does not propose to establish any position or exercise
limits for VXST options.\24\ In addition, the Exchange proposes that
VXST options be margined as ``broad-based index'' options.\25\ The
Exchange notes that, except as modified by this proposed rule change,
Chapters I through XIX and Chapter XXIV of its rules will apply to VXST
options.\26\
---------------------------------------------------------------------------

    \24\ See CBOE Rules 24.4(a) and 24.5. According to the Exchange,
VXST options will be subject to the same reporting requirements
triggered for other options dealt in on the Exchange. See Notice,
supra note 3, at 7242 and CBOE Rule 24.4.03.
    \25\ See CBOE Rules 12.3 and 24.4.04.
    \26\ See Notice, supra note 3, at 7242.
---------------------------------------------------------------------------

    The Exchange states that it has analyzed its capacity and
represents that it believes the Exchange and the Options Price
Reporting Authority (``OPRA'') have the necessary systems capacity to
handle the additional traffic associated with the listing of new series
that will result from the introduction of VXST options.\27\
---------------------------------------------------------------------------

    \27\ See id.
---------------------------------------------------------------------------

    The Exchange represents that it will use the same surveillance
procedures currently utilized for its other index options to monitor
trading in VXST options, as well as enhanced surveillance procedures at
expiration, several of which would be automated.\28\ The Exchange
further represents that these surveillance procedures will be adequate
to monitor trading in VXST options.\29\ The Exchange states that, for
surveillance purposes, it will have complete access to information
regarding trading activity in the pertinent underlying securities.\30\
---------------------------------------------------------------------------

    \28\ See id.
    \29\ See id.
    \30\ See id.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\31\
Specifically, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\32\ which requires, among
other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system and, in general, to protect investors and the public
interest. Specifically, the Commission believes that VXST options will
provide investors with an additional trading and hedging mechanism. In
addition, the Commission believes that the Exchange's proposal with
respect to position limits, margin, strike price intervals, minimum
trading increments, series openings, exercise limits, and other aspects
of the proposed rule change are appropriate and consistent with the
Act.
---------------------------------------------------------------------------

    \31\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \32\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As a national securities exchange, the Exchange is required, under
Section 6(b)(1) of the Act,\33\ to enforce compliance by its members
and persons associated with its members with the provisions of the Act,
Commission rules and regulations thereunder, and its own rules. In this
regard, the Commission notes that trading of VXST options will be
subject to Chapters I through XIX and Chapter XXIV of CBOE rules.\34\
Moreover, the Exchange has represented that it will use the same
surveillance procedures currently utilized for its other index options
to monitor trading in VXST options, as well as enhanced surveillance
procedures at expiration, several of which would be automated.\35\ The
Exchange has represented that these surveillance procedures will be
adequate to monitor trading in VXST options.\36\ The Exchange also
stated that it will have complete access to information regarding
trading activity in the pertinent underlying securities.\37\ In
approving the proposed listing and trading of the VXST options, the
Commission has also relied on the Exchange's representation that it and
the OPRA have the necessary systems

capacity to handle the additional traffic associated with the listing
of new series that will result from the introduction of VXST
options.\38\
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78f(b)(1).
    \34\ See supra note 26 and accompanying text.
    \35\ See supra note 28 and accompanying text.
    \36\ See supra note 29 and accompanying text.
    \37\ See supra note 30 and accompanying text.
    \38\ See supra note 27 and accompanying text.
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\39\ that the proposed rule change (SR-CBOE-2014-003) be, and
hereby is, approved.
---------------------------------------------------------------------------

    \39\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\40\
---------------------------------------------------------------------------

    \40\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-06758 Filed 3-26-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41528-41529]
[FR Doc No: 2021-16404]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-330, OMB Control No. 3235-0372]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, Washington, DC 20549-0213

Extension:
     Rule 15c2-12

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 15c2-12--Municipal
Securities Disclosure (17 CFR 240.15c2-12) under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act''). The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Paragraph (b) of Rule 15c2-12 requires underwriters of municipal
securities: (1) To obtain and review an official statement ``deemed
final'' by an issuer of the securities, except for the omission of
specified information prior to making a bid, purchase, offer, or sale
of municipal securities; (2) in non-competitively bid offerings, to
send, upon request, a copy of the most recent preliminary official
statement (if one exists) to potential customers; (3) to contract with
the issuer to receive, within a specified time, sufficient copies of
the final official statement to comply with Rule 15c2-12's delivery
requirement and the rules of the Municipal Securities Rulemaking Board
(``MSRB''); (4) to send, upon request, a copy of the final official
statement to potential customers for a specified period of time; and
(5) before purchasing or selling municipal securities in connection
with an offering, to reasonably determine that the issuer or the
obligated person has undertaken, in a written agreement or contract,
for the benefit of holders of such municipal securities, to provide
certain information on a continuing basis to the MSRB in an electronic
format as prescribed by the MSRB. The information to be provided
consists of: (1) Certain annual financial and operating information and
audited financial statements (``annual filings''); (2) notices of the
occurrence of any of 16 specific events (``event notices''); and (3)
notices of the failure of an issuer or

