Tuesday,

December 31, 2002 Part VI Environmental Protection Agency 40 CFR Part 58 National Ambient Air Quality Standard: Particulate Matter; Final Rule and Proposed Rule VerDate Dec< 13> 2002 09: 49 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\ FR\ FM\ 31DER5. SGM 31DER5 80326 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 58 [ AD   FRL   7388   4]

RIN 2060   AK05 National Ambient Air Quality Standard: Particulate Matter AGENCY: Environmental Protection Agency ( EPA). ACTION: Direct final rule.

SUMMARY: The EPA is taking direct final action to amend the national ambient air quality standards for particulate matter. The revision reduces to 15 percent the requirement that reporting organizations collocate 25 percent of State and local air monitoring station ( SLAMS) sites with a second sampler in order to estimate precision at a reporting organization level. The regulations describe the number of collocated sites required within a reporting organization. With today's action, EPA is making a simple change in the regulations by changing the requirement to collocate 25 percent of reporting organizations sites to 15 percent of the reporting organizations sites. The effect of this change will be to reduce the number of monitors which must be collocated. This in turn will reduce the cost of implementing and maintaining monitoring networks but without significantly affecting our confidence in the precision at the reporting organization level or in providing acceptable estimates of achievement of the precision Data Quality Objectives ( DQOs). Since reporting organizations are of unequal size in the number of monitors they implement, 15 percent was considered an acceptable limit of providing enough precision information for smaller reporting organizations while not unduly burdening larger reporting organizations. DATES: This direct final rule will be effective on March 31, 2003 without further notice, unless significant adverse comments are received by January 30, 2003. If significant adverse comments are received, we will publish a timely withdrawal in the Federal Register informing the public that this rule will not take effect. ADDRESSES: Written comments should be submitted ( in duplicate if possible) to: Air and Radiation Docket and Information Center ( 6102), Attention: Docket No. A96   51, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. In person or by courier, deliver comments ( in duplicate if possible) to: Air and Radiation Docket and Information Center ( 6102), Attention Docket A96   51, U. S. EPA, 401 M Street, SW., Washington, DC 20460. We request that you send a separate copy of your comments to Mr. Michael Papp, Monitoring and Quality Assurance Group ( C339   02), Emissions, Monitoring, and Analysis Division, U. S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711. FOR FURTHER INFORMATION CONTACT: For information concerning the direct final rule, contact Mr. Michael Papp, Monitoring and Quality Assurance Group ( C339   02), Emissions, Monitoring, and Analysis Division, U. S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone number ( 919) 541   2408.

SUPPLEMENTARY INFORMATION: We are publishing this direct final without prior proposal because we view this as noncontroversial and do not anticipate adverse comments. However, in the Proposed Rule section of this Federal Register, we are publishing a separate document that will serve as the proposal in the event that adverse comments are filed. If we receive any significant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this direct final rule. Any parties interested in commenting must do so at this time. Docket. The docket is an organized and complete file of information compiled by EPA in developing this direct final rule. The docket is a dynamic file because material is added throughout the rulemaking process. The docketing system is intended to allow members of the public and industries involved to readily identify and locate documents so that they can effectively participate in the rulemaking process. Along with the proposed and promulgated standards and their preambles, the docket contains the record in the case of judicial review. The docket number for this rulemaking is A   96   51. Worldwide Web ( WWW). In addition to being available in the docket, electronic copies of this action will be posted on the Technology Transfer Network ( TTN). Following signature, we will post a copy of the supplemental proposal on the Air Monitoring Technology Information Center's TTN Web site at http:// www. epa. gov/ ttn/ amtic/ pmcfr. html under the title `` PM 2.5 Collocated Precision Reduction.'' The TTN provides information and technology exchange in various areas of air pollution control. If you need more information regarding the TTN, call the TTN HELP line at ( 919) 541   5384. Authority. Sections 110, 301( a), and 319 of the Clean Air Act, as amended, 42 U. S. C. 7410, 7601 ( a), 7619.

I. Background The Clean Air Act as amended ( 1990 Amendments), established requirements for States to prepare and submit State Implementation plans ( SIPs) to EPA to implement and enforce national ambient air quality standards ( NAAQS). 42 U. S. C. 7401 et seq. Specifically, section 110 of the Clean Air Act ( Act) identifies particular requirements for these SIPs and lists the elements which each must contain in order to be approvable by EPA. Included in these provisions is the requirement that each SIP:

provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to   ( i) monitor, compile, and analyze data on ambient air quality, and ( ii) upon request, make such data available to the Administrator;

