                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                   REGION 1
                        5 POST OFFICE SQUARE, SUITE 100
                            BOSTON, MA  02109-3912

Technical Support Document

Date: 	    May 15, 2018

Subject:  EPA's Review of Connecticut's SIP Submittal Removing Step 2 GHG Sources from
              	  the Requirement to Obtain a PSD permit.

From:	    Donald Dahl, Environmental Engineer

Thru:	    Eric Wortman, Acting Manager
	    Air Permits, Toxics, and Indoor Programs Unit

TO: Files

The following table provides the EPA Region 1's analysis of Connecticut's state implementation plan (SIP) revision to clarify that the State's PSD rules do not require a source to obtain a permit solely because the source emits or has the potential to emit (PTE) Greenhouse Gases (GHGs) above the applicable thresholds. Based on this analysis, the EPA has found the State's revisions are consistent with the EPA's PSD regulations. Therefore, in the federal register notice associated with this TSD, the EPA is proposing to approve these revisions. The table below is organized by the State's individual SIP revision request submitted by Connecticut on February 28, 2018. The EPA proposes to amend the SIP by adding the language that is underlined and removing the text that is struck out in the table's first column.

State's Requested Change to the SIP
Relevant EPA Regulation
Action

Removal of Sections 22a-174-3a(a)(1)(H)-(J):

"(a) Applicability and Exemptions

 (1) Applicability. Prior to beginning actual construction of any stationary source or modification not otherwise exempted in accordance with subdivision (2) (A) to (C) of this subsection, the owner or operator shall apply for and obtain a permit to construct and operate under this section for any:

 * * *

 (H) New stationary source that emits, or has the potential to emit, equal to or greater than 100,000 tons per year of CO2e and one hundred (100) tons per year of greenhouse gases;

 (I) Major stationary source when such major stationary source undertakes a physical change or change in the method of operation that will result in a net emissions increase that is equal to or greater than 75,000 tons per year CO2e; or

 (J) Stationary source that emits, or has the
 potential to emit, equal to or greater than 100,000 tons per year of CO2e and one hundred (100) tons per year of greenhouse gases, when such stationary source undertakes a physical change or change in the method of operation that will result in a net emissions increase that is equal to or greater than 75,000 tons per year CO2e."

40 CFR 51.166(b)(48)(iv)(b) states:

  "The stationary source is an existing major stationary source for a regulated NSR pollutant that is not GHGs, and also will have an emissions increase of a regulated NSR pollutant, and an emissions increase of 75,000 tpy CO2e or more;"

On August 19, 2015 (see 80 FR 50199), EPA removed section 40 CFR 51.166(b)(48)(v) from its regulations. Prior to removal this section stated:

  "(v) Beginning July 1, 2011, in addition to the provisions in paragraph (b)(48)(iv) of this section, the pollutant GHGs shall also be subject to regulation:

     (a) At a new stationary source that will emit or have the potential to emit 100,000 tpy CO2e; or

     (b) At an existing stationary source that emits or has the potential to emit 100,000 tpy CO2e, when such stationary source undertakes a physical change or change in the method of operation that will result in an emissions increase of 75,000 tpy CO2e or more."
Approve based on the following:

1) The removal of Section 22a-174-3a(a)(1)(H) from the SIP is consistent with 40 CFR 51.166(b)(48)(v)(a) being  removed from EPA's regulation in 2015.

2) The removal of Section 22a-174-3a(a)(1)(I) from the SIP is approvable because this provision does not require the change at the source to also have an emission increase of a regulated air pollutant as required by 40 CFR 51.166(b)(48)(iv)(b) and is consistent with 40 CFR 51.166(b)(48)(v)(b) being removed from EPA's regulation in 2015.

3) The removal of Section 22a-174-3a(a)(1)(J) from the SIP is consistent with 40 CFR 51.166(b)(48)(v)(b) being removed from EPA's regulation in 2015.
Revising Section 22a-174-3a(j)(1)(E) as follows:

 "(j) Best Available Control Technology (BACT)

   (1) An owner or operator shall incorporate BACT for:

   * * *

   (E) Potential emissions of 75,000 tons or more per year of CO2e from each new major stationary source if the new major stationary source also has potential emissions of an air pollutant above the significant emission rate threshold in Table 3a(k)-1of subsection (k) of this section: or

40 CFR 51.166(b)(48)(iv)(a) states:

  "The stationary source is a new major stationary source for a regulated NSR pollutant that is not GHGs, and also will emit or will have the potential to emit 75,000 tpy CO2e or more;"

40 CFR 51.166(j)(2):

  "A new major stationary source shall apply best available control technology for each  regulated NSR pollutant that it would have the potential to emit in significant amounts."

40 CFR 51.166(b)(23)(ii):

  "Significant means, in reference to a net emissions increase or the potential of a source to emit a regulated NSR pollutant that paragraph (b)(23)(i) of this section, does not list, any emissions rate."
Approve: Connecticut's language requires a BACT analysis to be performed for greenhouse gases when a new major source has significant emissions that are not GHGs and the new source will have a PTE of 75,000 tons per year or more of CO2e.
Revising Sections 22a-174-3a(j)(1)(F)  -  (I) by deleting (F), (H), and (I) and revising and renumbering Section 22a-174-3a(j)(1)(G) as follows:

"Best Available Control Technology (BACT)
 (1) An owner or operator shall incorporate BACT for:

   * * *

   (F) Potential emissions of 100,000 tons or more per year of CO2e and potential emissions of one hundred (100) tons or more per year of greenhouse gases from each new stationary source and, from such a source, potential emissions of each air pollutant above the significant emission rate threshold in Table 3a(k)-1 of subsection (k) of this section;

   (G) (F)Potential emissions of 75,000 tons or more per year of CO2e from each physical change or change in the method of operation of a major stationary source; if the physical change or change in the method of operation is a major modification that has potential emissions of an air pollutant above the applicable significant emission rate threshold in Table 3a(k)-1 of subsection (k) of this section.

   (H) Potential emissions of 75,000 tons or more per year of CO2e from each physical change or change in the method of operation of a stationary source, where such stationary source:

   (i) Emits or has the potential to emit equal to or greater than 100,000 tons per year CO2e, and

   (ii) Emits or has the potential to emit equal to or greater than one hundred (100) tons or more per year of greenhouse gases; or

   (I) Potential emissions of 75,000 tons or more per year of CO2e and potential emissions of each air pollutant above the significant emission rate thresholds in Table 3a(k)-1 of subsection (k) of this section from each physical change or change in the method of operation of a stationary source, where such stationary source:

   (i) Emits or has the potential to emit equal to or greater than 100,000 tons per year CO2e, and

   (ii) Emits or has the potential to emit equal to or greater than one hundred (100) tons or more per year of greenhouse gases."
40 CFR 51.166(b)(2)(i): "Major modification means any physical change in or change in the method of operation of a major stationary source that would result in: a significant emissions increase (as defined in paragraph (b)(39) of this section) of a regulated NSR pollutant (as defined in paragraph (b)(49) of this section); and a significant net emissions increase of that pollutant from the major stationary source."

40 CFR 51.166(b)(48)(iv)(b): See above for relevant text.

40 CFR 51.166(j)(2):

  "A new major stationary source shall apply best available control technology for each a [sic] regulated NSR pollutant that it would have the potential to emit in significant amounts."

