[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Rules and Regulations]
[Pages 34031-34034]
[FR Doc No: 2018-14809]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0166; Product Identifier 2017-NM-169-AD; Amendment
39-19331; AD 2018-14-11]
RIN 2120-AA64

Airworthiness Directives; ATR-GIE Avions de Transport
R[eacute]gional Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
ATR-GIE Avions de Transport R[eacute]gional Model ATR72 airplanes. This
AD was prompted by a determination that more restrictive maintenance
instructions and airworthiness limitations are necessary. This AD
requires revising the maintenance or inspection program, as applicable,
to incorporate new or revised maintenance instructions and
airworthiness limitations. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective August 23, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 23,
2018.

ADDRESSES: For service information identified in this final rule,
contact ATR-GIE Avions de Transport R[eacute]gional, 1, All[eacute]e
Pierre Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62
21; fax +33 (0) 5 62 21 67 18; email aircraft.com">[email protected]aircraft.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0166.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0166; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Section, Transport Standards Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all ATR-GIE Avions de
Transport R[eacute]gional Model ATR72 airplanes. The NPRM published in
the Federal Register on March 22, 2018 (83 FR 12508). The NPRM was
prompted by a determination that more restrictive maintenance
instructions and airworthiness limitations are necessary. The NPRM
proposed to require revising the maintenance or inspection program, as
applicable, to incorporate new or revised maintenance instructions and
airworthiness limitations. We are issuing this AD to address fatigue
cracking, damage, and corrosion in principal structural elements, which
could result in reduced structural integrity of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2017-0223R1, dated December 15, 2017 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all ATR-GIE Avions de Transport
R[eacute]gional Model ATR72 airplanes. The MCAI states:

    The airworthiness limitations and certification maintenance
requirements (CMR) for ATR aeroplanes, which are approved by EASA,
are currently defined and published in the ATR72-101/-201/-102/-202/
-211/-212/-212A Time Limits (TL) document. These instructions have
been identified as mandatory actions for continued airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    Consequently, ATR published Revision 15 of the ATR72-101/-201/-
102/-202/-211/-212/-212A TL document, which contains new and/or more
restrictive CMRs and airworthiness limitation tasks.
    For the reasons described above, this [EASA] AD requires
accomplishment of the actions specified in the ATR72-101/-201/-102/-
202/-211/-212/-212A TL document Revision 15, hereafter referred to
as `the TLD' in this [EASA] AD.
    This [EASA] AD, in conjunction with two other [EASA] ADs related
to ATR42-200/-300/-320 (EASA AD 2017-0221) and ATR42-400/-500 (EASA
AD 2017-0222) aeroplanes, retains the requirements of EASA AD 2009-
0241 and EASA AD 2012-0193. Once all these three ADs are effective,
EASA will cancel EASA AD 2009-0242 and EASA AD 2012-0193.
    This [EASA] AD is revised to provide the correct issue date (02
May 2017) of the TLD. The original [EASA] AD inadvertently
referenced the EASA approval date for that document.

    This AD requires revising the maintenance or inspection program to
incorporate certain maintenance instructions and airworthiness
limitations. The unsafe condition is fatigue cracking, damage, and
corrosion in principal structural elements, which could result in
reduced structural integrity of the airplane. You may examine the MCAI
in the AD docket on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2018-0166.

Comment

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comment received on the
NPRM and the FAA's response.

Request To Correct Typographical Error

    Empire Airlines asked that airworthiness limitations (AWL) task
number 572401-1, identified in table 1 to paragraph (h) of this AD, be
changed to AWL task number 572402-1. Empire Airlines stated that AWL
task number 572401-1 corresponds to maintenance review board report
(MRBR) task numbers ZL-500-01-1 and ZL-600-01-1; and the MRBR task
numbers ZL-520-01-1 and ZL-620-01-1, identified in table 1 to paragraph
(h) of this AD, correspond with AWL task number 572402-1. Empire
Airlines provided substantiation data to this effect.
    We agree with the commenter that a typographical error was made in
the AWL task number 572401-1, identified in table 1 to paragraph (h) of
this AD. We have corrected this error accordingly.

Airworthiness Limitations Based on Type Design

    The FAA recently became aware of an issue related to the
applicability of ADs that require incorporation of an airworthiness
limitations section (ALS) revision into an operator's maintenance or
inspection program.
    Typically, when these types of ADs are issued by civil aviation
authorities of other countries, they apply to all airplanes covered
under an identified type certificate (TC). The corresponding FAA AD
typically retains applicability to all of those airplanes.
    In addition, U.S. operators must operate their airplanes in an
airworthy condition, in accordance with 14 CFR 91.7(a). Included in
this obligation is the requirement to perform any maintenance or
inspections specified in the ALS, and in accordance with the ALS as
specified in 14 CFR 43.16 and 91.403(c), unless an alternative has been
approved by the FAA.
    When a type certificate is issued for a type design, the specific
ALS, including revisions, is a part of that type design, as specified
in 14 CFR 21.31(c).
    The sum effect of these operational and maintenance requirements is
an obligation to comply with the ALS defined in the type design
referenced in the manufacturer's conformity statement. This obligation
may introduce a conflict with an AD that requires a specific ALS
revision if new airplanes are delivered with a later revision as part
of their type design.
    To address this conflict, the FAA has approved alternative methods
of compliance (AMOCs) that allow operators to incorporate the most
recent ALS revision into their maintenance/inspection programs, in lieu
of the ALS revision required by the AD. This eliminates the conflict
and enables the operator to comply with both the AD and the type
design.
    However, compliance with AMOCs is normally optional, and we
recently became aware that some operators choose to retain the AD-
mandated ALS revision in their fleet-wide maintenance/inspection
programs, including those for new airplanes delivered with later ALS
revisions, to help standardize the maintenance of the fleet. To ensure
that operators comply with the applicable ALS revision for newly
delivered airplanes containing a later revision than that specified in
an AD, we plan to limit the applicability of ADs that mandate ALS
revisions to those airplanes that are subject to an earlier revision of
the ALS, either as part of the type design or as mandated by an earlier
AD.
    This AD therefore applies to ATR-GIE Avions de Transport
R[eacute]gional Model ATR72-101, -102, -201, -202, -211, -212, and -
212A airplanes with an original certificate of airworthiness or
original export certificate of airworthiness that was issued on or
before the date of approval of the ALS revision identified in this AD.
Operators of airplanes with an original certificate of airworthiness or
original export certificate of airworthiness issued after that date
must comply with the airworthiness limitations specified as part of the
approved type design and referenced on the type certificate data sheet.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this final rule with the change described previously and minor
editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    ATR-GIE Avions de Transport R[eacute]gional has issued the ATR72
Time Limits document, Revision 15, dated May 2, 2017. This service
information describes preventive maintenance requirements and includes
updated limitations, tasks, thresholds and intervals to be incorporated
into the maintenance or inspection program. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 26 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:
    We have determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although we
recognize that this number may vary from operator to operator. In the
past, we have estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), we have determined that a per-
operator estimate is more accurate than a per-airplane estimate.
Therefore, we estimate the total cost per operator to be $7,650 (90
work-hours x $85 per work-hour).

