[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]
[Page 34453-34456]
[DOCID:fr17jn10-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-N-0284 and FDA-2009-D-0461]

Risk Evaluation and Mitigation Strategies; Notice of Public
Meeting; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 2-day
public meeting to obtain input on issues and challenges associated with
the development and implementation of risk evaluation and mitigation
strategies (REMS) for drugs and biological products. As FDA has taken
steps to implement the REMS provisions of the Federal Food, Drug, and
Cosmetic Act (FDCA), some stakeholders have raised concerns about the
impact of various REMS, and the growing number of REMS on the health
care system, as well as on individual prescribers, pharmacists,
distributors, and other affected stakeholders. To obtain public input
about the REMS program and its impact, and to gather additional input
on a draft guidance for industry issued on October 1, 2009 entitled
``Format and Content of Proposed Risk Evaluation and Mitigation
Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,''
FDA has decided to hold this public meeting. FDA wishes to give a wide
range of stakeholders the opportunity to provide input in this area,
and will take the information it obtains from the meeting into account
in its implementation of the REMS program and in the development of the
final guidance and future REMS guidances.

DATES: The meeting will be held on July 27 and 28, 2010, from 8:30 a.m.
to 4:30 p.m. Individuals who wish to present at the meeting must
register by July 6, 2010. The comment period for the draft guidance for
industry on ``Format and Content of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS
Modifications'' has been reopened until August 31, 2010.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. Identify each set of comments with the
corresponding docket number for either the public meeting or the draft
guidance as follows: Docket No. FDA-2010-N-0284, ``Risk Assessment and
Mitigation Strategies; Public Meeting,'' and Docket No. FDA-2009-D-
0461, Draft guidance for industry on ``Format and Content of Proposed
Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and
Proposed REMS Modifications.''

FOR FURTHER INFORMATION CONTACT: Kristen Everett, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, rm. 6228, Silver Spring, MD 20993, 301-796-
0453, FAX:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85).
Title IX, subtitle A, section 901 of FDAAA created new section 505-1 of
the FDCA, which authorizes FDA to require persons submitting new drug
applications (NDAs) or abbreviated new drug applications (ANDAs) for
prescription products, or biologics license applications (BLAs), to
submit and implement a REMS if FDA determines that a REMS is necessary
to ensure the benefits of a drug outweigh the risks of the drug. To
require a REMS for an already approved drug, FDA must have new safety
information as defined in the statute.
    FDAAA specifies the criteria FDA must consider in determining when
to require a REMS, the elements of a REMS that FDA must and may
require, and additional considerations when requiring a REMS with
elements to assure safe use. FDAAA also contains provisions that are
specifically directed to REMS for ANDAs and describes enforcement
actions for failure to comply with REMS. FDAAA contains provisions that
require the FDA to seek input from patients, physicians, pharmacists,
and other health care providers about how the elements to assure safe
use may be standardized to (1) not be unduly burdensome on patient
access to the drug and (2) to the extent practicable, minimize the
burden on the health care delivery system. A webinar will be available
on the agency's Web site at http://www.fda.gov/Drugs/NewsEvents/
ucm210201.htm 2 weeks before the meeting, describing in more detail the
statutory requirements for REMS.

II. REMS Draft Guidance and Comment Period

    FDA has been implementing the REMS FDAAA provisions for more than 2
years. On October 1, 2009, the Agency published in the Federal Register
(74 FR 80801) a notice of availability of a draft guidance for industry
entitled, ``Format and Content of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS
Modifications.'' Although comments on Agency guidances are welcome at
any time (see 21 CFR 10.115(g)(5)), to ensure that comments could be
considered as the Agency worked on the final version of the guidance,
interested persons were invited to comment on the draft guidance by
December 30, 2009. The draft guidance provides information

regarding FDA's current thinking on the format and content that should
be used for submissions of proposed REMS, including the availability of
templates for REMS and REMS supporting documents. It also includes
preliminary information on the content of assessments and proposed
modifications to approved REMS.
    In comments on the guidance, as well as in various other contexts,
stakeholders have raised concerns with the Agency about the use of
REMS, and the impact of both the variety of REMS and the growing number
of REMS on the health care system and on affected prescribers,
pharmacists, distributors, patients, and other affected stakeholders.
For example, some stakeholders have expressed concern regarding the
cumulative burden of REMS on the health care delivery system. Others
have raised concerns about prescribers' and pharmacists' costs of
implementing REMS, and some have raised questions about the impact of
REMS on patient access to therapies. FDA has decided to hold a public
meeting to hear from stakeholders about their opinions on how REMS are
working, and the effects of REMS on prescribers, pharmacists,
distributors, patients, and other stakeholders, and on the overall
health care system. At the same time, FDA is reopening the comment
period on the draft guidance for industry on ``Format and Content of
Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS
Assessments, and Proposed REMS Modifications'' until August 31, 2010.
FDA will take into account the input it receives through comments and
at the public meeting in its implementation of the FDAAA REMS
provisions when it finalizes the above guidance, and in the development
of future guidances regarding REMS for drugs and biological products.

