[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42070-42071]
[FR Doc No: 2013-16903]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9833-9]

Announcement of the Board of Directors for the National
Environmental Education Foundation

AGENCY: Office of External Affairs and Environmental Education,
Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The National Environmental Education Foundation (NEEF) was
created by Section 10 of Public Law 101-619, the National Environmental
Education Act of 1990. It is a private 501(c)(3) non-profit
organization established to promote and support education and training
as necessary tools to further environmental protection and sustainable,
environmentally sound development. It provides the common ground upon
which leaders from business and industry, all levels of government,
public interest groups, and others can work cooperatively to expand the
reach of environmental education and training programs beyond the
traditional classroom. The Foundation supports a grant program that
promotes innovative environmental education and training programs; it
also develops partnerships with government and other organizations to
administer projects that promote the development of an environmentally
literate public. The Administrator of the U.S. Environmental Protection
Agency, as required by the terms of the Act, announces the following
appointment to the National Environmental Education Foundation Board of
Trustees. The appointee is Carlos Alcazar, Chief Executive Officer of
Hispanic Communications Network.

FOR FURTHER INFORMATION CONTACT: For information regarding this Notice
of Appointment, please contact Mrs. Stephanie Owens, Deputy Associate
Administrator, Office of External Affairs and Environmental Education
(1701A), U.S. EPA, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
General information concerning NEEF can be found on their Web site at:
http://www.neefusa.org.

SUPPLEMENTARY INFORMATION:
    Additional Considerations: Great care has been taken to assure that
this new appointee not only has the highest degree of expertise and
commitment, but also brings to the Board diverse points of view
relating to environmental education. This appointment is a four-year
term which may be renewed once for an additional four years pending
successful re-election by the NEEF nominating committee.
    This appointee will join the current Board members which include:
     Arthur Gibson (NEEF Chair), Vice President, Environment,
Health and Safety, Baxter Healthcare Corporation
     JL Armstrong (NEEF Vice Chair), National Manager, Toyota
Motor Sales, USA, Inc.
     Kenneth Strassner (NEEF Treasurer), Vice President, Global
Environment, Safety, Regulatory and Scientific Affairs, Kimberly-Clark
Corporation
     Diane Wood (NEEF Secretary), President, National
Environmental Education Foundation
     Decker Anstrom, Former CEO, The Weather Channel Companies
     Raymond Ban, Executive Vice President, The Weather Channel
     Holly Cannon, Principal, Beveridge and Diamond, P.C.
     Megan Reilly Cayton, Co-Founder and CEO, Catrinka, LLC
     Phillipe Cousteau, Co-Founder and CEO, EarthEcho
International
     Manuel Alberto Diaz, Partner, Lydecker Diaz, L.L.P.
     Trish Silber, President, Aliniad Consulting Partners, Inc.
     Bradley Smith, Dean, Huxley College of the Environment,
Western Washington University
     Wonya Lucas, Former CEO, TV One
    Background: Section 10(a) of the National Environmental Education
Act of 1990 mandates a National Environmental Education Foundation. The
Foundation is established in order to extend the contribution of
environmental education and training to meeting critical environmental
protection needs, both in this country and internationally; to
facilitate the cooperation, coordination, and contribution of public
and private resources to create an environmentally advanced educational
system; and to foster an open and effective partnership among Federal,
State, and local government, business, industry, academic institutions,
community based environmental groups, and international organizations.
    The Foundation is a charitable and nonprofit corporation whose
income is exempt from tax, and donations to which are tax deductible to
the same extent as those organizations listed pursuant to section
501(c) of the Internal Revenue Code of 1986. The Foundation is not an
agency or establishment of the United States. The purposes of the
Foundation are--
    (A) Subject to the limitation contained in the final sentence of
subsection (d) herein, to encourage, accept, leverage, and administer
private gifts for the benefit of, or in connection with, the
environmental education and training activities and services of the
United States Environmental Protection Agency;
    (B) to conduct such other environmental education activities as
will further the development of an environmentally conscious and
responsible public, a well-trained and environmentally literate
workforce, and an environmentally advanced educational system;
    (C) to participate with foreign entities and individuals in the
conduct and coordination of activities that will further opportunities
for environmental education and training to address environmental
issues and problems involving the United States and Canada or Mexico.
    The Foundation develops, supports, and/or operates programs and
projects to educate and train educational and environmental
professionals, and to assist them in the development and

delivery of environmental education and training programs and studies.
    The Foundation has a governing Board of Directors (hereafter
referred to in this section as `the Board'), which consists of 13
directors, each of whom shall be knowledgeable or experienced in the
environment, education and/or training. The Board oversees the
activities of the Foundation and assures that the activities of the
Foundation are consistent with the environmental and education goals
and policies of the Environmental Protection Agency and with the
intents and purposes of the Act. The membership of the Board, to the
extent practicable, represents diverse points of view relating to
environmental education and training. Members of the Board are
appointed by the Administrator of the Environmental Protection Agency.
    Within 90 days of the date of the enactment of the National
Environmental Education Act, and as appropriate thereafter, the
Administrator will publish in the Federal Register an announcement of
appointments of Directors of the Board. Such appointments become final
and effective 90 days after publication in the Federal Register. The
directors are appointed for terms of 4 years. The Administrator shall
appoint an individual to serve as a director in the event of a vacancy
on the Board within 60 days of said vacancy in the manner in which the
original appointment was made. No individual may serve more than 2
consecutive terms as a director.

    Dated: June 28, 2013.
Bob Perciasepe,
Acting Administrator.

Carlos Alcazar

    Mr. Alcazar has been Chief Executive Officer and Executive Creative
Director of Hispanic Communications Network since 2005. Mr. Alcazar was
Vice President of Pearson, plc since 2001, Vice President,
International of Viacom since 1992, and Technology Instructor and
Bilingual Teacher at Los Angeles Unified School District since 1990.
    He serves on the board of the National Fatherhood Initiative, World
Affairs Council, Boy Scouts of America, Alliance for the Family, the
Ready to Learn Partnership and the Latino Advisory Council of the Boys
and Girls Club of America.
    Mr. Alcazar earned a bachelor's degree in business administration
in Political Science and Communications from University of California.
He speaks Spanish and French.

