MEMORANDUM

DATE:		June 25, 2014

TO:		Carbon Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Ben Machol, EPA/R9

SUBJECT:	6/16/14 Conversation With AEPCO Regarding Proposed Carbon Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY

      A phone call was held between EPA and the AEPCO on June 16, 2014 to discuss the proposed Carbon Power Plan for Existing Power Plants. The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014. The AEPCO representative raised the following points:           * Arizona was one of the states hardest hit by these proposed rules.    * Apache is their only asset. They don't have the flexibility to redispatch to natural gas. They are very concerned they'd end up with a stranded asset. They now have a $300M USDA RUS loan and they are a non-profit cooperative.    * There is so much natural gas combined cycle capacity in the state because many merchant generators built units thinking they could sell to the CA market. These units are now under capacity.    * Even with the state flexibility built into the proposal, AZ does not have much flexibility; they'd have to redispatch all coal to meet the proposed state goal.    * It's hard for everyone at their coop to get up to speed on the rules.        ATTENDEES

EPA:  Ben Machol, R9 (by phone)

AEPCO Michelle Freeark<EMAIL_ADDRESS>(by phone)


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Rules and Regulations]
[Pages 42011-42012]
[FR Doc No: 2013-16808]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0599]

Drawbridge Operation Regulations; The Gut, South Bristol, ME

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
SR129 Bridge across The Gut, mile 0.2, between Rutherford Island and
South Bristol, Maine. The bridge owner, Maine Department of

Transportation will be performing test borings at the bridge. This
deviation allows the bridge to delay bridge openings by ten minutes for
a four hour period to facilitate scheduled test borings at the bridge.

DATES: This deviation is effective from 10 a.m. through 2 p.m. on July
15, 2013.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2013-0599 and are available online
at www.regulations.gov, inserting USCG-2013-0599 in the ``Keyword'' and
then clicking ``Search''. They are also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. John McDonald, Project Officer, First Coast Guard
District, telephone<PHONE_NUMBER><EMAIL_ADDRESS>If you
have questions on viewing the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The SR129 Bridge, across The Gut, mile 0.2,
between Rutherford Island and South Bristol, Maine, has a vertical
clearance in the closed position of 3 feet above mean high water and 12
feet above mean low water. The bridge operating regulations are listed
at 33 CFR 117.5.
    The waterway is transited by recreational and commercial fishing
boats. There is an alternate route for navigation around Rutherford
Island and the bridge can be opened as soon as possible for an
emergency situation.
    The bridge owner, Maine Department of Transportation, requested a
temporary deviation from the normal operating schedule to facilitate
test boring operations.
    Under this temporary deviation the SR129 Bridge may delay bridge
openings by up to ten minutes between 10 a.m. and 2 p.m. on July 15,
2013 to facilitate moving a test boring rig out of the channel.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: July 1, 2013.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2013-16808 Filed 7-12-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Pages 75460-75462]
[FR Doc No: 2016-26136]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79153; File No. SR-OPRA-2016-02]

Options Price Reporting Authority; Notice of Filing and Immediate
Effectiveness of Proposed Amendment to the Plan for Reporting of
Consolidated Options Last Sale Reports and Quotation Information To
Amend OPRA's Non-Display Use Fees

October 25, 2016.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given that
on September 29, 2016, the Options Price Reporting Authority (``OPRA'')
submitted to the Securities and Exchange Commission (``Commission'') an
amendment to the Plan for Reporting of Consolidated Options Last Sale
Reports and Quotation Information (``OPRA Plan'').\3\ The OPRA Plan
Amendment would implement changes to OPRA's Non-Display Use Fees on
November 1, 2016. The Commission is publishing this notice to provide
interested persons an opportunity to submit written comments on the
OPRA Plan amendment.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ The OPRA Plan is a national market system plan approved by
the Commission pursuant to Section 11A of the Act and Rule 608
thereunder. See Securities Exchange Act Release No. 17638 (March 18,
1981), 22 SEC Docket 484 (March 31, 1981). The full text of the OPRA
Plan is available at http://www.opradata.com. The OPRA Plan provides
for the collection and dissemination of last sale and quotation
information on options that are traded on the participant exchanges.
The fourteen participants to the OPRA Plan are BATS BZX Exchange,
Inc., BATS EDGX Exchange, Inc., BOX Options Exchange, LLC, Chicago
Board Options Exchange, Incorporated, C2 Options Exchange,
Incorporated, International Securities Exchange, LLC, ISE Gemini,
LLC, ISE Mercury, LLC, Miami International Securities Exchange, LLC,
NASDAQ BX, Inc., NASDAQ PHLX LLC, The NASDAQ Stock Market LLC, NYSE
MKT LLC, and NYSE Arca, Inc.
---------------------------------------------------------------------------

I. Description and Purpose of the Plan Amendment

    OPRA proposes to amend footnotes 10 and 11 in the OPRA Fee Schedule
to clarify the application of OPRA's ``Non-Display Use'' fees in
certain respects.\4\ OPRA is not proposing any changes in the Non-
Display Use fees themselves, although OPRA does propose to add the word
``Monthly'' to the first phrase in the Non-Display Use Fee entry in the
Fee Schedule.
---------------------------------------------------------------------------

    \4\ OPRA proposed its current Non-Display Use fees in Securities
Exchange Act Release No. 77584 (April 12, 2016), 81 FR 22670 (April
18, 2016) (File No. OPRA-2015-01).
---------------------------------------------------------------------------

(a) Elimination of the Term ``Datafeed''

    OPRA proposes to eliminate the use of the term ``datafeed'' in
footnotes 10 and 11. Some OPRA Vendors have argued that the use of the
term ``datafeed'' in these footnotes provides a basis for saying that
the Non-Display Use fees are not applicable to their downstream OPRA
data recipients. That argument is based on a separate OPRA Policy
entitled ``Datafeeds.'' \5\ In that Policy, the term ``datafeed'' is
defined as ``any uncontrolled retransmission of OPRA market data.'' The
argument has been that an OPRA Vendor and its downstream data
recipients are not making Non-Display Use of OPRA data if the Vendor
``controls''--that is, entitles--the server on which the Non-Display
Use of the OPRA data is made.
---------------------------------------------------------------------------

    \5\ This Policy is available on the OPRA Web site under the
``Policies'' tab.
---------------------------------------------------------------------------

    From OPRA's perspective, this is clearly incorrect. The Datafeeds
Policy is directed to describing how OPRA data is received, in order to
explain the circumstances in which an OPRA data recipient needs to be a
party to a ``Vendor Agreement'', a ``Direct Access Rider'' and/or an
``Indirect Access Rider''. The Datafeeds Policy is not relevant to the
question of how OPRA data is used, specifically the question of whether
a particular use of OPRA data constitutes ``Non-Display Use.'' OPRA
believes that the Datafeeds Policy is irrelevant to the question of the
applicability of Non-Display Use fees.
    Nonetheless, OPRA recognizes that the use of the term ``datafeed''
in separate OPRA documents with

different meanings carries the potential for confusion and that the
description of OPRA's fees should be as clear as possible. Accordingly
OPRA is proposing to amend footnotes 10 and 11 in its Fee Schedule so
that the term ``datafeed'' is no longer used in the footnotes.

