[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Page 49322]
[FR Doc No: 2019-20283]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4458-DR; Docket ID FEMA-2019-0001]

Louisiana; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Louisiana (FEMA-4458-DR), dated August 27,
2019, and related determinations.

DATES: The declaration was issued August 27, 2019.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 27, 2019, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Louisiana resulting from Hurricane Barry during the period of
July 10 to July 15, 2019, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Louisiana.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, John E. Long, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Louisiana have been designated
as adversely affected by this major disaster:

    Allen, Iberia, Lafourche, Plaquemines, St. Mary, Terrebonne, and
Vermillion Parishes for Public Assistance.
    Ascension, Assumption, East Baton Rouge, East Feliciana,
Iberville, Jefferson, Orleans, St. Charles, St. Helena, St. John the
Baptist, Tangipahoa, and West Feliciana Parishes for debris removal
and emergency protective measures (Categories A and B), including
direct federal assistance.
    All areas within the State of Louisiana are eligible for
assistance under the Hazard Mitigation Grant Program.

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

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-20283 Filed 9-18-19; 8:45 am]
BILLING CODE 9111-23-P


U.S. Department 										55 Broadway
of Transportation										Cambridge, MA 02142

Research and
Innovative Technology
Administration

Volpe National Transportation Systems Center

April 15, 2011
MEMORANDUM

SUBJECT:	Ex parte meeting with Goodyear Rubber and Tire Company
FROM:		Gregory Powell, NHTSA
TO:		Docket No. NHTSA-2010-0079
This memorandum documents a teleconference held on Wednesday, April 15, 2011 between Goodyear Tire and Rubber Company, EPA, and DOT regarding the proposed fuel efficiency and greenhouse gas standards for medium‐and heavy‐duty vehicles and engines for model years 2014‐2018. The attendees included:
Goodyear: Sim Ford, Steve Pressler, Kevin Legg
EPA: Angela Cullen, Cheryl Bynum, Joe Bachman, Sam Waltzer
NHTSA/DOT: Rebecca Yoon, Mary Versailles, Jim Tamm, Maurice Hicks, Gregory Powell, Coralie Cooper

Representatives of the Goodyear Tire and Rubber Company, the Department of Transportation/NHTSA and the Environmental Protection Agency met at the request of the Department of Transportation/NHTSA to discuss Medium and Heavy Duty Tire rolling resistance for vocational vehicles.
Clarifications were sought regarding the capabilities, needs and levels of rolling resistance for vocational vehicles. In addition, the discussion provided additional insight to the process customer/supplier relationship for specifying tire technology in this market segment.


[Federal Register: September 24, 2007 (Volume 72, Number 184)]
[Notices]
[Page 54306-54308]
[DOCID:fr24se07-78]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56449; File No. SR-CBOE-2007-52]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change as Modified by
Amendment No. 1 Thereto Relating to $1 Strikes for VXD and VXN Options
and $1 Strikes for RVX, VIX, VXD and VXN LEAPs

September 17, 2007.
    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 11, 2007, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. On August 20, 2007, CBOE filed Amendment No. 1 to the
proposed rule change. The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes rules that would permit the Exchange to: (i) List and
trade CBOE Dow Jones Industrial Average Volatility Index (``VXD'')
options and Nasdaq-100 Volatility Index (``VXN'') options in $1 strike
price intervals; and (ii) list and trade CBOE Russell 2000 Volatility
Index (``RVX''), VXD, VXN and CBOE Volatility Index (``VIX'') LEAPs in
$1 strike price intervals. The text of the rule proposal is available
on the Exchange's Web site (http://www.cboe.org/legal), at the

Exchange's Office of the Secretary and at the Commission.

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

    In its filing with the Commission, CBOE 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. CBOE has prepared summaries, set forth in Sections A, B,
and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to permit the Exchange
to list and trade options on the CBOE Dow Jones Industrial Average
Volatility Index (``VXD'') and the Nasdaq-100 Volatility Index
(``VXN'') in $1 strike price intervals within certain parameters
described below.\3\ Additionally, the rule change proposes to permit
the Exchange to list and trade CBOE Russell Volatility Index (``RVX''),
CBOE Volatility Index (``VIX''), VXD, and VXN LEAPs in $1 strike price
intervals within certain parameters also described below.
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    \3\ The SEC previously approved the listing and trading of VXD
and VXN options, which the Exchange anticipates trading shortly. See
Securities Exchange Act Release No. 49563 (April 14, 2004), 69 FR
21589 (April 21, 2004) (approving SR-CBOE-2003-40).
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$1 Strikes for VXD and VXN Options

