[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38349-38353]
[FR Doc No: 2014-15719]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72498; File No. SR-NFA-2014-04]

Self-Regulatory Organizations; National Futures Association;
Notice of Filing of Proposed Rule Change to the Interpretive Notice to
NFA Compliance Rules 2-4 and 2-36: Prohibition on the Use of Certain
Electronic Funding Mechanisms

June 30, 2014.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Exchange Act''),\1\ and Rule 19b-7 under the Exchange Act,\2\ notice
is hereby given that on June 18, 2014, National Futures Association
(``NFA'') filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change described in Items I and II
below, which Items have been substantially prepared by the NFA. The
Commission is publishing this notice to solicit comments on the
proposed rule from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(7).
    \2\ 17 CFR 240.19b-7.
---------------------------------------------------------------------------

    On June 18, 2014, NFA submitted the proposed rule change to the
CFTC for approval. The CFTC has not yet approved the proposed rule
change.

I. Self-Regulatory Organization's Description and Text of the Proposed
Rule Change

    Under the proposed Interpretive Notice to NFA Compliance Rules 2-4
and 2-36: Prohibition on the Use of Certain Electronic Funding
Mechanisms (``Interpretive Notice''), NFA Members (``Members'') are
prohibited from allowing customers to fund futures or forex accounts
with a credit card or other electronic funding methods tied to a credit
card. The proposed Interpretive Notice does not prohibit Members from
allowing customers to fund futures or forex accounts with electronic
funding mechanisms that are tied to a customer's bank account at a
financial institution provided the funds deposited are drawn directly
from the customer's bank account. The Interpretive Notice requires,
however, that the Member be able to distinguish, prior to accepting
funds, between an electronic funding method that draws money from the
customer's account at a financial institution and a traditional credit
card, and be able to reject the credit card transaction before
accepting funds. The Interpretive Notice also requires Members offering
this type of electronic funding mechanism to provide adequate risk
disclosure in light of the customer's financial circumstances.
    The text of the Interpretive Notice is available on NFA's Web site
at www.nfa.futures.org, the Commission's Web site at www.sec.gov, NFA's
office, 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, NFA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NFA 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
    Section 15A(k) of the Exchange Act \3\ makes NFA a national
securities association for the limited purpose of regulating the
activities of NFA Members who are registered as brokers or dealers
under Section 15(b)(11) of the Exchange Act.\4\ The proposed
Interpretive Notice applies to all NFA Members, including those that
are registered as security futures brokers or dealers under Section
15(b)(11) of the Exchange Act.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78o-3(k).
    \4\ 15 U.S.C. 78o(b)(11).
---------------------------------------------------------------------------

    NFA adopted the Interpretive Notice to NFA Compliance Rules 2-4 and
2-36 prohibiting Members from allowing customers to fund futures or
forex accounts with a credit card or other electronic payment methods
tied to a credit card after an extensive study and analysis done at the
direction of NFA's Compliance and Risk Committee (``CRC''). The CRC's
study and analysis found significant customer protection concerns with
credit card funding in the retail forex area, and therefore NFA's Board
of Directors, upon the recommendation of the CRC, determined the only
appropriate action was to adopt this prohibition. The prohibition is
entirely consistent with NFA's longstanding position that it is a
violation of NFA Compliance Rule 2-4, and inconsistent with just and
equitable principles of trade, for Members to

encourage customers to borrow money to invest.\5\
---------------------------------------------------------------------------

    \5\ See In the Matter of First Investors Group of Pal Beaches,
Inc., et.al., NFA Case No. 95-BCC-011 (November 12, 1999).
---------------------------------------------------------------------------

    Many Forex Dealer Members (``FDMs'') offer their retail forex
customers the ability to fund their accounts directly using a credit
card or via an online payment facilitator (e.g., PayPal) that is
commonly tied to a credit card (Payment Facilitator(s)--Credit). The
CRC had several concerns with this practice, including that retail
customers may be using credit cards to open accounts with funds that
are borrowed and, therefore, not risk capital. The CRC's concern had
significant merit since a 2012 review of several FDM Web sites showed
that those FDMs promoted credit funding as the ``quickest,''
``easiest,'' and ``fastest'' method of investing.
    Given its concern, the CRC began considering whether it would be
appropriate for NFA to prohibit its Members from allowing customers to
fund their accounts (both forex and futures) via a credit card or a
Payment Facilitator--Credit. As part of its consideration, the CRC
directed NFA staff to conduct a detailed analysis of FDM account
funding practices, customer income levels, and customer account funding
origins. The analysis covered approximately 15,500 accounts held at
seven FDMs--all of which were registered as retail foreign exchange
dealers (``RFED'')--during 2012. The results of this analysis revealed:
     Credit card funding restrictions varied among the FDMs.
Several permitted the use of a credit card up to $10,000 per
transaction. One firm based its restriction on a customer's income
level and a permitted customer with a net income between $0-$19,000 to
fund an account with as much as $1,000 through a credit card;
     The average life of a retail forex trading account at an
RFED was 4 months regardless of the amount of the initial deposit;
     For the 4th quarter 2013, 72% of the accounts analyzed
were unprofitable;
     78% of all accounts were initially funded via credit card/
debit card/online payment facilitator;
     Almost 50% of all account holders reported a net income of
$50,000 or less; and
     Deposits made by credit card/debit card/online payment
facilitator were markedly lower than deposits made by wires or checks.
For example, for customers with a net income less than $50,000, the
average deposit via credit card/debit card/online payment facilitator
was approximately $1,050 whereas for checks or wires it was
approximately $6,650. This difference was also prevalent at other net
income levels, including above $100,000 where the average deposit via
credit card/debit card/online payment facilitator was approximately
$2,450 whereas for checks or wires it was approximately $28,000.
    Given the prevalence of credit card usage by customers to initially
fund retail forex accounts and the fact that such a large percentage of
those customers had a relatively low income level ($50,000 or less),
the CRC reviewed whether the FDMs provide specific risk disclosures
regarding the implications of funding via a credit card or a Payment
Facilitator--Credit and learned that none of the FDMs warned customers
that they should not use a credit card or Payment Facilitator--Credit
to borrow money to invest in retail forex.
    The CRC found the data very disturbing from a customer protection
perspective because it reveals that lower income individuals
predominantly use credit cards or Payment Facilitators--Credit to fund
their accounts and the vast majority of these individuals lose their
funds trading forex. Although the CRC recognized that it is possible
that all lower income individuals pay off their credit card balances
each month and are not borrowing funds to invest beyond the payment due
date, the CRC concluded that this possibility is simply implausible
given the low income levels.
    NFA Compliance Rule 2-4 requires Members and their Associates to
observe high standards of commercial honor and just and equitable
principles of trade in the conduct of their commodity futures business.
Similarly, NFA Compliance Rule 2-36(c) requires Members and their
Associates to observe high standards of commercial honor and just and
equitable principles of trade in the conduct of their forex business.
The CRC concluded that permitting customers to utilize funding
mechanisms that by their very nature allow retail customers to borrow
funds to invest in markets where the risk of loss can be substantial
and a total loss may occur simply is not consistent with a Member's
obligation to observe high standards of commercial honor and just and
equitable principles of trade. Given NFA's analysis of the FDMs'
customers' usage of credit cards and Payment Facilitators--Credit, and
the fact that credit cards and Payment Facilitators--Credit readily
allow individuals to borrow funds to purchase goods and services, the
CRC concluded that without adequate mechanisms in place to ensure that
customers are not borrowing funds to invest in the highly volatile
futures and forex markets, Members should not be permitted to allow
their customers to invest via electronic funding mechanisms.
    The Interpretive Notice does not ban forms of electronic funding
mechanisms that are tied to a customer's bank account at a financial
institution, such as a debit card or a PayPal account tied to a bank
account. The CRC found that these funding mechanism are acceptable and
appear consistent with a Member's obligation to observe high standards
of commercial honor and just and equitable principles of trade because
when a customer uses an electronic funding mechanism directly tied to
an account at a financial institution, the customer has funds on hand
that are immediately transferred from the customer's bank account to
the Member, which significantly reduces the likelihood that funds are
being borrowed to invest. However, in order for a Member to allow
customers to use electronic funding mechanisms, the Member must be able
to distinguish between those electronic funding mechanisms tied to a
credit card and those tied to a bank account and reject the ones tied
to a credit card.\6\
---------------------------------------------------------------------------

