[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Proposed Rules]
[Pages 71648-71653]
[FR Doc No: 2016-25005]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 216

[Docket No. FDA-2016-N-2462]

Amendments to the Regulation Regarding the List of Drug Products
That Have Been Withdrawn or Removed From the Market for Reasons of
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
proposing to amend its regulations to revise the list of drug products
that have been withdrawn or removed from the market because the drug
products or components of such drug products have been found to be
unsafe or not effective. Drugs appearing on this list may not be
compounded under the exemptions provided by sections 503A and 503B of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically,
the proposed rule would add three entries to this list of drug
products.

DATES: Submit either electronic or written comments on the proposed
rule by January 3, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-2462 for ``Amendments to the Regulation Regarding the List
of Drug Products That Have Been Withdrawn or Removed From the Market
for Reasons of Safety or Effectiveness.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/

regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Edisa Gozun, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5199, Silver Spring, MD 20993-0002, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Regulatory Action
    B. Summary of the Major Provisions of the Proposed Regulatory
Action
    C. Costs and Benefits
II. Background
    A. Relevant Provisions of the Statute
    B. The List of Drug Products in Sec.  216.24
    C. Regulatory History of the List
III. Description of the Proposed Rule
IV. Legal Authority
V. Analysis of Environmental Impact
VI. Economic Analysis of Impacts
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. References

I. Executive Summary

A. Purpose of the Regulatory Action

    FDA is proposing to amend its regulations to revise the list of
drug products that have been withdrawn or removed from the market
because the drug products or components of such drug products have been
found to be unsafe or not effective (referred to as ``the withdrawn or
removed list'' or ``the list'') (Sec.  216.24 (21 CFR 216.24)). Drugs
appearing on the withdrawn or removed list may not be compounded under
the exemptions provided by sections 503A and 503B of the FD&C Act (21
U.S.C. 353a and 353b).
    The Agency is proposing to add three entries (all drug products
containing aprotinin, all drug products containing bromocriptine
mesylate, and all intravenous drug products containing greater than a
16 milligram (mg) single dose of ondansetron hydrochloride) as
described in this document to the list in Sec.  216.24 of drug products
that cannot be compounded for human use under the exemptions provided
by either section 503A or 503B of the FD&C Act because they have been
withdrawn or removed from the market because such drug products or
components of such drug products have been found to be unsafe or not
effective.

B. Summary of the Major Provisions of the Proposed Regulatory Action

    We are proposing that the following drugs that have been withdrawn
or removed from the market because such drug products have been found
to be unsafe or not effective be added to the list in Sec.  216.24. The
specific entries proposed for addition to the list for each of these
drugs are provided as follows:
    Aprotinin: All drug products containing aprotinin.
    Bromocriptine mesylate: All drug products containing bromocriptine
mesylate for prevention of physiological lactation.
    Ondansetron hydrochloride: All intravenous drug products containing
greater than a 16 mg single dose of ondansetron hydrochloride.

C. Costs and Benefits

    The Agency is not aware of any routine use of the drug products
that FDA is proposing to add to the the withdrawn or removed list and,
therefore, does not estimate any compliance costs or loss of sales as a
result of the prohibition against compounding these drug products for
human use. The Agency has determined that this rulemaking is not a
significant regulatory action as defined by Executive Order 12866.

II. Background

A. Relevant Provisions of the Statute

    Section 503A of the FD&C Act describes the conditions that must be
satisfied for human drug products compounded by a licensed pharmacist
or licensed physician to be exempt from the following three sections of
the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
(concerning current good manufacturing practice); (2) section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and (3) section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug applications (NDAs) or abbreviated
new drug applications (ANDAs)).
    In addition, section 503B of the FD&C Act describes the conditions
that must be satisfied for a drug compounded for human use by or under
the direct supervision of a licensed pharmacist in an outsourcing
facility to be exempt from three sections of the FD&C Act: (1) Section
502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee-1)
(concerning drug supply chain security).
    One of the conditions that must be satisfied to qualify for the
exemptions under both sections 503A and 503B of the FD&C Act is that
the compounder does not compound a drug product that appears on a list
published by the Secretary of drug products that have been withdrawn or
removed from the market because such drug products or components of
such drug products have been found to be unsafe or not effective
(withdrawn or removed list) (see sections 503A(b)(1)(C), 503B(a)(4),
and 503B(a)(11) of the FD&C Act).

B. The List of Drug Products in Sec.  216.24

    The drug products listed in Sec.  216.24 (the withdrawn or removed
list) have been withdrawn or removed from the market because they have
been found to be unsafe or not effective and are ineligible for the
exemptions set forth in sections 503A and 503B of the FD&C Act. A drug
product that is included in the list codified at Sec.  216.24 is not
eligible for the exemptions provided in section 503A(a) of the FD&C
Act, and is subject to sections 501(a)(2)(B), 502(f)(1), and 505 of the
FD&C Act, in addition to other applicable provisions, if compounded. In
addition, a drug that is included in the list codified at Sec.  216.24
cannot qualify for the exemptions provided in section 503B(a) of the
FD&C Act, and is subject to sections 502(f)(1), 505, and 582 of the
FD&C Act, in addition to other applicable provisions, if compounded.

C. Regulatory History of the List

    Following the addition of section 503A to the FD&C Act on November
21, 1997, through the enactment of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115), FDA proposed a rule in the
Federal Register of October 8, 1998 (63 FR 54082), to establish the
original list of drug products that have been withdrawn or removed from
the market because the drug products or the components of such drug
products have been found to be unsafe or not effective (1998 proposed
rule) and therefore were not permitted to be compounded for human use
under the exemptions provided by section 503A(a).
    In the Federal Register of March 8, 1999 (64 FR 10944), FDA
published a final rule that codified the original list in Sec.  216.24
(1999 final rule).
    Following the addition of section 503B to the FD&C Act on November
27, 2013, through the enactment of the Drug Quality and Security Act
(Pub. L. 113-54), FDA proposed to amend the list in Sec.  216.24 on
July 2, 2014 (79 FR 37687); FDA published the final rule to amend Sec.
216.24 in the Federal Register of October 7, 2016 (81 FR 69668) (2016
final rule). Given that nearly identical

criteria apply for a drug to be included on the list referred to in
section 503A(b)(1)(C) and the list referred to in section 503B(a)(4) of
the FD&C Act, FDA revised and updated the list at Sec.  216.24 to
clarify that it applies for purposes of both sections 503A and 503B.