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

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

on a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-14-11 ATR-GIE Avions de Transport R[eacute]gional: Amendment
39-19331; Docket No. FAA-2018-0166; Product Identifier 2017-NM-169-
AD.

(a) Effective Date

    This AD is effective August 23, 2018.

(b) Affected ADs

    This AD affects AD 2000-23-26, Amendment 39-11999 (65 FR 70775,
November 28, 2000) (``AD 2000-23-26''); and AD 2008-04-19 R1,
Amendment 39-16069 (74 FR 56713, November 3, 2009) (``AD 2008-04-19
R1'').

(c) Applicability

    This AD applies to ATR-GIE Avions de Transport R[eacute]gional
Model ATR72-101, -102, -201, -202, -211, -212, and -212A airplanes,
certificated in any category; with an original certificate of
airworthiness or original export certificate of airworthiness issued
on or before May 2, 2017.

(d) Subject

    Air Transport Association (ATA) of America Code 05.

(e) Reason

    This AD was prompted by a determination that more restrictive
maintenance instructions and airworthiness limitations are
necessary. We are issuing this AD to prevent fatigue cracking,
damage, and corrosion in principal structural elements, which could
result in reduced structural integrity of the airplane.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 90 days after the effective date of this AD: Revise the
maintenance or inspection program, as applicable, to incorporate the
limitations and tasks at the applicable thresholds and intervals
specified in the Airworthiness Limitations Section (ALS), of the
ATR72 Time Limits document, Revision 15, dated May 2, 2017. The
initial compliance time for accomplishing the tasks specified in the
ALS of the ATR72 Time Limits document, Revision 15, dated May 2,
2017, is at the applicable time specified in the ALS, or within 90
days after the effective date of this AD, whichever occurs later,
except for the tasks identified in paragraph (h) of this AD.

(h) Initial Compliance Times for Certain Tasks

    For accomplishing airworthiness limitations (AWL) and
certification maintenance requirement (CMR)/maintenance significant
item (MSI) tasks identified in table 1 and table 2 to paragraph (h)
of this AD, the initial compliance time is at the applicable time
specified in the ALS of the ATR72 Time Limits document, Revision 15,
dated May 2, 2017, or at the applicable compliance time in table 1
or table 2 to paragraph (h) of this AD, whichever occurs later.
[GRAPHIC] [TIFF OMITTED] TR19JY18.004

[GRAPHIC] [TIFF OMITTED] TR19JY18.008

(i) No Alternative Actions, and Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (g) of this AD, no alternative actions (e.g.,
inspections), or intervals, may be used unless the actions and/or
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (k)(1) of
this AD.

(j) Terminating Action

    Accomplishing paragraph (g) of this AD terminates all
requirements of AD 2000-23-26 and AD 2008-04-19 R1.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR

39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Branch, send it to the
attention of the person identified in paragraph (l)(2) of this AD.
Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0223R1, dated December 15, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0166.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) ATR72 Time Limits document, Revision 15, dated May 2, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact ATR-
GIE Avions de Transport R[eacute]gional, 1, All[eacute]e Pierre
Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21;
fax +33 (0) 5 62 21 67 18; email aircraft.com">[email protected]aircraft.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on July 3, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-14809 Filed 7-18-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9480-9482]
[FR Doc No: 2010-4257]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket ID. FMCSA-2009-0011]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemptions; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 19 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. If granted, the exemptions would enable these
individuals to qualify as drivers of commercial motor vehicles (CMVs)
in interstate commerce without meeting the Federal vision standard.

DATES: Comments must be received on or before April 1, 2010.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2009-0011 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket ID for
this Notice. Note that DOT posts all comments received without change
to http://www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.'' FMCSA can renew exemptions
at the end of each 2-year period. The 19 individuals listed in this
notice have each requested an exemption from the vision requirement in
49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate
commerce. Accordingly, the Agency will evaluate the qualifications of
each applicant to determine whether granting an exemption will achieve
the required level of safety mandated by statute.

Qualifications of Applicants

Dwight A. Bennett

    Mr. Bennett, age 33, has had amblyopia in his right eye since
birth. The best corrected visual acuity in his right eye is count-
finger vision and in his left eye, 20/20. Following an examination in
2009, his optometrist noted, ``Patient has sufficient vision to operate
a commercial vehicle according to data shown today.'' Mr. Bennett
reported that he has driven straight

trucks for 12 years, accumulating 480,000 miles. He holds a Class C
operator's license from Maryland. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Arthur W. Boatright, Jr.

    Mr. Boatright, 49, has had aphakia, amblyopia and corneal scarring
in his left eye since childhood. The best corrected visual acuity in
his right eye is 20/15 and in his left eye, count-finger vision.
Following an examination in 2009, his optometrist noted, ``In my
medical opinion and from his driving history, I believe his condition
is stable at this time and he can safely operate a commercial
vehicle.'' Mr. Boatright reported that he has driven tractor-trailer
combinations for 17 years, accumulating 884,000 miles. He holds a Class
A operator's license from North Carolina. His driving record for the
last 3 years shows one crash, for which he was not cited, and no
convictions for moving violations in a CMV.

Larry D. Buchanan

    Mr. Buchanan, 56, has a prosthetic left eye due to a traumatic
injury sustained in 1961. The best corrected visual acuity in his right
eye is 20/20. Following an examination in 2009, his optometrist noted,
``It is my professional opinion that Larry can and does operate
machinery, as well as a motor vehicle.'' Mr. Buchanan reported that he
has driven straight trucks for 18 years, accumulating 450,000 miles. He
holds a Class A CDL from New Mexico. His driving record for the last 3
years shows one crash, for which he was not cited, and no convictions
for moving violations in a CMV.

