[Federal Register: July 30, 2009 (Volume 74, Number 145)]
[Proposed Rules]
[Page 37963-37965]
[DOCID:fr30jy09-15]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0658; Directorate Identifier 2009-NM-058-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-9-14, DC-9-
15, and DC-9-15F Airplanes; and McDonnell Douglas Model DC-9-20, DC-9-
30, DC-9-40, and DC-9-50 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 supersede an existing airworthiness
directive (AD) that applies to all McDonnell Douglas Model DC-9-14, DC-
9-15, and DC-9-15F airplanes; and McDonnell Douglas Model DC-9-20, DC-
9-30, DC-9-40, and DC-9-50 series airplanes. The existing AD currently
requires repetitive inspections for cracks of the main landing gear
(MLG) shock strut cylinder, and related investigative and corrective
actions if necessary. This proposed AD would add more work on airplanes
that have main landing gear shock struts with certain identified part
numbers. This proposed AD results from two reports of a collapsed MLG
and a report of cracks in two MLG cylinders. We are proposing this AD
to detect and correct fatigue cracks in the shock strut cylinder of the
MLG, which could result in a collapsed MLG during takeoff or landing,
and possible reduced structural integrity of the airplane.

DATES: We must receive comments on this proposed AD by September 14,
2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Wahib Mina, ANM-120L, FAA, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
California 90712-4137; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0658;
Directorate Identifier 2009-NM-058-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On September 7, 2005, we issued AD 2005-19-08, amendment 39-14273
(70 FR 54616, September 16, 2005), for all McDonnell Douglas Model DC-
9-14, DC-9-15, and DC-9-15F airplanes; and McDonnell Douglas Model DC-
9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes. That AD requires
repetitive inspections for cracks of the main landing gear (MLG) shock
strut cylinder, and related investigative and corrective actions if
necessary. That AD resulted from two reports of a collapsed MLG and a
report of cracks in two MLG cylinders. We issued that AD to detect and
correct fatigue cracks in the shock strut cylinder of the MLG, which
could result in a collapsed MLG during takeoff or landing, and possible
reduced structural integrity of the airplane.

Actions Since Existing AD Was Issued

    Since we issued AD 2005-19-08, the manufacturer revised the service
information referenced in that AD, i.e., Boeing Alert Service Bulletin
DC9-32A350, Revision 1, dated August 3, 2005, to add more work on
airplanes that have shock struts with part numbers 5924400-505 and
5924400-506.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin DC9-32A350, Revision
2, dated March 20, 2009, which specifies that shock struts having part
numbers 5924400-505 and 5924400-506 must be included with those struts
that require repetitive non-destructive testing inspections. The
remaining actions are otherwise unchanged.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe

condition that is likely to develop on other airplanes of the same type
design. For this reason, we are proposing this AD, which would
supersede AD 2005-19-08 and would retain its requirements. This
proposed AD would also require accomplishing the actions specified for
the additional shock struts.

Costs of Compliance

    There are about 644 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Average                                                  Number of
                                                               labor                                                     U.S.-
               Action                      Work hours         rate per          Parts            Cost per airplane     registered        Fleet cost
                                                                hour                                                   airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection.........................  4 to 6................        $80  None.................  $320 to $480 per               426  $136,320 to $204,480
                                                                                inspection cycle.                   per inspection
                                                                                cycle.
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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, Incorporation by
reference, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing amendment 39-14273 (70 FR
54616, September 16, 2005) and adding the following new AD:

McDonnell Douglas: Docket No. FAA-2009-0658; Directorate Identifier
2009-NM-058-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by September
14, 2009.

Affected ADs

    (b) This AD supersedes AD 2005-19-08.

Applicability

    (c) This AD applies to all McDonnell Douglas Model DC-9-14, DC-
9-15, and DC-9-15F airplanes; Model DC-9-21 airplanes; Model DC-9-
31, DC-9-32, DC-9-32 (VC-9C), DC-9-32F, DC-9-33F, DC-9-34, DC-9-34F,
and DC-9-32F (C-9A, C-9B) airplanes; Model DC-9-41 airplanes; and
Model DC-9-51 airplanes; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
gear.

