[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68225-68226]
[FR Doc No: 2022-24659]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Extension to Public Comment Period--Notice of Intent To
Prepare an Environmental Impact Statement, Initiate Section 106
Consultation, and Request for Scoping Comments for the Proposed
Airfield, Safety, and Terminal Improvement Project at West Virginia
International Yeager Airport, Charleston, Kanawha County, West Virginia

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

ACTION: Notice of a 12-day extension to the public scoping comment
period for the proposed Airfield, Safety, and Terminal Improvement
Project at West Virginia International Yeager Airport, Charleston,
Kanawha County, West Virginia.

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SUMMARY: The Federal Aviation Administration (FAA) is issuing this
notice to advise the public that the scoping comment period for the
proposed Airfield, Safety, and Terminal Improvement Project and its
connected actions (Proposed Action) has been extended by 12 days. This
notice announces the extension of the public comment period to solicit
public comments on the scope of the environmental impact statement
(EIS).

DATES: The EIS scoping comment period began on September 30, 2022, was
originally scheduled to end on November 17, 2022, and has been extended
to end on November 29, 2022. All comments must be received by no later
than 5 p.m. Eastern Time, Tuesday, November 29, 2022.

FOR FURTHER INFORMATION CONTACT: Mr. Andrew Brooks, Environmental
Program Manager, Eastern Regional Office, AEA-610, Federal Aviation
Administration, 1 Aviation Plaza, Jamaica, NY 11434. Telephone: 718-
553-2511.

SUPPLEMENTARY INFORMATION: The purpose of the scoping process is to
receive input from the public, as well as from federal, state, and
local agencies that have legal jurisdiction and/or special expertise,
with respect to any potential environmental impacts associated with the
Proposed Action, as well as concerns, issues, and alternatives they
believe should be addressed in the EIS. During the scoping process,
questions regarding the scope and EIS process will be considered. More
information about the Proposed Action, the EIS process, and the scoping
meetings can be found at www.yeagerairporteis.com.

    The scoping process for this EIS includes a comment period for
interested agencies and members of the public to submit comments with
respect to any potential environmental impacts associated with the
Proposed Action, or comments representing the concerns, issues, and
alternatives they believe should be addressed in the EIS.
    During the ongoing scoping comment period, the FAA received several
requests from members of the public for an extension to the comment
period. In response, the FAA has agreed to extend the scoping comment
period by 12 additional days. The public comment period on the scoping
phase of the EIS will now end at 5 p.m. eastern time on November 29,
2022. Comments should be addressed to the individual listed in For
Further Information Contact, or by email to
[email protected].

    Issued in Beaver, West Virginia, November 7, 2022.
Matthew Digiulian,
Manager, Beckley Airport Field Office, Airports Division, Eastern
Region.
[FR Doc. 2022-24659 Filed 11-10-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Notices]
[Page 2963-2964]
[DOCID:fr16ja08-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57129; File No. SR-ISE-2008-01]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fee Changes

 January 10, 2008.
    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 2, 2008, the International Securities Exchange, LLC
(``Exchange'' or ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the ISE. The ISE has designated this proposal as one
establishing or changing a due, fee, or other charge imposed by the ISE
under Section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2)
thereunder,\4\ 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to adopt a fee
cap for certain orders executed in the Exchange's Facilitation
Mechanism. The text of the proposed rule change is available on the
Exchange's Web site (http://www.ise.com), at the principal office of the

Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this proposed rule change is to adopt a fee cap for
orders executed in the Exchange's Facilitation Mechanism. Specifically,
ISE proposes to adopt a fee discount for certain orders of 7,500
contracts or more that are executed in the Exchange's Facilitation
Mechanism. Under this proposal, for orders that are executed in the
Exchange's Facilitation Mechanism, ISE will waive (1) the execution and
comparison fee on incremental volume above 7,500 contracts for Firm
Proprietary orders, Non-ISE Market Maker orders, and Customer orders in
Premium Products, and (2) the execution fee on incremental volume above
7,500 contracts for Customer orders in Second Market options.\5\ The
number of contracts at or under the threshold will be charged as per
the Exchange's Schedule of Fees. The Exchange currently does not have
any size-based discounts for single orders while other Exchanges do.
For example, the Chicago Board Options Exchange (``CBOE'') has a large
trade discount program under which it caps transaction fees after the
first 7,500 contracts for orders in options on the S&P 500 Index, the
first 5,000 contracts for orders in other index options, and the first
3,000 contracts for orders in ETF and HOLDRs options.\6\ Further, the
American Stock Exchange (``Amex'') also has a large trade discount
program under which it caps transaction, comparison and floor brokerage
fees after the first 2,000 contracts for orders in index, ETF and TIR
options.\7\ ISE believes that adopting a fee cap for large-sized orders
executed in its Facilitation Mechanism will help strengthen its
competitive position and encourage members to use the Exchange's
Facilitation Mechanism.
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    \5\ The Exchange clarified that there is no comparison fee for
orders in Second Market options. Telephone conversation between
Samir M. Patel, Assistant General Counsel, International Securities
Exchange, LLC and Richard Holley III, Senior Special Counsel,
Division of Trading and Markets, Commission (January 10, 2008).
    \6\ See CBOE Options Fee Schedule, Section 18.
    \7\ See Amex Options Fee Schedule, Section (9).
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    The Exchange proposes to adopt the proposed fee discount on a pilot
basis, until June 30, 2008. Further, the proposed cap would apply only
to non-discounted volume, that is, it will not apply to orders
previously discounted by other pricing incentives that currently appear
on the Exchange's Schedule of Fees.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\8\ in general, and
furthers the objectives of Section 6(b)(4),\9\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities. In particular, the proposed fee caps will result in
lower fees for certain large size orders executed in ISE's Facilitation
Mechanism.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
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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 on 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 rule change establishes or changes a due,
fee, or other charge imposed by the Exchange, it has become effective
pursuant to Section 19(b)(3) of the Act \10\ and Rule 19b-4(f)(2) \11\
thereunder. At any time within 60 days of the filing of such proposed
rule change, the Commission may summarily abrogate 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.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 19b-4(f)(2).
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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 No. SR-ISE-2008-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2008-01. 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 Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2008-01 and should be
submitted on or before February 6, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-645 Filed 1-15-08; 8:45 am]

BILLING CODE 8011-01-P


not necessary:  (i) Based on the risks of the prohibited cattle materials in the product to the target
animal and the benefits of the product to the target animal and (ii) to ensure a reasonable
certainty of no harm to humans from any food derived from the target animal to which the
product was administered, or (2) a description of how the requirements are not necessary to
ensure the safety of the product with respect to both the target animal and any food derived from
the target animal to which the product is administered (proposed § 500.200(b)(2)(ii)(D)).  FDA
would respond to all requests in writing and could impose conditions in granting a request. FDA
could also grant permission for an exception or alternative to the requirements on its own
initiative based on an evaluation of the criteria described previously.  A record of any exception
or alternative to the requirements in paragraph (b)(1) of proposed §§ 300.200, 500.200, 600.16,
895
.102
, and 1271.470 that is granted by FDA would be required to be maintained by the
applicant or manufacturer under the proposed recordkeeping requirements discussed in section
V.E of this document.
Although FDA believes that exceptions or alternatives to the requirements of this
proposed rule would be rare, the proposal would allow medical products for humans and drugs
for ruminants to be manufactured from or otherwise contain prohibited cattle materials if the
agency determines that the risk posed by the use of prohibited cattle materials in the product
would be outweighed by the benefits of the particular product or if the agency determines that
prohibiting the use of these materials would be otherwise unnecessary to ensure the safety of the
product.  In the case of drugs intended for use in food-producing ruminant species, the benefits
of the product relate primarily to the target animal species (ruminants), whereas the risks relate to

