Page 1 of 7 IUR Petition Review Report April 17, 2005 CASRNs and TSCA Inventory Chemical Names: 97 63 2 2 propenoic acid, 2 methyl, ethyl ester 97 86 9 2 propenoic acid, 2 methyl, 2 methylpropyl ester 97 88 1 2 propenoic acid, 2 methyl, butyl ester 688 84 6 2 propenoic acid, 2 methyl, 2 ethylhexyl ester Alternate Chemical Names Used in Petition: The petition request used non TSCA Inventory chemical names for some of the chemicals listed above. See Table 1 at the end of this report for the chemical names used in the petition request that differ from the TSCA Inventory chemical names.

Petitioner and Docket Number: Methacrylate Producers Association, Inc. OPPT 2004 0007 Summary of Decision: The petition review group recommends a denial for this petition as EPA has a current interest in the processing and use information collected under the Inventory Update Reporting rule ( IUR) ( see 40 CFR Part 710) for the four substances listed above. This recommendation is based, in part, on the determination by the petition review group that there is a direct application of the IUR processing and use information to complement data collected by or identified for use under the HPV Challenge Program. See Considerations A, C, D, E, and " Other."

Background: EPA received a petition requesting that the four chemicals listed above be added to the 40 CFR 710.46( b)( 2)( iv) list of specific chemical substances which are exempt from the reporting of industrial processing and use and commercial/ consumer use information required by 40 CFR 710.52( c)( 4). The chemical substances included on this " partial exemption" list are substances for which EPA has previously determined that there is a low current interest in the IUR processing and use information. However, as stated in the preamble to the amendment to the IUR rule promulgated on January 7, 2003 ( 68 FR 854), "... the need for processing and use information ... changes over time. The inclusion of a chemical substance under this partial exemption is not based on the potential risks of a chemical. This partial exemption is solely intended to provide a tool to assist the Agency in better managing the collection of processing and use information..." and is also " based on the Agency's current need for collecting IURA processing and use information." ( 68 FR 855) Additionally, the preamble states, " In determining whether there is low current interest in IURA processing and use information related to a specific chemical substance, EPA will look to the specific circumstances surrounding the chemical in question, and may use one or more of the considerations identified below, and/ or considerations not identified below, to make an informed decision." The considerations used by EPA in reviewing this petition and an analysis of how those considerations relate to the chemicals identified in this petition are set forth below. 1See the attached list of acronyms at the end of this report.

Page 2 of 7 Discussion: The petition review group considered information submitted with the petition, as well as other information including ( but not limited to): whether the petition substances are included in TRI, IRIS, or IARC; OECD HPV SIDS program status; HPV Challenge Program status; and their inclusion in other regulatory programs administered by EPA. 1 The petition stated that these four chemicals were under review in the OECD HPV SIDS program; since the submission of the petition, the review was completed and agreed upon during SIAM 18, held in April 2004. The petition stated that the information provided in each chemical's dossier, SIAR, and SIAP " should be sufficient for EPA to make the necessary determination to include these chemicals on the list for partial reporting exemption under IURA." The petition offered to provide draft documents and noted that once the reviews are complete the documents will be available through a specified website. The SIAP, summarizing the OECD HPV SIDS review, is now publicly available.

The petition did not link information to specific considerations cited in 40 CFR 710.46( b)( 2)( ii), but provided a general citation to OECD HPV SIDS review documents, as noted above, on these chemicals. General citations alone are of limited use in establishing a rationale for adding a chemical to the IUR partial exemption list.

Consideration A: Production volume.

The petition review group found that there was at least one site reporting to the 2002 IUR with a production volume for each of the four chemicals of 300,000 pounds or greater.

Consideration B: The substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects.

The petition did not identify specific information from the OECD HPV SIDS review that pertained to consideration B. The OECD review placed all four chemicals in a category, and used methyl methacrylate ( MMA) ( CAS 80 62 6), the C1 ester, as a robust reference chemical. The SIAP contained summary results of a variety of studies associated with human health and the environment and a conclusion that these chemicals " possess properties indicating a hazard for human health ( skin sensitization, skin and eye irritation)." It went on to say that 2 propenoic acid, 2 methyl, ethyl ester ( CASRN 97 63 2), 2 propenoic acid, 2 methyl, 2 methylpropyl ester ( CASRN 97 86 9), and 2 propenoic acid, 2 methyl, butyl ester ( CASRN 97 88 1) " possess properties indicating a hazard for the environment" and 2 propenoic acid, 2 methyl, 2 ethylhexyl ester ( CASRN 688 84 6) has properties suggesting a " potential concern for bioaccumulation." 2Risk is composed of hazard and exposure. In order to screen for potential risk in the U. S., both hazard data and exposure related data relative to U. S. situations are needed. Exposure is based upon manufacturing, processing, and use scenarios, all of which change over time as technology and other societal effects change. The changing nature of exposure scenarios means the potential risks associated with a chemical can also change, and therefore the collection of exposure related information over time is fundamental to identifying potential risks. ( See 68 FR 848, 852 for further discussion)

3For additional information on uses of IUR processing and use information, see IURA Data Use Plan, located in EPA's electronic docket OPPT 2002 0054, item number 0261.

4The OECD HPV SIDS program, while it is not U. S. based, is a program where OECD member countries are combining their resources to investigate the hazards associated with different chemicals. This allows all of the countries to benefit from this information. The U. S. uses information collected during and generated by the OECD HPV SIDS program as a starting point for assessing domestic issues.

Page 3 of 7 Consideration C: The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

The petition review group found that 2 propenoic acid, 2 methyl, 2 methylpropyl ester ( CASRN 97 86 9); 2 propenoic acid, 2 methyl, butyl ester ( CASRN 97 88 1); and 2 propenoic acid, 2 methyl, 2 ethylhexyl ester ( CASRN 688 84 6) are part of the HPV Challenge Program. The HPV Challenge Program seeks to collect and, where necessary, develop a screening level hazard data set for chemicals produced or imported in large quantities in the United States. EPA plans to screen and, as needed, further assess chemicals included under the HPV Challenge Program. For this purpose, the IUR processing and use information is needed by EPA to put the hazard data into context, complementing the HPV Challenge Program submission by providing EPA with exposure related information. 2 IUR reporting is needed at least once and, potentially, periodically thereafter to more accurately and realistically gauge potential exposure and provide information needed for screening, assessing, and managing exposures and risk. Other important uses of the reported information, even for low hazard chemicals, may include comparative exposure analyses, identification of safer substitutes, or pollution prevention investigations. 3 Consideration D: The availability of other complementary risk screening information.