Chad L. Burnham

    Mr. Burnham, 38, has a prosthetic right eye due to a traumatic
injury sustained at age 12. The best corrected visual acuity in his
left eye is 20/20. Following an examination in 2009, his optometrist
noted, ``In my medical opinion Chad Burnham has sufficient vision to
operate a commercial vehicle.'' Mr. Burnham reported that he has driven
straight trucks for 21 years, accumulating 630,000 miles and tractor-
trailer combinations for 8 years, accumulating 200,000 miles. He holds
a Class A CDL from Maine. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Chadwick S. Chambers

    Mr. Chambers, 34, has had amblyopia in his right eye since birth.
The best corrected visual acuity in his right eye is 20/200 and in his
left eye, 20/20. Following an examination in 2009, his ophthalmologist
noted, ``I certify in my medical opinion Mr. Chambers has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Chambers reported that he has driven straight trucks for
4 years, accumulating 20,000 miles and tractor-trailer combinations for
4 years, accumulating 12,000 miles. He holds a Class D operator's
license from Alabama. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Loren D. Chapman

    Mr. Chapman, 50, has had retinal detachment in his left eye since
2005. The best corrected visual acuity in his right eye is 20/20 and in
his left eye, 20/100. Following an examination in 2009, his optometrist
noted, ``It continues to be my personal opinion that Mr. Loren Chapman
can perform all the visual tasks and demands placed on him to safely
operate a commercial vehicle.'' Mr. Chapman reported that he has driven
tractor-trailer combinations for 23 years, accumulating 1.8 million
miles. He holds a Class A CDL from Minnesota. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

David A. Christenson

    Mr. Christenson, 71, has a prosthetic left eye due to a congenital
tumor. The best corrected visual acuity in his right eye is 20/25.
Following an examination in 2009, his optometrist noted, ``The patient
has sufficient vision to perform the driving tasks to operate a
commercial vehicle.'' Mr. Christenson reported that he has driven
tractor-trailer combinations for 10 years, accumulating 1 million
miles. He holds a Class A CDL from Nevada. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Charles R. Everett

    Mr. Everett, 45, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, 20/200. Following an examination in 2009, his optometrist
noted, ``I am confident his vision is sufficient to operate a
commercial vehicle.'' Mr. Everett reported that he has driven straight
trucks for 10 years, accumulating 130,000 miles. He holds a Class D
operator's license from Tennessee. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Julian R. Hall

    Mr. Hall, 66, has corneal scarring in his right eye due to a
traumatic injury sustained as a child. The best corrected visual acuity
in his right eye is light-perception only and in his left eye, 20/20.
Following an examination in 2009, his optometrist noted, ``In my
opinion, due to Mr. Hall's visual stability, clean driving record, and
visual fields, he is very capable to operate a commercial vehicle.''
Mr. Hall reported that he has driven buses for 33 years, accumulating
990,000 miles. He holds a Class B CDL from Texas. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Claude R. Havener

    Mr. Havener, 49, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, 20/200. Following an examination in 2009, his optometrist
noted, ``As long as he obeys the traffic law and drives carefully,
there is sufficient vision to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Havener reported that he has driven
straight trucks for 5 years, accumulating 93,600 miles. He holds a
Class B CDL from New York. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Paul K. Leger

    Mr. Leger, 46, has had retinal detachment in his left eye since
1996. The best corrected visual acuity in his right eye is 20/20 and in
his left eye, hand-motion vision. Following an examination in 2009, his
ophthalmologist noted, ``Mr. Leger qualifies to have sufficient vision
to perform driving tasks required to operate a commercial vehicle.''
Mr. Leger reported that he has driven straight trucks for 9 years,
accumulating 360,000 miles. He holds a Class B CDL from New Hampshire.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Robert L. Postell

    Mr. Postell, 46, has a prosthetic left eye due to a traumatic
injury sustained during childhood. The best corrected visual acuity in
his right eye is 20/20. Following an examination in 2009, his
optometrist noted, ``I certify that in my medical opinion, Mr. Postell
has sufficient vision to perform the driving

tasks required to operate a commercial vehicle.'' Mr. Postell reported
that he has driven straight trucks for 22 years, accumulating 704,000
miles and tractor-trailer combinations for 21 years, accumulating
735,000 miles. He holds a Class A CDL from Georgia. His driving record
for the last 3 years shows no crashes and one conviction for a moving
violation in a CMV, failure to stay in the proper lane.

Martin L. Reyes

    Mr. Reyes, 45, has retinal scarring in his left eye. The best
corrected visual acuity in his right eye is 20/20 and in his left eye,
20/200. Following an examination in 2009, his ophthalmologist noted,
``In my professional opinion he has adapted well to his vision deficit
and I feel professionally that he should be able to perform all his
duties as an electrician, including working at heights and driving a
commercial vehicle without any problems.'' Mr. Reyes reported that he
has driven straight trucks for 17 years, accumulating 297,500 miles. He
holds a Class A CDL from Illinois. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Gerald L. Rush, Jr.

    Mr. Rush, 50, has a prosthetic left eye due to a traumatic injury
sustained in 1989. The best corrected visual acuity in his right eye is
20/30. Following an examination in 2009, his optometrist noted, ``In my
medical opinion, the patient has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Rush
reported that he has driven straight trucks for 29 years, accumulating
1.2 million miles. He holds a Class B CDL from New Jersey. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Wayne J. Savage

    Mr. Savage, 46, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/15 and in his
left eye, 20/200. Following an examination in 2009, his optometrist
noted, ``In my opinion, Mr. Savage certainly has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Savage reported that he has driven straight trucks for 20 years,
accumulating 800,000 miles. He holds a Class B CDL from Virginia. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Gary F. Segur

    Mr. Segur, 53, has a prosthetic right eye due to a traumatic injury
sustained in 2004. The best corrected visual acuity in his left eye is
20/20. Following an examination in 2009, his optometrist noted, ``I
believe that Mr. Segur has suitable vision to drive a commercial
vehicle.'' Mr. Segur reported that he has driven straight trucks for 37
years, accumulating 925,000 miles, tractor-trailer combinations for 35
years, accumulating 1.7 million miles, and buses for 3 years,
accumulating 42,000 miles. He holds a Class A CDL from Michigan. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Alan T. Watterson

    Mr. Watterson, 58, has a prosthetic right eye due to a traumatic
injury sustained 30 years ago. The best corrected visual acuity in his
left eye is 20/20. Following an examination in 2009, his
ophthalmologist noted, ``In my medical opinion, he has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Watterson reported that he has driven straight trucks
for 33 years, accumulating 990,000 miles and tractor-trailer
combinations for 33 years, accumulating 660,000 miles. He holds a Class
A CDL from Massachusetts. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