42 U. S. C 7410( a)( 2)( B). Any air quality monitoring systems required in such SIP's were further required to utilize standard criteria and methodologies established by regulations to be promulgated by EPA pursuant to section 319 of the Act. When EPA promulgated NAAQS for fine particulate matter ( PM 2.5), it also adopted regulations for air sampling ( 62 FR 38833, July 18, 1997). These regulations included quality assurance ( QA) requirements in Appendix A based on data quality objectives developed using PM 2.5 data available in EPA's Aerometric Information Retrieval System ( AIRS) and other sources prior to the July 18, 1997 rulemaking. These QA objectives were developed to ensure that decision makers would have PM 2.5 data of adequate quality to support important decisions such as the comparison to the PM 2.5 NAAQS. In response to complaints that arose under previous regulations about the burden of QA requirements, 62 FR 38767, July 18, 1997 section IV, `` Discussion of Regulatory Revisions and Major Comments on Part 58,'' EPA stated that ``[ i] n an effort to assist State and local agencies in achieving the data quality objectives of the PM 2.5 monitoring program, an incentive program has been established that is based on network performance and VerDate Dec< 13> 2002 09: 49 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 31DER5. SGM 31DER5 80327 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Rules and Regulations maturity that can reduce these QA requirements.'' Within 40 CFR part 58, appendix A data quality objectives for precision ( 10 percent) and bias ( ± 10 percent) were identified. In order to meet the precision data quality objective, reporting organizations are currently required by the regulations to collocate 25 percent of the monitoring sites with a second federal reference method monitor. This second monitor would collect a sample every 6 days. The data quality objective is assessed using 3 years of this collocated information, which would provide approximately 182 values for any one site. Over the data collection years of 1999 and 2000, EPA performed data quality assessments on PM 2.5 data and found that the majority of the reporting organizations are achieving the precision data quality objective. In 2001, EPA also reviewed the original 1997 data quality objectives using the 1999 and 2000 PM 2.5 data set. Using this more robust data set, EPA determined that the precision data quality objective was less influential on decision errors than the bias data quality objective and therefore greater imprecision could be tolerated in the network without adverse effect on overall uncertainty and therefore decision making. Based on the data quality assessments and the evaluation of the original data quality objective, EPA concluded that a reduction in the precision siting requirement would not significantly affect confidence in precision estimates at the reporting organization level or in providing acceptable estimates of achievement of the precision DQO. Therefore, in keeping with the commitment established in the July 18, 1997 Federal Register document, EPA has determined that it would be appropriate to reduce the monitor collocation requirements. We view these amendments as noncontroversial and anticipate no adverse comments, and we are publishing these amendments in a direct final rule.

II. Administrative Requirements A. Executive Order 12866, Regulatory Planning and Review Under Executive Order 12866 ( 58 FR 51735, October 4, 1993), we must determine whether a regulatory action is `` significant'' and therefore subject to review by the Office of Management and Budget ( OMB) review and the requirements of the Executive Order. The Order defines `` significant regulatory action'' as one that is likely to result in a rule that may: ( 1) Have an annual effect on the economy of $ 100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; ( 2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; ( 3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligation of recipients thereof; or ( 4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. We have determined that this direct final rule does not qualify as a `` significant regulatory action'' under the terms of Executive Order 12866 and therefore, is not subect to review by OMB.

B. Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use.

This direct final rule is not subject to Executive Order 13211 ( 66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

C. Executive Order 13132, Federalism Executive Order 13132, entitled `` Federalism'' ( 64 FR 43255, August 10, 1999), requires that we develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects 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.'' Under section 6 of Executive Order 13132, we may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the State and local governments, or we consult with State and local officials early in the process of developing the proposed regulation. We also may not issue a regulation that has federalism implications and that preempts State law unless we consult with State and local officials early in the process of developing the proposed regulation. This direct final rule does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132. This rule is a revision to an existing rule governing the requirements for State and local monitoring networks and reduces the burden on affected States. Thus, the requirements of section 6 of the Executive Order do not apply to this direct final rule.

D. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments Executive Order 13175, entitled `` Consultation and Coordination with Indian Tribal Governments'' ( 65 FR 67249, November 9, 2000) requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' This direct final rule does not impose substantial direct compliance costs but lessens the existing requirements on the tribal governments. This rule revises an existing regulation which details the requirements for State, local and tribal air monitoring networks. Accordingly, the requirements of Executive Order 13175 do not apply to this action.

E. Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks Executive Order 13045 ( 62 FR 19885, April 23, 1997) applies to any rule that we determine ( 1) is `` economically significant'' as defined under Executive Order 12866, and ( 2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. We interpret Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5   501 of the Order has the potential to influence the regulation. This proposed rule is not subject to Executive Order 13045 because this does not establish an environmental VerDate Dec< 13> 2002 09: 49 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 31DER5. SGM 31DER5 80328 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Rules and Regulations standard intended to mitigate health or safety risks.

F. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA), Pub. L. 104   4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with `` Federal mandates'' that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $ 100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most costeffective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. We have determined that this direct final rule does not include a Federal mandate that may result in estimated costs of $ 100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector in any 1 year. This rule does not impose new requirements, but rather reduces somewhat the requirements of existing regulations for State and local air monitoring networks. We have also determined that this rule does not significantly or uniquely impact small governments. Therefore, the requirements of the Unfunded Mandates Act do not apply to this rule.

