[Federal Register: January 31, 2006 (Volume 71, Number 20)]
[Notices]
[Page 5094-5096]
[DOCID:fr31ja06-79]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53167; File No. SR-CBOE-2005-89]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Granting Approval of a Proposed Rule Change and
Amendment No. 1 Thereto Relating to the Adoption of a Hybrid Agency
Liaison System for Automated Handling of Inbound Orders That Are
Not Automatically Executed

January 23, 2006.
    On October 27, 2005, the Chicago Board Options Exchange,
Incorporated (``CBOE'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt a Hybrid Agency Liaison
(``HAL'') system for automated handling of inbound orders for option
classes trading on CBOE's Hybrid System (``Hybrid''). On December 7,
2005, the Exchange filed Amendment No. 1 to the

proposed rule change.\3\ The proposed rule change and Amendment No. 1
were published for comment in the Federal Register on December 15,
2005.\4\ No comments were received regarding the proposal, as amended.
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\ Amendment No. 1 replaced the original filing in its
entirety.
    \4\ See Securities Exchange Act Release No. 52928 (December 8,
2005), 70 FR 74388 (``Notice'').
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I. Description of the Proposal

    Hybrid currently provides electronic executions on the Exchange for
orders that are marketable against the Exchange's quote when it
represents the National Best Bid or Offer (``NBBO''). The entire
process for those orders is automated; however, many electronically-
received orders that are not automatically executed upon receipt by the
Hybrid System (usually because CBOE's disseminated quote is not the
NBBO) are routed to a PAR terminal for manual handling.\5\ In proposed
CBOE Rule 6.14, the Exchange proposes to automate the handling process
for certain orders in designated classes that would be routed to a PAR
terminal under the current rules--specifically, market orders and limit
orders that are marketable against CBOE's disseminated quote while that
quote is not the NBBO, and limit orders that improve CBOE's
disseminated quote (whether or not they are marketable against the
NBBO). These orders would be electronically exposed to all CBOE Market-
Makers appointed to the relevant option class as well as to all members
acting as agent for orders at the top of the Exchange's book in the
relevant option series (``Qualifying Members'').\6\ Like open outcry,
this exposure and subsequent allocation period \7\ (together, the ``HAL
auction'' or ``auction'') would afford crowd members an opportunity to
match the away NBBO price.\8\
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    \5\ See CBOE Rule 7.12, PAR Officials (setting forth the rules
for manual handling by the PAR Officials of orders routed to PAR
terminals).
    \6\ Of course, eligible recipients of these messages (CBOE
Market-Makers and Qualifying Members) may need to undertake some
programming modifications to receive and respond to these messages.
The Exchange will not require those programming changes.
    \7\ The allocation period affords Market-Makers and Qualifying
Members that were interested in trading with an exposed order an
opportunity to participate in the execution of an order following an
exposure period. Each Market-Maker or Qualifying Member that submits
an order or quote to trade with an order during the exposure or
allocation periods would be entitled to receive an allocation of the
order in accordance with the allocation algorithm in effect for the
options class pursuant to CBOE Rule 6.45A or 6.45B. See proposed
CBOE Rule 6.14(c).
    \8\ For a full description of the operation of the proposed HAL
auction, see Notice, supra note 4.
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    If any portion of an exposed order remains unexecuted at the end of
a HAL auction, then the remaining order would be booked if it is a
limit order that is not marketable, or, if marketable, routed to the
Exchange showing the NBBO via the options intermarket linkage. If the
price of the Linkage Order is no longer available on any market, then
HAL would execute the remainder of the order against the Exchange's
existing quote provided such execution would not result in a trade-
through. However, if the Exchange's quote is inferior to the Exchange's
best bid or offer at the time the order was received by HAL (``Exchange
Initial BBO''), then the order would be executed against the Market-
Makers that constituted the Exchange Initial BBO at a price equal to
the Exchange Initial BBO.
    In addition, the proposal provides for early termination of an
auction in certain cases-for instance, when the Hybrid System receives
an unrelated order on the opposite side of the market from the exposed
order that could trade against the exposed order at the prevailing NBBO
price; when the Hybrid System receives an unrelated order on the same
side of the market as the exposed order that is priced equal to or
better than the exposed order; or, in the case of exposure of an order
that is marketable against the Exchange Initial BBO, when a Market-
Maker whose quote is part of the Exchange Initial BBO attempts to move
its quote to an inferior price.\9\ In this last case, the auction would
terminate and the Exchange would not permit any Market-Maker quotes to
move to an inferior price until the exposed order was routed through
the Linkage or, if a superior price is no longer available on another
exchange, executed at the Exchange Initial BBO against the Market-
Makers that constituted the Exchange Initial BBO.\10\
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    \9\ For a full discussion of the auction termination provisions
in proposed CBOE Rule 6.14(d) and (e), see Notice, supra note 4.
    \10\ See proposed CBOE Rule 6.14(d)(iii) and (e)(iii).
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II. Discussion