The petition referred EPA to the OECD HPV SIDS review documents of these four substances, but did not identify specific information within those documents that would address consideration D. The results of the OECD HPV SIDS review, as documented in the SIAP, indicate that further work may be warranted. In the case of human health, the SIAP indicates that countries may wish to evaluate exposure scenarios not reviewed by the sponsor country. Concerns for the environment were identified. For 2 propenoic acid, 2 methyl, ethyl ester ( CASRN 97 63 2), 2 propenoic acid, 2 methyl, 2 methylpropyl ester ( CASRN 97 86 9), and 2 propenoic acid, 2 methyl, butyl ester ( CASRN 97 88 1), concerns for very high exposure levels were identified. For 2 propenoic acid, 2 methyl, 2 ethylhexyl ester ( CASRN 688 84 6), concerns for bioaccumulation were identified and further work within the OECD HPV program is planned. With the collection of IUR processing and use data for these chemicals, the U. S. will be able to identify domestic situations by combining the OECD HPV SIDS hazard data4 with the IUR Page 4 of 7 exposure related information, thereby identifying new or revised exposure scenarios. These new or revised scenarios will likely have differing potential risk screening results than the previous scenarios and will be specific to situations in the U. S. See consideration E below for further discussion of the IUR exposure related processing and use information.

Consideration E: The availability of comparable processing and use information.

The petition referred EPA to the OECD HPV SIDS review documents of these four substances, but did not identify specific information within those documents that addresses consideration E. The SIAP for these four substances ( dated April 2004) contains some general information on uses and global production, identifying that these four chemicals are used by industry to make polymers. The polymers are then used for applications such as automotive coatings, nail sculpturing, inks and dental products, and others. The uses vary among the four chemicals. The SIAR, which as of April 2005 is still in draft form and not publicly available, adds the percent of each chemical in each application. The U. S. information was obtained from a marketing firm in an apparently proprietary study that was published in 1999 and 2002. Based upon information in the SIAR, it appears that the 2002 report is the first one to include the amount of chemical used in each application category. Other information was provided by Japanese sources.

The conclusion of the OECD HPV SIDS review indicated that countries may wish to evaluate exposure scenarios not covered by the report. Although the U. S. was one of the sponsors of the OECD evaluation, the petition review group recognizes that since exposure scenarios change based on uses and available technology, information quickly becomes outdated and of limited use. Because of this, the relative importance of each use may change or new uses may develop. EPA believes tracking these changes is important, especially since the SIAP indicated both health and environmental issues for these four chemicals. The IUR provides current exposure related processing and use information in the United States every four years. This facilitates tracking changes in use patterns and the identification of new exposure scenarios, which is an important component of risk screening.

Additionally, the IUR contains some exposure related data elements not provided in the OECD HPV SIDS submission, such as data on the function of the chemical in the industrial processing and use category, the NAICS code associated with the use, and the number of potentially exposed workers and the number of sites associated with each use. For commercial and consumer uses, the IUR collects data on the amount of the chemical in various use categories, the concentration of the chemical in the use category, and the likelihood of inclusion in products intended for children. Furthermore, IUR information is updated every four years, is quantitative, and is specific to the United States.

Consideration F: Whether the potential risks for the chemical substance are adequately managed by EPA or another agency or authority.

The petition did not identify or discuss any risk management actions taken by EPA or another agency or authority with respect to the petitioned chemical( s). The petition did not explain why Page 5 of 7 the downstream processing and use information should be of low current interest in light of any such risk management actions.

Other Considerations/ Notes:

The SIAP, which contains a summary of the SIAR, contained the conclusion that all four chemicals are of low priority for further work within the OECD HPV SIDS program for human health, and that three of the substances are of low priority for further work for the environment. A designation of low priority for further work within the OECD HPV SIDS program means that further hazard testing is not needed to meet the purposes of OECD HPV SIDS at the time the review was performed. 2 Propenoic acid, 2 methyl, 2 ethylhexyl ester ( CASRN 688 84 6) was determined to be a candidate for further work for the environment ( Ref. 1). These judgements, however, do not determine the approach that an individual OECD member country must take in considering such a chemical. Rather, the OECD assessment is seen as a starting point for assessment in countries. In the U. S. case, it is a starting point for a screening level risk assessment, for which IUR exposure and use reporting provides screening level exposure information. In the past there have been a number of chemicals identified by OECD as a " low priority for further work," but for which EPA wanted to make a confirmatory priority judgement based on risk  i. e., screening level hazard information based on the OECD work plus screeninglevel exposure information based on the U. S. situation.

Table 1: Chemical Names Used in Petition that Differ from TSCA Inventory Chemical Names CASRN TSCA Inventory Chemical Name Chemical Name Used in Petition 97 63 2 2 propenoic acid, 2 methyl, ethyl ester Ethyl methacrylate 97 88 1 2 propenoic acid, 2 methyl, butyl ester n Butyl methacrylate 97 86 9 2 propenoic acid, 2 methyl, 2 methylpropyl ester iso Butyl methacrylate 688 84 6 2 propenoic acid, 2 methyl, 2 ethylhexyl ester Ethylhexyl methacrylate Cited Reference: 1) SIAP ( SIDS Initial Assessment Profile) for ethyl methacrylate, iso butyl methacrylate, n butyl methacrylate, and 2 ethylhexyl methacrylate. Dated April 2004. Available on the Web at http:// cs3 hq. oecd. org/ scripts/ hpv/ NewSIDS. asp Page 6 of 7 Sources Searched: ( Note: These sources are typically searched or reviewed to gather information presented in the petition review report.)

American Conference of Governmental Industrial Hygienists ( ACGIH) Threshold Limit Values ( TLV TWA). 2003. ACGIH, Cincinnati OH. pp. 12 61.