40 CFR 51.166(b)(23)(ii): See relevant text above.

  40 CFR 51.166(j)(3): "A major modification shall apply best available control technology for each a [sic] regulated NSR pollutant for which it would be a significant net emissions increase at the source. This requirement applies to each proposed emissions unit at which a net emissions increase in the pollutant would occur as a result of a physical change or change in the method of operation in the unit."
Approve: The removal of Sections 22a-174-3a(j)(1)(F), (H), and (I) from the SIP is consistent with 40 CFR 51.166(b)(48)(v)(a) being removed from the EPA's regulation in 2015.

The revised Section 22a-174-3a(j)(1)(G), which is now codified as subsection (F), requires a BACT analysis to be performed for greenhouse gases when a source is undertaking a major modification and the modification results in an increase of 75,000 tons or more per year of CO2e. This is consistent with the EPA's regulations.

Amending Section 22a-174-3a(k)(1) [applicability to the PSD permit program within the State's regulations] by revising subsections A and B and by revising subsection C in its entirety as follows:

   (1)	The provisions of this subsection shall apply to the owner or operator of any new major stationary source:
      (A) Major stationary source fFor each air pollutant emitted at a level equal to or greater than the threshold designated in Table 3a(k)-1 of this subsection from such new major stationary source located in an attainment area or unclassified area for such pollutant; and

      (B) Stationary source for greenhouse gases, if the source emits, or has the potential to emit, equal to or greater than 100,000 tons per year of CO2e and one hundred (100) tons per year of greenhouse gases; or]

      (B) For greenhouse gases, provided that:

       (i) The new major stationary source emits or has the potential to emit equal to or greater than 75,000 tons per year of CO2e, and

       (ii) The new major stationary source emits or has the potential to emit an air pollutant at a level equal to or greater than the threshold designated in Table 3a(k)-1 of this subsection from such new major stationary source located in an attainment area or unclassified area for such pollutant.

    (C) Major stationary source:

       (i) For each air pollutant emitted at a level equal to or greater than the threshold designated in Table 3a(k)-1 of this subsection from such new major stationary source located in an attainment area or unclassified area for such pollutant, and

       (ii) For greenhouse gases, if the source emits, or has the potential to emit, equal to or greater than 75,000 tons per year of CO2e.

    (C) For the purposes of this subsection, a major stationary source of NOx or VOC located in an
    ozone attainment or unclassifiable area and not located in the Ozone Transport Region, as such Region is identified in Section 7511c(a) of the Act, shall be treated as a major stationary source of ozone.
40 CFR 51.166(a)(7): "Applicability. Each plan shall contain procedures that incorporate the requirements in paragraphs (a)(7)(i) through (vi) of this section.

  (i) The requirements of this section apply to the construction of any new major stationary source (as defined in paragraph (b)(1) of this section) or any project at an existing major stationary source in an area designated as attainment or unclassifiable under sections 107(d)(1)(A)(ii) or (iii) of the Act."

40 CFR 51.166(b)(1)

  "Major stationary source means:

  (i)(a) Any of the following stationary sources of air pollutants which emits, or has the potential to emit, 100 tons per year or more of any regulated NSR pollutant . . ..

  * * *

  (ii) A major source that is major for volatile organic compounds or NOx shall be considered major for ozone"

Regulated NSR pollutant is defined in 40 CFR 51.166(b)(48)(iv)(a):

  "The stationary source is a new major stationary source for a regulated NSR pollutant that is not GHGs, and also will emit or will have the potential to emit 75,000 tpy CO2e or more;"

Approve for two reasons:

1) Table 3a(k)-1 in Connecticut's SIP contains the pollutant and emission rates that are significant, which are also equivalent to the EPA's definition of significant in 40 CFR 51.166(b)(23)(i). Therefore, under Connecticut's regulation, the new major source must have significant emissions of a regulated NSR pollutant other than GHGs in order for GHGs to be regulated within the PSD permit program.

2) The new language in Section 22a-174-3a(k)(1)(C) is equivalent to 40 CFR 51.166(b)(1)(ii)
(2) The provisions of this subsection shall apply to the owner or operator of any major modification:

   (A) Major modification  f For each air pollutant from such major modification located in an attainment area or unclassified area for such pollutant, that has:

      (i) Actual emissions that are equal to or greater than the significant emission rate thresholds in Table 3a(k)-1 of this subsection, and

      (ii) A net emissions increase that is equal to or greater than the significant emission rate thresholds in Table 3a(k)-1 of this subsection; and

 (B) Major stationary source when such major stationary source undertakes a physical change or change in the method of operation that will result in a net emissions increase that is equal to or greater than 75,000 tons per year CO2e; or

 (C) Stationary source that emits, or has the potential to emit, equal to or greater than 100,000 tons per year of CO2e and one hundred (100) tons per year of greenhouse gases, when such stationary source undertakes a physical change or change in the method of operation that will result in a net emissions increase that is equal to or greater than 75,000 tons per year CO2e.

 (B) For greenhouse gases, if:

   (i) An air pollutant from such major modification has emissions that exceed the emissions thresholds of subparagraph (A)(i) and (ii) of this subdivision,

   (ii) The net greenhouse gas emissions increase due to the modification equals or exceeds a value of 75,000 tons per year CO2e, and

   (iii) The net greenhouse gas emissions increase on a mass basis due to the modification exceeds a value of 0 tons per year.
40 CFR 51.166(b)(2)(i): "Major modification means any physical change in or change in the method of operation of a major stationary source that would result in: a significant emissions increase (as defined in paragraph (b)(39) of this section) of a regulated NSR pollutant (as defined in paragraph (b)(49) of this section); and a significant net emissions increase of that pollutant from the major stationary source."

40 CFR 51.166(b)(39): "Significant emissions increase means, for a regulated NSR pollutant, an increase in emissions that is significant (as defined in paragraph (b)(23) of this section) for that pollutant."

40 CFR 51.166(b)(23)(ii): "Significant means, in reference to a net emissions increase or the potential of a source to emit a regulated NSR pollutant that paragraph (b)(23)(i) of this section, does not list, any emissions rate."

40 CFR 51.166(b)(49)(iv): "Any pollutant that otherwise is subject to regulation under the Act as defined in paragraph (b)(48) of this section."

40 CFR 51.166(b)(48)(iv)(b): See above for relevant text.
Approve: Connecticut's regulations are consistent with the EPA's regulations.


[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Page 60233]
[FR Doc No: 2021-23661]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-113-000]

Alliance Pipeline, L.P.; Notice of Waiver Period for Water
Quality Certification Application

    On August 27, 2021, Alliance Pipeline, L.P. (Alliance) submitted to
the Federal Energy Regulatory Commission (Commission) a copy of its
application for a Clean Water Act section 401(a)(1) water quality
certification filed with Illinois Environmental Protection Agency
(IEPA), in conjunction with the above captioned project. Pursuant to 40
CFR 121.6, we hereby notify the IEPA of the following:

    Date of Receipt of the Certification Request: August 26, 2021.
    Reasonable Period of Time to Act on the Certification Request:
One year.
    Date Waiver Occurs for Failure to Act: August 26, 2022.

    If IEPA fails or refuses to act on the water quality certification
request by the above waiver date, then the agency certifying authority
is deemed waived pursuant to section 401(a)(1) of the Clean Water Act,
33 U.S.C. 1341(a)(1).