III. Description of the Proposed Rule

    FDA is proposing to amend Sec.  216.24 to add three drug products,
described in the following paragraphs, that have been withdrawn or
removed from the market because such drug products or components of
such drug products have been found to be unsafe or not effective.
    As with the 1999 final rule establishing the original list, and the
2016 final rule revising that list, the primary focus of this proposed
rule is on drug products that have been withdrawn or removed from the
market because they have been found to be unsafe. FDA may propose at a
later date to add other drug products to the list that have been
withdrawn or removed from the market because they have been found to be
not effective, or to update the list as new information becomes
available to the Agency regarding products that were removed from the
market because they have been found to be unsafe.
    The following drugs proposed for inclusion in Sec.  216.24 are
arranged alphabetically by the established names of the active
ingredients contained in the drug products that have been withdrawn or
removed from the market because such drug products or components of
such drug products have been found to be unsafe or not effective. For
some of the drug products, the proprietary or trade names of some or
all of the drug products that contained the active ingredient are also
given in the preamble paragraphs describing the withdrawn or removed
drug products. In some cases, the withdrawn or removed drug products
are identified according to the established name of the active
ingredient, listed as a particular salt or ester of the active moiety.
The following list includes the specific drug entry FDA is proposing to
add to Sec.  216.24, as well as a brief summary of the reasons why each
drug is being proposed for inclusion.
    a. Aprotinin: All drug products containing aprotinin.
    Bayer suspended marketing of aprotinin (TRASYLOL, NDA 20304) in
November 2007 for safety reasons. TRASYLOL, NDA 20304, was approved on
December 29, 1993. The indication for TRASYLOL, NDA 20304, was for
``prophylactic use to reduce perioperative blood loss and the need for
blood transfusion in patients undergoing cardiopulmonary bypass in the
course of coronary artery bypass graft surgery who are at increased
risk for blood loss and blood transfusion.'' Prominent known adverse
reactions associated with the use of the drug included anaphylactic
reactions (with some deaths reported) and impaired renal function. In
January 2006, Mangano et al. published a report that described the
results from a retrospective analysis of the use of aprotinin compared
to two other antifibrinolytic drugs (tranexamic acid and aminocaproic
acid) or no antifibrinolytic drugs in 4,374 patients undergoing cardiac
surgery (Ref. 1). The conclusions were that there was a statistically
greater likelihood of the development of renal dysfunction and the need
for hemodialysis, stroke, encephalopathy, myocardial infarction, and
congestive heart failure in patients treated with aprotinin than with
the other antifibrinolytic drugs or no antifibrinolytic drugs. On
February 8, 2006, FDA issued a Public Health Advisory on TRASYLOL, NDA
20304, that called attention to this new information (Ref. 2). On
September 21, 2006, FDA convened a meeting of its Cardiovascular and
Renal Advisory Committee to evaluate these and other data for the drug
(see http://www.fda.gov/ohrms/dockets/ac/cder07.htm#CardiovascularRenal
for meeting documents from the September 21, 2006, Cardiovascular and
Renal Advisory Committee meeting). The Cardiovascular and Renal
Advisory Committee voted that the benefits of TRASYLOL, NDA 20304,
compared to its risks warranted continued approvability for the
indication (Yes, 18; No, 0; Abstain, 1). Before the advisory committee
meeting, the sponsor had funded a study that evaluated a medical
database for the outcomes of patients undergoing coronary artery bypass
graft surgery (CABG) treated with aprotinin or other antifibrinolytics,
which concluded that there was an increased risk of in-hospital death
in the aprotinin-treated patients compared to those in patients treated
with aminocaproic acid. This information was subsequently published in
2008 by Schneeweiss et al. (Ref. 3). In 2007, Mangano et al. published
a report in 3,876 patients undergoing CABG surgery describing a higher
mortality after 5 years for those treated with aprotinin compared to
those treated with no antifibrinolytic drugs (Ref. 4). In the 2007
Mangano study, patients treated with either tranexamic acid or
aminocaproic acid did not experience a higher mortality at 5 years
compared to patients treated with no antifibrinolytic drug. These data
led to a reconvening of the Cardiovascular and Renal Advisory Committee
in a joint meeting with the Drug Safety and Risk Management Advisory
Committee on September 12, 2007 (joint meeting), at which these and
other data were reviewed (see http://www.fda.gov/ohrms/dockets/ac/cder07.htm#CardiovascularRenal for meeting documents from the September
12, 2007, Cardiovascular and Renal Advisory Committee meeting). The
Committees at the joint meeting were informed that there was an ongoing
prospective randomized trial of aprotinin, tranexamic acid, and
aminocaproic acid in patients undergoing CABG surgery with
cardiopulmonary bypass in Canada (named the BART study), but that the
results would not be available for several years. Some of the Committee
members at the joint meeting stated that the issue should be revisited
once the data from the BART study were available. The Advisory
Committees at the joint meeting voted that TRASYLOL, NDA 20304, should
continue to be authorized to be marketed in the United States. Shortly
after the joint meeting, FDA was informed that the Data Monitoring and
Safety Committee for the BART study had recommended that the BART trial
be terminated early because there appeared to be a greater frequency of
death in patients treated with aprotinin (6.0 percent) compared to
those treated in the combined tranexamic acid plus aminocaproic acid
group (3.9 percent). The study was subsequently published in 2008 by
Fergusson (Ref. 5). On October 25, 2007, FDA issued a Safety Alert for
Human Medical Products alerting the medical community about the
preliminary data from the BART trial (Ref. 6). On November 5, 2007, FDA
issued a press release stating that, at the Agency's request, the
sponsor had made a decision to suspend the marketing of TRASYLOL, NDA
20304, pending a review of the BART data for safety (Ref. 7). Although
some of the data from the BART trial were submitted to FDA and the
sponsor submitted its analysis of the data that was made available to
the company, FDA was never successful in obtaining the raw data from
the trial. Therefore, FDA was not able to conduct its own analyses of
the trial data. TRASYLOL, NDA 20304, has not returned to the U.S.
market since the sponsor announced its decision to suspend marketing in
2007. Aprotinin was made available by the sponsor for the treatment of
certain surgical patients with an established medical need using