[FR Doc. 2013-16903 Filed 7-12-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 7, 2007 (Volume 72, Number 235)]
[Notices]
[Page 69259-69261]
[DOCID:fr07de07-88]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56880; File No. SR-Amex-2006-96]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Approving Proposed Rule Change, as Modified by Amendment Nos. 1, 2, 3,
4, 5, and 6 Thereto, Relating to the Listing and Trading of Trust Units
of the Nuveen Commodities Income and Growth Fund

December 3, 2007.

I. Introduction

    On October 12, 2006, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change pursuant to section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder \2\ to list and trade trust units of the Nuveen Commodities
Income and Growth Fund (``Fund'') (``Shares'') pursuant to proposed
Amex Rules 1600 et. seq. On March 2, 2007, March 21, 2007, May 14,
2007, August 15, 2007, August 28, 2007, and September 17, 2007 the Amex
submitted Amendment Nos. 1, 2, 3, 4, 5, and 6, respectively, to the
proposed rule change. The proposed rule change, as amended, was
published for comment in the Federal Register on September 25, 2007.\3\
The Commission received one comment letter regarding the proposal.\4\
This order approves the proposed rule change, as amended.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 56465 (September 19,
2007), 72 FR 54489 (``Notice'').
    \4\ See letter to Nancy M. Morris, Secretary, Commission, from
John G. Gaine, President, Managed Funds Association (``MFA''), dated
October 15, 2007 (``MFA Letter'').
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II. Description of the Proposal

    The Exchange proposes to add Amex rules 1600 et seq. that would
permit the listing and trading of units of a trust or other similar
entity (``Trust Units'') that invests in the assets of a trust,
partnership, limited liability company, corporation or other similar
entity constituted as a commodity pool that holds investments
comprising or otherwise based on futures contracts, options on futures
contracts, forward contracts, commodities and high credit quality
short-term fixed income securities or other securities. Pursuant to
these proposed rules, the Amex proposes to list and trade the Shares,
which represent beneficial ownership interests in the assets of the
Fund, which in turn, consist solely of units (``Master Fund Units'') of
the Nuveen Commodities Income and Growth Master Fund LLC (the ``Master
Fund''). The Exchange also proposes to amend section 141 of the Amex
Company Guide (``Company Guide'') regarding listing fees to accommodate
the listing of Trust Units.\5\
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    \5\ The Amex original listing fee applicable to the listing of
the Fund is $5,000. Under Section 141 of the Company Guide, the
annual listing fee will be based upon the year-end aggregate number
of units in all series of the Fund outstanding at the end of each
calendar year.
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    As described in the Exchange's proposal,\6\ the Fund's primary
investment objective is to seek total return through broad exposure to
the commodities markets. The Fund's secondary objective is to provide
investors with monthly income and capital distributions not commonly
associated with commodity investments. The Master Fund will invest in
commodity futures and forward contracts, options on commodity futures
and forward contracts, and over-the-counter (``OTC'') commodity options
in the following commodity groups: energy, industrial metals, precious
metals, livestock, agriculturals, and tropical foods and fibers and may
in the future include other commodity investments that

become the subject of commodity futures trading.\7\
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    \6\ For a more detailed description of the Fund and Master Fund,
including their structure, investment objectives, holdings,
applicable exchange listing and trading rules, disclosure of pricing
information, surveillance, and other regulation, see Notice at
54489-94.
    \7\ For information regarding the futures contracts and other
investments in which the Master Fund may invest, see Notice at
54490.
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    The Fund and the Master Fund are commodity pools. The Master Fund
is managed by Nuveen Commodities Asset Management, LLC (the
``Manager''). The Manager is registered as a commodity pool operator
(the ``CPO'') and a commodity trading advisor (the ``CTA'') with the
Commodity Futures Trading Commission (``CFTC'') and is a member of the
National Futures Association (``NFA'').
    The Manager will serve as the CPO and CTA of the Fund and the
Master Fund. The Manager will determine the Master Fund's overall
investment strategy, including: (i) The selection and ongoing
monitoring of the Master Fund's sub-advisors; (ii) the management of
the Fund's and Master Fund's business affairs; and (iii) the provision
of certain clerical, bookkeeping and other administrative services.
Gresham Investment Management LLC (the ``Commodity Sub-Advisor'') will
invest on a notional basis substantially all of the Master Fund's
assets in commodity futures and forward contracts pursuant to a
proprietary commodity investment strategy (the Tangible Asset
Program[supreg] (``TAP[supreg]'')) \8\ and a risk management program.
The Commodity Sub-Advisor is a Delaware limited liability company and
is registered with the CFTC as a CTA and a CPO and is a member of the
NFA. The Commodity Sub-Advisor is also registered with the Commission
as an investment adviser. Nuveen Asset Management (the ``Collateral
Sub-Advisor''), an affiliate of the Manager, will invest the Master
Fund's collateral in short-term, investment grade quality debt
instruments. The Collateral Sub-Advisor is registered with the
Commission as an investment adviser.
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    \8\ TAP[supreg] is an actively managed, rules-based commodity
investment strategy. TAP[supreg] is fundamental in nature and is
designed to maintain consistent, fully collateralized exposure to
commodities as an asset class. TAP[supreg] does not require the
existence of price trends in order to be successful. TAP[supreg]
currently requires investment in futures or forward contracts for
three commodities in each of the energy, industrial metals,
livestock, agriculturals, tropical foods and fibers and precious
metal commodity groups. Commodity group weightings and individual
commodity weightings are chosen by a process that blends two-thirds
of five year global production value and one-third of five year
value of commodity futures contracts traded in dollars. The process
constrains the weightings of each commodity group such that no group
may constitute more than 35% of TAP[supreg] and no single commodity
interest can constitute more than 70% of its group. In addition,
each commodity is rebalanced.
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    The Exchange submits that proposed Amex Rules 1600 et seq. will
accommodate the listing and trading of Trust Units.\9\
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    \9\ Pursuant to Commentary .01 to proposed Amex Rule 1602, the
Exchange shall file separate proposals under Section 19(b) of the
Act before listing and trading separate and distinct Trust Units
designated on different underlying investments, commodities, assets
and/or portfolios.
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III. Comment Letter and Response