(b) Exception for Category 1 Non-Display Use by a Single UserID on
Behalf of Certain Data Recipients

    OPRA also proposes to add a sentence in footnote 10 to state that
the Category 1 Non-Display Use Fee \6\ does not apply to an OPRA data
recipient during a calendar month if the data recipient: ``(i) has a
single UserID that uses OPRA data for Non-Display Use and (ii) is not a
broker-dealer and does not place more than 390 orders in listed options
per day on average during the calendar month (counting orders for this
purpose in accordance with the rules of the OPRA Participant exchanges
to which it submits orders during the month) for its own beneficial
account(s).'' This sentence is intended to provide relief from the
Category 1 Non-Display Use Fee for a data recipient that has a single
UserID (a single natural person) that uses OPRA data for Category 1
Non-Display Use, unless the OPRA data recipient is acting as a broker-
dealer or is submitting orders to the OPRA Participant exchanges at a
rate (390 orders per day on average over a calendar month) that
indicates that it is making extensive use of OPRA data. Clause (ii) of
this sentence is phrased to take advantage of language in the rules of
the various OPRA Participant exchanges that uses the ``390 orders per
day on average during the calendar month'' concept for purposes of
determining whether a person submitting trades to the exchanges is
subject to rules applicable to public customers or to professional
traders. OPRA understands the rules of the various exchanges to be
similar enough in substance to allow for effective and meaningful
counting of orders sent to all of the OPRA Participant exchanges, even
though these rules are not stated in identical language.\7\ OPRA
believes that the same concept provides a reasonable basis for
distinguishing data recipients that are appropriately exempted from the
Category 1 Non-Display Use fee.\8\ OPRA believes that this exemption
from the application of the Category 1 Non-Display Use Fee would be
similar to one of the exemptions stated in the OPRA Fee Schedule from
the Subscriber Indirect Access Fee, which states that the Subscriber
Indirect Access Fee ``shall not apply to a subscriber . . . that
receives a data feed transmission on a single, stand-alone computer for
the sole purpose of providing a single-screen display of OPRA Data for
the subscriber's internal use.''
---------------------------------------------------------------------------

    \6\ ``Category 1'' Non-Display Use is defined in footnote 10 to
refer to Non-Display Use of OPRA data by a recipient of the data
``on its own behalf.''
    \7\ Although the precise language used by the various exchanges
to make this distinction varies from one to the next, all of the
exchanges use the ``390 orders per day on average during the
calendar month'' concept, and their specific provisions for counting
orders are similar enough to permit accurate counting of orders
across exchanges for the purposes of the distinction described in
the text. See, for example, Bats BZX Rules 16.1(a)(46) and
Interpretations and Policies .01 to Rule 16.1; BOX Options Exchange
LLC Rule 100(a)(50); CBOE Rule 1.1(ggg); ISE Rule 100(a)(37A) and
Rule 100(a)(37C); MIAX Rule 100 (definition of ``Priority Customer''
including Interpretation and Policy .01); Nasdaq PHLX LLC Rule
1000(b)(14); and NYSE Arca, Inc. Rule 6.1A(a)(4A).
    \8\ OPRA believes that it is not appropriate to make the same
distinction for Category 2 Non-Display Use fees (Category 2 Non-
Display Use is Non-Display Use of OPRA data on behalf of clients of
the OPRA data recipient) or for Category 3 Non-Display Use fees
(Category 3 Non-Display Use is for the purpose of internally
matching buy and sell orders within the OPRA data recipient).
---------------------------------------------------------------------------

(c) Clarification With Respect to Non-Display Use Fees and Professional
Subscriber Device-Based Fees

    OPRA is also proposing a separate change in footnote 10 to the OPRA
Fee Schedule for a purpose relating to the administration of the Non-
Display Use Fees. A few OPRA data recipients have tried to suggest that
if a device is subject to the Professional Subscriber Device-Based Fees
it is immune from Non-Display Use Fees, and that therefore by attaching
a display monitor to a server an OPRA data recipient can avoid payment
of Non-Display Use Fees even if the server is used for Non-Display Use
of OPRA data. OPRA believes that this is clearly incorrect, and that
this can be clearly seen in the first sentence of footnote 10 in its
current form (``Non-Display Use refers to the accessing, processing or
consuming . . . of OPRA market data . . . for a purpose other than in
support of the datafeed recipient's display or further internal or
external redistribution.'' (Emphasis added.)) Nonetheless, OPRA
believes that it is appropriate to make changes in footnote 10 to make
clearer that a device is subject both to the Professional Subscriber
Device-Based Fees and to Non-Display Use Fees if it is used both to
display OPRA data and for Non-Display Use of OPRA data.

(d) Addition of the Word ``Monthly'' in the Non-Display Use Fee Entry
in the Fee Schedule

    OPRA proposes to add the word ``Monthly'' to the heading of the
Non-Display Use Fee entry in its Fee Schedule, so that the entry reads
``Monthly Non-Display Use Fees.'' The absence of this word was recently
brought to the attention of OPRA staff. The word is used in the other
entries in OPRA's Fee Schedule that are for monthly fees, and OPRA
believes that for clarity the word should be used in this entry as
well.\9\ So far as OPRA staff is aware, no OPRA data recipient has
relied on the absence of the word to conclude that the Non-Display Use
fees are payable on any basis other than monthly.
---------------------------------------------------------------------------

    \9\ OPRA's original filing for Non-Display Use did clearly
identify the fees as monthly. See Securities Exchange Act Release
No. 77584, 81 FR 22760 at 22762 (``The OPRA Plan amendment adopted
fees for Non-Display Use as follows: A monthly fee of $2,000/
Enterprise for Category 1 . . .; a monthly fee of $2,000/Enterprise
for Category 2 . . .; and a monthly fee of $2,000/Platform for
Category 3 . . .'').
---------------------------------------------------------------------------

(e) Effect on OPRA Revenue of Proposed Changes; Discussions With Data
Recipients

    OPRA does not anticipate any material increase in its revenues as a
result of the changes described in this filing--indeed, on balance,
OPRA may not experience any increase at all in its revenues as a result
of the changes described in this filing. A few OPRA data recipients
that have resisted payment of Non-Display Use fees on the basis of the
assertion that they are not receiving the data through ``datafeeds''
will no longer be able to make that assertion, possibly resulting in a
small increase in OPRA's revenues. On the other hand, there may be
recipients of OPRA data that have been paying Category 1 Non-Display
Use fees and that may no longer pay them as a result of the express
exemption from Category 1 Non-Display Use fees for certain data
recipients with a single UserID that use OPRA data for Category 1 Non-
Display Use. OPRA believes that the change described in this filing to
make more explicit that payment of Device-based Fees does not make Non-
Display Use fees inapplicable will have no material effect on its
revenues.
    OPRA believes that the most important of these changes is the
deletion of the term ``datafeed'' in the footnotes to its Fee Schedule,
not because of its effect on OPRA revenues, but because of concerns
expressed to OPRA staff by data recipients that have been paying the
Non-Display Use fees

and have recently been told that their competitors may not be paying
the fees on the basis of the ``datafeed'' argument. OPRA recognizes
that equal treatment for persons similarly situated is an essential
aspect of its operations, and believes that elimination of the word
``datafeed'' is important to providing equal treatment for persons
making Non-Display Use of OPRA data. Similarly, OPRA believes that it
is appropriate to provide relief from the Non-Display Fee for all data
recipients that make limited Category 1 Non-Display Use of OPRA data
within the scope of the exception. Finally, OPRA believes that it is
appropriate to reinforce the concept that Non-Display Use Fees would be
applicable if Non-Display Use is being made of OPRA data, even if the
Non-Display Use is being made on a device that is subject to
Professional Subscriber Device-Based Fees, again in furtherance of the
fundamental concept that persons similarly situated should be treated
equally.
    The text of the amendment to the OPRA Plan is available at OPRA,
the Commission's Public Reference Room, the OPRA Web site at http://opradata.com, and on the Commission's Web site at www.sec.gov.