G. Regulatory Flexibility Act ( RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 ( SBREFA), 5 U. S. C. 601 et seq. The RFA generally requires that we conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. This direct final rule does not have a significant impact on a substantial number of small entities because no additional cost will be incurred by such entities because of the changes specified by the rule. The rule reduces the requirements for the number of sites at which collocated monitors are required. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

H. Paperwork Reduction Act This proposed rule does not contain any information collection requirements subject to the Office of Management and Budget review under the Paperwork Reduction Act of 1980, 44 U. S. C. 3501 et seq.

I. National Technology Transfer and Advancement Act Section 12( d) of the National Technology Transfer and Advancement Act of 1995 (`` NTTAA''), Pub. L. 104   113, § 12( d) ( 15 U. S. C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e. g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. In this direct final rule there is no consensus standard for the setting of a precision requirement for a monitoring network. The determination of the confidence needed in the estimates derived for a particular monitoring network determine the amount and quality of the precision information. EPA used accepted statistical practices for the generation of the number of collocated sites it felt was appropriate for use in the network and used similar techniques for determining that the requirement could be reduced.

J. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801, et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. We will submit a report containing this direct final rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this direct final rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This direct final is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 58 Environmental protection, Air pollution control, Reporting and recordkeeping requirements.

Dated: December 18, 2002. Christine Todd Whitman, Administrator.

For the reasons set forth in the preamble, title 40, chapter I, is amended as follows:

PART 58   [ AMENDED]

1. The authority citation for part 58 continues to read as follows: 42 U. S. C. 7401, 7416, 7601, and 7619. 2. In Appendix A to part 58, section 3.5.2 is amended by revising paragraph ( a)( 1) to read as follows:

Appendix A to Part 58   Quality Assurance Requirements for State and Local Air Monitoring Stations ( SLAMS)

* * * * * 3.5.2 * * * ( a) * * * ( 1) Have 15 percent of the monitors collocated ( values of .5 and greater round up).

* * * * * [ FR Doc. 02   32384 Filed 12   30   02; 8: 45 am]

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[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Notices]
[Page 32904-32905]
[DOCID:fr09jy09-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13365-000--Alaska]

City of Angoon, Alaska; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

July 1, 2009.
    On June 16, 2009, the City of Angoon filed an application pursuant
to section 4(f) of the Federal Power Act to study the feasibility of
the proposed Scenery Lake Project No. 13365 located in southeast
Alaska. The June 16 application amends the City of Angoon's initial
application for the Scenery Lake Project, which was accepted and
noticed by the Commission on June 1, 2009. The acceptance letter is
hereby rescinded, and this notice supersedes the June 1, 2009, Notice
of Preliminary Permit Application Accepted for Filing and Soliciting
Comments, Motions to Intervene, and Competing Applications for the
Scenery Lake Project. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of: (1) A 15-foot-high concrete
dam with spillway impounding Scenery Lake having a surface area of 520
to 610 acres and a storage capacity of 17,000 acre-feet; (2) a lake tap
or siphon with fish screen; (3) a 13,000-foot-long by 8-foot-diameter
power conduit; (4) a powerhouse containing two to four new generating
units having an installed capacity of 30 megawatts; (5) a proposed 29-
mile-long, 69- and 138-kilovolt transmission line; and (6) appurtenant
facilities. The proposed Scenery Lake Project would have an average
annual generation of 130 gigawatt-hours.
    Applicant Contact: Albert Howard, Mayor, City of Angoon, P.O. Box
189, Angoon, AK 99820; phone:<PHONE_NUMBER>.
    FERC Contact: Gina Krump,<PHONE_NUMBER><EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project, including a copy of
the application, can be viewed or printed on the ``eLibrary'' link of
the Commission's Web site at http://www.ferc.gov/docs-filing/
elibrary.asp. Enter the docket number (P-13365) in the docket number
field to

access the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16159 Filed 7-8-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Pages 39818-39820]
[FR Doc No: 2015-16859]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75364; File No. SR-FINRA-2015-024]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend FINRA Rule 7650A Relating to Submission
of Billing Disputes by FINRA/Nasdaq Trade Reporting Facility
Participants

July 6, 2015.
    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 July 1, 2015, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon receipt of this filing by the
Commission. 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.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 7650A (Collection of Fees)
to require FINRA members that are FINRA/Nasdaq Trade Reporting Facility
(``FINRA/Nasdaq TRF'') participants to submit billing disputes within
sixty days of receipt of the invoice to the FINRA/Nasdaq TRF. The
proposed rule change also would rename Rule 7650A as ``Collection of
Fees and Billing Policy.''
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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 FINRA/Nasdaq TRF is a facility of FINRA that is operated by The
NASDAQ OMX Group, Inc. (``NASDAQ OMX''). In connection with the
establishment of the FINRA/Nasdaq TRF, FINRA and NASDAQ OMX entered
into a limited liability company agreement (the ``LLC Agreement'').
Under the LLC Agreement, FINRA, the ``SRO Member,'' has sole regulatory
responsibility for the FINRA/Nasdaq TRF. NASDAQ OMX, the ``Business
Member,'' is primarily responsible for the management of the FINRA/
Nasdaq TRF's business affairs to the extent those affairs are not
inconsistent with the regulatory and oversight functions of FINRA. As
such, the Business Member establishes pricing for use of the FINRA/