48
both the health of the target animal as well as the safety of the food derived from the target
animal.  However, the agency does not weigh the benefits of a drug to an animal against the risks
of the drug to human health, but rather considers whether there is a reasonable certainty of no
harm to humans from the use of the drug in animals. Therefore, the reasonable certainty of no
harm standard would be applied when considering requests for exceptions or alternatives to the
proposed requirements for drugs intended for use in food-producing ruminant species. In all
cases, FDA intends to apply existing statutory safety standards in determining whether to grant a
written request for an exception or alternative to the proposed limitations on the use of prohibited
cattle materials. (See section V.E of this document for discussion.)
In the joint ANPRM, USDA’s FSIS sought comment on the issue of equivalence and
BSE requirements (whether the agency should consider a country’s BSE risk when determining
whether a country has implemented equivalent sanitary measures to those required by the United
States to prevent human exposure to the BSE agent) (69 FR 42287 at 42299 and 42300).  In the
Foods IFR, FDA sought comment on the standards that should be applied when determining
another country’s BSE status, providing an exemption for “BSE-free” countries, and how to
determine that countries meet any standards that might be developed (69 FR 42256 at 42263).
FDA here again requests comment on whether and, if so, on what basis to exempt products and
components of products from “BSE-free” countries from our respective requirements related to
BSE, including those issued by this proposed rule.
Proposed §§ 211.116 and 226.60, which would be part of FDA’s current good
manufacturing practice (CGMP) requirements for finished pharmaceuticals for humans and
ruminants and for type A medicated articles for ruminants would prohibit use of certain cattle
materials, as described in proposed §§ 300.200, 500.200 and 600.16.  The CGMP requirements

49
contain the minimum methods that must be used for the manufacture, processing, packing, or
holding of a drug to ensure that the drug meets the quality and purity characteristics that it
purports or is represented to possess. The CGMP requirements contained in part 211 (21 CFR
part 211) apply to finished pharmaceuticals and components of finished pharmaceuticals for both
humans and animals.
The CGMP requirements contained in part 226 (21 CFR part 226) apply to Type A
medicated articles. Type A medicated products are intended solely for use in the manufacture of
another Type A medicated article or a Type B or Type C medicated feed.  A Type A medicated
article consists of a new animal drug(s), with or without carrier, with or without inactive
ingredients. Type A medicated articles are new animal drugs, and the manufacture of a Type A
medicated article requires an approved new animal drug application (21 CFR part 514).
C.  Tallow and Tallow Derivatives
Tallow would be defined as "the rendered fat of cattle obtained by pressing or by
applying any other extraction process to tissues derived directly from discrete adipose tissue
masses or to other carcass parts and tissues" (proposed §§ 300.200(a)(6), 500.200(a)(6),
600
.16(a)(6), 895.102(a)(6) and 1271.470(a)(6)).  Tallow derivatives would be defined as any
chemical obtained through initial hydrolysis, saponification, or trans-esterification of tallow;
chemical conversion of material obtained by hydrolysis, saponification, or trans-esterification
may be applied to obtain the desired product (proposed §§ 300.200(a)(7), 500.200(a)(7),
600
.16(a)(7), 895.102(a)(7) and 1271.470(a)(7)).  For the reason described in section II.K of this
document, we are proposing that tallow with no more than 0.15 percent insoluble impurities and
tallow derivatives would not be defined as prohibited cattle materials under this rule even when
manufactured with prohibited materials (proposed §§ 300.200(a)(1), 500.200(a)(1), 600.16(a)(1),

50
895
.102
(a)(1) and 1271.470(a)(1)).  (Tallow made without using prohibited cattle materials
would not be subject to this purity requirement.)  We are proposing that the insoluble impurities
in tallow be measured by the method entitled “Insoluble Impurities” (AOCS Official Method Ca
3a-
4
6), American Oil Chemists’ Society (AOCS), 5
th
Edition, 1997, incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy,
precision, and sensitivity to the AOCS Official Method Ca 3a-46 (proposed §§ 300.200(a)(6),
500
.200
(a)(6), 600.16(a)(6), 895.102(a)(6) and 1271.470(a)(6)).  The AOCS Official Method Ca
3a-46 is currently used by the domestic tallow industry. Reference to the AOCS Official Method
Ca 3a-46 in this proposed definition does not exclude use of another method.  Any testing
method may be used that is equivalent to the AOCS Official Method Ca 3a-46 in accuracy,
precision, and sensitivity. Those wishing to use an alternate test would be responsible for
determining that it is equivalent to the AOCS Official Method Ca 3a-46; it would not be
necessary for FDA to approve the use of an alternate test.
Tallow that contains more than 0.15 percent insoluble impurities could be used if it
complies with the proposed requirements for cattle materials in proposed § 300.200 for drugs for
humans, proposed § 500.200 for drugs for ruminants, proposed § 600.16 for biological products,
proposed § 895.102 for medical devices for humans that are intended for use in or on the body,
and proposed § 1271.470 for HCT/Ps (e.g., made without the use of any prohibited cattle
materials).
We note that, regardless of its purity level, tallow to be used in medical products for
humans and drugs for ruminants would be subject to the other provisions of the act and would be
adulterated if, for example, it has been prepared, packed, or held under insanitary conditions

51
whereby it may have become contaminated with filth (section 501(a)(2)(A) of the act)(21 U.S.C.
351
(a)(2)(A)).
D.
Proposed Requirements Regarding Extralabel Drug Use in Animals
In 1994, Congress enacted the Animal Medicinal Drug Use Clarification Act
(AMDUCA)(Public Law 103-396).  This act authorizes the extralabel use of approved animal
and human drugs in animals.  The act, as well as FDA regulations in part 530 (21 CFR part 530),
sets out certain conditions for extralabel use and authorizes FDA to prohibit the extralabel use of
approved animal or human drugs in animals.  Because FDA, elsewhere in this proposed rule,
would prohibit the use of certain cattle materials in drugs for ruminants only, the agency is
concerned that ruminants could still be exposed to prohibited cattle materials through the
extralabel use in ruminants of a drug that was approved for a nonruminant species.  Also, the
agency is concerned about the extralabel use in ruminants of a drug that was approved for
humans to the extent an exception or alternative to these proposed requirements has been
granted.  Therefore, in order to prevent the intentional or unintentional use of a drug containing
prohibited cattle materials in ruminants, FDA is proposing to revise § 530.41 to prohibit in
ruminants the extralabel use of drugs containing prohibited cattle material and approved for use
in other animals (nonruminants) or for humans (proposed § 530.41(c)).
FDA is also proposing to add new § 530.42 that would require labels for drugs prohibited
from extralabel use in ruminants and described under proposed § 530.41(c) to bear or be
accompanied by labeling information to communicate to the user that extralabel use in ruminants
is prohibited. The proposed regulation would require label information to include the statement
"Federal law prohibits the extralabel use of this product in ruminants."  AMDUCA and the
implementing regulation at § 530.11, however, prohibit the extralabel use of an approved new

