lb ai/ Acre or lb ai/ gal* Acre/ day or gal/ day* M/ L/ A Derml.+ Inhln. Baseline ( Liquids) 4400 Low Pressure Handwand 5* ( WP/ WSP) N/ A ( Liquids) 40000 Hose end Sprayer Ornamentals ( woody and flowering plants), Shade Trees, Woody Shrubs and Vines 0.0024*

5* ( WP/ WSP) N/ A ( Liquids) 1300 Low Pressure Handwand 0.023 ( WP/ WSP) N/ A ( Liquids) 530 Hose end Sprayer Turf ( Lawns) 1.8 0.5 ( WP/ WSP) N/ A Note: ¹ Application rates are the maximum rates provided for propiconazole in all cases. ² Amount handled per day values are HED estimates of area treated based on Exposure SAC SOP # 12 " Recommended Revisions to the Standard Operating Procedures for Residential Exposure Assessments," and HED estimates. 51 7.1.4 Summary of Risk Concerns and Data Gaps for Handlers All residential handler exposure scenarios did not exceed HED's level of concern. [ Note: Although the risk for mixing/ loading/ applying propiconazole with a low pressure handwand is not a concern, ( MOE = 1100) it is important to note that most labels identify a hose end sprayer as the method of application. Additionally, all risk calculations were conducted using the maximum turf application rate ( 1.8 lb ai/ acre). However, a turf application rate of 0.51 lb ai/ acre was identified on a residential use product label ( 100 773). This lower application rate may better represent homeowner use.

Key data gaps have been identified and noted in the above table as N/ A. Neither ORETF nor PHED currently have data for hose end sprayer applications using wettable powder in water soluble packets ( see note in Section 1.5).

7.1.5 Recommendations for Refining Residential Handler Risk Assessment In order to refine this residential risk assessment, more data on actual use patterns including typical rates, timing, and areas treated would help better characterize propiconazole risks. Exposure studies for many equipment types that lack data or that are not well represented in PHED ( e. g., because of low replicate numbers or data quality) should also be considered based on the data gaps identified above and based on a review of the quality of the data used in this assessment.

7.2 Residential Post application Exposures and Risks HED uses the term " post application" to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. Propiconazole can be used in many areas that can be frequented by the general population including residential areas ( e. g., home lawns, golf courses). As a result, individuals can be exposed by entering these areas if they have been previously treated.

7.2.1 Residential Post application Exposure Scenarios A wide array of individuals of varying ages can potentially be exposed to propiconazole when they do activities in areas that have been previously treated. Post application exposure scenarios were developed for each residential setting where propiconazole can be used. Assessing post application exposures and risks resulting from residential uses is very similar to assessing occupational post application exposures and risks, except in residential assessments:

  Residential exposure assessments for propiconazloe were classified as short term exposure scenarios ( 1 30 days).

  Exposures were calculated for children as well as adults. 52   Non dietary ingestion exposures to toddlers were calculated ( i. e., soil ingestion, hand / object to mouth).

HED relies on a standardized approach for completing residential risk assessments that is based on current propiconazole labels and guidance contained in the following three documents.

  Series 875, Occupational and Residential Exposure Test Guidelines: Group B   Post application Exposure Monitoring Test Guidelines ( V 5.4, Feb. 1998) This document provides general risk assessment guidance and criteria for analysis of residue dissipation data.

  Standard Operating Procedures for Residential Exposure Assessment ( Dec. 1997). This document provides the overarching guidance for developing residential risk assessments including scenario development, algorithms, and values for inputs.

  Science Advisory Council For Exposure Policy 12 ( Feb. 2001): Recommended Revisions To The Standard Operating Procedures ( SOPs) For Residential Exposure Assessment This document provides additional, revised guidance for completing residential exposure assessments. When the guidance in current labels and these documents is considered, it is clear that HED should consider children as well as adults in its assessments. It is also clear that different age groups should be considered in different situations. The populations that were considered in the assessment include:

  Residential Adults: these individuals are members of the general population that are exposed to chemicals by engaging in activities at their residences ( e. g., in their lawns) and also in areas not limited to their residence ( e. g., golf courses or parks) previously treated with a pesticide. These kinds of exposures are attributable to a variety of activities and usually addressed by HED in risk assessments by considering a representative activity as the basis for the exposure calculation.

  Residential Children: children are members of the general population that can also be exposed in their residences ( e. g., on lawns) as well as other areas previously treated with a pesticide ( e. g., parks). These kinds of exposures are attributable to a playing outside. Toddlers have been selected as a sentinel ( or representative) population for turf. They are usually addressed by HED in risk assessments by considering representative activities in an exposure calculation.

The SOPs for Residential Exposure Assessment defines several scenarios that apply to uses specified in current labels. These scenarios served as the basis for the residential postapplication assessment along with the modifications to them and the additional data and approaches described above. HED used this guidance to define the exposure scenarios that essentially include dermal and non dietary ingestion exposure to toddlers and adults on treated lawns. The SOPs and the associated scenarios are presented below: 53   Post Application Dermal Potential Dose from Pesticide Residues on Turf: Postapplication dermal dose calculations for toddlers and adults from playing on treated turf;

  Post Application Potential Dose among Toddlers from Incidental Non dietary Ingestion of Pesticide Residues on Residential Lawns from hand to mouth Transfer: Postapplication dose calculations for toddlers from incidental non dietary ingestion of pesticide residues on treated turf from hand to mouth transfer ( i. e., those residues that are swallowed when toddlers get pesticide residues on their hands from touching treated turf and then put their hands in their mouth);

  Post Application Potential Dose among Toddlers from Incidental Non dietary Ingestion of Pesticide Residues on Residential Lawns from object to mouth Transfer: Postapplication dose calculations for toddlers from incidental non dietary ingestion of pesticide residues on treated turf from object to mouth transfer ( i. e., those residues that are swallowed when toddlers put treated turf in their mouths);

  Post Application Potential Dose among Toddlers from Incidental Ingestion of Soil from Pesticide Treated Residential Areas: Post application dose calculations for toddlers from incidental non dietary ingestion of pesticide residues from ingesting soil in a treated turf area ( i. e., those soil residues are swallowed when toddlers get pesticide residues on their hands from touching treated soil and then put their hands in their mouth);

The detailed residential post application calculations are presented in Appendix D of this document.