    Dated: October 20, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-23661 Filed 10-29-21; 8:45 am]
BILLING CODE 6717-01-P


1 INFORMATION COLLECTION REQUEST ( ICR) United States Environmental Protection Agency ( EPA) Part A of the Supporting Statement ( DRAFT  July 2004 )

1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title: Regulation of Fuels and Fuel Additives: Gasoline Volatility; Reporting Requirements for Parties Which Produce or Import Gasoline Containing Ethanol, and Reporting Requirements for Parties Seeking a Testing Exemption ( 40 CFR 80.27) EPA ICR Number 1367.07, OMB Control Number 2060 0178 1( b) Abstract Gasoline volatility, as measured by Reid Vapor Pressure ( RVP) in pounds per square inch ( psi), is controlled in the spring and summer in order to minimize evaporative hydrocarbon emissions from motor vehicles. The standards, 7.8 psi or 9.0 psi, for each state and the District of Columbia, are at 40 CFR 80.27 ( a). The addition of ethanol to gasoline increases the RVP by about one psi. Gasoline that contains at least nine volume percent ethanol is subject to a standard that is 1.0 psi greater. As an aid to compliance and enforcement, the regulation at 40 CFR 80.27 ( d)( 3) requires that the product transfer document ( PTD) which accompanies a shipment of gasoline containing ethanol shall contain a legible and conspicuous statement that the gasoline contains ethanol and the percentage concentration of ethanol. This is intended to deter the mixing within the distribution system, particularly in retail storage tanks, of gasoline which contains ethanol with gasoline that does not contain ethanol. Such mixing would likely result in a gasoline with an ethanol concentration of less than nine volume percent, but with an RVP above the standard. It is estimated that there are approximately 1,500 producers and importers ( mostly blenders as opposed to refiners and importers) of gasoline blended with ethanol. There are approximately 10,000 shippers/ distributors/ transferors, mostly truckers, of gasoline containing ethanol. It is estimated that each transferor handles about 300 shipments annually. Parties wishing to conduct research or emissions certification on gasoline that does not meet the volatility standard are required to obtain a testing exemption in accordance with 40 CFR 80.27( e). The EPA receives approximately two requests per year for testing exemptions.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection Section 211( h) of the Clean Air Act ( Act) requires EPA to promulgate regulations prohibiting the sale or distribution of gasoline whose volatility, as measured by RVP, exceeds certain standards during the high ozone season. The Act and regulations at 40 C. F. R. 80.27 and 80.28 permit gasoline containing nine percent ethanol to have an RVP that is one psi greater than 2 the standard that would otherwise apply. Normally, the gasoline distribution system treats gasoline as a fungible product. That is, gasolines from numerous sources are mixed together ( also known as commingling) in tanks at terminals and retail outlets. Therefore, without the required statement on the PTD, gasoline containing ethanol could easily be commingled with gasoline not containing ethanol. This could result in gasoline containing enough ethanol to cause a violation the RVP standard, but not at least nine percent ethanol to qualify for the one psi exemption allowed by the Act and regulations. Thus, it is imperative that gasoline marketers, shippers, and distributors know if a shipment of gasoline contains ethanol, and in what concentration. The required statement on the PTD of gasoline blended with ethanol will significantly aid industry compliance and EPA's ability to enforce the volatility standards.

Thus the rule requires that the customary business practice ( CBP) PTD for a shipment of gasoline containing ethanol state that the gasoline contains ethanol and the percentage concentration of ethanol. The rule does not have a recordkeeping requirement. However, PTDs are usually retained in the normal course of business for five years.

As required by section 211( h) of the Act, the Agency promulgated a final rule in 1991. The reporting requirement in 40 C. F. R. 80.27( d)( 3) was promulgated under authority of section 211( h) of the Act, 42 U. S. C. § 7545( h) and sections 114 and 208 of the Act, 42 U. S. C. § § 7414 and 7542, and provides:

" Each invoice, loading ticket, bill of lading, delivery ticket and other document which accompanies the shipment of gasoline containing ethanol shall contain a legible and conspicuous statement that the gasoline being shipped contains ethanol and the percentage concentration of ethanol."

These regulations provide for the enforcement of the standards for the maximum RVP that will be allowed during the high ozone portion of the year, extending from May 1 ( suppliers) or June 1 ( all other persons) through September 15. Regulatory control of volatility stems from a recognition of the major impact that increases in the RVP of gasoline have on the emissions of volatile organic compounds ( VOCs). Consequent to the excessive emission of VOCs is the formation of ozone in the ambient air, a major summertime health problem in many urban areas.

The reporting ( actually labeling) requirement is necessary because the Act gave ethanol blends a one pound per square inch ( psi) allowance above the otherwise applicable RVP standard. The records regarding the shipment of ethanol blends to a retailer or to any " midstream" distribution point will assist Agency enforcement officials, when inspecting those shipments, in identifying those gasoline blends that qualify for the one psi allowance and those parties who may be liable for violations if the blend does not qualify for the allowance. The records are also necessary to assist regulated parties in avoiding violations ( for example, mixing loads of gasoline with ten percent ethanol and loads without ethanol during the high ozone season can result in violations), and can be used by parties in establishing a legal defense. 3 Parties wishing to conduct research or emissions certification on gasoline that does not meet the volatility standard may obtain a testing exemption by providing the information specified at 40 CFR 80.27( e) to EPA. Thus, if a test facility were inspected by EPA, and gasoline was found that did not meet the standard, and the facility had an exemption, there would not be a violation.

2( b) Practical Utility/ Users of the Data The collection of information is necessary for the proper performance of the functions of the Agency and has practical utility. The information contained in the PTDs for gasoline blended with ethanol is used to identify those gasoline blends that may qualify for the one psi allowance, as provided by the Act and by the rule. The required record also helps prevent the commingling of gasoline containing the required amount of ethanol necessary to be eligible for the one psi waiver with gasoline not containing ethanol. Such commingling would usually result in a violation. The testing exemption provides flexibility for research or emissions certification.

The Agency enforcement officers need this information to identify violations and to identify violating parties. There is no recordkeeping requirement under this rule. Industry entities, including blenders of ethanol and gasoline, and distributors of gasoline containing ethanol, as well as retailers ( who ultimately receive the gasoline but have no recordkeeping requirements under the rule) need the information in order to prevent violations that can occur from commingling ethanol blends and non ethanol blends during the high ozone season.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication The information collection is not duplicative. The PTDs are the only records available to recipients of gasoline that document that ethanol has been blended into the gasoline. The reporting requirement for a testing exemption is the only practical approach.

3( b) Public Notice Required Prior to ICR Submission to OMB In compliance with the Paperwork Reduction Act, a public comment period of 60 days was announced in the Federal Register.

3( c) Consultations The general consensus is that the burden is very small. The information is generally computer generated, pre printed, or hand stamped on the PTDs. The rule does not require that the PTDs be retained. Only about two requests for testing exemptions are received annually.

3( d) Effects of Less Frequent Collection 4 This labeling activity is the minimum necessary to alert downstream distributors/ marketers that a shipment of gasoline contains ethanol. The labeling requirement applies only to those facilities producing, importing, or distributing gasoline blended with ethanol. The Agency allows maximum flexibility in the form of the labeling. Neither record maintenance nor reporting to the Agency is required. No new documents are required, since PTDs are routinely used in the gasoline distribution network. Testing exemptions are requested only as necessary.

3( e) General Guidelines The collection is in compliance with OMB guidelines. To the extent that some affected companies may be relatively small businesses, their informational requirements do not change since the requirement is already the minimal possible in order to give other businesses and EPA information that is necessary for compliance.

3( f) Confidentiality Information claimed as confidential is handled in accordance with EPA Freedom of Information Act regulations at 40 CFR 2.