Unsafe Condition

    (e) This AD results from two reports of a collapsed main landing
gear (MLG) and a report of cracks in two MLG cylinders. We are
issuing this AD to detect and correct fatigue cracks in the shock
strut cylinder of the MLG, which could result in a collapsed MLG
during takeoff or landing, and possible reduced structural integrity
of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.
    Restatement of Requirements of AD 2005-19-08 with Revised
Service Information:

Records Review

    (g) Except as required by paragraph (m) of this AD, before the
applicable compliance time specified in paragraph (h) or Table 1 of
this AD, as applicable, do the applicable actions in paragraphs
(g)(1) and (g)(2) of this AD.
    (1) For all airplane groups: Review the airplane maintenance
records of the MLG to determine its service history and the number
of landings on the MLG shock strut cylinder.
    (2) For Group 3 airplanes identified in the service bulletin:
Review the maintenance records to determine if the MLG cylinder on
each Group 3 airplane has always been on a Group 3 airplane, and do
the actions in paragraph (k) of this AD.

Inspection

    (h) Inspect the MLG shock strut cylinders for cracks using the
Option 1 or Option 2 non-destructive testing inspection described in
Boeing Alert Service Bulletin DC9-32A350, Revision 1, dated August
3, 2005; or Revision 2, dated March 20, 2009, except as required by
paragraph (m) of this AD. Inspect in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin DC9-
32A350, Revision 1, dated August 3, 2005; or Revision 2, dated March
20, 2009; except as required by paragraph (m) of this AD. After the
effective date of this AD, use only Boeing Alert Service Bulletin
DC9-32A350, Revision 2, dated March 20, 2009. Do the detailed
inspection before the accumulation of 60,000 total landings on the
MLG, or at the applicable grace period specified in Table 1 of this
AD, whichever occurs later, except as required by paragraph (m) of
this AD, and except as provided by paragraph (k) of this AD. If the
review of maintenance records is not sufficient to conclusively
determine the service history

and number of landings on the MLG shock strut cylinder, perform the
initial inspection at the applicable grace period specified in Table
1 of this AD.

               Table 1--Threshold and Repetitive Interval
------------------------------------------------------------------------
 Airplanes identified in the
 service bulletin  as group         Threshold        Repetitive interval
------------------------------------------------------------------------
1...........................  Within 18 months or   Intervals not to
                               650 landings after    exceed 650
                               October 21, 2005      landings.
                               (the effective date
                               of AD 2005-19-08),
                               whichever occurs
                               first.
2...........................  Within 18 months or   Intervals not to
                               500 landings after    exceed 500
                               October 21, 2005,     landings.
                               whichever occurs
                               first.
3, except as provided by      Within 18 months or   Intervals not to
 paragraph (k) of this AD.     2,500 landings        exceed 2,500
                               after October 21,     landings.
                               2005, whichever
                               occurs first.
4...........................  Within 18 months or   Intervals not to
                               2,100 landings        exceed 2,100
                               after October 21,     landings.
                               2005, whichever
                               occurs first.
------------------------------------------------------------------------

No Indication of Cracking Is Found

    (i) If no indication of cracking is found during the inspection
required by paragraph (h) of this AD, repeat the inspection in
accordance with Boeing Alert Service Bulletin DC9-32A350, Revision
1, dated August 3, 2005; or Boeing Alert Service Bulletin DC9-
32A350, Revision 2, dated March 20, 2009; at the applicable interval
specified in Table 1 of this AD, except as required by paragraph (m)
of this AD. After the effective date of this AD, use only Boeing
Alert Service Bulletin DC9-32A350, Revision 2, dated March 20, 2009,
of the service bulletin.

Related Investigative and Corrective Actions

    (j) If any indication of cracking is found during any inspection
required by paragraph (h) or (i) of this AD: Before further flight,
confirm the indication of cracking by doing all applicable related
investigative actions and doing the applicable corrective actions in
accordance with Boeing Alert Service Bulletin DC9-32A350, Revision
1, dated August 3, 2005; or Revision 2, dated March 20, 2009; except
as required by paragraph (m) of this AD. After the effective date of
this AD, use only Boeing Alert Service Bulletin DC9-32A350, Revision
2, dated March 20, 2009, of the service bulletin. Repeat the
inspection at the applicable threshold and interval specified in
paragraph (h) of this AD.

MLG Cylinder Previously Installed on Group 4 Airplanes

    (k) For MLG cylinders on Group 3 airplanes as identified in
Boeing Alert Service Bulletin DC9-32A350, Revision 1, dated August
3, 2005; or Revision 2, dated March 20, 2009: If the MLG cylinder
was previously installed on a Group 4 airplane, as identified in
Boeing Alert Service Bulletin DC9-32A350, Revision 1, dated August
3, 2005; or Revision 2, dated March 20, 2009; or if the service
history and number of landings cannot be determined, the MLG
cylinder must be inspected at the grace period and repetitive
interval that applies to Group 4 airplanes, as specified in Table 1
of this AD, except as required by paragraph (m) of this AD.