7.2.2 Data and Assumptions for Residential Post application Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing residential post application risk assessments. The assumptions and factors used in the risk calculations are consistent with current HED policy for completing residential exposure assessments ( i. e., SOPs For Residential Exposure Assessment). The assumptions and exposure factors used in this assessment include:

  Factors that are common to the occupational and residential Post application risk assessments, such as body weights for adults, analysis of residue dissipation data, and transfer coefficients are used in this assessment for the garden exposure scenarios. Please refer to the assumptions and factors in Section 5.1.1 for further information concerning these common values.

  HED combines risks resulting from exposures to individual chemicals when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. Within a residential assessment, the approach is to add together risks for individual exposure scenarios from all likely sources of exposure such 54 as after an application to turf or use on a pet. For propiconazole, HED has combined risks ( i. e., MOEs) for different kinds of exposures for the turf scenarios ( i. e., dermal, hand to mouth, object to mouth, and soil ingestion).

  Exposures to adults and children on treated turf have been addressed using the latest HED standard operating procedures for this scenario including:

  Study specific data was used for Turf Transferable Residue ( TTR) values in each scenario ( see note about submitted TTR data in Section <IP_ADDRESS>);

  A percent of the application rate has been used to calculate the day zero residue levels used for assessing risks from hand to mouth behaviors;

  20 percent of the application rate has been used to calculate the day zero residue levels used for assessing risks from object to mouth behaviors ( a higher percent transfer has been used for object to mouth behaviors, because it involves a teething action believed to be more analogous to DFR/ leaf wash sample collection where 20 percent is also used);

  The transfer coefficients used are those presented at the 1999 Agency presentation before the FIFRA Science Advisory Panel that have been adopted in routine practice by HED;

  Year old toddlers are expected to weigh 15 kg ( average of 1 to 6 year olds);

  Hand to mouth exposures are based on a frequency of 20 events/ hour and a surface area per event of 20 cm2 representing the palmar surfaces of three fingers;

  Saliva extraction efficiency is 50 percent meaning that every time the hand goes in the mouth approximately ½ of the residues on the hand are removed;

  Object to mouth exposures are based on a 25 cm2 surface area;

  Exposure durations are assumed to be 2 hours based on information in HED's Exposure Factors Handbook except for golfing which is 4 hours per day;

  100 percent of the application rate has been used to calculate the day zero soil residue levels used for assessing risks from soil ingestion behavior; soil residues are contained in the top centimeter and soil density is 0.67 mL/ gram.

  Dermal, hand and object to mouth, and soil ingestion are combined to represent an overall risk from exposure to turf while granular ingestion is considered to be a much more episodic behavior and is considered separately by HED. 55 7.2.3 Residential Post application Exposure and Non cancer Risk Estimates Dermal exposures and risks from residential uses were calculated in the same manner as described above in Section 6.1.3. The algorithms used for each type of calculation which have not been previously addressed in Section 6.1.3 are presented below.

  Dermal Exposure from Treated Lawns ( adult and toddler)

The approach used to calculate the dermal exposures that are attributable to exposure from contacting treated lawns is:

ADD = ( TTR0 * ET * TC * DA * CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day);

TTRt = turf transferable residue on day " 0" ( Fg/ cm2 );

ET = exposure time ( 2 hr/ day);

TC = transfer coefficient ( 14,500 cm2/ hr for adults and 5,200 cm2/ hr for toddlers); DA = dermal absorption factor ( 40%);

CF1 = weight unit conversion factor to convert : g units to mg for the daily exposure ( 0.001 mg/: g);

BW = body weight ( 70 kg for general population and 15 kg for toddlers).

Non dietary Ingestion Exposure from Treated Turf: Non dietary ingestion exposure from treated turf were calculated using the following equations.

  Hand to mouth Transfer of Pesticide Residues on Lawns ( toddler)

The approach used to calculate the non dietary ingestion exposures that are attributable to handto mouth behavior on treated turf is:

ADD = ( TTR0 * SA * FQ * ET * SE * CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day);

TTRt = turf transferable residue on day " 0" ( Fg/ cm2 ); 56 SA = surface area of the hands ( 20 cm2/ event);

FQ = frequency of hand to mouth activity ( 20 events/ hr);

ET = exposure time ( 2 hr/ day);

SE = extraction by saliva ( 50%);

CF1 = weight unit conversion factor to convert Fg units in the DFR value to mg for the daily exposure ( 0.001 mg/ Fg); and BW = body weight ( 15 kg).

  Object to mouth Transfer of Pesticide Residues on Lawns ( toddler)

The approach used to calculate exposures that are attributable to object to mouth behavior on treated turf that is represented by a child mouthing on a handful of turf is:

ADD = ( TTR0 * IgR* CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day);

TTRt = turf transferable residue on day " 0" ( Fg/ cm2);

IgR = ingestion rate of grass ( 25 cm2/ day);

CF1 = weight unit conversion factor to convert the Fg of residues on the grass to mg to provide units of mg/ day ( 1E 3 mg/ Fg); and BW = body weight ( 15 kg).

  Incidental Ingestion of Soil from Pesticide Treated Residential Areas ( toddler).

The approach used to calculate exposures that are attributable to soil ingestion is:

ADD = ( SR0 * IgR * CF1) / BW Where:

ADD = average daily dose ( mg/ kg/ day);

SR0t = soil residue on day " 0" ( 0.0022 Fg/ g);

IgR = ingestion rate of soil ( 100 mg/ day); 57 CF1 = weight unit conversion factor to convert the Fg of residues on the soil to grams to provide units of mg/ day ( 1E 6 g/ Fg); and BW = body weight ( 15 kg).