obligated person to make a submission required by a continuing
disclosure agreement (``failure to file notices'').
    Rule 15c2-12 is intended to enhance disclosure, and thereby reduce
fraud, in the municipal securities market by establishing standards for
obtaining, reviewing and disseminating information about municipal
securities by their underwriters.
    Municipal offerings of less than $1 million are exempt from the
rule, as are offerings of municipal securities issued in large
denominations that are sold to no more than 35 sophisticated investors
or have short-term maturities.
    It is estimated that approximately 28,000 issuers, 250 broker-
dealers and the MSRB will spend a total of 797,681 hours per year
complying with Rule 15c2-12.\1\ Based on data from the MSRB through
December 2020, issuers annually submit approximately 61,964 annual
filings to the MSRB. Commission staff estimates that an issuer will
require approximately seven hours to prepare and submit annual filings
to the MSRB. Therefore, the total annual burden on issuers to prepare
and submit 61,964 annual filings to the MSRB is estimated to be 433,748
hours. Based on data from the MSRB through December 2020, issuers
annually submit approximately 54,121 event notices to the MSRB.
Commission staff estimates that an issuer will require approximately
four hours to prepare and submit event notices to the MSRB. Therefore,
the total annual burden on issuers to prepare and submit 54,121 event
notices to the MSRB is estimated to be 216,484 hours. Based on data
from the MSRB through December 2020, issuers annually submit
approximately 3,597 failure to file notices to the MSRB. Commission
staff estimates that an issuer will require approximately two hours to
prepare and submit failure to file notices to the MSRB. Therefore, the
total annual burden on issuers to prepare and submit 3,597 failure to
file notices to the MSRB is estimated to be 7,194 hours. Commission
staff estimates that the total annual burden on broker-dealers to
comply with Rule 15c2-12 is 115,255 hours. Finally, Commission staff
estimates that the MSRB will incur an annual burden of 25,000 hours to
collect, index, store, retrieve and make available the pertinent
documents under Rule 15c2-12.
---------------------------------------------------------------------------

    \1\ 54,121 (annual number of event notices) x 4 (average
estimate of hours needed to prepare and submit each) + 61,964
(annual number of annual filings) x 7 (average estimate of hours
needed to prepare and submit each) + 3,597 (annual number of failure
to file notices) x 2 (average estimate of hours needed to prepare
and submit each) = 657,426 hours. 657,426 hours (estimated total
annual burden on issuers) + 25,000 (estimated total annual MSRB
burden) + 115,255 (estimated total annual burden on broker-dealers)
= 797,681 hours.
---------------------------------------------------------------------------

    The Commission estimates that up to 65% of issuers may use
designated agents to submit some or all of their continuing disclosure
documents to the MSRB. The Commission estimates that the average total
annual cost that may be incurred by issuers that use the services of a
designated agent will be $15,470,000.\2\ Further, the Commission
estimates that issuers will retain outside counsel to assist with
filing approximately 1,100 event notices. The Commission estimates the
average total annual cost incurred by issuers to retain outside counsel
to assist in the evaluation and preparation of certain event notices
will be $1,760,000.\3\ Thus, the total estimated cost to issuers to
comply with the rule is $17,230,000.\4\ The Commission estimates that
the MSRB will incur total annual costs of $670,000 to operate the
continuing disclosure service for the MSRB's Electronic Municipal
Market Access (``EMMA'') system.
---------------------------------------------------------------------------

    \2\ 28,000 (number of issuers) x .65 (percentage of issuers that
may use designated agents) x $850 (estimated average annual cost for
issuer's use of designated agent to submit filings to the Rule) =
$15,470,000.
    \3\ 1,100 (estimate of number of event notices requiring outside
counsel) x 4 (estimated number of hours for outside attorney to
assist in the preparation of such event notice) x $400 (hourly wage
for an outside attorney) = $1,760,000. The Commission recognizes
that the costs of retaining outside professionals may vary depending
on the nature of the professional services, but for purposes of this
PRA analysis we estimate that costs of outside counsel would be an
average of $400 per hour.
    \4\ $15,470,000 (estimated total cost for issuer's use of
designated agent to submit filings) + $1,760,000 (estimated total
cost for issuer to employ outside counsel in the examination,
preparation, and filing of certain event notices) = $17,230,000.
---------------------------------------------------------------------------