    \6\ One FDM indicated that it currently uses a third-party
provider to process credit and debit card transactions when they are
initiated by the customer. Accordingly, the third-party provider
uses a programming code, which allows its front-end processer to
identify whether a card is a credit or debit card based on the
digits listed on the card. This front-end processing system has the
ability to identify the card as a debit card even if the customer
elected to process the card as a credit transaction. In other words,
the system programming can distinguish between a debit card issued
by a bank with monies drawn from a checking or savings account, or a
traditional credit card. The third party provider is able to
automatically reject transactions that are credit card transactions.
---------------------------------------------------------------------------

    Under the Interpretive Notice, if a Member offers customers the
ability to use an electronic funding mechanism, then the Member must
utilize a processing system or some other electronic mechanism that can
ensure the funding device is a debit card or some other payment
facilitator that is tied directly to the customer's bank account at a
financial institution. Moreover, any Member offering this type of
funding mechanism, must also ensure that adequate risk disclosure is
provided to customers in light of the customers' financial
circumstances.
2. Statutory Basis
    NFA believes that the proposed rule change is authorized by, and
consistent with, Section 15A(k)(2)(B) of the

Exchange Act.\7\ That section sets out requirements for rules of a
futures association, registered under Section 17 of the Commodity
Exchange Act, that are a registered national securities association for
the limited purpose of regulating the activities of members who are
registered as brokers or dealers in security futures products pursuant
to Section 15(b)(11) of the Exchange Act. Under Section 15A(k)(2)(B),
the rules of such a limited purpose national securities association
must be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, and, in
general, to protect investors and the public interest in connection
with security futures products in a manner reasonably comparable to the
rules of a registered national securities association registered
pursuant to Section 15A(a) that are applicable to securities futures
products. NFA believes the proposed rule change meets these
requirements because NFA determined that permitting customers to use
credit cards to fund futures and forex accounts was inconsistent with
just and equitable principles of trade and the proposed Interpretive
Notice prohibits Members from permitting customers to use credit cards
to fund accounts.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3(k)(2)(B).
---------------------------------------------------------------------------

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

    NFA recognizes that the proposed rule change may impose a minor
burden on competition with respect to foreign customers that might be
able to use credit cards to fund accounts with foreign intermediaries
that are not Members of NFA. NFA concluded, however, that any burden
was outweighed by the need to adopt appropriate customer protection
measures. NFA also concluded that the burden was minimized by the fact
that the Interpretive Notice permits Members to offer customers the
ability to use an electronic funding mechanism that draws funds
directly from the customer's account at a financial institution,
provided the Member is able to distinguish between those electronic
funding mechanisms drawing funds directly from the customer's account
at a financial institution and those tied to a credit card and reject
those transactions tied to a credit card.

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

    The CRC requested feedback on the concept of prohibiting Members
from allowing customers to fund their forex or futures accounts with a
credit card or Payment Facilitator--Credit from NFA's Futures
Commission Merchant (``FCM''), Introducing Broker (``IB''), Commodity
Pool Operator (``CPO'') and Commodity Trading Advisor (``CTA'')
Advisory Committees. Each of these Committees fully supported a ban of
this practice for both futures and forex accounts. Given the importance
of this issue, the CRC did not obtain the views of NFA's FDM Advisory
Committee--which had recently lost most of its representatives due to
FDM withdrawals and consolidations--but rather obtained the FDMs' views
by issuing a Notice to all FDMs requesting their comments. The CRC also
met with affected members of the FDM community to further discuss their
comments.
    Specifically, NFA received comments from five of NFA's 17 FDMs (one
of which was filed by a law firm on behalf of the FDM), the Financial
Services Roundtable (``FSR'') and a retail forex customer. All but one
FDM strongly opposed a ban against FDMs accepting credit cards from
customers to fund forex trading accounts. Despite the fact that credit
card funding was not ``an insignificant portion'' of its business, this
FDM did not object to the proposed ban but requested a 60-day
implementation period in order to make operational changes to reject
credit card transactions while permitting debit card transactions and
to educate clients about the ban.
    The CRC carefully considered all of the comments received. Below is
a summary of the material comments and the CRC's response.
     Forex customers must react to market changes during non-
banking hours and credit cards are the only funding method to do so,
while checks or wire transfers often take too long to be credited to
prevent a margin close-out.
     Credit cards are more economical since FDMs do not charge
a fee to use them while banks charge fees for wire transfers and use of
Automated Clearing House (``ACH'').
     Credit card funding is one of the fastest, most
convenient, and lowest cost funding vehicles.
     Many FDMs represented to NFA that customers need to use
credit cards in order to quickly add funds in order to avoid forced
liquidation of their positions.
    The CRC recognized that credit cards may provide an efficient and,
in some instances, economical method for depositing funds into a
trading account. The CRC believed, however, that this benefit is vastly
outweighed by the risk associated with a customer borrowing funds to
invest in futures or forex. Moreover, the CRC believed that the
efficient and economical benefits of credit card funding can be
retained by permitting Members to offer customers the ability to use an
electronic funding mechanism that draws funds directly from the
customer's account at a financial institution, provided the Member is
able to distinguish between those electronic funding mechanisms drawing
funds directly from the customer's account at a financial institution
and those tied to a credit card and reject those transactions tied to a
credit card.
    Additionally, NFA's analysis revealed that very few forex positions
overall are auto-liquidated, customers generally add funds to their
account using the same method as their initial funding method, and
positions in accounts funded through a credit card are not less likely
to be auto-liquidated. In fact, NFA's analysis showed that those
accounts funded through a credit card actually had positions auto-
liquidated more frequently than those accounts funded through
traditional methods, although the percentage of auto-liquidations
remained relatively low.
     Funds deposited by traditional methods may ultimately be
drawn from credit sources.
    The CRC acknowledged that the prohibition could be circumvented
because accounts funded with deposits using traditional methods may
ultimately be drawn from credit sources. The CRC, however, concluded
that banning the direct use of credit cards would lessen the likelihood
of this occurrence because a customer can make an instantaneous
decision to use a credit card, whereas other forms of credit generally
take longer to obtain and provide the customer with more time to
consider the consequences of borrowing funds to invest. Moreover, the
CRC felt that credit cards are funding mechanism that lend themselves
to borrowing funds and permitting this type of funding mechanism is
directly contrary to NFA's longstanding position that it is a violation
of NFA Compliance Rule 2-4, and inconsistent with just and equitable
principles of trade, for Members and Associates to encourage customers
to borrow money to invest.
     The ban is overly broad since alternative payment
facilitators (e.g., PayPal, MoneyBookers and Google Checkout) may be
funded through a bank account or other debit sources.
    The CRC addressed this comment by providing that the ban did not
apply to electronic payment methods that are