7.2.4 Residential Post application Non cancer Risk Summary Detailed risk calculations for the various residential propiconazole assessments are included in Appendices C and D. A summary of risk estimates for residential post application risks for adults and children is provided in the following tables. Additionally, HED combines risk values resulting from separate post application exposure scenarios when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population ( see Table 16). [ Note: Propiconazole is classified as a non volatile chemical; therefore a residential ( inhalation) post application assessment is not needed].

Table 15: Adult Residential Risk Estimates for Post application Exposure to Propiconazole Exposure Scenario TC cm ² / hr Route of Exposure Application Rate MOE at Day 0 Outdoors Residential Turf ( Gen. High Contact Activities) 70000 Dermal 1.8 lb ai/ acre 350 Residential Turf ( Mowing) 500 Dermal 1.8 lb ai/ acre 50000 Note: Level of Concern: MOE = 100 Table 16: Toddler Residential Risk Estimates for Post application Exposure to Propiconazole Exposure Scenario TC cm ² / hr Route of Exposure Application Rate MOE at Day 0 1 Combined MOE Outdoors Hand to Mouth Activity on Turf N/ A Oral 1.8 lb ai/ acre 1100 Object to Mouth Activity on Turf N/ A Oral 1.8 lb ai/ acre 4500 Soil Ingestion N/ A Oral 1.8 lb ai/ acre 330000 Turf   General High Contact Activities 25000 Dermal 1.8 lb ai/ acre 210 170 Note: ¹ Combined MOE = NOAEL/( PDRhand to mouth + PDRobject to mouth + PDRincidental soil ingestion + ADDdermal) Level of Concern: MOE = 100 58 7.2.5 Summary of Residential Post application Risk Concerns and Data Gaps HED considered a number of exposure scenarios for products that can be used in the residential environment representing different segments of the population including toddlers and adults. In residential settings, HED does not use restricted entry intervals or other mitigation approaches to limit post application exposures because they are viewed as impractical and not enforceable. As such, risk estimates on the day of application are the key concern.

  For all short term post application scenarios, risks did not exceed HEDs level of concern ( MOEs > 100).

HED combines risks resulting from different routes of exposures to individuals when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. For propiconazole, HED has combined risk values ( i. e., MOEs) for children, the different routes of exposures associated with the turf ( dermal, hand to mouth, object to mouth, and soil ingestion). These are typically added together when pesticides are used on turf, because it is logical they can co occur. The combined risks did not exceed HED's level of concern ( i. e., the MOEs > 100).

7.2.6 Recommendations for Refining Residential Post application Risk Assessment In order to refine this residential assessment, data on actual use patterns including rates, timing, and the kinds of tasks that are required to better characterize propiconazole risks. 59 Appendices.

( A). Occupational ( B). Occupational Post Application ( C). Residential ( D). Residential Post Application 60


[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Pages 14682-14684]
[FR Doc No: 2020-05103]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0007 (formerly Docket No. 2001D-0221)]

Biological Product Deviation Reporting for Blood and Plasma
Establishments; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a revised final guidance entitled
``Biological Product Deviation Reporting for Blood and Plasma
Establishments; Guidance for Industry.'' The final guidance document
provides blood and plasma establishments with revised recommendations
related to biological product deviation (BPD) reporting. The guidance
is intended to assist blood and plasma establishments in determining
when a report is required, who submits the report, what information to
submit in the report, the timeframe for reporting, and how to submit
the report. The revised guidance explains that we do not consider post
donation information (PDI) events to require BPD reports. The revised
guidance also contains other technical updates and editorial revisions
to improve clarity and provide a more streamlined document. For the
purposes of this guidance, ``blood and plasma establishment'' includes
licensed manufacturers of blood and blood components, including Source
Plasma, unlicensed registered blood establishments, and transfusion
services. The guidance announced in this notice supersedes the document
entitled ``Guidance for Industry: Biological Product Deviation
Reporting for Blood and Plasma Establishments,'' dated October 2006.

DATES: The Agency is soliciting public comment, but is implementing
this guidance immediately, because the Agency has determined that prior
public participation is not feasible or appropriate. Submit either
electronic or written comments on Agency guidances at any time. The
announcement of the guidance is published in the Federal Register on
March 13, 2020.