II. Implementation of the OPRA Plan Amendment

    Pursuant to paragraph (b)(3)(i) of Rule 608 of Regulation NMS under
the Act, OPRA designated this amendment as establishing or changing
fees or other charges collected on behalf of all of the OPRA
Participant exchanges in connection with access to or use of OPRA
facilities. OPRA proposes to implement the revisions in the Non-Display
Use Fee footnotes that are described in this amendment on November 1,
2016. According to OPRA, implementation of the revisions as of that
date will permit OPRA to provide persons that may be affected by these
changes with thirty days' notice of the changes.
    The Commission may summarily abrogate the amendment within sixty
days of its filing and require refiling and approval of the amendment
by Commission order pursuant to Rule 608(b)(2) under the Act \10\ if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or the
maintenance of fair and orderly markets, to remove impediments to, and
perfect the mechanisms of, a national market system, or otherwise in
furtherance of the purposes of the Act.\11\
---------------------------------------------------------------------------

    \10\ See 17 CFR 242.608(b)(2).
    \11\ See 17 CFR 242.608(b)(3)(iii).
---------------------------------------------------------------------------

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the OPRA Plan
amendment is consistent with the Act. Comments may be submitted by any
of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-OPRA-2016-02 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-OPRA-2016-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the OPRA Plan amendment that are
filed with the Commission, and all written communications relating to
the OPRA Plan amendment between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of OPRA. 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-OPRA-2016-02 and should be
submitted on or before November 21, 2016.

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2016-26136 Filed 10-28-16; 8:45 am]
 BILLING CODE 8011-01-P


Beryllium Facility #2 – Plant Diagram

Photo #1 – shows a view of the machine shop, lathes and a lathe
operator.   The lathe operator manually inserts 10-12 foot metal rods
(containing 1% to 2% beryllium) into the long tubes seen in the
photograph.  In this photo the cutting shield which is used to control
cutting fluid splashes is in the up position with the operator preparing
for a run.  During operation the shield is down and the lathe
automatically feeds metal rods to the cutting end of the lathe.

Photo #2 – metal rods are automatically fed to the cutting end of the
lathe where the final product and cutting fluid flow into a trough where
the pins are collected.  The machinist stands at the cutting end, but
moves around throughout the machine shop to monitor the operation of the
lathes and collect random samples for inspection to ensure proper
operation of the lathes.  Cutting fluid is used to aid the cutting
process, to extend the life of the cutting tools and to control and
contain the release of dusts.

Photo #3 - An Air King M-35P downdraft booth was the lone operation
equipped with local exhaust ventilation.  The booth is approximately 6
feet high by 3 feet wide and 2 feet deep, and is equipped with a HEPA
filter and is exhausted to the outdoors.  The operator stands at the
face of the booth to grind and buff small diameter rods.  The booth is
used on an intermittent as needed basis to chamfer smaller diameter rods
on a bench grinder/buffer contained within the booth.

 PAGE

 PAGE   21


Wyeth Consumer Healthcare’s data received per 40 CFR 82.13(u); classified as Confidential Business Information (CBI).

CBI located at EPA headquarters 1310 L St NW.

 PAGE

 PAGE   1


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62807-62809]
[FR Doc No: 2013-24570]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70614; File No. SR-NASDAQ-2013-129]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Its Schedule of Fees and Credits Applicable to Execution and
Routing of Orders in Securities Priced at $1 or More per Share Under
Rule 7018

October 4, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on September 27, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been prepared by NASDAQ.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    NASDAQ is proposing amend its schedule of fees and credits
applicable to execution and routing of orders in securities priced at
$1 or more per share under Rule 7018. NASDAQ will implement the
proposed rule change on October 1, 2013.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange 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
    NASDAQ is proposing several changes to its schedule of fees and
credits applicable to execution and routing of orders in securities
priced at $1 or more per share under Rule 7018. First, NASDAQ currently
offers a credit of $0.0020 per share executed for midpoint pegged and
midpoint post-only orders (``midpoint orders'') that provide liquidity
if a member provides an average daily volume of more than 5 million
shares through midpoint orders during the month and the member's
average daily volume of liquidity provided through midpoint orders
during the month is at least 2 million shares more than in April 2013.
NASDAQ is proposing to eliminate this pricing tier for midpoint orders,
because no member has ever qualified for it. Accordingly, NASDAQ
believes that the tier has been ineffective at encouraging

members to make greater use of midpoint orders, and may be eliminated
without member impact. Under tiers that will remain in place, NASDAQ
pays a credit of $0.0017 per share executed for midpoint orders if the
member provides an average daily volume of 5 million or more shares
through midpoint orders during the month (without any requirement for
an increase above prior levels), and a credit of $0.0014 per share
executed for midpoint orders if the member provides an average daily
volume of less than 5 million shares through midpoint orders during the
month.
    Second, NASDAQ is modifying certain routing fees applicable to
orders routed to NASDAQ OMX PSX (``PSX''), so that the applicable fees
for routing to that venue will be generally consistent with fees for
routing to other venues. Specifically, NASDAQ currently charges $0.0028
per share executed for orders using the SOLV or SAVE routing strategies
\3\ that execute at PSX, while charging $0.0030 per share executed when
such orders execute at most other venues.\4\ NASDAQ is increasing the
fee for routing to PSX to match the $0.0030 per share executed fee for
other most venues. Similarly, NASDAQ currently charges $0.0028 per
share executed for order using the TFTY routing strategy \5\ that
execute at PSX, while charging $0.0030 per share executed when such
orders execute at the New York Stock Exchange (``NYSE'').\6\ NASDAQ is
increasing the fee for routing to PSX to match this $0.0030 per share
executed fee. The changes are designed to increase revenue in a period
of persistent low trading volumes and to simplify the routing fee
schedule. The changes are unlikely to have a significant impact on
members that use NASDAQ's routing services, since relatively few routed
orders are executed at PSX.
---------------------------------------------------------------------------