52
animal drug or human drug in or on animal feed. Since the extralabel use of all drugs in or on
animal feed is excluded from the extralabel use provisions of AMDUCA, FDA believes it is
unnecessary and potentially confusing to include the previous statement only on those feed
products that contain drugs described in proposed § 530.41(c).  Therefore, the labeling
requirement under proposed § 530.42 would apply to all products that contain drugs described in
proposed § 530.41(c) except those products used in or on an animal feed.  FDA intends for
sponsors of approved products that would be subject to proposed § 530.42 to revise their labeling
by the effective date of the final rule based on this proposal.  If necessary, FDA also would have
the ability under proposed § 300.200(b)(2)(iii) to impose a labeling condition on a human drug
regarding the extralabel use in ruminants of that human drug if an exception or alternative is
granted.
E.
Proposed Recordkeeping Requirements
We are proposing that applicants and manufacturers of medical products for humans and
drugs for ruminants that are manufactured from or otherwise contain material from cattle be
required to establish and maintain records that demonstrate that the material from cattle meets
the requirements of this proposed rule (proposed §§ 300.200(c)(1), 500.200(c)(1), 600.16(c)(1),
895
.102
(c)(1) and 1271.470(c)(1)).  Because at this time there is no way to screen reliably for the
presence of the BSE agent or for the presence of prohibited cattle materials, applicants and
manufacturers of medical products for humans and drugs for ruminants must depend on records
from the suppliers of cattle material to demonstrate that their source material is free from
prohibited cattle materials. Similarly, without adequate records, FDA may not know whether
applicants and manufacturers of medical products for humans and drugs for ruminants have
complied with the prohibitions against use of prohibited cattle materials.  Therefore, under

53
proposed §§ 300.200(c)(1), 500.200(c)(1), 600.16(c)(1), 895.102(c)(1) and 1271.470(c)(1),
applicants and manufacturers of medical products for humans and drugs for ruminants that are
manufactured from or otherwise contain material from cattle would be required to establish and
maintain records sufficient to demonstrate that the medical products for humans and drugs for
ruminants do not contain prohibited cattle materials.
1.
Types of Records
For example, to satisfy the requirement in proposed §§ 300.200(c)(1), 500.200(c)(1),
600
.16(c)(1), 895.102(c)(1), and 1271.470(c)(1) that records show the absence of prohibited
cattle materials, applicants and manufacturers of medical products for humans and drugs for
ruminants that are manufactured from or otherwise contain brain from cattle would have to
establish and maintain records to demonstrate, among other things, that the cattle brain used is
not from cattle over 30 months of age.
In general, we would expect that having the following types of records on FDA-regulated
medical products for humans or drugs for ruminants containing cattle material would be
sufficient to demonstrate that the product is not manufactured from and does not otherwise
contain prohibited cattle materials:
•
A signed and dated affirmation (with contact information) by a slaughter
establishment that cattle material supplied by that establishment in a particular
shipment does not contain prohibited cattle materials.  If two or more lots of cattle
material from different slaughter establishments are pooled into a final product,
then having records from each slaughter establishment should be sufficient.
•
For products containing tallow, records from a slaughter establishment affirming
that the tallow was produced from material containing no prohibited cattle

54
materials or records (i.e., signed, dated, with contact information) from the tallow
supplier affirming that the tallow contains no more than 0.15 percent insoluble
impurities (e.g., a certificate of analyses).
•
For products containing fetal calf materials, records from a slaughter
establishment affirming that the fetal calf material was obtained: (1) From cows
that were inspected and passed and (2) using procedures that ensure that the fetal
material was not contaminated with prohibited cattle materials during slaughter or
processing.
Consistent with CGMP recordkeeping requirements, applicants and manufacturers who
maintain documentation of compliance should maintain that information on a lot-by-lot basis.
The lot-by-lot records would ensure that each time a shipment of cattle material is sent or
received, there is documentation that a management official confirmed that the shipment was
free of any prohibited cattle material.
We request comments on alternative recordkeeping requirements that would ensure the
requirements of the proposed rule would be met.  We also request comments on whether existing
recordkeeping practices include the required information and, if not, what changes the proposal
would necessitate.  In addition, we request comment on whether the rule should specifically
require certain types of records.
2.
Proposed Periods for Records Retention
Th
e following record retention time periods would be required by this proposal:
•
For drugs for humans, we are proposing, consistent with our CGMP regulations
for these products (§ 211.180), to require that records be retained for at least 1
year after the expiration date of the drug (proposed § 300.200(c)(2)).

55
•
For drugs for humans lacking an expiration date, we are proposing, consistent
with our CGMP regulations for these products (§ 211.180), to require that records
be retained for at least 3 years after distribution of the last lot of the drug
(proposed § 300.200(c)(2)).
•
For drugs for ruminants other than Type A medicated articles, we are proposing,
consistent with our CGMP regulations for these products (§ 211.180), to require
that records be retained for at least 1 year after the expiration date of the product
(proposed § 500.200(c)(2)(ii)).  Because all new animal drugs are required to have
an expiration date, only the proposed 1-year records retention period would apply
to all drugs for ruminants.
•
For Type A medicated articles intended for use in ruminants, records would be
retained, consistent with our CGMP regulations for these products (§ 226.110),
for at least 2 years after distribution by the manufacturer (proposed §
500
.200
(c)(2)(i)).
•
For human biological products, we reference 21 CFR 600.12(b) for consistency
with established recordkeeping periods.  Records would be retained for no less
than 5 years after the records of manufacture have been completed or 6 months
after the latest expiration date for the individual product, whichever represents a
later date (proposed § 600.16(c)(2)).
•
For medical devices that are intended for use in or on the body, we reference 21
CFR 820.180(b) for consistency with established recordkeeping periods.  Records
would be retained for a period of time equivalent to the design and expected life

56
of the device, but in no case less than 2 years from the date of release for
commercial distribution by the manufacturer (proposed § 895.102(c)(2)).
•
For HCT/Ps, we reference § 1271.270(d) for consistency with established
recordkeeping periods.  Records would be retained for 10 years after their
creation unless otherwise stated in part 1271 (proposed § 1271.470(c)(2)).
As discussed previously, records documenting the absence of prohibited cattle materials
in medical products for humans and drugs for ruminants are needed to help applicants and
manufacturers ensure that they meet the proposed requirements of this rulemaking and to help
FDA monitor compliance.  It is important for recall purposes that records be retained for the
likely period of time during which the product might be used, so that FDA can assess compliance
with the requirements for cause or otherwise.  The proposed timeframes for retaining records
reflect the likely period of time during which medical products for humans and drugs for
ruminants covered by this proposed rule might be used.  The proposed timeframes for retaining
records are consistent with the relevant CGMP requirements in current rules.  Because of the
lengthy incubation period of BSE (see section II.C of this document), we are requesting
comment on whether records should be required for a longer period of time than proposed in this
rulemaking.  This may assist with traceback and may assist applicants and manufacturers in
proving that their products are not the source of BSE infection.
In the Foods Recordkeeping/Access proposed rule, we proposed that records for FDA-
regulated human food and cosmetics be retained for 2 years after the date the records were
created (69 FR 42256 at 42277).  FDA proposed this timeframe for these products so that the
records would be available during the entire shelf life of the products covered by that rule.