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

Electronic Submissions

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

public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2001-D-0007 for ``Biological Product Deviation Reporting for Blood
and Plasma Establishments; Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the final guidance to
the Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised document entitled
``Biological Product Deviation Reporting for Blood and Plasma
Establishments; Guidance for Industry.'' The final guidance document
provides blood and plasma establishments with revised recommendations
related to BPD reporting. The guidance is intended to assist blood and
plasma establishments in determining when a report is required, who
submits the report, what information to submit in the report, the
timeframe for reporting, and how to submit the report. The revised
guidance explains that we do not consider PDI events to require BPD
reports. The revised guidance also contains other technical updates and
editorial revisions to improve clarity and provide a more streamlined
document. For the purposes of this guidance, ``blood and plasma
establishment'' includes licensed manufacturers of blood and blood
components, including Source Plasma, unlicensed registered blood
establishments, and transfusion services. The guidance announced in
this notice supersedes the document entitled ``Guidance for Industry:
Biological Product Deviation Reporting for Blood and Plasma
Establishments,'' dated October 2006.
    FDA is also announcing the withdrawal of two obsolete memoranda to
blood establishments entitled ``Responsibilities of Blood
Establishments Related to Errors and Accidents in the Manufacture of
Blood and Blood Components,'' issued March 20, 1991, and ``Guidance
Regarding Post Donation Information Reports,'' issued December 10,
1993.
    The revised guidance explains that we do not consider PDI events to
require BPD reports under Sec.  606.171 (21 CFR 606.171) because these
events are no longer unexpected or unforeseeable based on 18 years of
data, which show that more than 18,000 reports of PDI events have been
submitted to FDA each fiscal year (FY) for the past 18 years.
    Every year, the Center for Biologics Evaluation and Research (CBER)
receives thousands of BPD reports of events associated with
manufacturing, to include testing, processing, packing, labeling, or
storage, or with the holding or distribution of both licensed and
unlicensed blood or blood components, including Source Plasma. Such an
event is reportable under Sec.  606.171 if certain criteria are met,
including that the event either: (1) Represents a deviation from
current good manufacturing practice (CGMP), applicable regulations,
applicable standards, or established specification that may affect the
safety, purity, or potency of the product; or (2) represents an
unexpected or unforeseeable event that may affect the safety, purity,
or potency of the product. The Agency's BPD reporting program is one of
the post-market surveillance tools that CBER uses to monitor blood
manufacturing and to detect potential blood safety issues.
    One type of BPD report received by FDA from blood establishments
involves PDI events. PDI includes information that a donor, or other
reliable source, provides to a blood establishment following a donation
(e.g., at a subsequent donation) that would have resulted in donor
deferral had it been known by the establishment at the time of
donation. In these situations, the relevant donor screening questions
were asked at the original donation, but the donor did not provide the
information at that time.
    In the Federal Register of November 7, 2000 (65 FR 66635), FDA
issued a final rule to amend the regulations for biological product
deviation reporting. In the October 2006 guidance, ``Biological Product
Deviation Reporting for Blood and Plasma Establishments,'' FDA
explained that it considered PDI events to be ``unexpected or

unforeseeable'' events for purposes of BPD reporting (see Sec.
606.171(b)(1)(ii)). Accordingly, establishments have been submitting
BPD reports regarding PDI that may affect the safety, purity, or
potency of a distributed product. PDI events continue to be reported,
and the numbers have increased over time. Reports of PDI events have
consistently been the highest number of reports received from blood
establishments, representing a significant burden to industry and FDA.
For example, from FYs 2000 through 2017, FDA has received approximately
18,000 to 40,000 PDI reports each year. The total number of PDI reports
submitted by blood establishments in FY 2017 was 37,265 of 51,434 total
BPD reports, representing approximately 72 percent of all BPD reports
submitted by blood establishments. In reviewing the data for the past
18 years, based on the extraordinarily high number of PDI reports, FDA
has concluded that PDI events are no longer ``unexpected or
unforeseeable,'' and will likely continue to occur. Because PDI events
are no longer ``unexpected or unforeseeable,'' and also do not
represent deviations from CGMP, applicable regulations, applicable
standards, or established specifications, such events are not
reportable under Sec.  606.171.
    FDA is issuing this guidance for immediate implementation in
accordance with Sec.  10.115(g)(3) (21 CFR 10.115(g)(3)) without
initially seeking prior comment because the Agency has determined that
prior public participation is not feasible or appropriate (see Sec.
10.115(g)(2)). Specifically, we made this determination because this
guidance presents a less burdensome policy for reporting BPDs that is
consistent with public health. It eliminates the reporting of PDI
events as BPD reports because these reports are no longer unexpected or
unforeseeable based on PDI data for the past 18 years, without
compromising public health protections.
    This guidance is expected to significantly reduce the BPD reporting
burden on industry and the burden on FDA to review these reports. Based
on the above FY 2017 PDI data, FDA expects that the elimination of PDI
reports will result in a 72 percent reduction in total BPD reports
received (elimination of 37,265 of 51,434 total reports in FY 2017).
FDA anticipates that this will substantially and proportionally reduce
the blood industry's estimated annual reporting burden under Sec.
606.171, which FDA recently estimated to be 92,384 total annual hours
(84 FR 70979 at 70981; December 26, 2019). The revised recommendations
are also consistent with public health.
    Given the substantial number of PDI reports FDA has received, the
Agency is aware that these events occur, and the submission of
additional PDI reports to FDA is unlikely to facilitate the
identification of manufacturing or safety issues. PDI events are not
associated with deviations from CGMP or other requirements, and blood
establishments generally have no control over information provided by
donors or third parties subsequent to a donation. Eliminating PDI
reports will enable blood establishments and FDA to prioritize
resources on BPD reports that are more likely to inform corrective
actions to protect the public health. Additionally, blood
establishments are required to comply with applicable regulations
regarding, among other things, establishing, maintaining, and following
standard operating procedures (SOPs) (see Sec.  606.100(b) (21 CFR
606.100(b)) and maintaining records (see Sec.  606.160 (21 CFR
606.160)). FDA will continue to assess SOPs and records associated with
PDI events during routine inspections of blood establishments. Thus,
this revised guidance presents a less burdensome policy for reporting
PDI events that is consistent with public health.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115). FDA is issuing this guidance for
immediate implementation in accordance with Sec.  10.115(g)(3) without
initially seeking prior comment because the Agency has determined that
prior public participation is not feasible or appropriate. The guidance
represents the current thinking of FDA on biological product deviation
reporting for blood and plasma establishments. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information under
Sec. Sec.  600.14 and 606.171 were approved under OMB control number
0910-0458; the collections of information under Sec. Sec.  606.100 and
606.160 were approved under OMB control number 0910-0116; the
collections of information under 21 CFR 211.192 and 211.198 were
approved under OMB control number 0910-0139; and the collections of
information under 21 CFR 601.12 were approved under OMB control number
0910-0338.

III. Electronic Access

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

    Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05103 Filed 3-12-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25109-25110]
[FR Doc No: 2019-11263]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. 2019-0103]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Airport
Grants Program

AGENCY: Federal Aviation Administration (FAA), DOT

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a renewal information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on March 11, 2019. The collection involves data from airport
sponsors and planning agencies to determine eligibility, and to ensure
proper use of Federal funds and project accomplishments for the Airport
Improvement Program. This is the 30-day notice.