3( g) Sensitive Questions There are no sensitive questions.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ SIC/ NAICS Codes The respondents are related to the following major group Standard Industrialization Classification ( SIC) codes:

2869  Denatured Alcohol Manufacturing 2911  Petroleum Refineries 4212  Gasoline Distributors 5171  Gasoline Bulk Stations and Terminals 5172  Gasoline Merchant Wholesalers ( except bulk stations, terminals)

5541  Retailers/ Wholesale Purchaser consumers The respondents are related to the following major group NAICS codes: 5 324110  Petroleum Refineries 325193  Denatured Alcohol Manufacturing 424710  Gasoline Bulk Stations and Terminals 424720  Gasoline Merchant Wholesalers ( except bulk stations, terminals)

4( b) Information Requested ( i) Data Items, Including Recordkeeping Requirements This ICR covers the reporting/ labeling requirement at 40 CFR 80.27( d)( 3) for the PTDs for shipments of gasoline containing ethanol. Ethanol is generally splash blended into a gasoline tanker truck at a terminal truck rack at ten volume percent. The blender creates a statement on the PTD that the product contains ten percent ethanol. The same is required for a refiner who produces gasoline blended with ethanol at a refinery and an importer of gasoline blended with ethanol. Each distributor/ transferor transfers this PTD on to the next transferor and ultimately to the retail level. Many refiners/ blenders/ importers already included this information on the PTDs prior to the EPA regulatory requirement ( also, some states already required this information), and for them this requirement represented no new burden. Even where it did represent a new burden, the information is now encoded automatically by computer or otherwise routinely stamped or entered on the PTD, resulting in an extremely small reporting burden. There is no burden for transferors, as they already had to transfer a PTD with each shipment of gasoline as a customary business practice ( CBP). This rule has no recordkeeping requirement. Parties needing a testing exemption must submit the information specified at 40 CFR 80.27( e).

( ii) Respondent Activities The following are required:

Read and comprehend the regulations.

Train personnel to meet the requirements.

Develop the information for the PTD and/ or testing exemption.

Gather and organize the information.

Review the information, perform quality assurance, and take corrective action, if necessary, to meet the regulatory requirements. 6 Enter the information onto the PTD or submit the request for a testing exemption to EPA.

5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY AND INFORMATION MANAGEMENT 5( a) Agency Activities The following are required:

Develop a thorough understanding of the regulatory requirements.

Convey the requirements and respond to inquiries in a clear manner.

Provide access to the regulations and guidance documents.

Timely process requests for testing exemptions.

Monitor compliance with the PTD requirement.

5( b) Collection Methodology and Management The information collection, to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public. Ethanol blender/ distributors generally use computer printed language stating that the product contains ten percent ethanol. This information is printed on PTDs, and in many cases the information itself was already printed prior to the rule. EPA also allows the use of coded statements to reduce the space the statement requires on the PTD. EPA may examine these records during investigations regarding gasoline exceeding the applicable RVP standard. Requests for a testing exemption are routinely reviewed and granted by EPA.

5( c) Small Entity Flexibility The information collection reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the Agency, including with respect to small entities, as defined by the Regulatory Flexibility Act ( 5 U. S. C. § 601( 6)), the use of such techniques as: ( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; ( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or ( 3) an exemption from coverage of the collection of information, or any part thereof. 7 The approach of this information collection holds burdens to the irreducible minimum consistent with obtaining the required compliance levels. The labeling requirement applies only to those entities that produce or distribute ethanol blends. It enables those parties, as well as retail level entities, to comply with the law. However, retail entities have no requirement to make or maintain records. Therefore, the smallest entities have no burden under this collection and for those small distributors who do have a burden, the burden is minimal. The information required is not in any prescribed format, allowing for maximum flexibility in how to print the information, including the use of short codes, and does not necessitate any new records. Therefore, no further flexibility is needed.

5( d) Collection Schedule There is no reporting requirement and there is no required maintenance period. There is no collection schedule; the statement is added to CBP transfer documents as each transaction takes place.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION It is estimated that there are 1,500 producers and importers of gasoline blended with ethanol. The vast majority is blended at terminals. Little ethanol is blended at a refinery or contained in imported gasoline Based on information received from respondents and from EPA experience, for most respondents the required information is automatically computer generated or preprinted on the PTDs. This means the reporting requirement is almost unmeasurable for these parties. Other parties may spend about ten seconds per transaction to stamp or otherwise enter the information on the PTDs. The average for all respondents is estimated to be about five seconds per transaction. There is no recordkeeping requirement. It is estimated to take four hours to prepare a request for a testing exemption.

Based on data from the U. S. Department of Labor, Bureau of Labor Statistics, ( 2003 data), EPA estimates that the hourly cost, including benefits and other employee costs, for this industry and for the period of this ICR, to be about $ 65 per hour for typical labor mix.

Almost all gasoline containing ethanol will be shipped by truck. Assume 30 percent of all gasoline contains ethanol. If 30 percent of the 130 billion gallons of gasoline that is consumed annually nationwide contains ethanol, this comes to 39 billion gallons of gasoline. If each truck carries 8,500 gallons of gasoline, then about 4,600,000 truckloads/ shipments of gasoline with ethanol are produced/ imported annually. Thus 4,600,000 PTDs will receive the required statement on ethanol content annually. 8 6( a) Estimating Respondent Burden For 4,600,000 PTDs ( responses), at and average burden of 5 seconds per PTD, the annual burden is 6,389 hours, or about four hours for each of the estimated 1,500 producers and importers. For two requests for testing exemptions, at four hours each, adds eight hours annually, for an annual total of 4,600,002 responses and 6,397 hours. There is no burden for the estimated 10,000 transferors because the transmittal of PTDs is a customary business practice.

6( b) Estimating Respondent Costs For producers and importers of gasoline containing ethanol, 6,389 hours at $ 65 per hour gives a total of $ 415,285, or about $ 277 per respondent ( 1,500 respondents) annually to generate the required statement on PTDs. For parties wishing a testing exemption, eight hours at $ 65 per hour gives a total of $ 520, or $ 260 per respondent. There are no costs for the 10,000 transferors.

There are no Purchased Services Costs. Annualized Startup Costs are estimated at $ 3,250, based on 50 new producers or importers annually and one hour of labor each ( 50 x $ 65 per hour = $ 3,250) to implement the requirement. There are no Annualized Capital Costs. Operating and maintenance ( O& M) costs are for copying and postage for the two exemption requests annually, and are estimated at $ 10 each for a total of $ 20.

6( c) Estimating EPA Burden and Cost The labeling activity that is the subject of this ICR imposes no burden or costs on the Agency. The Agency would conduct inspections even without the requirement but the required information facilitates the investigation of possible violations.

6( d) Reasons for Change of Burden The use of ethanol in gasoline has increased by about 50% since the previous ICR. Thus, the annual number of respondents is estimated to have increased from 1,000 in the previous ICR to 1,500, and the annual number of PTDs that will contain the required language has increased from 3,000,000 in the previous ICR to 4,600,000.

6( e) Burden Statement There are no EPA forms on which to place a statement.

