Public Health Service Act, the current label (except that only one
representative container or carton label need be submitted where
differences exist only in the quantity of contents statement or the bar
code), the package insert (if any), and a representative sampling of
any other labeling. This labeling submission must include the content
of labeling as defined in Sec.  207.1(b).
    (3) Animal drugs. (i) For each animal drug that is subject to
section 512 of the Federal Food, Drug, and Cosmetic Act, which includes
but is not limited to, new animal drugs that have been approved,
conditionally approved, or indexed under sections 512, 571, or 572 of
the Federal Food, Drug, and Cosmetic Act, a copy of all current
labeling (except that only one representative container or carton label
need be submitted where differences exist only in the quantity of
contents statement), including the content of labeling as defined in
Sec.  207.1(b);
    (ii) For all other animal drugs, a copy of the current label
(except that only one representative container or carton label need be
submitted where differences exist only in the quantity of contents
statement), the package insert, the content of labeling as defined in
Sec.  207.1(b), and a representative sampling of any other labeling;
    (4) All other. For all other listed drugs, including unfinished
drugs, the label (if any), except that only one representative label
need be submitted where differences exist only in the quantity of
contents statement.
    (e) Advertisements. (1) A representative sampling of advertisements
for a human prescription drug that is not subject to section 505 of the
Federal Food, Drug, and Cosmetic Act or section 351 of the Public
Health Service Act;
    (2) If we request it for good cause, a copy of all advertisements
for a particular drug described in paragraph (e)(1) of this section,
including advertisements described in Sec.  202.1(l)(1) of this
chapter. Such advertisements must be submitted within 30 calendar days
after our request.
    (f) Private label distributor products. A listing submission for a
human drug distributed by a private label distributor described in
Sec.  207.41(c)(2) must include information specified in Sec.
207.53(b) through (e) as applicable and:
    (1) The appropriate NDC(s) (as described in Sec.  207.33) that
include the private label distributor's labeler code and all package
code variations;
    (2) The name, mailing address, telephone number, and email address
of the private label distributor; and
    (3) For drugs bearing the NDC(s) reported under paragraph (f)(1) of
this section, labeling as described in paragraphs (d)(1) through (4) of
this section, as applicable, that accompanies the private label
distributor's product.

Sec.  207.54  What listing information must a registrant submit for a
drug that it salvages?

    A registrant who also relabels or repacks a drug that it salvages
must list the drug it relabels or repacks in accordance with Sec.
207.53 rather than in accordance with this section. A registrant who
performs only salvaging with respect to a drug must provide the
following listing information for that drug.
    (a) The NDC assigned to the drug immediately before the drug is
received by the registrant for salvaging;
    (b) The lot number and expiration date of the salvaged drug
product; and
    (c) The name and Unique Facility Identifier for each establishment
where the registrant salvages the drug.

Sec.  207.55  What additional drug listing information may FDA require?

    For a particular listed drug, upon our request, the registrant must
briefly state the basis for its belief that the drug is not subject to
section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or
section 351 of the Public Health Service Act.

Sec.  207.57  What information must registrants submit when updating
listing information and when?

    Registrants must review and update listing information at a
minimum, as follows:
    (a) Registrants must provide listing information at the time of
annual establishment registration for any drug manufactured, repacked,
relabeled, or salvaged by them for commercial distribution that has not
been listed previously.
    (b) Registrants must review and update their drug listing
information each June and December. When doing so, registrants must:
    (1)(i) Provide listing information, in accordance with Sec. Sec.
207.49, 207.53, and 207.54, for any drug manufactured, repacked,
relabeled, or salvaged by them for commercial distribution that has not
been previously listed;
    (ii) Submit the date that they discontinued the manufacture,
repacking, relabeling or salvaging for commercial distribution of a
listed drug and provide the expiration date of the

last lot manufactured, repacked, relabeled, or salvaged;
    (iii) Submit the date that they resumed the manufacture, repacking,
or relabeling for commercial distribution of a drug previously
discontinued, and provide any required listing information not
previously submitted; and
    (iv) Submit any material changes in any information previously
submitted pursuant to Sec. Sec.  207.49, 207.53, 207.54, or other
relevant sections of this part; or
    (2) For each listed drug, certify that no changes subject to
reporting under paragraph (b)(1)(iv) of this section have occurred if
no such changes have occurred since the last review and update. If a
drug is discontinued and FDA has received the information required
under paragraph (b)(1)(ii) of this section, no further certifications
are necessary for the discontinued drug. After initial electronic
listing, registrants may satisfy the listing update requirement with
respect to unchanged listing information by making a single ``no
changes'' certification during the annual registration update under
Sec.  207.29(b) applicable to all of the registrant's listed drugs for
which no changes have been made since the previous annual registration
update.
    (c) Registrants are encouraged to submit listing information for
every drug subject to listing under this part prior to commercial
distribution and are encouraged to update listing information at the
time of any change affecting information previously submitted.

Subpart E--Electronic Format for Registration and Listing

Sec.  207.61  How is registration and listing information provided to
FDA?

    (a) Electronic format. (1) Except as provided in Sec.  207.65, all
information submitted under this part must be transmitted to FDA in
electronic format by using our electronic drug registration and listing
system, in a form that we can process, review, and archive. We may
periodically issue guidance on how to provide registration and listing
information in electronic format (specifying for example method of
transmission, media, file formats, preparation, and organization of
files).
    (2) Information provided in electronic format must comply with part
11 of this chapter, except as follows:
    (i) Advertisements and labeling, including the content of labeling,
required under this part are exempt from the requirements in Sec.
11.10(a), (c) through (h), and (k) of this chapter and the
corresponding requirements in Sec.  11.30 of this chapter.
    (ii) All other information submitted under this part is exempt from
the requirements in Sec.  11.10(b), (c), and (e) of this chapter and
the corresponding requirements in Sec.  11.30 of this chapter.
    (b) English language. Drug establishment registration and drug
listing information must be provided in the English language. The
content of labeling must be provided at a minimum in the English
language. Where Sec.  201.15(c) of this chapter permits product
labeling solely in a foreign language, the content of labeling must be
submitted in that language along with an accurate English translation.

Sec.  207.65  How can a waiver of the electronic submission requirement
be obtained?

    (a) All information submitted under this part must be transmitted
to FDA electronically in accordance with Sec.  207.61(a) unless FDA has
granted a request for waiver of this requirement prior to the date on
which submission of such information is due. Submission of a request
for waiver does not excuse timely compliance with the registration and
listing requirements. FDA will grant a waiver request if FDA determines
that the use of electronic means for submission of registration and
listing information is not reasonable for the registrant making the
waiver request.
    (b) Waiver requests under this section must be submitted in writing
and must include the specific reasons why electronic submission is not
reasonable for the registrant and a U.S. telephone number and mailing
address where FDA can contact the registrant. All waiver requests must
be sent to: SPL Coordinator, U.S. Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Silver Spring, MD 20993.
    (c) If FDA grants the waiver request, FDA may limit its duration
and will specify terms of the waiver and provide information on how to
submit establishment registration, drug listings, other information,
and updates, as applicable.

Subpart F--Miscellaneous

Sec.  207.69  What are the requirements for an official contact and a
United States agent?

    (a) Official contact. Registrants subject to the registration
requirements of this part must designate an official contact for each
establishment. The official contact is responsible for:
    (1) Ensuring the accuracy of registration and listing information;
and
    (2) Reviewing, disseminating, routing, and responding to all
communications from FDA including emergency communications.
    (b) United States agent. Registrants of foreign establishments
subject to this part must designate a single United States agent. The
United States agent must reside or maintain a place of business in the
United States and may not be a mailbox, answering machine or service,
or other place where a person acting as the United States agent is not
physically present. The United States agent is responsible for:
    (1) Reviewing, disseminating, routing, and responding to all
communications from FDA including emergency communications;
    (2) Responding to questions concerning those drugs that are
imported or offered for import to the United States;
    (3) Assisting FDA in scheduling inspections; and
    (4) If FDA is unable to contact a foreign registrant directly or
expeditiously, FDA may provide the information and/or documents to the
United States agent. FDA's providing information and/or documents to
the United States agent is equivalent to providing the same information
and/or documents to the foreign registrant.