Agency for Toxic Substances and Disease Registry ( ATSDR) ToxFAQsTM ( Frequently asked questions about contaminants found at hazardous waste sites). Available at http:// www. atsdr. cdc. gov/ toxfaq. html California Air Resources Board List of Toxic Air Contaminant Fact Sheets, available at http:// arbis. arb. ca. gov/ toxics/ tac/ toctbl. htm California EPA, Safe Drinking Water and Toxic Enforcement Act of 1986: List of chemicals known to the State to cause cancer or reproductive toxicity. Listing as of Nov. 14, 2003. Available at http:// www. oehha. ca. gov/ prop65/ CRNR_ notices/ list_ changes/ 111403lsta. html International Agency of Research on Cancer ( IARC) Overall Evaluations of Carcinogenicity to Humans. Available at http:// monographs. iarc. fr/ monoeval/ crthall. html Interagency Testing Committee ( ITC) Priority Testing List. Available at http:// tsca itc. syrres. com/ Chemicals/

National Advisory Committee Acute Exposure Guideline Levels ( AEGLs). Available at http:// www. epa. gov/ oppt/ aegl/ index. htm Organisation for Economic Cooperation and Development ( OECD) Integrated HPV Database, http:// cs3 hq. oecd. org/ scripts/ hpv/ index. asp United Nations Environment Programme ( UNEP) persistent organic pollutants ( POPs), available at http:// www. chem. unep. ch/ pops/ default. html United Nations Environment Programme ( UNEP) Ozone Secretariat, Summary Control Measures, available at http:// www. unep. org/ ozone/ Treaties_ and_ Ratification/ 2B_ montreal_ protocol. asp U. S. EPA Clean Air Act ( CAA) Hazardous Air Pollutants ( HAPs). Available in the Clean Air Act, section 112( b), available at http:// www. epa. gov/ air/ caa/ caa112. txt U. S. EPA. Emergency Planning and Community Right to Know Act Section 313, List of Toxic Chemicals. 2001. Office of Environmental Information, EPA 260 B 01 001, available at http:// www. epa. gov/ tri/ chemical/ chemlist2001. pdf U. S. EPA HPV ( High Production Volume) Challenge Program and Voluntary Children's Chemical Evaluation Program ( VCCEP) Web sites under the EPA Chemical Right to Know Initiative, http:// www. epa. gov/ chemrtk U. S. EPA Integrated Risk Information System ( IRIS) Substance List. Available at http:// www. epa. gov/ iris/ subst/ index. html U. S. EPA. National Recommended Water Quality Criteria: 2002. Office of Water. EPA 822 R 02 047. Available at http:// www. epa. gov/ waterscience/ pc/ revcom. pdf U. S. EPA. 2004 Edition of the Drinking Water Standards and Health Advisories. Office of Water. EPA 822 R 04 005. Available at http:// www. epa. gov/ waterscience/ drinking/ standards/ dwstandards. pdf U. S. EPA Substance Registry System ( SRS). Available at http:// www. epa. gov/ srs/

U. S. Occupational Safety and Health Administration ( OSHA) Permissible Exposure Limits ( PELs), available at http:// www. osha. gov/ SLTC/ pel/ index. html List of Acronyms Page 7 of 7 ACGIH American Conference of Governmental Industrial Hygienists AEGL Acute Exposure Guideline Level ARB Air Resources Board ATSDR Agency for Toxic Substances and Disease Registry CAA Clean Air Act CASRN Chemical Abstract Service Registry Number CICAD Concise International Chemical Assessment Document CPSC Consumer Product Safety Commission EHC Environmental Health Criteria EPA Environmental Protection Agency EU European Union FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act GRAS Generally Recognized as Safe HAP Hazardous Air Pollutant HPV High Production Volume HSDB Hazardous Substances Databank IARC International Agency of Research on Cancer ICCA International Council of Chemical Associations IFCS International Forum on Chemical Safety IPCS International Programme on Chemical Safety IRIS Integrated Risk Information System IRPTC International Register of Potentially Toxic Chemicals ITC Interagency Testing Committee IUCLID International Uniform Chemical Information Database IUR Inventory Update Reporting Rule IURA Inventory Update Reporting Rule Amendment NAICS North American Industry Classification System NIOSH National Institute for Occupational Safety and Health OECD Organisation for Economic Cooperation and Development OECD HPV SIDS or OECD HPV SIDS program OECD/ SIDS HPV Chemicals Programme OPP Office of Pesticide Programs OPPT Office of Pollution Prevention and Toxics OSHA Occupational Safety and Health Administration PEL Permissible Exposure Limit POP Persistent Organic Pollutant SIAM SIDS Initial Assessment Meeting SIAP SIDS Initial Assessment Profile SIAR SIDS Initial Assessment Report SIDS Screening Information Data Set SRS Substance Registry System TLV TWA Threshold Limit Value Time Weighted Average TRI Toxics Release Inventory TSCA Toxic Substances Control Act UNEP United Nations Environment Programme VCCEP Voluntary Children's Chemical Evaluation Program


[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27803-27804]
[FR Doc No: E9-13614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0260]

Draft Guidance for Industry: Questions and Answers Regarding the
Reportable Food Registry as Established by the Food and Drug
Administration Amendments Act of 2007; Availability; Announcement of
Further Delay in Implementation of the Food and Drug Administration
Amendments Act of 2007

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Questions and

Answers Regarding the Reportable Food Registry as Established by the
Food and Drug Administration Amendments Act of 2007.'' The draft
guidance, when finalized, will assist the industry in complying with
the Reportable Food Registry requirements prescribed by the Food and
Drug Administration Amendments Act of 2007 (FDAAA). FDA is also
announcing a further delay in the implementation of the Reportable Food
Registry (the Registry) of FDAAA until September 8, 2009, to consider
any comments received on the draft guidance and through the agency's
planned outreach initiatives, and to allow for further testing of the
electronic portal for reportable foods.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on the
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 27, 2009.

ADDRESSES: Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments on the draft guidance to http://www.regulations.gov. Submit
written requests for single copies of the draft guidance to the Office
of Food Defense, Communication and Emergency Response, Center for Food
Safety and Applied Nutrition (HFS-005), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Faye Feldstein, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Questions and Answers Regarding the Reportable
Food Registry as Established by the Food and Drug Administration
Amendments Act of 2007.'' The draft guidance is intended to assist
those parties responsible for complying with the Reportable Food
Registry requirements prescribed by FDAAA.
    FDA is issuing this draft guidance as a level 1 draft guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternate approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Notice of Further Delay in Implementation

    On September 27, 2007, the President signed FDAAA into law (Public
Law 110-85). Section 1005 of FDAAA amends the Federal Food, Drug, and
Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f),
among other things. Section 417 of the act requires the Secretary of
Health and Human Services to establish within FDA a Reportable Food
Registry (the Registry); the Registry is to be established not later
than 1 year after the date of enactment (i.e., by September 27, 2008).
    To further the development of the Registry, section 417 of the act
requires FDA to establish, also within 1 year after the date of
enactment (i.e., by September 27, 2008), an electronic portal (the
Reportable Food electronic portal) by which instances of reportable
food must be submitted to FDA by responsible parties and may be
submitted by public health officials.
    FDA made the decision that the most efficient and cost effective
means to implement the requirements of section 417 of the act relating
to the Registry was to utilize the business enterprise system currently
under development within the agency: the MedWatch\Plus\ Portal. This
would permit the agency to establish an electronic portal through which
instances of reportable food may be submitted to the agency. However,
FDA recognized that the MedWatch\Plus\ Portal would not be implemented
in time to meet the September 27, 2008, deadline for establishing the
Reportable Food electronic portal and therefore announced that it was
delaying its implementation until spring 2009 (73 FR 30405; May 27,
2008).
    The agency now expects the system to be operational on September 8,
2009, and is therefore announcing that the implementation of the
requirements of section 417 of the act will be further delayed until
September 8, 2009.
    In the interim, FDA strongly encourages persons to continue to
report instances of adulterated food through existing mechanisms, such
as notifying the relevant FDA District office, until such time as the
Registry and its associated electronic portal are fully implemented.