a treatment protocol under an investigational new drug application
(IND) (Ref. 8). Expanded access to aprotinin through this treatment
protocol is no longer available (see https://clinicaltrials.gov/ct2/show/NCT00611845?term=aprotinin&rank=4). FDA is not aware of any data
that would give us reason to believe that the safety issues identified
as having been associated with aprotinin should be restricted to a
particular formulation, concentration, indication, route of
administration, or dosage form. For these reasons, FDA is proposing to
include all drug products containing aprotinin on the withdrawn or
removed list.
    b. Bromocriptine mesylate: All drug products containing
bromocriptine mesylate for prevention of physiological lactation.
    Bromocriptine mesylate was associated with risks of hypertension,
seizures, and cardiovascular accidents, and the unfavorable benefit-
risk balance was specific to the use of bromocriptine mesylate for the
prevention of physiological lactation. In 1980, PARLODEL (bromocriptine
mesylate) was approved for the prevention of physiological lactation as
an acceptable alternative to estrogenic therapy. Subsequently, FDA
received postmarket reports of serious and life-threatening adverse
reactions (hypertension, seizures, and cerebrovascular accidents)
associated with the use of bromocriptine mesylate to suppress
lactation. According to the approved labeling for PARLODEL, dated July
15, 1988 (Ref. 9), serious adverse reactions reported in postpartum
women included 50 cases of hypertension, 38 cases of seizures
(including 4 cases of status epilepticus), 15 cases of strokes, and 3
cases of myocardial infarction. These cases were discussed at a 1989
Fertility and Maternal Health Drugs Advisory Committee meeting (Ref.
10). FDA presented reports of its safety findings, which included 28
reports of hypertension, 36 reports of seizures, and 19 reports of
cerebrovascular accidents. FDA had received 85 cases of serious adverse
events, including 10 deaths, since the approval of bromocriptine
mesylate for lactation suppression in 1980 (August 23, 1994 (59 FR
43347)). The Fertility and Maternal Health Drugs Advisory Committee
recommended that no drug then labeled for lactation suppression
including bromocriptine mesylate be used for this indication. FDA
subsequently asked that all manufacturers of these drugs voluntarily
remove this indication from drug labeling. All but Sandoz, the
manufacturer of PARLODEL, complied with FDA's request. In a document
published in the Federal Register of August 23, 1994, FDA concluded
that the risks of hypertension, seizures, and cardiovascular accidents
outweighed the product's marginal benefit in preventing postpartum
lactation. Accordingly, FDA proposed to withdraw approval of the
indication recommending bromocriptine mesylate for preventing
physiological lactation in the NDA for PARLODEL, under section 505(e)
of the FD&C Act, on the basis that the drug is no longer shown to be
safe for this indication. FDA withdrew approval of PARLODEL for the
indication of prevention of physiological lactation in a document
published in the Federal Register of January 17, 1995 (60 FR 3404).
Withdrawal of PARLODEL's indication for the prevention of physiological
lactation became effective on February 16, 1995. FDA's review of the
withdrawal indicates that the withdrawal of bromocriptine mesylate for
prevention of physiological lactation was fundamentally based on an
unfavorable benefit-risk balance specific to this indication and not to
other approved indications (such as treatment of Parkinson's disease,
acromegaly, and prolactin-secreting adenomas). For this reason, FDA is
proposing to include all drug products containing bromocriptine
mesylate for prevention of physiological lactation on the withdrawn or
removed list.
    c. Ondansetron hydrochloride: All intravenous drug products
containing greater than a 16 mg single dose of ondansetron
hydrochloride.
    Ondansetron (ondansetron hydrochloride (HCl)) Injection, USP, 32
mg, in 50 milliliters (mL), single intravenous (IV) dose, was
associated with a specific type of irregular heart rhythm called QT
interval prolongation, and the data suggest that any dose above the
maximum recommendation of 16 mg per dose intravenously has the
potential for increased risk of QT prolongation. In September 2011, FDA
issued a Drug Safety Communication noting concerns that the 32 mg
single IV dose of ZOFRAN (ondansetron HCl) and generic versions of that
product could increase the risk of abnormal changes in the electrical
activity of the heart, which could result in a potentially fatal
abnormal heart rhythm (Ref. 11). Based on data subsequently collected
from a study conducted at FDA's request by ZOFRAN's sponsor,
GlaxoSmithKline (GSK), that identified a significant QT prolongation
effect in connection with the 32 mg single IV dose, FDA approved GSK's
supplemental application to remove the 32 mg single IV dose information
from the labeling for ZOFRAN and has worked with manufacturers of all
32 mg single IV dose ondansetron HCl products to have them removed from
the market. On June 29, 2012, FDA issued a Drug Safety Communication to
notify health care professionals that the 32 mg single IV dose of
ondansetron HCl, indicated for prevention of nausea and vomiting
associated with initial and repeat courses of emetogenic cancer
chemotherapy in adult patients, should be avoided due to the risk of QT
interval prolongation, which can lead to Torsades de Pointes, an
abnormal, potentially fatal heart rhythm (Ref. 12). Subsequently, FDA
informed the holders of one NDA and four ANDAs for ondansetron HCl that
the Agency believes that, in light of the safety concern associated
with ondansetron HCl in the 32 mg single IV dose, these drug products
should be removed from the market. The application holders agreed to
voluntarily remove their respective 32 mg single IV dose ondansetron
HCl products from the market and requested that FDA withdraw approval
of their respective applications under 21 CFR 314.150(d). On December
4, 2012, FDA issued an updated Drug Safety Communication alerting
health care professionals that these products would be removed from the
market because of their potential for serious cardiac risks (Ref. 13).
In the Federal Register of June 10, 2015 (80 FR 32966), FDA announced
that it was withdrawing the approval of these five applications. On the
same day, in a different document in the Federal Register (80 FR
32962), FDA announced its determination under 21 CFR 314.161 and
314.162(a)(2) that the NDA for Ondansetron (ondansetron HCl) Injection,
USP, 32 mg/50 mL, single IV dose was withdrawn from sale for reasons of
safety. As explained in the review of ondansetron HCl 32 mg single IV
dose for the withdrawn or removed list (see tab 5 of the FDA briefing
document for the June 17-18, 2015, Pharmacy Compounding Advisory
Committee, available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm), for those approved products for IV ondansetron HCl that
remain on the market, the current dosage and administration
recommendation for adults and pediatric patients (6 months to 18 years)
is three 0.15 mg/kilogram doses, up to a maximum of 16 mg per dose,
infused intravenously over 15 minutes, and any dose above the maximum
recommended

16 mg per IV dose has the potential for increased risk of QT
prolongation. For these reasons, FDA is proposing to include all IV
drug products containing greater than a 16 mg single dose of
ondansetron HCl on the withdrawn or removed list.
    On June 17, 2015, FDA presented these three proposed entries to the
Pharmacy Compounding Advisory Committee (see the Federal Register of
May 22, 2015 (80 FR 29717)). In addition to these three proposed
entries, FDA presented a potential entry for all drug products
containing more than 325 mg of acetaminophen per dosage unit to the
Pharmacy Compounding Advisory Committee. The addition of all drug
products containing more than 325 mg of acetaminophen per dosage unit
to the list remains under consideration by the Agency.
    The Pharmacy Compounding Advisory Committee voted in favor of
including each of FDA's four proposed entries on the list. Although an
open public hearing session was scheduled at this meeting to allow
members of the public to present their views and opinions on the
proposed entries to the committee members and the Agency prior to the
vote by the Pharmacy Compounding Advisory Committee, no members of the
public signed up to participate. A transcript of the June 2015 Pharmacy
Compounding Advisory Committee meeting and briefing information that
includes reviews and background on the proposed entries may be found at
the Division of Dockets Management (see ADDRESSES) and at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm.