Sec.  207.77  What legal status is conferred by registration and
listing?

    (a) Registration of an establishment or listing of a drug does not
denote approval of the establishment, the drug, or other drugs of the
establishment, nor does it mean that a product may be legally marketed.
Any representation that creates an impression of official approval or
that a drug is approved or is legally marketable because of
registration or listing is misleading and constitutes misbranding.
    (b) FDA's acceptance of registration and listing information,
inclusion of a drug in our database of drugs, or assignment of an NDC
does not denote approval of the establishment or the drug or any other
drugs of the establishment, nor does it mean that the drug may be
legally marketed. Any representation that creates the impression that a
drug is approved or is legally marketable because it appears in our
database of drugs, has been assigned or displays an NDC, or the
establishment has been assigned an establishment registration number or
Unique Facility Identifier is misleading and constitutes misbranding.
Failure to comply with Sec.  207.37 may also constitute misbranding.
    (c) Neither registration nor listing constitutes a determination by
FDA that a product is a drug as defined by section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act. Registration or listing may,
however, be evidence that a

facility intends to or does manufacture, repack, relabel, distribute,
or salvage drugs or that a product is intended to be a drug.

Sec.  207.81  What registration and listing information will FDA make
available for public disclosure?

    (a) Except as provided in paragraphs (b) and (c) of this section,
the following information will be available for public disclosure, upon
request or at FDA's discretion:
    (1) All establishment registration information, and
    (2) After a drug is marketed, information obtained under Sec.
207.33, Sec.  207.49, Sec.  207.53, Sec.  207.54, or Sec.  207.57.
    (b) Unless such information is publicly available or FDA finds that
confidentiality would be inconsistent with protection of the public
health, FDA will not make publicly available:
    (1) Any information submitted under Sec.  207.55 as the basis upon
which it has been determined that a particular drug is not subject to
section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or
section 351 of the Public Health Service Act,
    (2) The names of any inactive ingredients submitted under Sec.
207.49(a)(4) for which the registrant makes a valid assertion of
confidentiality under Sec.  20.61 of this chapter or other provision of
law, or
    (3) Drug listing information obtained under Sec.  207.33(d)(3),
Sec.  207.49(a)(9) and (12), Sec.  207.53(b) and (c), or Sec.
207.54(a) or (c).
    (c) FDA may determine, in limited circumstances and on a case-by-
case basis, that it would be consistent with the protection of the
public health and the Freedom of Information Act to exempt from public
disclosure specific information identified in paragraph (a) of this
section.

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

0
9. The authority citation for part 314 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a,
356b, 356c, 356e, 371, 374, 379e, 379k-1.

0
10. In Sec.  314.81, revise paragraph (b)(3)(iv) to read as follows:

Sec.  314.81  Other postmarketing reports.

* * * * *
    (b) * * *
    (3) * * *
    (iv) Withdrawal of approved drug product from sale. (a) Within 30
calendar days of the withdrawal of an approved drug from sale,
applicants who are manufacturers, repackers, or relabelers subject to
part 207 of this chapter must submit the following information about
the drug, in accordance with the applicable requirements described in
Sec. Sec.  207.61 and 207.65:
    (1) The National Drug Code (NDC);
    (2) The identity of the drug by established name and by proprietary
name, if any;
    (3) The new drug application number or abbreviated application
number;
    (4) The date on which the drug is expected to be no longer in
commercial distribution. FDA requests that the reason for withdrawal of
the drug from sale be included with the information.
    (b) Within 30 calendar days of the withdrawal of an approved drug
from sale, applicants who are not subject to part 207 of this chapter
must submit the information listed in paragraphs (b)(3)(iv)(a)(1)
through (4) of this section. The information must be submitted either
electronically or in writing to the Drug Registration and Listing
Office, Food and Drug Administration, Center for Drug Evaluation and
Research.
    (c) Reporting under paragraph (b)(3)(iv)(a) of this section
constitutes compliance with the requirements of Sec.  207.57 of this
chapter to update drug listing information with respect to the
withdrawal from sale.
* * * * *

Sec.  314.125  [Amended]

0
11. Amend Sec.  314.125 in paragraph (b)(11) by removing the words ``or
processed''.

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
12. The authority citation for part 514 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b,
360ccc, 371, 379e, 381.

0
13. In Sec.  514.111 add paragraph (a)(12) to read as follows:

Sec.  514.111  Refusal to approve an application.

    (a) * * *
    (12) The drug will be produced in whole or in part in an
establishment that is not registered and not exempt from registration
under section 510 of the Federal Food, Drug, and Cosmetic Act and part
207 of this chapter.
* * * * *

PART 515--MEDICATED FEED MILL LICENSE

0
14. The authority citation for part 515 continues to read as follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  515.10  [Amended]

0
15. In Sec.  515.10(b)(8), remove the phrase ``Sec. Sec.  207.20 and
207.21'' and add in its place the phrase ``part 207''.

PART 601--LICENSING

0
16. The authority citation for part 601 continues to read as follows:

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec. 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).

0
17. In Sec.  601.2, add paragraph (f) to read as follows:

Sec.  601.2  Applications for biologics licenses; procedures for
filing.

* * * * *
    (f) Withdrawal from sale of approved biological products. A holder
of a biologics license application (BLA) must report to FDA, in
accordance with the requirements of Sec. Sec.  207.61 and 207.65, the
withdrawal from sale of an approved biological product. The information
must be submitted to FDA within 30 working days of the biological
product's withdrawal from sale. The following information must be
submitted: The holder's name; product name; BLA number; the National
Drug Code; and the date on which the product is expected to be no
longer in commercial distribution. The reason for the withdrawal of the
biological product is requested but not required to be submitted.

PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR
MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED
DEVICES

0
18. The authority citation for part 607 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374,
381, 393; 42 U.S.C. 262, 264, 271.

0
19. Revise the heading for part 607 to read as set forth above.

0
20. Add Sec.  607.1 to subpart A to read as follows:

Sec.  607.1  Scope.

    (a) This part establishes establishment registration and product
listing requirements for manufacturers of human blood and blood
products.
    (b) This part establishes establishment registration and product
listing requirements for manufacturers of products that meet the
definition of a device under the Federal Food, Drug, and Cosmetic Act
and that are licensed under section 351 of the Public Health

Service Act, as well as licensed biological products used in the
manufacture of a licensed device.

0
21. In Sec.  607.3 revise the second sentence in paragraph (b) and add
paragraphs (k) and (l) to read as follows:

Sec.  607.3  Definitions.

* * * * *
    (b) * * * For the purposes of this part only, blood and blood
product also means those products that meet the definition of a device
under the Federal Food, Drug, and Cosmetic Act and that are licensed
under section 351 of the Public Health Service Act, as well as licensed
biological products used in the manufacture of a licensed device.
* * * * *
    (k) Importer means a person in the United States that is an owner,
consignee, or recipient, at the time of entry, of a foreign
establishment's blood product that is imported into the United States.
    (l) Foreign for the purpose of registration and listing under this
part when used to modify the term ``establishment'' refers to an
establishment that is located in a foreign country and is the site
where a blood product that is imported or offered for import into the
United States was manufactured.

0
22. Revise Sec.  607.7 to read as follows:

Sec.  607.7  Establishment registration and product listing of blood
banks and other firms manufacturing human blood and blood products.