tied to a bank account at a financial institution provided that the
Member is able to distinguish between electronic payment mechanisms
that are tied to a bank account and traditional credit card
transactions and reject the credit card transactions before accepting
funds.
     FDMs have other procedures in place to ensure that
customers only use risk capital even if the source is a credit card.
     NFA has other rules that ensure that customers do not
invest funds in excess of risk capital (Rule 2-36 ``know your
customer,'' risk disclosure requirements, and guidance requiring FCMs
to prominently disclose that customers should only fund with risk
capital).
    The CRC acknowledged that NFA had other rules in place to guard
against customers investing in excess of risk capital and that FDMs
should have other procedures in place to ensure customers only use risk
capital even if the source was a credit card. The CRC concluded,
however, that based on the analysis conducted and the fact that credit
cards by their nature permit easy access to borrowed funds any
disclosure alone is an insufficient customer protection measure to
address the issue.
     Banks that issue credit cards consider a customer's credit
worthiness in determining the customer's credit limit, which is a built
in risk safeguard.
    The CRC did not believe this provided a credible rationale to
permit credit card funding. Retail customers should not be borrowing
funds to invest in futures or forex. Regardless of the credit limit
determined by a bank, a customer should not be using borrowed funds to
invest in the volatile futures or forex markets where the risk of loss
may be substantial.
     Certain foreign jurisdictions permit credit card funding.
     Credit cards are permitted in numerous industries in which
``customer funds are put at risk with far fewer safeguards than retail
forex trading,'' including the New York State Lottery, which provides
customers the option of signing up for subscriptions to certain lottery
games using credit cards, and the Nassau County New York OTB permits
individuals to make deposits via credit card to their permanent
wagering account.
    The CRC was not persuaded by the comment that many foreign
jurisdictions permit customers to use credit cards to fund forex
accounts. The CRC felt that the customer protection concerns raised by
this practice were far too disturbing and the fact that foreign
jurisdictions may permit this practice did not outweigh these concerns.
The CRC also found entirely unpersuasive the fact that other
industries, particularly off-track betting parlors or lottery related
agencies, permitted customers to use credit cards.
     The FDMs opposing a ban on funding via a credit card
recommended that NFA address this issue short of imposing a
prohibition. For example, these FDMs believe that NFA should do one or
more of the following--prohibit heavy promotion of credit card funding,
require account withdrawals to go back to the original funding credit
card, establish a monthly deposit cap for credit card funding, enhance
disclosures regarding risk capital usage, issue prominent warnings
regarding credit card usage to underscore the risks of using this
funding means if a customer does not have sufficient bank funds to
cover the deposit, and recommending that customers pay off credit card
balances monthly by the due date.
    The CRC considered other alternatives and concluded that given the
customer protection concerns raised, and the fact that credit cards are
any easy source of borrowed funds, the only way to address the issues
was to prohibit Members from allowing customers to use credit cards or
other electronic methods unless the Member could distinguish between
electronic payments that are tied to a bank account and traditional
credit card transactions and reject the credit card transactions.
     The FSR's letter claimed banning credit cards and the use
of credit cards through payment facilitators (e.g. Paypal) is a
significant regulatory action that has far reaching implications. The
FSR urged NFA to consider viable alternatives and seek comments from
those outside the forex industry.
    The CRC determined that one of NFA's primary responsibilities is
the protection of customers in the futures and forex industries and
that the prohibition was necessary to achieve this objective. The CRC
also observed that NFA's mandate is not to promote the business
interests of credit card companies.

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

    The proposed rule change is not effective because the CFTC has not
approved the proposed rule change.
    Section 19(b)(7)(C) of the Act provides, inter alia that ``[a]ny
proposed rule change of a self-regulatory organization that has taken
effect pursuant to [Section 19(b)(7)(B) of the Act] may be enforced by
such self-regulatory organization to the extent such rule is not
inconsistent with the provisions of the title, the rules and
regulations thereunder, and applicable Federal law. At any time within
60 days of the date of effectiveness of the proposed rule change, the
Commission, after consultation with the CFTC, may summarily abrogate
the proposed rule change and require that the proposed rule change be
refiled in accordance with the provisions of Section 19(b)(1) of the
Exchange Act.

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 Exchange 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-NFA-2014-04 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NFA-2014-04. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NFA. 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 publicly available. All
submissions should refer to File

Number SR-NFA-2014-04 and should be submitted on or before July 28,
2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(73).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2014-15719 Filed 7-3-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Page 23017]
[FR Doc No: 2020-08772]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-1601-000]

Huntley Solar, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Huntley Solar, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 11, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.

    Dated: April 20, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-08772 Filed 4-23-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11846-11847]
[FR Doc No: 2011-4814]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

24th Meeting: RTCA Special Committee 206: EUROCAE WG 76 Plenary:
AIS and MET Data Link Services

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 206: EUROCAE WG 76 Plenary:
AIS and MET Data Link Services meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 206: EUROCAE WG 76 Plenary: AIS and
MET Data Link Services.

DATES: The meeting will be held March 21-25, 2011 from 9 a.m. to 5 p.m.

ADDRESSES: The meeting will be held at Honeywell Aerospace, Phoenix
(DV), 21111 North 19th Avenue, Phoenix, AZ 85027-2704.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a RTCA Special Committee 206: EUROCAE WG 76
Plenary: AIS and MET Data Link Services meeting. The agenda will
include:

March 21--Monday

     9 a.m.--Opening Plenary.
      Chairmen's remarks and Host's comments.
      Introductions.
      Approval of previous meeting minutes.
      Review and approve meeting agenda.
      Schedule for this week.
      Action Item Review.
      Working Group 1, Work Plan--WG1 Chairmen.
      Working Group 2, Work Plan--WG2 Chairmen.
      Working Group 3, Recommendations--WG3 Chairmen.
      Current status and deliverables of SESAR JU Project
08.03.03 (Identify and Develop Aeronautical (and Meteorological) ATM
Information Services)--Roger Li.
     1 p.m.--WG1, WG2, and WG3 Meetings.

March 22-24, Tuesday, Wednesday, and Thursday

     9 a.m.--WG1, WG2, and WG3 Meetings.

March 25--Friday

     9 a.m.--WG1, WG2, and WG3 Meetings.
     10 a.m.--Plenary Session.
      Working Group Reports.
      Action Item Review.
      Other Business.
      Meeting plans and dates.
     12 p.m.--Adjourn.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on February 25, 2011.
Robert L. Bostiga,
RTCA Advisory Committee.
[FR Doc. 2011-4814 Filed 3-2-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7383-7388]
[FR Doc No: 2019-03810]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3240]

List of Bulk Drug Substances for Which There Is a Clinical Need
Under Section 503B of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is evaluating
substances that have been nominated for inclusion on a list of bulk
drug substances (active pharmaceutical ingredients) for which there is
a clinical need (the 503B Bulks List). Drug products that outsourcing
facilities compound using bulk drug substances on the 503B Bulks List
can qualify for certain exemptions from the Federal Food, Drug, and
Cosmetic Act (FD&C Act) provided certain conditions are met. This
notice identifies two bulk drug substances that FDA has considered and
is not including on the list at this time: Nicardipine hydrochloride
and vasopressin. Additional bulk drug substances nominated by the
public for inclusion on this list are currently under consideration and
will be the subject of future notices.

DATES: The announcement of the notice is published in the Federal
Register on March 4, 2019.