    \3\ SAVE is a routing option under which orders may either (i)
route to BX and PSX, check the NASDAQ book for available shares, and
then route to other destinations on the applicable routing table, or
(ii) may check NASDAQ first and then route to destinations on the
applicable routing table. If shares remain un-executed after
routing, they are posted to the book. Once on the book, if the order
is subsequently locked or crossed by another market center, NASDAQ
will not route the order to the locking or crossing market center.
SOLV is a routing option under which orders may either (i) route to
BX and PSX, check NASDAQ, and then route to other destinations on
the applicable routing table, or (ii) may check NASDAQ first and
then route to destinations on the applicable routing table. If
shares remain un-executed after routing, they are posted to the
book. Once on the book, if the order is subsequently locked or
crossed by another accessible market center, NASDAQ will route the
order to the locking or crossing market center.
    \4\ The exception is NASDAQ OMX BX (``BX''). For SAVE and SOLV
orders that execute at BX, NASDAQ charges no fee and pays no rebate,
reflecting the fact that BX itself pays a small credit with respect
to orders that access liquidity.
    \5\ TFTY is a routing option under which orders check NASDAQ for
available shares only if so instructed by the entering firm and are
thereafter routed to destinations on the applicable routing table.
If shares remain un-executed after routing, they are posted to the
book. Once on the book, if the order is subsequently locked or
crossed by another market center, the System will not route the
order to the locking or crossing market center.
    \6\ The routing table applicable to TFTY generally favors
routing destinations that charge no or low execution fees, and would
generally route to such destinations before routing to higher cost
destinations such as NYSE and PSX. For TFTY orders that execute at
BX (which pays a small credit for executions), NASDAQ charges no fee
and pays no rebate. For TFTY orders that execute at destinations
other than BX, PSX, and NYSE, NASDAQ charges $0.0005 per share
executed, consistent with the lower cost of routing to such
destinations.
---------------------------------------------------------------------------

    Third, NASDAQ is reducing the credit paid with respect to QCST and
QDRK orders \7\ that execute at BX from $0.0014 per share executed to
$0.0011 per share executed. The change will make the credit paid with
respect to orders routed to BX more consistent with the credits paid by
BX itself, which have been modified in recent months.\8\ In addition,
the change will reduce costs in a period of persistent low trading
volumes and is unlikely to have a significant impact on members that
use NASDAQ's routing services, since relatively few routed orders are
executed at BX.
---------------------------------------------------------------------------

    \7\ QDRK is a routing option under which orders check NASDAQ for
available shares and simultaneously route the remaining shares to
destinations on the applicable routing table that are not posting
Protected Quotations within the meaning of Regulation NMS. If shares
remain un-executed after routing, they are posted on the book. Once
on the book, if the order is subsequently locked or crossed by
another market center, NASDAQ will not route the order to the
locking or crossing market center.
     QCST is a routing option under which orders check NASDAQ for
available shares and simultaneously route the remaining shares to
destinations on the applicable routing table that are not posting
Protected Quotations within the meaning of Regulation NMS and to
certain, but not all, exchanges. If shares remain un-executed after
routing, they are posted on the book. Once on the book, if the order
is subsequently locked or crossed by another market center, NASDAQ
will not route the order to the locking or crossing market center.
    \8\ SR-BX-2013-054 (September 27, 2013); Securities Exchange Act
Release No. 70339 (September 6, 2013), 78 FR 56249 (September 12,
2013) (SR-BX-2013-051). Depending on volumes of orders routed to BX
in a given month, NASDAQ may receive a credit of either $0.0013 or
$0.0007 per share executed with respect to such orders. The
reduction of the credit paid by NASDAQ thereby reduces the extent to
which NASDAQ pays an extra credit to encourage the use of the QDRK
and QCST strategies, which were introduced earlier in the year but
which have seen a recent increase in use. Securities Exchange Act
Release No. 68839 (February 6, 2013), 78 FR 9957 (February 12, 2013)
(SR-NASDAQ-2013-014).
---------------------------------------------------------------------------

2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\9\ in general, and with
Sections 6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which NASDAQ operates or controls, and is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The change to eliminate the rebate tier applicable to midpoint
orders is reasonable because the tier has never applied to any members
since its inception and therefore the change will not result in a fee
increase. Similarly, the change is consistent with an equitable
allocation of fees and is not unfairly discriminatory because members
that use midpoint orders will continue to be eligible for the tiers for
which they currently qualify (either $0.0017 or $0.0014 per share
executed, depending on their volume levels). Accordingly, the change
will not affect the allocation of fees and rebates among members and
will not have a discriminatory impact on any members.
    The change with respect to fees for routing to PSX is reasonable
because it will make the applicable fees for routing to PSX consistent
with the fees for routing to other venues. Moreover, the change will
result in a modest increase of only $0.0002 per share executed for
SAVE, SOLV, and TFTY orders when they access liquidity on PSX. The
change is consistent with an equitable allocation of fees and not
unfairly discriminatory because it will eliminate an existing disparity
between the fees charged for routing to PSX and routing to certain
other destinations, thereby making the applicable fees more consistent.
In addition, the change is equitable and not unfairly discriminatory
because it affects only those members that opt to use NASDAQ's optional
routing services, and will in any event have a minimal impact because
few orders using the strategies execute at PSX.
    The change with respect to QCST and QDRK orders routed to BX is
reasonable because it will make the credit paid by NASDAQ more
consistent with the credit received by NASDAQ from BX with respect to
such orders. Moreover, the change will result in a modest decrease of
only $0.0003 per share executed with respect to the applicable

credit. The change is consistent with an equitable allocation of fees
and not unfairly discriminatory because it will reduce the extent to
which NASDAQ pays an extra credit to encourage the use of the QDRK and
QCST strategies, thereby making the credit paid to NASDAQ members more
consistent with credits paid by BX. In addition, the change is
equitable and not unfairly discriminatory because it affects only those
members that opt to use NASDAQ's optional routing services, and will in
any event have a minimal impact because few orders using the strategies
execute at BX.

B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\11\ NASDAQ notes
that it operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee levels
at a particular venue to be excessive, or rebate opportunities
available at other venues to be more favorable. In such an environment,
NASDAQ must continually adjust its fees to remain competitive with
other exchanges and with alternative trading systems that have been
exempted from compliance with the statutory standards applicable to
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, NASDAQ believes that the degree to which fee
changes in this market may impose any burden on competition is
extremely limited. In this instance, although the proposed change with
respect to midpoint orders has the effect of eliminating a rebate tier,
the tier had not been successful at encouraging greater use of midpoint
orders, and so its elimination is unlikely to have an impact on the
order routing decisions of NASDAQ members. Moreover, other incentive
tiers with respect to midpoint orders remain in place. Similarly, the
proposed changes with respect to routing fees are expected to have a
minimal effect on members that opt to use NASDAQ's routing services,
because few routed orders execute at PSX or BX; moreover, the amount of
the fee increase (for PSX) or credit reduction (for BX) is small. In
addition, numerous alternatives exist to the routing services offered
by NASDAQ. Thus, if any of the changes are [sic] unattractive to market
participants, it is likely that NASDAQ will lose market share as a
result. As a result of these considerations, NASDAQ does not believe
that the proposed changes will impair the ability of members or
competing order execution venues to maintain their competitive standing
in the financial markets.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and paragraph (f) of Rule 19b-4
thereunder.\13\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2013-129 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2013-129. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such
filing also will be available for inspection and copying at the
principal offices of the Exchange. 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-NASDAQ-2013-129, and should be submitted on or before
November 12, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-24570 Filed 10-21-13; 8:45 am]
BILLING CODE 8011-01-P


payable by death or maturity, without regard to any charges that may be
assessed upon such termination and before deduction of any outstanding
contract loan.
    (4) Cash surrender value means the amount available in cash upon
voluntary termination of a contract by its owner before it becomes
payable by death or maturity, after any charges assessed in connection
with the termination have been deducted and before deduction of any
outstanding contract loan.
    (5) Contract processing day means any day on which charges under
the contract are deducted from the separate account.