    All owners or operators of establishments that engage in the
manufacturing of blood products are required to register, pursuant to
section 510 of the Federal Food, Drug, and Cosmetic Act. Registration
and listing of blood products must comply with this part. Registration
does not permit any blood bank or similar establishment to ship blood
products in interstate commerce.

0
23. In Sec.  607.20 revise the first sentence in paragraph (c) to read
as follows:

Sec.  607.20  Who must register and submit a blood product list.

* * * * *
    (c) Except in the case of licensed device manufacturers, no
registration fee is required. * * *

0
24. In Sec.  607.21 revise the last sentence to read as follows:

Sec.  607.21  Times for establishment registration and blood product
listing.

    * * * Owners or operators of all establishments so engaged must
register annually between October 1 and December 31 and must update
their blood product listing every June and December.

0
25. Revise Sec.  607.22 to read as follows:

Sec.  607.22  How to register establishments and list blood products.

    (a) Initial and subsequent registrations and product listings must
be submitted electronically through the Blood Establishment
Registration and Product Listing system, or any future superseding
electronic system. This information must be submitted in accordance
with part 11 of this chapter, except for the requirements in Sec.
11.10(b), (c), and (e), and the corresponding requirements in Sec.
11.30. All information submitted under this part must be transmitted to
FDA electronically unless FDA has granted a request for waiver of this
requirement prior to the date on which the information is due.
Submission of a request for waiver does not excuse timely compliance
with the registration and listing requirements. FDA will grant a waiver
request if FDA determines that the use of electronic means for
submission of registration and listing information is not reasonable
for the registrant making the waiver request.
    (b) Waiver requests under this section must be submitted in writing
and must include the specific reasons why electronic submission is not
reasonable for the registrant and a U.S. telephone number and mailing
address where FDA can contact the registrant. All waiver requests must
be sent to the Director of FDA's Center for Biologics Evaluation and
Research through the Document Control Center (see addresses in Sec.
600.2).
    (c) If FDA grants the waiver request, FDA may limit its duration
and will specify terms of the waiver and provide information on how to
submit establishment registration, drug listings, other information,
and updates, as applicable.

0
26. Revise Sec.  607.25 to read as follows:

Sec.  607.25  Information required for establishment registration and
blood product listing.

    (a) The Blood Establishment Registration and Product Listing system
requires furnishing or confirming registration information required by
the Federal Food, Drug, and Cosmetic Act. This information includes the
name and street address of the establishment, including post office
code; a registration number if previously assigned by FDA and a Unique
Facility Identifier in accordance with the system specified under
section 510 of the Federal Food, Drug, and Cosmetic Act; all trade
names used by the establishment; the kind of ownership or operation
(that is, individually owned partnership, or corporation); and the name
of the owner or operator of such establishment. The term ``name of the
owner or operator'' must include, in the case of a partnership, the
name of each partner and, in the case of a corporation, the name and
title of each corporate officer and director and the name of the State
of incorporation. The information required must be given separately for
each establishment, as defined in Sec.  607.3(c).
    (b) The following information must also be provided:
    (1) A list of blood products by established name as defined in
section 502(e) of the Federal Food, Drug, and Cosmetic Act and by
proprietary name, if any, which are being manufactured for commercial
distribution at the identified establishment and which have not been
included in any list previously submitted to FDA through the Blood
Establishment Registration and Product Listing system or any future
superseding electronic system.
    (2) For each blood product so listed that is subject to section 351
of the Public Health Service Act, the license number of the
manufacturer issued by the Center for Biologics Evaluation and
Research, Food and Drug Administration.
    (3) For each blood product listed, the registration number if
previously assigned by FDA and the Unique Facility Identifier of the
parent establishment. An establishment not owned, operated, or
controlled by another firm or establishment is its own parent
establishment.

0
27. In Sec.  607.26 revise the first sentence to read as follows:

Sec.  607.26  Amendments to establishment registration.

    Changes in individual ownership, corporate or partnership
structure, location, or blood product handling activity must be
submitted electronically through the Blood Establishment Registration
and Product Listing system, or any future superseding electronic
system, as an amendment to registration within 5 calendar days of such
changes. * * *

0
28. In Sec.  607.30 revise the introductory text of paragraph (a) to
read as follows:

Sec.  607.30  Updating blood product listing information.

    (a) After submission of the initial blood product listing
information, every person who is required to list blood products under
Sec.  607.20 must submit electronically through the Blood Establishment
Registration and Product

Listing system, or any future superseding electronic system, at a
minimum once in June and December of every year, the following
information:
* * * * *

0
29. Revise Sec.  607.35 to read as follows:

Sec.  607.35  Blood product establishment registration number.

    An establishment registration number will be assigned to each blood
product establishment registered in accordance with this part.

0
30. Revise Sec.  607.37 to read as follows:

Sec.  607.37  Public disclosure of establishment registration and blood
product listing information.

    (a) Except as provided in paragraph (b) of this section, all
registration and listing information obtained under Sec. Sec.  607.25,
607.26, and 607.30 will be made available for public disclosure through
the Center for Biologics Evaluation and Research (CBER) Blood
Establishment Registration Database Web site by using the CBER
electronic Web-based application or by going in person to the Food and
Drug Administration, Division of Freedom of Information Public Reading
Room (see addresses in Sec.  20.120(a) of this chapter).
    (b) FDA may find, in limited circumstances and on a case-by-case
basis, that it would be consistent with the protection of the public
health to exempt from public disclosure specific listing information
obtained under Sec.  607.25 or Sec.  607.30.
    (c) Other requests for information regarding blood establishment
registrations and blood product listings should be directed to the Food
and Drug Administration, Center for Biologics Evaluation and Research
Office of Communication, Outreach, and Development, 10903 New Hampshire
Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002.

0
31. Revise Sec.  607.39 to read as follows:

Sec.  607.39  Misbranding by reference to establishment registration,
validation of registration, or to registration number.

    Registration of an establishment, validation of registration, or
assignment of a registration number does not in any way denote approval
of the firm or its products nor does it mean that the products may be
legally marketed. Any representation that creates an impression of
official approval because of establishment registration, validation of
registration, or possession of a registration number is misleading and
constitutes misbranding.

0
32. In Sec.  607.40 revise paragraphs (d) introductory text and (d)(3)
and add paragraph (e) to read as follows:

Sec.  607.40  Establishment registration and blood product listing
requirements for foreign blood product establishments.

* * * * *
    (d) Each foreign establishment required to register under paragraph
(a) of this section must submit the name, address, telephone number,
and email address of its United States agent as part of its initial and
updated registration information in accordance with subpart B of this
part. Each foreign establishment must designate only one United States
agent.
* * * * *
    (3) The foreign establishment or the United States agent must
report changes in the United States agent's name, address, telephone
number, or email address to FDA within 30 calendar days of the change.
    (e) Each foreign establishment required to register under paragraph
(a) of this section must register and list blood products using the
Blood Establishment Registration and Product Listing system, or any
superseding electronic system, unless FDA waives the electronic
submission requirement in accordance with Sec.  607.22.

0
33. In Sec.  607.65 add paragraph (g) to read as follows:

Sec.  607.65  Exemptions for blood product establishments.

* * * * *
    (g) Persons who engage solely in the production of any plasma
derivative, including, but not limited to, albumin, Immune Globulin,
Factor VIII and Factor IX, bulk product substances such as
fractionation intermediates or pastes, or recombinant versions of
plasma derivatives or animal derived plasma derivatives. These persons
must register and list under part 207 of this chapter.

0
34. Add subpart E, consisting of Sec.  607.80, to part 607 to read as
follows:

Subpart E--Establishment Registration and Product Listing Of
Licensed Devices

Sec.  607.80  Applicability of part 607 to licensed devices.