III. Paperwork Reduction Act of 1995

    This draft guidance document contains a collection of information
that requires clearance by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995. FDA intends to submit the
collection of information to OMB in the near future for emergency
processing. At that time, the agency will publish a notice in the
Federal Register soliciting comments on the collection of information.
    The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in question 28 of the guidance have been approved under OMB control no.
0910-0249.

IV. Comments

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

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm or http://www.regulations.gov.

    Dated: June 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13614 Filed 6-10-09; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Notices]
[Pages 22767-22768]
[FR Doc No: 2020-08593]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88677; File No. SR-NYSE-2019-54]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of a Longer Period for Commission Action on
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To Permit the Exchange To List and Trade Exchange Traded
Products

April 17, 2020.
    On October 3, 2019, New York Stock Exchange LLC (``Exchange'')
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 and trade Exchange Traded Products that have a component NMS Stock
listed on the Exchange or that are based on, or represent an interest
in, an underlying index or reference asset that includes an NMS Stock
listed on the Exchange. The proposed rule change was published for

comment in the Federal Register on October 23, 2019.\3\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 87329 (Oct. 17,
2019), 84 FR 56864 (``Notice'').
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    On December 5, 2019, pursuant to Section 19(b)(2) of the Act,\4\
the Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ On January 17, 2020, the Commission instituted proceedings
under Section 19(b)(2)(B) of the Act \6\ to determine whether to
approve or disapprove the proposed rule change.\7\ The Commission has
received no comment letters on the proposal.
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    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 87671, 84 FR 67763
(Dec. 11, 2019).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 88003, 85 FR 4051
(Jan. 23, 2020). Specifically, the Commission instituted proceedings
to allow for additional analysis of the proposed rule change's
consistency with Section 6(b)(5) of the Act, 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,'' and
``to protect investors and the public interest.'' See id. at 4053
(citing 15 U.S.C. 78f(b)(5)).
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    Section 19(b)(2) of the Act \8\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The date
of publication of notice of filing of the proposed rule change was
October 23, 2019. April 20, 2020, is 180 days from that date, and June
19, 2020, is 240 days from that date.
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    \8\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider this proposed
rule change. Accordingly, the Commission, pursuant to Section 19(b)(2)
of the Act,\9\ designates June 19, 2020, as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-NYSE-2019-54).
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    \9\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(57).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08593 Filed 4-22-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 162 (Wednesday, August 23, 2023)]
[Notices]
[Pages 57505-57508]
[FR Doc No: 2023-18104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98158; File No. SR-BX-2023-020]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Set Fees for the
Purchase of Field-Programmable Gate Array Technology as an Optional
Delivery Mechanism for BX Totalview

August 17, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 9, 2023, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to set fees for the purchase of field-
programmable gate array (``FPGA'') technology as an optional delivery
mechanism for BX TotalView.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/bx/rules, at the
principal office of the Exchange, 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
    The purpose of the proposed rule change is to establish a fee
schedule for the purchase of field-programmable gate array (``FPGA'')
technology as an optional delivery mechanism for BX TotalView (``BX
FPGA Service'').\3\ This follows a recently-filed proposal to offer
FPGA technology as an optional delivery mechanism for BX TotalView.\4\
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    \3\ This Proposal was initially filed by the Exchange on May 23,
2023. See Securities Exchange Act Release No. 97627 (May 31, 2023),
88 FR 37112 (June 6, 2023) (SR-BX-2023-014). On July 7, 2023, that
filing was withdrawn and replaced to provide supplemental
information. See Securities Exchange Act Release No. 97946 (July 19,
2023), 88 FR 47937 (July 25, 2023) (SR-BX-2023-016). On August 9,
2023, the second filing was withdrawn and replaced with the instant
filing, which provides additional information without changing the
Proposal in substance.
    \4\ See SR-BX-2023-011 (``A proposal to offer field-programmable
gate array (`FPGA') technology as an optional delivery mechanism for
BX TotalView.''), available at https://listingcenter.nasdaq.com/rulebook/BX/rulefilings. A proposal to establish a fee schedule for
the use of FPGA technology for the Phlx exchange is being filed
concurrently with this proposal.
---------------------------------------------------------------------------

FPGA
    FPGA is a hardware-based delivery mechanism that utilizes an
integrated circuit that is programmed to reduce ``jitter''--a technical
term of art referring to the deviation in amplitude, phase timing or
width of a signal pulse in a digital signal--that will allow data to be
processed in a more predictable, or ``deterministic,'' fashion.
Reducing jitter can be useful for certain customers due to the
variability in the timing of market data packets transmitted by an
exchange over the course of the trading day. Orders, and therefore
market data packets, typically accumulate in larger numbers at the
beginning and end of the trading day, as well as during the peaks of
activity that occur at random intervals during the day. These bursts of
activity may alter the time interval between the delivery of data
packets because software processes information at variable rates
depending on load to the system. Processing times may increase at
higher loads, and decrease during periods of lesser activity. FPGA
technology processes data packets at a constant time interval, without
regard to the number of packets processed. Higher levels of determinism
mean less variable queuing, which improves the predictability of data
transfer, particularly during times of peak market activity.