IV. Legal Authority

    Sections 503A and 503B of the FD&C Act provide the principal legal
authority for this proposed rule. As described previously in the
Background section of this document, section 503A of the FD&C Act
describes the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist or licensed physician to be exempt
from three sections of the FD&C Act (sections 501(a)(2)(B), 502(f)(1),
and 505). One of the conditions that must be satisfied to qualify for
the exemptions under section 503A of the FD&C Act is that the licensed
pharmacist or licensed physician does not compound a drug product that
appears on a list published by the Secretary in the Federal Register of
drug products that have been withdrawn or removed from the market
because such drug products or components of such drug products have
been found to be unsafe or not effective (see section 503A(b)(1)(C) of
the FD&C Act). Section 503A(c)(1) of the FD&C Act also states that the
Secretary shall issue regulations to implement section 503A, and that
before issuing regulations to implement section 503A(b)(1)(C)
pertaining to the withdrawn or removed rule, among other sections, the
Secretary shall convene and consult an advisory committee on
compounding unless the Secretary determines that the issuance of such
regulations before consultation is necessary to protect the public
health.
    Section 503B of the FD&C Act describes the conditions that must be
satisfied for a drug compounded for human use by or under the direct
supervision of a licensed pharmacist in an outsourcing facility to be
exempt from three sections of the FD&C Act (sections 502(f)(1), 505,
and 582). One of the conditions in section 503B of the FD&C Act that
must be satisfied to qualify for the exemptions is that the drug does
not appear on a list published by the Secretary of drugs that have been
withdrawn or removed from the market because such drugs or components
of such drugs have been found to be unsafe or not effective (see
section 503B(a)(4)). To be eligible for the exemptions in section 503B,
a drug must be compounded in an outsourcing facility in which the
compounding of drugs occurs only in accordance with section 503B,
including as provided in section 503B(a)(4).
    Thus, sections 503A and 503B of the FD&C Act, in conjunction with
our general rulemaking authority in section 701(a) of the FD&C Act (21
U.S.C. 371(a)), serve as our principal legal authority for this
proposed rule revising FDA's regulations on drug products withdrawn or
removed from the market because the drug product or a component of the
drug product have been found to be unsafe or not effective in Sec.
216.24.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because small businesses are not expected to incur any
compliance costs or loss of sales due to this regulation, we propose to
certify that the proposed rule will not have a significant economic
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $146 million, using the most current (2015) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    This proposed rule would amend Sec.  216.24 concerning human drug
compounding. Specifically, the proposed rule would add to or modify the
list of drug products that may not be compounded under the exemptions
provided by sections 503A and 503B of the FD&C Act because the drug
products have been withdrawn or removed from the market because such
drug products or components of such drug products have been found to be
unsafe or not effective (see section II of this document). We are
proposing to add three entries to the list. We are not aware of any
routine compounding for human use of the drug products that are the
subject of this proposed rule, and therefore do not estimate any
compliance costs or loss of sales if the proposal is adopted. However,
we invite the submission of comments and solicit current compounding
usage data for these drug products, if they are compounded for human
use.

    Unless we certify that a rule will not have a significant economic
impact on a substantial number of small entities, the Regulatory
Flexibility Act requires us to analyze regulatory options to minimize
any significant economic impact of a regulation on small entities. Most
pharmacies meet the Small Business Administration definition of a small
entity, which is defined as having annual sales less than $25.5 million
for this industry. We are not aware of any routine compounding of these
drug products and do not estimate any compliance costs or loss of sales
to small businesses as a result of the prohibition against compounding
these drug products. Therefore, we propose to certify that this
proposed rule will not have a significant economic impact on a
substantial number of small entities.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects 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. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

IX. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. Mangano, D.T., I.C. Tudor, and C. Dietzel, ``The Risk Associated
With Aprotinin in Cardiac Surgery,'' New England Journal of
Medicine, 354(4):353-365, 2006.
2. FDA News Release, ``FDA Issues Public Health Advisory for
Trasylol'' (February 8, 2006), available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108592.htm.
3. Schneeweiss, S., J.D. Seeger, J. Landon, and A.M. Walker,
``Aprotinin During Coronary-Artery Bypass Grafting and Risk of
Death,'' New England Journal of Medicine, 358:771-783, 2008.
4. Mangano, D.T., Y. Miao, A. Vuylsteke, et al., ``Mortality
Associated With Aprotinin During 5 Years Following Coronary Artery
Bypass Graft Surgery,'' Journal of the American Medical Association,
297(5):471-479, 2007.
5. Fergusson, D.A., P.C. H[eacute]bert, C.D. Mazer, et al., ``A
Comparison of Aprotinin and Lysine Analogues in High-Risk Cardiac
Surgery,'' New England Journal of Medicine, 358(22):2319-2331, 2008.
6. FDA Alert--Aprotinin Injection (Marketed as Trasylol) (October
25, 2007), available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150815.htm.
7. FDA News Release, ``FDA Requests Marketing Suspension of
Trasylol'' (November 5, 2007), available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109021.htm.
8. FDA News Release, ``Manufacturer Removes Remaining Stocks of
Trasylol Access Limited to Investigational Use'' (May 14, 2008),
available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116895.htm.
9. FDA-PARLODEL (bromocriptine mesylate) Information, available at
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM449535.pdf.
10. FDA Fertility and Maternal Health Drugs Advisory Committee
Meeting Minutes (June 1 and 2, 1989), available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM449535.pdf.
11. FDA Drug Safety Communication--Abnormal Heart Rhythms May Be
Associated with Use of Zofran (Ondansetron)(September 15, 2011),
available at http://www.fda.gov/Drugs/DrugSafety/ucm271913.htm.
12. FDA Drug Safety Communication--New Information Regarding QT
Prolongation with Ondansetron (Zofran) (June 29, 2012), available at
http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm.
13. FDA Drug Safety Communication--Updated Information on 32 mg
Intravenous Ondansetron (Zofran) Dose and Pre-Mixed Ondansetron
Products (December 4, 2012), available at http://www.fda.gov/Drugs/DrugSafety/ucm330049.htm.

List of Subjects in 21 CFR Part 216

    Drugs, Prescription drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 216 be amended as follows:

PART 216--HUMAN DRUG COMPOUNDING

0
1. The authority citation for part 216 continues to read as follows:

    Authority: 21 U.S.C. 351, 352, 353a, 353b, 355, and 371.

0
2. Amend Sec.  216.24 by adding, in alphabetical order, to the list of
drugs ``Aprotinin'', ``Bromocriptine mesylate'', and ``Ondansetron
hydrochloride'' to read as follows:

Sec.  216.24  Drug products withdrawn or removed from the market for
reasons of safety or effectiveness.

* * * * *
    Aprotinin: All drug products containing aprotinin.
* * * * *
    Bromocriptine mesylate: All drug products containing bromocriptine
mesylate for prevention of physiological lactation.
* * * * *
    Ondansetron hydrochloride: All intravenous drug products containing
greater than a 16 milligram single dose of ondansetron hydrochloride.
* * * * *

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25005 Filed 10-17-16; 8:45 am]
 BILLING CODE 4164-01-P


May 24   28, 2003   Episode ° Plots provide ozone concentration and wind vectors ID Description AP Apex JN Jean JO Joe Neal MQ Mesquite PL Hendersen PV Palo Verde School LV Las Vegas Airport NE Nellis Air Force S1 Reid Gardner 1 S3 Reid Gardner 3 CAL CalWash 3 Monitoring Stations


[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Rules and Regulations]
[Pages 20229-20234]
[FR Doc No: 2013-07209]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0994; Directorate Identifier 2012-NM-119-AD;
Amendment 39-17402; AD 2013-06-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
for all The Boeing Company Model 737-600, -700, -700C, -800, -900, and
-900ER series airplanes. That AD currently requires repetitive
inspections of the aft attach lugs of the elevator tab control
mechanisms, and replacement of any discrepant elevator tab control
mechanism. This new AD requires replacing the left and right elevator
tab control mechanisms with elevator tab control mechanisms that have
the modified attach lugs, which would terminate the existing
requirements. This AD was prompted by reports of failure of the aft
attach lugs on the elevator tab control mechanisms, which resulted in
severe elevator vibration; and reports of gaps in elevator tab control
mechanisms and analysis indicating that additional elevator tab control
mechanisms might have bearings that will come loose. We are issuing
this AD to prevent discrepancies in the aft attach lugs of the elevator
tab control mechanism, which could result in severe elevator and tab
vibration. Consequent structural failure of the elevator or horizontal
stabilizer could result in loss of structural integrity and aircraft
control.

DATES: This AD is effective May 9, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of May 9, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
September 9, 2010 (75 FR 52242, August 25, 2010).
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of April
29, 2010 (75 FR 21499, April 26, 2010).