David E. Williford

    Mr. Williford, 61, has had amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/20
and in his left eye, 20/50. Following an examination in 2009, his
optometrist noted, ``In my medical opinion, Mr. Williford has
sufficient visual acuity, color vision and peripheral vision to perform
the driving tasks required to operate a commercial vehicle.'' Mr.
Williford reported that he has driven straight trucks for 4 years,
accumulating 320,000 miles and tractor-trailer combinations for 1 year,
accumulating 80,000 miles. He holds a Class A CDL from North Carolina.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Larry W. Winkler

    Mr. Winkler, 59, has a prosthetic left eye due to a traumatic
injury sustained in 1997. The best corrected visual acuity in his right
eye is 20/20. Following an examination in 2009, his optometrist noted,
``In my medical opinion, Larry Winkler is stable with no anticipated
changes. He has sufficient vision to operate a commercial vehicle.''
Mr. Winkler reported that he has driven straight trucks for 26\1/2\
years, accumulating 715,500 miles. He holds a Class A CDL from
Missouri. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business April 1, 2010. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: February 22, 2010.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2010-4257 Filed 3-1-10; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Notices]
[Page 23721-23727]
[DOCID:fr20my09-67]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0546]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Data
Collection Using MedWatch\Plus\ Portal and Rational Questionnaire

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 June
19, 2009.

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-NEW and
title ``Electronic Data Collection Using MedWatch\Plus\ Portal and
Rational Questionnaire.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, 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.

Electronic Data Collection Using MedWatch\Plus\ Portal and Rational
Questionnaire

    FDA is implementing electronic data collection to improve adverse
event reporting across the agency. FDA's current processes and systems
for adverse event reporting vary across its centers and are not optimal
for the efficient collection of voluntary and mandatory adverse event
reports, product problems/consumer complaints, or errors associated
with the use of FDA-regulated products. Current FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and 1932a) are an outgrowth of a paper
process era and frequently result in the submission of inconsistent and
poor quality information. In addition, the agency is limited in its
ability to modify its paper forms to keep pace with changes in the
types of regulated products and the information necessary to meet
evolving standards to ensure post market safety. Further, the existing
supporting business processes are not able to efficiently manage the
information being provided on the paper forms. For example, the upfront
data integrity constraints on required (vital) data limit the extent of
reviewable information on items such as reporter identification of one
or more subject product types (animal and human food/feed, drug--animal
or human, device, etc.), reporter name, date of occurrence, related
details, and followup information. Data collected on paper forms must
be manually transcribed into an electronic format for usability and
analysis. Furthermore, these forms are not very intuitive for a casual
reporter (e.g., consumers of FDA-regulated products), that is, the
paper forms lack the features available in an electronic system that
assist a new user in understanding what information is being requested.
    FDA has launched the development and implementation of a new
electronic system for collecting, submitting and processing adverse
event reports and other safety information for all FDA-regulated
products. This new system, MedWatch\Plus\ Portal, will enhance the
current MedWatch collection system and integrate the agency's existing
safety reporting systems into the various FDA Adverse Event Report
Systems (FAERS). FAERS will enable FDA staff to more efficiently
analyze thousands of safety reports and to identify potential safety
problems earlier than would be possible using paper forms. The
MedWatch\Plus\ Portal provides one central point-of-entry for persons
submitting information to FDA. The agency believes that one central
point-of-entry will better enable persons to submit their information.
In addition, mandatory reporters will be able to use the Internet to
access the MedWatch\Plus\ Portal to report safety concerns about
dietary supplements, nonprescription drugs, and human and animal food,
thus fulfilling the mandatory reporting requirements of the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA)
(Public Law 109-462) and the Food and Drug Administration Amendments
Act of 2007 (FDAAA) (Public Law 110-85).
    The MedWatch\Plus\ Portal involves the development of a single Web-
based portal and a user-friendly data collection tool, the ``Rational
Questionnaire,'' which will make it easy for anyone to report a safety
problem. The Rational Questionnaire will ask users simple questions to
help guide them to determine what information they should provide.
Anyone will be able to use the questionnaire to submit adverse event,
product problem/consumer complaint, and medication use error reports to
the FDA. For example, a healthcare practitioner could report an adverse
event; a medical device maker could report a safety concern about a
product; a pet owner could report a problem that their pet experienced
associated with the use of an animal drug or animal food; a parent
could report a reaction that their child experienced associated with
the use of a cosmetic; and a consumer could report a concern about a
drug they are taking at home, or about a food that may have made them
ill. The system will compile the users' responses into a standardized
report that would be routed to the appropriate FDA organizational
component(s) for review and analysis.
    There are several types of information that will be submitted to
FDA via the MedWatch\Plus\ Portal and Rational Questionnaire. Some of
the information is required to be submitted to FDA (mandatory
reporting) and some of the information is submitted voluntarily
(voluntary reporting). The majority of the information to be collected
using the MedWatch\Plus\ Rational Questionnaire has been approved
previously by OMB under the PRA. Recently, additional information
collection has been mandated by DSNDCPA and FDAAA. A complete list of
information collections, their current OMB approval numbers, as well as
citations to the relevant statute, regulation or guidance information
for each is depicted in table 1 of this document.

                    Table 1-- Information Collections
------------------------------------------------------------------------
                                                 Relevant
                                                 Statute,     Mandatory
   FDA          FDA Form No.        OMB No.   Regulation or     (M) or
  Center                                         Guidance     Voluntary
                                               Information       (V)
------------------------------------------------------------------------
Center                     3500   0910-0291   MedWatch Form  V
 for                                           FDA 3500,
 Biologic                                      Voluntary
 s                                             Reporting
 Evaluati                                      Instructions
 on and
 Research/
 Center
 for Drug
 Evaluati
 on and
 Research
 (CBER/
 CDER)
------------------------------------------------------------------------
CBER/CDER                 3500A   0910-0291   21 CFR         M
                                               310.305,
                                               314.80,
                                               314.98,
                                               600.80 and
                                               1271.350
------------------------------------------------------------------------
Center                     3500   0910-0291   MedWatch Form  V
 for                                           FDA 3500,
 Devices                                       Voluntary
 and                                           Reporting
 Radiolog                                      Instructions
 ical
 Health
 (CDRH)
------------------------------------------------------------------------
CDRH                      3500A   0910-0291   21 CFR Part    M
                                               803
------------------------------------------------------------------------
Center                     3500   0910-0291   None           V
 for Food
 Safety
 and
 Applied
 Nutritio
 n
 (CFSAN)
------------------------------------------------------------------------