    The benefits of determinism depend on the use case of the customer,
as well as the customer's specific system architecture.
    Higher determinism does not necessarily mean lower latency. The
concepts of determinism and latency are related, but distinct.
Determinism refers to predictability in the rate of data transmission;
latency refers to the time required to process data or transport it
from one location to another. Low latency is not necessarily
deterministic, and higher determinism does not necessarily mean low
latency. As such, use of FPGA technology will increase determinism, but
does not guarantee lower latency at all times.\5\
---------------------------------------------------------------------------

    \5\ Because software can be impacted by workload, FPGA
technology in general can provide lower latency during periods of
peak activity. The same FPGA technology that will support the BX
FPGA Service is also broadly commercially available for purchase
from third-party sellers unrelated to the Exchange.
---------------------------------------------------------------------------

    Among customers that seek a higher degree of determinism, the
benefits of FPGA technology vary, as FPGA technology is one possible
solution, among a catalog of possible solutions, for increasing the
consistency and predictability of message throughput over the course of
the trading day. Some customers are able to adequately control jitter
without using FPGA technology; other customers address jitter using
specialized software, coding or other design solutions in conjunction
with FPGA; still others use FPGA alone. The specific choice depends on
a complex analysis of the customer's information technology systems in
the context of their particular use cases.
    FPGA is a broadly-available, commonly-used type of programmable
circuit that can be modified to suit different use cases. It is used in
a wide spectrum of industries, including the consumer electronics,
automotive, and aerospace, as well as in a variety of industrial
applications. It is not unique to the financial services industry,\6\
or to the Exchange.
---------------------------------------------------------------------------

    \6\ See, e.g., Contrive Datum Insights, ``Field-Programmable
Gate Array (FPGA) Market is expected to reach around USD 22.10
Billion by 2030, Grow at a CAGR of 15.12% during Forecast Period
2023 to 2030,'' (February 21, 2023), available at https://www.globenewswire.com/en/news-release/2023/02/21/2612772/0/en/Field-Programmable-Gate-Array-FPGA-Market-Is-Expected-To-Reach-around-USD-22-10-Billion-by-2030-Grow-at-a-CAGR-Of-15-12-during-Forecast-Period-2023-To-2030-Data-By-Contrive-Datum-I.html (describing the
general size and state of the FPGA market in 2023).
---------------------------------------------------------------------------

    FPGA technology has been offered by the Nasdaq Stock Exchange for
over a decade, and the Nasdaq Options Market for nearly as long,\7\ and
has been cited by the SEC as an example of a technology useful in the
distribution of market data products.\8\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 67297 (June 28,
2012), 77 FR 39752 (July 5, 2012) (SR-Nasdaq-2012-063) (introducing
FPGA technology); see also Nasdaq Data News 2012-13, available at
http://www.nasdaqtrader.com/TraderNews.aspx?id=dn2012-13
(introducing TotalView FPGA service as of August 1, 2012);
Securities Exchange Act Release No. 74745 (April 16, 2015), 80 FR
22588 (April 22, 2015) (SR-Nasdaq-2015-035) (establishing FPGA for
the Nasdaq Options Market); The Nasdaq Stock Market LLC Rules,
Equity 7, Section 126(c) (Hardware-Based Delivery of Nasdaq Depth
data).
    \8\ See Securities Exchange Act Release No. 90610, 86 FR 18596,
18647 (April 9, 2021) (File No. S7-03-20) (listing field
programmable gate array services as an example of a technological
innovation that could be employed by competing consolidators as part
of the Market Data Infrastructure rule).
---------------------------------------------------------------------------

    The Exchange proposes to offer the BX FPGA Service in conjunction
with the Exchange's depth of book feed, BX TotalView. BX TotalView is a
real-time market data product that provides full order depth using a
series of order messages to track the life of customer orders in the BX
market, as well as trade data for BX executions and administrative
messages such as Trading Action messages, Symbol Directory, and Event
Control messages.\9\
---------------------------------------------------------------------------

    \9\ See Nasdaq BX, Inc. Rules, Equity 7, Section 123 (BX
TotalView); see also Securities Exchange Act Release No. 59307
(January 28, 2009), 74 FR 6069 (February 4, 2009) (establishing fees
for BX TotalView).
---------------------------------------------------------------------------

    Customers that choose to purchase BX TotalView without the BX FPGA
Service will receive the same data as customers that elect to purchase
BX TotalView with the BX FPGA Service.

Proposed Fees

    BX proposes internal distribution fees of $3,500 per month and
external distribution fees of $350 for the BX FPGA Service; customers
that elect to use the BX FPGA Service for both internal and external
distribution will pay both fees.\10\ These fees are in addition to
Market Data Distributor Fees,\11\ fees for BX TotalView,\12\ and other
fees for Distribution Models.\13\ Customers that elect to receive BX
depth of book data without using the BX FPGA Service will pay no fee in
addition to the underlying fees listed above.
---------------------------------------------------------------------------

    \10\ The difference in amount for external and external
distribution reflects Nasdaq's experience that the Exchange's FPGA
hardware is best employed at the point of ingestion, as the utility
of FPGA technology falls as the data moves farther from the source.
    \11\ See Nasdaq BX, Inc. Rules, Equity 7, Section 119.
    \12\ See Id., Section 123.
    \13\ See Id., Section 126.
---------------------------------------------------------------------------

    The proposed fees for the BX FPGA Service are substantially lower
than fees for the Nasdaq FPGA Service, which are set at $25,000 per
Distributor for internal only distribution, $2,500 for external only,
and $27,500 for internal and external distribution.\14\ The difference
is based, in part, on a comparison of peak activity at the two
exchanges. As noted above, high levels of determinism are particularly
valuable during periods of peak activity.
---------------------------------------------------------------------------

    \14\ See The Nasdaq Stock Market LLC Rules, Equity 7 (Pricing
Schedule), Section 126(c) (Hardware-based delivery of Nasdaq depth
data).
---------------------------------------------------------------------------

    Although there is considerable variation in the number of messages
at various peaks, as well as the duration of peak activity, the
proposed fees are roughly comparable to the differences in average peak
activity at the BX exchange relative to the Nasdaq exchange. Exchange
staff have also discussed the proposed fees with customers, and
believe, based on those discussions and their own business judgment,
that the proposed fees fairly reflect the value of the BX FPGA Service.
A number of customers provisionally agree with this assessment, and
have indicated that they are interested in testing it.
    No other exchange currently offers FPGA technology as a separate
service in conjunction with the delivery of a proprietary data feed,
and therefore there are no other fees for comparison.
    If BX is incorrect in its determination that the proposed fees
reflect the underlying value of the BX FPGA Service, customers will not
purchase the product. The BX FPGA Service is not necessary for a
customer to ingest and process depth of book information, and those
customers that seek a higher degree of determinism have a number of
options at their disposal to reduce jitter without using the BX FPGA
Service.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act,\15\ in general, and furthers the objectives of
sections 6(b)(4) and 6(b)(5) of the Act,\16\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Proposal is reasonable and unlikely to burden the market
because the purchase of the BX FPGA Service is optional for all
categories of customers. No customer and no category of customers (such
as, for example, vendors, proprietary trading firms, banks, hedge
funds, market makers, or high frequency trading firms) are required to
purchase the BX FPGA

Service for either legal or technological reasons--even a customer that
seeks to reduce jitter.\17\
---------------------------------------------------------------------------