    Manufacturers of products that meet the definition of a device
under the Federal Food, Drug, and Cosmetic Act and that are licensed
under section 351 of the Public Health Service Act, as well as licensed
biological products used in the manufacture of a licensed device, must
register and list following the procedures under this part, with
respect to their manufacture of those products, unless otherwise noted
in this section.

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS

0
35. The authority citation for part 1271 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.

Sec.  1271.1  [Amended]

0
36. Amend Sec.  1271.1 in paragraphs (a) and (b)(2) by removing
``207.20(f)'' and adding in its place ``207.9(a)(5)''; in paragraph (a)
by removing the term ``a unified'' and adding in its place the term
``an electronic''; and in paragraph (b)(2) by removing the phrase ``in
subpart B of this part'' and adding in its place the phrase ``in part
207 (if a drug and/or biological product) of this chapter or part 807
(if a device) of this chapter''.

0
37. In Sec.  1271.3 add paragraphs (mm) and (nn) to read as follows:

Sec.  1271.3  How does FDA define important terms in this part?

* * * * *
    (mm) Importer means a company or individual in the United States
that is the owner, consignee, or recipient, at the time of entry, of
the foreign establishment's HCT/P that is imported into the United
States.
    (nn) United States agent means a person residing or maintaining a
place of business in the United States whom a foreign establishment
designates as its agent. This definition excludes mailboxes, answering
machines or services, or other places where an individual acting as the
foreign establishment's agent is not physically present.

Sec.  1271.20  [Amended]

0
38. Amend Sec.  1271.20 by removing ``207.20(f)'' and adding in its
place ``207.9(a)(5)'' and by removing the phrase ``subparts B, C, and D
of this part'' and adding in its place ``subparts C and D of this
part''.

0
39. Revise Sec.  1271.22 to read as follows:

Sec.  1271.22  How do I register and submit an HCT/P list?

    (a) You must use the electronic registration and listing system at
http://www.fda.gov/cber/tissue/tisreg.htm in accordance with Sec.
1271.25 for:
    (1) Establishment registration,
    (2) HCT/P listings, and
    (3) Updates of registration and HCT/P listing.
    (b) FDA will periodically issue guidance on recommended procedures
for providing registration and listing information in electronic format
(for

example, method of transmission, media, file formats, preparation, and
organization of files).
    (c) You must provide the information under paragraph (a) of this
section in accordance with part 11 of this chapter, except for the
requirements in Sec.  11.10(b), (c), and (e) and the corresponding
requirements in Sec.  11.30.

0
40. Add Sec.  1271.23 to subpart B to read as follows:

Sec.  1271.23  How is a waiver from the electronic format requirements
requested?

    (a) You may request a waiver from the requirement in Sec.  1271.22
that information must be provided to FDA in electronic format.
Submission of a request for waiver does not excuse timely compliance
with the registration and listing requirements. FDA will grant a waiver
request if FDA determines that the use of electronic means for
submission of registration and listing information is not reasonable
for the registrant making the waiver request.
    (b) Waiver requests under this section must be submitted in writing
and must include the specific reasons why electronic submission is not
reasonable for the registrant and a U.S. telephone number and mailing
address where FDA can contact the registrant. Waiver requests may be
sent to the Center for Biologics Evaluation and Research (CBER),
Document Control Center (see addresses in Sec.  600.2 of this chapter).
    (c) If FDA grants the waiver request, FDA may limit its duration
and will specify terms of the waiver and provide information on how to
submit establishment registration, listings, other information, and
updates, as applicable.

0
41. In Sec.  1271.25 revise paragraphs (a) introductory text and (a)(2)
and (3), add paragraphs (a)(5) and (6), revise paragraph (c)(4), and
add paragraph (d) to read as follows:

Sec.  1271.25  What information is required for establishment
registration and HCT/P listing?

    (a) Your establishment registration must include:
* * * * *
    (2) Each physical location, including the street address, telephone
number, email address, and the postal service ZIP code of the
establishment;
    (3) The name, address, telephone number, email address, and title
of the reporting official;
* * * * *
    (5) Each foreign establishment must also submit the name, address,
telephone number, and email address of each importer that is known to
the establishment, and the name of each person who imports or offers
for import such HCT/P to the United States for purposes of importation;
and
    (6) Each foreign establishment must also submit the name, address,
telephone number, and email address of its United States agent.
    (i) The United States agent must reside or maintain a place of
business in the United States.
    (ii) Upon request from FDA, the United States agent must assist FDA
in communications with the foreign establishment, respond to questions
concerning the foreign establishment's products that are imported or
offered for import into the United States, and assist FDA in scheduling
inspections of the foreign establishment. If the Agency is unable to
contact the foreign establishment directly or expeditiously, FDA may
provide information or documents to the United States agent, and such
an action is equivalent to providing the same information or documents
to the foreign establishment.
    (iii) The foreign establishment or the United States agent must
report changes in the United States agent's name, address, telephone
number, or email address to FDA within 30 calendar days of the change.
* * * * *
    (c) * * *
    (4) Any material change in any information previously submitted.
Material changes include any change in registration and listing
information, submitted, such as whether the HCT/P meets the criteria
set out in Sec.  1271.10.
    (d) If your HCT/P is described under Sec.  1271.20 and is regulated
under a BLA, you must submit the information required under part 207 of
this chapter using the procedures under subpart E of part 207.

0
42. Revise Sec.  1271.26 to read as follows:

Sec.  1271.26  When must I amend my establishment registration?

    If the ownership or location of your establishment changes, or if
there is a change in the United States agent's name, address, telephone
number, or email address, you must submit an amendment to registration
within 30 calendar days of the change.

    Dated: August 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20471 Filed 8-30-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Proposed Rules]
[Pages 58722-58726]
[FR Doc No: 2011-24356]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 76, No. 184 / Thursday, September 22, 2011 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0991; Directorate Identifier 2010-NM-134-AD]
RIN 2120-AA64

Airworthiness Directives; the Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) that applies to certain Model 747-100, 747-100B, 747-
200B, 747-200C, 747-200F, 747-400F, 747SR, and 747SP series airplanes,
without a stretched upper deck or stretched upper deck modification.
The existing AD currently requires repetitive inspections for cracks of
each affected tension tie and of the surrounding structure, and related
investigative and corrective actions if necessary. This proposed AD
would also require, for certain airplanes, modifying the tension tie
structure or tension tie and frame structure at certain stations; and a
post-modification inspection of the modified area and post-modification
repetitive inspections of the unmodified area, and repair if necessary.
Doing the modification would terminate the repetitive inspection
requirements in the existing AD. This proposed AD would reduce the
compliance time and add inspections for certain airplanes. This
proposed AD results from reports that certain airplanes have tension
ties that are susceptible to widespread fatigue damage. This proposed
AD also results from reports of cracks on the forward and aft tension
tie channels at station (STA) 740 and STA 760, and a determination that
initial inspection intervals need to be reduced. We are proposing this
AD to prevent tension ties from becoming severed or disconnected from
the frames, which could lead to rapid in-flight decompression.

DATES: We must receive comments on this proposed AD by November 7,
2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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 service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Steven Fox, Senior Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue, SW., Renton, Washington 98057-3356; phone:
(425) 917-6425; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-0991;
Directorate Identifier 2010-NM-134-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On December 30, 2005, we issued AD 2006-01-07, Amendment 39-14446
(71 FR 1947, January 12, 2006), for certain Model 747-100, 747-100B,
747-200B, 747-200C, 747-200F, 747-400F, 747SR, and 747SP series
airplanes. That AD requires detailed and high-frequency eddy current
(HFEC) inspections for cracks of each affected tension tie and of the
surrounding structure, and related investigative and corrective actions
if necessary. That AD resulted from a report of a crack in the tension
tie at the body station (BS) 820 frame connection, and cracks found on
the Boeing 747SR fatigue-test airplane in both the tension ties and
frames at the tension tie to frame connections at BS 800, 820, and 840.
We issued that AD to find and fix cracks in the tension ties, which
could lead to cracks in the skin and body frame and result in rapid in-
flight depressurization of the airplane.