    The Commission received one comment letter, submitted by the
MFA,\10\ which expressed concerns about the daily disclosure of the
Fund's holdings and net asset value (``NAV''). MFA believed that such
daily disclosure is proper in the case of traditional exchange-traded
funds (``ETFs'') because it facilitates the daily creation and
redemption of units, which lowers the tracking error between an ETF's
NAV and the trading price of such ETF.\11\ In the case of the Fund,
however, which does not provide for a continuous creation and
redemption process, MFA argued that disclosure of the Fund's assets has
no ``commercially reasonable purpose,'' and may frustrate continued
innovation and ultimately harm investors. The MFA believed that daily
disclosure could allow market participants to discover proprietary
trading strategies through reverse engineering. MFA argued that this
could result in front-running and also remove incentives for the
formation of new closed-end funds and strategies.\12\ Likewise, daily
disclosure of the Fund's NAV, in the MFA's view, is not necessary and
may have negative consequences. MFA believed that closed-end exchange-
traded commodity pools such as the Fund should be subject to the same
NAV and portfolio holding disclosure requirements applicable to closed-
end exchange-traded registered investment companies.\13\
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    \10\ See MFA Letter, supra note 4.
    \11\ See id. at 1-2.
    \12\ See id. at 2-4.
    \13\ See id. at 4-5. MFA noted that many closed-end registered
investment companies report their NAV weekly and the Investment
Company Act of 1940 requires only quarterly portfolio holdings
disclosure for closed-end registered investment companies.
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    In its response,\14\ the Exchange disagreed with the MFA regarding
disclosure of the Fund's NAV. Amex argued that daily disclosure allows
investors to determine whether actual discounts or premiums to NAV per
share based on supply and demand and future expectation are consistent
with market fundamentals.\15\ With respect to the daily disclosure of
the Fund's holdings, Amex largely agreed with MFA's comments, noting
that it did not believe the daily portfolio holdings disclosure
requirement to be particularly helpful or necessary, and agreeing that
the Fund's structure does not provide for a mechanism to cause the
market price per share to track NAV per share.\16\
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    \14\ See letter to Nancy M. Morris, Secretary, Commission, from
Jeffrey P. Burns, Vice President and Associate General Counsel,
Exchange, dated November 7, 2007.
    \15\ Id. at 3.
    \16\ Id. at 1-2. Though the Exchange in its current letter
believed that there was significant justification to eliminate the
proposed requirement or daily portfolio holdings disclosure, the
Exchange did not file an amendment to propose such a change with
respect to the Fund.
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IV. Discussion and Commission Findings

    After careful review, 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.\17\ In particular, the Commission finds that the proposed
rule change is consistent with section 6(b)(5) of the Act,\18\ which
requires that the rules of an exchange be designed, among other things,
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
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    \17\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \18\ 15 U.S.C. 78f(b)(5).
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    The Commission further believes that the proposal is consistent
with section 11A(a)(1)(C)(iii) of the Act,\19\ which sets forth
Congress's finding that it is in the public interest and appropriate
for the protection of investors and the maintenance of fair and orderly
markets to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities. As described in the Notice, the Exchange represents that
futures, forwards and related exchange traded options, quotes and last
sale information for the commodity contracts held by the Fund are
widely disseminated through a variety of market data vendors worldwide,
including Bloomberg and Reuters. In addition, the Exchange further
represents that complete real-time data for such futures, forwards and
exchange traded options is available by subscription from Reuters and
Bloomberg. The relevant futures and forward exchanges also provide
delayed futures and forward contract information on current and past
trading

sessions and market news free of charge on their respective Web sites.
The contract specifications for the futures and forward contracts are
also available from the futures and forward exchanges on their Web
sites as well as other financial informational sources. Finally, the
Web site for the Fund and the Manager, which will be publicly
accessible at no charge, will contain the following information: (a)
The prior business day's NAV and the reported closing price; (b)
calculation of the premium or discount of such price against such NAV;
and (c) other applicable quantitative information.
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    \19\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    Furthermore, the Commission believes that the proposal to list and
trade the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately.
The Commission notes that the Exchange will, prior to listing, obtain a
representation from the Fund that the NAV per share will be calculated
daily and made available to all market participants at the same
time.\20\ In addition, the Exchange represents that disclosure of the
portfolio composition of the Fund will be made to all market
participants at the same time.\21\ Moreover, the Exchange notes that
each of the Manager, the Commodity Broker, and the Commodity Sub-
Advisor has represented to the Exchange that it will establish firewall
procedures with respect to personnel who have access to information
concerning changes and adjustments to components of the Fund to prevent
the use and dissemination of material non-public information.\22\
Further, the trading of the Shares is subject to the specialist
prohibitions in Proposed Amex Rule 1603.
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    \20\ See proposed Amex Rule 1602(a)(ii).
    \21\ See Notice, supra note 3, at note 15.
    \22\ See Notice at 54492.
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    The Commission also believes that the Exchange's trading halt rules
are reasonably designed to prevent trading in the Shares when
transparency is impaired. Proposed Amex Rule 1602(b)(ii) provides that
the Exchange will halt trading in the Shares if the circuit breaker
parameters of Amex Rule 117 have been reached. In exercising its
discretion to halt or suspend trading in the Shares, the Exchange may
consider factors such as those set forth in Amex Rule 918C(b) in
addition to other factors that may be relevant. In particular, if the
portfolio holdings and net asset value per share are not being
disseminated as required, the Exchange may halt trading during the day
in which the interruption to the dissemination of the portfolio
holdings or net asset value per share occurs. If the interruption to
the dissemination of the portfolio holdings or net asset value per
share persists past the trading day in which it occurred, the Exchange
will halt trading no later than the beginning of the trading day
following the interruption.
    The Commission further believes that the trading rules and
procedures to which the Shares will be subject pursuant to this
proposal are consistent with the Act. The Exchange has represented that
the Shares are equity securities subject to Amex's rules governing the
trading of equity securities.
    In support of this proposal, the Exchange has made the following
representations:
    (1) The Exchange's surveillance procedures are adequate to properly
monitor the trading of the Shares. Specifically, Amex will rely on its
existing surveillance procedures governing Index Fund Shares. In
addition, Amex has represented that it has information sharing
agreements with the InterContinental Exchange, the Chicago Mercantile
Exchange, and the New York Mercantile Exchange and may obtain market
surveillance information from other exchanges, including the Chicago
Board of Trade, London Metals Exchange, and the New York Board of Trade
through the Intermarket Surveillance Group.
    (2) Prior to the commencement of trading, the Exchange will inform
its members and member organizations in an Information Circular
regarding the prospectus or delivery requirements that apply to the
Shares. The Information Circular will also provide guidance with regard
to member firm compliance responsibilities when effecting transactions
in the Shares and highlighting the special risks and characteristics of
the Funds and Shares, as well as applicable Exchange rules. In
addition, the Information Circular will also reference the fact that
there is no regulated source of last sale information regarding
physical commodities and note the respective jurisdictions of the SEC
and CFTC .
    This approval order is based on the Exchange's representations.
    Finally, the Commission believes that the daily disclosure
requirements relating to the Fund's holdings and NAV are appropriate.
Specifically, the Commission believes that daily disclosure of the
Fund's NAV per share should aid investors in determining the degree to
which the Shares are tracking the Fund's NAV per share. The Commission
believes that the same is true for daily disclosure of the holdings of
the Fund as such disclosure provides additional transparency. In
addition, the Commission notes that the Exchange did not file an
amendment seeking to change this disclosure requirement. Accordingly,
the Commission does not believe that the commenter's assertions form a
basis either to disapprove or to delay approval of the Exchange's
proposed rule change and listing of the Fund.

V. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\23\ that the proposed rule change (SR-Amex-2006-96), as modified,
be, and it hereby is, approved.
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    \23\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-23747 Filed 12-6-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46641-46646]
[FR Doc No: 2020-16852]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1136, FDA-2020-D-1137, FDA-
2020-D-1138, FDA-2020-D-1139, and FDA-2020-D-1140]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidance documents have been implemented without prior comment, but
they remain subject to comment in accordance with the Agency's good
guidance practices.

DATES: The announcement of the guidances is published in the Federal
Register on August 3, 2020. The guidance documents have been
implemented without prior comment, but they remain subject to comment
in accordance with the Agency's good guidance practices.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management

Staff, FDA will post your comment, as well as any attachments, except
for information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of these
guidances to the address noted in table 1. Send two self-addressed
adhesive labels to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; Kimberly Thomas, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6220, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Erica Takai,
Center for Devices and Radiological Health (CDRH), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, HFZ-450,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Phil Chao, Center for Food
Safety and Applied Nutrition (CFSAN), CPK1 Rm 1C001, HFS-024, Food and
Drug Administration, College Park, MD 20740,<PHONE_NUMBER>; Diane Heinz,
Center for Veterinary Medicine (CVM), Food and Drug Administration,
MPN2 RME435 HFV-6, 7500 Standish Pl., Rockville, MD 20855, 240-402-
5692.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services, pursuant to the
authority under section 319 of the Public Health Service Act (PHS Act),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, President Donald J. Trump declared
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020; on July 23, 2020, it was extended again,
effective July 25, 2020. These PHE Determinations are available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (85 FR 16949, the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidance documents related to the COVID-19 PHE. These
procedures, which operate within FDA's established good guidance
practices regulations, are intended to allow FDA to rapidly disseminate
Agency recommendations and policies related to COVID-19 to industry,
FDA staff, and other stakeholders. The March 25, 2020, notice stated
that due to the need to act quickly and efficiently to respond to the
COVID-19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related guidance
documents. Therefore, FDA will issue COVID-19-related guidance
documents for immediate implementation without prior public comment
(see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec.
10.115(g)(2))). The guidances are available at FDA's web page titled
``COVID-19-Related Guidance Documents for Industry, FDA Staff, and
Other Stakeholders'' (https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page titled
``Search for FDA Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidance
documents that FDA issued during the relevant period, as included in
Table 1. This notice announces COVID-19-related guidances that are
posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidance documents:

                        Table 1--Guidance Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
            Docket No.                      Center              Title of guidance        request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1106...................  CDER.................  Temporary Policy for<EMAIL_ADDRESS>                                                            Preparation of Certain      Please include the
                                                            Alcohol-Based Hand          docket number FDA-2020-D-
                                                            Sanitizer Products During   1106 and complete title
                                                            the Public Health           of the guidance in the
                                                            Emergency (COVID-19)        request.
                                                            (March 2020) (Updated
                                                            June 1, 2020).
FDA-2020-D-1106...................  CDER.................  Policy for Temporary<EMAIL_ADDRESS>                                                            Compounding of Certain      Please include the
                                                            Alcohol-Based Hand          docket number FDA-2020-D-
                                                            Sanitizer Products During   1106 and complete title
                                                            the Public Health           of the guidance in the
                                                            Emergency (March 2020)      request.
                                                            (Updated June 1, 2020).
FDA-2020-D-1106...................  CDER.................  Temporary Policy for<EMAIL_ADDRESS>                                                            Manufacture of Alcohol      Please include the
                                                            for Incorporation Into      docket number FDA-2020-D-
                                                            Alcohol-Based Hand          1106 and complete title
                                                            Sanitizer Products During   of the guidance in the
                                                            the Public Health           request.
                                                            Emergency (COVID-19)
                                                            (March 2020) (Updated
                                                            June 1, 2020).
FDA-2020-D-1136...................  CDER.................  Temporary Policy on<EMAIL_ADDRESS>                                                            Prescription Drug           Please include the
                                                            Marketing Act               docket number FDA-2020-D-
                                                            Requirements for            1136 and complete title
                                                            Distribution of Drug        of the guidance in the
                                                            Samples During the COVID-   request.
                                                            19 Public Health
                                                            Emergency (June 8, 2020).
FDA-2020-D-1136...................  CDER.................  Statistical Considerations<EMAIL_ADDRESS>                                    CBER, CDRH, CVM......   for Clinical Trials         Please include the
                                                            During the COVID-19         docket number FDA-2020-D-
                                                            Public Health Emergency     1136 and complete title
                                                            Guidance for Industry       of the guidance in the
                                                            (June 2020).                request.
FDA-2020-D-1136...................  CDER, CVM, CBER......  Good Manufacturing<EMAIL_ADDRESS>                                                            Practice Considerations     Please include the
                                                            for Responding to COVID-    docket number FDA-2020-D-
                                                            19 Infection in Employees   1136 and complete title
                                                            in Drug and Biological      of the guidance in the
                                                            Products Manufacturing      request.
                                                            (June 2020).
FDA-2020-D-1137...................  CBER.................  Development and Licensure   Office of Communication,
                                                            of Vaccines to Prevent      Outreach and
                                                            COVID-19 (June 2020).       Development, 10903 New
                                                                                Hampshire Ave., Bldg.
                                                                                71, Rm. 3128, Silver
                                                                                Spring, MD 20993-0002.
                                                                                Phone 1-800-835-4709 or
<PHONE_NUMBER>, email
<EMAIL_ADDRESS>FDA-2020-D-1138...................  CDRH.................  Enforcement Policy for Non- CDRH-
                                                            Invasive Remote             [email protected]
                                                            Monitoring Devices Used     Please include the
                                                            to Support Patient          document number 20014
                                                            Monitoring During the       and complete title of
                                                            Coronavirus Disease 2019    the guidance in the
                                                            (COVID-19) Public Health    request.
                                                            Emergency (Revised)
                                                            (March 20, 2020) (Updated
                                                            June 5, 2020).
FDA-2020-D-1138...................  CDRH.................  Notifying CDRH of a         CDRH-
                                                            Permanent Discontinuance    [email protected]
                                                            or Interruption in          Please include the
                                                            Manufacturing of a Device   document number 20032
                                                            Under Section 506J of the   and complete title of
                                                            FD&C Act During the COVID-  the guidance in the
                                                            19 Public Health            request.
                                                            Emergency (May 6, 2020)
                                                            (Updated June 19, 2020).
FDA-2020-D-1138...................  CDRH, CBER...........  Effects of the COVID-19     CDRH-
                                                            Public Health Emergency     [email protected]
                                                            on Formal Meetings and      Please include the
                                                            User Fee Applications for   document number 20040
                                                            Medical Devices--           and complete title of
                                                            Questions and Answers       the guidance in the
                                                            (June 2020).                request.
FDA-2020-D-1139...................  CFSAN................  Reporting a Temporary       INFOCenter-
                                                            Closure or Significantly    [email protected]
                                                            Reduced Production by a     Please include the
                                                            Human Food Establishment    docket number, FDA-2020-
                                                            and Requesting FDA          D-1139, and complete
                                                            Assistance During the       title of the guidance in
                                                            COVID-19 Public Health      the request.
                                                            Emergency (May 27, 2020).
----------------------------------------------------------------------------------------------------------------

    Although these guidance documents have been implemented immediately
without prior comment, FDA will consider all comments received and
revise the guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CDER Guidances

    The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521).
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

                                     Table 2--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                 Another guidance
      COVID-19 guidance title         CFR cite referenced     referenced in COVID-19       OMB Control No(s).
                                      in COVID-19 guidance           guidance
----------------------------------------------------------------------------------------------------------------
Good Manufacturing Practice          21 CFR 211, 211.22,    (1) ICH Q7 Good             0910-0130
 Considerations for Responding to     211.28(d), 211.100.    Manufacturing Practice     0910-0139
 COVID-19 Infections in Employees    21 CFR 212.20,          Guidance for Active        0910-0667
 in Drug and Biological Products      212.30, 212.50,        Pharmaceutical             0910-0675
 Manufacturing--June 2020.            212.70, 212.71.        Ingredients.               0910-0759
                                     21 CFR 600.10(c)(1)..  (2) ICH Q5A Viral Safety    0910-0032
                                                             Evaluation of              0910-0669
                                                             biotechnology Products
                                                             Derived From Cell Lines
                                                             of Human or Animal Origin.
                                                            (3) ICH Q9 Quality Risk
                                                             Management.
                                                            (4) Planning for the
                                                             Effects of High
                                                             Absenteeism to Ensure
                                                             Availability of Medically
                                                             Necessary Drug Products.
                                                            (5) Enforcement Policy for
                                                             Sterilizers, disinfectant
                                                             Devices, and Air
                                                             Purifiers During the
                                                             Coronavirus Disease 2019
                                                             (COVID-19) Public Health
                                                             Emergency..
                                                            (6) Temporary Policy
                                                             Regarding Non-Standard
                                                             PPE Practices for Sterile
                                                             Compounding by Pharmacy
                                                             Compounders not
                                                             Registered as Outsourcing
                                                             Facilities During the
                                                             COVID-19 Public Health
                                                             Emergency..
                                                            (7) GFI #271 Reporting and
                                                             Mitigating Animal Drug
                                                             Shortages during the
                                                             COVID-19 Public Health
                                                             Emergency..
Temporary Policy on Prescription     21 CFR 203...........  ..........................  0910-0435
 Drug Marketing Act Requirements
 for Distribution of Drug Samples
 during the COVID-19 Public Health
 Emergency--Guidance for Industry.
Temporary Policy for Preparation of  27 CFR Part 20 and 21  (1) Temporary Compounding   0910-0045
 Certain Alcohol-Based Hand                                  of Certain Alcohol-Based   0910-0139
 Sanitizer Products During the                               Hand Sanitizer Products    0910-0230
 Public Health Emergency (COVID-                             During the Public Health   0910-0291
 19)--UPDATE of guidance announced                           Emergency (COVID-19).      0910-0340
 in March 2020.                                             (2) Temporary Policy for    0910-0641
                                                             Manufacture of Alcohol     0910-0645
                                                             for Incorporation Into     0910-0800
                                                             Alcohol-Based Hand
                                                             Sanitizer Products During
                                                             the Public Health
                                                             Emergency (COVID-19).
                                                            (3) Adverse Event
                                                             Reporting Requirements.
Temporary Policy for Manufacture of  27 CFR Part 20 and 21  None......................  0910-0045
 Alcohol for Incorporation Into                                                         0910-0139
 Alcohol-Based Hand Sanitizer                                                           0910-0230
 Products During the Public Health                                                      0910-0291
 Emergency (COVID-19)--UPDATE of                                                        0910-0340
 guidance announced in March 2020.                                                      0910-0641
                                                                                0910-0645
                                                                                0910-0800
Policy for Temporary Compounding of  .....................  (1) Temporary Policy for    0910-0045
 Certain Alcohol-Based Hand                                  Preparation of Certain     0910-0139
 Sanitizer Products During the                               Alcohol-Based Hand         0910-0230
 Public Health Emergency                                     Sanitizer Products During  0910-0291
 Immediately in Effect Guidance for                          the Public Health          0910-0340
 Industry--UPDATE of guidance                                Emergency (COVID-19).      0910-0641
 announced in March 2020.                                   (2) Temporary Policy for    0910-0645
                                                             Manufacture of Alcohol     0910-0800
                                                             for Incorporation into
                                                             Alcohol-Based Hand
                                                             Sanitizer Products During
                                                             the Public Health
                                                             Emergency (COVID-19).
----------------------------------------------------------------------------------------------------------------