    \17\ Not all customers of depth of book information process at
sufficiently high speeds for jitter to become a concern. Neither
FPGA hardware nor its substitutes are required to ingest depth of
book information.
---------------------------------------------------------------------------

    The Nasdaq exchange has over ten years of experience in selling the
Nasdaq FPGA Service. That experience has shown that the vast majority
of Nasdaq depth customers do not find value in the Nasdaq FPGA Service.
The Exchange expects customers that do not find value in the Nasdaq
FPGA Service to make a similar decision with respect to the BX FPGA
Service, and continue to ingest BX TotalView as they do now.
    For those customers that may seek to increase determinism, the
purchase of FPGA technology from the BX exchange will be only one of
several options available. FPGA technology is not unique to the
Exchange or even the financial services industry. Third-party data
vendors offer FPGA technology services. Customers may also install
their own FPGA hardware for internal use. All of these are viable
options; the benefits of any particular option will depend on the
particular customer's systems and use cases.
    Customers may also choose not to address jitter using FPGA
technology at all. As noted above, FPGA technology processes the data
at a consistently predictable rate relative to software. This
predictability in the rate of processing may not be advantageous or
optimal for all systems receiving the exchange data feed.
    The design of data processing architecture is complex. The
ingestion of data from an exchange is just one step in the life-cycle
of trading. Customers must also generate and submit orders, evaluate
trades, and then generate new orders while interacting with multiple
exchanges. All of these steps are part of a single trading system.
Changing any one step in the process--by, for example, purchasing the
BX FPGA Service when other exchanges may not offer FPGA--often results
in the need for changes to other aspects of the process. As such, the
decision to buy the BX FPGA Service will be based on whether the
service is compatible with the customer's trading system as a whole,
not just on whether it may facilitate the processing of data from a
single exchange. The appropriateness of any particular solution will
depend on the customer's system architecture, and the specific use
cases for the market data consumed.
    To illustrate the choice faced by exchange customers, consider the
decisions made by the two consolidated data processors, the UTP and CTA
Plans, two different systems that use dissimilar means to achieve an
optimal solution. Both perform the same task--combining quotes and
trades from all U.S. exchanges into a consolidated data feed with
relatively low jitter. Yet only one processor--the CTA Plan--uses FPGA
hardware, while the other--the UTP Plan--does not.
    This is because the UTP Plan's design, coding and hardware achieve
the desired level of determinism without FPGA technology. The CTA Plan,
by contrast, elected to incorporate FPGA technology into its system
design. Notwithstanding these different design decisions, both plans
achieve broadly similar levels of performance. FPGA technology is
therefore not essential to addressing jitter, but rather is one option
among many to address the issue.
    Market data customers face an array of choices to optimize
determinism, much like the UTP and CTA Plans. For example, a customer
may purchase and deploy its own FPGA hardware, without purchasing the
proposed FPGA technology service from the Exchange, after receiving
data from the Exchange. Another customer may find use of the BX FPGA
Service, which lowers the level of jitter prior to the customer's
receipt of the data, to be a better fit for its system architecture.
The solution chosen will vary based on the needs and design choices of
the customer.
    The experience of the Nasdaq exchange in offering the Nasdaq FPGA
Service shows that customers sensitive to jitter often avail themselves
of substitutes for FPGA technology, a decision that can change over
time. Over the past decade, a total of 21 current or potential users of
the Nasdaq FPGA Service--all of which sought a higher degree of
determinism--substituted the Nasdaq FPGA Service with an alternative
solution. Six of these customers were in the process of developing and
testing the Nasdaq FPGA Service, but ultimately decided not to purchase
it before completing this process. The remaining 15 customers purchased
the Nasdaq FPGA Service, only to cancel it after using it. Because all
of these customers continued to utilize the underlying data, these
cancelations demonstrate that the BX FPGA Service, like the Nasdaq FPGA
Service, will be an optional service, even for those customers that
seek to reduce jitter.
    Moreover, as noted above, no other exchange currently offers FPGA
technology in conjunction with their proprietary data feeds as a
separate service, notwithstanding the fact that it is a widely
available technology, providing further evidence that customers have
multiple options at their disposal to address jitter.
    In the experience of the Nasdaq exchange, the Nasdaq FPGA Service
is purchased by vendors, proprietary trading firms, banks, high-
frequency trading firms, hedge funds, and market makers. The Nasdaq
exchange is aware of no systematic differences within any of these
categories among market participants that choose to use or not to use
the Nasdaq FPGA Service.
    Few customers of Nasdaq TotalView purchase the Nasdaq FPGA Service.
This is because the bulk of customers consume Nasdaq TotalView for
display (i.e., human) usage. FPGA technology impacts performance at a
speed that a human cannot process, and there is no need for FPGA
technology for such usage.
    Of the customers that receive Nasdaq TotalView from Nasdaq (either
through a direct feed or an extranet connection), and are in a position
to utilize the Nasdaq FPGA Service, only about 15 percent purchase it.
    Most strikingly, only approximately 3% of market makers at Nasdaq
purchase the Nasdaq FPGA Service.\18\ This may seem a surprising
result, given that market makers, by definition, trade throughout the
day and during periods of peak activity, but, as noted above, customers
have several options: purchase FPGA services from a third-party vendor,
implement FPGA technology on their own, or configure their systems to
process data during peaks without the use of FPGA. The fact that only
about 3% of market makers at the Nasdaq exchange purchase the Nasdaq
FPGA Service demonstrates that most customers make use of alternative
solutions. As such, the determining factor in whether to purchase the
Nasdaq FPGA Service is not the category of customer, but rather the
compatibility of that service with the customer's specific systems
architecture and technical requirements, which can and do change over
time as systems are modified, replaced or updated.
---------------------------------------------------------------------------

    \18\ The 3% figure represents the percentage of designated
market makers by market participant identifier (``MPID'') that
currently purchase the Nasdaq FPGA Service relative to all MPIDs on
the Nasdaq Market Center. The MPID is a unique four-letter mnemonic
assigned to each Participant in the Nasdaq Market Center. A
Participant may have one or more than one MPID. See The Nasdaq Stock
Market LLC Rules, Equity 1, Section 1(a)(11).
---------------------------------------------------------------------------

    For all of these reasons, customers can discontinue the use of the
BX FPGA Service at any time, or decide not to purchase it, for any
reason, including the level of fees.

    Customers that choose not to purchase the BX FPGA Service are not
impacted by the proposal.
    The BX FPGA Service will be available to all customers on a non-
discriminatory basis, and therefore the proposed fees are not designed
to permit unfair discrimination between customers, issuers, brokers, or
dealers.