ADDRESSES: Submit electronic comments on bulk drug substances nominated
for the 503B Bulks List to Docket No. FDA-2015-N-3469. Submit written
comments on bulk drug substances nominated for the 503B Bulks List to
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Hankla, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5216,

Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Drug Compounding

    Compounded drug products can serve an important role for patients
for whom an FDA-approved drug product is not appropriate, such as
patients who have an allergy and need a medication to be made without a
certain dye or hospital inpatients who need infusions of a drug
combined with a particular diluent not specified in the approved
product labeling. However, they also pose a higher risk to patients
than FDA-approved drugs. In 2012, contaminated injectable drug products
that a State-licensed compounding pharmacy shipped to patients and
healthcare practitioners across the country caused a fungal meningitis
outbreak that resulted in more than 60 deaths and 750 cases of
infection.\1\ This was the most serious of a long history of outbreaks
and other serious adverse events associated with contaminated,
superpotent, or otherwise poor quality compounded drugs.
---------------------------------------------------------------------------

    \1\ See https://www.cdc.gov/HAI/outbreaks/meningitis.html.
---------------------------------------------------------------------------

    In response to this outbreak, Congress enacted the Drug Quality and
Security Act (Pub. L. 113-54), which, among other things, added new
section 503B to the FD&C Act (21 U.S.C. 353b) and created a new
category of compounders known as outsourcing facilities.\2\ Drug
products compounded by outsourcing facilities in accordance with the
conditions of section 503B are exempt from the following three sections
of the FD&C Act: Section 505 (21 U.S.C. 355) (concerning the approval
of drugs under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)); section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use);
and section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain
security requirements).\3\
---------------------------------------------------------------------------

    \2\ See Public Law 113-54, section 102(a), 127 Stat. 587, 587-
588 (2013). Other compounders, which are not the subject of this
notice, are regulated under section 503A of the FD&C Act (21 U.S.C.
353a). These include licensed pharmacists in State-licensed
pharmacies or Federal facilities, and licensed physicians, who have
not registered an outsourcing facility with FDA. Drug products
compounded by section 503A compounders are exempt from sections 505
(new drug approval requirements), 502(f)(1) (labeling with adequate
directions for use), and 501(a)(2)(B) (CGMP requirements) if the
conditions of section 503A are met, including that compounding is
based on the receipt of valid prescriptions for identified
individual patients (section 503A(a)). In general, section 503A
compounders do not register with and are not routinely inspected by
FDA and are primarily overseen by the States.
    \3\ Section 503B(a) of the FD&C Act.
---------------------------------------------------------------------------

    Drug products compounded under the conditions in section 503B are
not exempt from current good manufacturing practice (CGMP) requirements
in section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).\4\
Outsourcing facilities are also subject to FDA inspections according to
a risk-based schedule, specific adverse event reporting requirements,
and other conditions that help to mitigate the risks of the drug
products they compound.\5\ Outsourcing facilities may or may not obtain
prescriptions for identified individual patients and may, therefore,
distribute compounded drugs to healthcare practitioners for ``office
stock'' to hold in their offices in advance of patient need.\6\
---------------------------------------------------------------------------

    \4\ Compare section 503A(a) of the FD&C Act (exempting drugs
compounded in accordance with section 503A from CGMP requirements)
with section 503B(a) of the FD&C Act (not exempting drugs compounded
in accordance with section 503B from CGMP requirements).
    \5\ Section 503B(b)(4) and (5) of the FD&C Act.
    \6\ Section 503B(d)(4)(C) of the FD&C Act.
---------------------------------------------------------------------------

    Because compounded drug products are not FDA-approved, they have
not undergone FDA premarket review for safety, effectiveness, and
quality. Although outsourcing facilities must comply with CGMP
requirements and are inspected by FDA according to a risk-based
schedule, their drug products have not been determined to be safe or
effective for the conditions of use reflected in drug product labeling
and have not been subjected to a premarket inspection or associated
with a finding of manufacturing quality, all of which are part of the
drug approval process. Because compounded drug products are subject to
a lower regulatory standard than FDA-approved drug products, they
should only be used by patients who could not use an FDA-approved drug
product.
    When a compounded drug is appropriate for a patient, outsourcing
facilities may be able to prepare that drug using an FDA-approved drug
product as the starting material. On other occasions it may be
necessary to compound the drug from a bulk drug substance.\7\ Section
503B limits the bulk drug substances that outsourcing facilities can
use in compounding to those that are used to compound drugs in shortage
or that appear on a list developed by FDA of bulk drug substances for
which there is a clinical need. Section 503B includes this limitation,
among others, to help prevent outsourcing facilities from growing into
conventional manufacturing operations making unapproved new drug
products. Allowing outsourcing facilities to compound a drug product
from a bulk drug substance that is a component of an FDA-approved drug
product because of, for instance, economic incentives, when a patient's
clinical needs could be met by the approved drug product or a drug
product compounded from the approved drug product would reduce the
incentive for applicants to seek FDA approval of drug products and to
continue to market them. The drug approval process is critical to
ensure pharmaceuticals meet regulatory standards established for
quality, safety, and effectiveness. In addition, when it is feasible to
compound a drug product by starting with an approved drug product,
there are certain benefits of doing so over starting with a bulk drug
substance, including benefits relating to the assurances associated
with premarket review by FDA for safety, effectiveness, and quality.
---------------------------------------------------------------------------

    \7\ For a fuller discussion of these issues, see FDA's guidance
for industry entitled ``Evaluation of Bulk Drug Substances Nominated
for Use in Compounding Under Section 503B of the Federal Food, Drug,
and Cosmetic Act'' (503B Bulks Evaluation Guidance), particularly
sections II.B. and C., available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM602276.pdf.
---------------------------------------------------------------------------

    In sum, section 503B's limitation on the 503B Bulks List to bulk
drug substances for which there is a clinical need serves important
public health functions. First, it helps to limit patient exposure to
compounded drug products, which have not been demonstrated to be safe
and effective, to those situations in which the compounded drug product
is necessary for patient treatment. Second, it preserves the incentives
for applicants to invest in the research and testing required to obtain
FDA approval and to continue to manufacture FDA-approved drug products,
thereby helping to maintain a supply of high-quality, safe, and
effective drugs.

B. Statutory and Regulatory Background

    Section 503B of the FD&C Act describes the conditions that must be
satisfied for drug products compounded by an outsourcing facility to be
exempt from the approval, labeling, and drug supply chain security
requirements cited above.\8\ One of the conditions that must be met for
a drug product compounded by an outsourcing facility to qualify for
exemptions under section 503B is that the outsourcing facility may not
compound a drug using a bulk drug substance unless the bulk drug
substance appears on a list established by the Secretary of Health and
Human

Services identifying bulk drug substances for which there is a clinical
need (the 503B Bulks List); or the drug compounded from such bulk drug
substances appears on the drug shortage list in effect under section
506E of the FD&C Act (FDA's drug shortage list) (21 U.S.C. 356e) at the
time of compounding, distribution, and dispensing.\9\
---------------------------------------------------------------------------

    \8\ Section 503B(a) of the FD&C Act.
    \9\ Section 503B(a)(2)(A) of the FD&C Act.
---------------------------------------------------------------------------

    Section 503B directs FDA to establish the 503B Bulks List by (1)
publishing a notice in the Federal Register proposing bulk drug
substances to be included on the list, including the rationale for such
proposal; (2) providing a period of not less than 60 calendar days for
comment on the notice; and (3) publishing a notice in the Federal
Register designating bulk drug substances for inclusion on the
list.\10\
---------------------------------------------------------------------------

    \10\ Section 503B(a)(2)(A)(i)(I) to (III) of the FD&C Act.
---------------------------------------------------------------------------

    For purposes of section 503B, bulk drug substance means an active
pharmaceutical ingredient as defined in 21 CFR 207.1(b).\11\ Active
pharmaceutical ingredient means any substance that is intended for
incorporation into a finished drug product and is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease, or to affect the
structure or any function of the body, but the term does not include
intermediates used in the synthesis of the substance.12 13
---------------------------------------------------------------------------