DATES: Written comments should be submitted by July 1, 2019.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: Patricia Dickerson by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's

performance; (b) the accuracy of the estimated burden; (c) ways for FAA
to enhance the quality, utility and clarity of the information
collection; and (d) ways that the burden could be minimized without
reducing the quality of the collected information. The agency will
summarize and/or include your comments in the request for OMB's
clearance of this information collection.
    OMB Control Number: 2120-0569.
    Title: Same title as above.
    Form Numbers: FAA Forms 5100-100, 5100-101, 5100-108, 5100-110,
5100-126, 5100-127, 5100-128, 5100-129, 5100-130, 5100-131, 5100-132,
5100-133, 5100-134, 5100-135, 5100-136, 5100-137, 5100-138, 5100-139,
5100-140, 5100-141, 5100-142, 5370-1.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on March 11, 2019 (84 FR 8779) and this is the 30-day
notice. Codification of certain U.S. Transportation laws at 49 U.S.C.,
repealed the Airport and Airway Improvement Act of 1982, as amended,
and the Aviation Safety and Noise Abatement Act of 1979, as amended,
and re-codified them without substantive change at Title 49 U.S.C.,
which is referred to as the ``Act.'' The Act provides funding for
airport planning and development projects at airports included in the
National Plan of Integrated Airport Systems (NPIAS). The Act also
authorizes funds for noise compatibility planning and to carry out
noise compatibility programs. The information required by this program
is necessary to protect the Federal interest in safety, efficiency, and
utility of the airport. Data is collected to meet report requirements
of 2 CFR part 200 for certifications and representations, financial
management and performance measurement.
    Respondents: Approximately 13,000 applications.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: Approximately 9 Hours.
    Estimated Total Annual Burden: Approximately 118,000 hours.

    Issued in Washington, DC, on May 24, 2019.
Murrell Stinnette,
Acting Deputy Director, Federal Aviation Administration/Office of
Airport Planning & Programming/APP-2.
[FR Doc. 2019-11263 Filed 5-29-19; 8:45 am]
BILLING CODE 4910-13-P


Success through Innovation. Creating New Technologies for Urethane Chemical Systems and Equipment. www. foamsupplies. com foam supplies, inc.

Home Office: 4387 North Rider Trail * Earth City, MO 63045 1103 Texas Office: 590 Benjamin's Way * Lewisville, TX 75057 314 344 3330 * 800 325 4875 * Fax: 314 344 3331 972 436 7008 * 800 325 4875 * Fax: 972 436 0243 January 12, 2004 Ms. Suzanne Kocchi EPA VIA EMAIL: kocchi. suzanne@ epamail. epa. gov Dear Suzie,

As we have been discussing the demand for HCFC 141b in the urethane foams sector, I have come up with a few facts and opinions that may interest you. These are the basis for my support to EPA's proposed use ban to culminate the phase out of 141b ( 65 FR 42653).

First, in the face of the impending production ban of HCFC 141b scheduled for 01 01 2003, Foam Supplies, Inc. chose to convert to alternative blowing agents early, mostly HFC 134a. Thus, we had successfully eliminated any need for 141b prior to that date. If a small business such as ours could do it, I don't see why the larger corporations cannot.

Secondly, most of my competitors are the four major global isocyanate producers. For the past 6 8 months, we have received numerous phone calls from their existing customer base with an interest in our new product, ecomate. This interest is generated largely by the message from their current suppliers about stockpiled 141b. They have been given deadlines for switching over to alternative products. Some were told they would have to convert by the end of 2003. Others would receive extensions to finish qualifying anywhere from January 30, 2004 to June 30, 2004 but, all were told that stockpiles are dwindling and the end is near. In light of this, it does not appear that there is going to be much need for the 141b beyond that point.

Thirdly, we still see competition, on occasion, offering 141b blown systems to customers but, it has invariably been only to new customers, on a short term basis, or to customers outside the U. S.

Finally, FSI has developed and qualified a new blowing agent known as ecomate. ecomate is a non ODP, non GWP alternative blowing agent which received SNAP approval on August 21, 2003. It has been tested in field and laboratory situations sideby side with the other primary HCFC 141b alternatives and has proven to be comparable to all of them in every physical property category including thermal efficiency and dimensional stability. While we have converted a number of facilities over to ecomate in 2003, we have qualified but not switched over many others. We have been told repeatedly that there are only one or two reasons for delaying the change. Number 1, they are waiting for the finalization of VOC exempt status for ecomate, which we are expecting to be published any day. Number 2, they don't have to switch because of the availability of systems containing HCFC 141b. They have a comfort level with the product they are using and as long as they can use it, they will.

For all of these reasons, FSI supports EPA's effort to finalize its decision on the use of HCFC 141b in foam products.

Sincerely,

Tim Kalinowski President


                EPA ICR No. 1446.11; OMB Control No. 2070-0112

                                  APPENDIX A

                   Toxic Substances Control Act Section 6(e)
                                15 USC 2605(e)
TITLE 15 - Commerce and trade

CHAPTER 53 - Toxic substances control

SUBCHAPTER I - Control of toxic substances

Sec. 2605. - Regulation of hazardous chemical substances and mixtures

* * *

(e) Polychlorinated biphenyls

      (1) Within six months after January 1, 1977, the Administrator shall promulgate rules to -

      (A) prescribe methods for the disposal of polychlorinated biphenyls, and

            (B) require polychlorinated biphenyls to be marked with clear and adequate warnings, and instructions with respect to their processing, distribution in commerce, use, or disposal or with respect to any combination of such activities.

      Requirements prescribed by rules under this paragraph shall be consistent with the requirements of paragraphs (2) and (3).