    The Commission finds that the proposed rule change, as amended, is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\11\ In particular, the Commission believes that the proposal
is consistent with the requirements of Section 6(b)(5) of the Act,
which requires, among other things, that the rules of a national
securities exchange be designed to promote just and equitable
principles of trade, serve to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and
protect investors and the public interest.\12\
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    \11\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
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    The Exchange noted in its proposal that the proposed Hybrid Agency
Liaison system would be an improvement over open outcry auctions
because HAL, an automated process, would reduce the duration of the
auction to three seconds or less.\13\ In addition, customer order
protections built into proposed CBOE Rule 6.14 (such as, most
significantly, the guarantee that the customer order will receive an
execution at the Exchange Initial BBO if no better price is available
when the auction ends or is terminated) \14\ should guarantee that any
order that is the subject of a HAL auction will be executed at a price
at least as good as the price disseminated by the Exchange at the time
the order was received by HAL.\15\ Thus, the HAL auction provisions
should ensure both that orders that are ineligible for automatic
execution under the CBOE's rules because the CBOE is not at the NBBO
are handled electronically rather than manually, and that CBOE Market-
Makers honor their disseminated quotes, regardless of whether an
auction has been initiated.
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    \13\ CBOE's proposed Rule 6.14(b) limits the total exposure and
allocation time to three seconds.
    \14\ See proposed CBOE Rule 6.14(b)(i), (b)(ii), (d)(iii), and
(e)(iii).
    \15\ See proposed CBOE Rule 6.14(b)(i) and (ii).
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    In addition, the Commission notes that the Exchange proposes to
incorporate into its proposed rule provisions that would provide that a
pattern or practice of submitting unrelated orders that cause an
exposure period to conclude early and the dissemination of information
regarding exposed orders to third parties will be deemed conduct
inconsistent with just and equitable principles of trade and a
violation of CBOE Rule 4.1 and other Exchange rules.\16\ The Commission
believes that these provisions will require the CBOE to surveil for,
and hopefully help to limit, any potential ``gaming'' of the HAL
system.
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    \16\ See proposed CBOE Rule 6.14, Interpretations and Policies
.01 and .02.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\17\ that the proposed rule change (File No. SR-

CBOE-2005-89), as amended, is approved.
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    \17\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-1166 Filed 1-30-06; 8:45 am]

BILLING CODE 8010-01-P


MEMORANDUM TO: 304( m) Record ( EPA Docket Number OW 2003 0074)

FROM: Bob Southworth, ERG Senior Environmental Engineer DATE: October 30, 2003 SUBJECT: Review of the TWPE Loads for Selected Nonferrous Metals Manufacturing Facilities Calculated Using 2000 TRI Data This memorandum presents the results of a review of the Toxic Weighted Pound Equivalent ( TWPE) loads for selected nonferrous metals ( NFM) manufacturing facilities calculated using 2000 Toxic Release Inventory ( TRI) data. It provides background information on the NFM manufacturing facilities that released 93 percent of the TWPE load, discusses the pollutants with the highest TWPE loads, and identifies the NFM manufacturing facilities that released the pollutants with the highest TWPE loads. The TRIReleases2000 database contains pollutant loads for both direct and indirect discharging facilities. The development of this database is discussed in more detail in the data dictionary entitled TRIReleases2000 Data Dictionary, dated December 12, 2003. Please note that indirect dischargers in the NFM manufacturing industry are not discussed in this memorandum because the scaled TWPE load for the indirect dischargers is only 17,058 pounds.

Background Six of the direct discharging NFM manufacturing facilities in the 2000 TRI database released 93 percent of the TWPE load for the NFM manufacturing industry. Four of those facilities released 86 percent of the TWPE load. Four have a Standard Industrial Classification ( SIC) Code of 3334 and two have a SIC Code of 3339. The total TWPE load discharged by NFM manufacturing facilities that reported a release to surface water in the 2000 TRI database was 971,191. Attachment A lists the TWPE loads calculated using 2000 TRI data by facility and by pollutant. The percentage of the total TWPE load for each pollutant by facility and the cumulative percentage of the total TWPE for each pollutant by facility also are presented in Attachment A.

Pollutants With High TWPE Loads The TWPE loads for three pollutants comprise 93 percent of the total TWPE load for NFM manufacturing facilities calculated using 2000 TRI data. Table 1 lists the three pollutants and the TWPE load for each pollutant. MEMORANDUM October 30, 2003 Page 2 2 TABLE 1 TWPE LOAD FOR TOP THREE POLLUTANTS Pollutant TWPE ( pounds)

Polycyclic aromatic compounds1 831,010 Vanadium compounds1 37,495 Sodium nitrite1 34,727 Total 903,232 1 Non conventional pollutant All three pollutants are non conventional pollutants. One pollutant ( i. e., polycyclic aromatic compounds) accounts for 92 percent of the TWPE load for the top three pollutants.

Facilities With Highest TWPE Loads The following NFM manufacturing facilities discharged the three pollutants with the highest TWPE load. The number in parenthesis is the TRI identification number for the facility.