III. FDA Actions Under FDAAA

    Section 901 of FDAAA became effective March 25, 2008. Between March
25, 2008, and March 25, 2010, FDA approved 110 new REMS for NDAs and
BLAs, and two deemed REMS.\1\ Table 1 shows the various types of
approved REMS.
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    \1\ Section 909 of FDAAA provides that drugs approved with
elements to assure safe use before FDAAA was enacted were deemed to
have REMS. Sponsors of these products were required to submit
proposed REMS by September 21, 2008.

Table 1. New REMS Approved Between March 25, 2008, and March 25, 2010\1\
------------------------------------------------------------------------
 REMS Elements (in addition to a timetable
 for submission of assessments of the REMS)          No. Approved
------------------------------------------------------------------------
Medication Guide (MG) Only                   75
------------------------------------------------------------------------
Communication plan (CP) alone or with a MG   25
------------------------------------------------------------------------
Elements to assure safe use alone or with    10
 CP and/or MG
------------------------------------------------------------------------
Total new REMS approved                      110
------------------------------------------------------------------------
\1\ ``New REMS'' means REMS approved since FDAAA took effect for drugs
  that did not previously have risk management plans in place.

    As shown in Table 1, 68 percent of the newly approved REMS
contained only a Medication Guide and a timetable for submission of
assessments of the REMS (the only element required in all REMS). Before
FDAAA, a drug with only a Medication Guide would not have been
considered to have a risk management plan. Instead, Medication Guides
were considered part of labeling.
    Less than 10 percent of the new REMS contain elements to assure
safe use; however, these new REMS are in addition to the 16 previously
approved risk management plans with elements to assure safe use that
have been deemed to be REMS.
    In each case where a REMS was required, FDA made the finding that a
REMS was necessary to ensure that the benefits of the drug outweighed
the risks. In the case of REMS with elements to assure safe use, the
types of REMS that place the greatest burden on participants in the
program and on the health care system, FDA determined that without
these elements to assure safe use, the drug could not be approved, or
if previously approved, would need to be withdrawn from the market. It
is these types of REMS that seem to be of most concern to stakeholders
who have communicated concerns about the REMS program.
    Most of the REMS with elements to assure safe use require
prescriber education and certification about the specific risks of the
drug covered by the REMS and the drug's appropriate use. In some cases,
prescribers are required to counsel patients about the risks of the
drug. They also may be required to enroll patients in the REMS, and
they may be asked to have the patient sign a prescriber/patient
agreement. All of these actions are intended to promote informed,
appropriate prescribing of the particular drug, and provide information
to the patient about the risks and appropriate use of the drug.
However, FDA has heard from prescribers who are concerned about having
to enroll in many different programs, obtain different certifications,
and comply with various requirements for counseling their patients.
They are concerned that these restrictive programs interfere with the
practice of medicine and are costly to implement without any
reimbursement for the costs incurred. Patients have expressed the
concern individually and through patient advocacy groups that
prescribers may refuse to participate in the REMS, so they may be
deprived of access to necessary drugs.
    Many of the REMS with elements to assure safe use require
pharmacists or pharmacies to be certified, and in several REMS with
elements to assure safe use, pharmacists are required to determine
whether the prescription presented by the patient was written by a
certified prescriber or whether the patient is authorized to receive
the drug. Sometimes pharmacists are also provided educational materials
so that they can counsel patients on the safe and appropriate use of
the drug. FDA has heard from pharmacy organizations that complying with
these requirements can cause a disruption in usual workflow, and these
organizations have expressed concern that there is no additional
compensation for pharmacists complying with REMS requirements. In
addition, pharmacists have said that the multiplicity of programs
requiring separate enrollment and certification are unduly burdensome
on the pharmacy, as is the lack of a single source for information on
all REMS requirements.
    In some REMS, to help ensure that the REMS is appropriately
implemented, the sponsor will elect to distribute only through a
central pharmacy or pharmacies that agree to abide by the terms of the
REMS. Some health care organizations have expressed the concern that
these arrangements disrupt their ability to provide drugs to patients
in their system, and are anticompetitive in nature. (See the citizen
petition filed under 21 CFR 10.30 by Kaiser Foundation Health Plan,
Inc., Docket No. FDA-2009-P-0602, available on the Internet at http://
www.regulations.gov.)
    A few REMS with elements to assure safe use require that drugs be
dispensed only in particular settings, such as hospitals. Some require
patients to be monitored for the development of undesirable reactions
to the drug or, in the case of drugs that can adversely affect a fetus,
require pregnancy testing to prevent fetal exposure to the drug.
Stakeholders have expressed concerns