      (2) 	(A)Except as provided under subparagraph (B), effective one year after January 1, 1977, no person may manufacture, process, or distribute in commerce or use any polychlorinated biphenyl in any manner other than in a totally enclosed manner.

            (B) The Administrator may by rule authorize the manufacture, processing, distribution in commerce or use (or any combination of such activities) of any polychlorinated biphenyl in a manner other than in a totally enclosed manner if the Administrator finds that such manufacture, processing, distribution in commerce, or use (or combination of such activities) will not present an unreasonable risk of injury to health or the environment.

            (C) For the purposes of this paragraph, the term ''totally enclosed manner'' means any manner which will ensure that any exposure of human beings or the environment to a polychlorinated biphenyl will be insignificant as determined by the Administrator by rule.

      (3) 	(A) Except as provided in subparagraphs (B) and (C) -

                  (i) no person may manufacture any polychlorinated biphenyl after two years after January 1, 1977, and

                  (ii) no person may process or distribute in commerce any polychlorinated biphenyl after two and one-half years after such date.

            (B) Any person may petition the Administrator for an exemption from the requirements of subparagraph (A), and the Administrator may grant by rule such an exemption if the Administrator finds that -

                  (i) an unreasonable risk of injury to health or environment would not result, and

                  (ii) good faith efforts have been made to develop a chemical substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for such polychlorinated biphenyl.

      An exemption granted under this subparagraph shall be subject to such terms and conditions as the Administrator may prescribe and shall be in effect for such period (but not more than one year from the date it is granted) as the Administrator may prescribe.

            (C) Subparagraph (A) shall not apply to the distribution in commerce of any polychlorinated biphenyl if such polychlorinated biphenyl was sold for purposes other than resale before two and one half years after October 11, 1976.

      (4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be promulgated in accordance with paragraphs (2), (3), and (4) of subsection (c) of this section.

      (5) This subsection does not limit the authority of the Administrator, under any other provision of this chapter or any other Federal law, to take action respecting any polychlorinated biphenyl


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57185]
[FR Doc No: 2021-22336]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3567-EM; Docket ID FEMA-2021-0001]

Vermont; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Vermont (FEMA-3567-EM), dated August 22,
2021, and related determinations.

DATES: The declaration was issued August 22, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 22, 2021, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Vermont resulting from Tropical Storm Henri
beginning on August 22, 2021, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of Vermont.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance and reimbursement
for mass care including evacuation and shelter support.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, John F.
Boyle, of FEMA is appointed to act as the Federal Coordinating Officer
for this declared emergency.
    The following areas of the State of Vermont have been designated as
adversely affected by this declared emergency:

    Addison, Bennington, Caledonia, Chittenden, Essex, Franklin,
Grand Isle, Lamoille, Orange, Orleans, Rutland, Washington, Windham,
and Windsor Counties for emergency protective measures (Category B),
limited to direct Federal assistance and reimbursement for mass care
including evacuation and shelter support.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22336 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Notices]
[Pages 35702-35704]
[FR Doc No: 2019-15672]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86411; File No. SR-CBOE-2019-037]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
To Amend Rule 12.3 by Extending the Credit Option Margin Pilot Program
Through July 20, 2020

July 18, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 16, 2019, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 12.3 by extending the Credit
Option Margin Pilot Program through July 20, 2020. The text of the
proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On February 2, 2011, the Commission approved the Exchange's
proposal to establish a Credit Option Margin Pilot Program
(``Program'').\5\ The proposal became effective on a pilot basis to run
on a parallel track with FINRA Rule 4240 that similarly operates on an
interim pilot basis.\6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 63819 (February 2,
2011), 76 FR 6838 (February 8, 2011) order approving (SR-CBOE-2010-
106). To implement the Program, the Exchange amended Rule 12.3(l),
Margin Requirements, to make Cboe Option's margin requirements for
Credit Options consistent with Financial Industry Regulatory
Authority (``FINRA'') Rule 4240, Margin Requirements for Credit
Default Swaps. Cboe Options Credit Options (i.e., Credit Default
Options and Credit Default Basket Options) are analogous to credit
default swaps.
    \6\ See Securities Exchange Act Release No. 59955 (May 22,
2009), 74 FR 25586 (May 28, 2009) (Notice of Filing and Order
Granting Accelerated Approval of Proposed Rule Change; SR-FINRA-
2009-012).
---------------------------------------------------------------------------

    On January 17, 2012, the Exchange filed a rule change to, among
other things, decouple the Program with the FINRA program and to extend
the expiration date of the Program to January 17, 2013.\7\ The Program,
however, continues to be substantially similar to the provisions of the
FINRA program. Subsequently, the Exchange filed rule changes to extend
the program until January 17, 2014, January 16, 2015, January 15, 2016,
January 17, 2017, July 18, 2017, July 18, 2018 and July 18, 2019,
respectively.\8\ The Exchange believes that extending the expiration
date of the Program further will allow for further analysis of the
Program and a determination of how the Program should be structured in
the future. Thus, the Exchange is now currently proposing to extend the
duration of the Program for an additional year until July 20, 2020.\9\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 66163 (January 17,
2012), 77 FR 3318 (January 23, 2012) (SR-CBOE-2012-007).
    \8\ See Securities Exchange Act Release Nos. 68539 (December 27,
2012), 78 FR 138 (January 2, 2013) (SR-CBOE-2012-125), 71124
(December 18, 2013), 78 FR 77754 (December 24, 2013) (SR-CBOE-2013-
123), 73837 (December 15, 2014), 79 FR 75850 (December 19, 2014)
(SR-CBOE-2014-091), 76824 (January 5, 2016), 81 FR 1255 (January 11,
2016) (SR-CBOE-2015-118), 79621 (December 14, 2016) 81 FR 95236
(December 27, 2016) (SR-CBOE-2016-089), 81083 (July 6, 2017) 82 FR
32219 (July 12, 2017) (SR-CBOE-2017-051), and 83672 (July 19, 2018)
83 FR 35305 (July 25, 2018) (SR-CBOE-2018-052).
    \9\ The Exchange is filing the proposed rule change for
immediate effectiveness. The Exchange is proposing that the
implementation date of the proposed rule change will be July 18,
2019. The proposed rule change will expire on July 20, 2020, which
is the same date FINRA's corresponding program expires.