Facility Name Facility Location ( ID) SIC Reynolds Metals Company Longview, WA ( 98632RYNLD40291) 3334 ALCOA Badin, NC ( 28009LMNMCHWY74) 3334 Reynolds Metals Company Massena, NY ( 13662RYNLDSOUTH) 3334 U. S. Vanadium Corp Hot Springs, AK ( 71901SVNDM5911M) 3339 Osram Sylvania Products Towanda, PA ( 18848GTPRDHAWES) 3339 Northwest Aluminum Co. The Dalles, OR ( 97058NRTH3313W) 3334 Table 2 lists the NFM manufacturing facilities that released the highest percentage of the TWPE load for the top three pollutants and the percentage of the TWPE load released by the facility. MEMORANDUM October 30, 2003 Page 3 3 TABLE 2 NFM MANUFACTURING FACILITIES THAT RELEASED THE HIGHEST PERCENTAGE OF THE TOP THREE POLLUTANTS Pollutant Facility Percentage of TWPE Released by Facility Polycyclic aromatic compounds1 Reynolds Metals  Longview ALCOA Reynolds Metals  Massena Northwest Aluminum Co 50 41 5 4 Vanadium compounds1 U. S. Vanadium Corporation 100 Sodium nitrite1 Osram Sylvania Prod. Inc. 100 1 Non conventional pollutant As shown above, four NFM manufacturing facilities released the total TWPE load for polycyclic aromatic compounds. One hundred percent of the TWPE load for vanadium compounds and sodium nitrite is from one NFM manufacturing facility.

Except for one of the pollutants ( i. e., benzo( a) pyrene) in the group of polycyclic aromatic compounds reported on Form R, there are no limits for the above pollutants in the effluent limitations guidelines ( ELG) for the NFM manufacturing industry. If EPA decides not to establish limits for the other pollutants in an ELG, limits for those pollutants and a revised limit for benzo( a) pyrene could be established on a case by case basis in a National Pollutant Discharge Elimination System permit based on Best Professional Judgement. This is a feasible approach because the TWPE load for the pollutants is released to surface water by a small number of NFM manufacturing facilities.

Attachment ATTACHMENT A TWPE LOADS CALCULATED USING 2000 TRI DATA BY POLLUTANT AND BY NONFERROUS METALS MANUFACTURING FACILITY


[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Notices]
[Page 57497]
[FR Doc No: 2017-26130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82176; File No. SR-NYSEArca-2017-87]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change, as Modified by Amendment No. 2, To List and Trade Shares of the
JPMorgan Long/Short ETF Under NYSE Arca Rule 8.600-E

November 29, 2017.
    On September 26, 2017, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the
JPMorgan Long/Short ETF (``Fund'') under NYSE Arca Rule 8.600-E. The
proposed rule change was published for comment in the Federal Register
on October 16, 2017.\3\ On November 17, 2017, the Exchange filed
Amendment No. 1 to the proposed rule change, which amended and
superseded the proposed rule change as originally filed. On November
27, 2017, the Exchange filed Amendment No. 2 to the proposed rule
change, which amended and superseded the proposed rule change as
modified by Amendment No. 1.\4\ The Commission has received no comments
on the proposed rule change.
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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. 81842 (October 10,
2017), 82 FR 48127.
    \4\ In Amendment No. 2, the Exchange: (1) Changed the name of
the Fund; (2) moved cash and cash equivalents from the ``other
investments'' category to the ``principal investments'' category;
(3) specified that no more than 10% of the equity weight of the
Fund's portfolio will be invested in non-exchange-traded American
Depositary Receipts; (4) provided additional information regarding
the Fund's holding of over-the-counter contingent value rights; (5)
provided additional information regarding the availability of
information for the Shares; and (6) made other clarifications,
corrections, and technical changes. Amendment No. 2 is available at
https://www.sec.gov/comments/sr-nysearca-2017-87/nysearca201787-2724825-161541.pdf.
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    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is November 30, 2017. The Commission is extending this 45-day time
period.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change, as
modified by Amendment No. 2. Accordingly, the Commission, pursuant to
Section 19(b)(2) of the Act,\6\ designates January 14, 2018, as the
date by which the Commission shall either approve or disapprove, or
institute proceedings to determine whether to disapprove, the proposed
rule change (File Number SR-NYSEArca-2017-87), as modified by Amendment
No. 2.
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    \6\ Id.
    \7\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-26130 Filed 12-4-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37657-37661]
[FR Doc No: 2014-15561]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-8337]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
Part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction

or acquisition of buildings in identified SFHAs for communities not
participating in the NFIP and identified for more than a year on FEMA's
initial FIRM for the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment procedures under 5 U.S.C. 553(b), are impracticable and
unnecessary because communities listed in this final rule have been
adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR Part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR Part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current Effective Map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
            Region I