Nasdaq TRF, and such pricing is implemented pursuant to FINRA rules
that must be filed with the SEC and be consistent with the Act. In
addition, the Business Member is obligated to pay the cost of
regulation and is entitled to the profits and losses, if any, derived
from the operation of the FINRA/Nasdaq TRF.
    Pursuant to the FINRA Rule 7600A Series, FINRA members that are
FINRA/Nasdaq TRF participants are charged fees (Rule 7620A) and also
may qualify for credits for trade reporting to the FINRA/Nasdaq TRF
(Rule 7610A). These rules are administered by NASDAQ OMX, in its
capacity as the ``Business Member'' and operator of the FINRA/Nasdaq
TRF on behalf of FINRA,\4\ and NASDAQ OMX collects all fees on behalf
of the FINRA/Nasdaq TRF.
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    \4\ FINRA's oversight of this function performed by the Business
Member is conducted through a recurring assessment and review of TRF
operations by an outside independent audit firm.
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    On June 23, 2015, FINRA filed a proposed rule change to adopt Rule
7650A to require FINRA members that are FINRA/Nasdaq TRF participants
to provide a clearing account number for an account at National
Securities Clearing Corporation (``NSCC'') to the FINRA/Nasdaq TRF for
purposes of permitting NASDAQ OMX, on behalf of the FINRA/Nasdaq TRF,
to debit any undisputed or final fees due and owing under the FINRA
Rule 7600A Series relating to the FINRA/Nasdaq TRF.\5\
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    \5\ See Securities Exchange Act Release No. 75339 (June 30,
2015) (Notice of Filing and Immediate Effectiveness; File No. SR-
FINRA-2015-021).
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    FINRA is proposing to amend Rule 7650A to add a new paragraph (b)
to require all billing disputes to be submitted to the FINRA/Nasdaq TRF
in writing \6\ and accompanied by supporting documentation within sixty
days of receipt of an invoice. This process is expected to conserve
resources, which are expended when untimely billing disputes require
research of applicable fees and other information beyond two months
after the invoice was issued. The proposed billing policy would apply
only to fees due and owing by the member under the Rule 7600A Series.
FINRA notes that the same policy with respect to billing disputes is in
place today for NASDAQ Options Market (``NOM'') Participants \7\ and
has been proposed for NASDAQ equity participants relating to exchange
fees and charges under Nasdaq Stock Market rules, effective July 1,
2015.\8\ FINRA also is proposing to rename Rule 7650A as ``Collection
of Fees and Billing Policy.''
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    \6\ The invoice specifies the contact person(s) to whom to
address billing disputes.
    \7\ See NOM Rules at Chapter XV, Section 7, entitled ``NASDAQ
Options Fee Disputes.''
    \8\ See Securities Exchange Act Release No. 74895 (May 7, 2015),
80 FR 27352 (May 13, 2015) (Notice of Filing and Immediate
Effectiveness; File No. SR-NASDAQ-2015-050).
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    FINRA has filed the proposed rule change for immediate
effectiveness and requested waiver of the 30-day operative delay. FINRA
proposes that the proposed rule change will become operative on July 1,
2015. The proposed billing policy would apply to invoices for trade
reporting activity occurring in July 2015 and thereafter.\9\
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    \9\ The proposed billing policy would not apply to invoices
related to June 2015 (or prior) billing.
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2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\10\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. Consistent with SR-NASDAQ-2015-050, the proposed
requirement that billing disputes under the Rule 7600A Series be
submitted to the FINRA/Nasdaq TRF within sixty days from receipt of the
invoice would set an objective standard and would be fair and applied
uniformly to all members that are FINRA/Nasdaq TRF participants. In
addition, consistent with SR-NASDAQ-2015-050, sixty days is ample time
for members to review an invoice and dispute any billing related to
trade reporting activity for that time period. As noted above, an
identical billing policy applies today with respect to NOM participants
and has been proposed for NASDAQ equity participants.
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    \10\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA 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. As described above, and
consistent with the LLC Agreement, the proposed billing policy is
identical to the billing policy NASDAQ OMX currently has in place for
NOM participants and is also identical to the billing policy proposed
by Nasdaq for Nasdaq equity participants under Nasdaq Stock Market
rules. As the Business Member, NASDAQ OMX has the obligation of
assessing the potential impacts of the proposed billing policy in its
own rulemaking. FINRA notes that Nasdaq's billing policy was subject to
proposed rule changes filed by Nasdaq with the Commission.\11\
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    \11\ See, e.g., Securities Exchange Act Release No. 74895 (May
7, 2015), 80 FR 27352 (May 13, 2015) (Notice of Filing and Immediate
Effectiveness; File No. SR-NASDAQ-2015-050).
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    Consistent with SR-NASDAQ-2015-050, the proposed billing policy
would apply uniformly to all members that are FINRA/Nasdaq TRF
participants, as it does today with NOM participants and as proposed
for Nasdaq equity participants. In addition, consistent with SR-NASDAQ-
2015-050, the proposed billing policy would conserve FINRA/Nasdaq TRF
resources, which are expended when untimely billing disputes require
staff to research applicable fees and other information beyond two
months after the invoice is issued.