57
3
.
Location of Records
We are proposing that records be maintained at the applicant’s or manufacturer’s
establishment or at a reasonably accessible location.  Records would be considered to be
reasonably accessible if they are accessible from an onsite location (proposed §§ 300.200(c)(3),
500
.200
(c)(3), 600.16(c)(3), 895.102(c)(3) and 1271.470(c)(3)). Electronic recordkeeping
requirements for all types of FDA required recordkeeping are addressed under part 11 (21 CFR
part 11).  These requirements would pertain to any records that would be required by this
proposed rule.
Proposed §§ 300.200(c)(4), 500.200(c)(4), 600.16(c)(4), 895.102(c)(4) and
127
1.47
0(c)(4) provide that records required by this subpart must be readily available to FDA for
inspection and copying.  All the records would be required to be in English.
Because of inherent difficulties in accessing records maintained at foreign
establishments, we are proposing requirements for importers of record of medical products for
humans and drugs for ruminants (proposed §§ 300.200(c)(5), 500.200(c)(5), 600.16(c)(5),
895
.102
(c)(5) and 1271.470(c)(5)).  When filing entry with the U.S. Customs and Border
Protection, importers of record of a product manufactured from or otherwise containing cattle
material would be required to affirm that the product for import was manufactured from or
otherwise contains cattle material and affirm that the product was manufactured in accordance
with proposed §§ 300.200(b), 500.200(b), 600.16(b), 895.102(b) and 1271.470(b), as applicable.
If the product was manufactured from or otherwise contains cattle material, then the importer of
record would be required, if requested, to provide to FDA within 5 days records that would be
sufficient to demonstrate that the product was not manufactured from and does not contain

58
prohibited cattle material.  FDA expects that the content of these records would be the same as
that described as being sufficient for domestic products.
FDA believes 5 days is a reasonable amount of time for the importer of record to respond
while still allowing FDA sufficient time to review the documents to make an initial admissibility
decision before the conditional release period for the product expires.  If the importer of record
fails to provide FDA with the records within 5 days, the product would be subject to detention
because it would appear to be adulterated, and the owner or consignee would be afforded notice
and an opportunity for hearing in accordance with section 801(a) of the act (21 U.S.C. 381).
VI.  Legal Authority
FDA has the authority to take the actions proposed in this rule under various statutory
provisions.  These provisions include sections 201, 301, 501, 502, 505, 512, 516, 519, 701, 704,
and 801(a) of the act (21 U.S.C. 321, 331, 351, 352, 355, 360b, 360f, 360i, 371, 374, and 381(a))
and sections 351, 361, and 368 of the PHS Act (42 U.S.C. 262, 264, and 271).
With respect to drugs for humans, including drugs that are biological products, FDA is
proposing these regulations under the adulteration provision in section 501(a)(2)(B) of the act,
and under sections 201, 505, 701(a) and (b), 704, and 801(a) of the act.
Under section 501(a)(2)(B) of the act, FDA has the authority to impose requirements
necessary to ensure that drugs meet the requirements of the act with respect to identity, strength,
quality, and purity.  Under section 501(a)(2)(B) of the act, a drug is adulterated if:
the methods used in, or the facilities and controls used for, its
manufacture, processing, packing, or holding do not conform to or
are not operated or administered in conformity with current good
manufacturing practice to assure that such drug meets the

59
requirements of this Act as to safety and has the identity and
strength, and meets the quality and purity characteristics, which it
purports or is represented to possess.
FDA is proposing to amend its CGMP regulations (proposed § 211.116) to prohibit the
use of certain cattle materials in human drug products and components, including biological
products, as provided by proposed §§ 300.200 and 600.16.  Proposed §§ 300.200 and 600.16
would require that no drug or biological product "be manufactured from or otherwise contain
prohibited cattle materials" unless FDA has granted a request for an exception or alternative to
the requirements.  Proposed § 211.116 would apply to drugs, including biological products, that
are directly subject to the CGMP regulations.  For drugs not directly subject to the CGMP
regulations, such as active pharmaceutical ingredients and source materials, section 501(a)(2)(B)
of the act supports the proposed requirements in §§ 300.200 and 600.16.
As provided in proposed §§ 300.200(d) and 600.16(d), a drug or biological product that
fails to comply with the requirements of §§ 300.200(b) and 600.16(b), respectively, would be
adulterated under section 501(a)(2)(B) of the act.  Because of the possibility of disease
transmission to humans from exposure to prohibited cattle materials, prohibiting such cattle
materials in drugs and biological products will help ensure that they meet the requirements of the
act with respect to safety and have the identity, and meet the quality and purity characteristics
they are purported or represented to possess.
Section 201(p) of the act defines a new drug to include "[a]ny drug *** the composition
of which is such that such drug is not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for
use under the conditions prescribed, recommended, or suggested in the labeling thereof ***."

60
Based on the scientific data and information available to FDA regarding the possibility of disease
transmission to humans from exposure to prohibited cattle materials, under this proposed rule
any human drug manufactured from, or otherwise containing, prohibited cattle materials is not
generally recognized as safe and effective (GRAS/GRAE), and therefore is a new drug under
section 201(p) of the act.
Section 505(a) of the act requires that "[n]o person shall introduce or deliver for
introduction into interstate commerce any new drug, unless an approval of an application filed
pursuant to subsection (b) or (j) [of section 505] is effective with respect to such drug."  Under
section 505 of the act, new drug applications must demonstrate that a drug is safe and effective
for its intended use(s).  Because of the possibility of disease transmission to humans from
exposure to prohibited cattle materials, prohibiting such cattle materials in drugs will help ensure
that drugs are safe for their intended use(s).  Based on the scientific data and information
available to FDA regarding the possibility of disease transmission to humans from exposure to
prohibited cattle materials, under this proposed rule FDA would not approve an application or
supplement for a drug containing prohibited cattle materials unless an exception or alternative
has been granted based upon the Center Director’s determination that the safety standard in
section 505 of the act would still be met. In addition, under the proposed rule, a drug containing
prohibited cattle materials that is already subject to an approval would no longer be shown to be
safe based on the presence of prohibited cattle materials, and would be in violation of section
505
of the act unless an exception or alternative for use of the prohibited cattle materials has
been granted.  Section 505 of the act also allows FDA to impose additional conditions on an
application product on a case-by-case basis, should such conditions be necessary to ensure that
the product meets the standard for approval set forth in section 505 of the act.

61
Under section 701(a) of the act, FDA is authorized to issue regulations for the act's
efficient enforcement.  The proposed regulations would require measures to ensure that drugs for
humans, including biologics, are being manufactured, processed, packed, or held in conformity
with CGMP, and to ensure that new drugs comply with section 505 of the act, which would
allow for efficient enforcement of the act.  Under the proposed regulations, applicants and
manufacturers of drugs for humans that are manufactured from or otherwise contain material
from cattle also would be required to establish and maintain records that document the absence
of prohibited cattle materials in such products and have such records readily available to FDA
for inspection and copying. These proposed recordkeeping requirements are also authorized
under sections 501(a)(2)(B) and 505(k) of the act.
Once material is removed from cattle, we may not be able to obtain the information
necessary to determine whether it is prohibited cattle material.  For example, we would not know
from examination of a spinal cord whether the source animal was 30 months of age or over at the
time of slaughter, or whether it was inspected and passed.  Because at this time there is no way to
test reliably for the presence of the BSE agent or the presence of the cattle materials prohibited in
proposed § 300.200, applicants and manufacturers of drugs for humans would have to depend on
records from their suppliers of cattle materials to ensure that their source material does not
contain any cattle materials prohibited under proposed § 300.200.  Without adequate records,
FDA cannot know whether applicants and manufacturers of drugs for humans have complied
with the prohibitions against certain cattle materials under proposed § 300.200.  Therefore, the
proposed recordkeeping requirements are necessary for the efficient enforcement of these rules
and authorized under section 701(a) of the act.  Under proposed § 300.200(e) and 600.16(e), the