    \11\ 21 CFR 207.3.
    \12\ Section 503B(a)(2) of the FD&C Act and 21 CFR 207.1.
    \13\ Inactive ingredients are not subject to section 503B(a)(2)
of the FD&C Act and will not be included in the 503B Bulks List
because they are not included within the definition of a bulk drug
substance. Pursuant to section 503B(a)(3), inactive ingredients used
in compounding must comply with the standards of an applicable
United States Pharmacopeia or National Formulary monograph, if a
monograph exists.
---------------------------------------------------------------------------

II. Methodology for Developing the 503B Bulks List

A. Process for Developing the List

    In the Federal Register of December 4, 2013 (78 FR 72838), FDA
requested nominations for specific bulk drug substances for the Agency
to consider for inclusion on the 503B Bulks List. In response to that
request, interested groups and individuals nominated a wide variety of
substances. However, many of those nominations were not for substances
used in compounding as active pharmaceutical ingredients or did not
include sufficient information to allow FDA to evaluate the nominated
substance. To improve the efficiency of the process for the development
of the list of bulk drug substances, FDA reopened the nomination
process in the Federal Register of July 2, 2014 (79 FR 37750) and
provided more detailed information on what it needs to evaluate
nominations for the list. On October 27, 2015 (80 FR 65770), the Agency
opened a new docket, FDA-2015-N-3469, to provide an opportunity for
interested persons to submit new nominations of bulk drug substances or
to renominate substances with sufficient information.
    As FDA evaluates bulk drug substances, it intends to publish
notices for public comment in the Federal Register that describe its
proposed position on each substance along with the rationale for that
position.\14\ After considering any comments on FDA's proposals
regarding whether to include nominated substances on the 503B Bulks
List, FDA intends to consider whether input from the Pharmacy
Compounding Advisory Committee (PCAC) on the nominations would be
helpful to the Agency in making its determination, and if so, it will
seek PCAC input.\15\ Depending on its review of the docket comments and
other relevant information before the Agency, FDA may finalize its
proposed determination without change, or it may finalize a
modification to its proposal to reflect new evidence or analysis
regarding clinical need. FDA will then publish in the Federal Register
a final determination identifying the bulk drug substances for which it
has determined there is a clinical need and FDA's rationale in making
that final determination. FDA will also publish in the Federal Register
a final determination regarding those substances it considered but
found that there is no clinical need to use in compounding and FDA's
rationale in making this decision.
---------------------------------------------------------------------------

    \14\ This is consistent with procedures set forth in section
503B(a)(2)(A)(i). Although the statute only directs FDA to issue a
Federal Register notice and seek public comment when it proposes to
include bulk drug substances on the 503B Bulks List, we intend to
seek comment when the Agency has evaluated a nominated substance and
proposes either to include or not to include the substance on the
list.
    \15\ Section 503B does not require FDA to consult the PCAC
before developing a 503B Bulks List.
---------------------------------------------------------------------------

    FDA intends to maintain a current list of all bulk drug substances
it has evaluated on its website, with separate lists for bulk drug
substances it has placed on the 503B Bulks List and those it has
decided not to place on the 503B Bulks List. FDA will only place a bulk
drug substance on the 503B Bulks List where it has determined there is
a clinical need for outsourcing facilities to compound drug products
using the bulk drug substance. If a clinical need to compound drug
products using the bulk drug substance has not been demonstrated, based
on the information submitted by the nominator and any other information
considered by the Agency, FDA will not place a bulk drug substance on
the 503B Bulks List.
    FDA intends to evaluate the bulk drug substances nominated for the
503B Bulks List on a rolling basis. FDA will evaluate and publish in
the Federal Register its proposed and final determinations in groups of
bulk drug substances until all nominated substances that were
sufficiently supported have been evaluated and either placed on the
503B Bulks List or identified as bulk drug substances that were
considered but determined not to be appropriate for inclusion on the
503B Bulks List.\16\
---------------------------------------------------------------------------

    \16\ On June 10, 2016 (81 FR 37502), FDA announced the
availability of a guidance for industry (revised January 2017)
entitled ``Interim Policy on Compounding Using Bulk Drug Substances
Under Section 503B of the Federal Food, Drug, and Cosmetic Act'';
available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf.
This guidance provides additional information regarding FDA's
policies for bulk drug substances nominated for the 503B Bulks List
pending our review of nominated substances under the ``clinical
need'' standard.
---------------------------------------------------------------------------

B. Analysis of Substances Nominated for the List

    As noted above, section 503B(a)(2)(A)(i) provides that the 503B
Bulks List is to include ``bulk drug substances for which there is a
clinical need.'' The Agency is evaluating bulk drug substances that
were nominated for inclusion on the 503B Bulks List, proceeding case by
case, under the standard provided by the statute.\17\ In applying this
standard to make determinations regarding the substances set forth in
this notice, FDA interprets the phrase ``bulk drug substances for which
there is a clinical need'' to mean that the 503B Bulks List may include
a bulk drug substance if: (1) There is a clinical need for an
outsourcing facility to compound a drug product, and (2) the drug
product must be compounded using the bulk drug substance. FDA is not
interpreting supply issues, such as backorders, to be within the
meaning of ``clinical need'' for compounding with a bulk drug
substance. Section 503B separately provides for compounding from bulk
drug substances under the exemptions from the FD&C Act discussed above
if the drug product compounded from the bulk drug

substance is on the FDA drug shortage list at the time of compounding,
distribution, and dispensing. Additionally, we are not considering cost
of the compounded drug product as compared with an FDA-approved drug
product when assessing ``clinical need.''
---------------------------------------------------------------------------

    \17\ See 503B Bulks Evaluation Guidance, supra n.7 (describing
FDA's policies for developing the 503B Bulks List, including the
interpretation of the phrase ``bulk drug substances for which there
is a clinical need,'' as it is used in section 503B).
---------------------------------------------------------------------------

    The bulk drug substances that we are addressing in this notice are
components of FDA-approved drug products, and we evaluated them by
asking the following questions:
    (1) Is there a basis to conclude, for each FDA-approved product
that includes the nominated bulk drug substance, that (a) an attribute
of the FDA-approved drug product makes it medically unsuitable to treat
certain patients for a condition that FDA has identified for
evaluation, and (b) the drug product proposed to be compounded is
intended to address that attribute?
    (2) Is there a basis to conclude that the drug product proposed to
be compounded must be produced from a bulk drug substance rather than
from an FDA-approved drug product?
    The reason for question (1) is that unless an attribute of the FDA-
approved drug is medically unsuitable for certain patients, and the
drug product to be compounded is intended to address that attribute, we
do not expect that there will be a clinical need for a patient to use a
compounded drug product. Rather, such compounding would unnecessarily
expose patients to the risks associated with drug products that have
not been shown to meet the standards applicable to FDA-approved drug
products for safety, effectiveness, quality, and labeling and would
undermine the drug approval process. The reason for question (2) is
that to place a bulk drug substance on the 503B Bulks List, FDA must
determine that there is a clinical need for outsourcing facilities to
compound a drug product using the bulk drug substance rather than
starting with an FDA-approved drug product.
    If the answer to both of these questions is ``yes,'' there may be
clinical need for outsourcing facilities to compound using the bulk
drug substance, and we would analyze the question further.\18\ If the
answer to either of these questions is ``no,'' there generally would
not be a basis to conclude that there is a clinical need to compound
drug products using the bulk drug substance instead of administering or
starting with an approved drug product, and we would generally not
include the bulk drug substance on the 503B Bulks List.
---------------------------------------------------------------------------

    \18\ Under the analysis described in FDA's 503B Bulks Evaluation
Guidance, the additional analysis would consist of the consideration
of four additional factors. We did not answer ``yes'' to both of the
threshold questions for nicardipine hydrochloride or vasopressin, so
we did not consider these additional factors in our determination
not to include nicardipine hydrochloride or vasopressin on the 503B
Bulks List.
---------------------------------------------------------------------------

III. Substances Proposed for the 503B Bulks List

    In August 2018, the Agency issued a Federal Register notice in
which it evaluated three nominated bulk drug substances under the
statutory standard--bumetanide, nicardipine hydrochloride, and
vasopressin--and proposed not to include them on the 503B Bulks List
(the August notice). In this notice, after review of the comments
submitted to the docket for the August notice, FDA is making its final
determination with regard to nicardipine hydrochloride and vasopressin.
At this time, FDA is not making a final determination regarding
bumetanide. This substance remains under consideration by FDA.