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

    Additionally, the Exchange believes that it is in the public
interest to extend the expiration date of the Program because it will
continue to allow the Exchange to list Credit Options for trading. As a
result, the Exchange will remain competitive with the Over-the-Counter
Market with respect to swaps and security-based swaps. In the future,
if the Exchange proposes an additional extension of the Credit Option
Margin Pilot Program or proposes to make the Program permanent, then
the Exchange will submit a filing proposing such amendments to the
Program.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\10\ Specifically, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \11\ requirements that the rules
of an exchange be designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitation transactions in securities, 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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \12\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
    \12\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes that the proposed rule change
will further the purposes of the Act because, consistent with the goals
of the Commission at the initial adoption of the program, the margin
requirements set forth by the proposed rule change will help to
stabilize the financial markets. In addition, the proposed rule change
is substantially similar to existing FINRA Rule 4240.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Specifically, the Exchange
believes that, by extending the expiration of the Program, the proposed
rule change will allow for further analysis of the Program and a
determination of how the Program shall be structured in the future. In
doing so, the proposed rule change will also serve to promote
regulatory clarity and consistency, thereby reducing burdens on the
marketplace and facilitating investor protection.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \13\ and
Rule 19b-4(f)(6) \14\ thereunder.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, as required under Rule
19b-4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of the filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange states that waiver of the 30-day operative delay
will allow it to maintain the status quo, thereby reducing market
disruption. The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest, as it will allow the Program to continue uninterrupted,
thereby avoiding investor confusion that could result from a temporary
interruption of the Program. For this reason, the Commission designates
the proposed rule change to be operative upon filing.\15\
---------------------------------------------------------------------------

    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2019-037 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2019-037. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for

inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-CBOE-2019-037 and
should be submitted on or before August 14, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-15672 Filed 7-23-19; 8:45 am]
 BILLING CODE 8011-01-P


                                 Attachment C
 Docket Numbers for Fumigant Reregistration Eligibility Decisions and Supporting Documents

Soil Fumigant Dockets:
Documents to support the reregistration or registration actions for the group of soil fumigants listed below can be found in the public docket at www.regulations.gov under the following docket numbers:

Methyl bromide: 			EPA-HQ-OPP-2005-0123
1,3-dichloropropene:			EPA-HQ-OPP-2005-0124
Metam sodium:			EPA-HQ-OPP-2005-0125
Metam potassium			EPA-HQ-OPP-2005-0125
Dazomet: 				EPA-HQ-OPP-2005-0128
Chloropicrin: 				EPA-HQ-OPP-2007-0350
Dimethyl disulfide (DMDS):		EPA-HQ-OPP-2007-0092
Methyl Isothiocyanate:		EPA-HQ-OPP-2005-0125

Non-soil Fumigant Dockets:
Documents to support the reregistration or registration actions for the group of non-soil fumigants listed below can be found in the public docket at www.regulations.gov under the following docket numbers:

Methyl bromide:			EPA-HQ-OPP-2013-0269
Aluminum phosphide:			EPA-HQ-OPP-2013-0081
Magnesium phosphide:		EPA-HQ-OPP-2013-0081
Phosphine:				EPA-HQ-OPP-2013-0081
Sulfuryl fluoride:			EPA-HQ-OPP-2009-0136


[Federal Register Volume 75, Number 241 (Thursday, December 16, 2010)]
[Rules and Regulations]
[Pages 78606-78607]
[FR Doc No: 2010-31505]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-B-1160]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Interim rule.

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SUMMARY: This interim rule lists communities where modification of the
Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because
of new scientific or technical data. New flood insurance premium rates
will be calculated from the modified BFEs for new buildings and their
contents.

DATES: These modified BFEs are currently in effect on the dates listed
in the table below and revise the Flood Insurance Rate Maps (FIRMs) in
effect prior to this determination for the listed communities.
    From the date of the second publication of these changes in a
newspaper of local circulation, any person has ninety (90) days in
which to request through the community that the Deputy Federal
Insurance and Mitigation Administrator reconsider the changes. The
modified BFEs may be changed during the 90-day period.

ADDRESSES: The modified BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The modified BFEs are not listed for each
community in this interim rule. However, the address of the Chief
Executive Officer of the community where the modified BFE
determinations are available for inspection is provided.
    Any request for reconsideration must be based on knowledge of
changed conditions or new scientific or technical data.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The modified BFEs are the basis for the floodplain management
measures that the community is required either to adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These modified BFEs, together with the floodplain management
criteria required by 44 CFR 60.3, are the minimum that are required.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own or pursuant to policies established by other
Federal, State, or regional entities. The changes in BFEs are in
accordance with 44 CFR 65.4.
    National Environmental Policy Act. This interim rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This interim rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This interim rule involves no
policies that have federalism implications under Executive Order 13132,
Federalism.
    Executive Order 12988, Civil Justice Reform. This interim rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