Actions Since Existing AD Was Issued

    The preamble to AD 2006-01-07, Amendment 39 14446 (71 FR 1947,
January 12, 2006), specifies that we consider the requirements to be
``interim action'' and that the manufacturer was developing a
modification to address the unsafe condition. That AD explains that we
might consider further rulemaking if a

modification is developed, approved, and available. The manufacturer
now has developed such a modification, and we have determined that
further rulemaking is indeed necessary; this proposed AD follows from
that determination.
    This proposed AD also results from reports of cracks on the forward
and aft tension tie channels at station (STA) 740 and STA 760 on a
Model 747-400F airplane, and a determination that initial inspection
compliance times need to be reduced.

Relevant Service Information

    AD 2006-01-07, Amendment 39-14446 (71 FR 1947, January 12, 2006),
refers to Boeing Special Attention Service Bulletin 747-53-2502, dated
April 21, 2005, as the appropriate source of service information for
doing the required actions. We have reviewed Boeing Alert Service
Bulletin 747-53A2502, Revision 1, dated June 17, 2010. For Group 2
airplanes, Boeing Alert Service Bulletin 747-53A2502, Revision 1, dated
June 17, 2010, reduces the compliance time for the detailed and HFEC
inspections of the tension ties; adds a one-time general visual
inspection of the tension ties for correct configuration; adds a
detailed and open fastener-hole HFEC inspection for cracks in the
tension tie and frame if an incorrect configuration is found; and adds
repair of the cracked tension tie, or instructions to contact Boeing
for repair instructions.
    We have also reviewed Boeing Alert Service Bulletin 747-53A2605,
Revision 1, dated May 27, 2010, which is not applicable to Model 747SP
airplanes. Boeing Alert Service Bulletin 747-53A2605, Revision 1, dated
May 27, 2010, describes procedures for modification of the left- and
right-side tension tie structure or tension tie and frame structure at
certain body stations, repetitive inspections of the modified area,
repetitive detailed inspections for cracks on the unmodified area of
the tension tie, and repair if necessary.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to develop on other airplanes of the
same type design. For this reason, we are proposing this AD, which
would supersede AD 2006-01-07, Amendment 39-14446 (71 FR 1947, January
12, 2006), and would retain the requirements of the existing AD with a
reduced compliance time for certain airplanes. This proposed AD would
also require accomplishing the actions specified in Boeing Alert
Service Bulletin 747-53A2502, Revision 1, dated June 17, 2010; and
Boeing Alert Service Bulletin 747-53A2605, Revision 1, dated May 27,
2010; as described previously. Doing the modification specified in this
proposed AD ends the existing repetitive inspections in the existing
AD.

No Repetitive Intervals for Post-Modification Inspections of the
Modified Areas

    Boeing Alert Service Bulletin 747-53A2605, Revision 1, dated May
27, 2010, specifies to contact Boeing for the intervals for the
repetitive post-modification inspections of the modified areas, nor
does this proposed AD include those intervals. Post-modification
inspection guidance for paragraph (j)(2) of this proposed AD may be
defined in an approved alternative method of compliance (AMOC).

Changes to Existing AD

    In this NPRM, we have identified the legal name of the manufacturer
as published in the most recent type certificate data sheet for the
affected airplane models.
    Boeing Commercial Airplanes has received an Organization
Designation Authorization (ODA), which replaces the previous
designation as a Delegation Option Authorization (DOA) holder. We have
revised paragraph (n) of this proposed AD to add delegation of
authority to Boeing Commercial Airplanes ODA to approve an alternative
method of compliance for certain repairs required by this AD.
    We have added a new paragraph (d) to this NPRM to provide the Air
Transport Association (ATA) of America subject code 53: Fuselage. This
code is added to make this proposed AD parallel with other new AD
actions. We have re-identified subsequent paragraphs accordingly.

Differences Between the Proposed AD and the Service Information

    The service bulletins specify to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes ODA whom we have authorized to make those findings.
    Boeing Alert Service Bulletin 747-53A2605, Revision 1, dated May
27, 2010, includes a modification for all airplanes except for Model
747SP airplanes. This proposed AD requires that modification for Model
747SP airplanes.

Costs of Compliance

    There are about 276 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Average                                                   Number of
                                                               labor                                                      U.S.-
               Action                      Work hours         rate per           Parts            Cost per airplane    registered        Fleet cost
                                                                hour                                                    airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection (required by AD 2006-01-  8 per tension tie             $85  $0....................  Between $5,440 and            141  Between $767,040 and
 07, Amendment 39-14446 (71 FR        location, between 8                                        $8,160 per                         $1,150,560 per
 1947, January 12, 2006)).            and 12 tension tie                                         inspection cycle.                  inspection cycle.
                                      locations per
                                      airplane, depending
                                      on airplane
                                      configuration.
One-time inspection (new proposed    6.....................         85  None..................  510..................          86  $43,860.
 action for Group 2 airplanes).
Modification (new proposed action).  Between 30 and 85,             85  Between $18,657 and     Between $21,207 and            86  Between $1,823,802
                                      depending on airplane              $635,004.               642,229.                           and $55,231,694.
                                      configuration.

Inspection for unmodified area.....  2 per tension tie              85  None..................  Between $1,360 and             86  Between $116,960 and
                                      location, between 8                                        $2,040.                            $175,440.
                                      and 12 tension tie
                                      locations per
                                      airplane, depending
                                      on airplane
                                      configuration.
Inspection for modified area.......  2 per tension tie              85  None..................  Between $1,360 and             86  Between $116,960 and
                                      location, between 8                                        $2,040.                            $175,440.
                                      and 12 tension tie
                                      locations per
                                      airplane, depending
                                      on airplane
                                      configuration.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-14446 (71 FR
1947, January 12, 2006) and adding the following new AD:

The Boeing Company: Docket No. FAA-2011-0991; Directorate Identifier
2010-NM-134-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by November
7, 2011.

Affected ADs

    (b) This AD supersedes AD 2006-01-07, Amendment 39-14446 (71 FR
1947, January 12, 2006).

Applicability

    (c) This AD applies to The Boeing Company Model 747-100, 747-
100B, 747-200B, 747-200C, 747-200F, 747-400F, 747SR, and 747SP
series airplanes, certificated in any category, as identified in
Boeing Alert Service Bulletin 747-53A2502, Revision 1, dated June
17, 2010.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Unsafe Condition

    (e) This proposed AD results from reports that certain airplanes
have tension ties that are susceptible to widespread fatigue damage.
This proposed AD also results from reports of cracks on the forward
and aft tension tie channels at station (STA) 740 and STA 760, and a
determination that initial inspection compliance times need to be
reduced. The Federal Aviation Administration is issuing this AD to
prevent tension ties from becoming severed or disconnected from the
frames, which could lead to rapid in-flight decompression.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of Requirements of AD 2006-01-07, Amendment 39-14446 (71 FR
1947, January 12, 2006), With Reduced Compliance Time for Certain
Airplanes