Actions Accomplished in Accordance With Original Issue of Service
Bulletin

    (l) For airplanes with shock struts that have part numbers other
than 5924400-505 and 5924400-506: Actions done before the effective
date of this AD in accordance with Boeing Alert Service Bulletin
DC9-32A350, dated December 3, 2004, are acceptable for compliance
with the corresponding actions required paragraphs (h), (i), (j),
and (k) of this by this AD.

New Requirements of This AD

    (m) For airplanes with shock struts that have part numbers
5924400-505 and 5924400-506: Do the actions required by paragraphs
(g), (h), (i), (j), and (k), as applicable, in accordance with
Boeing Alert Service Bulletin DC9-32A350, Revision 2, dated March
20, 2009. Do the actions at the time specified in those paragraphs,
except where Table 1 of this AD specifies a compliance time after
October 21, 2005, the compliance time for these airplanes is within
the specified compliance time after the effective date of this AD.

Alternative Methods of Compliance (AMOCs)

    (n)(1) The Manager, Los Angeles Aircraft Certification Office,
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Wahib Mina, ANM-120L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (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, Los Angeles 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 July 22, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-18157 Filed 7-29-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]
[Page 72055-72058]
[DOCID:fr26no08-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0162]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
Product Labeling: Medication Guide Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the

Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
December 26, 2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0393.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance:

Prescription Drug Product Labeling: Medication Guide Requirements (OMB
Control Number 0910-0393--Extension)

    FDA regulations require the distribution of patient labeling,
called Medication Guides, for certain prescription human drug and
biological products used primarily on an outpatient basis that pose a
serious and significant public health concern requiring distribution of
FDA-approved patient medication information. These Medication Guides
inform patients about the most important information they should know
about these products in order to use them safely and effectively.
Included is information such as the drug's approved uses,
contraindications, adverse drug reactions, and cautions for specific
populations, with a focus on why the particular product requires a
Medication Guide. These regulations are intended to improve the public
health by providing information necessary for patients to use certain
medication safely and effectively.
    The regulations contain the following reporting requirements that
are subject to the PRA. The estimates for the burden hours imposed by
the following regulations are listed in the table 1 of this document:
     21 CFR 208.20--Applicants must submit draft Medication
Guides for FDA approval according to the prescribed content and format.
     21 CFR 208.24(e)--Each authorized dispenser of a
prescription drug product for which a Medication Guide is required,
when dispensing the product to a patient or to a patient's agent, must
provide a Medication Guide directly to each patient unless an exemption
applies under Sec.  208.26 (21 CFR 208.26).
     21 CFR 208.26(a)--Requests may be submitted for exemption
or deferral from particular Medication Guide content or format
requirements.
     21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application
holders must submit changes to Medication Guides to FDA for prior
approval as supplements to their applications.
    In the Federal Register of March 18, 2008 (73 FR 14471), FDA
published a 60-day notice requesting public comment on the information
collection provisions. We received the following comments:
    (Comment 1) The comments said that FDA's estimate of the hourly
burden for pharmacists to comply with the Medication Guide requirements
is inaccurate, and that pharmacists spend significantly more time
determining whether a Medication Guide is required, tracking
appropriate Medication Guides from manufacturers or distributors,
explaining to the patient what the Medication Guide is, in addition to
patient counseling. The comments noted that FDA's estimate that a
pharmacist spends 0.0014 hours (5 seconds) to distribute each
Medication Guide remains unchanged since the December 1, 1998, final
rule entitled ``Prescription Drug Product Labeling; Medication Guide
Requirements,'' even though the Medication Guide program has continued
to expand (63 FR 66378). The comments said that FDA's estimates are
inadequate and fail to consider the operational realities pharmacists
now face in complying with the program. The comments said that pharmacy
personnel spend tens of thousands of hours obtaining and distributing
Medication Guides for each new prescription and all refills for
Medication Guide medications.
    Response: FDA agrees with the comments. However, the comments did
not suggest an alternative burden estimate for Medication Guide
distribution by pharmacists. We are increasing the burden estimate for
Sec.  208.24(e) to 3 minutes for each Medication Guide distributed by
pharmacists. If the commenters believe that this estimate is
insufficient, we request comments on why an alternative estimate would
be more accurate. We are also increasing to 25 the number of Medication
Guides that FDA receives per year under Sec.  208.20.
    (Comment 2) The comments also said that there are distributor costs
to comply with the Medication Guide requirements, and table 1 in the
March 18, 2008, Federal Register notice omitted Sec.  208.24(c), which
provides that ``Each distributor or packer that receives Medication
Guides * * * shall provide those Medication Guides * * * to each
authorized dispenser to whom it ships a container of drug product.''
The comments said that the burden to distributors and packers to
distribute Medication Guides--the process of tracking, sorting,
matching, and shipping multiple versions of Medication Guides for
multiple products--should be included in the analysis.
    Response: FDA agrees with the comments and is willing to include a
burden estimate for Sec.  208.24(c). We are requesting comments on
specific estimates for this requirement.
    (Comment 3) The remaining issues raised by the comments in response
to the March 18, 2008, Federal Register notice are generally the same
as the issues raised during FDA's public hearing on the use of
Medication Guides to distribute drug risk information to patients
(announced in the Federal Register of April 9, 2007 (72 FR 17559)) and
the same as the comments submitted to that docket. (One commenter also
referenced comments previously submitted to FDA in the ``June 2006
White Paper on Patient Safety Implications on Implementation of the
Current FDA-Mandated Medication Guide Program''). On July 2, 2007, FDA
posted a ``Summary of Public Hearing on FDA's Use of Medication Guides
to Distribute Drug Risk Information to Patients'' at http://
www.fda.gov/cder/meeting/SummaryPublicHearingMedicationGuides.htm. The
issues raised in conjunction with the public hearing, as well as the
comments summarized below, are still under consideration at FDA, and we
have not yet decided what actions we will take in response to
suggestions to modify the Medication Guide program.
    The following is a summary of the comments received on the March
18, 2008, notice; these comments do not pertain to the specific burden
estimates, but were taken into consideration by FDA.
    (Comment 4) The comments said that despite stating in the
Medication Guide final rule that FDA will use Medication Guides
sparingly, the agency continues to add new Medication Guides for drugs
in a manner inconsistent with its

