[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71623-71624]
[FR Doc No: 2013-28598]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0716]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Designated New Animal
Drugs for Minor Use and Minor Species

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.

DATES: Fax written comments on the collection of information by
December 30, 2013.

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 emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0605.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
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.

Designated New Animal Drugs for Minor Use and Minor Species; 21 CFR
Part 516--(OMB Control Number 0910-0605)--Extension

    Description: The Minor Use and Minor Species Animal Health Act of
2004 (MUMS) (Pub. L. 108-282) amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to authorize FDA to establish new
regulatory procedures intended to make more medications legally
available to veterinarians and animal owners for the treatment of minor
animal species as well as uncommon diseases in major animal species.
This legislation provides incentives designed to help pharmaceutical
companies overcome the financial burdens they face in providing
limited-demand animal drugs. These incentives are only available to
sponsors whose drugs are ``MUMS-designated'' by FDA. Minor use drugs
are drugs for use in major species (cattle, horses, swine, chickens,
turkeys, dogs, and cats) that are needed for diseases that occur in
only a small number of animals either because they occur infrequently
or in limited geographic areas. Minor species are all animals other
than the major species; for example, zoo animals, ornamental fish,
parrots, ferrets, and guinea pigs. Some animals of agricultural
importance are also minor species. These include animals such as sheep,
goats, catfish, and honeybees. Participation in the MUMS program is
completely optional for drug sponsors so the associated paperwork only
applies to those sponsors who request and are subsequently granted
``MUMS designation.'' The rule specifies the criteria and procedures
for requesting MUMS designation as well as the annual reporting
requirements for MUMS designees.
    Section 516.20 (21 CFR 516.20) provides requirements on the content
and format of a request for MUMS-drug designation; Sec.  516.26 (21 CFR
516.26) provides requirements for amending MUMS-drug designation;
provisions for change in sponsorship of MUMS-drug designation can be
found under Sec.  516.27 (21 CFR 516.27); under Sec.  516.29 (21 CFR
516.29) are provisions for termination of MUMS-drug designation; under
Sec.  516.30 (21 CFR 516.30) are requirements for annual reports from
sponsor(s) of MUMS-designated drugs; and under Sec.  516.36 (21 CFR
516.36) are provisions for insufficient quantities of MUMS-designated
drugs.
    Description of Respondents: Pharmaceutical companies that sponsor
new animal drugs.
    In the Federal Register of July 2, 2013 (78 FR 39734), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
516.20; Content and format of                 15               5              75              16           1,200
 MUMS request...................
516.26; Requirements for                       3               1               3               2               6
 amending MUMS designation......
516.27; Change in sponsorship...               1               1               1               1               1

516.29; Termination of MUMS                    2               1               2               1               2
 designation....................
516.30; Requirements for annual               15               5              75               2             150
 reports........................
516.36; Insufficient quantities.               1               1               1               3               3
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,362
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this reporting requirement was derived in
our Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the current investigational new animal drug/new animal
drug application reporting requirements for similar actions by this
same segment of the regulated industry and from previous interactions
with the minor use/minor species community.

    Dated: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28598 Filed 11-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Rules and Regulations]
[Pages 5032-5034]
[FR Doc No: 2015-01184]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0525; Directorate Identifier 2013-NM-235-AD;
Amendment 39-18078; AD 2015-02-11]
RIN 2120-AA64

Airworthiness Directives; Airbus 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 certain
Airbus Model A330-300, A340-200, and A340-300 series airplanes. This AD
was prompted by a report of substantial inner skin disbonding damage
found on a rudder. This AD requires performing an inspection for damage
of certain rudders, and repair if necessary. We are issuing this AD to
detect and correct damage of the rudder, which could result in reduced
structural integrity of the rudder.

DATES: This AD becomes effective March 6, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 6,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0525; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80;
email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
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 certain Airbus Model A330-
300, A340-200, and A340-300 series airplanes. The NPRM published in the
Federal Register on August 13, 2014 (79 FR 47387).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2013-0270R1, dated November 27, 2013 (referred
to after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for Airbus Model A330-
300, A340-200, and A340-300 series airplanes. The MCAI states:

    One A310 operator found substantial inner skin disbonding damage
on a rudder. The results of the subsequent investigation revealed
that the most probable cause of this damage was a blunt impact with
no visible damage from outside during the rudder handling. Such type
of damage might grow with pressure variation during ground-air-
ground cycles, and tests performed with other rudders showed a rapid
propagation of damage during artificial pressure cycling.
    This condition, if not detected and corrected, could affect the
structural integrity of the rudder.
    For the affected A310 and A300-600 aeroplanes, EASA issued AD
2013-0039 [http://ad.easa.europa.eu/blob/easa_ad_2013_0039.pdf/AD_2013-0039], to address and correct this potential unsafe
condition.
    As potentially affected rudders can also be installed on A330
and A340 aeroplanes, Airbus issued Alert Operator Transmission (AOT)
A55L001-12 [dated December 20, 2012], pending Aircraft Maintenance
Manual (AMM) 27-21-41 PB401 revision, to provide operators with
updated rudder handling procedures.
    EASA issued AD 2013-0270 [http://ad.easa.europa.eu/blob/easa_ad_2013_0270.pdf/AD_2013-0270], to require identification of
affected rudders P/N [part number] A55471500XXX (where XXX stands
for any numerical value), a one-time ultrasonic test (UT) inspection
of each affected rudder to detect signs of disbonding and, depending
on findings, accomplishment of applicable corrective action(s).
    After [EASA] AD 2013-0270 was issued, operators commented that
the batch of rudders to be inspected was not correctly defined.
    For the reason described above, [EASA] AD 2013-0270 is revised
to clarify that no action is required for rudders previously
inspected in accordance with Airbus Service Bulletin (ASB) A330-55-
3038 or SB A340-55-4034 [which are required by FAA AD 2009-10-11,
Amendment 39-15907 (74 FR 23622, May 20, 2009)], as applicable to
aeroplane model, provided the rudder has never been removed and/or
installed on an aeroplane since this inspection.