    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number. Please direct your
written comments to: David Bottom, Director/Chief Information Officer,
Securities and Exchange Commission, c/o Cynthia Roscoe, 100 F Street
NE, Washington, DC 20549, or send an email to<EMAIL_ADDRESS>
    Dated: July 28, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-16404 Filed 7-30-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 210 (Tuesday, November 1, 2022)]
[Notices]
[Pages 65776-65779]
[FR Doc No: 2022-23728]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2440]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Biologics License Applications Procedures and
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with biologics license application (BLA) procedures and
requirements.

DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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-2022-N-2440 for ``Biologics License Applications Procedures and
Requirements.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Biologics License Applications Procedures and Requirements

OMB Control Number 0910-0338--Extension

    This information collection supports Agency regulations and
recommendations found in associated guidance pertaining to BLA
procedures and requirements. A BLA is a request for permission to
introduce, or deliver for introduction, a biological product into
interstate commerce (601.2 (21 CFR 601.2)). BLAs are regulated under
parts 600 through 680 (21 CFR parts 600 through 680). A BLA is
submitted by any legal person or entity who is engaged in manufacture
or an applicant for a license who takes responsibility for compliance
with product and establishment standards. Interested persons may visit
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber for
additional information, including available Agency resources.
    Regulations in part 601 set forth applicable procedures for the
submission of license application information, including content and
format elements. The regulations also explain requirements for
suspension, revocation, and reissuance of BLAs and communicate
procedures for requesting a hearing. Additionally, the information
collection includes the submission of manufacturing change information
governed by section 506A of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 356a), as well as postmarketing reports for
approved human drugs and licensed biological products governed by
section 506B of the FD&C Act (21 U.S.C. 356b). Finally, regulations in
parts 610 through 680 establish both general and specific biological
product standards.
    To implement these provisions, we have developed the following
collection instruments:

1. Forms

    Form FDA 356h, Application to Market a New or Abbreviated New Drug
or Biologic for Human Use, provides a uniform format for submitting
BLAs. Form FDA 356h is a fillable PDF form that may be submitted
through our Electronic Submission Gateway (ESG), for which respondents
must create and maintain a user account. Utilizing Form FDA 356h helps
to ensure that an application is complete and contains all the
necessary information, so that delays due to lack of information may be
avoided. In addition, the form provides key information to FDA for
efficient handling and distribution to the appropriate staff for
review. We have recently made minor updates to Form FDA 356h resulting
from the October 3, 2022, reauthorization of the Prescription Drug User
Fee Act (PDUFA). In this collection we account for BLAs submitted using
Form FDA 356h.
    Form FDA 2252, Transmittal of Annual Report for Drugs and Biologics
for Human Use, is used by an applicant of a licensed biological product
to submit annual reports required by Sec.  601.70(b) (21 CFR
601.70(b)). Form FDA 2252 is also a fillable PDF form and approved in
OMB control number 0910-0001; however, in this information collection
we account for submissions pertaining to biological products.
    Form FDA 2253, Transmittal of Advertisements and Promotional
Labeling for Drugs and Biologics for Human Use, was developed for use
by respondents to transmit specimens of advertisements and promotional
labeling (e.g., circulars, package labels, container labels, etc.), as
well as labeling changes. The submission of this information is
required by 601.12 (21 CFR 601.12) for biological products and by 21
CFR 314.81 for drug products. Form FDA 2253 is a fillable PDF form and
is approved for use in OMB control number 0910-0001; however, in this
information collection we account for submissions pertaining to
biological products.
    Form FDA 3674, Certificate of Compliance Under 42 U.S.C.
282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank, was
developed for use by respondents to certify submissions as required by
section 402(j)(5)(B) of the PHS Act and is submitted through our ESG.
Form FDA 3674 is a fillable PDF form and is approved for use in OMB
control number 0910-0616; however, in this information collection we
account for submissions pertaining to biological products.

2. Cover Sheets

    As provided for under part 601.2(a), we also utilize cover sheets,
so denoted for purposes of identifying specific content information
within a given application.