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; 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, WA. 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 AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kelly McGuckin, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2010-17-19, Amendment 39-16413 (75 FR 52242,
August 25, 2010). (That AD superseded AD 2010-09-05, Amendment 39-16270
(75 FR 21499, April 26, 2010).) That AD applies to the specified
products. The NPRM published in the Federal Register on September 20,
2012 (77 FR 58330). That NPRM proposed to continue to require
repetitive inspections of the aft attach lugs of the elevator tab
control mechanisms, and replacement of any discrepant elevator tab
control mechanism. That NPRM also proposed to require replacing the
left and right elevator tab control mechanisms with elevator tab
control mechanisms that have modified attach lugs, which would
terminate the existing requirements.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(77 FR 58330, September 20, 2012) and the FAA's response to each
comment. Aviation

Partners Boeing stated that the installation of winglets per
supplemental type certificate (STC) ST00830SE (http://rgl.faa.gov/
Regulatory--and--Guidance--Library/rgstc.nsf/0/
408e012e008616a7862578880060456c/$FILE/ST00830SE.pdf) does not affect
the accomplishment of the manufacturer's service instructions. United
Airlines stated that it agrees with the proposal.

Request To Remove Parts Installation Prohibition

    Boeing requested that we remove paragraph (v) (``New Parts
Installation Prohibition'') from the NPRM (77 FR 58330, September 20,
2012). Boeing stated that we should allow installation of mechanisms
having part number (P/N) 251A2430-13, -14, -15, -16, -17, or -18 within
the compliance time specified in the NPRM, and allow continued
operations under the provisions of Boeing Alert Service Bulletin 737-
27A1297, Revision 1, dated August 2, 2010; and AD 2010-17-19, Amendment
39-16413 (75 FR 52242, August 25, 2010). Likewise, Boeing requested
that we allow installation of mechanisms having P/N 251A2430-101, -102,
-103, -104, -105, or -106 within the compliance time specified in the
NPRM, and allow continued operations under the provisions of Boeing
Alert Service Bulletin 737-27A1299, dated July 1, 2011; and Boeing
Alert Service Bulletin 737-27A1299, Revision 1, dated April 16, 2012;
which are approved as alternative methods of compliance (AMOCs) to AD
2010-17-19. The commenter stated that paragraph (v) of the NPRM (which
would prohibit installing those parts as of the effective date of the
AD) would reduce operator flexibility by prematurely forcing
incorporation of Boeing Service Bulletin 737-27-1300, dated April 16,
2012, before the end of the 60-month compliance period. The commenter
added that this also would prevent incorporation of Boeing Alert
Service Bulletin 737-27A1299, Revision 1, dated April 16, 2012, which
Boeing plans to recommend that operators incorporate by April 2013 if
they cannot complete terminating action by that date.
    We partially agree with the request. We agree to allow operators
the continued flexibility of using the noted mechanisms in accordance
with the provisions of AD 2010-17-19, Amendment 39-16413 (75 FR 52242,
August 25, 2010), or AMOCs specified in Boeing Alert Service Bulletin
737-27A1299, dated July 1, 2011, and Boeing Alert Service Bulletin 737-
27A1299, Revision 1, dated April 16, 2012, before the replacement
specified in paragraph (u) of this AD. That replacement is required for
airplanes with line numbers 1 through 3909 inclusive. This will provide
flexibility and still maintain an adequate level of safety. We
disagree, however, with deleting paragraph (v) of this AD. The
referenced mechanisms have contributed to a known unsafe condition and
must not be used as a spare after the incorporation of paragraph (u) of
this AD (which requires replacement of these mechanisms). We have
changed paragraph (v) in this final rule to limit the prohibition
against installing the referenced parts to a time after the
requirements of paragraph (u) have been accomplished for airplanes with
line numbers 1 through 3909 inclusive. For airplanes with line numbers
3910 and subsequent, mechanisms with modified aft attach lugs have been
installed in production; for these airplanes, the parts referenced in
paragraph (v) of this AD are prohibited from installation as of the
effective date of this AD.

Request To Revise Identity of Referenced Mechanisms

    Boeing requested that we revise paragraph (t) of the NPRM (77 FR
58330, September 20, 2012) to limit the affected mechanisms to
mechanism P/Ns ``251A2430-13, -14, -15, -16, -17, or -18.'' Boeing
stated that this paragraph should not apply to P/N 251A2430-23 and -24
mechanisms, because their installation is terminating action for the
NPRM. The commenter added that paragraph (t) of the NPRM also does not
apply to the -101, -102, -103, -104, -105, or -106 mechanism, which
have a minimum proposed repetitive inspection requirement of 800 flight
hours (not 300 flight hours).
    We do not agree to incorporate the requested changes in the final
rule. Paragraph (t) of the AD restates the requirements of paragraph
(t) of AD 2010-17-19, Amendment 39-16413 (75 FR 52242, August 25,
2010). The replacement required by paragraph (u) of this new AD
terminates the requirements of AD 2010-17-19, including paragraph (t).
The FAA approved an AMOC to AD 2010-17-19 for Boeing Alert Service
Bulletin 737-27A1299, dated July 1, 2011; and Boeing Alert Service
Bulletin 737-27A1299, Revision 1, dated April 16, 2012; for the
requirements of paragraph (t) for the -101, -102, -103, -104, -105, and
-106 mechanisms; as specified in paragraph (x)(4) of this AD, that AMOC
still applies. We have not changed the final rule regarding this issue.

Request To Remove Compliance Time Restriction

    Boeing requested that we revise the NPRM (77 FR 58330, September
20, 2012) to delete ``and until the effective date of this new AD''
from the second sentence of paragraph (t) of the proposed AD. The
commenter stated that operators should be allowed to install P/N
251A2430-13, -14, -15, -16, -17, or -18 mechanisms within the
compliance period specified in the NPRM and continue operations under
the provisions of Boeing Alert Service Bulletin 737-27A1297, Revision
1, dated August 2, 2010; and AD 2010-17-19, Amendment 39-16413 (75 FR
52242, August 25, 2010).
    We agree with the request and have revised paragraph (t)
accordingly in this final rule. We are also clarifying the requirements
of paragraph (t) in this final rule for line numbers 3910 and
subsequent, which are produced with part numbers that terminate the
requirements of AD 2010-17-19, Amendment 39-16413 (75 FR 52242, August
25, 2010).

Request To Revise Cost Estimate

    Delta requested that we revise the estimated costs in the NPRM (77
FR 58330, September 20, 2012). Delta stated that the cost information
provided in the NPRM does not reflect the most current information
available in Boeing Service Bulletin 737-27-1300 Information Notice
(IN) 01, dated April 19, 2012, which gives a total of 16 task hours for
each installed mechanism (32 hours per airplane) and 10 hours for each
modified component (20 hours per airplane).
    We agree, and have revised the cost estimate accordingly in this
final rule.