B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS This section is not applicable because statistical methods are not used in the data collection associated with the Gasoline Volatility Rule. 9 July 13, 2004 ( 4: 08pm)

C:\ dmautop\ temp\ DCTM_ ARP. wpd


[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Proposed Rules]
[Pages 29414-29419]
[FR Doc No: 2019-13084]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0444; Product Identifier 2019-NM-028-AD]
RIN 2120-AA64

Airworthiness Directives; Various Transport Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for various transport airplanes. This proposed AD was prompted by
reports of smoke and fumes in the flight deck. This proposed AD would
require modification of certain universal serial bus (USB) receptacles
located in the flight deck. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 8,
2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Fokker
Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL
Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>internet http://www.myfokkerfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0444; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0444;
Product Identifier 2019-NM-028-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact the FAA receives about this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0259R1, dated February 7, 2019 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for the following airplanes on which
certain USB receptacles were installed using certain Fokker service
information:
     Fokker Services B.V. Model F.27 Mark 050 airplanes.
     Fokker Services B.V. Model F.28 Mark 3000 airplanes.
     Fokker Services B.V. Model F28 Mark 0070 and Mark 0100
airplanes.
     Airbus SAS Model A318-111 airplanes.
     Airbus SAS Model A319-111, -112, -114, -115, and -132
airplanes.
     Airbus SAS Model A320-211, -212, -214, -231, -232, and -
251N airplanes.
     Airbus SAS Model A321-211, -231, -232, -251N and -253N
airplanes.
     Airbus SAS Model A330-202, -223, -243, -322 and -343
airplanes.
     Airbus SAS Model A340-312 and -313 airplanes.
     ATR--GIE Avions de Transport R[eacute]gional Model ATR42-
500 airplanes.
     ATR--GIE Avions de Transport R[eacute]gional Model ATR72-
212 and -212A airplanes.
     The Boeing Company Model 737-300, -400, -500, -700, -800
and -900ER series airplanes.
     The Boeing Company Model 757-200 series airplanes.
     The Boeing Company Model 767-200 and -300 series
airplanes.
     The Boeing Company Model 777-200LR series airplanes.
     Bombardier, Inc., Model CL-600-2B16 (601-3A, 601-3R, and
604 Variants) airplanes.
     Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series
700, 701 & 702) airplanes.
     Bombardier, Inc., Model DHC-8-202, -311, -315 and -402
airplanes.
    The MCAI states:

    Several occurrences on various aeroplanes have been reported of
smoke and fumes in the cockpit, due to overheating of an Electronic
Flight Bag (EFB) [universal serial bus] USB receptacle, which had
been installed by [Fokker Services] FS Supplemental Type Certificate
(STC), [service bulletin] SB, or minor modification, either an
Engineering Change Request (ECR) or Compliance Record Report (CRR),
as applicable. Investigation results revealed that each of these
events was caused by a short circuit in the EFB charging cable.
    This condition, if not corrected, could lead to further events
of smoke/fumes in the cockpit, possibly resulting in excessive
flight crew workload and/or injury to flight deck occupants.
    To address this unsafe condition, the USB manufacturer developed
a modification (change to USB receptacle [part number] P/N LS03-
05050-B), and Fokker Services published the applicable SB/EB to
provide those modification instructions, installing current limiting
and overheat protection.
    For the reason described above, EASA issued AD 2018-0259 to
require modification of each affected part. That [EASA] AD also
prohibited (re)installation of affected parts.
    Since that [EASA] AD was issued, FS issued Revision 2 of EBA320-
0167 and Revision 1 of EBDHC8-0035, redefining the affected
aeroplanes. It was determined that aeroplanes with EBA320-0151
embodied are not affected, as this involves a USB power supply from
another manufacturer. It was also determined that aeroplanes with FS
EBDHC8-0033 embodied (part of EASA STC 10046185) are not affected by
the [EASA] AD, as that mod is a holder-only installation. This
[EASA] AD is revised accordingly.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0444.

Related Service Information Under 1 CFR Part 51

    Fokker Services B.V. has issued the following service information,
which describes procedures for modifying the electronic flight bag USB
receptacles located in the flight deck, including current limiting and
overheat protection. These documents are distinct since they apply to
different airplane models.
     Fokker Services F28 Generic Service Bulletin SBF28-46-002,
Revision 0, dated July 27, 2018.
     Fokker Services F50/60 Generic Service Bulletin SBF50-46-
006, Revision 0, dated July 27, 2018.
     Fokker Services F100/700 Generic Service Bulletin SBF100-
46-008, Revision 0, dated July 27, 2018.
     Fokker Services Engineering Bulletin EBA320-0167, Revision
2, dated December 13, 2018.
     Fokker Services Engineering Bulletin EBA330-0011, Revision
0, Sequence 9, dated July 27, 2018.
     Fokker Services Engineering Bulletin EBA340-0005, Revision
0, Sequence 8, dated July 27, 2018.
     Fokker Services Engineering Bulletin EBAT72-0013, Revision
0, Sequence 7, dated July 27, 2018.
     Fokker Services Engineering Bulletin EBB737-0156, Revision
3, dated February 25, 2019.
     Fokker Services Engineering Bulletin EBB757-0020, Revision
1, dated October 2, 2018.
     Fokker Services Engineering Bulletin EBB767-0023, Revision
1, dated October 3, 2018.
     Fokker Services Engineering Bulletin EBB777-0009, Revision
1, dated October 3, 2018.
     Fokker Services Engineering Bulletin EBCL60-0010, Revision
1, dated August 30, 2018.
     Fokker Services Engineering Bulletin EBDHC8-0035, Revision
1, dated December 13, 2018.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI and
service information referenced above. The FAA is proposing this AD
because we evaluated all the relevant information and determined the
unsafe condition described previously is likely to exist or develop on
other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Costs of Compliance

    The FAA estimates that this proposed AD affects 14 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
3 work-hours x $85 per hour = $255...........................            * $0             $255           $3,570
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data on the parts costs for the required actions.

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

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Transport Category Airplanes: Docket No. FAA-2019-0444; Product
Identifier 2019-NM-028-AD.

(a) Comments Due Date

    We must receive comments by August 8, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in figure 1 to
paragraph (c) of this AD, certificated in any category, having an
affected part (defined in paragraph (g) of this AD) installed as
specified in the applicable service information identified in figure
1 to paragraph (c) of this AD.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TP24JN19.000

[GRAPHIC] [TIFF OMITTED] TP24JN19.001

BILLING CODE 4910-13-C

(d) Subject

    Air Transport Association (ATA) of America Code 46, Information
systems.

(e) Reason

    This AD was prompted by reports of smoke and fumes in the flight
deck. We are issuing this AD to address smoke and fumes in the
flight deck, which could result in excessive flightcrew workload and
injury to flight deck occupants.

(f) Compliance

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

(g) Definition

    For the purpose of this AD, an ``affected part'' is a universal
serial bus (USB) receptacle manufactured by Lone Star Aviation,
Corporation, having part number LS03-05050-A.

(h) Modification

    Within 12 months after the effective date of this AD, modify
each affected part in accordance with the Accomplishment
Instructions of the applicable Fokker Services B.V. service
information identified in paragraphs (h)(1) through (h)(13) of this
AD.
    (1) Fokker Services Engineering Bulletin EBA320-0167, Revision
2, dated December 13, 2018.
    (2) Fokker Services Engineering Bulletin EBA330-0011, Revision
0, Sequence 9, dated July 27, 2018.
    (3) Fokker Services Engineering Bulletin EBA340-0005, Revision
0, Sequence 8, dated July 27, 2018.
    (4) Fokker Services Engineering Bulletin EBAT72-0013, Revision
0, Sequence 7, dated July 27, 2018.
    (5) Fokker Services Engineering Bulletin EBB737-0156, Revision
3, dated February 25, 2019.
    (6) Fokker Services Engineering Bulletin EBB757-0020, Revision
1, dated October 2, 2018.
    (7) Fokker Services Engineering Bulletin EBB767-0023, Revision
1, dated October 3, 2018.
    (8) Fokker Services Engineering Bulletin EBB777-0009, Revision
1, dated October 3, 2018.
    (9) Fokker Services Engineering Bulletin EBCL60-0010, Revision
1, dated August 30, 2018.
    (10) Fokker Services Engineering Bulletin EBDHC8-0035, Revision
1, dated December 13, 2018.
    (11) Fokker Services F28 Generic Service Bulletin SBF28-46-002,
Revision 0, dated July 27, 2018.
    (12) Fokker Services F50/60 Generic Service Bulletin SBF50-46-
006, Revision 0, dated July 27, 2018.
    (13) Fokker Services F100/700 Generic Service Bulletin SBF100-
46-008, Revision 0, dated July 27, 2018.