    The guidance, Statistical Considerations for Clinical Trials during
the COVID-19 Public Health Emergency, contains no collection of
information. Therefore, clearance by OMB under the PRA is not required.

B. CBER Guidances

    The guidance listed in the table below refer to previously approved
collection of information. This collection of information is subject to
review by the OMB under the PRA. The collection of information in the
following FDA regulations and guidance have been approved by OMB as
listed in the following table:

                                     Table 3--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                               Another guidance title
       COVID-19 guidance title        CFR cite referenced  in   referenced  in COVID-      OMB Control No(s).
                                         COVID-19 guidance           19 guidance
----------------------------------------------------------------------------------------------------------------
Development and Licensure of          21 CFR part 312........  ......................  0910-0114
 Vaccines to Prevent COVID-19.        21 CFR part 58.........  ......................  0910-0119
                                      21 CFR part 50.........  ......................  0910-0130
                                      21 CFR parts 210, 211,   ......................  0910-0139
                                       and 610.
                                      221 CFR part 600.......  ......................  0910-0308
                                      221 CFR part 601.......  ......................  0910-0338
                                                               --Form FDA 3500A......  0910-0291
                                                               --Establishment and     0910-0581
                                                                Operation of Clinical  0910-0595
                                                                Trial Data Monitoring
                                                                Committees.
                                                               --Emergency Use
                                                                Authorization of
                                                                Medical Products and
                                                                Related Authorities.
----------------------------------------------------------------------------------------------------------------

C. CDRH Guidances

    The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the following table:

                                     Table 4--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                               Another guidance title
       COVID-19 guidance title        CFR cite referenced  in   referenced  in COVID-      OMB Control No(s).
                                         COVID-19 guidance           19 guidance
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Non-Invasive   807, subpart E.........  ......................  0910-0120
 Remote Monitoring Devices Used to    800, 801, and 809......  ......................  0910-0485
 Support Patient Monitoring During
 the Coronavirus Disease 2019 (COVID-
 19) Public Health Emergency
 (Revised) (March 20, 2020) (Updated
 June 5, 2020).
Effects of the COVID-19 Public        .......................  Requests for Feedback   0910-0756
 Health Emergency on Formal Meetings                            and Meetings for
 and User Fee Applications for                                  Medical Device
 Medical Devices--Questions and                                 Submissions: The Q-
 Answers (June 22, 2020).                                       Submission Program:
                                                                Guidance for Industry
                                                                and Food and Drug
                                                                Administration Staff.
                                                               Emergency Use           0910-0595
                                                                Authorization of
                                                                Medical Products and
                                                                Related Authorities;
                                                                Guidance for Industry
                                                                and Other
                                                                Stakeholders.
                                      814, subparts A through  ......................  0910-0231
                                       E.
                                      807, subpart E.........  ......................  0910-0120
                                                               De Novo Classification  0910-0844
                                                                Process (Evaluation
                                                                of Automatic Class
                                                                III Designation):
                                                                Guidance for Industry
                                                                and Food and Drug
                                                                Administration Staff.
                                      814, subpart H.........  ......................  0910-0332
                                      812....................  ......................  0910-0078
----------------------------------------------------------------------------------------------------------------

    The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table. This guidance also contains a
new collection of information not approved under a current collection.
This new collection of information has been granted a PHE waiver from
the PRA by the Department of Health and Human Services (HHS) on March
19, 2020, under section 319(f) of the PHS Act. Information concerning
the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 5--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                      CFR cite        Another guidance                           New collection
    COVID-19 guidance title        referenced  in      referenced  in     OMB Control No(s).    covered by  PHE
                                  COVID-19 guidance   COVID-19 guidance                            PRA waiver
----------------------------------------------------------------------------------------------------------------
Notifying CDRH of Permanent      807, subparts A                         0910-0625
 Discontinuance or Interruption   through D.         Emergency Use       0910-0595
 in Manufacturing of a Device                         Authorization of
 Under Section 506J of the FD&C                       Medical Products
 Act During the COVID-19 Public                       and Related
 Health Emergency (Revised)                           Authorities;
 (May 6, 2020) (Updated June                          Guidance for
 19, 2020).                                           Industry and
                                                      Other
                                                      Stakeholders.
                                                                                Notifications to
                                                                                FDA about
                                                                                changes in the
                                                                                production of
                                                                                certain medical
                                                                                device products
                                                                                that will help
                                                                                the Agency
                                                                                prevent or
                                                                                mitigate
                                                                                shortages of
                                                                                such devices
                                                                                during the COVID-
                                                                                19 public health
                                                                                emergency.
                                                                                Updates to FDA
                                                                                every two weeks
                                                                                after initial
                                                                                notification on
                                                                                the shortage
                                                                                situation,
                                                                                including the
                                                                                expected
                                                                                timeline for
                                                                                recovery.
                                                                                Voluntary
                                                                                submission of
                                                                                other
                                                                                information that
                                                                                enables FDA to
                                                                                work more
                                                                                effectively with
                                                                                manufacturers
                                                                                and other
                                                                                entities to
                                                                                prevent or limit
                                                                                any negative
                                                                                impact on
                                                                                patients or
                                                                                healthcare
                                                                                providers during
                                                                                the COVID-19
                                                                                public health
                                                                                emergency.
----------------------------------------------------------------------------------------------------------------