CFSAN\1\                  3500A   OMB         Pub. L. 109-   M
                                   approval    462; Section
                                   is in       761(b)(1) of
                                   process     the Federal
                                               Food, Drug,
                                               and Cosmetic
                                               Act (the
                                               act) (21
                                               U.S.C. 379aa-
                                               1(b)(1))
------------------------------------------------------------------------
CFSAN/                     None   This        Pub. L. 110-   M
 Center                            notice      85; Section
 for                               solicits    417 of the
 Veterina                          comments    act (21
 ry                                on this     U.S.C. 350f)
 Medicine                          proposed
 (CVM)\1\                          new
                                   collectio
                                   n
------------------------------------------------------------------------
CVM                       1932a   0910-0284   Veterinary     V
                                               Adverse Drug
                                               Reaction,
                                               Lack of
                                               Effectivenes
                                               s, or
                                               Product
                                               Defect
                                               Report Form
                                               and
                                               Instructions
------------------------------------------------------------------------
CVM                        1932   0910-0284   21 CFR 514.80  M
------------------------------------------------------------------------
CVM\1\                     None   This        Pub. L. 110-   V
                                   notice      85; Section
                                   solicits    1002 of
                                   comments    FDAAA
                                   on this
                                   proposed
                                   new
                                   collectio
                                   n
------------------------------------------------------------------------
Office of                  None   This        None           V
 Regulato                          notice
 ry                                solicits
 Affairs                           comments
 (ORA)                             on this
                                   proposed
                                   new
                                   collectio
                                   n
------------------------------------------------------------------------
\1\ New reporting requirements included in DSNDCPA and FDAAA.

    The single portal and a harmonized, Web-based format for submitting
safety information will greatly enhance the ability of FDA to protect
the public health. FDA will analyze electronic adverse event and safety
reports for all marketed products and track safety signals throughout
the life cycle of FDA-regulated products. FDA intends to review the
information the agency receives to ensure that the submitters comply
with the criteria established by the Federal Food, Drug, and Cosmetic
Act (the act), where required.
    Description of respondents: The respondents to this collection of
information include all persons submitting mandatory or voluntary
information electronically to FDA via the MedWatch\Plus\ Portal and
Rational Questionnaire.
    FDA expects that all of its centers and ORA will be utilizing the
electronic reporting capabilities of MedWatch\Plus\ Portal by Fiscal
Year 2011. Thus, FDA has prepared its estimate of the annual reporting
burden on the basis that the majority of all submissions will be
submitted electronically.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of
October 23, 2008 (73 FR 63153), FDA published a 60-day notice
requesting public comment on the proposed information collection. FDA
received five letters in response to the four specified aspects of the
collection of information, each containing one or more comments.
    (Comment 1) Several comments commended FDA for implementing
electronic data collection to improve adverse event reporting and
expected the new format to greatly improve the agency's ability to
utilize adverse event, product problem/consumer complaints, and
medication use error reports submitted to FDA.
    (Response) FDA agrees. As discussed previously in this document,
the new system will enhance the current MedWatch collection system and
integrate the Agency's existing adverse event reporting systems. This
will enable FDA staff to more efficiently analyze thousands of safety
reports and to identify potential safety problems earlier than would be
possible using paper forms.
    (Comment 2) One comment recommended that FDA continue to allow the
submission of adverse event reports via paper. Another comment
requested that FDA allow for a paper based contingency in the event
that the MedWatch\Plus\ system becomes unavailable.
    (Response) FDA agrees. The agency is not eliminating paper, or
telephone reporting. We will continue to support and accept reports
submitted to us by mail, fax or telephone including when the system is
unavailable.
    (Comment 3) One comment stated that FDA should recognize that the
major component of the reporting burden is in the assembly of data, not
in the transmission of data. The comment suggested that the submission
of mandatory data to the MedWatch system will take 1 hour per initial
report and from one-half hour to 3 hours for supplemental reports.
    (Response) FDA agrees that the assembly of data is a major
component of the reporting burden. However, the agency notes that the
comment did not provide any data to support the burden hour figures set
forth. Thus, FDA has not changed the burden hour estimates in tables 1
and 2 of this document.
    (Comment 4) Several comments suggested that FDA consider using
pilot programs in the different stages of developing the system. One
comment suggested using a pilot with the proposed questionnaire.
Another comment asked FDA to consider developing a pilot project with
electronic medical record software vendors to assess the functionality
and determine the impact on the practitioner's time to complete the
submission. A third comment offered to provide the assistance of its
professional association members to assess the functionality of the
MedWatch\Plus\ portal and rational questionnaire.
    (Response) FDA agrees. The agency intends to utilize internal and
external early adopters for user acceptance testing that will include a
test site environment for beta testing prior to implementation of the
portal. However, the integration of electronic medical record software
is not in scope for the planned releases of MedWatch\Plus\ portal and
rational questionnaire.
    (Comment 5) One comment expressed concern that those wanting to use
the Web portal would not be able to find it.