    Similar to other volatility indexes, VXD and VXN are calculated
using real-

time quotes of out-of-the-money and at-the-money and second nearly
index puts and calls on the Dow Jones Industrial Index (``DJIA'') and
the Nasdaq-100 Index (``NDX'') respectively. VXD and VXN are quoted in
absolute numbers that represent the volatility of the DJIA and the NDX
respectively in percentage points per annum. For example, a VXD level
of 11.63 (the closing value of the VXD on April 26, 2007) represents an
annualized volatility of 11.637% in the DJIA Index and a VXN level of
15.97 (the closing value of the VXN on April 26, 2007) represents an
annualized volatility of 15.77% in the NDX.
    As with other proprietary CBOE volatility indexes, VXD and VXN
levels fluctuate quite differently than individual equity securities or
indexes of individual equity securities. Specifically, indexes such as
VXD and VXN that track volatility are ``mean-reverting,'' a statistical
term used to describe a strong tendency for the volatility index to
move toward its long-term historical average level. In other words, at
historically low volatility index levels, there is a higher probability
that the next big move will be up rather than down. Conversely, at
historically high volatility index levels, the next big move is more
likely to be down rather than up.
    Thus, as exemplified by VXD and VXN, volatility indexes tend to
move within set ranges, and even when a level moves outside that range,
the tendency towards mean-reversion often results in the volatility
index returning to a level within the range. In the case of VXD, the
historical average index value since January 2, 2002 is 16.92. Since
January 2002, VXD has fluctuated in a range between 9.28 and 41.85.
Furthermore, VXD closed under 25 for 85% of the days on which the level
was calculated since 2002 (1,171 days out of a total of 1,372 days) and
has closed under 30 for 91% of the days on which the level was
calculated since 2002 (1,245 days out of a total of 1,372 days). VXD
has closed between 10 and 25 for 82% of the days on which the level was
calculated since 2002 (1,130 days out of a total of 1,372 days).
    In the case of VXN, the historical average index value since
January 2, 2002 is 26.14. Since January 2002, VXN has fluctuated in a
range between 12.61 and 60.66. Furthermore, VXN closed under 25 for 61%
of the days on which the level was calculated since 2002 (822 days out
of a total of 1,355 days) and has closed under 30 for 73% of the days
on which the level was calculated since 2002 (987 days out of a total
of 1,355 days). VXN has closed between 15 and 30 for 66% of the days on
which the level was calculated since 2002 (895 days out of a total of
1,355 days).
    Because of the generally limited range in which VXD and VXN have
fluctuated, the Exchange believes that investors will be better served
if the Exchange is able to list $1 strike price intervals in VXD and
VXN option series. To address this, the Exchange is proposing to list
series at $1 or greater strike price intervals for each expiration on
up to 5 VXD and VXN option series above and 5 VXD and VXN option series
below the current index level.\4\ Additional series at $1.00 or greater
strike price internals could be listed for each expiration as the
current index levels of VXD and VXD, respectively, move from the
exercise price of the VXD and VXN options series that already have been
opened for trading on the Exchange in order to maintain at least 5 VXD
and VXD option series above and 5 VXD and VXN option series below the
current index levels respectively. As the current index level of RVX,
VIX, VXD and VXN moves from the exercise price of those RVX, VIX, VXD
and VXN options and LEAPs series that already have been opened for
trading on the Exchange, the Exchange may open for trading additional
series at $1.00 or greater strike price intervals for each expiration
on up to 5 RVX, VIX, VXD and VXN option and LEAPs series above and 5
RVX, VIX, VXD and VXN option and LEAPs series below the current index
level.
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    \4\ The Commission previously approved the listing of VIX and
RVX options at $1 strike intervals. See Securities Exchange Act
Release No. 54192 (July 21, 2006), 71 FR 43251 (July 31, 2006)
(approving SR-CBOE-2006-27); see also Securities Exchange Act
Release No. 55425 (March 8, 2007), 72 FR 12238 (March 15, 2007)
(approving SR-CBOE-2006-73).
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    For purposes of adding strike prices at $1.00 or greater strike
price intervals, as well as at $2.50 or greater strike price intervals,
the ``current index level'' would be defined as the ``implied forward
level'' of VXN and VXD for each expiration.\5\ The Exchange believes
that the $1 strike price intervals will more closely bracket the levels
of VXN and VXD when it remains locked within a static range, as
currently exists, and will enable investors to assume more dynamic
volatility index option positions that reflect greater possibilities of
settling in-the-month.
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    \5\ With respect to $2.50 or greater strikes, the $2.50 or
greater strike price intervals will be reasonably related to the
current index value of VXN and VXD at or about the time such series
are first opened for trading. The term ``reasonably related to the
current index value of the underlying index'' means that the
exercise price is within 30% of the current index value. The
Exchange may also open additional $2.50 or greater strike price
series that are more than 30% away from the current index value,
provided that demonstrated customer interest exists for such series,
as expressed by institutional, corporate, or individual customers or
their brokers. See Interpretations and Policies .01(d) and .04 of
Rule 24.9.
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    The Exchange intends to determine implied forward levels of VXN and
VXD through the use of VXN and VXD futures prices respectively. Its
reasons for using this approach are explained below.
    By way of background, option prices reflect the market's
expectation of the price of the underlying at expiration, which is
referred to as the ``forward'' level. For stock indexes such as the
DJIA and the NDX, the best estimate of the forward level is the
current, or ``spot,'' price adjusted for the ``carry,'' which is the
financing cost of owning the component stocks in the index less the
dividends paid by those stocks. For volatility indexes such as VXD and
VXN, a better estimate than the standard ``cash and carry'' model for
calculating the forward levels of VXN and VXD at each expiration is
reflected in the prices of the options that will be used to calculate
VXN and VXD on that expiration day. For example, December 2007 DJIA
options will be used to calculate VXD on the November 2007 VXD
expiration date. Likewise, February 2008 VXN options are tied to the
implied volatility of March 2008 NDX options, and so on.
    One important property of implied volatility is that it exhibits a
``term structure.'' In other words, the implied volatility of options
expiring on different dates can trade at different levels and can move
independently. Another property related to the term structure is that
implied volatility tends to trend toward the market's expectation of a
long-term ``average'' value. As a result, a large spike in one-month
implied volatility might not affect implied volatility of longer-dated
options very much at all.
    The Exchange states that the VXD futures contract and the VXN
futures contract were first listed for trading on CBOE Futures
Exchange, LLC (``CFE'') on March 26, 2004 and July 6, 2007,
respectively.\6\ The Exchange believes that traders will likely use VXD
and VXN futures prices as a proxy for forward VXD and VXN levels. CBOE
believes that using these prices is an accurate and transparent method
for determining the ``current index level'' used to center the limited
range in which $1 or greater strikes in VXD and