Sec.  270.8b-1  [Amended]

0
28. Amend Sec.  270.8b-1 by removing ``270.8b-32'' everywhere it
appears and adding ``270.8b-31'' in its place.

0
29. Amend Sec.  270.11a-2 by revising paragraphs (c) and (d) and
removing the parenthetical authority at the end of the section to read
as follows:

Sec.  270.11a-2  Offers of exchange by certain registered separate
accounts or others the terms of which do not require prior Commission
approval.

* * * * *
    (c) If the offering account imposes a front-end sales load on the
acquired security, then such sales load shall be a percentage that is
no greater than the excess of the rate of the front-end sales load
otherwise applicable to that security over the rate of any front-end
sales load previously paid on the exchanged security.
    (d) If the offering account imposes a deferred sales load on the
acquired security and the exchanged security was also subject to a
deferred sales load, then any deferred sales load imposed on the
acquired security shall be calculated as if:
    (1) The holder of the acquired security had been the holder of that
security from the date on which he became the holder of the exchanged
security; and
    (2) Purchase payments made for the exchanged security had been made
for the acquired security on the date on which they were made for the
exchanged security.
* * * * *

0
30. Revise Sec.  270.14a-2 to read as follows:

Sec.  270.14a-2  Exemption from section 14(a) of the Act for certain
registered separate accounts and their principal underwriters.

    (a) A registered separate account, and any principal underwriter
for such account, shall be exempt from section 14(a) of the Act (15
U.S.C. 80a-14(a)) with respect to a public offering of variable annuity
contracts participating in such account.
    (b) Any registered management investment company which has as a
promoter an insurance company and which offers its securities to
separate accounts of such insurance company that offer variable annuity
contracts and are registered under the Act as unit investment trusts
(``trust accounts''), and any principal underwriter for such investment
company, shall be exempt from section 14(a) with respect to such
offering and to the offering of such securities to trust accounts of
other insurance companies.
    (c) Any registered management investment company exempt from

section 14(a) of the Act pursuant to paragraph (b) of this section
shall be exempt from sections 15(a), 16(a), and 32(a)(2) of the Act (15
U.S.C. 80a-15(a), 80a-16(a), and 80a-31(a)(2)), to the extent
prescribed in Sec. Sec.  270.15a-3, 270.16a-1, and 270.32a-2 (Rules
15a-3, 16a-1, and 32a-2 under the Act), provided that such investment
company complies with the conditions set forth in Rules 15a-3, 16a-1,
and 32a-2 as if it were a separate account.

0
31. Revise Sec.  270.26a-1 to read as follows:

Sec.  270.26a-1  Payment of administrative fees to the depositor or
principal underwriter of a unit investment trust; exemptive relief for
separate accounts.

    For purposes of section 26(a)(2)(C) of the Act, payment of a fee to
the depositor of or a principal underwriter for a registered unit
investment trust, or to any affiliated person or agent of such
depositor or underwriter (collectively, ``depositor''), for bookkeeping
or other administrative services provided to the trust shall be allowed
the custodian or trustee (``trustee'') as an expense, provided that
such fee is an amount not greater than the expenses, without profit:
    (a) Actually paid by such depositor directly attributable to the
services provided; and
    (b) Increased by the services provided directly by such depositor,
as determined in accordance with generally accepted accounting
principles consistently applied.

Sec.  270.26a-2   [Removed]

0
32. Remove Sec.  270.26a-2.

Sec.  270.27a-1   [Removed]

0
33. Remove Sec.  270.27a-1.

Sec.  270.27a-2   [Removed]

0
34. Remove Sec.  270.27a-2.

Sec.  270.27a-3   [Removed]

0
35. Remove Sec.  270.27a-3.

Sec.  270.27c-1  [Removed and Reserved]

0
36. Remove and reserve Sec.  270.27c-1.

Sec.  270.27d-2  [Removed and Reserved]

0
37. Remove and reserve Sec.  270.27d-2.

Sec.  270.27e-1  [Removed and Reserved]

0
38. Remove and reserve Sec.  270.27e-1.

Sec.  270.27f-1   [Removed and Reserved]

0
39. Remove and reserve Sec.  270.27f-1.

Sec.  270.27g-1   [Removed and Reserved]

0
40. Remove and reserve Sec.  270.27g-1.

Sec.  270.27h-1  [Removed and Reserved]

0
41. Remove and reserve Sec.  270.27h-1.

0
42. Add Sec.  270.27i-1 to read as follows:

Sec.  270.27i-1  Exemption from Section 27(i)(2)(A) of the Act during
annuity payment period of variable annuity contracts participating in
certain registered separate accounts.

    A registered separate account, and any depositor of or underwriter
for such account, shall, during the annuity payment period of variable
annuity contracts participating in such account, be exempt from the
requirement of paragraph (1) of section 27(i)(2)(A) of the Act that a
periodic payment plan certificate be a redeemable security.

PART 274--FORMS PRESCRIBED UNDER THE INVESTMENT COMPANY ACT OF 1940

0
43. The general authority citation for part 274 continues to read as
follows:

    Authority:  15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m,
78n, 78o(d), 80a-8, 80a-24, 80a-26, 80a-29, and Pub. L. 111-203,
sec. 939A, 124 Stat. 1376 (2010), unless otherwise noted.
* * * * *

Sec.  274.11  [Removed and Reserved]

0
44. Remove and reserve Sec.  274.11.

0
45. Revise Form N-3 (referenced in Sec. Sec.  239.17a and 274.11b) to
read as follows:

    Note: The text of Form N-3 will not appear in the Code of
Federal Regulations.

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0
46. Effective January 1, 2022, Form N-3 (referenced in Sec. Sec.
239.17a and 274.11b) is further amended by:
0
 a. In Item 1, removing paragraph (a)(11); and
0
 b. In Item 31(a), removing Instruction 4(f).

0
47. Revise Form N-4 (referenced in Sec. Sec.  239.17b and 274.11c) to
read as follows:

    Note: The text of Form N-4 will not appear in the Code of
Federal Regulations.

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0
50. Effective January 1, 2022, Form N-6 (referenced in Sec. Sec.
239.17c and 274.11d) is amended by removing paragraph (a)(9) of Item 1.

Sec.  274.127e-1  [Removed]

0
51. Remove Sec.  274.127e-1.

Sec.  274.127f-1  [Removed]

0
52. Remove Sec.  274.127f-1.

Sec.  274.302  [Removed]

0
53. Remove Sec.  274.302.

Sec.  274.303  [Removed]

0
54. Remove Sec.  274.303.

    By the Commission.

    Dated: March 11, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-05526 Filed 4-30-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63651-63656]
[FR Doc No: 2018-26724]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0779]

Current Good Manufacturing Practice--Guidance for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the FD&C Act;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a revised draft guidance entitled
``Current Good Manufacturing Practice--Guidance for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the FD&C
Act.'' This revised draft guidance describes FDA's policies regarding
compounders registered under section 503B of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) as outsourcing facilities and the current
good manufacturing practice (CGMP) requirements in FDA regulations.
Based on feedback from stakeholders and comments received on the
initial draft guidance, the guidance is being revised, in part, to
reflect further consideration of how CGMP requirements should be
applied in light of the size and scope of an outsourcing facility's
operations.