Massachusetts:
    Acushnet, Town of, Bristol         250048  April 3, 1981,     July 16, 2014.........  July 16, 2014
     County.                                    Emerg; July 19,
                                                1982, Reg; July
                                                16, 2014, Susp.
    Barnstable, Town of,               250001  October 27, 1972,  ......do*.............   Do.
     Barnstable County.                         Emerg; April 3,
                                                1978, Reg; July
                                                16, 2014, Susp.
    Berkley, Town of, Bristol          250050  February 19,       ......do..............   Do.
     County.                                    1974, Emerg;
                                                July 3, 1978,
                                                Reg; July 16,
                                                2014, Susp.
    Berlin, Town of, Worcester         250294  August 11, 1975,   ......do..............   Do.
     County.                                    Emerg; June 18,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Beverly, City of, Essex            250077  August 16, 1974,   ......do..............   Do.
     County.                                    Emerg; March 18,
                                                1986, Reg; July
                                                16, 2014, Susp.
    Bolton, Town of, Worcester         250296  March 10, 1975,    ......do..............   Do.
     County.                                    Emerg; June 18,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Bourne, Town of, Barnstable        255210  April 30, 1971,    ......do..............   Do.
     County.                                    Emerg; June 29,
                                                1973, Reg; July
                                                16, 2014, Susp.
    Boylston, Town of,                 250297  August 26, 1975,   ......do..............   Do.
     Worcester County.                          Emerg; July 2,
                                                1981, Reg; July
                                                16, 2014, Susp.
    Brewster, Town of,                 250003  July 21, 1975,     ......do..............   Do.
     Barnstable County.                         Emerg; June 19,
                                                1985, Reg; July
                                                16, 2014, Susp.
    Chatham, Town of,                  250004  July 9, 1975,      ......do..............   Do.
     Barnstable County.                         Emerg; August 1,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Clinton, Town of, Worcester        250300  May 26, 1977,      ......do..............   Do.
     County.                                    Emerg; June 15,
                                                1982, Reg; July
                                                16, 2014, Susp.
    Dennis, Town of, Barnstable        250005  December 10,       ......do..............   Do.
     County.                                    1971, Emerg;
                                                October 6, 1976,
                                                Reg; July 16,
                                                2014, Susp.
    Dighton, Town of, Bristol          250052  March 9, 1973,     ......do..............   Do.
     County.                                    Emerg; June 18,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Eastham, Town of,                  250006  March 1, 1974,     ......do..............   Do.
     Barnstable County.                         Emerg; July 3,
                                                1986, Reg; July
                                                16, 2014, Susp.
    Fairhaven, Town of, Bristol        250054  October 8, 1971,   ......do..............   Do.
     County.                                    Emerg; March 16,
                                                1976, Reg; July
                                                16, 2014, Susp.
    Fall River, City of,               250055  September 14,      ......do..............   Do.
     Bristol County.                            1977, Emerg;
                                                September 30,
                                                1981, Reg; July
                                                16, 2014, Susp.
    Falmouth, Town of,                 255211  July 23, 1971,     ......do..............   Do.
     Barnstable County.                         Emerg; May 18,
                                                1973, Reg; July
                                                16, 2014, Susp.

    Freetown, Town of, Bristol         250056  August 11, 1975,   ......do..............   Do.
     County.                                    Emerg; June 18,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Gloucester, City of, Essex         250082  December 1, 1972,  ......do..............   Do.
     County.                                    Emerg; January
                                                17, 1986, Reg;
                                                July 16, 2014,
                                                Susp.
    Harwich, Town of,                  250008  December 10,       ......do..............   Do.
     Barnstable County.                         1973, Emerg;
                                                September 30,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Ipswich, Town of, Essex            250086  July 30, 1975,     ......do..............   Do.
     County.                                    Emerg; August 5,
                                                1985, Reg; July
                                                16, 2014, Susp.
    Lynn, City of, Essex County        250088  August 9, 1974,    ......do..............   Do.
                                                Emerg; February
                                                1, 1985, Reg;
                                                July 16, 2014,
                                                Susp.
    Marblehead, Town of, Essex         250091  January 16, 1974,  ......do..............   Do.
     County.                                    Emerg; July 3,
                                                1985, Reg; July
                                                16, 2014, Susp.
    Mashpee, Town of,                  250009  November 24,       ......do..............   Do.
     Barnstable County.                         1972, Emerg;
                                                September 15,
                                                1978, Reg; July
                                                16, 2014, Susp.
    New Bedford, City of,              255216  February 25,       ......do..............   Do.
     Bristol County.                            1972, Emerg;
                                                July 6, 1973,
                                                Reg; July 16,
                                                2014, Susp.
    Newbury, Town of, Essex            250096  October 6, 1972,   ......do..............   Do.
     County.                                    Emerg; March 15,
                                                1977, Reg; July
                                                16, 2014, Susp.
    Newburyport, City of, Essex        250097  October 6, 1972,   ......do..............   Do.
     County.                                    Emerg; February
                                                15, 1978, Reg;
                                                July 16, 2014,
                                                Susp.
    Northborough, Town of,             250321  June 10, 1975,     ......do..............   Do.
     Worcester County.                          Emerg; November
                                                15, 1979, Reg;
                                                July 16, 2014,
                                                Susp.
    Orleans, Town of,                  250010  December 4, 1973,  ......do..............   Do.
     Barnstable County.                         Emerg; September
                                                4, 1986, Reg;
                                                July 16, 2014,
                                                Susp.
    Provincetown, Town of,             255218  November 26,       ......do..............   Do.
     Barnstable County.                         1971, Emerg;
                                                March 2, 1973,
                                                Reg; July 16,
                                                2014, Susp.
    Rehoboth, Town of, Bristol         250062  February 11,       ......do..............   Do.
     County.                                    1972, Emerg;
                                                September 1,
                                                1977, Reg; July
                                                16, 2014, Susp.
    Rowley, Town of, Essex             250101  N/A, Emerg;        ......do..............   Do.
     County.                                    December 3,
                                                2009, Reg; July
                                                16, 2014, Susp.
    Salem, City of, Essex              250102  June 23, 1972,     ......do..............   Do.
     County.                                    Emerg; March 15,
                                                1977, Reg; July
                                                16, 2014, Susp.
    Sandwich, Town of,                 250012  December 29,       ......do..............   Do.
     Barnstable County.                         1972, Emerg;
                                                June 18, 1980,
                                                Reg; July 16,
                                                2014, Susp.
    Saugus, Town of, Essex             250104  August 25, 1975,   ......do..............   Do.
     County.                                    Emerg; January
                                                19, 1983, Reg;
                                                July 16, 2014,
                                                Susp.
    Seekonk, Town of, Bristol          250063  July 25, 1975,     ......do..............   Do.
     County.                                    Emerg; September
                                                5, 1979, Reg;
                                                July 16, 2014,
                                                Susp.
    Shrewsbury, Town of,               250332  April 11, 1975,    ......do..............   Do.
     Worcester County.                          Emerg; June 4,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Somerset, Town of, Bristol         255220  November 13,       ......do..............   Do.
     County.                                    1970, Emerg;
                                                March 17, 1972,
                                                Reg; July 16,
                                                2014, Susp.
    Southborough, Town of,             250333  August 11, 1975,   ......do..............   Do.
     Worcester County.                          Emerg; October
                                                15, 1981, Reg;
                                                July 16, 2014,
                                                Susp.
    Swampscott, Town of, Essex         250105  September 29,      ......do..............   Do.
     County.                                    1972, Emerg;
                                                September 3,
                                                1976, Reg; July
                                                16, 2014, Susp.
    Swansea, Town of, Bristol          255221  June 12, 1970,     ......do..............   Do.
     County.                                    Emerg; August 6,
                                                1971, Reg; July
                                                16, 2014, Susp.
    Truro, Town of, Barnstable         255222  November 26,       ......do..............   Do.
     County.                                    1971, Emerg;
                                                April 20, 1973,
                                                Reg; July 16,
                                                2014, Susp.
    Yarmouth, Town of,                 250015  May 26, 1972,      ......do..............   Do.
     Barnstable County.                         Emerg; May 2,
                                                1977, Reg; July
                                                16, 2014, Susp.