VXN options will be listed and the broader range in which $2.50 or
greater strikes in VXD and VXN options will be listed.
---------------------------------------------------------------------------

    \6\ The VIX futures contract was first listed for trading on CFE
on March 26, 2004 and the RVX futures contract was first listed for
trading on CFE on July 6, 2007.
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    Additionally, the Exchange is proposing that it would not list
series with $1 intervals within $0.50 of an existing $2.50 strike price
with the same expiration month (e.g., if there is an existing 12.50
strike, the Exchange would not list a 12 or 13 strike).

$1 Strike LEAPs for RVX, VIX, VXN and VXD.

    Similar to the rationale advanced for $1 strikes for options, the
Exchange is proposing rules to permit $1 strike intervals for RVX, VIX,
VXD and VXN LEAPs. Typically, LEAPs strike prices moves in increments
of $2.50 and $5.00 and such incremental pricing is suited for long-term
contracts on traditional equity and stock index products. However, as
discussed above, the levels of volatility indexes fluctuate quite
differently than equities and stock indexes. As a ``mean-reverting''
product, volatility indexes gravitate towards their historical average
levels; thus, limiting the range of movement.
    As with volatility index options, the Exchange is proposing to list
series at $1 or greater strike price intervals for each expiration on
up to 5 RVX, VIX, VXD and VXN LEAPs series above and 5 RVX, VIX, VXD
and VXN LEAPs series below the current index level. As the current
index level of RVX, VIX, VXD and VXN moves from the exercise price of
those RVX, VIX, VXD and VXN options and LEAPs series that already have
been opened for trading on the Exchange, the Exchange may open for
trading additional series at $1.00 or greater strike price intervals
for each expiration on up to 5 RVX, VIX, VXD and VXN option and LEAPs
series above and 5 RVX, VIX, VXD and VXN option and LEAPs series below
the current index level. For purposes of adding strike prices at $1.00
or greater strike price intervals, as well as at $2.50 or greater
strike price intervals, the ``current index level'' would be defined as
the ``implied forward level'' of RVX, VIX, VXN and VXD for each
expiration.