3. Guidance Documents

    The guidance document ``Cooperative Manufacturing Arrangements for
Licensed Biologics,'' (November 2008), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologics, discusses
strategies for meeting an increased need for flexible manufacturing
arrangements. Since cooperative manufacturing arrangements can take a
considerable amount of time to develop, the guidance is intended to be
useful for planning purposes in the early phases of product
development. Many companies that perform only limited aspects of
manufacturing processes are interested in sharing or contracting parts
of manufacturing to facilitate product development and manufacturing
flexibility. The guidance discusses recommended communication between
licensed manufacturers and contract manufacturers regarding changes to
production and facilities, results of tests and investigations
regarding the product, types of products manufactured in the contract
facility, and standard operating procedures. We believe that the
information collection provisions in the guidance do not create a new
burden for respondents. We believe the reporting and recordkeeping
provisions are part of usual and customary business practices.
    All Agency guidance documents issued are consistent with our good
guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable database of our
guidance documents at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    Respondents to this collection of information are licensed
manufacturers of biological products. Based on the number of 2021
fiscal year application submissions, we estimate there are 371 such
respondents. The total annual responses are based on the number of
submissions (i.e., license applications, labeling and other
supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. The
hours per response are based on informal communications with industry
and our experience with the information collection.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
21 CFR section or other citation; activity   Form FDA No.      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses                                        \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a) and 610.60 through 610.65;                   356h              51           1.078              55  860.........................          47,300
 Application for biologics license
 (includes labeling).
601.5(a); Requirement to notify FDA of                  NA              17          1.0589              18  0.33 (20 minutes)...........               6
 intention to discontinue manufacture of a
 product or all products.
601.6(a); Requirement to provide FDA with               NA               1               1               1  0.33 (20 minutes)...........               1
 copy of notification to selling agents
 and distributors upon suspension of its
 license.
601.12(a)(5); Requirement to inform FDA of              NA             327          10.263           3,356  1...........................           3,356
 changes to an approved application.
601.12(b)(1), (b)(3), and (e); Requirement            356h             195           5.795           1,130  80..........................          90,400
 to inform FDA of changes to an approved
 application.
601.12(c)(1) and (3); Requirement to                  356h             153          4.6536             712  50..........................          35,600
 inform FDA of changes to an approved
 application.
601.12(c)(5); Requirement to inform FDA of            356h              73           2.740             200  50..........................          10,000
 changes to an approved application.
601.12(d)(1), (d)(3), and (f)(3);                     356h             279           3.398             948  24..........................          22,752
 Requirement to inform FDA of changes to
 an approved application.
601.12(f)(1); Requirement to inform FDA of            2253              64            2.75             176  40..........................           7,040
 changes to an approved application.
601.12(f)(2); Requirement to inform FDA of            2253              66           1.758             116  20..........................           2,320
 changes to an approved application.
601.12(f)(4) and 601.45; Requirement to               2253             173         340.416          58,892  10..........................         588,920
 inform FDA of changes to an approved
 application.
601.27(b); Request for deferred submission              NA               9           1.778              16  24..........................             384
 of some or all safety and effectiveness
 assessments.
601.27(c); Request for full or partial                  NA               8               1               8  8...........................              64
 waiver of safety and effectiveness
 assessments.
601.70(b) and (d), and 601.28; Annual                 2252             101            1.84             186  24..........................           4,464
 progress reports of postmarketing studies.
610.15(d); Request for exceptions or                    NA               1               1               1  1...........................               1
 alternatives to the regulation for
 constituent materials.
680.1(c); Requirement to annually update a              NA               9               1               9  2...........................              18
 license file with the list of source
 materials and the suppliers of the
 materials.
680.1(b)(3)(iv); Requirement to notify FDA              NA               1               1               1  2...........................               2
 when certain diseases are detected in
 source materials.
601.12; Amendments/Resubmissions..........            356h             170          27.888            4741  20..........................          94,820
Section 402(j)(5)(B) of the PHS Act;                  3674           1,291               1           1,291  0.28 (17 minutes)...........             358
 Certification to accompany biological
 product applications.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ..............  ............................         907,806
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The numbers in this column have been rounded to the nearest whole number.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR section; activity         Number of      disclosures    Total annual    Average burden per    Total
                                    respondents   per respondent    disclosures        disclosure      hours \2\
----------------------------------------------------------------------------------------------------------------
601.6(a); Requirement to notify                1              20              20  0.33 (20 minutes)..          7
 selling agents and distributors
 upon suspension of license.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The number in this column has been rounded to the nearest whole number.

    Our estimated burden for the information collection reflects an
overall increase of 467,907 hours and a corresponding increase in
responses. We attribute part of this adjustment in the total hours to
an increase in the number of submissions that we have received under
601.12(b)(1) and (3), (e), and (f)(4), and 601.45 over the last few
years, which accounts for an increase of 467,549 hours. An additional
increase of 358 hours is associated with certifications on Form FDA
3674.

    Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23728 Filed 10-31-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Rules and Regulations]
[Pages 69990-69992]
[FR Doc No: 2021-26604]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0796; Project Identifier MCAI-2021-00098-R;
Amendment 39-21824; AD 2021-24-03]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus Helicopters Model AS355NP helicopters. This AD was prompted by a
report of mechanical deformation found on the protective cover (also
referred to as switch guard) of the ``SHEAR'' control pushbutton
installed on a co-pilot collective stick of a Model EC225LP helicopter,
caused by incorrect handling; due to having an identical design switch
guard installed on the pilot collective stick, Model AS355NP
helicopters are also affected. This AD requires replacement of the
protective cover of the ``SHEAR'' control pushbutton, and re-
identification of the pilot collective stick, as specified in a
European Union Aviation Safety Agency (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective January 13, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 13,
2022.

ADDRESSES: For EASA material incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
phone: +49 221 8999 000; email: [email protected]; internet:
www.easa.europa.eu. You may find the EASA material on the EASA website
at https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. It is also available
in the AD docket at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0796.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by

searching for and locating Docket No. FAA-2021-0796; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
EASA AD, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, Compliance & Airworthiness Division, FAA,
950 L'Enfant Plaza N SW, Washington, DC 20024; phone:<PHONE_NUMBER>;
email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0027R1, dated January 22, 2021
(EASA AD 2021-0027R1), to correct an unsafe condition for all Airbus
Helicopters (formerly Eurocopter) Model AS355NP helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Airbus Helicopters
Model AS355NP helicopters. The NPRM published in the Federal Register
on September 23, 2021 (86 FR 52853). The NPRM was prompted by a report
of mechanical deformation found on the protective cover (also referred
to as switch guard) of the ``SHEAR'' control pushbutton installed on a
co-pilot collective stick of a Model EC225LP helicopter, caused by
incorrect handling; due to having an identical design switch guard
installed on the pilot collective stick, Model AS355NP helicopters are
also affected. The NPRM proposed to require replacement of the
protective cover of the ``SHEAR'' control pushbutton, and re-
identification of the pilot collective stick, as specified in EASA AD
2021-0027R1.
    The FAA is issuing this AD to address mechanical deformation on the
protective cover of the ``SHEAR'' control pushbutton installed on the
pilot collective stick. The unsafe condition, if not addressed, could
result in unintended shearing of the hoist cable, possibly resulting in
injury to hoisted person(s). See EASA AD 2021-0027R1 for additional
background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these helicopters. Except for minor editorial changes,
this AD is adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0027R1 requires replacement of the protective cover of
the ``SHEAR'' control pushbutton, and re-identification of the pilot
collective stick. This material is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 2 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................            $360             $530           $1,060
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known costs
in the cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2021-24-03 Airbus Helicopters: Amendment 39-21824; Docket No. FAA-
2021-0796; Project Identifier MCAI-2021-00098-R.

(a) Effective Date

    This airworthiness directive (AD) is effective January 13, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Helicopters Model AS355NP
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6700, Rotorcraft
Flight Control.

(e) Unsafe Condition

    This AD was prompted by a report of mechanical deformation found
on the protective cover (also referred to as switch guard) of the
``SHEAR'' control pushbutton installed on a co-pilot collective
stick of a Model EC225LP helicopter, caused by incorrect handling;
due to having an identical design switch guard installed on the
pilot collective stick, Model AS355NP helicopters are also affected.
The FAA is issuing this AD to address mechanical deformation on the
protective cover of the ``SHEAR'' control pushbutton installed on
the pilot collective stick. The unsafe condition, if not addressed,
could result in unintended shearing of the hoist cable, possibly
resulting in injury to hoisted person(s).

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0027R1, dated January 22, 2021 (EASA AD 2021-0027R1).

(h) Exceptions to EASA AD 2021-0027R1

    (1) Where EASA AD 2021-0027R1 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) This AD does not require the ``Remarks'' section of EASA AD
2021-0027R1.

(i) Flight Condition Limitation

    As of the effective date of this AD: Do not perform external
load operations until the modification required by Paragraph (1) of
EASA AD 2021-0027R1 is complete.

(j) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-
0027R1 specifies to submit certain information to the manufacturer,
this AD does not include that requirement.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (l) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; phone:<PHONE_NUMBER>; email: [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0027R1,
dated January 22, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0027R1, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]; internet: www.easa.europa.eu. You may find the
EASA material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0796.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 10, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-26604 Filed 12-8-21; 8:45 am]
BILLING CODE 4910-13-P