original intent. The comments said that FDA intended Medication Guides
to be used only when a drug posed very serious or significant side
effects, and that it anticipated the program to be limited to a small
number of products, and not more than 5 to 10 products per year. The
comments said that by 2004, about 20 products required Medication
Guides, and that starting in 2005, FDA began requiring Medication
Guides for entire medication classes, which have grown to include
antidepressants, nonsteroidal anti-inflammatory drugs, and attention
deficit hyperactivity disorder and sleep disorder drugs. The comments
said that today almost 300 million prescriptions per year for over
10,000 separate drug products are subject to the Medication Guide
requirement, and pharmacists are dispensing Medication Guides for
substantially more drugs than originally estimated. The comments said
that this has created significant burdens for pharmacists.
    (Comment 5) The comments said that there is no evidence that a
Medication Guide is a good vehicle for risk communication, and FDA has
not provided evidence that the program is valuable to patients or
improves the safe and effective use of prescription drugs. The comments
said that given the amount of information patients are likely to
receive with their prescriptions, they face a tremendous challenge in
actually reading each piece of information. As a result, the comments
said, many patients are likely to not read any material provided to
them. Those patients that desire to gain additional information about
their therapy but are unable to read each document are placed in a
position of having to decide which document distributed to them is more
important than the other. The comments said that FDA should first
evaluate whether patients actually read the Medication Guides
distributed to them, and then assess whether the information contained
in a Medication Guide is easily understood by patients. The comments
said that many patients are likely to find the information difficult to
understand or confusing, and that many patients, especially older and
disabled patients, have cognitive impairments that may pose tremendous
challenges in understanding information contained in a Medication
Guide. The comments also asked whether the information contained in the
Medication Guide is already available to patients. For example, the
comments said that pharmacists provide counseling on the safe and
effective use of medication to their patients at the time of
dispensing, and are able to translate highly complex information about
a drug's characteristics, use parameters, side-effects and abuse
potential. The comments said this counseling by pharmacists, coupled
with other information already distributed to patients, such as
consumer medication information and the patient package insert or the
patient information sheet, raises questions about the need for the
Medication Guide program. The comments also said that FDA has not made
sufficient data available to the public to support the position that
the Medication Guide program is important to communicate risk, and FDA
should release all data from its surveys and studies for review and
comment by health care provider groups. The comments said that this
data will help generate a more accurate estimate of the burden imposed
on the public as a result of the Medication Guide program.
    (Comment 6) The comments said that pharmacists face difficulties in
obtaining Medication Guides. The comments said that some Medication
Guides are included with the product itself in the package insert, some
are provided in tear-off sheets, and some are available electronically.
The comments said that the lack of a standardized delivery model
complicates efforts to operationally streamline dispenser and
distribution systems for duplicating and providing Medication Guides.
In addition, pharmacists at times need to call a toll-free number to
order hard copies of the Medication Guides for distribution. The
comments said that FDA should establish standards for manufacturer
distribution of medication guides and establish a single toll-free
number or Internet site for pharmacies to use to obtain Medication
Guides.
    (Comment 7) The comments said that FDA should waive certain
Medication Guide formatting requirements to permit pharmacies to print
Medication Guides through existing pharmacy computer systems. The
comments said that permitting pharmacies to print Medication Guides
would enhance their distribution and will free pharmacists' time to use
for patient counseling and care. The comments also said FDA should
permit pharmacies to e-mail Medication Guides to their patients.
    (Comment 8) The comments said that a single, uniform Medication
Guide should be used for all brand and generic versions of the same
drug, or for drugs within the same therapeutic class, with similar risk
warnings, and that each brand and generic manufacturer of the same drug
or the same class of drug should not have to produce its own Medication
Guide. The comments said that for medications that have unique and rare
side effects that are not shared with the other drugs in the same
class, FDA should consider having a class Medication Guide that
specifically lists per paragraph each drug in the class while
highlighting risk information that is unique to certain medications
within that class.
    (Comment 9) The comments said that Medication Guides should only be
required the first time a prescription is filled, and thereafter only
when requested by a patient for that prescription's refill.
    (Comment 10) The comments said to eliminate duplication and enhance
the usefulness of patient information, a single, manufacturer-produced,
patient-oriented FDA-approved Medication Information Document should be
developed for each drug that currently requires a Medication Guide.
This single document could combine consumer medication information and
Medication Guide information. The comments said they are willing to
work with FDA and other interested stakeholders in designing and
implementing such a program. Alternatively, the comments said that FDA
should standardize the information that must be included in the
Medication Guide and require a consistent format, look, and feel to
Medication Guide information.
    (Comment 11) The comments said that physicians and other providers
should give the Medication Guide directly to the patient at the time
the prescription is written. The comments said the physician is in the
best position to discuss not only the possible risks associated with
the medication but to also discuss alternative therapies if necessary.
The comments also said that FDA should consider ways that prescribers
could be better informed about medications that require Medication
Guides.
    (Comment 12) The comments said that the Medication Guide
requirements were imposed on distribution and dispensing entities that
were neither prepared nor operationally structured (for example, lack
of space, staff, and equipment) to prepare and provide for their
dissemination.
    Based on the comments in ``Comment (1)'' of this document, FDA has
revised the estimated annual reporting burden as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
208.20                            25                  1                 25                320              8,000
----------------------------------------------------------------------------------------------------------------
208.24(e)                     59,000              5,000        295,000,000               0.05         14,750,000
----------------------------------------------------------------------------------------------------------------
208.26(a)                          1                  1                  1                  4                  4
----------------------------------------------------------------------------------------------------------------
314.70 (b)(3)(ii)                  5                  1                  5                 72                360
 and 601.12(f)
----------------------------------------------------------------------------------------------------------------
Total                                                                                14,758,364
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28064 Filed 11-25-08; 8:45 am]