about these types of restrictions, citing burden and cost.
    Several of the REMS with elements to assure safe use require that
the drug be dispensed only with documentation of conditions to assure
safe use. For example, patient enrollment may be required in a program
designed to make sure the patient is educated about the risks of the
drug, the importance of follow-up, monitoring, if applicable, and
reporting of adverse events. Stakeholders have raised concerns about
the effect of such restrictions on patient access to medications and
about the costs to prescribers and pharmacists to implement such a
program.
    All REMS include a timetable for submission of assessments. The
timing for assessments is at a minimum 18 months, 3 years, and 7 years,
but for drugs that have REMS with elements to assure safe use, the
assessments can be more frequent. Sponsors must assess the REMS and
determine whether the goals of the REMS are being met. REMS assessment
reports generally summarize surveys of patients and prescribers, data
on compliance with the REMS processes, drug use, and information on
certain outcomes.
    Because FDA regulates the holders of approved applications to
market drugs, the REMS requirements are imposed on sponsors, not
directly on other participants in the health care system. Thus,
sponsors must establish the education and certification programs and
the monitoring systems, and implement the REMS requirements. Yet
sponsors do not control the other participants in the health care
system, and it may be difficult to get the participants to comply with
the REMS requirements. Furthermore, because in most cases the REMS
programs are established by individual sponsors and are tailored to the
characteristics of the drug, the population using the drug, and the way
the drug is prescribed and distributed, it can be difficult to
standardize the elements of REMS to reduce their burden. Finally, it
may be difficult to determine whether a REMS is working effectively
and, if so, which specific elements of the REMS are working well.
    As FDA continues to require and approve REMS for drugs, it is
important to hear more from stakeholders about their concerns.
Therefore, FDA has decided to hold this public meeting.

IV. Purpose and Scope of Meeting

    The purpose of this meeting is to receive information and comments
on issues with REMS from a broad group of stakeholders including
interested prescribers, pharmacists, patients, third party payers,
application holders, and the public.
    Although any comments are welcome, FDA is particularly interested
in obtaining information and public comment on the following issues:

A. Requirement for a REMS

    In each case where a REMS was required, FDA made the statutorily
required finding that a REMS was necessary to ensure that the benefits
of the drug outweighed the risks. Section 505-1 lists the factors FDA
must consider in determining whether to require a REMS as follows:
     The estimated size of the population likely to use the
drug
     The seriousness of the disease or condition that is to be
treated with the drug
     The expected benefit of the drug with respect to the
disease or condition
     The expected or actual duration of treatment with the drug
     The seriousness of any known or potential adverse events
that may be related to the drug and the background incidence of such
events in the population likely to use the drug
     Whether the drug is a new molecular entity
    In addition, for REMS with elements to assure safe use, the
elements to assure safe use must:
     Be commensurate with the specific serious risk listed in
the labeling of the drug
     Not be unduly burdensome on patient access to the drug,
considering the risk and, in particular, patients with serious or life-
threatening diseases or conditions and patients who have difficulty
accessing health care (such as patients in rural or medically
underserved areas)
     To the extent practicable, conform with elements to assure
safe use for other drugs with similar serious risks, and
     Be designed to be compatible with established
distribution, procurement, and dispensing systems for drug.
    1. How should these factors be evaluated individually and in
relation to each other to determine whether a REMS is appropriate?
    2. How should the factors be evaluated individually and in relation
to each other to determine what type of REMS is appropriate (i.e., what
elements should be included in the REMS: Medication Guide,
communication plan, elements to assure safe use, implementation
system)?
    3. Are there other factors that FDA should consider besides the
statutorily enumerated factors in deciding whether to require a REMS,
and if FDA believes a REMS is necessary, what type of REMS should be
required?