Another comment suggested that FDA initiate a public education campaign
to ensure potential users are aware of the new system and use the new
system correctly.
    (Response) FDA agrees and is working with National Institutes of
Health and the FDA Internet teams to follow the HHS Internet guidelines
for Web design. We expect that the link to the MedWatch\Plus\ portal
and rational questionnaire will be prominently displayed on the FDA
home page. FDA also intends to reach out to our industry stakeholders,
as well as professional organizations and community interest groups.
The rational questionnaire will provide the user with detailed
navigation instructions to include drop-down menus, lists of values and
controlled vocabularies where possible. In addition, FDA will issue
guidance and technical documents for the iterative releases of the
rational questionnaire. The FDA intends to provide a phased approach.
The first release will include Reportable Food Reports. Early Warning
Pet Food Recall and adverse event reports for veterinary drug products
will follow. Other product reports (CFSAN, CVM, CDER, CBER and CDRH)
will be rolled out in later releases.
    (Comment 6) One comment suggested that FDA include a means by which
adverse events associated with other products could be reported using
the MedWatch\Plus\ portal and rational questionnaire, including:
devices used in animals, compounded drugs for animals, and biologics
used in animals.
    (Response) FDA agrees that individuals should be able to report
adverse events associated with devices used in animals and adverse
reactions associated with compounded drugs for animals. For example,
when the MedWatch\Plus\ portal is operational, reporters will be able
to use the animal adverse event view of the rational questionnaire to
submit these reports. Furthermore, adverse event reports submitted
through the portal for biologic products used for animals will be
forwarded to the U.S. Department of Agriculture.
    (Comment 7) One comment suggested that the Naranjo scale be
incorporated into the rational questionnaire.
    (Response) FDA disagrees. The Naranjo scale is a causality
assessment tool. FDA does not plan to require assessment of causality
by reporters who already suspect a product-event association and have
made the decision to report by accessing the MedWatch\Plus\ portal.
    (Comment 8) One comment suggested that FDA should adjust its
business processes to effectively leverage and appropriately respond to
rapidly changing data in terms of number of reports, varying quality,
and potential impact to signal detection.
    (Response) FDA agrees. The rational questionnaire will facilitate
the collection of consistent, complete, accurate information and
produce a structured report utilizing the HL7-ICSR data exchange
message. The agency will continue to support the submission of
``batched'' adverse event reports through the FDA electronic submission
gateway. FDA is moving toward the use of the HL7-ICSR message exchange;
however, acceptable, alternative data exchange message formats (e.g.,
E2BM, E2BR) will be supported for a period of time that has not been
yet been determined.
    (Comment 9) One comment suggested that the MedWatch\Plus\ portal
and rational questionnaire should document who submits the information
and stated that the type of submitter (e.g., pharmacist, physician,
patient) provides a good indication of the accuracy of and the reasons
behind the information provided.
    (Response) FDA agrees that information describing the type of
submitter is useful. The rational questionnaire reporting views will be
created to include questions describing who the reporter is, the type
of report (adverse event, product problem/consumer complaint or product
use error), whether the reporting is mandatory, and identify the
suspect product. From that information, the agency can infer the type
of submitter as follows: General citizen, health care professional, and
whether or not the reporter is a mandatory or voluntary reporter.
    (Comment 10) One comment recommended that FDA obtain contact
information from all individuals who submit adverse event reports,
arguing that false reports could be submitted more readily if
individual contact submission is not required for report submission.
The comment also noted that such information would allow FDA to follow
up with individuals and verify reported information in the event that
FDA had questions or concerns regarding an individual report.
    (Response) FDA is encouraging all users to provide contact
information in all reports which both verifies the source of the report
and allows FDA to conduct any needed followup. However, FDA will accept
voluntary reports submitted by anonymous sources. Only mandatory
reporters will be required to include their contact information.
    (Comment 11) One comment urged FDA to consider how duplicate
reporting through different mechanisms will be reduced or eliminated.
    (Response) FDA agrees. We have a system requirement that addresses
our abilities to assess and link duplicate reports to minimize the
problem of duplicate reporting. In addition, the Web portal will allow
followup information as well as attachments to be entered and linked to
a previously submitted report.
    (Comment 12) One comment suggested that FDA should incorporate the
Alternative Summary Report (ASR) methodology in MedWatch\Plus\.
    (Response) FDA is considering including summary reporting (ASRs) in
future releases of the rational questionnaire, but the exact mechanism
has not been determined.
    (Comment 13) The rational questionnaire should not have
supplemental questions, which are not required by the agency's
regulations at 21 CFR Part 803.
    (Response) The rational questionnaire will include the information
mandated by regulation, legislation or otherwise deemed necessary by
the agency for a complete report. Reporters will not be required to
submit information in response to optional questions.
    (Comment 14) One comment recommended that a single acknowledgement
bearing the MDR report number and the official time receipt stamp be
transmitted to the sender within one hour of the MDR submission.
Another comment noted that the FDA 3500A form is the evidentiary record
of the MDR. The comment went on to express concern about how the
MedWatch\Plus\ system would acknowledge the submission of the adverse
event report in the required timeframe.
    (Response) FDA agrees. The reporter will receive an electronic
response with an acknowledgement containing a unique FDA identification
number, which the reporter can save and print. The acknowledgement
receipt will be generated immediately by the MedWatch\Plus\ system. The
reporter may also print and save an electronic copy of their report. If
the reporter creates an account, the reporter will have access, for an
undetermined finite period of time, to both their in-process and
previously submitted reports using the MedWatch\Plus\ system. However,
FDA notes that voluntary reporters who report anonymously will not
receive such a response because we will not have their email address,
but they will be able to print and save an electronic copy of their
report.