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 not necessary or appropriate in
furtherance of the purposes of the Act.
    This Proposal, a response to customer demand, is a product of a
competitive marketplace. To date, lower levels of peak activity at the
BX Exchange relative to the Nasdaq exchange have been associated with
low levels of customer interest in this product. Recently, however, BX
has heard from customers interested in using FPGA technology for BX
TotalView. To address this customer demand, and to drive liquidity to
the BX Exchange by making it a more attractive trading venue, BX has
decided to offer this product.
    Approval of this Proposal will further promote competition by
providing market participants additional choices in the transmission of
depth of book data.
    Nothing in the Proposal burdens inter-market competition (the
competition among self-regulatory organizations) because approval of
the Proposal does not impose any burden on the ability of other
exchanges to compete. As noted above, FPGA technology is generally
available and any exchange has the ability to offer it if it so
chooses.
    Nothing in the Proposal burdens intra-market competition (the
competition among consumers of exchange data) because the BX FPGA
Service will be available to any customer under the same fee schedule
as any other customer, and any market participant that wishes to
purchase the BX FPGA Service can do so on a non-discriminatory basis.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A)(ii) of the Act.\19\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule 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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-BX-2023-020 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-BX-2023-020. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-BX-2023-020 and should be
submitted on or before September 13, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-18104 Filed 8-22-23; 8:45 am]
BILLING CODE 8011-01-P


P-21-0087 Sanitized Support Documents Index:
 P-21-0087 Sanitized Premanufacture Notice (linked)
 P-21-0087 Sanitized Determination Document (linked)
 P-21-0087 Sanitized CHEM Report (attached)
 P-21-0087 Sanitized Fate Report (attached)
 P-21-0087 Sanitized ECO Report (attached)
 P-21-0087 Sanitized ENG Report (attached)
 P-21-0087 Sanitized EXP Report (attached)
 P-21-0087 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77125-77126]
[FR Doc No: 2022-27344]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0710]

Circumstances That Constitute Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection; Draft Guidance for Industry,
Revision 1; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled, ``Circumstances that
Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device
Inspection.'' The FDA Reauthorization Act of 2017 (FDARA) amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case
with a drug, a device is deemed to be adulterated if the owner,
operator, or agent of the factory, warehouse, or establishment at which
the device is manufactured, processed, packed, or held delays, denies,
or limits an FDA inspection. This draft guidance describes, for both
drugs and now devices, the types of behaviors (actions, inactions, and
circumstances) that the FDA considers to constitute delaying, denying,
or limiting inspection, or refusing to permit entry or inspection. Once
finalized, this draft guidance is intended to supersede the October
2014 FDA final guidance for industry entitled, ``Circumstances that
Constitute Delaying, Denying, Limiting, or Refusing a Drug
Inspection.'' However, until this draft guidance is finalized, the
October 2014 FDA guidance remains in effect until it is withdrawn and
will continue to reflect FDA's current thinking on this issue. FDA is
particularly interested in comments on the inclusion of devices to the
October 2014 guidance.

DATES: Submit either electronic or written comments on the draft
guidance by February 14, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2013-D-0710 for ``Circumstances that Constitute Delaying, Denying,
Limiting, or Refusing a Drug or Device Inspection.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for a single hard copy of the draft
guidance to the Division of Operational Policy, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Drive, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Lola Burford, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Dr., Rockville, MD 20857, [email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) added section 501(j) to the
FD&C Act (21 U.S.C. 351(j)) to deem adulterated a drug that ``has been
manufactured, processed, packed, or held in any factory, warehouse, or
establishment and the owner, operator, or agent of such factory,
warehouse, or establishment delays, denies, or limits an inspection, or
refuses to permit entry or inspection.'' Section 707(b) of FDASIA
required the Food and Drug Administration to issue guidance that
defined the circumstances that would constitute delaying, denying, or
limiting inspection, or refusing to permit entry or inspection, for
purposes of section 501(j) of the FD&C Act. In the Federal Register of
October 22, 2014 (79 FR 63130), FDA announced the availability of a
guidance for industry entitled, ``Circumstances that Constitute
Delaying, Denying, Limiting, or Refusing a Drug Inspection''
(hereinafter, 2014 guidance).
    Subsequently, on August 18, 2017, FDARA (Pub. L. 115-52) was signed
into law. Section 702 of FDARA amended the scope of section 501(j) of
the FD&C Act to provide that, as the case with drugs, devices are
deemed to be adulterated if an FDA inspection is delayed, denied,
limited, or refused by the owner, operator, or agent of the
establishment at which the device is manufactured, processed, packed,
or held. This draft guidance is intended to update the 2014 final
guidance to incorporate devices and to explain the circumstances that
FDA would consider to constitute delaying, denying, or limiting
inspection, or refusing to permit entry or inspection, resulting in a
drug or device manufactured in the facility being deemed adulterated.
The 2014 guidance will remain in effect and will continue to reflect
FDA's current thinking regarding circumstances that would constitute
delaying, deny, or limiting inspection, or refusing to permit entry or
inspection, for purposes of 501(j) of the FD&C Act with respect to drug
inspections, until this draft guidance is finalized.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Circumstances that Constitute Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection'' and will supersede the 2014
guidance. 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

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Circumstances that Constitute Delaying,
Denying, Limiting, or Refusing a Drug or Device Inspection'' may send
an email request to [email protected] to receive an
electronic copy of the document.

    Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27344 Filed 12-15-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2596-2598]
[FR Doc No: 2019-01390]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85036; File No. SR-IEX-2019-01]

Self-Regulatory Organizations; Investors Exchange LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Reject
Market Orders With a Time-in-Force of DAY That Are Entered in the Pre-
Market Session for Non-IEX-Listed Securities