           Region III

Pennsylvania:
    Allen, Township of,                421928  March 1, 1977,     ......do..............   Do.
     Northampton County.                        Emerg; May 19,
                                                1981, Reg; July
                                                16, 2014, Susp.
    Bangor, Borough of,                420716  June 1, 1973,      ......do..............   Do.
     Northampton County.                        Emerg; February
                                                2, 1977, Reg;
                                                July 16, 2014,
                                                Susp.
    Bath, Borough of,                  420717  August 8, 1975,    ......do..............   Do.
     Northampton County.                        Emerg; February
                                                17, 1988, Reg;
                                                July 16, 2014,
                                                Susp.
    Bethlehem, City of,                420718  September 1,       ......do..............   Do.
     Northampton and Lehigh                     1972, Emerg;
     Counties..                                 July 3, 1978,
                                                Reg; July 16,
                                                2014, Susp.
    Bethlehem, Township of,            420980  January 23, 1974,  ......do..............   Do.
     Northampton County.                        Emerg; June 4,
                                                1980, Reg; July
                                                16, 2014, Susp.
    Bushkill, Township of,             421929  March 23, 1977,    ......do..............   Do.
     Northampton County.                        Emerg; March 4,
                                                1988, Reg; July
                                                16, 2014, Susp.
    Chapman, Borough of,               422251  May 20, 1980,      ......do..............   Do.
     Northampton County.                        Emerg; July 30,
                                                1982, Reg; July
                                                16, 2014, Susp.
    East Allen, Township of,           420981  October 19, 1973,  ......do..............   Do.
     Northampton County.                        Emerg; February
                                                11, 1983, Reg;
                                                July 16, 2014,
                                                Susp.