D. CFSAN Guidances

    The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table. This guidance also contains a
new collection of information not approved under a current collection.
This new collection of information has been granted a PHE waiver from
the PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act.
Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                    Table 6--CFSAN Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                      CFR cite        Another guidance                           New Collection
    COVID-19 guidance title        referenced  in       referenced in     OMB Control No(s).    covered by  PHE
                                  COVID-19 guidance   COVID-19 guidance                            PRA waiver
----------------------------------------------------------------------------------------------------------------
Reporting a Temporary Closure    21 CFR part 1,      ..................  0910-0502             Establishments
 or Significantly Reduced         subpart H.                                                    have the option
 Production by a Human Food                                                                     to report to FDA
 Establishment and Requesting                                                                   temporary
 FDA Assistance During the                                                                      closures or
 COVID-19 Public Health                                                                         significant
 Emergency.                                                                                reductions of
                                                                                production and
                                                                                to request
                                                                                assistance from
                                                                                FDA.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     The FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     the FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16852 Filed 7-31-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Notices]
[Pages 44707-44708]
[FR Doc No: 2021-17316]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2008-0707; FRL-8866-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Data Reporting Requirements for State and
Local Vehicle Emission Inspection and Maintenance (I/M) Programs
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Data Reporting Requirements for
State and Local Vehicle Emission Inspection and Maintenance (I/M)
Programs (EPA ICR Number 1613.07, OMB Control Number 2060-0252) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through October 31,
2021. Public comments were previously requested via the Federal
Register on March 1, 2021, which included a 60-day comment period
ending on April 30, 2021. This notice allows for an additional 30 days
for public comments. A fuller description of the ICR is given below,
including its estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before September 13,
2021.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2008-0707, online using www.regulations.gov (our preferred method),
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's
policy is that all comments received will be included in the public
docket without change including any personal information provided,
unless the comment includes profanity, threats, information claimed to
be Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.
    Out of an abundance of caution for members of the public and our
staff, the EPA Docket Center and Reading Room has remained closed to
public visitors since March 31, 2020, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone, and webform. We encourage the
public to submit comments via https://www.regulations.gov, as there is
a temporary suspension of mail delivery to EPA, and no hand deliveries
are currently accepted. For further information on EPA Docket Center
services and the current status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Joe Winkelmann, Office of
Transportation and Air Quality, U.S. Environmental Protection Agency,
2000 Traverwood, Ann Arbor, Michigan 48105; telephone number: 734-214-
4255; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov. For further information and updates on EPA Docket
Center services, please visit us online at https://www.epa.gov/dockets.
    Abstract: Clean Air Act section 182 and EPA's regulations (40 CFR
part 51, subpart S) establish the requirements for state and local I/M
programs that are included in state implementation plans (SIPs). To
provide general oversight and support to these programs, EPA requires
that state agencies with basic and enhanced I/M programs collect two
varieties of reports for submission to the Agency:
     An annual report providing general program operating data
and summary statistics, addressing the program's current design and
coverage, a summary of testing data, enforcement program efforts,
quality assurance and quality control efforts, and other miscellaneous
information allowing for an assessment of the program's relative
effectiveness; and
     A biennial report on any changes to the program over the
two-year period and the impact of such changes, including any
deficiencies discovered and corrections made or planned.
    General program effectiveness is determined by the degree to which
a program misses, meets, or exceeds the

emission reductions committed to in the state's approved SIP, which, in
turn, must meet or exceed the minimum emission reductions expected from
the relevant performance standard, as promulgated under 40 CFR part 51,
subpart S, in response to requirements established in section 182 of
the Clean Air Act. This information is used by EPA to determine a
program's progress toward meeting requirements under 40 CFR part 51,
subpart S, and to provide background information in support of program
evaluations. Additional information regarding the current renewal of
this ICR as well as previous renewals can be found in Docket ID No.
EPA-HQ-OAR-2008-0707.
    Form Numbers: None.
    Respondents/affected entities: State governments.
    Respondent's obligation to respond: Mandatory (40 CFR 51.366).
    Estimated number of respondents: 26 (total).
    Frequency of response: Annual and biennial.
    Total estimated burden: 2,236 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $148,824 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 172 hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB due to a reduction in the number of respondents covered by the
collection.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-17316 Filed 8-12-21; 8:45 am]
BILLING CODE 6560-50-P


Huntington County Wind Rose Analysis  2002 Wind Speed and Wind Direction on 4 Highest 8 hour Ozone Days Maximum 8 hour ozone concentration of 89 ppb Maximum 8 hour ozone concentration of 90 ppb Maximum 8 hour ozone concentration of 90 ppb Maximum 8 hour Ozone concentration of 90 ppb


[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Page 74783]
[FR Doc No: 2014-29502]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
December 18, 2014 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: December 11, 2014.
Brent J. Fields,
Secretary.
[FR Doc. 2014-29502 Filed 12-12-14; 11:15 am]
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[ Federal Register: October 12, 2004 ( Volume 69, Number 196)] [ Notices] [ Page 60621 60623] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr12oc04 49]

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ENVIRONMENTAL PROTECTION AGENCY [ RCRA 2004 0007; FRL 7826 5 ]

Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Identification, Listing and Rulemaking Petitions ( Renewal), EPA ICR Number 1189.14, OMB Control Number 2050 0053 AGENCY: Environmental Protection Agency.

ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that an Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on November 30, 2004. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its expected burden and cost.

DATES: Additional comments may be submitted on or before November 12, 2004.

ADDRESSES: Submit your comments, referencing docket ID number RCRA 2004 0007, to ( 1) EPA online using EDOCKET ( our preferred method), by email to rcra docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Resource Conservation and Recovery Act ( RCRA) Docket, Mail Code 5305T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Narendra Chaudhari, Office of Solid Waste, Mail Code 5304W, U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 0454; fax number: ( 703) 308 0514; email address: chaudhari. narendra@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 10, 2004 ( 69 FR 32545), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments on this ICR. EPA has established a public docket for this ICR under Docket ID number RCRA 2004 0007, which is available for public viewing at the RCRA Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 ( 202) 566 1744, and the telephone number for the RCRA Docket is ( 202) 566 0270. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the public 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 above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, Confidential Business Information ( CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the [[ Page 60622]]

official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ epadocket.

Title: Identification, Listing and Rulemaking Petitions ( Renewal). Abstract: Under 40 CFR 260.20( b), all rulemaking petitioners must submit basic information with their demonstrations, including name, address, and statement of interest in the proposed action. Under Sec. 260.21, all petitioners for equivalent testing or analytical methods must include specific information in their petitions and demonstrate to the satisfaction of the Administrator that the proposed method is equal to, or superior to, the corresponding method in terms of its sensitivity, accuracy, and reproducibility. Under Sec. 260.22, petitions to amend part 261 to exclude a waste produced at a particular facility ( more simply, to delist a waste) must meet extensive informational requirements. When a petition is submitted, the Agency reviews materials, deliberates, publishes its tentative decision in the Federal Register, and requests public comment. EPA also may hold informal public hearings ( if requested by an interested person or at the discretion of the Administrator) to hear oral comments on its tentative decision. After evaluating all comments, EPA publishes its final decision in the Federal Register. 40 CFR 260.30 260.31, and 260.33 comprise the standards, criteria, and procedures for variances from classification as a solid waste for three types of materials, materials that are collected speculatively without sufficient amounts being recycled; materials that are reclaimed and then reused within the original primary production process in which they were generated; and materials which have been reclaimed, but must be reclaimed further before the materials are completely recovered. Under 40 CFR 260.32 and 260.33 are regulations governing the procedures and criteria for obtaining a variance for classification as a boiler. This variance is available to owners or operators of enclosed flame combustion devices. 40 CFR 261.3 and 261.4 contain provisions that allow generators to obtain a hazardous waste exclusion for certain types of wastes. Facilities applying for these exclusions must submit a notification, or supporting information and/ or keep detailed records. Under Sec. 261.3( a)( 2)( iv), generators may obtain a hazardous waste exclusion for wastewater mixtures subject to Clean Water Act regulation. Under Sec. 261.3( c)( 2)( ii)( C), generators may obtain an exclusion for certain nonwastewater residues resulting from high temperature metals recovery ( HTMR) processing of K061, K062 and F006 waste. Also, under Sec. 261.4( a)( 20)( ii)( A), generators and intermediate handlers may obtain a hazardous waste exclusion for zinc bearing hazardous secondary materials that are to be incorporated into zinc fertilizers. In addition, under Sec. 261.4( b)( 6), generators of chromium containing waste may obtain a hazardous waste exclusion under certain conditions. Also addressed under this section is the shipment of samples between generators and laboratories for the purpose of testing to determine their characteristics or composition. Sample handlers who are not subject to the Department of Transportation ( DOT) or the United States Postal Service ( USPS) shipping requirements must comply with the information requirements of Sec. 261.4( d)( 2). When intended for treatability studies, hazardous waste otherwise subject to regulation under Subtitle C of the Resource Conservation and Recovery Act ( RCRA) is exempted from these regulations, provided that the requirements in Sec. 261.4( e)( f) are met, including the following information requests: initial notification, record keeping, reporting, and final notification. In addition, generators and collectors of treatability study samples also may request quantity limit increases and time extensions, as specified in Sec. 261.4( e)( 3). 40 CFR 261.31( b)( 2)( ii) governs procedures and informational requirements for generators and treatment, storage and disposal facilities to obtain exemptions from listing as F037 and F038 wastes. Also under this section are regulations promulgated in 1990 under Sec. 261.35( b) and ( c) governing procedures and information requirements for the cleaning or replacement of all process equipment that may have come into contact with chlorophenolic formulations or constituents thereof, including, but not limited to, treatment cylinders, sumps, tanks, piping systems, drip pads, fork lifts, and trams. EPA anticipates that some data provided by respondents will be claimed as Confidential Business Information ( CBI). Respondents may make a business confidentiality claim by marking the appropriate data as CBI. Respondents may not withhold information from the Agency because they believe it is confidential. Information so designated will be disclosed by EPA only to the extent set forth in 40 CFR part 2. 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 40 CFR are listed in 40 CFR part 9 and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection varies depending on the type of petition or demonstration. For example, it is estimated that the average reporting burden per respondent ranges from 0.00 hours ( equipment cleaning and replacement) to 788 hours ( preparation of a delisting petition). The average recordkeeping burden per respondent ranges from 63.75 hours ( equipment cleaning and replacement) to 1.75 hours ( delisting petition). 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; 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. Respondents/ Affected Entities: Business. Estimated Number of Respondents: 155. Frequency of Response: Varies. Estimated Total Annual Hour Burden: 21,511 hours. Estimated Total Annualized Cost Burden: $ 2,206,000, includes $ 895,000 annualized capital/ startup or O& M costs. Changes in the Estimates: There is an increase of 701 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due primarily to respondents submitting a greater number of relatively more complex delisting petitions to EPA, which [[ Page 60623]]

require collection of additional information and more time to prepare the petitions. The burden increase is an adjustment to the existing estimates based on data gathered through consultations with EPA Regional Offices and the regulated community and not a result of program changes.

Dated: September 28, 2004. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 04 22872 Filed 10 8 04; 8: 45 am]

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