(i) Parts Installation Prohibition

    After modification of an airplane as required by paragraph (h)
of this AD, no person may install an affected part on that airplane.

(j) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using the service information specified in
paragraphs (j)(1) through (j)(7) of this AD.
    (1) Fokker Services Engineering Bulletin EBA320-0167, Revision
1, dated August 30, 2018.
    (2) Fokker Services Engineering Bulletin EBDHC8-0035, Revision
0, dated July 27, 2018.
    (3) Fokker Services Engineering Bulletin EBB737-0156, Revision
1, dated August 30, 2018.
    (4) Fokker Services Engineering Bulletin EBB737-0156, Revision
2, dated October 3, 2018.
    (5) Fokker Services Engineering Bulletin EBB757-0020, Revision
0, dated July 27, 2018.
    (6) Fokker Services Engineering Bulletin EBB767-0023, Revision
0, dated July 27, 2018.
    (7) Fokker Services Engineering Bulletin EBB777-0009, Revision
0, dated July 27, 2018.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (l)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Fokker Services B.V.'s EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2018-0259R1, dated February 7,
2019, for related information. This MCAI may be found in the AD
docket on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0444.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130
EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31

(0)88-6280-111; email<EMAIL_ADDRESS>internet http://www.myfokkerfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.

    Issued in Des Moines, Washington, on June 4, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-13084 Filed 6-21-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Notices]
[Pages 67786-67787]
[FR Doc No: 2011-28372]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65644; File No. SR-Phlx-2011-123]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order
Granting Approval of Proposed Rule Change Relating to the Quarterly
Trading Requirements Applicable to Registered Options Traders

October 27, 2011.

I. Introduction

    On August 24, 2011, NASDAQ OMX PHLX LLC (``Phlx'' or ``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
change the quarterly trading requirements applicable to Registered
Options Traders (``ROTs''). The proposed rule change was published for
comment in the Federal Register on September 9, 2011.\3\ The Commission
received no comment letters on the proposal. This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 65257 (September 2,
2011), 76 FR 55996.
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange proposes to modify the quarterly trading requirements
applicable to ROTs. ROTs can be either Streaming Quote Traders
(``SQTs''), Remote SQTs (``RSQTs'') or non-SQT ROTs. The quarterly
trading requirements apply to two types of ROTs: SQTs and non-SQT ROTs.
    Currently, Phlx Rule 1014 contains two quarterly trading
requirements--in person and in assigned. First, Commentary .01 requires
that in order for an ROT (other than an RSQT or a Remote Specialist) to
receive specialist margin treatment for off-floor orders in any
calendar quarter, the ROT must execute the greater of 1,000 contracts
or 80% of his total contracts that quarter in person (not through the
use of orders) and 75% of his total contracts that quarter in assigned
options.
    Second, the ``in assigned'' quarterly trading requirement in
current Commentary .03 requires that, except for unusual circumstances,
at least 50% of the trading activity in any quarter (measured in terms
of contract volume) of an ROT (other than an RSQT) shall ordinarily be
in classes of options to which he is assigned. Temporarily undertaking
the obligations of paragraph (c) of Phlx Rule 1014 at the request of a
member of the Exchange in non-assigned classes of options shall not be
deemed trading in non-assigned option contracts.
    The Exchange proposes to amend Commentary .01 to adopt a new
quarterly requirement such that an ROT (other than an RSQT or a Remote
Specialist) would be required to trade 1,000 contracts and 300
transactions on the Exchange each quarter. Transactions executed in the
trading crowd where the contra-side is an ROT would not be included.
The Exchange proposes that this requirement would be a pure trading
requirement, not limited to assigned options and in person trading.
Accordingly, the new trading requirement could be fulfilled with trades
and contracts that are not in assigned options and not executed in
person.
    In addition, the Exchange proposes to amend the in person trading
requirement in Commentary .01 in two ways. First, the Exchange proposes
to exclude transactions executed in the trading crowd where the contra-
side is an ROT from the existing in person trading requirement. Second,
the Exchange proposes to permit non-SQT ROTs to use orders entered in
person to meet the in person trading requirement. The Exchange
represents that the only other way to participate in trades other than
through the use of orders is by quoting; while SQTs quote
electronically by ``streaming'' quotations into the Exchange, non-SQT
ROTs may only quote verbally in response to floor brokers representing
orders in the trading crowd. The Exchange believes that the limitation
on the use of orders with respect to non-SQT ROTs is obsolete, as, over
time, following the movement toward a more electronic trading platform
in options, it has become difficult for such ROTs to comply with the
trading requirement without using orders. The Exchange represents that
non-SQT ROTs can only comply with the in person quarterly trading
requirement by participating in crowd trades, which they cannot
control, in terms of frequency.
    The Exchange believes that the proposed new trading requirement
coupled with the proposed changes to the existing ``in person'' trading
requirement should encourage a more regular presence and thus result in
more active market making. In addition, Phlx states that excluding
transactions where the contra-side is another ROT should encourage more
regular and active market making.

III. Discussion

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\4\
Specifically, the Commission finds that the proposal is consistent with
Section 6(b)(5) of the Act,\5\ which requires, among other things, that
the rules of a national securities exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts, 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.
---------------------------------------------------------------------------

    \4\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposed changes to the trading
requirements applicable to ROTs should encourage more active market
making and thereby promote the provision of liquidity to the market. In
particular, by excluding in crowd ROT-to-ROT transactions from the
quarterly trading requirements applicable to a ROT, the proposal should
help to encourage the regular posting of liquidity. The Commission
believes that these

proposed changes to the quarterly trading requirements should enhance
the market making function performed by ROTs and thereby serve to
maintain fair and orderly markets and generally promote the protection
of investors and the public interest.

IV. Conclusion

    It Is Therefore Ordered, pursuant to Section 19(b)(2) of the
Act,\6\ that the proposed rule change (SR-Phlx-2011-123) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-28372 Filed 11-1-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Rules and Regulations]
[Pages 45063-45068]
[FR Doc No: 2023-14716]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2023-N-0963]

Nomenclature Change for Dockets Management; Technical Amendment

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to reflect a change in the name of Division of Dockets
Management to Dockets Management Staff and information regarding
copies. This action is editorial in nature and is intended to improve
the accuracy of the Agency's regulations.

DATES: This rule is effective July 14, 2023.

FOR FURTHER INFORMATION CONTACT: Karen Malvin, Dockets Management
Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR chapter I to update
Dockets Management Staff's name change and information regarding
copies.
    Publication of this document constitutes final action on the
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because this
amendment to the regulations provides only a technical change to update
the organizational information for Dockets Management Staff.

List of Subjects

21 CFR Part 3

    Administrative practice and procedure, Biologics, Drugs, Medical
devices.

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization
and functions (Government agencies).

21 CFR Part 7

    Administrative practice and procedure, Consumer protection,
Reporting and recordkeeping requirements.