1. Nicardipine Hydrochloride

    Nicardipine hydrochloride has been nominated for inclusion on the
503B Bulks List.\19\ The proposed route of administration is
intravenous, the proposed dosage form is injection, and the proposed
strength is 0.1 to 2.5 milligrams per milliliter (mg/mL). This
nominated bulk drug substance is a component of FDA-approved drug
products (e.g., NDAs 022276 and 019734). FDA has approved nicardipine
hydrochloride drug products as 0.1 mg/mL and 0.2 mg/mL solutions ready
for intravenous administration (or ``ready to use'') and as a 2.5 mg/mL
single-dose vial that must be diluted prior to
infusion.20 21 The single dose vial (NDA 022276) contains an
excipient, benzoic acid; the ready-to-use solutions (NDA 019734) do not
contain benzoic acid.
---------------------------------------------------------------------------

    \19\ See Docket No. FDA-2015-N-3469, document no. FDA-2015-N-
3469-0002.
    \20\ See, e.g., labeling available as of the date of this notice
at https://www.accessdata.fda.gov/spl/data/32756b4e-a977-47ac-9620-0c1ed74d7606/32756b4e-a977-47ac-9620-0c1ed74d7606.xml (ready-to-use)
and https://www.accessdata.fda.gov/spl/data/5444784f-fefe-4352-afd1-b4c487165f3a/5444784f-fefe-4352-afd1-b4c487165f3a.xml (for
dilution).
    \21\ Nicardipine hydrochloride is also approved as an oral
capsule. See, e.g., ANDA 074642.
---------------------------------------------------------------------------

    Because nicardipine hydrochloride is a component of FDA-approved
drug products, we considered whether (1) there is a basis to conclude
that an attribute of each FDA-approved drug product makes each one
medically unsuitable to treat certain patients for a condition that FDA
has identified for evaluation, and the nicardipine hydrochloride drug
product proposed to be compounded is intended to address that attribute
in each FDA-approved drug product; and (2) whether the drug product
proposed to be compounded must be compounded using a bulk drug
substance.
a. Suitability of FDA-Approved Drug Products.
    The nomination proposed to include on the list nicardipine
hydrochloride injection compounded to concentrations of 0.1 mg/mL
through 2.5 mg/mL. The nomination does not identify attributes of the
approved nicardipine hydrochloride products that make them medically
unsuitable to treat certain patients and that the proposed compounded
drug products are intended to address. Specifically, the nomination did
not explain why ready-to-use nicardipine hydrochloride injection at 0.1
mg/mL and 0.2 mg/mL, and the 2.5 mg/mL single dose vial (for dilution)
are medically unsuitable for certain patients.
    A commenter on FDA's proposal not to include nicardipine
hydrochloride on the 503B Bulks List indicated that an attribute of
approved nicardipine hydrochloride injections, the presence of the
excipient benzoic acid, makes those approved drug products medically
unsuitable for patients who have an allergy to benzoic acid and that
drug products would be compounded from the bulk drug substance
nicardipine hydrochloride without benzoic acid. However, the commenter
did not acknowledge the availability of FDA-approved benzoic acid-free
nicardipine hydrochloride ready-to-use solutions for intravenous
administration or explain why these approved drug products would be
medically unsuitable for patients who have an allergy to benzoic
acid.\22\
---------------------------------------------------------------------------

    \22\ See NDAs 022276 and 019734.
---------------------------------------------------------------------------

    Accordingly, with respect to the nicardipine hydrochloride drug
products proposed to be compounded, FDA finds no basis to conclude that
an attribute of each of the approved drug products makes each one
medically unsuitable to treat certain patients for a condition that FDA
has identified for evaluation.
b. Whether the Drug Product Must Be Compounded From a Bulk Drug
Substance
    The nomination provided no basis to conclude that drug products
containing nicardipine hydrochloride must be compounded using a bulk
drug substance rather than using an FDA-approved drug product. The
nomination

and a related comment assert that it would be preferable to compound a
drug product using a bulk drug substance than using an approved drug
product that requires dilution. However, the nomination and comment do
not take the position or provide support for the position that a bulk
drug substance must be used to prepare the proposed concentrations of
nicardipine hydrochloride. For example, the nomination does not
indicate that the desired concentrations of nicardipine hydrochloride
could not be prepared by diluting the approved drug product in a form
that is suitable for patient administration. Nor is FDA aware of data
or information suggesting this cannot be done. We note that the
approved labeling of a nicardipine hydrochloride drug product directs
the drug product to be diluted to a concentration within that range. We
do not consider whether a benzoic acid-free nicardipine hydrochloride
drug product must be compounded using the bulk drug substance because
benzoic acid-free nicardipine hydrochloride product is FDA-approved at
concentrations of 0.1 mg/mL and 0.2 mg/mL and because patients for whom
these FDA-approved drug products may be medically unsuitable were not
identified in section III.1.a. In sum, FDA finds no basis to conclude
that drug products must be compounded using a bulk drug substance
rather than the approved drug product.

2. Vasopressin

    Vasopressin was nominated for inclusion on the 503B Bulks List to
compound drug products that treat septic shock, post-cardiotomy shock,
diabetes insipidus, and hypotension.\23\ The proposed route of
administration is intravenous; the proposed dosage form is injection.
The nominators proposed a range of specific concentrations (0.1, 0.2,
0.4, and 1 units/mL (U/mL)) and concentrations above that range without
identifying any specific concentration. This nominated bulk drug
substance is the active ingredient of the FDA-approved drug VASOSTRICT
(NDA 204485). VASOSTRICT is approved as a 20 U/mL intravenous infusion
that, per its labeling, should be diluted with normal saline or 5
percent dextrose in water to either 0.1 U/mL or 1 U/mL for intravenous
administration.\24\
---------------------------------------------------------------------------

    \23\ See Docket No. FDA-2015-N-3469, documents No. FDA-2015-N-
3469-0012 and -0023.
    \24\ The labeling as of the date of this notice is available at
https://www.accessdata.fda.gov/spl/data/4166e423-659e-4fe4-8a3c-2394434d00dd/4166e423-659e-4fe4-8a3c-2394434d00dd.xml.
---------------------------------------------------------------------------

    VASOSTRICT is available in a multidose vial that contains the
preservative agent chlorobutanol and in a single dose vial that does
not contain chlorobutanol. The VASOSTRICT labeling includes a
contraindication regarding chlorobutanol that applies to the
chlorobutanol-containing product.\25\ Because vasopressin is a
component of an FDA-approved drug product, we considered whether (1)
there is a basis to conclude that an attribute of each FDA-approved
drug product containing vasopressin makes each one medically unsuitable
to treat certain patients for a condition that FDA has identified for
evaluation, and the vasopressin drug product proposed to be compounded
is intended to address that attribute; and (2) whether the drug product
proposed to be compounded must be compounded using a bulk drug
substance.
---------------------------------------------------------------------------