62
failure of an applicant or manufacturer to comply with the requirements of §§ 300.200(c) and
600
.16(c), respectively, would render a drug or biological product adulterated.
We are also proposing provisions relating to records regarding imported drugs for
humans under sections 801(a) and 701(b) of the act.  Importers of record of such a drug product
manufactured from or otherwise containing cattle material would be required to affirm that such
a drug product for import was manufactured from or contains cattle material, and affirm that it
was manufactured in compliance with the proposed rule.  If such a drug was manufactured from
or otherwise contains cattle material, then importers of record would also be required, if
requested, to provide records to FDA within 5 days sufficient to demonstrate compliance.  Under
proposed §§ 300.200(f) and 600.16(f), failure of an importer of record to comply with those
requirements causes a drug for humans to appear to be adulterated.
Section 801(a) of the act provides requirements with regard to imported drugs and
provides for refusal of admission into the United States of drugs for humans that appear to be
adulterated.  Section 701(b) of the act authorizes the Secretaries of Treasury
2
and Health and
Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of
the act.
Because most biological products, including blood, are also drugs, the sections of the act
discussed previously provide legal authority for issuing a regulation limiting the use of
prohibited cattle materials in such biological products. There is, however, additional legal
authority for the proposed rule's requirements with respect to biological products generally.
Section 351(a)(2)(A) of the PHS Act (42 U.S.C. 262(a)(2)(A)) requires that FDA "establish, by
2
Under the Homeland Security Act of 2002 (Public Law 107-296), the Secretary of the Treasury has
delegated all relevant Customs revenue authorities to the Secretary of Homeland Security, who has, in
turn, delegated them to the Commissioner of Customs and Border Protection (CBP or Customs).  If
finalized, we will issue this rule jointly with the Department of Homeland Security.


[Federal Register: June 2, 2009 (Volume 74, Number 104)]
[Proposed Rules]
[Page 26317-26322]
[DOCID:fr02jn09-22]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0454; Directorate Identifier 2008-NM-156-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 747-400, 747-400D, and
747-400F Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Boeing Model 747-400, 747-400D, and 747-400F series airplanes.
For all airplanes, this proposed AD would require installing new pump
control and time delay relays, doing related investigative and
corrective actions if necessary, and changing the wiring for the center
and main fuel tanks override/jettison fuel pumps; and, for certain
airplanes, installing new relays and wiring for the horizontal
stabilizer override/jettison fuel pumps. This proposed AD would also
require a revision to the maintenance program to incorporate
Airworthiness Limitation No. 28-AWL-24 and No. 28-AWL-26. For certain
airplanes, this proposed AD would also require installing an automatic
shutoff system for the horizontal stabilizer tank fuel pumps and
installing a new integrated display system. This proposed AD results
from fuel system reviews conducted by the manufacturer. We are
proposing this AD to prevent uncommanded operation of certain override/
jettison pumps which could cause overheat, electrical arcs, or
frictional sparks, and could lead to an ignition source inside a fuel
tank. This condition, in combination with flammable fuel vapors, could
result in a fuel tank explosion and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by July 17, 2009.

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 AD, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P.O. Box
3707, MC 2H-65, Seattle, Washington 98124-2207; telephone<PHONE_NUMBER>,
extension 1, fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>Internet
https://www.myboeingfleet.com.

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: Jon Regimbal, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6506; fax<PHONE_NUMBER>.

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-2009-0454;
Directorate Identifier 2008-NM-156-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

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the

service history of airplanes subject to those regulations, and existing
maintenance practices for fuel tank systems. As a result of those
findings, we issued a regulation titled ``Transport Airplane Fuel Tank
System Design Review, Flammability Reduction and Maintenance and
Inspection Requirements'' (66 FR 23086, May 7, 2001). In addition to
new airworthiness standards for transport airplanes and new maintenance
requirements, this rule included Special Federal Aviation Regulation
No. 88 (``SFAR 88,'' Amendment 21-78, and subsequent Amendments 21-82
and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.
    Safety assessments conducted by Boeing indicate that there is a
risk of an ignition source in the main and center fuel tanks for Model
747-400, 747-400D, and 747-400F series airplanes, and in the horizontal
stabilizer fuel tanks of Model 747-400 series airplanes, if the
override/jettison pump continues to run for an extended time after the
fuel level goes below the pump inlet. The pump is normally commanded
off if the fuel level goes below the pump inlet, but if a single
failure in the pump control circuitry occurs, a pump can continue to
run after it is commanded off. Uncommanded operation of certain
override/jettison pumps could cause overheat, electrical arcs, or
frictional sparks, and could lead to an ignition source inside a fuel
tank. This condition, in combination with flammable fuel vapors, could
result in a fuel tank explosion and consequent loss of the airplane.

Other Related Rulemaking

    Installing a new integrated display system (IDS) in accordance with
Boeing Service Bulletin 747-31-2376, 747-31-2377, or 747-31-2378, all
dated September 5, 2006, as applicable, would provide an acceptable
substitute for complying with certain paragraphs of the ADs listed
below.
     Paragraph E. of AD 90-09-06, amendment 39-6581 (55 FR
15217, April 23, 1990). That AD applies to all Model 747 series
airplanes and requires, among other actions, installing a system to
provide visual warning signals to alert flightcrew members and ground
crew personnel of certain incorrect indications.
     Paragraph (b) of AD 91-13-10 R1, amendment 39-8158 (57 FR
2446, January 22, 1992). That AD applies to certain Boeing Model 747
and 767 series airplanes and requires, among other actions, replacing
the engine indicating and crew alerting system (EICAS) computers.
     Paragraph (d)(1) of AD 96-07-09, amendment 39-9558 (61 FR
14608, April 3, 1996). That AD applies to all Boeing Model 747-400,
757, and 767 series airplanes and requires, among other actions,
installing an upgraded EICAS computer that provides ``advisory''
messages to the flightcrew to indicate an impending engine fuel filter
bypass condition for each engine.
     Paragraph (a)(3)(iii) of AD 2000-02-22, amendment 39-11540
(65 FR 5222, February 3, 2000). That AD applies to certain Boeing Model
747-400 series airplanes and requires, among other actions, modifying
the IDS software.
     Paragraph (a)(2)(ii) of AD 2000-12-21, amendment 39-11799
(65 FR 39079, June 23, 2000). [A correction of that AD was published in
the Federal Register on July 18, 2000 (65 FR 44432).] That AD requires,
among other actions, modifying the IDS software.
     Paragraph (d)(2)(iv) of AD 2003-16-16, amendment 39-13269
(68 FR 51439, August 27, 2003). That AD applies to certain Boeing Model
747-400 series airplanes and requires, among other actions, installing
new IDS software in six integrated display units and three electronic
flight information (EFI)/EICAS interface units.
     Paragraph (d)(1) of AD 2004-10-05, amendment 39-13635 (69
FR 28052, May 18, 2004). That AD applies to certain Boeing Model 747-
400, 747-400D, 747-400F, 757-200, 757-200PF, 757-200CB, 767-200, 767-
300, and 767-300F series airplanes. That AD requires, among other
actions for Model 747-400, -400D, and -400F series airplanes, replacing
the three EFIS/EICAS interface units (EIU), installing new software in
the integrated display units (IDUs) and EIUs, replacing certain central
maintenance computers (CMCs), and installing new software in the CMCs.
    For airplanes with a horizontal stabilizer fuel tank and with
horizontal stabilizer tank fuel pump auto-shutoff installed, installing
a new IDS in accordance with Boeing Service Bulletin 747-31-2376, 747-
31-2377, or 747-31-2378, all dated September 5, 2006, as applicable,
would provide an acceptable method for complying with certain
paragraphs of the ADs listed below, provided the certificate
limitations enclosed with FAA Letter 140S-06-343, dated November 17,
2006, are incorporated into the limitations section of the applicable
airplane flight manual (AFM) revision specified in the applicable AD.
     Paragraph (a) of AD 2001-12-21, amendment 12777 (66 FR
33170, June 21, 2001). That AD applies to all Boeing Model 747 series
airplanes and requires, among other actions, revising the Limitations
Section of the AFM to include procedures to prevent dry operation of
the center wing fuel tank override/jettison pumps and, for certain
airplanes, to prohibit operation of the horizontal stabilizer tank
transfer pumps in-flight.
     Paragraph (a) of AD 2001-21-07, amendment 39-12478 (66 FR
54652, October 30, 2001). That AD applies to certain Boeing Model 747
series airplanes and requires, among other actions, revising the AFM to
specify the amount of fuel necessary for operating the override/
jettison fuel pumps, and to specify not resetting the circuit breakers
for the override/jettison fuel pumps if they are tripped.
     Paragraph (c)(2) of AD 2002-19-52, amendment 39-12900 (67
FR 61253, September 30, 2002). That AD applies to all Boeing Model 737-
600, -700, -700C, -800, and -900 series airplanes; Model 747 series
airplanes; and Model 757 series airplanes. That AD requires, among
other actions, revising the AFM