Request To Extend Compliance Time for Related AMOC

    Delta, American, and Boeing requested that we revise the NPRM (77
FR 58330, September 20, 2012) to extend the compliance time for the
AMOC associated with AD 2010-17-19, Amendment 39-16413 (75 FR 52242,
August 25, 2010). American and Delta stated that we should allow that
AMOC to remain valid until the accomplishment of the actions specified
in paragraph (u) of the NPRM to allow the fullest benefit of the clip
installation. Boeing stated that paragraph (v) of the NPRM conflicts
with paragraph (x)(3) of the NPRM regarding the AMOC. Delta stated that
Boeing Alert Service Bulletin 737-27A1299, Revision 1, dated April 16,
2012, notes that the AMOC was intended as interim action and has an

expiration date of June 30, 2016; Delta concluded that AMOC approval
would therefore expire before the 60-month compliance time specified in
the NPRM for the replacement in paragraph (u) of the NPRM.
    We agree with the requests, for the reasons provided by the
commenters. We have changed paragraph (x)(4) in this final rule to
extend the expiration of the referenced AMOCs.

Request To Clarify Reporting Requirement

    Delta requested that we revise the NPRM (77 FR 58330, September 20,
2012) to clarify the required methods and requirements for reporting
completion of the retrofit. Delta noted that paragraph (u) of the NPRM
specifies to replace the elevator tab control mechanism in accordance
with the Accomplishment Instructions of Boeing Service Bulletin 737-27-
1300, dated April 16, 2012. Delta stated that the last step of those
instructions specifies reporting retrofit completions to Boeing using
the service request application on MyBoeingFleet.com. Delta noted that
the NPRM does not specifically identify any requirement to report the
tab mechanism retrofit completions.
    We agree to clarify the reporting requirements: Although Boeing
Service Bulletin 737-27-1300, dated April 16, 2012, specifies
submitting a report, there is no new reporting requirement to report
completion of the replacement required by paragraph (u) of this AD. We
have changed paragraph (u) in this final rule to state that there is no
reporting requirement as part of the replacement.

Request To Revise Applicability

    American requested that we revise paragraph (c) (``Applicability'')
of the NPRM (77 FR 58330, September 20, 2012) to match the
applicability of paragraph (u) (mechanism replacement) of the NPRM
(which applied to line numbers 1 through 3909 inclusive). American
stated that Boeing Alert Service Bulletin 737-27A1297, Revision 2,
dated April 16, 2012; and Boeing Alert Service Bulletin 737-27A1299,
Revision 1, dated April 16, 2012; have been revised to limit the
effectivity of this issue.
    We disagree with the request to revise the applicability. The
applicability of this final rule includes the effectivity of those
service bulletins. But the applicability of this AD extends to all
Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes to
account for spares that might also be installed on those airplanes, as
specified in paragraph (v) (``New Parts Installation Prohibition'') in
this final rule. We have not revised the final rule further regarding
this issue.

Explanation of Change Made to This AD

    We have added paragraph (x)(3) in this final rule to specify that
an AMOC that provides an acceptable level of safety may be used for any
repair required by this AD if that repair is approved by the Boeing
Commercial Airplanes Organizational Designation Authorization (ODA)
that has been authorized by the Manager of the Seattle Aircraft
Certification Office to make those findings.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 58330, September 20, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 58330, September 20, 2012).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 1,096 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
            Action                    Labor cost             Parts cost                Cost per product
----------------------------------------------------------------------------------------------------------------
Retained actions..............  7 work-hours x $85     $0...................  $595 per inspection cycle.
                                 per hour = $595 per
                                 inspection cycle.
Mechanism replacement (one      32 work-hours x $85    $58,579\1\ $1,140      $62,439 per airplane.
 option for terminating          per hour = $2,720.     (installation kit).
 action).
Mechanism modification and      52 work-hours x $85    $5,858 (for the        $13,563 per airplane.
 replacement (one option for     per hour = $4,420.     modification) $1,140
 terminating action).                                   (installation kit)
                                                        $2,145 (tooling\2\).
----------------------------------------------------------------------------------------------------------------
\1\ This is the estimated cost for both a left and right mechanism. Boeing is planning a seed/exchange program
  so operators are not forced to purchase a new mechanism.
\2\ Per the Boeing service information, tooling is available from Boeing for $90 per day.

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 AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),

    (3) Will not affect intrastate aviation in Alaska, 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010), and
adding the following new AD:

2013-06-05 The Boeing Company: Amendment 39-17402; Docket No. FAA-
2012-0994; Directorate Identifier 2012-NM-119-AD.

(a) Effective Date

    This AD is effective May 9, 2013.

(b) Affected ADs

    This AD supersedes AD 2010-17-19, Amendment 39-16413 (75 FR
52242, August 25, 2010).

(c) Applicability

    This AD applies to all The Boeing Company Model 737-600, -700, -
700C, -800, -900, and -900ER series airplanes, certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 27, Flight Controls.

(e) Unsafe Condition

    This AD was prompted by reports of failure of the aft attach
lugs on the elevator tab control mechanisms, which resulted in
severe elevator vibration. This AD also results from reports of gaps
in elevator tab control mechanisms and analysis that additional
elevator tab control mechanisms might have bearings that will come
loose. We are issuing this AD to prevent discrepancies in the aft
attach lugs of the elevator tab control mechanism, which could
result in severe elevator and tab vibration. Consequent structural
failure of the elevator or horizontal stabilizer could result in
loss of structural integrity and aircraft control.

(f) Compliance

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

(g) Retained Repetitive Inspections for Group 1 Airplanes

    This paragraph restates the requirements of paragraph (g) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
Group 1 airplanes, as identified in Boeing Alert Service Bulletin
737-27A1297, dated April 16, 2010: Except as required by paragraph
(h) of this AD, within 12 days after April 29, 2010 (the effective
date of AD 2010-09-05, Amendment 39-16270 (75 FR 21499, April 26,
2010)), do a detailed inspection for discrepancies of the inboard
and outboard aft attach lugs of the left and right elevator tab
control mechanisms, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-27A1297, dated
April 16, 2010. Repeat the inspection thereafter at intervals not to
exceed 300 flight hours. Doing the replacement specified in
paragraph (l) of this AD before September 9, 2010 (the effective
date of AD 2010-17-19), terminates the requirements of this
paragraph. Doing the inspection required by paragraph (n) of this AD
terminates the requirements of this paragraph.

(h) Retained Extended Twin Operations (ETOPS) Flight Provisions

    This paragraph restates the requirements of paragraph (h) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
Group 1 airplanes as identified in Boeing Alert Service Bulletin
737-27A1297, dated April 16, 2010: Beginning 7 days after April 29,
2010 (the effective date of AD 2010-09-05, Amendment 39-21499 (75 FR
21499, April 26, 2010)), no person may operate an airplane on an
ETOPS flight unless the initial inspection required by paragraph (g)
of this AD has been accomplished. Doing the inspection required by
paragraph (n) of this AD terminates the requirements of this
paragraph.

(i) Retained One-Time Inspection for Group 2, Configuration 1,
Airplanes

    This paragraph restates the requirements of paragraph (i) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
Group 2, Configuration 1, airplanes as identified in Boeing Alert
Service Bulletin 737-27A1297, dated April 16, 2010: Within 30 days
after April 29, 2010 (the effective date of AD 2010-09-05, Amendment
39-16270 (75 FR 21499, April 26, 2010)), do a one-time detailed
inspection for discrepancies of the inboard and outboard aft attach
lugs of the left and right elevator tab control mechanisms, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-27A1297, dated April 16, 2010. Doing the
inspection required by paragraph (n) of this AD terminates the
requirements of this paragraph.