BILLING CODE 4160-01-S


                                                  Energy Data Verification Form                                                       OMB Control No. 2060-0347 Due to EPA 4/17/2015 Step 1: Verify building name and address Property Name (note that this is the name that will be used on 		Yes, the property name is correct. the recognition certificate and any outreach materials): 			 No, this is incorrect. I would like the name of the property 3190 Fairview Park	to be listed as:

Portfolio Manager Building ID#:					____________________________  1345536								 Yes, the building address is correct 								 No, this is incorrect.  I have corrected the address in Portfolio Property Address:							Manager to read: 3190 Fairview Park Drive, Falls Church, Virginia 22042	___________________________

Step 2: Verify gross floor area: 260924 sq. ft.

Does this square footage include all supporting functions such as kitchens and break rooms used by staff, storage areas, administrative areas, elevators, stairwells, atriums, vent shafts, etc.?

Also note that existing atriums should only include the base floor area that they occupy. Interstitial (plenum) space between the floors should not be included in the total.

Finally, gross floor area is not the same as leasable space. Leasable space is a subset of gross floor area.

 Yes, this is correct.

 No, this is incorrect. I have added and/or corrected this data in my Portfolio Manager account, and resubmitted my property data using this link: https://portfoliomanager.energystar.gov/pm/reports/dataRequest/accept/41005f7b-d45e-4039-bd34-34fef7cf633e

Step 3: Verify meter data

Verify that each energy meter entry that appears in Portfolio Manager for the baseline and competition periods (January through December of 2013 and 2014) is correct and matches the actual meter readings as reported by the utility.

Also verify that ALL energy use associated with this property is represented in Portfolio Manager, and that no meter is shared with another property. Also verify that the property was operating business as usual throughout the competition period.  Yes, all meters are represented and all entries are correct.

 No, one or more meters, or meter entries, is incorrect or missing. I have added and/or corrected them in my Portfolio Manager account, and resubmitted my property data using this link:    https://portfoliomanager.energystar.gov/pm/reports/dataRequest/accept/41005f7b-d45e-4039-bd34-34fef7cf633e

              Professional Engineer or Registered Architect Stamp

Step 4: Signature of Professional Engineer or Registered ArchitectI certify that the information contained on this form is true and accurate to  the best of my knowledge.

Name: _______________________________	Date: ________________

Signature: ____________________________________________________

Step 5: Send form to EPA Send a signed, scanned PDF of this document to EPA by April 17.  If this is a  EPA Form No. 5900-375 hardship, please contact EPA to make other arrangements prior to April 17.  All correspondence can be sent to<EMAIL_ADDRESS>The public reporting and recordkeeping burden for this collection of information is estimated to average 1.5 hour per response.  Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460.  Include the OMB control number in any correspondence.  Do not send the completed form to this address.

EPA Form No. 5900-375


[Federal Register: November 2, 2007 (Volume 72, Number 212)]
[Rules and Regulations]
[Page 62105-62107]
[DOCID:fr02no07-2]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 23

[Docket No. 274, Special Condition 23-214-SC]

Special Conditions; Cessna Aircraft Company Model 208B, Garmin
G1000; Protection of Systems for High Intensity Radiated Fields (HIRF)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued to Cessna Aircraft
Company, for an amended type certificate for the Model 208B airplane.
This airplane will have novel and unusual design features when compared
to the state of technology envisaged in the applicable airworthiness
standards. These novel and unusual design features include the
installation of electronic flight instrument system (EFIS) displays
model G1000 manufactured by Garmin for which the applicable regulations
do not contain adequate or appropriate airworthiness standards for the
protection of these systems from the effects of high intensity radiated
fields (HIRF). These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to the airworthiness standards applicable to
these airplanes.

DATES: The effective date of these special conditions is October 26,
2007. Comments must be received on or before December 3, 2007.

ADDRESSES: Comments may be mailed in duplicate to: Federal Aviation
Administration, Regional Counsel, ACE-7, Attention: Rules Docket Clerk,
Docket No. CE274, Room 506, 901 Locust, Kansas City, Missouri 64106.
All

comments must be marked: Docket No. CE274. Comments may be inspected in
the Rules Docket weekdays, except Federal holidays, between 7:30 a.m.
and 4 p.m.

FOR FURTHER INFORMATION CONTACT: Jim Brady, Aerospace Engineer,
Standards Office (ACE-111), Small Airplane Directorate, Aircraft
Certification Service, Federal Aviation Administration, 901 Locust,
Room 301, Kansas City, Missouri 64106; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA has determined that notice and
opportunity for prior public comment hereon are impracticable because
these procedures would significantly delay issuance of the approval
design and thus delivery of the affected aircraft. In addition, the
substance of these special conditions has been subject to the public
comment process in several prior instances with no substantive comments
received. The FAA, therefore, finds that good cause exists for making
these special conditions effective upon issuance.

Comments Invited

    Interested persons are invited to submit such written data, views,
or arguments as they may desire. Communications should identify the
regulatory docket or notice number and be submitted in duplicate to the
address specified above. All communications received on or before the
closing date for comments will be considered by the Administrator. The
special conditions may be changed in light of the comments received.
All comments received will be available in the Rules Docket for
examination by interested persons, both before and after the closing
date for comments. A report summarizing each substantive public contact
with FAA personnel concerning this rulemaking will be filed in the
docket. Commenters wishing the FAA to acknowledge receipt of their
comments submitted in response to this notice must include a self-
addressed, stamped postcard on which the following statement is made:
``Comments to Docket No. 274.'' The postcard will be date stamped and
returned to the commenter.