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 \12\ and Rule 19b-
4(f)(6) thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative before 30 days from the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\14\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    FINRA has asked the Commission to waive the 30-day operative delay.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The proposed rule change proposes a billing policy that is identical to
the billing policy proposed by Nasdaq relating to fees under Nasdaq
Stock Market rules pursuant to SR-NASDAQ-2015-050. The operative date

of proposed rule change SR-NASDAQ-2015-050 is July 1, 2015. FINRA
believes, and the Commission agrees, that it would be more efficient to
implement the billing policy under this proposed rule change on the
same date as the billing policy under SR-NASDAQ-2015-050, rather than
on a piecemeal basis. Therefore, the Commission hereby waives the 30-
day operative delay and designates the proposed rule change to be
operative upon filing with the Commission.\15\
---------------------------------------------------------------------------

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

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (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 (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2015-024 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-FINRA-2015-024. 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 Web site (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 Web site 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 such filing also will be available
for inspection and copying at the principal offices of FINRA. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2015-024, and should
be submitted on or before July 31, 2015

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

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

Brent J. Fields,
Secretary.
[FR Doc. 2015-16859 Filed 7-9-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44904-44906]
[FR Doc No: 2011-18867]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2011-0424; FRL-9443-7]

Agency Information Collection Activities; Proposed Collection;
Comment Request; State Water Quality Program Management Resource
Analysis; EPA ICR No. 2433.01

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request for a new Information Collection Request (ICR) to the
Office of Management and Budget (OMB). Before submitting the ICR to OMB
for review and approval, EPA is soliciting comments on specific aspects
of the proposed information collection as described below.

DATES: Comments must be submitted on or before September 26, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2011-0424, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>(Identify Docket ID number EPA-
HQ-OW-2011-0424, in the subject line.)
     Fax:<PHONE_NUMBER>.
     Mail: Water Docket, Environmental Protection Agency,
Mailcode: 4203M, 1200 Pennsylvania Ave., NW., Washington, DC 20460].
``Please include a total of three copies.''
     Hand Delivery: EPA Docket Center, EPA West, Room 3334,
1301 Constitution Avenue, NW., Washington, DC. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2011-
0424. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Kit Farber, Planning, Information, and
Resource Management Staff, Office of Wastewater Management, Mail Code
4201M, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
501-2346; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2011-0424, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Water Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What information collection activity or ICR does this apply to?

    Affected entities: Entities potentially affected by this action are
state governments. Major respondents are state governments.
    Title: State Water Quality Program Management Resource Analysis.
    ICR numbers: EPA ICR No. 2433.01, OMB Control No. 2040-NEW.
    ICR status: This ICR is for a new information collection activity.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: EPA, in partnership with states, is conducting the State
Water Quality Program Management Resource Analysis to enumerate current
and future expenditures and resources for the administration and
management of state water quality programs, and to quantify the
resource needs for the administration and management of state water
quality programs to implement the Clean Water Act (CWA). This effort
builds on an expenditure and resource needs data collection effort
conducted by EPA in collaboration with the states in 1998 and 2000.
    EPA requires this information to comprehend resource expenditures
and needs for the administration and management of the water quality
programs under 33 U.S.C. 1251 et seq. This effort, supported by EPA and
the states, is necessary to develop strategies for better managing
state water quality programs that implement the CWA, thus ensuring the
long-term sustainability, efficiency, and effectiveness of these
programs. This effort also helps states and EPA to effectively target
resources to meet EPA's FY 2011-2015 strategic goals of protecting the
nation's waters and enforcing environmental laws.
    This is a one-time collection effort by the Office of Wastewater
Management and responses to this ICR are voluntary. The data collection
will facilitate creation of a detailed activity-based workload model to
serve as a long-term budgeting, program management, and progress
tracking tool for the states and EPA to use in the future.
    This information will be collected by EPA and made available to the
states and to the public in accordance with the requirements of the
Freedom of Information Act.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 63
hours per response. Approximately 20 states are expected to respond to
this one-time information collection request, for a total estimated
annual burden of 1,252 hours and a total estimated cost of $49,740. The
total estimated burden for this information collection activity,
including the Agency, is 1,731 hours nationally; the estimated total
cost is $86,518. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential state respondents: 20.
    Frequency of response: One time.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 1,731 hours.
    Estimated total annual costs: $86,518. This estimate includes
annual labor costs only, since no capital or operation and maintenance
costs are associated with this ICR.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: July 19, 2011.
James A. Hanlon,
Director, Office of Wastewater Management.
[FR Doc. 2011-18867 Filed 7-26-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76709-76710]
[FR Doc No: 2011-31488]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12642-003 North Carolina]