B. Establishing the Goals of A REMS

    1. When FDA requires a REMS, how should the goals be expressed? For
example:
    a. Should the goal be to reduce the risk to zero (e.g., zero fetal
exposures or cases of agranulocytosis), even if it is recognized as an
aspirational and not an achievable goal?
    b. Should the goal be expressed in terms of risk reduction either
to some minimum level (e.g., not more than 100 fetal exposures) or as
compared to a baseline, assuming there is a known baseline from which
risk reduction can be measured (e.g., reduce fetal exposures by 90
percent)?
    c. What factors should FDA consider in establishing the goals of a
REMS?
    d. What criteria might be considered for modifying a REMS
(increasing or decreasing elements, or eliminating it all together)?

C. Issues Regarding Elements to Assure Safe Use

    1. Is there evidence that REMS with elements to assure safe use
have adversely affected appropriate patient access to approved drugs?
    a. What features of a REMS with elements to assure safe use are
most likely to adversely affect appropriate patient access to approved
drugs?
    b. What design features or safeguards could be incorporated into
elements to assure safe use to reduce any negative impact on
appropriate patient access?
    2. Is there evidence that REMS with elements to assure safe use
have improved patient safety?
    3. Is there evidence that REMS with elements to assure safe use
have adversely affected patient safety?
    4. How have REMS with elements to assure safe use affected the
health care delivery system?
    a. What features of a REMS with elements to assure safe use are
most likely to adversely affect the health care delivery system?
    b. What design features could be incorporated into elements to
assure safe use to reduce any negative impact on the health care
delivery system? For example, can training and certification of health
care providers be streamlined? If so, how?
    c. How should REMS with elements to assure safe use be made
compatible with established distribution systems so as to minimize the
burden on the health care delivery system?
    5. Some REMS are implemented by distribution of drugs through a
central pharmacy system, and some are

implemented through a retail pharmacy system.
    a. What are the advantages and disadvantages of the various models
of drug distribution under a REMS?
    b. Should sponsors be permitted to choose the drug distribution
system they prefer to manage the risks, or should a common distribution
system be employed for REMS?
    6. Can implementation of elements to assure safe use be
standardized (e.g., could uniform systems for providing prescriber and
pharmacist education or certification be developed)?
    a. Is there a preferred way to standardize the elements to assure
safe use (e.g., based on the nature of the risk, across a class of
drugs with common risks, or around certain elements such as prescriber
education or pharmacy certification)?
    b. What are the advantages and disadvantages of standardizing the
way elements to assure safe use are implemented on:
    i. Patient safety?
    ii. Patient access?

D. Evaluating the Effectiveness of REMS

    1. How should REMS be monitored and assessed to determine their
effectiveness, considering the different types of REMS elements (e.g.,
Medication Guides, communication plans, elements to assure safe use)?
    2. How should the overall burden on the health care system of a
REMS with elements to assure safe use be monitored and assessed,
considering the different types of elements to assure safe use (e.g.,
training or certification of prescribers and pharmacists,
implementation of patient registries)?
    3. Should metrics for determining the effectiveness of a REMS be
specified at the time the REMS is approved? How should the appropriate
metrics be determined?
    4. Are surveys the optimal method to assess patient and health care
provider understanding of the serious risks and safe use of the drug?
Are there alternative methods that should be considered?

E. Effects of REMS on Generic Drugs

    1. Section 505-1(f)(8) states that no holder of an approved
application shall use any element to assure safe use required by the
Secretary to block or delay approval of an application under section
505(b)(2) or (j) or to prevent application of an element to assure safe
use to a drug that is the subject of an abbreviated new drug
application. What steps should FDA take to ensure that REMS are not
used to block or delay generic competition?
    2. FDAAA requires that innovator and generic sponsors use a single
shared system to provide a REMS with elements to assure safe use,
unless a waiver is granted. What design or process features should be
taken into account when designing an innovator REMS to facilitate use
of a single shared system when generics are approved?

F. Protection of Patient Information

    1. Some REMS with elements to assure safe use require enrollment of
patients and health care providers in a program, or require a patient
registry as a condition of prescribing or dispensing a drug.
    a. What, if any, privacy concerns are raised by these programs?
    b. Does enrollment in a REMS program or a patient registry without
requiring a specific collection of health information raise the same
privacy concerns?
    2. What steps should FDA take to reduce concerns about patient
privacy when REMS with such elements to assure safe use are determined
to be necessary to ensure the benefits of a drug outweigh its risks?

V. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and will be on a first come, first served basis. Individuals who
wish to present at the public meeting must register by email to
<EMAIL_ADDRESS>on or before June 30, 2010, and provide
complete contact information, including name, title, affiliation,
address, email, and phone number. In section IV of this document, FDA
has included questions for comment. You should identify by number each
question you wish to address in your presentation, so that FDA can
consider that in organizing the presentations. FDA will do its best to
accommodate requests to speak, and will determine the amount of time
allotted to each presenter and the approximate time that each oral
presentation is scheduled to begin. An agenda will be available
approximately 2 weeks before the meeting on the Agency Web site at
http://www.fda.gov/Drugs/NewsEvents/ucm210201.htm.
    If you need special accommodations because of disability, please
contact Kristen Everett (see FOR FURTHER INFORMATION CONTACT) at least
7 days before the meeting.
    A live Web cast of this meeting will be available on the Agency Web
site at http://www.fda.gov/Drugs/NewsEvents/ucm210201.htm on the day of
the meeting. A video record of the meeting will be available at the
same Web address for 1 year.

VI. Comments

    Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by August 31, 2010. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

VII. Transcripts

    Transcripts of the meeting will be available for review at the
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 30 days after the meeting. A
transcript will also be made available in either hard copy or on CD-
ROM, upon submission of a Freedom of Information request. Written
requests are to be sent to Division of Freedom of Information (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, rm. 6-30, Rockville, MD 20857.

    Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14547 Filed 6-11-10; 4:15 pm]
BILLING CODE 4160-01-S


[Federal Register: November 26, 2007 (Volume 72, Number 226)]
[Proposed Rules]
[Page 65901-65903]
[DOCID:fr26no07-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0226; Directorate Identifier 2007-NM-187-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-300, -400, and -500
Series Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Boeing Model 737-300, -400, and -500 series airplanes. This
proposed AD would require repetitive inspections for cracking of the
body buttock line (BBL) 0.07 floor beam between body station (BS) 651
and BS 676 and between BS 698 and BS 717, and related investigative and
corrective actions if necessary. This AD also provides an optional
terminating action for the repetitive inspections. This proposed AD
results from reports of cracking in the BBL 0.07 floor beam. We are
proposing this AD to prevent failure of the main deck floor beams at
certain body stations due to fatigue cracking, which could result in
rapid decompression of the airplane.

DATES: We must receive comments on this proposed AD by January 10,
2008.

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, P.O. Box 3707, Seattle, Washington 98124-2207.

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: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,

1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6440; 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-2007-0226;
Directorate Identifier 2007-NM-187-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.

Other Related Rulemaking

    On July 12, 2001, we issued AD 2001-14-20, amendment 39-12331 (66
FR 38354, July 24, 2001), applicable to certain Boeing Model 737-100
and -200 series airplanes. AD 2001-14-20 requires repetitive
inspections to find fatigue cracking in the main deck floor beams
located at certain body stations, and repair if necessary. AD 2001-14-
20 also provides for optional terminating action for the repetitive
inspections. AD 2001-14-20 addresses fatigue cracking in the main deck
floor beams on Model 737-100 and -200 series airplanes, while this
proposed AD would address the same unsafe condition on Boeing Model
737-300, -400, and -500 series airplanes.

Discussion

    Since we issued AD 2001-14-20, several operators have reported
cracking in the body buttock line (BBL) 0.07 floor beam on Model 737-
300, -400, and -500 series airplanes. The cracks were similar to those
found on the Model 737-100 and -200 series airplanes, which are
addressed by AD 2001-14-20. Investigation revealed that the cracks were
caused by fatigue resulting from pressurization flexure. Failure of the
main deck floor beam at certain body stations due to fatigue cracking
could result in rapid decompression of the airplane.