    East Bangor, Borough of,           422252  February 15,       ......do..............   Do.
     Northampton County.                        1977, Emerg;
                                                February 12,
                                                1982, Reg; July
                                                16, 2014, Susp.
    Easton, City of,                   425383  June 18, 1971,     ......do..............   Do.
     Northampton County.                        Emerg; October
                                                17, 1978, Reg;
                                                July 16, 2014,
                                                Susp.
    Forks, Township of,                421930  September 19,      ......do..............   Do.
     Northampton County.                        1975, Emerg;
                                                July 16, 1980,
                                                Reg; July 16,
                                                2014, Susp.
    Freemansburg, Borough of,          420721  March 30, 1973,    ......do..............   Do.
     Northampton County.                        Emerg; September
                                                1, 1977, Reg;
                                                July 16, 2014,
                                                Susp.
    Glendon, Borough of,               422254  August 7, 1975,    ......do..............   Do.
     Northampton County.                        Emerg; January
                                                16, 1980, Reg;
                                                July 16, 2014,
                                                Susp.
    Hanover, Township of,              420722  January 19, 1973,  ......do..............   Do.
     Northampton County.                        Emerg; August 1,
                                                1977, Reg; July
                                                16, 2014, Susp.
    Lehigh, Township of,               421931  June 10, 1975,     ......do..............   Do.
     Northampton County.                        Emerg; December
                                                15, 1981, Reg;
                                                July 16, 2014,
                                                Susp.
    Lower Mount Bethel,                420724  April 18, 1973,    ......do..............   Do.
     Township of, Northampton                   Emerg; March 1,
     County.                                    1977, Reg; July
                                                16, 2014, Susp.
    Lower Nazareth, Township           422253  January 3, 1977,   ......do..............   Do.
     of, Northampton County.                    Emerg; May 4,
                                                1988, Reg; July
                                                16, 2014, Susp.
    Lower Saucon, Township of,         420982  January 30, 1974,  ......do..............   Do.
     Northampton County.                        Emerg; September
                                                28, 1979, Reg;
                                                July 16, 2014,
                                                Susp.
    Moore, Township of,                420983  January 28, 1974,  ......do..............   Do.
     Northampton County.                        Emerg; October
                                                17, 1978, Reg;
                                                July 16, 2014,
                                                Susp.
    Nazareth, Borough of,              420725  March 15, 1976,    ......do..............   Do.
     Northampton County.                        Emerg; October
                                                8, 1982, Reg;
                                                July 16, 2014,
                                                Susp.
    North Catasauqua, Borough          420727  May 9, 1975,       ......do..............   Do.
     of, Northampton County.                    Emerg; July 16,
                                                1981, Reg; July
                                                16, 2014, Susp.
    Northampton, Borough of,           420726  February 1, 1974,  ......do..............   Do.
     Northampton County.                        Emerg; May 3,
                                                1982, Reg; July
                                                16, 2014, Susp.
    Palmer, Township of,               420728  October 22, 1971,  ......do..............   Do.
     Northampton County.                        Emerg; December
                                                28, 1976, Reg;
                                                July 16, 2014,
                                                Susp.
    Pen Argyl, Borough of,             421926  December 26,       ......do..............   Do.
     Northampton County.                        1974, Emerg;
                                                June 25, 1976,
                                                Reg; July 16,
                                                2014, Susp.
    Plainfield, Township of,           421147  April 4, 1974,     ......do..............   Do.
     Northampton County.                        Emerg; January
                                                16, 1980, Reg;
                                                July 16, 2014,
                                                Susp.
    Portland, Borough of,              420729  June 3, 1974,      ......do..............   Do.
     Northampton County.                        Emerg; September
                                                16, 1981, Reg;
                                                July 16, 2014,
                                                Susp.
    Roseto, Borough of,                422255  March 7, 1978,     ......do..............   Do.
     Northampton County.                        Emerg; December
                                                1, 1987, Reg;
                                                July 16, 2014,
                                                Susp.
    Stockertown, Borough of,           420730  August 25, 1975,   ......do..............   Do.
     Northampton County.                        Emerg; December
                                                4, 1979, Reg;
                                                July 16, 2014,
                                                Susp.
    Upper Mount Bethel,                421933  September 15,      ......do..............   Do.
     Township of, Northampton                   1975, Emerg;
     County.                                    September 30,
                                                1981, Reg; July
                                                16, 2014, Susp.
    Upper Nazareth, Township           421934  May 13, 1977,      ......do..............   Do.
     of, Northampton County.                    Emerg; February
                                                25, 1983, Reg;
                                                July 16, 2014,
                                                Susp.
    Walnutport, Borough of,            420732  January 28, 1974,  ......do..............   Do.
     Northampton County.                        Emerg; June 1,
                                                1978, Reg; July
                                                16, 2014, Susp.
    Washington, Township of,           421156  April 15, 1974,    ......do..............   Do.
     Northampton County.                        Emerg; September
                                                30, 1988, Reg;
                                                July 16, 2014,
                                                Susp.
    West Easton, Borough of,           420733  July 9, 1973,      ......do..............   Do.
     Northampton County.                        Emerg; March 1,
                                                1979, Reg; July
                                                16, 2014, Susp.
    Williams, Township of,             421036  December 17,       ......do..............   Do.
     Northampton County.                        1973, Emerg;
                                                September 14,
                                                1979, Reg; July
                                                16, 2014, Susp.
    Wilson, Borough of,                421927  July 17, 1974,     ......do..............   Do.
     Northampton County.                        Emerg; January
                                                16, 1980, Reg;
                                                July 16, 2014,
                                                Susp.
    Wind Gap, Borough of,              420734  November 14,       ......do..............   Do.
     Northampton County.                        1975, Emerg; May
                                                19, 1981, Reg;
                                                July 16, 2014,
                                                Susp.
    Virginia: City of Richmond,        510129  August 29, 1973,   ......do..............   Do.
     Independent City.                          Emerg; June 15,
                                                1979, Reg; July
                                                16, 2014, Susp.

            Region V

Indiana:
    Alton, Town of, Crawford           180031  March 19, 1984,    ......do..............   Do.
     County.                                    Emerg; March 19,
                                                1984, Reg; July
                                                16, 2014, Susp.
    Crawford County,                   180472  December 18,       ......do..............   Do.
     Unincorporated Areas.                      1979, Emerg;
                                                January 17,
                                                1986, Reg; July
                                                16, 2014, Susp.
    English, Town of, Crawford         180032  March 25, 1976,    ......do..............   Do.
     County.                                    Emerg; January
                                                3, 1986, Reg;
                                                July 16, 2014,
                                                Susp.
    Leavenworth, Town of,              180035  March 16, 1983,    ......do..............   Do.
     Crawford County.                           Emerg; August 1,
                                                1983, Reg; July
                                                16, 2014, Susp.
    Marengo, Town of, Crawford         180033  January 6, 1976,   ......do..............   Do.
     County.                                    Emerg; September
                                                16, 1982, Reg;
                                                July 16, 2014,
                                                Susp.