Repetitive Inspections and Corrective Actions

    (g) For Group 1, and Groups 3 through 6 airplanes identified in
Boeing Special Attention Service Bulletin 747-53-2502, dated April
21, 2005; at the applicable time in paragraph (g)(1) or (g)(2) of
this AD: Do detailed and high-frequency eddy current inspections for
cracking of each affected tension tie and of the surrounding
structure. If any cracking is found: Before further flight, do all
applicable corrective and related investigative actions. Do all
actions in accordance with the Accomplishment Instructions of Boeing
Special Attention Service Bulletin 747-53-2502, dated April 21,
2005; or Boeing Alert Service Bulletin 747-53A2502, Revision 1,
dated June 17, 2010. Where Boeing Special Attention Service Bulletin
747-53-2502, dated April 21, 2005; or Boeing Alert Service Bulletin
747-53A2502, Revision 1, dated June 17, 2010; specifies to contact
Boeing for repair instructions: Before further flight, repair the
area using a method approved in accordance with paragraph (n) of
this AD. As of the effective date of this AD, only Boeing Alert
Service Bulletin 747-53A2502, Revision 1,

dated June 17, 2010, may be used for the actions required in this
paragraph.
    (1) For airplanes identified in Boeing Special Attention Service
Bulletin 747-53-2502, dated April 21, 2005, as Groups 1, 3, and 6
airplanes: Do the first inspections before the accumulation of
20,000 total flight cycles, or within 1,000 flight cycles after
February 16, 2006 (the effective date of AD 2006-01-07, Amendment
39-14446 (71 FR 1947, January 12, 2006)), whichever occurs later;
and repeat the inspections thereafter at intervals not to exceed
4,000 flight cycles until the modification required by paragraph (j)
of this AD is accomplished.
    (2) For airplanes identified in Boeing Special Attention Service
Bulletin 747-53-2502, dated April 21, 2005, as Group 4 and 5
airplanes: Do the first inspections before the accumulation of
17,000 total flight cycles, or within 1,000 flight cycles after
February 16, 2006, whichever occurs later; and repeat the
inspections thereafter at intervals not to exceed 3,000 flight
cycles until the modification required by paragraph (j) of this AD
is accomplished.

Inspection for Group 2 Airplanes With Reduced Compliance Times

    (h) For Group 2 airplanes identified in Boeing Alert Service
Bulletin 747-53A2502, Revision 1, dated June 17, 2010: At the
applicable times specified in paragraphs (h)(1) and (h)(2) of this
AD, do detailed and high-frequency eddy current inspections for
cracking of each affected tension tie and of the surrounding
structure, in accordance with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 747-53-2502, dated April
21, 2005; or Boeing Alert Service Bulletin 747-53A2502, Revision 1,
dated June 17, 2010. If any cracking is found: Before further
flight, do all applicable corrective and related investigative
actions. Do all actions in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 747-53-
2502, dated April 21, 2005; or Boeing Alert Service Bulletin 747-
53A2502, Revision 1, dated June 17, 2010. Where Boeing Special
Attention Service Bulletin 747-53-2502, dated April 21, 2005; or
Boeing Alert Service Bulletin 747-53A2502, Revision 1, dated June
17, 2010; specify to contact Boeing for repair instructions: Before
further flight, repair the area using a method approved in
accordance with paragraph (n) of this AD. As of the effective date
of this AD, only Boeing Alert Service Bulletin 747-53A2502, Revision
1, dated June 17, 2010, may be used. Repeat the inspections
thereafter at intervals not to exceed 3,000 flight cycles until the
modification required by paragraph (j) of this AD is accomplished.
    (1) For STA 780 through 940: Before the accumulation of 17,000
total flight cycles, or within 1,000 flight cycles after February
16, 2006, whichever occurs later.
    (2) For STA 720, 740, and 760: At the earlier of the times of
paragraph (h)(2)(i) or (h)(2)(ii).
    (i) Before the accumulation of 17,000 total flight cycles, or
within 1,000 flight cycles after February 16, 2006, whichever occurs
later.
    (ii) Before the accumulation of 8,000 total flight cycles, or
within 1,000 flight cycles after the effective date of this AD,
whichever occurs later.

New Requirements of This AD

One-Time Inspection for Group 2 Airplanes

    (i) For airplanes identified in Boeing Alert Service Bulletin
747-53A2502, Revision 1, dated June 17, 2010, as Group 2 airplanes:
Before the accumulation of 8,000 total flight cycles, or within
1,000 flight cycles after the effective date of this AD, whichever
occurs later: Do a general visual inspection for correct
configuration, as identified in Boeing Alert Service Bulletin 747-
53A2502, Revision 1, dated June 17, 2010, of each affected tension
tie and of the surrounding structure, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2502, Revision 1, dated June 17, 2010.
    (1) If all tension ties match the correct configurations
specified in the Accomplishment Instructions of Boeing Alert Service
Bulletin 747-53A2502, Revision 1, dated June 17, 2010, no further
work is required by this paragraph.
    (2) If any incorrect configuration is found, before further
flight, do detailed and open fastener-hole HFEC inspections for
cracks in the tension tie and frame, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2502, Revision 1, dated June 17, 2010.
    (i) If no crack is found during the inspection required by
paragraph (i)(2) of this AD, before further flight, install the
correct configuration for the tension ties at locations where the
incorrect configuration was found, using a method approved in
accordance with the procedures specified in paragraph (n) of this
AD.
    (ii) If any crack is found during the inspection required by
paragraph (i)(2) of this AD, before further flight, do the actions
in paragraphs (i)(2)(ii)(A) and (i)(2)(ii)(B) of this AD.
    (A) Repair the crack in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2502, Revision
1, dated June 17, 2010, except where Boeing Alert Service Bulletin
747-53A2502, Revision 1, dated June 17, 2010, specifies to contact
Boeing for appropriate action: Before further flight, repair the
crack using a method approved in accordance with the procedures
specified in paragraph (n) of this AD.
    (B) Install the correct configuration for the tension ties at
locations where the incorrect configuration was found, using a
method approved in accordance with the procedures specified in
paragraph (n) of this AD.

Modification

    (j) Before the accumulation of 30,000 total flight cycles, or
within 3,000 flight cycles after the effective date of this AD,
whichever occurs later, modify the left- and right-side tension tie
structure or left- and right-side tension tie and frame structure,
at specified stations, in accordance with the applicable method
specified in paragraph (j)(1) or (j)(2) of this AD. Accomplishment
of the modification in this paragraph terminates the repetitive
inspection requirements in paragraphs (g)(1), (g)(2), and (h) of
this AD.
    (1) For airplanes identified in Boeing Alert Service Bulletin
747-53A2605, Revision 1, dated May 27, 2010: Do the modification, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-53A2605, Revision 1, dated May 27, 2010.
    (2) For airplanes not identified in Boeing Alert Service
Bulletin 747-53A2605, Revision 1, dated May 27, 2010: Do the
modification, using a method approved in accordance with paragraph
(n) of this AD.

    Note 1: For airplanes identified in paragraph (j)(2) of this AD,
post-modification inspection guidance may be defined in an approved
alternative method of compliance (AMOC) for paragraph (j)(2) of this
AD.

Post-Modification Inspection of the Modified Areas

    (k) For airplanes identified in paragraph (j)(1) of this AD,
within 20,000 flight cycles after doing the modification required by
paragraph (j) of this AD, do an inspection for cracks of the
modified areas of the left- and right-side tension tie structure and
frame structure, in accordance with a method approved with the
procedures specified in paragraph (n) of this AD. If any crack is
found during any inspection required by this paragraph, before
further flight, repair the crack using a method approved in
accordance with the procedures specified in paragraph (n) of this
AD.

Post-Modification Repetitive Inspections of the Unmodified Areas

    (l) For airplanes identified in paragraph (j)(1) of this AD,
within 6,000 flight cycles after doing the modification required by
paragraph (j) of this AD, do a detailed inspection for cracks on the
unmodified areas of the left- and right-side tension tie structure
and frame structure, at certain stations, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2605, Revision 1, dated May 27, 2010. If any crack is found
during any inspection required by this paragraph, before further
flight, repair the crack using a method approved in accordance with
the procedures specified in paragraph (n) of this AD. Repeat the
inspection of the unmodified areas thereafter at intervals not to
exceed 6,000 flight cycles.