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Parts 12, 13, and 15

    Administrative practice and procedure.

21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.

21 CFR Part 17

    Administrative practice and procedure, Penalties.

21 CFR Part 20

    Confidential business information, Courts, Freedom of information,
Government employees.

21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and
recordkeeping requirements.

21 CFR Part 60

    Administrative practice and procedure, Drugs, Food additives,
Inventions and patents, Medical devices, Reporting and recordkeeping
requirements.

21 CFR Part 100

    Administrative practice and procedure, Food labeling, Food
packaging, Foods, Intergovernmental relations.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 109

    Food packaging, Foods, Polychlorinated biphenyls (PCBs).

21 CFR Part 165

    Beverages, Bottled water, Food grades and standards.

21 CFR Part 170

    Administrative practice and procedure, Food additives, Reporting
and recordkeeping requirements.

21 CFR Part 184

    Food additives.

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 314

    Administrative practice and procedure, Confidential business

information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 328

    Alcohol and alcoholic beverages, Labeling, Over-the-counter drugs.

21 CFR Part 330

    Over-the-counter drugs.

21 CFR Parts 341, 350, and 355

    Labeling, Over-the-counter drugs.

21 CFR Part 369

    Labeling, Medical devices, Over-the-counter drugs.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCBs).

21 CFR Part 509

    Animal foods, Packaging and containers, Polychlorinated biphenyls
(PCBs).

21 CFR Parts 514 and 516

    Administrative practice and procedure, Animal drugs, Confidential
business information; Reporting and recordkeeping requirements.

21 CFR Part 570

    Animal feeds, Animal foods, Food additives.

21 CFR Part 573

    Animal feeds, Food additives.

21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.

21 CFR Part 740

    Cosmetics, Labeling.

21 CFR Part 808

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 830

    Administrative practice and procedure, Labeling, Medical devices,
Reporting and recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.

21 CFR Part 861

    Administrative practice and procedure, Medical devices, Reporting
and recordkeeping requirements.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.

21 CFR Part 1010

    Administrative practice and procedure, Electronic products,
Exports, Radiation protection.

21 CFR Part 1240

    Communicable diseases, Public health, Travel restrictions, Water
supplies.

21 CFR Part 1250

    Air carriers, Foods, Maritime carriers, Motor carriers, Public
health, Railroads, Water supplies.

21 CFR Part 1271

    Biologics, Communicable diseases, Drugs, HIV/AIDS, Human cells and
tissue-based products, Medical devices, Reporting and recordkeeping
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter I is amended as follows:

PART 3--PRODUCT JURISDICTION

0
1. The authority citation for part 3 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-
360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216,
262, 264.

Sec.  3.5  [Amended]

0
2. In Sec.  3.5, amend paragraph (a)(1) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 5--ORGANIZATION

0
3. The authority citation for part 5 continues to read as follows:

    Authority:  5 U.S.C. 552; 21 U.S.C. 301-397.

Sec.  5.1110  [Amended]

0
4. In Sec.  5.1110, amend paragraph (a) by removing ``Division of
Dockets Management'' wherever it appears and adding in its place
``Dockets Management Staff''.

PART 7--ENFORCEMENT POLICY

0
5. The authority citation for part 7 continues to read as follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n,
264.

Sec.  7.42  [Amended]

0
6. In Sec.  7.42, amend paragraph (b)(3) introductory text by removing
``Division of Dockets Management'' and adding in its place ``Dockets
Management Staff''.

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURE

0
7. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.

0
8. In part 10, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

0
9. In Sec.  10.30, revise paragraph (b)(2) to read as follows:

Sec.  10.30  Citizen petition.

* * * * *
    (b) * * *
    (2) Mail, delivery services, or other non-electronic submissions. A
petition (including any attachments), that is not electronically
submitted under paragraph (b)(1) of this section, must be submitted in
accordance with paragraph (b)(3) of this section and Sec.  10.20 and
delivered to this address: Dockets Management Staff, Department of
Health and Human Services, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. Submit two copies (original and
redacted version) for confidential petitions. Otherwise, only one copy
is necessary.
* * * * *

PART 12--FORMAL EVIDENTIARY PUBLIC HEARING

0
10. The authority citation for part 12 continues to read as follows:

    Authority:  21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42
U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-
558, 701-721; 28 U.S.C. 2112.

0
11. In part 12, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

0
12. In Sec.  12.80, revise paragraph (a) to read as follows:

Sec.  12.80  Filing and service of submissions.

    (a) Submissions, including pleadings in a hearing, are to be filed
with Dockets Management Staff under Sec.  10.20 of this chapter except
that two copies need be submitted (original and redacted version) for
confidential petitions. Otherwise, only one copy is necessary. To
determine compliance with filing deadlines in a hearing, a submission
is considered submitted on the date it is actually received by Dockets
Management Staff. When this part allows a response to a submission and
prescribes a period of time for the filing of the response, an
additional 3 days are allowed for the filing of the response if the
submission is served by mail.
* * * * *

PART 13--PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

0
13. The authority citation for part 13 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b-263n, 264.

0
14. In part 13, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
15. The authority citation for part 14 continues to read as follows:

    Authority:  5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub.
L. 113-54.

0
16. In part 14, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 15--PUBLIC HEARING BEFORE THE COMMISSIONER

0
17. The authority citation for part 15 continues to read as follows:

    Authority:  5 U.S.C. 553; 15 U.S.C. 1451-1461; 21 U.S.C. 141-
149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201,
262, 263b-263n, 264.

0
18. In part 15, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

17--CIVIL MONEY PENALTIES HEARINGS

0
19. The authority citation for part 17 is revised to read as follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
20. In part 17, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

0
21. In Sec.  17.31, revise paragraph (a)(1) to read as follows:

Sec.  17.31  Form, filing, and service of papers.

    (a) * * *
    (1) Documents filed with Dockets Management Staff (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852, shall include two copies (original and redacted version) for
confidential petitions. Otherwise, only one copy is necessary.
* * * * *

PART 20--PUBLIC INFORMATION

0
22. The authority citation for part 20 continues to read as follows:

    Authority:  5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582;
21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b-263n, 264, 265, 300u--300u-5, 300aa-1.

Sec.  20.120  [Amended]

0
23. In Sec.  20.120, amend paragraphs (c) introductory text and (c)(3)
by removing ``Division of Dockets Management's'' and adding in its
place ``Dockets Management Staff's''.

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
24. The authority citation for part 25 continues to read as follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42
U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3
CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3
CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980
Comp., p. 356-360.

0
25. In part 25, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 60--PATENT TERM RESTORATION

0
26. The authority citation for part 60 continues to read as follows:

    Authority:  21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C.
156; 42 U.S.C. 262.

0
27. In part 60, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 100--GENERAL

0
28. The authority citation for part 100 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 337, 342, 343, 348, 371.

Sec.  100.1  [Amended]

0
29. In Sec.  100.1, amend paragraphs (d)(3) and (f)(3) and (4) by
removing ``Division of Dockets Management'' wherever it appears and
adding in its place ``Dockets Management Staff''.

PART 109--UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION
AND FOOD-PACKAGING MATERIAL

0
30. The authority citation for part 109 continues to read as follows:

    Authority:  21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.

0
31. In part 109, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 165--BEVERAGES

0
32. The authority citation for part 165 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.

Sec.  165.110  [Amended]

0
33. In Sec.  165.110, amend paragraph (b)(4)(iii)(F) introductory text
by removing ``Division of Dockets Management'' and adding in its place
``Dockets Management Staff''.