Background

    On January 29, 2007, Cessna Aircraft Company, applied to the FAA
for a new Amended Type Certificate for the project airplane. The Model
208B is currently approved under TC No. A37CE. The proposed
modification incorporates a novel or unusual design feature, such as
digital avionics consisting of an EFIS that is vulnerable to HIRF
external to the airplane.

Type Certification Basis

    Under the provisions of 14 CFR part 21, Sec.  21.101, Cessna
Aircraft Company must show that the project aircraft meets the
following provisions, or the applicable regulations in effect on the
date of application for the change to the project:
    14 CFR part 23 of the Federal Aviation Regulations, effective
February 1, 1965, as amended by Amendments 23-1 through 23-28; 14 CFR
part 36, effective December 1, 1969, as amended by Amendments 36-1
through 36-18; SFAR 27 effective February 1, 1974, as amended by
Amendments 27-1 through 27-4. Special Conditions as follows; 23-ACE-3:
Dynamic Evaluation, Engine Installation; Equivalent Level of Safety as
follows: 14 CFR part 23, Sec.  23.955(f)(2), Fuel System. Compliance
with ice protection has been demonstrated in accordance with Sec.
23.1419 when ice protection equipment is installed in accordance with
the airplane equipment list and is operated per the Pilot's Operating
Handbook and FAA Approved Airplane Flight Manual; as applicable, and
Sec.  23.1301 of Amendment 23-20; Sec. Sec.  23.1309, 23.1311, and
23.1321 of Amendment 23-49; and Sec.  23.1322 of Amendment 23-43;
exemptions, if any; and the special conditions adopted by this
rulemaking action.

Discussion

    If the Administrator finds that the applicable airworthiness
standards do not contain adequate or appropriate safety standards for
the Model 208B because of novel or unusual design features of an
airplane, special conditions are prescribed under the provisions of
Sec.  21.16.
    Special conditions, as appropriate, as defined in Sec.  11.19, are
issued in accordance with Sec.  11.38 after public notice and become
part of the type certification basis in accordance with Sec.
21.101(b)(2).
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model already included on the same type
certificate to incorporate the same novel or unusual design feature,
the special conditions would also apply to the other model under the
provisions of Sec.  21.101.

Novel or Unusual Design Features

    Cessna Aircraft Company plans to incorporate certain novel and
unusual design features into an airplane for which the airworthiness
standards do not contain adequate or appropriate safety standards for
protection from the effects of HIRF. These features include EFIS, which
are susceptible to the HIRF environment, that were not envisaged by the
existing regulations for this type of airplane.
    Protection of Systems from High Intensity Radiated Fields (HIRF):
Recent advances in technology have given rise to the application in
aircraft designs of advanced electrical and electronic systems that
perform functions required for continued safe flight and landing. Due
to the use of sensitive solid state advanced components in analog and
digital electronics circuits, these advanced systems are readily
responsive to the transient effects of induced electrical current and
voltage caused by the HIRF. The HIRF can degrade electronic systems
performance by damaging components or upsetting system functions.
    Furthermore, the HIRF environment has undergone a transformation
that was not foreseen when the current requirements were developed.
Higher energy levels are radiated from transmitters that are used for
radar, radio, and television. Also, the number of transmitters has
increased significantly. There is also uncertainty concerning the
effectiveness of airframe shielding for HIRF. Furthermore, coupling to
cockpit-installed equipment through the cockpit window apertures is
undefined.
    The combined effect of the technological advances in airplane
design and the changing environment has resulted in an increased level
of vulnerability of electrical and electronic systems required for the
continued safe flight and landing of the airplane. Effective measures
against the effects of exposure to HIRF must be provided by the design
and installation of these systems. The accepted maximum energy levels
in which civilian airplane system installations must be capable of
operating safely are based on surveys and analysis of existing radio
frequency emitters. These special conditions require that the airplane
be evaluated under these energy levels for the protection of the
electronic system and its associated wiring harness. These external
threat levels, which are lower than previous required values, are
believed to represent the worst case to which an airplane would be
exposed in the operating environment.
    These special conditions require qualification of systems that
perform critical functions, as installed in aircraft, to the defined
HIRF environment in paragraph 1 or, as an option to a fixed

value using laboratory tests, in paragraph 2, as follows:
    (1) The applicant may demonstrate that the operation and
operational capability of the installed electrical and electronic
systems that perform critical functions are not adversely affected when
the aircraft is exposed to the HIRF environment defined below:

------------------------------------------------------------------------
                                                       Field strength
                                                      (volts per meter)
                     Frequency                     ---------------------
                                                       Peak     Average
------------------------------------------------------------------------
10 kHz-100 kHz....................................         50         50
100 kHz-500 kHz...................................         50         50
500 kHz-2 MHz.....................................         50         50
2 MHz-30 MHz......................................        100        100
30 MHz-70 MHz.....................................         50         50
70 MHz-100 MHz....................................         50         50
100 MHz-200 MHz...................................        100        100
200 MHz-400 MHz...................................        100        100
400 MHz-700 MHz...................................        700         50
700 MHz-1 GHz.....................................        700        100
1 GHz-2 GHz.......................................       2000        200
2 GHz-4 GHz.......................................       3000        200
4 GHz-6 GHz.......................................       3000        200
6 GHz-8 GHz.......................................       1000        200
8 GHz-12 GHz......................................       3000        300
12 GHz-18 GHz.....................................       2000        200
18 GHz-40 GHz.....................................        600        200
------------------------------------------------------------------------
The field strengths are expressed in terms of peak root-mean-square
  (rms) values.

or,

    (2) The applicant may demonstrate by a system test and analysis
that the electrical and electronic systems that perform critical
functions can withstand a minimum threat of 100 volts per meter (RMS),
electrical field strength, from 10 kHz to 18 GHz. When using this test
to show compliance with the HIRF requirements, no credit is given for
signal attenuation due to installation.
    A preliminary hazard analysis must be performed by the applicant,
for approval by the FAA, to identify either electrical or electronic
systems that perform critical functions. The term ``critical'' means
those functions whose failure would contribute to, or cause, a failure
condition that would prevent the continued safe flight and landing of
the airplane. The systems identified by the hazard analysis that
perform critical functions are candidates for the application of HIRF
requirements. A system may perform both critical and non-critical
functions. Primary electronic flight display systems, and their
associated components, perform critical functions such as attitude,
altitude, and airspeed indication. The HIRF requirements apply only to
critical functions.
    Compliance with HIRF requirements may be demonstrated by tests,
analysis, models, similarity with existing systems, or any combination
of these. Service experience alone is not acceptable since normal
flight operations may not include an exposure to the HIRF environment.
Reliance on a system with similar design features for redundancy as a
means of protection against the effects of external HIRF is generally
insufficient since all elements of a redundant system are likely to be
exposed to the fields concurrently.

Applicability

    As discussed above, these special conditions are applicable to the
Model 208B, Garmin G1000 project. Should Cessna Aircraft Company apply
at a later date for an amended or supplemental type certificate to
modify any other model on the same type certificate to incorporate the
same novel or unusual design feature, the special conditions would
apply to that model as well under the provisions of Sec.  21.101.

Conclusion

    This action affects only certain novel or unusual design features
on one model of airplane. It is not a rule of general applicability and
affects only the applicant who applied to the FAA for approval of these
features on the airplane.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. For this reason, and because a
delay would significantly affect the certification of the airplane,
which is imminent, the FAA has determined that prior public notice and
comment are unnecessary and impracticable, and good cause exists for
adopting these special conditions upon issuance. The FAA is requesting
comments to allow interested persons to submit views that may not have
been submitted in response to the prior opportunities for comment
described above.

List of Subjects in 14 CFR Part 23

    Aircraft, Aviation safety, Signs and symbols.

Citation

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and
21.101; and 14 CFR 11.38 and 11.19.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Model 208B, Garmin G1000 project
airplane modified by Cessna Aircraft Company to add an EFIS.
    1. Protection of Electrical and Electronic Systems from High
Intensity Radiated Fields (HIRF). Each system that performs critical
functions must be designed and installed to ensure that the operations,
and operational capabilities of these systems to perform critical
functions, are not adversely affected when the airplane is exposed to
high intensity radiated electromagnetic fields external to the
airplane.
    2. For the purpose of these special conditions, the following
definition applies: Critical Functions: Functions whose failure would
contribute to, or cause, a failure condition that would prevent the
continued safe flight and landing of the airplane.

    Issued in Kansas City, Missouri on October 26, 2007.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft Certification Service.
 [FR Doc. E7-21599 Filed 11-1-07; 8:45 am]

BILLING CODE 4910-13-P