    (Comment 15) One comment asked that FDA engage stakeholders in a
public consultation process and asked FDA to subject a draft of the
rational questionnaire to a public consultation period to permit
manufacturers, patients, and other stakeholders to comment prior to
finalizing a questionnaire for production use.
    (Response) FDA agrees. We plan to use internal and external
stakeholders in user acceptance testing. Additionally, the agency
intends to hold two public meetings for Reportable Foods and give
presentations on the Web-based portal and the rational questionnaire at
professional organization and industry meetings.
    (Comment 16) One comment suggested that FDA make the electronic
collection tool user friendly and asked that the questionnaire be made
accessible and intuitive for a broad population to use, with easy to
understand data entry instructions and a user-friendly interface that
requires limited computer or technical expertise to complete. Another
comment stated that the effectiveness of the rational questionnaire
would depend on the length of time required for the user to complete
the adverse event report.
    (Response) FDA agrees that the rational questionnaire should be
user friendly. We are taking every available step in developing this
tool to ensure that it is user-friendly and accessible for public use
while minimizing user time. Such steps include utilizing both internal
and external expertise with Web-techniques and leveraging current
technology. The agency is following HHS Web standards in developing the
portal and rational questionnaire and plans to collect feedback during
the user acceptance testing.
    (Comment 17) Another comment suggested that questions on the
rational questionnaire should be prioritized to capture the most
important questions and information first in a shorter period of time.
Another comment suggested that FDA should use an electronic approach
that will ensure that reporters only see and fill out those fields
relevant to the event that they are reporting.
    (Response) FDA agrees that the questions should be prioritized. The
rational questionnaire is designed to request the mandatory information
first, then present the optional questions. In addition, the specific
reporting situations will use a tree-branching logic approach. The
reporter will be provided only those fields necessary to providing a
full report and they will not see questions that are not needed, which
helps in prioritizing the information.
    (Comment 18) One comment suggested that FDA create an intelligent
questionnaire that aligns with the reporter's knowledge base and
experience. Another comment requested that FDA provide an advanced
method of submitting information using the rational questionnaire that
would allow individuals familiar with the system to more quickly and
efficiently input the information.
    (Response) FDA agrees. FDA is aware that persons familiar with the
reporting process do not want to be led through the questionnaire
because they know what information they want to report. The agency is
planning future releases of the rational questionnaire with an ``Expert
Reporter'' mode for those who are familiar with the information and
frequent reporters. FDA notes that if a user chooses to establish an
account with FDA, the system will be designed so that when the user
properly signs in, the system will pre-populate the point-of-contact
information. In addition, when a report is submitted, a user will be
able to retain and save unique identifying information which can be
used to access a previously filed report for additional followup
reporting.
    (Comment 19) One comment suggested that FDA ensure that the
MedWatch\Plus\ portal is interoperable with software that institutions
currently use to document suspected adverse drug events internally.
    (Response) The MedWatch\Plus\ portal is available to all users
through the Internet, without requiring the use of special software.
The portal will also allow submission of attachments to reports in
commonly-used file formats, such as Microsoft Word, Excel and Adobe.
The agency intends to publish guidance that will provide a list of
acceptable file types. In the event that a user would like to submit an
attachment that is in an unacceptable file type, the agency intends to
communicate with the user via a message providing instructions for file
types we will accept and contact information for a help desk providing
IT support and additional assistance to the public. The current
MedWatch\Plus\ portal and rational questionnaire project scope does not
include the integration with electronic medical record software, but
may be considered in the future as medical software systems mature and
are increasingly utilized.
    (Comment 20) One comment asked FDA to ensure interoperability
utilizing HL7 or other appropriate standards. Another comment asked FDA
to utilize international consensus standards in electronic case
reporting.
    (Response) FDA agrees. The MedWatch\Plus\ rational questionnaire
will produce an HL7-ICSR data exchange message and the portal will
accept HL7-ICSR compliant exchange messages that are formatted outside
the rational questionnaire. As noted previously in this document, the
agency will continue to support the submission of `batched' adverse
event reports through the FDA electronic submission gateway. FDA is
moving toward the use of the HL7-ICSR message exchange; however,
acceptable, alternative data exchange message formats (e.g., E2BM,
E2BR) will be supported for a period of time that has not been yet been
determined. We intend to use structured and controlled vocabularies and
terminologies where they exist.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 2--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                       Number of       Annual Frequency     Total Annual        Hours per
   FDA Activity       Respondents       per  Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Voluntary View                37,565                  1             37,565                0.6             22,539
----------------------------------------------------------------------------------------------------------------
Mandatory View                   645                199            128,403                1.0            128,403
 using
 MedWatch\Plus\
 Rational
 Questionnaire\2\
----------------------------------------------------------------------------------------------------------------
Mandatory View                 2,578              199.2            513,613                0.6            308,168
 using direct
 Gateway-to-
 Gateway
 transmission\2\
----------------------------------------------------------------------------------------------------------------

Reportable Food                1,200                  1              1,200                0.6                720
 (human and
 animal)
 Mandatory View
----------------------------------------------------------------------------------------------------------------
Reportable Food                1,200                  1              1,200                0.6                720
 (human and
 animal)
 Voluntary View
----------------------------------------------------------------------------------------------------------------
Early Warning                    540                  1                540                0.6                324
 Recall Voluntary
 View
----------------------------------------------------------------------------------------------------------------
Total                                                                                460,874
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The reporter may choose to use the MedWatch\Plus\ Rational Questionnaire or a direct Gateway-to-Gateway
  transmission to submit a Mandatory report. FDA believes that these are different reporting burdens for these
  two types of transmission of information. The reporting burden for use of the MedWatch\Plus\ Rational
  Questionnaire Mandatory View is estimated to be 1 hour. The reporting burden for a direct Gateway-to-Gateway
  transmission is estimated to be 0.6 hours. Current reporting estimates indicate that approximately 80 percent
  of the Mandatory Reports would be submitted via a Gateway-to-Gateway transmission and 20 percent of reports
  would be received via the MedWatch\Plus\ Rational Questionnaire in the future. The Mandatory View reporting
  burden estimates reflect this calculation.

    The term ``Voluntary View'' refers to the MedWatch\Plus\ Rational
Questionnaire as it appears to a respondent submitting a voluntary
report. The term ``Mandatory View'' refers to the Gateway-to-Gateway
and the MedWatch\Plus\ Rational Questionnaire as it appears to a
respondent submitting a mandatory report. The estimated number of
responses and hours per response for the voluntary view and the
mandatory view are based on FDA's experience and the average number of
voluntary reports and mandatory reports submitted to FDA in 2007 (and
in the case of mandatory dietary supplement reports, those submitted to
FDA from January 1, 2008, to April 15, 2008) via the existing methods
of submission, including paper submission. The term, ``Reportable Food
(human and animal) Mandatory View'' refers to the MedWatch\Plus\
Rational Questionnaire as it appears to a respondent submitting a
mandatory report under section 417 of the act (21 U.S.C. 350f). The
term, ``Reportable Food (human and animal) Voluntary View'' refers to
the MedWatch\Plus\ Rational Questionnaire as it appears to the
respondent submitting a voluntary report under section 417 of the act.
The estimated number of responses and hours per response for the
reportable food (human and animal) mandatory and voluntary views are
based on FDA's experience with reports recently submitted to FDA that
would be considered ``Reportable Food'' reports in the future. The
term, ``Early Warning Recall Voluntary View,'' refers to the
MedWatch\Plus\ Rational Questionnaire as it appears to a respondent
submitting a mandatory report under FDAAA Section 1002 of the act
(Public Law 110-85). The estimated number of responses and hours per
response for the early warning recall voluntary view are based on FDA's
experience with reports recently submitted to FDA that would be
considered ``Early Warning Recall'' reports in the future.
    In an effort to meet the needs of all reporters, the Rational
Questionnaire will allow for the submission of a report by completing
certain minimum data elements. Both mandatory and voluntary reporters
will see and be provided the opportunity to submit additional optional
information. A reporter can answer one, a few, or all of the optional
questions. Reporters are strongly encouraged to submit as much optional
information as possible. This will help to ensure FDA has sufficient
information to identify products and problems, and enhance their
ability to address these problems.
    The optional questions serve a purpose for both the reporter and
FDA. The reporter may believe that additional information is needed for
FDA to fully understand the event/problem and the optional questions
provide an opportunity to provide such information. For FDA, the
optional questions may aid in fully understanding the problem and may
eliminate the need for extensive followup with the reporter. Because
reporters can choose to answer none, one, a few, or all of the optional
questions, we estimated the maximum time needed to submit a safety
report online for both voluntary and mandatory reporters in the hours
per response column in table 2 of this document.
    The agency's estimate of the number of respondents and the total
annual responses in table 2 of this document is based on the mandatory
and voluntary reports submitted to the centers and ORA. The estimated
total annual responses in table 2 are based on initial reports.
Followup reports, if any, are not counted as new reports. FDA estimates
that it will receive 37,565 voluntary reports [23,033 (CBER/CDER) +
4,369 (CDRH) + 5,000 (CFSAN) + 163 (CVM) + 5,000 (ORA) = 37,565]. FDA
estimates that it will receive 642,016 mandatory reports [459,121
(CBER/CDER) + 146,274 (CDRH) + 856 (CFSAN) + 35,765 (CVM) + 0 (ORA) =
642,016].
    FDA received 23,033 voluntary reports to CBER/CDER during 2007.
Based on this experience, FDA estimates that CBER and CDER,
collectively, will receive 23,033 voluntary reports annually from
23,033 users of the electronic reporting system. FDA estimates the
reporting burden for a voluntary report to be 0.6 hours, for a total
burden of 13,820 hours (23,033 reports x 0.6 hours = 13,819.8 hours).
    FDA received 459,121 mandatory reports to CBER/CDER during 2007.
Based on this experience, FDA estimates that CBER and CDER,
collectively, will receive 459,121 mandatory reports annually from 600
users of the electronic reporting system. FDA estimates the maximum
reporting burden for a mandatory report to be 1 hour, for a total
burden of 459,121 hours (459,121 reports x 1 hour) or a minimum burden
of 312,202 hours with ((459,121 reports x 80% x 0.60 hour) + (459,121
reports x 20% x 1 hour) = 312,202.28 hours).
    FDA received 4,369 voluntary reports to CDRH during 2007. Based on
this experience, FDA estimates that CDRH will receive 4,369 voluntary
reports annually from 4,369 users of the electronic reporting system.
FDA estimates the reporting burden for a voluntary report to be 0.6
hours, for a total burden of 2,621 hours (4,369 reports x 0.6 hours =
2,621.4 hours).