PART 201--LABELING

0
34. The authority citation for part 201 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358,
360, 360b, 360ccc, 360ccc-1, 360ee, 360gg-360ss, 371, 374, 379e; 42
U.S.C. 216, 241, 262, 264.

Sec.  201.63  [Amended]

0
35. In Sec.  201.63, amend paragraph (d) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

0
36. The authority citation for part 312 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371;
42 U.S.C. 262.

0
37. In part 312, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

0
38. The authority citation for part 314 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f,
356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.

0
39. In part 314, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 328--OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL
INGESTION THAT CONTAIN ALCOHOL

0
40. The authority citation for part 328 is revised to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 371.

Sec.  328.10  [Amended]

0
41. In Sec.  328.10, amend paragraph (e) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

0
42. The authority citation for part 330 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6,
371.

0
43. In part 330, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

0
44. The authority citation for part 341 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Sec.  341.85  [Amended]

0
45. In Sec.  341.85, amend paragraph (c)(4) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 350--ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE

0
46. The authority citation for part 350 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Sec.  350.60  [Amended]

0
47. In Sec.  350.60, remove ``Dockets Management Branch'' and add in
its place ``Dockets Management Staff''.

PART 355--ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

0
48. The authority citation for part 355 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Sec.  355.70  [Amended]

0
49. In Sec.  355.70, amend paragraph (a) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 369--INTERPRETIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES
FOR OVER-THE-COUNTER SALE

0
50. The authority citation for part 369 is revised to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Sec.  369.21  [Amended]

0
51. In Sec.  369.21, remove ``Division of Dockets Management'' and add
in its place ``Dockets Management Staff''.

 PART 500--GENERAL

0
52. The authority citation for part 500 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.

Sec.  500.80  [Amended]

0
53. In Sec.  500.80, amend paragraph (a) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 509--UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-
PACKAGING MATERIAL

0
54. The authority citation for part 509 continues to read as follows:

    Authority:  21 U.S.C. 336, 342, 346, 346a, 348, 371.

0
55. In part 509, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
56. The authority citation for part 514 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b,
360ccc, 371, 379e, 381.

Sec.  514.200  [Amended]

0
57. In Sec.  514.200, amend paragraph (c)(1) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
58. The authority citation for part 516 continues to read as follows:

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.

Sec.  516.28  [Amended]

0
59. In Sec.  516.28, amend the introductory text by removing ``Division
of Dockets Management'' and adding ``Dockets Management Staff'' in its
place.

PART 570--FOOD ADDITIVES

0
60. The authority citation for part 570 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 346a, 348, 371.

0
61. In part 570, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

Sec.  570.35  [Amended]

0
62. In Sec.  570.35, amend paragraph (b)(2) by removing ``Division of
Dockets Management's'' and adding in its place ``Dockets Management
Staff's''.

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS

0
63. The authority citation for part 573 continues to read as follows:

    Authority:  21 U.S.C. 321, 342, 348.

Sec.  573.460  [Amended]

0
64. In Sec.  573.460, amend paragraphs (a)(1)(i) and (a)(2)(i) by
removing ``Division of Dockets Management'' and adding in its place
``Dockets Management Staff''.

PART 601--LICENSING

0
65. The authority citation for part 601 continues to read as follows:

    Authority:  15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).

Sec.  601.51  [Amended]

0
66. In Sec.  601.51, amend paragraph (d)(2) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 740--COSMETIC PRODUCT WARNING STATEMENTS

0
67. The authority citation for part 740 is revised to read as follows:

    Authority:  15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-

360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263,
264; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).

Sec.  740.2  [Amended]

0
68. In Sec.  740.2, amend paragraph (b) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL
MEDICAL DEVICE REQUIREMENTS

0
69. The authority citation for part 808 continues to read as follows:

    Authority:  21 U.S.C. 360j, 360k, 371.
    Section 808.1 also issued under Sec. 709, Public Law 115-52, 131
Stat. 1065-67.

0
70. In part 808, revise all references to ``Division of Dockets
Management'' to read ``Dockets Management Staff''.

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
71. The authority citation for part 814 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

Sec.  814.9  [Amended]

0
72. In Sec.  814.9, amend paragraph (d)(2) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 830--UNIQUE DEVICE IDENTIFICATION

0
73. The authority citation for part 830 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j,
371.

Sec.  830.10  [Amended]

0
74. In Sec.  830.10, amend paragraph (a) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
75. The authority citation for part 860 continues to read as follows:

    Authority:  21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i,
360j, 371, 374.

Sec.  860.5  [Amended]

0
76. In Sec.  860.5, amend paragraphs (c)(2) and (d)(2) by removing
``Division of Dockets Management'' and adding in its place ``Dockets
Management Staff''.

PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT

0
77. The authority citation for part 861 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371,
374; 42 U.S.C. 262, 264.

Sec.  861.38  [Amended]

0
78. In Sec.  861.38, amend paragraph (c) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 895--BANNED DEVICES

0
79. The authority citation for part 895 continues to read as follows:

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.

Sec.  895.21  [Amended]

0
80. In Sec.  895.21, amend paragraph (d)(8) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 900--MAMMOGRAPHY

0
81. The authority citation for part 900 continues to read as follows:

    Authority:  21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

Sec.  900.18  [Amended]

0
82. In Sec.  900.18, amend paragraphs (d)(2) and (4) by removing
``Division of Dockets Management'' and adding in its place ``Dockets
Management Staff''.

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

0
83. The authority citation for part 1010 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss,
371, 381.

Sec.  1010.4  [Amended]

0
84. In Sec.  1010.4, amend paragraph (c)(3) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

0
85. In Sec.  1010.5, revise paragraph (c) introductory text to read as
follows:

Sec.  1010.5  Exemptions for products intended for United States
Government use.

* * * * *
    (c) Application for exemption. If you are submitting an application
for exemption, or for amendment or extension thereof, you must submit
two copies (original and redacted version) for confidential petitions
to Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one
copy is necessary. For an exemption under the criteria prescribed in
paragraph (a)(1) of this section, the application shall include the
information prescribed in paragraphs (c)(1) through (13) of this
section. For an exemption under the criteria prescribed in paragraph
(a)(2) of this section, the application shall include the information
prescribed in paragraphs (c)(3) through (13) of this section. An
application for exemption, or for amendment or extension thereof, and
correspondence relating to such application shall be made available for
public disclosure in Dockets Management Staff, except for confidential
or proprietary information submitted in accordance with part 20 of this
chapter. Information classified for reasons of national security shall
not be included in the application. Except as indicated in this
paragraph (c), the application for exemption shall include the
following:
* * * * *

PART 1240--CONTROL OF COMMUNICABLE DISEASES

0
86. The authority citation for part 1240 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 264, 271.

Sec.  1240.62  [Amended]

0
87. In Sec.  1240.62, amend paragraph (d) by removing ``Division of
Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 1250--INTERSTATE CONVEYANCE SANITATION

0
88. The authority citation for part 1250 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 264, 271.

Sec.  1250.51  [Amended]

0
89. In Sec.  1250.51, amend paragraph (f)(4)(ii) by removing ``Division
of Dockets Management'' and adding in its place ``Dockets Management
Staff''.

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS

0
90. The authority citation for part 1271 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.

Sec.  1271.37  [Amended]

0
91. In Sec.  1271.37, amend paragraph (a) introductory text by removing
``Division of Dockets Management'' and adding in its place ``Dockets
Management Staff''.

    Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14716 Filed 7-13-23; 8:45 am]
BILLING CODE 4164-01-P