    \25\ The labeling states that VASOSTRICT is ``contraindicated in
patients with known allergy or hypersensitivity to 8-L-arginine
vasopressin or chlorobutanol.'' However, this contraindication is
not applicable to the formulation of VASOSTRICT marketed without
chlorobutanol. As described in the package insert, the VASOSTRICT 10
mL solution contains chlorobutanol, while the 1 mL solution does
not.
---------------------------------------------------------------------------

a. Suitability of FDA-Approved Drug Product
    The nominations propose vasopressin for the 503B Bulks List so that
it can be used to compound drug product at various concentrations, some
lower than undiluted VASOSTRICT and others higher. However, the
nominations and the comments do not identify an attribute of VASOSTRICT
that makes it medically unsuitable for patients and that the compounded
products are intended to address.
    The nomination that refers to products with a higher concentration
than VASOSTRICT does not identify any data or information as to the
need for a higher concentration than the approved product, nor does the
nomination identify specific higher concentrations it proposes to
compound. In addition, the nomination does not identify patients for
whom a concentration at or below 20 U/mL is medically unsuitable and
who would therefore require a higher concentration, and FDA is not
aware of patients who would need concentrations above 20 U/mL.
    Both nominations also propose to compound vasopressin at specific
concentrations lower than undiluted VASOSTRICT. However, the proposed
concentrations are within the range described in the labeling for the
FDA-approved drug product, and the proposed route of administration
(intravenous) is the same as that of VASOSTRICT. The nominations do not
identify an attribute of the approved drug product that would make it
medically unsuitable for patients or show that the compounded drug
product would address that attribute.
    Commenters on FDA's proposal not to include vasopressin on the 503B
Bulks List assert that an attribute of VASOSTRICT that makes it
medically unsuitable to treat patients is that it contains a
preservative, chlorobutanol. Chlorobutanol-containing VASOSTRICT is
contraindicated in patients who have an allergy or hypersensitivity to
this excipient. However, the commenters fail to acknowledge that the
preservative-free formulation of VASOSTRICT is also marketed and fail
to explain why that formulation would be medically unsuitable for
patients who have an allergy to chlorobutanol.
    Accordingly, with respect to the vasopressin drug products proposed
to be compounded, FDA finds no basis to conclude that an attribute of
VASOSTRICT makes it medically unsuitable to treat certain patients.
b. Whether the Drug Product Must Be Compounded From a Bulk Drug
Substance
    As noted previously, the nominations propose to compound drug
products containing vasopressin at concentrations that are lower than
undiluted VASOSTRICT, but that are within the range of VASOSTRICT's
final, post-dilution concentrations. The nominations do not take the
position or provide support for the position that a bulk drug substance
rather than the FDA-approved drug product must be used to prepare these
lower concentrations. For example, the nominations do not explain, or
even suggest, that the desired concentration of vasopressin cannot be
prepared by diluting the approved drug product.\26\ We do not consider
whether a chlorobutanol-free vasopressin drug product must be
compounded using the bulk drug substance because a chlorobutanol-free
vasopressin product is FDA-approved and because patients for whom this
FDA-approved drug product may be medically unsuitable were not
identified in section III.2.a. In addition, in light of the analysis in
section III.2.a. above, we do not

consider whether a bulk drug substance must be used to compound a
vasopressin drug product at concentrations higher than 20 U/mL. In sum,
FDA finds no basis to conclude that drug products must be compounded
using a bulk drug substance rather than the approved drug product.
---------------------------------------------------------------------------

    \26\ For example, the nomination does not take the position or
provide support for a position that a drug product prepared by
starting with the approved drug product would be unsuitable for
patient administration. We also note that outsourcing facilities
often prepare ready-to-use forms of drug products for healthcare
practitioners by compounding (e.g., diluting) approved drug
products, including VASOSTRICT.
---------------------------------------------------------------------------

IV. Other Issues Raised in Nominations and Comments

    The nominations for nicardipine hydrochloride and vasopressin and
some comments state that there could be a benefit in the availability
of drug products containing each of these bulk drug substances that do
not require dilution prior to administration. We note first, with
respect to nicardipine hydrochloride, that two ready-to-use nicardipine
drug products are FDA-approved, and the comments do not identify
patients for whom these products are medically unsuitable. More
broadly, as explained above, when a bulk drug substance is a component
of an approved drug, FDA asks whether there is a basis to conclude that
an attribute of each approved drug product makes each one medically
unsuitable to treat certain patients for their condition, an
interpretation that protects patients and the integrity of the drug
approval process. The nominations and comments do not show that the
approved drug product, when not manufactured in the ready-to-use form,
is medically unsuitable for certain patients. Nor do the nominations
and comments establish that drug products in the relevant
concentrations, including ready-to-use products, cannot be prepared
from the approved nicardipine and vasopressin drug products.\27\
Rather, they propose to compound a ready-to-use product from bulk drug
substances to seek improved efficiency for prescribers or healthcare
providers, or to address the possibility that the approved drug might
be mishandled by a medical professional. That is not clinical need to
compound a drug product using a bulk drug substance.
---------------------------------------------------------------------------

    \27\ With respect to vasopressin specifically, a comment states
that vasopressin cannot be produced in ready-to-use form because the
approved drug product is labeled with an in-use time of 18 hours
room temperature or 24 hours refrigerated once diluted. In contrast,
the commenter says that it could compound a ``pre-diluted'' drug
product from bulk vasopressin with a beyond-use-date (BUD) of 60
days. We note that, in accordance with CGMP provisions, outsourcing
facilities can conduct stability studies on vasopressin compounded
using the approved drug product to assign a BUD based on data.
---------------------------------------------------------------------------

    The nominations for nicardipine hydrochloride and vasopressin and
some comments also include statements that these substances should be
added to the 503B Bulks List because compounding from the bulk drug
substance could help outsourcing facilities to address drug shortages
and disruptions in supply of approved drugs intended for injection. As
noted above, section 503B contains a separate provision for compounding
from bulk drug substances to address a drug shortage, and we do not
interpret the other price- and supply-related issues advanced by the
nomination to be within the meaning of ``clinical need'' for
compounding with a bulk drug substance.

V. Conclusion

    For the reasons stated above, we find no clinical need for an
outsourcing facility to compound using the bulk drug substances
nicardipine hydrochloride and vasopressin and, therefore, we are not
including nicardipine hydrochloride and vasopressin on the 503B Bulks
List.

    Dated: February 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03810 Filed 3-1-19; 8:45 am]
 BILLING CODE 4164-01-P


Draft June 2003 Laboratory name: Laboratory ID:

Method 1622/ 1623 Slide Examination Form Client sample number: Internal laboratory sample ID ( if applicable):

Analyst: 10 mL subsample ID ( if packed pellet > 0.5 mL):

Examination/ confirmation completion date: Volume examined ( in L) on this slide: Exam./ confirm. completion time : ( must be completed within 7 days of staining) Positive staining control acceptable 9 YES 9 NO Negative staining control acceptable 9 YES 9 NO Cryptosporidium Results Object located by FA No. Shape ( oval or round) Size L x W ( µ m) DAPI  DAPI + D. I. C. Light blue internal staining, no distinct nuclei, green rim ( A) Intense blue internal staining ( B) Number of nuclei stained sky blue ( C) Empty oocysts ( D) Oocysts with amorphous structure ( E) Oocysts with internal structure ( F)

Number of sporozoites 1 2 3 4 5 6 7 8 9 10 Total FA number from this slide: D. I. C.  Total number of empty oocysts ( D):

DAPI : Total number ( A): D. I. C.  Total number of oocysts with amorphous structure ( E):

DAPI +: Total number ( B): D. I. C.  Total number of oocysts with internal structure ( F):

DAPI +: Total number ( C): Total count DAPI + ( C) that show structure by D. I. C. ( F):

Giardia Results Object located by FA No. Shape ( oval or round) Size L x W ( µ m) DAPI  DAPI + D. I. C.