    Milltown, Town of, Crawford        180034  February 13,       ......do..............   Do.
     and Harrison Counties.                     1976, Emerg;
                                                October 15,
                                                1985, Reg; July
                                                16, 2014, Susp.
Michigan:
    Eden, Township of, Mason           261274  November 22,       ......do..............   Do.
     County.                                    2013, Emerg; N/
                                                A, Reg; July 16,
                                                2014, Susp.
    Hamlin, Township of, Mason         260134  July 2, 1975,      ......do..............   Do.
     County.                                    Emerg; December
                                                17, 1987, Reg;
                                                July 16, 2014,
                                                Susp.
    Pere Marquette, Charter            260582  October 9, 1975,   ......do..............   Do.
     Township of, Mason County.                 Emerg; July 3,
                                                1985, Reg; July
                                                16, 2014, Susp.
    Summit, Township of, Mason         260307  September 27,      ......do..............   Do.
     County.                                    1974, Emerg;
                                                December 17,
                                                1987, Reg; July
                                                16, 2014, Susp.

           Region VI

           Louisiana:
    Addis, Town of, West Baton         220240  April 30, 1973,    ......do..............   Do.
     Rouge Parish.                              Emerg; August
                                                15, 1977, Reg;
                                                July 16, 2014,
                                                Susp.
    Brusly, Town of, West Baton        220241  April 30, 1973,    ......do..............   Do.
     Rouge Parish.                              Emerg; August
                                                15, 1977, Reg;
                                                July 16, 2014,
                                                Susp.
    Port Allen, City of, West          220242  April 30, 1973,    ......do..............   Do.
     Baton Rouge Parish..                       Emerg; January
                                                24, 1978, Reg;
                                                July 16, 2014,
                                                Susp.
    West Baton Rouge Parish,           220239  April 30, 1973,    ......do..............   Do.
     Unincorporated Areas.                      Emerg; April 3,
                                                1978, Reg; July
                                                16, 2014, Susp.

           Region VII

Kansas:
    Concordia, City of, Cloud          200060  April 23, 1975,    ......do..............   Do.
     County.                                    Emerg; July 1,
                                                1987, Reg; July
                                                16, 2014, Susp.
    Glasco, City of, Cloud             200061  July 23, 1975,     ......do..............   Do.
     County.                                    Emerg; July 1,
                                                1987, Reg; July
                                                16, 2014, Susp.
----------------------------------------------------------------------------------------------------------------
*-do- = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: June 17, 2014.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2014-15561 Filed 7-1-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34345-34347]
[FR Doc No: 2016-12651]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3327]

Agency Information Collection Activities; Proposed Collection;
Comment Request; E6(R2) Good Clinical Practice; International Council
for Harmonisation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (the PRA), Federal Agencies are required to publish notice in
the Federal Register concerning each proposed collection of information
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collections of information marked as
``ADDENDUM'' in the draft guidance entitled ``E6(R2) Good Clinical
Practice'' (E6(R2) draft guidance). The E6(R2) draft guidance was
prepared under the auspices of the International Council for
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The E6(R2) draft guidance amends
the guidance entitled ``E6 Good Clinical Practice: Consolidated
Guidance'' (E6(R1) consolidated guidance), issued in April 1996, to
encourage implementation of improved and more efficient approaches to
clinical trial design, conduct, oversight, recording, and reporting
while continuing to ensure human subject protection and data integrity.
Standards regarding electronic records and essential documents intended
to increase clinical trial quality and efficiency have also been
updated. The E6(R2) draft guidance was intended to improve clinical
trial quality and efficiency while maintaining human subject
protection. This notice solicits comments on the collection of
information in the draft guidance concerning the development of a
system to manage quality, as well as information to include in a
clinical study report about the quality management approach.

DATES: Submit either electronic or written comments on the collection
of information by August 1, 2016 on the ``ADDENDUM'' sections of the
E6(R2) draft guidance.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 Submission'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-D-3327 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; E6(R2) Good Clinical Practice;
International Council for Harmonisation.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food

and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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.

E6(R2) Good Clinical Practice Draft Guidance; International Council for
Harmonisation OMB Control Number 0910-NEW

I. Background

    In the Federal Register of September 29, 2015 (80 FR 58492), we
announced the availability of and requested public comments on the
E6(R2) draft guidance. The draft guidance is the product of the ICH E6
Expert Working Group of the ICH. The E6(R2) draft guidance provides
additions to the E6(R1) consolidated guidance that are identified as
``ADDENDUM'' and marked with vertical lines on both sides of the text.
The additions are intended to encourage implementation of the described
approaches and processes to improve the quality and efficiency of
clinical trials while maintaining the protection of human subjects. The
E6(R2)draft guidance includes information collection provisions that
are subject to review by OMB under the PRA. This Federal Register
notice begins the process of requesting public comment and obtaining
OMB approval for those information collections that are new and are not
already covered by previously approved collections of information.