(j) Corrective Actions for Paragraphs (g), (i), and (k) of This AD

    This paragraph restates the requirements of paragraph (j) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). If,
during any inspection required by paragraph (g), (i), or (k) of this
AD, any discrepancy is found, before further flight, replace the
elevator tab control mechanism by doing the actions specified in
paragraphs (j)(1) and (j)(2) of this AD.
    (1) Do a detailed inspection for discrepancies of the
replacement elevator tab control mechanism; and, if no discrepancy
is found, install the replacement elevator tab control mechanism; in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-27A1297, dated April 16, 2010. If any
discrepancy is found, then that elevator tab control mechanism
cannot be installed and the actions specified in this paragraph must
be done before further flight on another replacement elevator tab
control mechanism.
    (2) Re-inspect the installed elevator tab control mechanism
using the inspection procedure specified in paragraph (i) of this
AD.

(k) Retained Repetitive Inspections for Certain Group 2, Configuration
1, Airplanes

    This paragraph restates the requirements of paragraph (k) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
Group 2, Configuration 1, airplanes as identified in Boeing Alert
Service Bulletin 737-27A1297, dated April 16, 2010, on which the
elevator tab control mechanism is replaced with a mechanism other
than a new, Boeing-built mechanism: Within 300 flight hours after
doing the replacement, do a detailed inspection for discrepancies of
the inboard and outboard aft attach lugs of the left and right
elevator tab control mechanisms, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
27A1297, dated April 16, 2010. Repeat the inspection thereafter at
intervals not to exceed 300 flight hours. Doing the replacement
specified in paragraph (l) of this AD before September 9, 2010 (the
effective date of AD 2010-17-19, Amendment 39-16413 (75 FR 52242,
August 25, 2010)), is terminating action for this paragraph. Doing
the inspection required by paragraph (n) of this AD terminates the
requirements of this paragraph.

(l) Terminating Action Credit for Paragraphs (g), (i), and (k) of This
AD

    This paragraph restates the requirements of paragraph (l) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010).
Replacing an elevator tab control mechanism with a new, Boeing-built
mechanism before September 9, 2010 (the effective date of AD 2010-
17-19), as specified in paragraphs (l)(1) and (l)(2) of this AD,
terminates the inspections required by paragraphs (g), (i), and (k)
of this AD. Replacement of the elevator tab control mechanism on or
after September 9, 2010 (the effective date of AD 2010-17-19), does
not terminate the inspections required by paragraphs (g), (i), and
(k) of this AD.

    Note 1 to paragraph (l) of this AD:  Additional guidance can be
found in paragraphs 3.B.7.b.(1)(a)(1) and 3.B.7.b.(1)(a)(2) of the
Accomplishment Instructions of Boeing Alert Service Bulletin

737-27A1297, dated April 16, 2010, for establishing whether the
mechanism is Boeing built.

    (1) Do a detailed inspection for discrepancies of the new,
Boeing-built replacement elevator tab control mechanism; and, if no
discrepancy is found, install the replacement elevator tab control
mechanism; in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-27A1297, dated April 16, 2010. If
any discrepancy is found, then that elevator tab control mechanism
cannot be installed and the actions specified in this paragraph must
be done on another new, Boeing-built replacement elevator tab
control mechanism.
    (2) Re-inspect the installed elevator tab control mechanism
using the inspection procedure specified in paragraph (i) of this
AD.

(m) Retained Reporting for Paragraphs (g), (i), and (k) of This AD

    This paragraph restates the requirements of paragraph (m) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
airplanes identified in Boeing Alert Service Bulletin 737-27A1297,
dated April 16, 2010: At the applicable time specified in paragraph
(m)(1) or (m)(2) of this AD, submit a report of any findings
(positive and negative) of the first inspection required by
paragraphs (g), (i), and (k) of this AD, and any positive findings
from the repetitive inspections required by paragraphs (g) and (k)
of this AD, to Boeing Commercial Airplanes Group, Attention:
Manager, Airline Support, email<EMAIL_ADDRESS>The report
must include the inspection results including a description of any
discrepancies found, the airplane line number, and the total number
of flight cycles and flight hours accumulated on the airplane.
    (1) If the inspection was done on or after April 29, 2010 (the
effective date of AD 2010-09-05, Amendment 39-16270 (75 FR 21499,
April 26, 2010)): Submit the report within 10 days after the
inspection.
    (2) If the inspection was done before April 29, 2010 (the
effective date of AD 2010-09-05, Amendment 39-16270 (75 FR 21499,
April 26, 2010)): Submit the report within 10 days after April 29,
2010 (the effective date of AD 2010-09-05).

(n) Retained Repetitive Inspections

    This paragraph restates the requirements of paragraph (n) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
airplanes having line numbers 1 through 3909 inclusive: At the
applicable time specified in paragraph (n)(1), (n)(2), or (n)(3) of
this AD, do a detailed inspection for discrepancies of the inboard
and outboard aft attach lugs of the left and right elevator tab
control mechanisms, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-27A1297, Revision
1, dated August 2, 2010. For Groups 1 and 2 airplanes identified in
Boeing Alert Service Bulletin 737-27A1297, Revision 1, dated August
2, 2010, repeat the inspection thereafter at intervals not to exceed
300 flight hours, except as provided by paragraph (t)(2) of this AD.
For Group 3 airplanes identified in Boeing Alert Service Bulletin
737-27A1297, Revision 1, dated August 2, 2010, repeat the inspection
thereafter at intervals not to exceed 1,800 flight hours, except as
required by paragraphs (p) and (t)(2) of this AD. Doing the
inspection specified in this paragraph terminates the requirements
of paragraphs (g), (h), (i), and (k) of this AD.
    (1) For Group 1 airplanes identified in Boeing Alert Service
Bulletin 737-27A1297, Revision 1, dated August 2, 2010: Within 300
flight hours after doing an inspection in accordance with Boeing
Alert Service Bulletin 737-27A1297, dated April 16, 2010, or within
30 days after September 9, 2010 (the effective date of AD 2010-17-
19, Amendment 39-16413 (75 FR 52242, August 25, 2010)), whichever
occurs later.
    (2) For Group 2 airplanes identified in Boeing Alert Service
Bulletin 737-27A1297, Revision 1, dated August 2, 2010: At the later
of the times specified in paragraphs (n)(2)(i) and (n)(2)(ii) of
this AD.
    (i) Before the accumulation of 2,000 total flight cycles or
4,000 total flight hours, whichever occurs first.
    (ii) Within 14 days after September 9, 2010 (the effective date
of AD 2010-17-19, Amendment 39-16413 (75 FR 52242, August 25,
2010)).
    (3) For Group 3 airplanes identified in Boeing Alert Service
Bulletin 737-27A1297, Revision 1, dated August 2, 2010: Within 180
days or 1,800 flight hours after September 9, 2010 (the effective
date of AD 2010-17-19, Amendment 39-16413 (75 FR 52242, August 25,
2010)), whichever occurs first.

(o) Retained Corrective Actions for Paragraphs (n) and (p) of This AD

    This paragraph restates the requirements of paragraph (o) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). If,
during any inspection required by paragraph (n) or (p) of this AD,
any discrepancy is found, before further flight, replace the
elevator tab control mechanism by doing the actions specified in
paragraphs (o)(1) and (o)(2) of this AD.
    (1) Do a detailed inspection for discrepancies of the
replacement elevator tab control mechanism; and, if no discrepancy
is found, install the replacement elevator tab control mechanism; in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-27A1297, Revision 1, dated August 2, 2010. If
any discrepancy is found, then that elevator tab control mechanism
cannot be installed and the actions specified in this paragraph must
be done before further flight on another replacement elevator tab
control mechanism.
    (2) Re-inspect the installed elevator tab control mechanism
using the inspection procedure specified in paragraph (n) of this
AD.