Capacity

    CBOE has analyzed its capacity and represents that it believes the
Exchange and the Options Price Reporting Authority have the necessary
systems capacity to handle the additional traffic associated with the
listing and trading of the $1 strikes for VXD and VXN option and of the
$1 strikes for RVX, VIX, VXD and VXN LEAPs.
2. Statutory Basis
    The Exchange believes this rule proposal is consistent with the Act
and the rules and regulations under the Act applicable to a national
securities exchange and, in particular, the requirements of Section
6(b) of the Act.\7\ Specifically, the Exchange believes that the
proposed rule change is consistent with the Section 6(b)(5) Act \8\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and, in general, to protect investors and the public
interest.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
purposes of the Act.
C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others
    The Exchange neither solicited nor received comments on the
proposal.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-52 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-CBOE-2007-52. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
am and 3 pm. Copies of such filing also will be available for
inspection and copying at the principal office of CBOE. 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-CBOE-2007-52 and should
be submitted on or before October 15, 2007..

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-18729 Filed 9-21-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68500-68502]
[FR Doc No: 2021-26182]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0280]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Financial Disclosure by Clinical Investigators

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on ``Financial Disclosure by
Clinical Investigators.''

DATES: Submit either electronic or written comments on the collection
of information by January 31, 2022.

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 January 31, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 31, 2022. 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-2012-N-0280 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Financial Disclosure by Clinical
Investigators.'' 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on

respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.

Financial Disclosure by Clinical Investigators

OMB Control Number 0910-0396--Extension

    Respondents to this collection are sponsors of marketing
applications that contain clinical data from studies covered by the
regulations. These sponsors represent pharmaceutical, biologic, and
medical device firms. Respondents are also clinical investigators who
provide financial information to the sponsors of marketing
applications.
    Table 1 shows information that is the basis of the estimated number
of respondents in tables 2 through 4.

 Table 1--Estimated Number of Applications, Clinical Trials, and Investigators Subject to the Regulation by Type
                                               of Application \1\
----------------------------------------------------------------------------------------------------------------
                                   Total number      Number of
        Application type                of         applications      Number of trials            Number of
                                   applications      affected                                  investigators
----------------------------------------------------------------------------------------------------------------
Drugs:
    New drug application (NDA),               55              55  3 to 10...............  3 to 100
     new molecular entity (NME).
    NDA non-NME.................              78              37  3 to 10...............  3 to 100
    NDA efficacy supplement.....             196             119  1 to 3................  10 to 30
    Abbreviated new drug                     821               1  1.1...................  2
     application (ANDA).
    ANDA supplement.............          10,894               1  1.....................  2
CBER Biologics:
    Biologics license                         10              10  3 to 10...............  3 to 100
     application (BLA).
    BLA efficacy supplement.....              30              30  1 to 3................  10 to 30
CDER Biologics:
    BLAs........................              25              25  3 to 10...............  3 to 100
    BLA efficacy supplements....             102              65  1 to 3................  10 to 30
Medical Devices:
    Premarket approval (PMA)....              39              39  1 to 31...............  10 to 20
    PMA supplement..............              29              29  to 3..................  3 to 10
    Reclassification devices....               0               0  0.....................  0
    510(k)......................           3,947             247  1.....................  3 to 10
    De Novo requests............              63              57  1 to 3................  10 to 20
----------------------------------------------------------------------------------------------------------------
Source: Agency estimates.

    FDA estimates the burden of this collection of information as
follows:

Reporting Burden

    Under Sec.  54.4(a) (21 CFR 54.4(a)), applicants submitting an
application that relies on clinical studies must submit a complete list
of clinical investigators who participated in a covered clinical study,
and must either certify to the absence of certain financial
arrangements with clinical investigators (Form FDA 3454) or, under
Sec.  54.4(a)(3), disclose to FDA the nature of those arrangements and
the steps taken by the applicant or sponsor to minimize the potential
for bias (Form FDA 3455).
    FDA estimates that almost all applicants submit a certification
statement under Sec.  54.4(a)(1) and (2). Preparation of the statement
using Form FDA 3454 should require no more than 1 hour per study. The
number of respondents is based on the estimated number of affected
applications.
    When certification is not possible and disclosure is made using
Form FDA 3455, the applicant must describe, under Sec.  54.4(a)(3), the
financial arrangements or interests and the steps that were taken to
minimize the potential for bias in the affected study. As the applicant
would be fully aware of those arrangements and the steps taken to
address them, describing them will be straightforward. The Agency
estimates that it will take about 5 hours to prepare this narrative.
Based on our experience with this collection, FDA estimates that
approximately 10 percent of the respondents with affected applications
will submit disclosure statements.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Certification--54.4(a)(1) and                715               1             715               1             715
 (2)--Form FDA 3454.............
Disclosure--54.4(a)(3)--Form FDA              72               1              72               5             360
 3455...........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Recordkeeping Burden

    Under Sec.  54.6 (21 CFR 54.6), the sponsors of covered studies
must maintain complete records of compensation agreements with any
compensation paid to nonemployee clinical investigators, including
information showing any financial interests held by the clinical
investigator, for 2 years after the date of approval of the
applications. Sponsors of covered studies maintain many

records regarding clinical investigators, including protocol agreements
and investigator resumes or curriculum vitae. FDA estimates than an
average of 15 minutes will be required for each recordkeeper to add
this record to the clinical investigators' file.