    Note 2: Boeing Alert Service Bulletin 747-53A2605, Revision 1,
dated May 27, 2010, refers to Section 51-10-02 of the Boeing 747-
400F Structural Repair Manual (SRM) and Section 51-10-01 of the
Boeing 747-100/200/300 SRM as additional sources of guidance for
removing small cracks and fatigue damage material from the existing
holes in the unmodified center section of the tension tie channels.
Where those SRM sections state that ``zero-timing must only be used
where specifically permitted in an SRM chapter-section-repair,''
this AD allows the zero-timing procedures specified in those SRM
sections.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (m) Actions done in accordance with Boeing Alert Service
Bulletin 747-53A2605,

dated October 8, 2009, before the effective date of this AD are
acceptable for compliance with the corresponding actions required by
paragraphs (j), (k), and (l) of this AD.

Alternative Methods of Compliance (AMOCs)

    (n)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be e-mailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) Certain actions required by paragraph (g) of this AD are
approved as AMOCs for the requirements specified in paragraphs
(n)(4)(i), (n)(4)(ii), and (n)(4)(iii) of this AD. All provisions of
the referenced ADs in paragraphs (n)(4)(i), (n)(4)(ii), and
(n)(4)(iii) of this AD, including applicable post-modification
inspection thresholds, remain fully applicable and must be complied
with.
    (i) Repairs or modifications of the aft tension tie channels
done in accordance with this AD are AMOCs for the repair
requirements of paragraph A. of AD 84-19-01, Amendment 39-4913 (49
FR 35365, September 17, 1984), and paragraphs (a)(2) and (b)(2) of
AD 94-13-06, Amendment 39-8946 (59 FR 32879, June 27, 1994).
    (ii) The inspection requirements of this AD are AMOCs for the
post-modification inspection requirements of paragraph B. of AD 84-
19-01, Amendment 39-4913 (49 FR 35365, September 17, 1984), and
paragraph (b) of AD 94-13-06, Amendment 39-8946 (59 FR 32879, June
27, 1994).
    (iii) The inspection requirements of this AD are AMOCs for the
inspections of Structural Significant Item (SSI) F-19A of Boeing
Supplemental Structural Inspection Document D6-35022, Revision G,
dated December 2000, as required by paragraphs (h) and (i) of AD
2004-07-22 R1, Amendment 39-15326 (73 FR 1052, January 7, 2008),
corrected on February 14, 2008 (73 FR 8589).

Related Information

    (o) For more information about this AD, contact Steven Fox,
Senior Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle
ACO, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6425; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    (p) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on September 14, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-24356 Filed 9-21-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 21 (Tuesday, February 1, 2011)]
[Notices]
[Pages 5639-5642]
[FR Doc No: 2011-2131]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63778; File No. SR-EDGA-2011-01]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 11.9

January 26, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 21, 2011, the EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated the proposed rule change as constituting a non-
controversial rule change under Rule 19b-4(f)(6) under the Act,\3\
which renders the proposal effective upon filing with the Commission.
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.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 11.9 to add its routing
options, which are currently contained in its fee schedule, to the rule
and to introduce additional options to the rule. The text of the
proposed rule change is attached as Exhibit 5 and is available on the
Exchange's Web site at http://www.directedge.com, at the Exchange's
principal office, and at the Public Reference Room of the Commission.

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

    In its filing with the Commission, the Exchange 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. The self-regulatory organization has prepared summaries,
set forth in Sections A, B and C below, of the most significant aspects
of such statements.

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

1. Purpose
    The Exchange's current fee schedule contains a list of routing
options. The Exchange proposes to move the current list of routing
options from the fee schedule and codify it in Rule 11.9(a)(3). In
addition, the Exchange proposes to amend the existing routing option
descriptions to provide additional clarity and introduce additional
routing options to Rule 11.9(a)(3).
    The Exchange intends to implement the rule change upon filing with
the Commission with respect to all routing options, except ROOC, which
the Exchange intends to implement on or about February 14, 2011.
    First, the Exchange proposes to move its discussion of available
routing options, which is located at the end of the fee schedule, and
codify it in Rule 11.9(b)(3)(a)-(s).
    Currently, the fee schedule has the following descriptions of
routing strategies:

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

------------------------------------------------------------------------
ROUQ...................................  sweeps the EDGA book, then
                                          routes to other destination
                                          centers.
ROUC...................................  sweeps the EDGA book, then
                                          sequentially sweeps the
                                          balance, if any, to the
                                          following destinations: other
                                          destination centers, then
                                          Nasdaq OMX BX, NYSE, and the
                                          remainder posts to EDGX.
ROUD...................................  sweeps the EDGA book before
                                          being routed to other
                                          destination centers.
ROUE...................................  sweeps the EDGA book, then
                                          other destination centers, and
                                          any remainder routes to other
                                          market centers.
ROUZ...................................  sweeps the EDGA book before
                                          interacting with solicited
                                          orders on a price/time
                                          priority basis.
INET...................................  sweeps the EDGA book and
                                          removes liquidity from Nasdaq,
                                          if the order is marketable, or
                                          posts on Nasdaq, if the order
                                          is non-marketable.

ROBA...................................  sweeps the EDGA book and routes
                                          to BATS BZX Exchange as an
                                          immediate or cancel (IOC)
                                          order, with the remainder
                                          being cancelled if there is no
                                          execution.
ROBX...................................  sweeps the EDGA book and routes
                                          to Nasdaq BX Exchange as an
                                          immediate or cancel (IOC)
                                          order, with the remainder
                                          being cancelled if there is no
                                          execution.
ROBY...................................  sweeps the EDGA book and routes
                                          to BATS BYX Exchange as an
                                          immediate or cancel (IOC)
                                          order, with the remainder
                                          being cancelled if there is no
                                          execution.
------------------------------------------------------------------------