DATES: Submit either electronic or written comments on the revised
draft guidance by February 11, 2019 to ensure that the Agency considers
your comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
concerning the collection of information under the Paperwork Reduction
Act of 1995 (PRA) proposed in the revised draft guidance by February
11, 2019.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0779 for ``Current Good Manufacturing Practice--Guidance for
Human Drug Compounding Outsourcing Facilities Under Section 503B of the
FD&C Act.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information

redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues under the PRA to
the Office of Management and Budget (OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title ``Current Good Manufacturing Practice--Guidance for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the FD&C
Act.''
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Marci Kiester, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2258, Silver Spring, MD 20993-0002, 301-
796-0600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Current Good Manufacturing Practice--Guidance for
Human Drug Compounding Outsourcing Facilities Under Section 503B of the
FD&C Act.'' Under section 503B(b) of the FD&C Act (21 U.S.C. 353b(b)),
a compounder can register as an outsourcing facility with FDA. Drug
products compounded in an outsourcing facility can qualify for
exemptions from FDA approval requirements in section 505 of the FD&C
Act (21 U.S.C. 355), the requirement to label products with adequate
directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)), and the drug supply chain security requirements in section
582 of the FD&C Act (21 U.S.C. 360eee-1), if the requirements in
section 503B are met. Outsourcing facilities are inspected by FDA
according to a risk-based schedule and must comply with other
provisions of the FD&C Act, including CGMP requirements under section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)). FDA intends to issue CGMP
regulations specific to outsourcing facilities. Until final regulations
are issued, this draft guidance describes FDA's policies regarding
outsourcing facilities and the CGMP requirements in 21 CFR parts 210
and 211.
    This draft guidance revises the draft guidance for industry
entitled ``Current Good Manufacturing Practice--Interim Guidance for
Human Drug Compounding Outsourcing Facilities Under Section 503B of the
FD&C Act,'' which published in July 2014 (79 FR 37743). This revised
draft guidance applies to drugs compounded in accordance with section
503B. In addition, this guidance generally applies to drugs that
outsourcing facilities repackage and biological products that
outsourcing facilities mix, dilute, or repackage in accordance with
relevant guidance for outsourcing facilities. This revised draft
guidance reflects FDA's intent to recognize the differences between
outsourcing facilities and conventional drug manufacturers and to
tailor CGMP requirements to the nature of the specific compounding
operations conducted by outsourcing facilities while maintaining the
minimum standards necessary to protect patients from the risks of
contaminated or otherwise substandard drug products.
    The comment period on the initial draft guidance ended on September
2, 2014. FDA received 26 comments on the draft guidance. In response to
received comments or on its own initiative, FDA made changes and
updates in the revised draft guidance as follows.
    FDA received a number of comments regarding the requirements in FDA
regulations applicable to nonsterile drug products because the draft
guidance focused primarily on sterile compounding. To address these
comments, the revised draft guidance differentiates between
requirements applicable to sterile drug products and nonsterile drug
products where appropriate. The revised draft guidance also
distinguishes the risks presented by using sterile and nonsterile
components in producing sterile drug products and offers
recommendations and policies on quality control commensurate with the
risk. Further, the revised draft guidance addresses concerns raised
regarding FDA's policies in several other areas. FDA made significant
revisions to address comments on (1) stability testing, including the
assignment of a beyond use date (BUD) as an expiration date; (2)
release testing; (3) the potential use of a drug master file to address
contract laboratory testing arrangements and testing of component
quality before use in compounding; (4) the use of accredited third-
party laboratories to perform testing; (5) a clear definition of ``in-
use time,'' distinguishing it from ``BUD'' and ``expiration date''; and
(6) reserve samples.
    We note that the default BUDs and storage conditions associated
with nonsterile drug products described in this revised draft guidance
differ from those described for nonsterile repackaged drug products in
FDA's guidance for industry entitled ``Repackaging of Certain Human
Drug Products by Pharmacies and Outsourcing Facilities'' (Repackaging
guidance). FDA believes that the BUDs described in this revised draft
CGMP guidance are also relevant to nonsterile drug products repackaged
by outsourcing facilities. When this guidance is finalized, we intend
to make conforming revisions to the BUDs for repackaged nonsterile drug
products in the Repackaging guidance, as appropriate.
    Finally, this revised draft contains revisions to the conditions
under which the Agency generally would not intend to take regulatory
action regarding the requirement to test the finished product before
release (see Sec.  211.165 (21 CFR 211.165)). These revisions make a
broader range of production volumes eligible for the relevant
enforcement policy, which we believe would encourage additional
compounders to register as outsourcing facilities. Compared to
compounders that are not registered under section 503B of the

FD&C Act, outsourcing facilities are subject to increased Federal
oversight through FDA inspection on a risk-based schedule, as well as
to additional standards that help to assure the quality of their
compounded drug products. Outsourcing facilities produce drug products
for hospitals, clinics, or healthcare practitioners to keep on hand as
``office stock'' for patients who present with an immediate need for
them. The revised draft guidance addresses standards critical to
reducing the risk of patient harm while balancing appropriate
flexibility. FDA is seeking public comment on whether the conditions
outlined in the revised draft appropriately balance the risks and needs
associated with drugs produced for office stock, including comments on
the production volumes specified in the guidance.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``Current
Good Manufacturing Practice--Guidance for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the FD&C Act.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from OMB for each collection of information that 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 for 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 collection of information associated with this
document, FDA invites comments on these topics: (1) Whether the
proposed information collected 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 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.

1. Quality Assurance Activities

    A quality control unit must be established by outsourcing
facilities to oversee various aspects of drug production and to monitor
quality assurance (see, e.g., Sec.  211.22 (21 CFR 211.22)). The
responsibilities of the quality control unit must be established in
procedures (Sec.  211.22(d)) and should include investigations and
development and oversight of appropriate corrective and preventive
actions regarding results of tests and examinations, unexpected results
or trends, failures that occur during validation or revalidation of
sterilization or depyrogenation processes, stability failures,
environmental and personnel monitoring results that exceed alert or
action limits, process deviations or equipment malfunctions that
involve critical equipment, and complaints that indicate possible drug
product contamination or other risks to patients. The quality control
unit must periodically (at least annually) review records of
compounding operations to evaluate the quality standards for each drug
product to determine the need for changes in specifications or control
procedures (21 CFR 211.180(e)).
    FDA estimates that annually approximately 74 outsourcing facilities
\1\ (``No. of Recordkeepers'' in table 1, row 1) will individually
establish approximately 13 procedures on the responsibilities of the
quality control unit (``No. of Records per Recordkeeper'' in table 1,
row 1) as described in section III.A of the guidance. FDA also
estimates that preparing and maintaining these procedures will take
approximately 3 hours for each record (``Average Burden per
Recordkeeping'' in table 1, row 1).
---------------------------------------------------------------------------

    \1\ This figure is based on the number of outsourcing facilities
that were registered on July 27, 2018.
---------------------------------------------------------------------------

2. Facility Design

    The revised draft guidance describes those elements of facility
design of outsourcing facilities that are considered critical to
assuring the quality of sterile drug products at those facilities. For
example, the draft guidance states that sterile drugs should be
produced only in ISO 5 (International Organization for Standardization)
or better air quality and that the ISO 5 zone or critical area must be
qualified (i.e., shown to meet the specifications) (see Sec. Sec.
211.42 and 211.113(b) (21 CFR 211.42 and 211.113(b))). The revised
draft guidance lists certain studies and tests that should be
successfully performed for outsourcing facilities and states that the
results of these studies and tests should be documented.
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 2) will individually document
approximately 20 studies and tests (``No. of Records per Recordkeeper''
in table 1, row 2) that are critical to assuring the quality of sterile
drug products. FDA also estimates that preparing and maintaining each
record as described in the guidance will take on average approximately
1.5 hours for each record (``Average Burden per Recordkeeping'' in
table 1, row 2).