to advise the flightcrew of certain operating restrictions for
maintaining minimum fuel levels.
     Paragraph (a) of AD 2002-24-52, amendment 39-12993 (68 FR
14, January 2, 2003). That AD applies to all Boeing Model 747-400, -
400D, and -400 F series airplanes and requires, among other actions,
revising the AFM to require the flightcrew to maintain certain minimum
fuel levels in the center wing fuel tank, and to prohibit the use of
the horizontal stabilizer fuel tank.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin 747-28A2280, dated
August 7, 2008. This service bulletin describes procedures for
installing new pump control and time delay relays, doing related
investigative and corrective actions if necessary, and changing the
wiring for the center and main fuel tanks override/jettison fuel pumps.
The related investigative and corrective actions include doing a
general visual inspection for corrosion of the ground stud assembly
during the installation of the P914 relay panel and cleaning or
replacing the ground stud assembly if necessary. Boeing Alert Service
Bulletin 747-28A2280 specifies that the installation of a new
integrated display system (IDS), as described in the following service
bulletins, must be done before or at the same time as the actions in
the alert service bulletin:
     Boeing Service Bulletin 747-31-2376, dated September 5,
2006, for Model 747-400, and -400F series airplanes that have General
Electric engines, except for airplanes having variable numbers (V/Ns)
RL429, RL430, RL473, RL511, and RL521, which received new software in
production.
     Boeing Service Bulletin 747-31-2377, dated September 5,
2006, for Model 747-400, and -400F series airplanes that have Pratt &
Whitney engines, except for airplanes having V/Ns RL456, RL492, and
RL502, which received new software in production.
     Boeing Service Bulletin 747-31-2378, dated September 5,
2006, for Model 747-400, -400D, and -400F series airplanes that have
Rolls Royce engines.
    We have also reviewed Boeing Alert Service Bulletin 747-28A2281,
dated December 13, 2007, for Model 747-400 series airplanes. This
service bulletin describes procedures for installing new relays and
wiring in the horizontal stabilizer override/jettison fuel pumps.
Boeing Alert Service Bulletin 747-28A2281 specifies that the
installation of a new automatic shutoff system for the horizontal
stabilizer tank (HST) fuel pumps, as described in the following service
bulletin, must be done before or at the same time as the actions in the
alert service bulletin: Boeing Service Bulletin 747-28A2262, Revision
1, dated May 8, 2008, for Model 747-400 series airplanes, except for
airplanes having V/Ns RM403, RM441, RM442, RM443, and RM445.
    We have also reviewed Section 9, ``Airworthiness Limitations (AWLs)
and Certification Maintenance Requirements (CMRs),'' Boeing 747-400
Maintenance Planning (MPD) Data Document D621U400-9, Revision April
2008 (hereafter referred to as ``Document D621U400-9''). Sub-section D
of Document D621U400-9 describes AWLs for fuel tank systems. Sub-
section D of Document D621U400-9 includes the following fuel system
AWLs:
     AWL No. 28-AWL-24, which is a repetitive functional test
to verify continued functionality of the automatic shutoff system for
the fuel boost pump of the HST. This AWL applies to Model 747-400
airplanes, line numbers (L/Ns) 1343 and subsequent, and those that have
been modified in accordance with Boeing Service Bulletin 747-28A2262.
     AWL No. 28-AWL-26, which is a repetitive operational test
to verify the continued functionality of the uncommanded on system for
the override/jettison pump of the main 2 and main 3 fuel tanks. This
AWL applies to Model 747-400, -400D, and -400F airplanes, L/Ns 1380 and
subsequent, and those that have been modified in accordance with Boeing
Alert Service Bulletin 747-28A2280.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
This proposed AD would require, for all airplanes installing new pump
control and time delay relays, doing related investigative and
corrective actions if necessary, and changing the wiring for the center
and main fuel tanks override/jettison fuel pumps; and, for certain
airplanes, installing new relays and wiring for the horizontal
stabilizer override/jettison fuel pumps. This proposed AD would also
require a revision to the maintenance program to incorporate
Airworthiness Limitation No. 28-AWL-24 and No. 28-AWL-26. For certain
airplanes, this proposed AD would also require installing an automatic
shutoff system for the horizontal stabilizer tank fuel pumps and
installing a new integrated display system.

Costs of Compliance

    We estimate that this proposed AD would affect 102 airplanes of
U.S. registry. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD. The average labor rate
is $80 per work hour.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
               Action                      Work hours                 Parts            Cost per  product     registered airplanes        Fleet cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Installing relays/changing wiring    375 to 394............  $65,015 to $65,451....  $95,015 to $96,971...  102..................  $9,691,530 to
 for center and main fuel tanks.                                                                                $9,891,042.
Installing a new IDS and revising    2 to 3................  $0....................  Up to $240...........  Up to 102............  Up to $24,480.
 the AFM when done (prior/
 concurrent action).
Installing relays and wiring for     73 to 79..............  $0....................  $5,840 to $6,320.....  74...................  $432,160 to $467,680.
 horizontal stabilizer tank (HST).
Installing a new automatic shutoff   44....................  $4,112................  $7,632...............  74...................  $564,768.
 for the HST.
Revising the maintenance program...  1.....................  $0....................  $80..................  102..................  $8,160.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 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 this 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 have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

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 adding the following new AD:

Boeing: Docket No. FAA-2009-0454; Directorate Identifier 2008-NM-
156-AD.

Comments Due Date

    (a) We must receive comments by July 17, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 747-400, 747-400D, and 747-
400F series airplanes, certificated in any category; as identified
in Boeing Alert Service Bulletins 747-28A2280, dated August 7, 2008,
and 747-28A2281, dated December 13, 2007.