Wilkesboro Hydroelectric Company, LLC; Notice of Availability of
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the application for license for the W.
Kerr Scott Hydropower Project that would be located at the existing
U.S. Army Corps of Engineers' (Corps) W. Kerr Scott Dam and Reservoir
on the Yadkin River, near the Town of Wilkesboro, in Wilkes County,
North Carolina. The project would occupy 3.5 acres of federal lands
administered by the Corps.
    Commission staff has prepared an environmental assessment (EA) for
the project. The EA contains staff's analysis of the potential
environmental effects of the project, and concludes that licensing the
project, with appropriate environmental protective measures, would not
constitute a major federal action that would significantly affect the
quality of the human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-(866) 208-3676, or for
TTY,<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    Any comments should be filed within 30 days from the date of this
notice. Comments may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://

www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support.
    Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426.

FOR FURTHER INFORMATION CONTACT: Jennifer Adams at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
    Dated: December 1, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-31488 Filed 12-7-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Proposed Rules]
[Pages 12534-12537]
[FR Doc No: 2019-06188]

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

Food and Drug Administration

21 CFR Part 610

[Docket No. FDA-2018-N-4757]
RIN 0910-AH95

Revocation of the Test for Mycoplasma

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
proposing to amend the biologics regulations by removing the specified
test for the presence of Mycoplasma for live virus vaccines and
inactivated virus vaccines produced from in vitro living cell cultures.
FDA is proposing this action because the existing test for Mycoplasma
is restrictive in that it identifies only one test method in detail to
be used even though other methods also may be appropriate. More
sensitive and specific methods exist and are currently being practiced,
and removal of the specific method to test for Mycoplasma provides
flexibility for accommodating new and evolving technology and
capabilities without

diminishing public health protections. This action is part of FDA's
implementation of Executive Orders 13771 and 13777. Under these
Executive orders, FDA is comprehensively reviewing existing regulations
to identify opportunities for repeal, replacement, or modification that
will result in meaningful burden reduction, while allowing the Agency
to achieve our public health mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments on the proposed
rule by June 17, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 17, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-4757 for ``Revocation of the Test for Mycoplasma.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Introduction
    B. Need for Regulation
III. Legal Authority
IV. Description of the Proposed Rule
    A. Scope
    B. Appropriate Controls Would Remain in Place
V. Proposed Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination with Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA proposes to remove the regulation requiring a specified test
for the presence of Mycoplasma for live virus vaccines produced from in
vitro living cell cultures and inactivated virus vaccines produced from
such living cell cultures because the regulation is restrictive in that
it identifies only one test method in detail to be used even though
other methods also may be appropriate. More sensitive and specific
methods exist and are currently being practiced, and removal of the
required test for Mycoplasma provides flexibility for accommodating new
and evolving technology and capabilities without diminishing public
health protections.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule removes Sec.  [thinsp]610.30 (21 CFR 610.30),
which details the method for Mycoplasma testing of samples of the virus
harvest pool and control fluid pool of live virus vaccines and
inactivated virus vaccines produced from in vitro living cell cultures.

C. Legal Authority

    FDA is taking this action under the biological products provisions
of the Public Health Service Act (the PHS Act), and the drugs and
general

administrative provisions of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).

D. Costs and Benefits

    Because this proposed rule would not impose any additional
regulatory burdens, this regulation is not anticipated to result in any
compliance costs and the economic impact is expected to be minimal.

II. Background

A. Introduction

    On February 24, 2017, Executive Order 13777, ``Enforcing the
Regulatory Reform Agenda'' (https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda, 82 FR
12285; March 1, 2017) was issued. One of the provisions in the
Executive order requires Agencies to evaluate existing regulations and
make recommendations to the Agency head regarding their repeal,
replacement, or modification, consistent with applicable law. As part
of this initiative, FDA is proposing to revoke a regulation as
specified in this proposed rule.