    FDA received 146,274 mandatory reports to CDRH during 2007. Based
on this experience, FDA estimates that CDRH will receive 146,274
mandatory reports annually from 1,665 users of the electronic reporting
system (a group comprised of facilities, importers, and manufacturers).
FDA estimates the maximum reporting burden for a mandatory report to be
1 hour, for a total burden of 146,274 hours (146,274 reports x 1 hour =
146,274 hours) or a minimum burden of 99,466 hours with ((146,274
reports x 80% x 0.60 hour) + (146,274 reports x 20% x 1 hour) =
99,466.32 hours). FDA received 5,000 voluntary reports to CFSAN during
2007. Based on this experience, FDA estimates that CFSAN will receive
5,000 voluntary reports annually from 5,000 users of the electronic
reporting system. FDA estimates the reporting burden for a voluntary
report to be 0.6 hours, for a total burden of 3,000 hours (5,000
reports x 0.6 hours = 3,000 hours).
    FDA received 214 mandatory dietary supplement reports to CFSAN from
January 1, 2008, to April 15, 2008. Based on this experience, FDA
estimates that CFSAN will receive 856 mandatory reports annually from
150 users of the electronic reporting system. FDA estimates the maximum
reporting burden for a mandatory report to be 1 hour, for a total
burden of 856 hours (856 reports x 1 hour = 856 hours) or a minimum
burden of 582 hours with ((856 reports x 80% x 0.60 hour) + (856
reports x 20% x 1 hour) = 582.08 hours).
    FDA received 163 voluntary reports to CVM during 2007. Based on
this experience, FDA estimates that CVM will receive 163 voluntary
reports annually from 163 users of the electronic reporting system. FDA
estimates the reporting burden for a voluntary report to be 0.6 hours
for a total burden of 98 hours (163 reports x 0.6 hours = 97.8 hours).
    FDA received 35,765 mandatory reports to CVM during 2007. Based on
this experience, FDA estimates that CVM will receive 35,765 mandatory
reports annually from 808 users of the electronic reporting system. FDA
estimates the maximum reporting burden for a mandatory report to be 1
hour, for a total burden of 35,765 hours (35,765 reports x 1 hour =
35,765 hours) or a minimum burden of 24,320 hours with ((35,765 reports
x 80% x 0.6 hour) + (35,765 reports x 20% x 1 hour) = 24,320.20 hours).
    FDA received 5,000 voluntary reports to ORA during 2007. Based on
this experience, FDA estimates that ORA will receive 5,000 voluntary
reports annually from 5,000 users of the electronic reporting system.
FDA estimates the reporting burden for a voluntary report to be 0.6
hours, for a total burden of 3,000 hours (5,000 reports x 0.6 hours =
3,000 hours). ORA does not receive mandatory reports.
    FDAAA, Section 1005, the Reportable Food Registry, established new
electronic mandatory and voluntary reporting requirements for instances
of ``reportable'' food, meaning an article of food (other than infant
formula) for which there is a reasonable probability that the use of,
or exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals. FDA received 625 voluntary
food complaints leading to adverse events from January 1, 2008, to June
30, 2008, and there were 206 and 182 Class 1 Recalls for human food in
Fiscal Years 2006 and 2007, respectively. Based on these experiences,
FDA estimates that FDA could receive 200 to 1,200 ``reportable'' food
reports annually from 200 to 1,200 mandatory and voluntary users of the
electronic reporting system. FDA will utilize the upper-bound estimate
of 1,200 for these calculations. FDA estimates the reporting burden for
a mandatory ``reportable'' food report to be 0.6 hours, for a total
burden of 720 hours (1,200 reports x 0.6 hours = 720 hours). FDA
estimates the reporting burden for a voluntary ``reportable'' food
report to be 0.6 hours, for a total burden of 720 hours (1,200 reports
x 0.6 hours = 720 hours).
    FDAAA, Section 1002, Early Warning Recall, mandated FDA establish a
system to receive voluntary pet food complaint reports and provide an
Early Warning Recall system for the public. FDA received 270 voluntary
pet food reports from January 1, 2008, to June 30, 2008. FDA received
10,740 and 99 pet food complaints in FY 2007 and 2006, respectively.
Based on these experiences, FDA estimates that FDA could receive 540
voluntary pet food reports annually from 540 users of the electronic
reporting system. FDA estimates the reporting burden for a voluntary
``Early Warning Recall'' report to be 0.6 hours, for a total burden of
324 hours (540 reports x 0.6 hours = 324 hours).

    Dated: May 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11687 Filed 5-19-09; 8:45 am]

BILLING CODE 4160-01-S