    Note 1:  This AD requires revisions to certain operator
maintenance documents to include a new inspection. Compliance with
this inspection is required by 14 CFR 91.403(c). For airplanes that
have been previously modified, altered, or repaired in the areas
addressed by this inspection, the operator may not be able to
accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance (AMOC)
according to paragraph (m) of this AD. The request should include a
description of changes to the required inspection that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Unsafe Condition

    (e) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent uncommanded
operation of certain override/jettison pumps which could cause
overheat, electrical arcs, or frictional sparks, and could lead to
an ignition source inside a fuel tank. This condition, in
combination with flammable fuel vapors, could result in a fuel tank
explosion and consequent loss of the airplane.

Compliance

    (f) Comply with this AD within the compliance times specified,
unless already done.

Installations and Wiring Changes

    (g) Within 60 months after the effective date of this AD, do the
actions in paragraphs (g)(1) and (g)(2) of this AD, as applicable.
    (1) For Model 747-400, -400D, and -400F series airplanes:
Install new pump control and time delay relays and do related
investigative and all applicable corrective actions, and change the
wiring for the center and main fuel tanks override/jettison fuel
pumps, in accordance with the Accomplishment Instructions of Boeing
Alert Service Bulletin 747-28A2280, dated August 7, 2008. Do all
related investigative and applicable corrective actions before
further flight.
    (2) For Model 747-400 series airplanes: Install new relays and
wiring for the horizontal stabilizer override/jettison fuel pumps in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-28A2281, dated December 13, 2007.

Prior/Concurrent Requirements

    (h) Prior to or concurrently with the actions required by
paragraph (g) of this AD, do the applicable actions in paragraphs
(h)(1) and (h)(2) of this AD.
    (1) For Model 747-400, -400D, and -400F series airplanes
identified in paragraphs (h)(1)(i), (h)(1)(ii), and (h)(1)(iii) of
this AD: Install a new integrated display system (IDS) in accordance
with the Accomplishment Instructions of the applicable service
bulletin listed in paragraph (h)(1)(i), (h)(1)(ii), or (h)(1)(iii)
of this AD.
    (i) For Model 747-400, -400D, and -400F series airplanes that
have General Electric engines except airplanes having variable
numbers (V/Ns) RL429, RL430, RL473, RL511, and RL521: Boeing Service
Bulletin 747-31-2376, dated September 5, 2006.
    (ii) For Model 747-400 and -400F series airplanes that have
Pratt & Whitney engines except airplanes having V/Ns RL456, RL492,
and RL502: Boeing Service Bulletin 747-31-2377, dated September 5,
2006.
    (iii) For Model 747-400 and -400F series airplanes that have
Rolls Royce engines: Boeing Service Bulletin 747-31-2378, dated
September 5, 2006.
    (2) For Model 747-400 series airplanes except V/Ns RM403, RM441
through RM443 inclusive, and RM445: Install a new automatic shutoff
system for the horizontal stabilizer tank (HST) fuel pumps in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 747-28A2262, Revision 1, dated May 8, 2008. Installations
accomplished before the effective date of this AD in accordance with
Boeing Service Bulletin 747-28A2262, dated March 15, 2007, are
acceptable for compliance with the installation required by this
paragraph.

Maintenance Program Revision

    (i) Concurrently with accomplishing the actions required by
paragraph (g) of this AD, revise the maintenance program by
incorporating Airworthiness Limitation (AWL) No. 28-AWL-24 and No.
28-AWL-26 of Section 9, ``Airworthiness Limitations (AWLs) and
Certification Maintenance Requirements (CMRs),'' Boeing 747-400
Maintenance Planning (MPD) Data Document D621U400-9, Revision April
2008. The inspection interval for AWL No. 28-AWL-24 and AWL No. 28-
AWL-26 starts on the date the modification is incorporated.

No Alternative Inspections or Inspection Intervals

    (j) After accomplishing the action specified in paragraph (i) of
this AD, no alternative actions or intervals may be used unless the
inspections or inspection intervals are approved as an AMOC in
accordance with the procedures specified in paragraph (m) of this
AD.

Acceptable Action for Certain ADs

    (k) For Model 747-400, -400D, and -400F series airplanes:
Installing a new IDS in accordance with paragraph (h)(1) of this AD
is an acceptable method of compliance for the action in the
applicable AD paragraph listed in Table 1 of this AD.

  Table 1--Actions for Which Paragraph (h)(1) of This AD Is an Acceptable Method of Compliance (No Certificate
                                                  limitations)
----------------------------------------------------------------------------------------------------------------
            The action in--                                                Of--
----------------------------------------------------------------------------------------------------------------
(1) Paragraph E........................  AD 90-09-06, amendment 39-6581.
(2) Paragraph (b)......................  AD 91-13-10 R1, amendment 39-8158.
(3) Paragraph (d)(1)...................  AD 96-07-09, amendment 39-9558.
(4) Paragraph (a)(3)(iii)..............  AD 2000-02-22, amendment 39-11540.
(5) Paragraph (a)(2)(ii)...............  AD 2000-12-21, amendment 39-11799.
(6) Paragraph (d)(2)(iv)...............  AD 2003-16-16, amendment 39-13269.
(7) Paragraph (d)(1)...................  AD 2004-10-05, amendment 39-13635.
----------------------------------------------------------------------------------------------------------------

    (l) For Model 747-400, -400D, and -400F series airplanes with a
horizontal stabilizer fuel tank and with horizontal stabilizer tank
fuel pump auto-shutoff installed: Installing a new IDS in accordance
with paragraph (h)(1) of this AD is an acceptable method of
compliance for the action in the applicable AD paragraph listed in
Table 2 of this AD, provided the certificate limitations included in
the following statement are incorporated into the Limitations
Section of the applicable airplane flight manual (AFM) in place of
the certificate limitation required by the AFM revision specified in
the applicable AD listed in Table 2 of this AD. This may be done by
inserting a copy of this AD in the AFM.

``Certificate Limitations

Center Wing Tank

    The center wing tank (CWT) fuel quantity indication system must
be operative to dispatch with CWT mission fuel.
    The CWT must contain a minimum of 17,000 pounds (7,700
kilograms) prior to engine start, if the CWT override/jettison pumps
are to be selected ON during takeoff.
    If the FUEL LOW CTR L or R message is displayed, both CWT
override/jettison pump(s) must be selected OFF.
    If the FUEL PRESS CTR L or R message is displayed, the
corresponding CWT override/jettison pump must be selected OFF.

Horizontal Stabilizer Tank

    The following additional limitations must be followed if the
horizontal stabilizer tank is fueled and used:
    The horizontal stabilizer tank (HST) fuel quantity indication
system must be operative to dispatch with HST mission fuel.
    If either the FUEL PMP STB L or R message is displayed while on
the ground, both HST pumps must be selected OFF.
    If either the FUEL PRES STB L or R message is displayed, both
HST pumps must be selected OFF.

Defueling

    Prior to defueling any fuel tanks, perform a lamp test of the
respective Fuel Pump Low Pressure indication lights. When defueling,
the Fuel Pump Low Pressure indication lights must be monitored and
the fuel pumps positioned to OFF at the first indication of fuel
pump low pressure. When defueling with passengers on board, fuel
pump switches must be selected OFF at or above approximately 7,000
pounds (3,200 kilograms) for the center wing tank, 3,000 pounds
(1,400 kilograms) for main tanks, and 2,100 pounds (1,000 kilograms)
for the horizontal stabilizer tank. (These requirements apply for
defueling or transferring between tanks.)

Warnings and Notes Applicable to All Fuel Operations

Warning

    Do not reset a tripped fuel pump circuit breaker.

Warning

    Do not cycle CWT and HST pump switches from ON to OFF to ON with
any continuous low pressure indication present.