B. Need for Regulation

    It has become increasingly clear that the test for Mycoplasma
requirements is too restrictive for live virus vaccines and inactivated
virus vaccines produced from in vitro living cell cultures because they
specify particular methodologies when alternatives may be available
that provide the same or greater level of assurance of safety.
Modifications to mycoplasma testing described in Sec.  610.30 must meet
the requirements of 21 CFR 610.9.
    Thus, the Agency believes that the regulation may no longer reflect
the current testing procedures as a general matter and that it is more
appropriate, flexible, and efficient to identify appropriate testing
requirements for particular products in the biologics license
application (BLA).
    This proposed rule would remove the specified test for the presence
of Mycoplasma to provide flexibility for accommodating new and evolving
technology and capabilities without diminishing public health
protections. Removal of this regulation would allow manufacturers of
live virus vaccines produced from in vitro living cell cultures and
inactivated virus vaccines produced from such living cell cultures to
select the most scientifically appropriate Mycoplasma testing method to
assure the safety, purity, and potency of their vaccines.
    These newer technologies can result in higher sensitivity and
specificity of Mycoplasma detection and could reduce the time required
to complete testing for Mycoplasma. Removal of this regulation would
not remove Mycoplasma testing requirements specified in individual
BLAs. A manufacturer of a live virus vaccine produced from in vitro
living cell cultures and inactivated virus vaccines produced from such
living cell cultures would continue to be required to follow the
Mycoplasma test requirements specified in its BLA, unless the BLA were
revised to modify or replace the test through a supplement in
accordance with Sec.  [thinsp]601.12(c) (21 CFR 601.12(c)). FDA would
review proposed changes to a manufacturer's approved biologics license
in the context of that particular application to ensure that any such
action is appropriate.
    The proposed rule, if finalized, will remove the regulation;
however, a manufacturer would continue to be required to test for
Mycoplasma as specified in its BLA. If finalized, this action will
provide regulated industry with flexibility, as appropriate, to employ
advances in science and technology as they become available, without
diminishing public health protections. As appropriate, the Agency will
describe the appropriate tests for particular products in
manufacturers' BLAs.

III. Legal Authority

    FDA is issuing this proposed rule under the biological products
provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a, and 264) and
the drugs and general administrative provisions of the FD&C Act (21
U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371,
372, 374, and 381). Under these provisions of the PHS Act and the FD&C
Act, we have the authority to issue and enforce regulations designed to
ensure that biological products are safe, pure, and potent, and prevent
the introduction, transmission, and spread of communicable disease.

IV. Description of the Proposed Rule

A. Scope

    The test for Mycoplasma in Sec.  [thinsp]610.30 is intended to
ensure that live virus vaccines produced from in vitro living cell
cultures, and inactivated virus vaccines produced from such living cell
cultures do not contain Mycoplasma. Currently the regulation details
the method for Mycoplasma testing of samples of the virus harvest pool
and control fluid pool of live virus vaccines and inactivated virus
vaccines produced from in vitro living cell cultures. Removal of this
regulation would eliminate a restrictive and duplicative requirement
and accommodate new and evolving technology.
    We are proposing to remove the specified test for the presence of
Mycoplasma for live virus vaccines produced from in vitro living cell
cultures and inactivated virus vaccines produced from such living cell
cultures. FDA is proposing this action because the existing specified
test for the presence of Mycoplasma is restrictive and duplicative of
requirements that are also specified in the BLA. This change is
intended to remove restrictive or duplicative requirements and
accommodate new and evolving technology and capabilities without
diminishing public health protections. Removal of this regulation would
not remove Mycoplasma testing requirements specified in individual
BLAs. A biological product manufacturer would continue to be required
to follow the Mycoplasma testing requirements specified in its BLA
unless the BLA were revised to modify or replace the test through a
supplement in accordance with Sec.  601.12(c). FDA would review
proposed changes to a manufacturer's approved biologics license in the
context of that particular license to ensure that any such action is
appropriate.
    FDA is proposing to remove the requirements contained in Sec.
[thinsp]610.30 from the regulations. As a result of removing Sec.
[thinsp]610.30, we would also remove and reserve 21 CFR part 610,
subpart D. FDA is proposing this action because the testing method
described in the regulation is restrictive and more sensitive and
specific testing methods are now available.

B. Appropriate Controls Would Remain in Place

    FDA believes that if this rulemaking becomes finalized as proposed,
we would be able to continue to ensure that appropriate controls remain
in place. If the proposed rule is finalized and the regulation calling
for a specific test for Mycoplasma is eliminated, manufacturers would
continue to be required to perform a test for Mycoplasma described in
their BLAs for their licensed live virus vaccines produced from in
vitro living cell cultures and their inactivated virus vaccines
produced from such cultures. Such requirement would remain in effect
unless the BLA were revised to modify or replace the test through a
supplement in accordance with Sec.  [thinsp]601.12(c). FDA would review
proposed changes to a manufacturer's approved biologics license in the
context of that particular license to

ensure that any such action is appropriate.

V. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule
become effective 30 days after the date of its publication in the
Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this proposed rule would increase flexibility and
does not add any new regulatory responsibilities, we propose to certify
that the proposed rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $150 million, using the most current (2017) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    We believe industry will largely maintain their current practices
following the removal of Sec.  610.30 Test for Mycoplasma. Although
manufacturers of live virus vaccines and inactivated virus vaccines
produced from in vitro living cell cultures may experience some
unquantifiable cost savings from streamlining their testing procedures,
we predict no quantifiable cost savings. FDA will also maintain its
current practices, similarly generating no quantifiable cost savings.
Therefore, we expect this proposed rule to be cost neutral.
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

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

IX. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects 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. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have
substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

XI. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA/Economics Staff, ``Elimination of 21 CFR 610.30 Test for
Mycoplasma, Preliminary Regulatory Impact Analysis, Preliminary
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act
Analysis,'' 2018. (Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.)