(p) Retained Reduced Repetitive Inspection Interval for Group 3
Airplanes

    This paragraph restates the requirements of paragraph (p) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
Group 3 airplanes as identified in Boeing Alert Service Bulletin
737-27A1297, Revision 1, dated August 2, 2010, on which the elevator
tab control mechanism is replaced during the actions required by
paragraph (o) of this AD: Within 300 flight hours after doing the
replacement, do a detailed inspection for discrepancies of the
inboard and outboard aft attach lugs of the replaced elevator tab
control mechanism, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-27A1297, Revision
1, dated August 2, 2010. Repeat the inspection of the replaced
elevator tab control mechanism thereafter at intervals not to exceed
300 flight hours, except as provided by paragraph (t)(2) of this AD.

(q) Retained Credit for Previous Action

    This paragraph restates the provisions specified in paragraph
(q) of AD 2010-17-19, Amendment 39-16413 (75 FR 52242, August 25,
2010). For Group 1 airplanes as identified in Boeing Alert Service
Bulletin 737-27A1297, Revision 1, dated August 2, 2010: Inspections
done in accordance with Boeing Alert Service Bulletin 737-27A1297,
dated April 16, 2010, are acceptable for compliance with only the
initial inspection required by paragraph (n) of this AD.

(r) Retained Reporting for Paragraphs (n) and (p) of This AD

    This paragraph restates the requirements of paragraph (r) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010). For
airplanes having line numbers 1 through 3909 inclusive: At the
applicable time specified in paragraph (r)(1) or (r)(2) of this AD,
submit a report of any findings (positive and negative) of the first
inspection required by paragraphs (n) and (p) of this AD, except for
airplanes on which a report required by paragraph (m) of this AD has
been submitted, only submit positive findings; and submit a report
of any positive findings from the repetitive inspections required by
paragraphs (n) and (p) of this AD; to Boeing Commercial Airplanes
Group, Attention: Manager, Airline Support, email:
<EMAIL_ADDRESS>The report must include the inspection
results including a description of any discrepancies found, the
airplane line number, and the total number of flight cycles and
flight hours accumulated on the airplane.
    (1) If the inspection was done on or after September 9, 2010
(the effective date of AD 2010-17-19, Amendment 39-16413 (75 FR
52242, August 25, 2010)): Submit the report within 10 days after the
inspection.
    (2) If the inspection was done before September 9, 2010 (the
effective date of AD 2010-17-19, Amendment 39-16413 (75 FR 52242,
August 25, 2010)): Submit the report within 10 days after September
9, 2010 (the effective date of AD 2010-17-19).

(s) Retained Provision Regarding Not Returning Parts

    This paragraph restates the provision specified in paragraph (s)
of AD 2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010).
Although Boeing Alert Service Bulletin 737-27A1297, dated April 16,
2010; and Boeing Alert Service Bulletin 737-27A1297, Revision 1,
dated August 2, 2010; specify to return the affected elevator tab
control mechanism to the manufacturer, this AD does not require the
return of the part to the manufacturer.

(t) Retained Parts Installation Limitations

    This paragraph restates the requirements of paragraph (t) of AD
2010-17-19, Amendment 39-16413 (75 FR 52242, August 25, 2010), with
revised limitations. As of September 9, 2010 (the effective date of
AD 2010-17-19), and until the replacement required by paragraph (u)
of this AD for airplanes with line numbers 1 through 3909 inclusive,
or until the effective date of this new AD for airplanes with line
numbers 3910 and subsequent, as applicable: Comply with the
conditions specified in paragraphs (t)(1) and (t)(2) of this AD.
    (1) No person may install an elevator tab control mechanism,
part number (P/N) 251A2430-(), on any airplane, unless the mechanism
has been inspected before and after installation using the
inspection procedures specified in paragraphs (o)(1) and (o)(2) of
this AD, and no discrepancies have been found.
    (2) An elevator tab control mechanism, P/N 251A2430-(), may be
installed, provided that the inspection specified in paragraph (n)
of this AD is done within 300 flight hours after doing the
installation, and that the inspection specified in paragraph (n) of
this AD is repeated thereafter at intervals not to exceed 300 flight
hours.

(u) New Replacement

    For airplanes having line numbers 1 through 3909 inclusive:
Within 60 months after the effective date of this AD, replace the
left and right elevator tab control mechanisms with elevator tab
control mechanisms that have new machined aft attach lugs, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 737-27-1300, dated April 16, 2012. This replacement
terminates the requirements of paragraphs (g) through (t) of this
AD. Although Boeing Service Bulletin 737-27-1300, dated April 16,
2012, specifies submitting a report, there is no requirement to
report completion of the replacement required by paragraph (u) of
this AD.

(v) New Parts Installation Prohibition

    As of the effective date of this AD, no person may install, on
any airplane identified in paragraph (v)(1) or (v)(2) of this AD, an
elevator tab control mechanism having P/N 251A2430-13, -14, -15, -
16, -17, -18, -101, -102, -103, -104, -105, or -106.
    (1) Airplanes on which the replacement in paragraph (u) of this
AD has been accomplished.
    (2) Airplanes with line numbers 3910 and subsequent.

(w) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(x) Alternative Methods of Compliance (AMOCs)

    (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 emailed 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) AMOCs approved for AD 2010-17-19, Amendment 39-16413 (75 FR
52242, August 25, 2010), are approved as AMOCs for the corresponding
provisions of this AD. The expiration of the AMOCS to AD 2010-17-19,
as specified in the service information identified in paragraphs
(x)(4)(i) and (x)(4)(ii) of this AD, is extended to remain valid
until accomplishment of the requirements of paragraph (u) of this
AD.
    (i) Boeing Alert Service Bulletin 737-27A1299, dated July 1,
2011 (which is not incorporated by reference in this AD).
    (ii) Boeing Alert Service Bulletin 737-27A1299, Revision 1,
dated April 16, 2012 (which is not incorporated by reference in this
AD).

(y) Related Information

    For more information about this AD, contact Kelly McGuckin,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW.,
Renton, Washington 98057-3356; phone:<PHONE_NUMBER>; fax: 425-917-
6590; email<EMAIL_ADDRESS>
(z) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 9, 2013.
    (i) Boeing Service Bulletin 737-27-1300, dated April 16, 2012.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
September 9, 2010 (75 FR 52242, August 25, 2010).
    (i) Boeing Alert Service Bulletin 737-27A1297, Revision 1, dated
August 2, 2010.
    (ii) Reserved.
    (5) The following service information was approved for IBR on
April 29, 2010 (75 FR 21499, April 26, 2010).
    (i) Boeing Alert Service Bulletin 737-27A1297, dated April 16,
2010.
    (ii) Reserved.
    (6) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (7) You may view this service information at FAA, You may review
copies of the referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (8) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on March 20, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-07209 Filed 4-3-13; 8:45 am]
BILLING CODE 4910-13-P