3. Control Systems and Procedures for Maintaining Suitable Facilities

    The revised draft guidance describes procedures that should be
established and followed that assign responsibility for sanitation and
describe the cleaning schedules, methods, equipment, and materials to
be used in cleaning buildings and facilities. For multiuse facilities
and nondedicated equipment, changeover and cleaning procedures for
equipment and utensils must be established and followed to prevent
contamination (see Sec. Sec.  211.42 and 211.67). Procedures for
cleaning and disinfecting must also be established (see Sec. Sec.
211.42, 211.56, and 211.67). If powder drugs are handled, procedures
must be established and followed to appropriately manage cross-
contamination risk (Sec.  211.100 (21 CFR 211.100)). Processes and
procedures should minimize contamination risks posed by the number and
complexity of manipulations, number of simultaneous operations and
workstations, and staging of materials used in the process. Temperature
and humidity must be maintained in cleanrooms; such controls are
critical to reduce microbial growth (see 21 CFR 211.46). In addition,
the guidance describes that procedures should ensure recording of
instances when there is a loss of positive pressure in the cleanroom
during production.
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 3) will individually
establish and maintain approximately 6 records (procedures and
documentation) for

maintaining suitable outsourcing facilities (``No. of Records per
Recordkeeper'' in table 1, row 3). FDA also estimates that preparing
and maintaining each record as described in the guidance will take on
average approximately 5 hours for each record (``Average Burden per
Recordkeeping'' in table 1, row 3).

4. Environmental and Personnel Monitoring

    The revised draft guidance states that operations and appropriate
written procedures designed to prevent microbial contamination include
a well-defined and documented program for environmental monitoring that
evaluates the potential routes of microbial contamination of the human
drug that could arise from the air, surfaces, process, operation, and
personnel practices (see Sec. Sec.  211.42(c)(10)(iv), 211.100, and
211.113(b)). Personnel monitoring should include a routine program for
daily/shift monitoring of operators' gloves and an appropriate schedule
for monitoring other critical sites of the gown (e.g., gown sleeves for
hood work) during or immediately after completion of aseptic
operations; establish and justify limits that are based on the
criticality of the operation relative to the contamination risk to the
product; and call for an investigation of results that exceed the
established levels or demonstrate an adverse trend, a determination of
the impact on the sterility assurance of finished products intended to
be sterile, and the development and execution of appropriate corrective
actions. This monitoring should take place before planned disinfection
so that actual operating conditions are being assessed. In addition, an
outsourcing facility or its contract laboratory should establish
procedures for establishing the validity of media if microbiological
media used in performing tests, including environmental and personnel
monitoring, are not purchased from a qualified supplier.
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 4) will individually
establish approximately 1,200 environmental and personnel monitoring
procedures and records to document test results (``No. of Records per
Recordkeeper'' in table 1, row 4) for aseptic processing areas. FDA
also estimates that preparing and maintaining the environmental and
personnel monitoring procedures as described in the guidance will take
on average approximately 0.25 hours for each record (``Average Burden
per Recordkeeping'' in table 1, row 4).

5. Containers and Closures

    Scientifically sound and appropriate criteria for containers and
closures must be established to ensure that containers and closures
used for drug products are suitable for each drug product for which
they will be used (see Sec.  211.160(b) (21 CFR 211.160(b))).
Appropriate procedures must be established for testing the containers
and closures to determine whether they meet the criteria for use, and
the tests and results must be documented (see 21 CFR 211.84(d)(3) and
211.184). Procedures for storage, if appropriate, of sterilized
containers or closures must be established in a manner to prevent
contamination and to maintain sterility (see 21 CFR 211.80(a) and (b)).
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 5) will individually
establish and maintain approximately 300 procedures and pieces of
documentation for testing containers and closures (``No. of Records per
Recordkeeper'' in table 1, row 5) in the aseptic processing areas. FDA
also estimates that preparing and maintaining these procedures and
documentation as described in the guidance will take on average
approximately 0.25 hours for each record (``Average Burden per
Recordkeeping'' in table 1, row 5).

6. Equipment

    Procedures should be established and records maintained for routine
calibration and maintenance of equipment (mechanical, electronic, or
automated).
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 6) will individually
establish and maintain approximately 150 procedures and pieces of
documentation for the calibration and maintenance of equipment (``No.
of Records per Recordkeeper'' in table 1, row 6). FDA also estimates
that preparing and maintaining these records will take on average
approximately 0.25 hours for each record (``Average Burden per
Recordkeeping'' in table 1, row 6).

7. Components

    Procedures should be established and records maintained concerning
the source and quality of components such as raw materials or
ingredients used in producing nonsterile and sterile drug products at
outsourcing facilities. The revised draft guidance also states that FDA
generally does not intend to take regulatory action against an
outsourcing facility regarding testing components if an adequate
supplier quality agreement is in place and maintained appropriately.
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 7) will individually
establish and maintain approximately 150 records of testing to ensure
the quality of components used in producing drug products, as
recommended in the guidance (``No. of Records per Recordkeeper'' in
table 1, row 7). FDA also estimates that preparing and maintaining
these records will take on average approximately 4 hours for each
record (``Average Burden per Recordkeeping'' in table 1, row 7).

8. Production and Process Controls

    Production and process documentation and procedures, such as batch
records, must be established to assure the quality of drug products at
outsourcing facilities (see Sec.  211.100). Training on aseptic
technique, cleanroom behavior, gowning, and procedures covering aseptic
manufacturing area operations must be established (see 21 CFR
211.25(a)). The validation of sterilization operations (e.g., holding
vessels, filling equipment, lyophilizers) and periodic verification
activities and results must be documented (see Sec.  211.113(b)).
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 8) will individually
establish and maintain approximately 1,325 records pertaining to
production and process controls, such as validation procedures and
training, to ensure the quality of sterile drug products (``No. of
Records per Recordkeeper'' in table 1, row 8). FDA also estimates that
preparing and maintaining these records, as described in the guidance,
will take on average approximately 0.25 hours for each record
(``Average Burden per Recordkeeping'' in table 1, row 8).