February 1, 2019.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on January 28, 2019, the Investors Exchange LLC (``IEX'' or
the ``Exchange'') 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 self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Pursuant to the provisions of Section 19(b)(1) under the Act,\4\
and Rule 19b-4 thereunder,\5\ IEX is filing with the Commission a
proposed rule change to reject market orders with a time-in-force \6\
of DAY that are entered in the Pre-Market Session \7\ for non-IEX-
listed securities, including for the Opening Process for non-IEX-listed
securities pursuant to Rule 11.231 (the ``Opening Process''). The
Exchange has designated this rule change as ``non-controversial'' under
Section 19(b)(3)(A) of the Act \8\ and provided the Commission with the
notice required by Rule 19b-4(f)(6) thereunder.\9\
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    \4\ 15 U.S.C. 78s(b)(1).
    \5\ 17 CRF [sic] 240.19b-4.
    \6\ See Rule 11.190(c).
    \7\ See Rule 1.160(z).
    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4.
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    The text of the proposed rule change is available at the Exchange's
website at www.iextrading.com, at the principal office of the Exchange,
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 self-regulatory organization
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 statement [sic] may be examined
at the places specified in Item IV below. The self-regulatory
organization 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
Background
    The purpose of this proposed rule change is to reject market orders
with a time-in-force of DAY that are entered in the Pre-Market Session
for non-IEX-listed securities, including for the Opening Process. On
July 24, 2017, the Commission approved a proposed rule change filed by
the Exchange to amend IEX Rule 11.231 to modify the manner in which the
Exchange opens trading for non-IEX-listed securities beginning at the
start of Regular Market Hours (the ``Opening Process'').\10\
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    \10\ See Securities Exchange Act Release No. 81195 (July 24,
2017), 82 FR 35250 (July 28, 2017).
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    Pursuant to Rule 11.231, the Exchange attempts to perform the
Opening Process in each non-IEX-listed security, in which all eligible
interest resting on the Order Book in the Pre-Market Session available
for continuous trading (i.e., orders on the ``Continuous Book'') as
well as all eligible interest queued for execution in the Regular
Market Session \11\ (i.e., orders on the ``Cross Book'') is executed at
a single price. Currently, prior to the beginning of Regular Market
Hours,\12\ Users that wish to participate in the Opening Process may
enter limit, non-routable market, and pegged orders designated with a
time-in-force of DAY and limit orders designated with a time-in-force
of GTX, which queue in the System and are eligible for execution in the
Opening Process (i.e., orders on the Cross Book); interest resting on
the Order Book in the Pre-Market Session available for continuous
trading (i.e., orders on the Continuous Book) are also eligible for
execution in the Opening Process (collectively, ``Cross Eligible
Orders'').
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    \11\ See Rule 1.160(gg).
    \12\ See Rule 1.160(gg).
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    Cross Eligible Orders resting on the Continuous Book are ranked by
the price at which they are resting on the Continuous Book and Cross
Eligible Orders resting on the Cross Book are ranked by the limit price
defined by the User, if any, except in the case of pegged orders, which
are ranked by their current book price (in each case, the order's
``resting price'').\13\
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    \13\ See Rule 11.220(a)(2). See also Rule 11.231(a)(1).
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    The Exchange proposes to reject market orders with a time-in-force
of DAY that are entered in the Pre-Market Session for non-IEX-listed
securities, including for the Opening Process. Specifically, as
proposed, market orders marked DAY submitted before the open of the
Regular Market Session would be rejected for non-IEX-listed securities,
but will be queued by the System until the Opening Auction (or Halt
Auction, as applicable) for IEX-listed securities pursuant to IEX Rule
11.350,\14\ except market orders marked DAY that are designated to
route pursuant to Rule 11.230(c).\15\ The Exchange is not proposing any
further changes to the handling or functional behavior of market
orders. Finally, the Exchange is proposing a conforming change to Rule
11.220 (Priority of Orders) to reflect that, as proposed, market orders
will not be eligible for execution in the Opening Process for non IEX-
listed securities.
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    \14\ See Rule 11.350(a)(1)(A)(iii).
    \15\ See Rule 11.190(a)(2)(E)(iii).
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2. Statutory Basis
    IEX believes that the proposed rule change is consistent with the
provisions of Section 6(b) \16\ of the Act in general, and furthers the
objectives of Section 6(b)(5) of the Act \17\ in particular, in that it
is 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.
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    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(5).
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    Specifically, the Exchange believes the proposed rule change is
consistent with the protection of investors and the public interest in
that it is designed to prevent market participants from entering market
orders with a time-in-force of DAY on IEX instead of the primary
listing market, that could cause an opening match price on IEX that
significantly deviates from the current market for the security.\18\
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    \18\ The Exchange notes as well that it does not accept Market-
On-Open orders for the Opening Process because such orders could
have a similar impact.
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    Based on informal conversations with various market participants,
the Exchange understands that market orders with a time-in-force of DAY
are often entered during the pre-market session by market participants
to interact in opening auctions on the listing exchange for listed
securities. Accordingly, IEX and other listing exchange [sic] accept
market orders with a time-in-force of DAY for such auctions.\19\ While
the IEX Opening Process is designed to provide an opportunity to match
buy and sell orders at a price that is reflective of market conditions
for the security, the Exchange also appreciates the important goal of
aggregating liquidity in the opening auction (as well as the closing
auction) on the listing exchange to facilitate price discovery for the
auction. Therefore, the Exchange believes that restricting market
participants from entering market orders with a time-in-force of DAY in
non-IEX-listed securities may facilitate the aggregation of liquidity
in the primary market opening auction and enhance market-wide price
discovery, consistent with the protection of investors and the public
interest. In addition, the Exchange believes the proposed change would
not significantly impact the protection of investors or the public
interest because prior to offering the Opening Process for non-IEX-
listed securities,\20\ the Exchange rejected market orders with a time-
in-force of DAY that were entered before the Regular Market Session,
and such interest was not eligible for the prior opening mechanism.
Thus, the proposed rule change does not present any new or novel issues
not already considered by the Commission.
---------------------------------------------------------------------------

    \19\ See supra note 11 [sic]. See also, e.g., Cboe BZX Exchange,
Inc. Rules 11.23(a)(8) and 11.9(b)(7).
    \20\ See supra note 10.
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    Lastly, the Exchange believes the proposed conforming change to
Rule 11.220 is consistent with the protection of investors and the
public interest in that it will make the Exchange's rules more concise
and accurate, to the benefit of all market participants.

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

    IEX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. With respect

to intra-market competition, the Exchange notes that the proposed
changes will apply to all Members on a fair and equal basis.
Furthermore, market participants seeking to interact in the Opening
Process may continue to enter other Cross Eligible Orders on fair and
equal terms. With respect to inter-market competition, the Exchange
believes that the proposed change does not result in any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. To the contrary, the Exchange believes that
rejecting market orders with a time-in-force of DAY to avoid causing an
opening match price that deviates from the current market for the
security will support, and thereby promote competition between the
Exchange's Opening Process and the opening mechanisms offered by other
market centers, while avoiding unnecessary fragmentation of order flow
intended for the primary market's opening auction.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
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 \21\ and Rule 19b-
4(f)(6) thereunder.\22\
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    \21\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \22\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    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 shall institute proceedings to
determine whether the proposed rule 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-IEX-2019-01 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-IEX-2019-01. 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-IEX-2019-01, and should be submitted on
or before February 28,  2019.
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    \23\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-01390 Filed 2-6-19; 8:45 am]
 BILLING CODE 8011-01-P