Relevant Service Information

    We have reviewed Boeing Service Bulletin 737-57-1210, Revision 2,
dated June 13, 2007. For Model 737-300, -400, and -500 series
airplanes, the service bulletin describes procedures for accomplishing
repetitive detailed inspections for cracking of the BBL 0.07 floor beam
between body station (BS) 651 and BS 676 and between BS 698 and BS 717,
and doing related investigative and corrective actions if necessary.
The related investigative action includes doing a high frequency eddy
current (HFEC) inspection of the fastener holes for cracking (1) prior
to modifying the floor beam, or (2) if any cracking is found in the web
(between BS 651 and BS 676 and between BS 698 and BS 717) or in the
upper chord (between BS 651 and BS 676) during the detailed inspection.
The corrective actions include the following:
     Repairing any cracking in accordance with the service
bulletin, if cracking is found in the web (between BS 651 and BS 676
and between BS 698 and BS 717) or in the upper chord (between BS 651
and BS 676) during the detailed inspection but no cracking is found
during the HFEC inspection. Accomplishing the repair would eliminate
the need for the repetitive inspections for the area in which the
repair is installed.
     Contacting Boeing for repair instructions, (1) if cracking
is found in the web (between BS 651 and BS 676 and between BS 698 and
BS 717) or in the upper chord (between BS 651 and BS 676) during the
HFEC inspections, (2) if cracking is found in the chords or stiffeners
(between BS 698 and BS 717) or outside the typical crack locations
(between BS 651 and BS 676 and between BS 698 and BS 717) during the
detailed inspection, or (3) if cracking is found during the HFEC prior
to modifying the floor beam.
    The service bulletin also provides procedures for modifying the
floor beam, if no cracking is found during the detailed and HFEC
inspections. Accomplishing the modification (optional terminating
action) would eliminate the need for the repetitive inspections for the
area in which the modification is installed.
    Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other airplanes
of this same type design. For this reason, we are proposing this AD,
which would require accomplishing the actions specified in the service
information described previously, except as discussed under
``Difference Between the Proposed AD and Service Bulletin.''

Difference Between the Proposed AD and Service Bulletin

    The service bulletin specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     Using a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by an Authorized Representative
for the Boeing Commercial Airplanes Delegation Option Authorization
Organization whom we have authorized to make those findings.

Costs of Compliance

    There are about 1,961 airplanes of the affected design in the
worldwide fleet. This proposed AD would affect about 599 airplanes of
U.S. registry. The proposed inspections would take about 4 work hours
per airplane, at an average labor rate of $80 per work hour. Based on
these figures, the estimated cost of the proposed AD for U.S. operators
is $191,680, or $320 per airplane, per inspection cycle.

Authority for This Rulemaking

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

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or

on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

Boeing: Docket No. FAA-2007-0226; Directorate Identifier 2007-NM-
187-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by January
10, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-300, -400, and -500
series airplanes, certificated in any category; as identified in
Boeing Service Bulletin 737-57-1210, excluding Appendix A, Revision
2, dated June 13, 2007.

Unsafe Condition

    (d) This AD results from reports of cracking in the body buttock
line (BBL) 0.07 floor beam. We are issuing this AD to prevent
failure of the main deck floor beams at certain body stations due to
fatigue cracking, which could result in rapid decompression of the
airplane.

Compliance

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

Inspections and Related Investigative/Corrective Actions

    (f) Before the accumulation of 20,000 total flight hours, or
within 7,000 flight cycles after the effective date of this AD,
whichever occurs later: Do the detailed inspections for cracking of
the BBL 0.07 floor beam between body station (BS) 651 and BS 676 and
between BS 698 and BS 717, and do all the applicable related
investigative and corrective actions before further flight, by
accomplishing all of the applicable actions specified in paragraphs
B.2. and B.4. of the Accomplishment Instructions of Boeing Service
Bulletin 737-57-1210, excluding Appendix A, Revision 2, dated June
13, 2007, except as provided by paragraph (g) of this AD. Repeat the
inspections thereafter at intervals not to exceed 7,000 flight
cycles. Installing a repair in accordance with paragraphs B.2. and
B.4. of the Accomplishment Instructions of the service bulletin, or
doing the modification in accordance with paragraph (h) of this AD,
terminates the repetitive inspections for the applicable area only.

Exception to Corrective Action

    (g) If any cracking is found during any inspection required by
this AD, and Boeing Service Bulletin 737-57-1210, excluding Appendix
A, Revision 2, dated June 13, 2007, specifies to contact Boeing for
appropriate action: Before further flight, repair the cracking using
a method approved in accordance with the procedures specified in
paragraph (i) of this AD.

Optional Terminating Action

    (h) If no cracking is found during the detailed inspection and
related investigative action required by paragraph (f) of this AD:
Accomplishing the modification of the BBL 0.07 floor beam between BS
651 and BS 676 and between BS 698 and BS 717, as applicable, in
accordance with paragraphs B.2. and B.4., as applicable, of the
Accomplishment Instructions of Boeing Service Bulletin 737-57-1210,
excluding Appendix A, Revision 2, dated June 13, 2007, terminates
the repetitive inspections for the applicable area only.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (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 appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (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 an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who 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.

    Issued in Renton, Washington, on November 13, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-22923 Filed 11-23-07; 8:45 am]

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