9. Release Testing

    Drug products produced at outsourcing facilities must be tested to
determine whether they meet final product specifications before release
for distribution, and procedures for final release testing must be
established and followed (Sec. Sec.  211.165 and 211.167).
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 9) will individually
establish and maintain approximately 1,725 records pertaining to final
release testing of drug products, including release testing

procedures and documentation (``No. of Records per Recordkeeper'' in
table 1, row 9). FDA also estimates that preparing and maintaining
these records, as described in the guidance, will take on average
approximately 1.5 hours for each record (``Average Burden per
Recordkeeping'' in table 1, row 9).
    If sterility testing is not completed before release under certain
conditions described in Appendix A of the guidance, procedures should
be established that specify that if the product fails to meet a
criterion for sterility, all healthcare and other facilities that
received the product should be immediately notified of the test results
and provided with any appropriate information and recommendations to
aid in the treatment of patients; the notification should be
documented; and FDA should be notified in writing.
    FDA estimates that annually approximately 10 outsourcing facilities
(``No. of Respondents'' in table 2, row 1) will individually send
approximately 1 notification of test results to all healthcare and
other facilities that received the drug product and provide them with
any appropriate information and recommendations to aid in the treatment
of patients (No. of Disclosures per Respondent'' in table 2, row 1).
FDA also estimates that preparing and sending each notification will
take approximately 5 hours (``Average Burden per Disclosure'' in table
2, row 1).
    FDA also estimates that annually approximately 10 outsourcing
facilities (``No. of Respondents'' in table 3) will individually submit
to FDA 1 notification of the test results for any drug product that
fails to meet a sterility criterion (``No. of Responses per
Respondent'' in table 3). Preparing and submitting this information
will take approximately 5 hours per notification (``Average Burden per
Response'' in table 3).

10. Laboratory Controls

    Each laboratory used to conduct testing of components, in-process
materials, and finished drug products for outsourcing facilities must
follow written procedures for the conduct of each test and must
document the results; establish sampling and testing procedures to
ensure that components, in-process materials, and drug products conform
to the product specifications; keep complete records of all tests
performed to ensure compliance with established specifications and
standards, including examinations and assays; and, if using a validated
or an established compendial test, verify and document that the test
procedure works under the conditions of actual use (see Sec. Sec.
211.160 and 211.194).
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 10) will individually
establish and maintain approximately 200 laboratory records as
described in the guidance (``No. of Records per Recordkeeper'' in table
1, row 10). FDA also estimates that preparing and maintaining these
records will take on average approximately 0.5 hours for each record
(``Average Burden per Recordkeeping'' in table 1, row 10).

11. Stability/Expiration Dating

    Stability testing is used to ensure that a drug product will retain
its quality (e.g., strength) and remain sterile, if applicable, through
the labeled expiration date. The draft guidance states that procedures
established by outsourcing facilities for assessing the stability of
drug products must include the following: Using stability-indicating
test methods that are reliable, meaningful, and specific; evaluating
samples of the drug product in the same container-closure system in
which the drug product will be marketed; evaluating samples for
stability that are representative of the lot or batch from which they
were obtained and are stored under suitable conditions; and testing to
evaluate antimicrobial effectiveness for drug products labeled or
intended to be multiple dose (see Sec. Sec.  211.122, 211.160, and
211.166). The guidance states that regardless of whether an expiration
date or BUD to be used as an expiration date is used, container-closure
integrity testing and antimicrobial effectiveness testing (for products
labeled as multiple dose) are required to be completed before a batch
is released (see Sec. Sec.  211.166 and 211.167). Each of these studies
only needs to be conducted once for each formulation and container-
closure system, and a bracketing or matrixing approach can be
considered to minimize the amount of testing needed. Outsourcing
facilities are also responsible for including appropriate labeled
directions for use for drug products, which may include in-use time if
the product requires additional manipulation before administration.
Appropriate studies, including stability studies, would need to support
the stated in-use time.
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 11) will individually
establish and maintain approximately 75 procedures for stability
studies to determine an expiration date (``No. of Records per
Recordkeeper'' in table 1, row 11) for drug products. FDA also
estimates that preparing and maintaining these procedures as described
in the guidance will take approximately 5 hours for each record
(``Average Burden per Recordkeeping'' in table 1, row 11).
    FDA also estimates that annually approximately 74 outsourcing
facilities (``No. of Respondents'' in table 2, row 2) will add
approximately 540 expiration dates to the labeling of drug products
(``No. of Disclosures per Respondent'' in table 2, row 2). FDA also
estimates that preparing the labeling will take approximately 0.25
hours (``Average Burden per Disclosure'' in table 2, row 2).

12. Packaging and Labels

    Packaging of drugs must ensure the sterility, if applicable, and
integrity of the product until it is administered to a patient, product
labels must contain required information, and labeling operations must
include controls to prevent mixups (see Sec. Sec.  211.94, 211.122,
211.125, 211.130, and 211.134). The following must be implemented by
outsourcing facilities for packaging and labeling operations to ensure
the quality of drug products: The container, closure, and packaging
systems adequately protect against foreseeable external factors in
storage, shipment, and use that can cause contamination or
deterioration; packaging records include specimens or copies of all
labels used; adequate controls are established for issuing labels,
examining issued labels, and reconciling used labels to prevent mixups;
different labeling and packaging operations are adequately separated to
prevent mixups; and controls are established that ensure proper
identification of any filled containers of products that are stored
unlabeled for any period of time (see Sec. Sec.  211.94, 211.122,
211.125, 211.130, 211.134, and 211.188).
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 12) will individually
establish and maintain approximately 20 procedures for packaging and
labeling operations (``Records per Recordkeeper'' in table 1, row 12)
for drug products. FDA also estimates that preparing and maintaining
these procedures as described in the guidance will take approximately
5.5 hours for each record (``Average Burden per Recordkeeping'' in
table 1, row 12).

13. Reserve Samples

    An appropriately identified reserve sample that is representative
of each lot or batch of drug product must be retained and stored under
conditions

consistent with product labeling (21 CFR 211.170).
    FDA estimates that annually approximately 74 outsourcing facilities
(``No. of Recordkeepers'' in table 1, row 13) will individually
establish and maintain approximately 12 procedures and records for
reserve samples (``Records per Recordkeeper'' in table 1, row 13) for
drug products. FDA also estimates that preparing and maintaining these
procedures and records as described in the guidance will take
approximately 0.5 hours for each record (``Average Burden per
Recordkeeping'' in table 1, row 13).
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality assurance activities................              74              13             962  3.........................................           2,886
Facility design.............................              74              20           1,480  1.5.......................................           2,220
Control systems and procedures for                        74               6             444  5.........................................           2,220
 maintaining suitable facilities.
Environmental and personnel monitoring......              74           1,200          88,800  0.25 (15 minutes).........................          22,200
Containers and closures.....................              74             300          22,200  0.25 (15 minutes).........................           5,550
Equipment...................................              74             150          11,100  0.25 (15 minutes).........................           2,775
Components..................................              74             150          11,100  4.........................................          44,400
Production and process controls.............              74           1,325          98,050  0.25 (15 minutes).........................          24,513
Release testing.............................              74           1,725         127,650  1.5.......................................         191,475
Laboratory controls.........................              74             200          14,800  0.5 (30 minutes)..........................           7,400
Stability/Expiration dating.................              74              75           5,550  5.........................................          27,750
Packaging and labels........................              74              20           1,480  5.5.......................................           8,140
Reserve samples.............................              74              12             888  0.5 (30 minutes)..........................             444
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................         341,973
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
             Type of disclosure                  Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification that a drug product fails to                 10               1              10  5.........................................              50
 meet a sterility criterion.
An expiration date is added to the drug                   74             540          39,960  0.25 (15 minutes).........................           9,990
 product's label.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          10,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                     Table 3--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                         Type of reporting                              Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification to FDA that a drug product fails to meet a sterility                10                1               10                5               50
 criterion.........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: December 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26724 Filed 12-10-18; 8:45 am]
 BILLING CODE 4164-01-P