                                                   Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                           21 CFR section                               Number of       records per      Total annual         per        Total hours \2\
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6................................................             715                1              715             0.25              179
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

Third-Party Disclosure Burden

    Under Sec.  54.4(b), clinical investigators supply to the sponsor
of a covered study financial information sufficient to allow the
sponsor to submit complete and accurate certification or disclosure
statements. Clinical investigators are accustomed to supplying such
information when applying for research grants. Also, most people know
the financial holdings of their immediate family and records of such
interests are generally accessible because they are needed for
preparing tax records. For these reasons, FDA estimates that the time
required for this task may range from 5 to 15 minutes; we used the
median, 10 minutes, for the average burden per disclosure (see table
1).

                                               Table 4--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                          21 CFR section                               Number of      disclosures per    Total annual    Average burden  Total hours \2\
                                                                      respondents       respondent       disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(b)--Clinical Investigators...................................          13,082                 1           13,082             0.17            2,224
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    The burden for this information collection request has changed
since the last OMB approval. Our estimated burden for the information
collection reflects a 298 hour increase. We have adjusted our estimated
burden for the information collection to reflect the number of
submissions we received in the last few years. Additionally, for
products regulated by the Center for Devices and Radiological Health,
we now include De Novo requests as a type of application that may rely
on clinical studies. For products regulated by the Center for Drug
Evaluation and Research, we now include biologics license applications
(BLAs) and BLA efficacy supplements that were inadvertently excluded
from our last information collection request as a type of application.

    Dated: November 24, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26182 Filed 12-1-21; 8:45 am]
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[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36312-36313]
[FR Doc No: 2014-14934]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0312; FRL-9912-93-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Emission Guidelines for Commercial and
Industrial Solid Waste Incineration (CISWI) Units (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Emission Guidelines for
Commercial and Industrial Solid Waste Incineration (CISWI) Units (40
CFR part 60, Subpart DDDD) (Renewal)'' (EPA ICR No. 2385.06, OMB
Control No. 2060-0664) to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act (44
U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is
currently approved through June 30, 2014. Public comments were
previously requested via the Federal

Register (78 FR 35023) on June 11, 2013 during a 60-day comment period.
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 July 28, 2014.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0312, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    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.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; 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 or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 61, subpart A, and any changes
or additions to the Provisions specified at 40 CFR part 60, subpart
DDDD. Owners or operators of the affected facilities must submit
initial notification, performance tests, and periodic reports and
results. Owners and operators are also required to maintain records of
the occurrence and duration of any startup, shutdown or malfunction in
the operation of an affected facility, or any period when the
monitoring system is inoperative.
    Form Numbers: None.
    Respondents/affected entities: Owners or operators of commercial
and industrial solid waste incineration units.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart DDDD).
    Estimated number of respondents: 57 (total).
    Frequency of response: Initially, occasionally, semiannually, and
annually.
    Total estimated burden: 7,378 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $8,694,601 (per year), includes $8,271,404
annualized capital or operation & maintenance costs.
    Changes in the Estimates: The change in the burden and cost
estimates occurred because the standard has been in effect for more
than three years and the requirements are different during initial
compliance as compared to on-going compliance. The previous ICR
reflected those burdens and costs associated with the initial
activities for subject facilities. This includes purchasing monitoring
equipment, conducting performance tests and establishing recordkeeping
systems. This ICR, by in large, reflects the on-going burden and costs
for existing facilities. Activities for existing source include
continuously monitoring of pollutants and the submission of annual
performance test results and semiannual reports of exceedances. The
overall result is a decrease in burden hours and labor costs. However,
there is an increase in the total O&M costs as this ICR reflects the
burden associated with annual performance testing requirement of the
Emission Guidelines.
    In addition to the changes above, this ICR revises the number of
respondents using the latest Agency estimates, and corrects the number
of responses as the previous ICR incorrectly included internal records
as a response. This attributes to a decrease in the number of
respondents and number of responses.

Spencer W. Clark,
Acting Director, Collection Strategies Division.
[FR Doc. 2014-14934 Filed 6-25-14; 8:45 am]
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