    The Exchange proposes to amend Rule 11.9(b)(2) to cross-reference
the routing options listed in proposed Rule 11.9(b)(3), as described in
more detail below.
    The Exchange proposes to describe how its routing options work in
Rule 11.9(b)(3). The Exchange's system (``System'') provides a variety
of routing options. Routing options may be combined with all available
order types and times-in-force, with the exception of order types and
times-in-force whose terms are inconsistent with the terms of a
particular routing option. The System will consider the quotations only
of accessible markets. The term ``System routing table'' refers to the
proprietary process for determining the specific trading venues to
which the System routes orders and the order in which it routes them.
The Exchange reserves the right to maintain a different System routing
table for different routing options and to modify the System routing
table at any time without notice. The System routing options are
described in more detail below.
    The ROUC strategy currently states that under this strategy an
order sweeps the book then sequentially sweeps the balance, if any, to
the following destinations: Other destination centers, then Nasdaq OMX
BX, NYSE, and the remainder posts to EDGX. The Exchange proposes to
amend the description to state that it is a routing option under which
an order checks the System for available shares, and then is sent
sequentially to destinations on the System routing table, Nasdaq OMX
BX, and NYSE. If shares remain unexecuted after routing, they are
posted on the EDGX Exchange (``EDGX'') book. The Exchange will place
this proposed description in Rule 11.9(b)(3)(a).
    The ROUD strategy description states that it sweeps the book before
being routed to other destination centers. The Exchange proposes to
revise this description to state that an order routed under this
strategy checks the System for available shares and then is sent
sequentially to destinations on the System routing table. The ROUE
routing strategy currently states that it sweeps the book, then other
destination centers, and any remainder routes to other market centers.
The Exchange proposes to revise this description to state that it
checks the System for available shares, and then is sent to
destinations on the System routing table. The revised descriptions of
the ROUD and ROUE routing strategies, as described above, will be
placed in proposed Rules 11.9(b)(3)(b)-(c).
    The INET strategy is currently described as a strategy that sweeps
the EDGA book and removes liquidity from Nasdaq, if the order is
marketable, or posts on Nasdaq, if the order is non-marketable. The
Exchange proposes to revise the description to read that ``such an
order checks the System for available shares and then is sent to
Nasdaq. If shares remain unexecuted after routing, they are posted on
Nasdaq book.'' The proposed description of the INET routing strategy,
as described above, will be placed in proposed Rule 11.9(b)(3)(d).
    The Exchange's current description of the ROBA strategy states that
it is a strategy under which an order sweeps the book and routes to
BATS BZX Exchange as an immediate or cancel (IOC) order, with the
remainder being cancelled if there is no execution. The Exchange
proposes to revise such description to read that such order checks the
System for available shares and then is sent to BATS BZX Exchange as an
IOC order. If shares remain unexecuted after routing, they are
cancelled. The proposed description will be placed in Rule
11.9(b)(3)(e).
    ROBX is currently described as a strategy under which an order
sweeps the book and routes to Nasdaq BX Exchange as an IOC order, with
the remainder being cancelled if there is no execution. This
description is proposed to be revised to read that such order ``checks
the System for available shares and then is sent to Nasdaq BX Exchange
as an immediate or cancel (IOC) order. If shares remain unexecuted
after routing, they are cancelled.''
    ROBY is currently described as a strategy under which an order
sweeps the EDGA book and routes to BATS BYX Exchange as an immediate or
cancel (IOC) order, with the remainder being cancelled if there is no
execution. This description is proposed to be revised to state that
such order ``checks the System for available shares and then is sent to
BATS BYX Exchange as an IOC order. If shares remain unexecuted after
routing, they are cancelled.'' The revised descriptions of the ROBX and
ROBY strategies are proposed to be placed in Rules 11.9(b)(3)(f)-(g).
    The Exchange proposes to codify the following strategies in Rule
11.9(b)(3)(h)-(s) as well:
    In proposed rule 11.9(b)(3)(h), the Exchange proposes to describe
the ROUT routing option as a routing option under which an order checks
the System for available shares and then is sent to destinations on the
System routing table.
    In proposed rule 11.9(b)(3)(i), the Exchange proposes to describe
the ROUX routing option under which an order checks the System for
available shares and then is sent to destinations on the System routing
table.
    In proposed rule 11.9(b)(3)(j), the Exchange proposes to describe
the RDOT routing option as a routing option under which an order checks
the System for available shares and then is sent sequentially to
destinations on the System routing table. If shares remain unexecuted
after routing, they are sent to the NYSE.
    In proposed rule 11.9(b)(3)(k), the Exchange proposes to describe
the RDOX routing option under which an order checks the System for
available shares, and then is sent to the NYSE.
    In proposed rule 11.9(b)(3)(l), the Exchange proposes to describe
the ROLF routing option under which an order checks the System for
available shares, and then is sent to LavaFlow ECN.
    In proposed rule 11.9(b)(3)(m), the Exchange proposes to describe
the ROPA routing option under which an order checks the System for
available shares and then is sent to NYSE Arca as an immediate or
cancel order (IOC). If shares remain unexecuted after routing, they are
cancelled.
    In proposed rule 11.9(b)(3)(n), the Exchange proposes to describe
the IOCX routing option under which an order checks the System for
available shares and then is sent to EDGX.
    In proposed rule 11.9(b)(3)(o), the Exchange proposes to describe
the IOCT routing option under which an order checks the System for
available shares and then is sent sequentially to destinations on the
System routing table. If shares remain unexecuted after routing, they
are sent to EDGX.
    In proposed rule 11.9(b)(3)(p), the Exchange proposes to describe
the ROOC routing option for orders that the entering firm wishes to
designate for participation in the opening or closing process of a
primary listing market

(NYSE, Nasdaq, NYSE Amex, or NYSE Arca) if received before the opening/
closing time of such market. If shares remain unexecuted after
attempting to execute in the opening or closing process, they are
either posted to the book, executed, or routed like a ROUT routing
option, as described in proposed Rule 11.9(b)(3)(h), above.
    The Exchange also proposes to introduce the SWPA and SWPB routing
strategies and add them to proposed Rules 11.9(b)(3)(q)-(r). Under the
SWPA strategy, an order would check the System for available shares and
then would be sent to Protected Quotations and only for displayed size.
Under this strategy, orders would not have to contain sufficient size
to execute against all Protected Quotations (emphasis added). If any
shares remain unexecuted, such remainder will be cancelled back to the
User. Under the SWPB routing strategy, an order would check the System
for available shares and then is sent to Protected Quotations and only
for displayed size. Under this strategy, orders would have to contain
sufficient size to execute against all Protected Quotations. The entire
SWPB order will be cancelled back to the User immediately if at the
time of entry there is insufficient quantity in the SWPB order to
fulfill the displayed size of all Protected Quotations. The Exchange
believes that the proposed introduction of the SWPA/B routing options
will provide market participants with greater flexibility in routing
orders consistent with Regulation NMS. This proposed rule change is
similar to NASDAQ Rule 4758(a)(1)(A)(vi) (NASDAQ's ``MOPP'' strategy)
and BATS Exchange, Inc. Rule 11.13(a)(3)(D) (``Parallel T'').\4\
---------------------------------------------------------------------------

    \4\ See, e.g., NASDAQ Rule 4758, BATS Rule 11.13(a)(3)(D).
---------------------------------------------------------------------------

    The Exchange also proposes to describe the IOCM routing option and
add it to Rule 11.9(b)(3)(s).
    IOCM is a routing strategy under which an order checks the System
for available shares and then is sent to EDGX as an immediate or cancel
(IOC) Mid-Point Match (``MPM'') order.\5\ If there is no liquidity at
EDGX to execute at the midpoint, the order is subsequently cancelled.
---------------------------------------------------------------------------

    \5\ EDGX Rule 11.5(c)(7) defines a Mid-Point Match (MPM) order
as an order with an instruction to execute it at the midpoint of the
NBBO. A MPM order may be a Day Order, Fill-or-Kill Order, or IOC
Order. The Exchange notes that members can send in a MPM order
directly to EDGX Exchange, Inc. (``EDGX'') without routing through
the EDGA platform as an IOCM routing option.
---------------------------------------------------------------------------

    In addition, the Exchange also believes that the proposed
introduction of the routing options, described above, will provide
market participants with greater flexibility in routing orders, without
having to develop their own complicated routing strategies.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b)(5) of the Act,\6\ which requires the rules of an
exchange to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The proposed change to introduce the routing options
described above will provide market participants with greater
flexibility in routing orders without developing complicated order
routing strategies on their own. In addition, it will provide
additional clarity and specificity to the Exchange's rules regarding
routing strategies and will further enhance transparency with respect
to Exchange routing offerings.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) \7\ of the Act and Rule 19b-4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\9\ However,
Rule 19b-4(f) (6)(iii) \10\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay. The Exchange notes that
waiver of this requirement will allow the Exchange to immediately offer
Exchange Users new routing strategies, and with respect to the ROOC
option, as soon as the technology for such strategy is completed. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because such waiver would allow the new routing strategies to become
immediately available, and, with respect to the ROOC option, available
on or about February 14, 2011, and would immediately provide additional
clarity and specificity to the Exchange's rules regarding routing
strategies and further enhance transparency with respect to Exchange
routing offerings. For this reason, the Commission designates the
proposed rule change to be operative upon filing with the
Commission.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
    \10\ Id.
    \11\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2011-01 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-EDGA-2011-01. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's 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 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 publicly available. All submissions
should refer to File Number SR-EDGA-2011-01 and should be submitted on
or before February 22, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Elizabeth M. Murphy,
Secretary.
---------------------------------------------------------------------------

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

[FR Doc. 2011-2131 Filed 1-31-11; 8:45 am]
BILLING CODE 8011-01-P