0
Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Date and name of
         State and county           Location and case No.     newspaper where     Chief executive officer of    Effective date of       Community No.
                                                            notice was published           community               modification
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona: Maricopa.................  City of Tempe........  September 16, 2010,    The Honorable Hugh          January 21, 2011.....  040054
                                    (10-09-2035P)........   September 23, 2010,    Hallman, Mayor, City of
                                                            Arizona Business       Tempe, 31 East 5th
                                                            Gazette.               Street, Tempe, AZ 85281.
Arizona: Mojave...................  Fort Mojave Indian     September 10, 2010,    Mr. Timothy Williams,       August 31, 2010......  040133
                                     Reservation.           September 17, 2010,    Chairman, Fort Mojave
                                    (10-09-1826P)........   The Kingman Daily      Indian Reservation, 500
                                                            Miner.                 Merriman Avenue, Needles,
                                                                                CA 92363.
Arizona: Pinal....................  Town of Florence.....  September 24, 2010,    The Honorable Vikki         January 31, 2011.....  040084
                                    (10-09-1057P)........   October 1, 2010,       Kilvinger, Mayor, Town of
                                                            Casa Grande Dispatch.  Florence, 775 North Main
                                                                                Street, Florence, AZ
                                                                                85232.
Arizona: Yavapai..................  Unincorporated areas   August 27, 2010,       Mr. Chip Davis, Chairman,   January 3, 2011......  040093
                                     of Yavapai County.     September 3, 2010,     Yavapai County Board of
                                    (10-09-0965P)........   The Daily Courier.     Supervisors, 10 South 6th
                                                                                Street, Cottonwood, AZ
                                                                                86326.

California: Riverside.............  City of Riverside....  September 3, 2010,     The Honorable Ronald O.     August 27, 2010......  060260
                                    (10-09-0680P)........   September 10, 2010,    Loveridge, Mayor, City of
                                                            The Press-Enterprise.  Riverside, 3900 Main
                                                                                Street, Riverside, CA
                                                                                92522.
Colorado: Jefferson...............  Unincorporated areas   September 16, 2010,    Ms. Kathy Hartman, Chair,   January 21, 2011.....  080087
                                     of Jefferson County.   September 23, 2010,    Jefferson County Board of
                                    (10-08-0546P)........   Westminster Window.    Commissioners, 100
                                                                                Jefferson County Parkway,
                                                                                Golden, CO 80419.
Colorado: Jefferson...............  City of Westminster..  September 16, 2010,    The Honorable Nancy         January 21, 2011.....  080008
                                    (10-08-0546P)........   September 23, 2010,    McNally, Mayor, City of
                                                            Westminster Window.    Westminster, 4800 West
                                                                                92nd Avenue, Westminster,
                                                                                CO 80031.
Colorado: Pueblo..................  City of Pueblo.......  September 3, 2010,     Mr. Lawrence Atencio,       January 10, 2011.....  085077
                                    (10-08-0862P)........   September 10, 2010,    President, Pueblo City
                                                            The Pueblo Chieftain.  Council, 1 City Hall
                                                                                Place, Pueblo, CO 81003.
Florida: Lake.....................  City of Clermont.....  September 3, 2010,     The Honorable Harold        January 10, 2011.....  120133
                                    (10-04-4299P)........   September 10, 2010,    Turville, Jr., Mayor,
                                                            Daily Commercial.      City of Clermont, 685
                                                                                West Montrose Street,
                                                                                Clermont, FL 34711.
Florida: Lake.....................  Unincorporated areas   September 3, 2010,     Mr. Welton G. Caldwell,     January 10, 2011.....  120421
                                     of Lake County.        September 10, 2010,    Chairman, Lake County
                                    (10-04-4299P)........   Daily Commercial.      Board of Commissioners,
                                                                                Lake County, P.O. Box
                                                                                7800, Tavares, FL 32778.
Florida: Monroe...................  Unincorporated areas   September 17, 2010,    The Honorable Sylvia        September 10, 2010...  125129
                                     of Monroe County.      September 24, 2010,    Murphy, Mayor, Monroe
                                    (10-04-5258P)........   Key West Citizen.      County, 1100 Simonton
                                                                                Street, Key West, FL
                                                                                33040.
Georgia: DeKalb...................  Unincorporated areas   September 9, 2010,     Mr. W. Burrell Ellis, Jr.,  October 4, 2010......  130065
                                     of DeKalb County.      September 16, 2010,    Chief Executive Officer,
                                    (10-04-4217P)........   The Champion           DeKalb County, 330 West
                                                            Newspaper.             Ponce De Leon Avenue,
                                                                                Decatur, GA 30030.
Hawaii: Maui......................  Unincorporated areas   September 10, 2010,    The Honorable Charmaine     January 18, 2011.....  150003
                                     of Maui County.        September 17, 2010,    Tavares, Mayor, Maui
                                    (10-09-1230P)........   The Maui News.         County, 200 South High
                                                                                Street, 9th Floor,
                                                                                Wailuku, HI 96793.
Kansas: Johnson...................  City of Leawood......  September 15, 2010,    The Honorable Peggy J.      January 20, 2011.....  200167
                                    (10-07-2021P)........   September 22, 2010,    Dunn, Mayor, City of
                                                            The Johnson County     Leawood, 4800 Town Center
                                                            Sun.                   Drive, Leawood, KS 66211.
North Carolina: Chatham...........  Unincorporated areas   September 9, 2010,     Mr. Charlie Horne,          January 14, 2011.....  370299
                                     of Chatham County.     September 16, 2010,    Manager, Chatham County,
                                    (10-04-0659P)........   The Chatham News.      P.O. Box 1809, 12 East
                                                                                Street, Pittsboro, NC
                                                                                27312.
North Carolina: Wake..............  Unincorporated areas   September 7, 2010,     Mr. David Cooke, Manager,   January 12, 2011.....  370368
                                     of Wake County.        September 14, 2010,    Wake County, P.O. Box
                                    (09-04-2504P)........   The News & Observer.   550, Raleigh, NC 27602.
Utah: Weber.......................  City of Ogden........  September 3, 2010,     The Honorable Matthew R.    January 10, 2011.....  490189
                                    (10-08-0035P)........   September 10, 2010,    Godfrey, Mayor, City of
                                                            Standard Examiner.     Ogden, 2549 Washington
                                                                                Boulevard, Suite 910,
                                                                                Ogden, UT 84401.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: December 3, 2010.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-31505 Filed 12-15-10; 8:45 am]
BILLING CODE 9110-12-P