II. Burden Estimates for the E6(R2) Draft Guidance

    The E6(R2) draft guidance recommends that sponsors develop and
maintain a system to manage quality when designing, conducting,
recording, evaluating, reporting, and archiving clinical trials. The
draft guidance also recommends that the sponsor describe the quality
management approach implemented in the trial and summarize important
deviations from the predefined quality tolerance limits in the clinical
study report. We are requesting OMB approval for the following
collections of information identified in the ``ADDENDUM'' sections of
the E6(R2) draft guidance and are inviting public comments on these
sections.
    In table 1 of this document, we estimate that approximately 1,457
sponsors of clinical trials of human drugs will develop approximately
1,457 quality management systems per year (as described in section 5.0
of the E6(R2) draft guidance). We further estimate that it will take
sponsors approximately 60 hours to develop and implement each quality
management system, totaling 87,420 hours annually. These estimates are
based on the number of annual investigational new drug applications
(IND) and new drug applications (NDA) submitted to the Center for Drug
Evaluation and Research in previously approved collections of
information. The estimated number of sponsors that will develop a
quality management system as described in the guidance, as well as the
estimated number of hours it will take, is based on FDA interactions
with sponsors about activities that support drug development plans.
    In table 2 of this document, we estimate that approximately 1,457
sponsors of clinical trials of human drugs will describe the quality
management approach implemented in a clinical trial and summarize
important deviations from the predefined quality tolerance limits in a
clinical study report (as described in section 5.0.7 of the E6(R2)
draft guidance). We further estimate that sponsors will submit
approximately 4.6 responses per respondent and that it will take
sponsors 3 hours to complete this reporting task, totaling 20,107
reporting hours annually. These estimates are based on past experiences
with IND, NDA, and previously approved collections of information.
    In table 3 of this document, we estimate that approximately 218
sponsors of clinical trials of biological products will develop
approximately 218 quality management systems per year (as described in
section 5.0.7 of the E6(R2) draft guidance). We further estimate that
it will take sponsors approximately 60 hours to develop and implement
each quality management system, totaling 13,080 hours annually. These
estimates are based on past experiences with INDs, biologics license
applications (BLA), and previously approved collections of information.
    In table 4 of this document, we estimate that 218 sponsors of
biological products will describe the quality management approach
implemented in a clinical trial and summarize important deviations from
the predefined quality tolerance limits in a clinical study report (as
described in section 5.0.7 of the E6(R2) draft guidance). We further
estimate that sponsors will submit approximately 3.69 responses per
respondent and that it will take sponsors 3 hours to complete this
reporting task, totaling 2,413 reporting hours annually. As described
previously, these estimates are also based on past experiences with
IND, BLA, and previously approved collections of information.
    FDA estimates the burden of this collection of information as
follows:

                                           Table 1--Estimated Annual Recordkeeping Burden for Human Drugs \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
      E6(R2) Good Clinical Practice; International Council for          Number of       records per      Total annual         per          Total hours
             Harmonisation; Draft Guidance for Industry               recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5.0--Quality Management (including sections 5.0.1 to 5.0.7)           1,457                1            1,457               60           87,420

Developing a Quality Management System.............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                             Table 2--Estimated Annual Reporting Burden for Human Drugs \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
      E6(R2) Good Clinical Practice; International Council for          Number of      responses per     Total annual    Average burden    Total hours
             Harmonisation; Draft Guidance for Industry                respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5.0.7--Risk Reporting......................................           1,457              4.6            6,702                3           20,107
Describing the Quality Management Approach Implemented in a
 Clinical Trial and Summarizing Important Deviations From the
 Predefined Quality Tolerance Limits in a Clinical Study Report....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                            Table 3--Estimated Annual Recordkeeping Burden for Biologics \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
      E6(R2) Good Clinical Practice; International Council for          Number of       records per     Total records    Average burden    Total hours
             Harmonisation; Draft Guidance for Industry               recordkeepers     recordkeeper                       per record
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5.0--Quality Management (including 5.0.1 to 5.0.7).........             218                1              218               60           13,080
Developing a Quality Management System.............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                              Table 4--Estimated Annual Reporting Burden for Biologics \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
      E6(R2) Good Clinical Practice; International Council for          Number of      responses per     Total annual    Average burden    Total hours
             Harmonisation; Draft Guidance for Industry                 responses        respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 5.0.7--Risk Reporting......................................             218             3.69              804                3            2,413
Describing the Quality Management Approach Implemented in a
 Clinical Trial and Summarizing Important Deviations From the
 Predefined Quality Tolerance Limits in a Clinical Study Report....
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The collections of information included in the sections marked as
``ADDENDUM'' in the E6(R2) draft guidance also refers to previously
approved collections of information found in FDA regulations. These
collections of information are subject to review by OMB under the PRA.
The collections of information found in 21 CFR part 11 have been
approved under OMB control number 0910-0303; the collections of
information found in 21 CFR part 312 have been approved under OMB
control number 0910-0014; and collections of information found in 21
CFR part 314 have been approved under OMB control number 0910-0001. The
collections of information found in 21 CFR part 601 have been approved
under OMB control number 0910-0338.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12651 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P