Note

    There is no change to the maximum zero fuel gross weight found
in the airplane flight manual.

Note

    In a low fuel situation, both CWT override/jettison pumps may be
selected ON and all CWT fuel may be used.

Note

    In a low fuel situation, both HST transfer pumps may be selected
ON and all HST fuel may be used.

Note

    The CWT and the HST may be emptied normally during an emergency.

Note

    The limitations contained in these certificate limitations
supersede any conflicting basic airplane flight manual
limitations.''

    Note 2: When a statement identical to that in paragraph (l) of
this AD has been included in the general revisions of the AFM, the
general revisions may be inserted into the AFM, and the copy of this
AD may be removed from the AFM.

    Note 3: The certificate limitations in paragraph (l) of this AD
are also included as an enclosure to FAA Letter 140S-06-343, dated
November 17, 2006.

 Table 2--Actions for Which Paragraph (h)(1) of This AD Is an Acceptable Method of Compliance (With Certificate
                                                  Limitations)
----------------------------------------------------------------------------------------------------------------
            The action in--                                                Of--
----------------------------------------------------------------------------------------------------------------
(1) Paragraph (a)......................  AD 2001-12-21, amendment 39-12277.
(2) Paragraph (a)......................  AD 2001-21-07, amendment 39-12478.
(3) Paragraph (c)(2)...................  AD 2002-19-52, amendment 39-12900.
(4) Paragraph (a)......................  AD 2002-24-52, amendment 39-12993.
----------------------------------------------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (m)(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. Send information to ATTN: Jon
Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Or, e-mail information to<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance

time for this AD, follow the procedures in 14 CFR 39.19. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your principal maintenance inspector (PMI) or principal avionics
inspector (PAI), as appropriate, or lacking a principal inspector, your
local Flight Standards District Office. The AMOC approval letter must
specifically reference this AD.

    Issued in Renton, Washington, on May 11, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-12742 Filed 6-1-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Notices]
[Pages 17782-17786]
[FR Doc No: 2016-07132]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2015-0255]

Request for Comments

AGENCY: Office of the Secretary, U.S. Department of Transportation.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the U.S. Department of
Transportation (DOT) will forward the Information Collection Request
(ICR) abstracted below to the Office of Management and Budget (OMB) for
clearance. The ICR describes the nature of the information collection
and its expected cost and burden hours. The Federal Register Notice,
with a 60-day comment period soliciting comments on the questionnaire,
was published on December 30, 2015, [FR Vol. 80, No. 250, page 81671].
One comment was received.

DATES: Comments on this notice must be received by April 29, 2016.

ADDRESSES: Interested persons are invited to submit comments regarding
this proposal to the DOT/OST Desk Officer, Office of Information and
Regulatory Affairs, Office of Management and Budget, Docket Library,
Room 10102, 725 17th Street NW., Washington, DC 20503, or by email to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Sam Brooks, Equal Opportunity
Specialist (S-33), Departmental Office of Civil Rights, Office of the
Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue
SE., Washington, DC 20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Form Title(s): Voluntary Web-Based Questionnaire of Airport
Concession Disadvantaged Business Enterprises and Disadvantaged
Business Enterprise Firms.
    Form Number: None.
    OMB Control Number: None.
    Abstract: The DOT's Operating Administrations distribute
substantial funds each year to finance construction projects initiated
by state and local governments, public transit and airport agencies.
The DOT has the important responsibility of ensuring that firms
competing for DOT-assisted contracts for these projects are not
disadvantaged by unlawful discrimination. The DOT's most important tool
for meeting this requirement has been its Disadvantaged Business
Enterprise (DBE) program, which originally began in 1980 as a minority/
women's business enterprise program established by regulation under the
authority of Title VI of the Civil Rights Act of 1964 and other
nondiscrimination statutes that apply to DOT financial assistance
programs. The DBE program was reauthorized by Congress several times
since its inception; most recently in the ``Fixing America's Surface
Transportation Act'' or the ``FAST-ACT,'' (P.L. 114-94, December 4,
2015), See more at: https://www.transportation.gov/civil-rights/disadvantaged-business-enterprise#sthash.67nZv63S.dpuf, which funded
surface transportation programs for highways, highway safety, and
transit. Section 1101(b) of the Act describes Congress's findings
regarding the continued need for the DBE program due to the
discrimination and related barriers that pose significant obstacles for
minority and women-owned businesses seeking federally-assisted surface
transportation work. The DBE program focuses primarily on construction
and professional services contracts, while the airport concession
disadvantaged business enterprise (ACDBE) program focuses on lease and
supplier agreements for food, beverage, retail, and car rental
services. Congress raised concerns that discrimination and related
barriers continue to pose obstacles to disadvantaged firms seeking to
do business at U.S. airports. The information requested will assist DOT
in measuring whether both programs are achieving the objectives to
create a level playing field on which ACDBEs/DBEs can compete fairly
and assist in the development of ACDBE/DBE firms to compete
successfully in the marketplace.
    The single comment that was received by DOT during the 60-day
comment period was provided by a trade association and had four
components. The association (1) asked DOT to use the data collection
measure to address the issue of out-of-date DBE directories; (2)
observed that prime contractors need better information on the types of
construction work DBEs are able to perform; (3) requested that the
questionnaire ``query DBE firms on the issue of training;'' and (4)
asked DOT to evaluate the responses regarding perceived barriers or
challenges from the perspective of all parties. After careful
consideration, DOT makes due note of all four components. Only items
(1) and (3) appear to request changes to proposed questions. However,
as these items are not strictly germane to the stated purpose
(measuring the objective of creating a level playing field) of the
questionnaire, the Department respectfully declines to alter the
content of the questions.
    The questionnaire will be for the use of ACDBE and DBE certified
firms, so that they can provide information regarding the nature of
their business and bidding history, and perceived barriers/challenges
that may have prevented them from receiving a contract or successfully
competing in DOT's ACDBE/DBE program. A link to the questionnaire will
be made available by DOT's Departmental Office of Civil Rights for use
by the Department's state and local recipients, which can in turn post
this link on their own Web sites.

The information collected will be used to assist DOT in measuring
whether the ACDBE/DBE program is achieving its objectives. The DOT
estimates that it takes an individual approximately 10 minutes to
complete the questionnaire.
    Type of Request: New information collection.
    Affected Public: Airport Concession Disadvantaged Business
Enterprises and Disadvantaged Business Enterprises certified under the
authority of 49 CFR parts 23 and 26.
    Total Annual Estimated Burden: 628 hours.
    Frequency of Collection: An individual's completion of the
questionnaire is solely voluntary.
    Comments are Invited on: Any aspect of this information collection,
including
    (a) whether the proposed collection of information is necessary for
the proper performance of DOT's ACDBE/DBE program; (b) the accuracy of
the estimated burden; (c) ways for the Department to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. Comments should be sent to the address in
the preamble. All responses to this notice will be summarized and
included in the request for Office of Management and Budget approval.
All comments will also become a matter of public record.

    Issued in Washington, DC, on March 23, 2016.
Habib Azarsina,
OST Privacy and PRA Officer, U.S. Department of Transportation.

[GRAPHIC] [TIFF OMITTED] TN30MR16.275

[GRAPHIC] [TIFF OMITTED] TN30MR16.276

[GRAPHIC] [TIFF OMITTED] TN30MR16.277

[FR Doc. 2016-07132 Filed 3-29-16; 8:45 am]
 BILLING CODE 4910-9X-P