Light blue internal staining, no distinct nuclei, green rim ( A) Intense blue internal staining ( B) Number of nuclei stained sky blue ( C) Empty cysts ( D) Cysts with amorphous structure ( E) Cysts with internal structure ( F)

Number of nuclei Median body Axonemes 1 2 3 4 5 6 7 8 9 10 Total FA number from this slide: D. I. C.: Total number of empty cysts ( D):

DAPI: Total number ( A): D. I. C.: Total number of cysts with amorphous structure ( E): DAPI+: Total number ( B): D. I. C.: Total number of cysts with one internal structure ( F): DAPI+: Total number ( C): D. I. C.: Total number of cysts with > one internal structure ( F):

Total number DAPI + ( C) that show structure by D. I. C. ( F):


[Federal Register Volume 78, Number 180 (Tuesday, September 17, 2013)]
[Rules and Regulations]
[Pages 57047-57049]
[FR Doc No: 2013-22295]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0119; Directorate Identifier 2011-SW-034-AD;
Amendment 39-17541; AD 2013-16-03]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter France (Eurocopter) Model AS350 and AS355 helicopters, to
require inspecting for a crack in the control lever attachment yokes,
and if needed, replacing the tail rotor gearbox (TGB). This AD is
prompted by improper casting of TGB casing assemblies, which may lead
to cracking. A crack in the control lever attachment yokes could cause
a loss of tail rotor pitch control, and consequently, loss of control
of the helicopter.

DATES: This AD is effective October 22, 2013.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of October 22,
2013.

ADDRESSES: For service information identified in this AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the foreign authority's AD,
any incorporated-by-reference service information, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (phone:<PHONE_NUMBER>) is U.S.
Department of Transportation, Docket Operations Office, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On February 11, 2013, at 78 FR 9634, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 to include an AD that would apply to Eurocopter Model AS350
and AS355 helicopters. The NPRM proposed to require inspecting for a
crack in the control lever attachment yokes, and if needed, replacing
the TGB. The proposed requirements were intended to prevent a crack in
the control lever attachment yokes, which could cause a loss of tail
rotor pitch control, and consequently, loss of control of the
helicopter.
    The NPRM was prompted by AD No. 2011-0104, dated May 27, 2011,
issued by the European Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, to correct
an unsafe condition for the Eurocopter Model AS 350 and AS 355
helicopters. EASA advises that cracks were found on some TGB casing

assemblies when a dye-penetrant inspection was performed after the
machining of the control lever attachment yokes. The inspection
followed the repair of the manufacturing mold. EASA reports that cracks
in the TGB casing assemblies, if not detected and corrected, could lead
to a crack on the control lever attachment yokes, which could cause the
loss of tail rotor pitch control and subsequent loss of control of the
helicopter.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we received no comments on the NPRM (78 FR 9634, February
11, 2013).

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed except the reference to the
Aerospace Material Specification 2647 or equivalent has been removed
and we are now incorporating by reference procedures for the
Fluorescent Penetrant Inspection. These changes are consistent with the
intent of the proposals in the NPRM (78 FR 9634, February 11, 2013) and
will not increase the economic burden on any operator nor increase the
scope of the AD.

Differences Between This AD and the EASA AD

    We require inspecting for a crack in the attachment yokes of the
TGB casing assemblies within 100 hours time-in-service (TIS). EASA
requires that the inspection be conducted within 26 months or 660
flight hours if the TGB casing assemblies have less than 550 flight
hours and within 110 flight hours or 13 months if the TGB casing
assemblies have 550 or more flight hours. We do not include the Model
AS350BB helicopter because it is not type certificated in the United
States, but we do include models AS350C and AS350D1.

Related Service Information

    Eurocopter issued Alert Service Bulletin (ASB) No. AS350-65.00.46
for Model AS350 helicopters and ASB AS355-65.00.22 for AS355
helicopters. Both ASBs are Revision 0 and dated May 18, 2011. The ASBs
call for non-destructive inspections, such as a dye-penetrant
inspection, to check for cracks in the attachment yokes of the TGB
casing assemblies. If there is a crack, the ASBs call for replacing the
TGB with an airworthy TGB and returning the replaced TGB to Eurocopter.

Costs of Compliance

    We estimate that this AD affects 693 helicopters of U.S. Registry
and that labor costs average $85 per work-hour. We estimate that it
takes two work-hours to inspect TGB casing assemblies for a cost of
$170 per helicopter, and $117,810 for the U.S. fleet. No parts are
needed. Replacing the TGB requires five work hours for a labor cost of
$425. Parts cost $37,825 for a total cost of $38,250 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on helicopters identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-16-03 EUROCOPTER FRANCE HELICOPTERS (EUROCOPTER): Amendment 39-
17541; Docket No. FAA-2013-0119; Directorate Identifier 2011-SW-034-
AD.

(a) Applicability

    This AD applies to Eurocopter AS350C, D, D1, B, BA, B1, B2, and
B3; and AS355E, F, F1, F2, N, and NP helicopters, with a tailrotor
gearbox (TGB) casing assembly, part number (P/N) 350A33-1090-02 and
serial number (S/N) MA47577, MA47585, MA47587 through MA47593,
MA47597 through MA47600, MA47602, MA47604, MA47606, MA47610,
MA47613, MA47615, MA47617, MA47619 through MA47624, MA47626,
MA47628, or MA47631 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in the control
lever attachment yoke of the TGB casing assembly, which could result
in loss of tail rotor pitch control and loss of helicopter control.

(c) Effective Date

    This AD becomes effective October 22, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 100 hours time-in-service:
    (1) Remove the control lever, as depicted in Figure 1, item (b),
of Eurocopter Alert Service Bulletin (ASB) No. AS350-65.00.46

or No. AS355-65.00.22, both Revision 0 and both dated May 18, 2011,
as applicable for your model helicopter.
    (2) Strip the paint from the TGB control lever attachment yokes,
as depicted in Figure 2, item (z), of the ASB No. AS350-65.00.46 or
No. AS355-65.00.22, as applicable to your model helicopter.
    (3) Perform a Fluorescent Penetrant Inspection (FPI) in
accordance with paragraph 3.B.2 of ASB No. AS350-65.00.46 or No.
AS355-65.00.22, as applicable to your model helicopter, on the TGB
control lever attachment yokes for a crack. You are only required to
follow the actions defined in this ASB paragraph pertaining to the
FPI.
    (4) If a crack exists, before further flight, replace the TGB
with an airworthy TGB.
    (5) If there is no crack, clean the inspected area and apply
chemical conversion coating (Alodine 1200 or equivalent), Epoxy
primer, and top coat paint.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort
Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency AD No. 2011-0104, dated May 27, 2011. You may view the EASA
AD at http://www.regulations.gov by searching for and locating it in
Docket No. FAA-2013-0119.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor
Gearbox.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Eurocopter Alert Service Bulletin No. AS350-65.00.46,
Revision 0, dated May 18, 2011.
    (ii) Eurocopter Alert Service Bulletin No. AS355-65.00.22,
Revision 0, May 18, 2011.
    (3) For Eurocopter service information identified in this AD,
contact American Eurocopter Corporation, 2701 N Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at http://www.eurocopter.com/techpub.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on July 26, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-22295 Filed 9-16-13; 8:45 am]
BILLING CODE 4910-13-P