List of Subjects in 21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 610 be
amended as follows:

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
1. The authority citation for part 610 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

Subpart D--[Removed and Reserved]

0
2. Remove and reserve subpart D, consisting of Sec.  610.30.

    Dated: March 26, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-06188 Filed 4-1-19; 8:45 am]
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[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10620-10621]
[FR Doc No: 2016-04448]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2015-0335; FRL-9943-13-OW]

Request for Public Comment on the Draft EPA-USGS Technical
Report: Protecting Aquatic Life From Effects of Hydrologic Alteration

AGENCY: Environmental Protection Agency (EPA) and United States
Geological Survey (USGS).

ACTION: Notice of availability.

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SUMMARY: The Environmental Protection Agency (EPA) and the United
States Geological Survey are releasing a draft technical report:
Protecting Aquatic Life from Effects of Hydrologic Alteration, for a
60-day public comment period. This report was developed because
hydrologic alteration can be a contributor of impairment for water
bodies that are designated to support aquatic life. Stresses on aquatic
life associated with hydrologic alteration may be further exacerbated
through climate change. Recent climate trends have included the change
in frequency and duration of extreme weather events, such as droughts
and floods, which can have an impact on flow and affect aquatic life.
    The report is a nonprescriptive framework with information to help
states, tribes, territories, water resource managers, and other
stakeholders responsible for the maintenance of hydrologic flow regime
to quantify flow targets for the preservation of aquatic life and
habitat. This report also provides information on the relationship
between hydrologic condition and water quality and gives examples of
what some states and authorized tribes have done to address flow
concerns using the Clean Water Act. The framework can also be used to
translate narrative criteria and develop flow targets to protect
aquatic life and habitat.

DATES: Comments must be received on or before May 2, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2015-0335, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. EPA
may publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e., on the web, cloud, or
other file sharing system). For additional submission methods, the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Diana Eignor, Health and Ecological
Criteria Division, Office of Water (Mail Code 4304T), Environmental
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. How can I Get Copies of This Document and Other Related Information?

    1. Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Water Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Water
Docket is<PHONE_NUMBER>. For additional information about EPA's public
docket, visit EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

II. How will this document be used?

    This draft report is a nonprescriptive framework that can be used
to help quantify targets for flow regime components that are protective
of aquatic life and their habitats. Flow targets can help states,
tribes, and territories to prepare for changes in historic flow
patterns. Maintaining flow targets may help increase a stream's
resilience to climate change by reducing or avoiding intensification of
existing stresses. This document, even after issued in final form, is
not a rule, and it is therefore not mandatory for states and authorized
tribes to adopt this framework into their water quality standards. Once
the comment period has ended, EPA and the USGS will consider the
comments, revise the document, as appropriate, and then publish a final
document that will serve as a source of information for states, tribes,
territories, and other stakeholders.

III. Solicitation of Scientific Views

    EPA and USGS are soliciting additional scientific views, data, and
information regarding the science and technical approach used in the
derivation of this draft technical document on hydrologic alteration.

IV. Additional Information

    EPA and USGS each conducted internal peer reviews of the report,
and EPA managed a contractor-led independent external peer review of
the Draft EPA-USGS Technical Report: Protecting Aquatic Life from
Effects of Hydrologic Alteration. EPA will make the external peer
review comments and Agency responses to these comments available in the
docket with the revised draft technical document at http://www.regulations.gov.

    Dated: February 22, 2016.
Joel Beauvais,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2016-04448 Filed 2-29-16; 8:45 am]
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[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Notices]
[Page 7625-7626]
[DOCID:fr08fe08-111]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2008-02]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before February 28, 2008.

ADDRESSES: You may send comments identified by Docket Number FAA-2008-
0053 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov
 and follow the instructions for sending your

comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.

     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you

provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management

Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Judith Watson<PHONE_NUMBER>, FAA New
England Region Headquarters, 12 New England Executive Park, Burlington,
MA 01803 or Frances Shaver<PHONE_NUMBER>, Office of Rulemaking,
Federal Aviation Administration, 800 Independence Avenue, SW.,
Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on February 4, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2008-0053.
    Petitioner: McCauley Propeller Systems.
    Section of 14 CFR Affected: Sec.  21.231(a).
    Description of Relief Sought: The petitioner seeks relief to permit
the issuance of a delegation option authorization for type, production,
and airworthiness certification of propellers manufactured for use on
turbopropeller and reciprocating engines of not more than 1,650 brake
horsepower.
 [FR Doc. E8-2389 Filed 2-7-08; 8:45 am]

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