    Required actions include an elasticity of laminate checker
inspection of the rudder side panel to detect external and internal
disbonding, and a woodpecker or tap test inspection to detect external
disbonding, and repair if necessary. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0525-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the NPRM (79 FR
47387, August 13, 2014) and the FAA's response.

Request To Correct Certain Document Numbers

    Lufthansa Technik (Lufthansa) asked that we correct certain
document

numbers for the service information identified in paragraph (h) of the
NPRM (79 FR 47387, August 13, 2014). Lufthansa stated that paragraph
(h) of the NPRM incorrectly refers to Airbus Service Bulletins A300-55-
3038 and A310-55-4034, instead of Airbus Service Bulletins A330-55-3038
and A340-55-4034, both dated November 7, 2007.
    We agree with the commenter for the reason provided. We have
corrected the document numbers for the service information identified
in paragraph (h) of this AD accordingly.

Compliance Time Change

    We revised the compliance time in paragraph (g) of this AD for the
part numbers and serial numbers that cannot be identified from ``before
further flight'' to ``within 3 months after the effective date of this
AD.'' We have also revised the compliance time in paragraph (h) of this
AD for the ultrasonic test inspection from ``before further flight'' to
``within 3 months after the effective date of this AD.'' This
compliance time corresponds to the compliance time specified in the
MCAI. We have determined this compliance time will provide an
acceptable level of safety.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 47387, August 13, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 47387, August 13, 2014).

Related Service Information

    Airbus has issued Alert Operators Transmission A55L001-12, dated
December 20, 2012. The service information describes procedures for an
inspection for damage of certain rudders. You can find this information
at http://www.regulations.gov by searching for and locating Docket No.
FAA-2014-0525.

Costs of Compliance

    We estimate that this AD affects 74 airplanes of U.S. registry.
    We also estimate that it will take about 12 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $0 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $75,480, or $1,020 per product.
    We have received no definitive data that would enable us to provide
a cost estimate for the on-condition actions specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0525; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

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):

2015-02-11 Airbus: Amendment 39-18078. Docket No. FAA-2014-0525;
Directorate Identifier 2013-NM-235-AD.

(a) Effective Date

    This AD becomes effective March 6, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A330-301, -302, -303, -321, -
322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212,
-213, -311, -312, and -313 airplanes; certificated in any category;
except airplanes on which Airbus Modification 41800 has been
embodied in production.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Reason

    This AD was prompted by a report of substantial inner skin
disbonding damage on a rudder. We are issuing this AD to detect and
correct damage of the rudder, which could result in reduced
structural integrity of the rudder.

(f) Compliance

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

(g) Rudder Assembly Identification

    Within 3 months after the effective date of this AD, inspect for
the rudder assembly part number and serial number, in accordance
with Airbus Alert Operators Transmission (AOT) A55L001-12, dated
December 20, 2012. If the part number or serial number cannot be
identified, within 3 months after the effective date of this AD,
identify the part number and serial number using a method

approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(h) Inspection

    If a rudder assembly having any part number starting with
A55471500 or A55471500XXX (where XXX stands for any numerical value)
is found during the inspection required by paragraph (g) of this AD,
and that rudder assembly has been inspected before the effective
date of this AD, as specified in Airbus Service Bulletin A330-55-
3038, dated November 7, 2007 (which is not incorporated by reference
in this AD); or Airbus Service Bulletin A340-55-4034, dated November
7, 2007 (which is not incorporated by reference in this AD); as
applicable; and that rudder assembly has been removed and installed
on any airplane after the inspection or that has been inspected off-
wing: Within 3 months after the effective date of this AD, do an
ultrasonic test inspection for damage (e.g., disbonding and liquid
ingress) of the rudder side panel along the Z-profile and in the
booster area, in accordance with Airbus AOT A55L001-12, dated
December 20, 2012. If any damage is found, before further flight, do
the inspections specified in paragraphs (h)(1) and (h)(2) of this AD
to confirm disbonding damage, in accordance with Airbus AOT A55L001-
12, dated December 20, 2012.
    (1) Do an elasticity of laminate checker inspection to detect
external and internal disbonding.
    (2) Do a woodpecker or tap test inspection to detect external
disbonding.

(i) Repair

    If any disbonding or damage (e.g. liquid ingress) is confirmed
during any inspection required by paragraphs (h), (h)(1), and (h)(2)
of this AD, repair at the time specified in paragraph (i)(1),
(i)(2), or (i)(3) of this AD, as applicable.
    (1) If the disbonding is less than or equal to 50 millimeters
(mm) in width and less than or equal to 150 mm in length: Before
further flight, vent the rudder core using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or EASA; or Airbus's EASA DOA. Within 100 flight
cycles after venting the rudder core, do a permanent repair using a
method approved by the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA.
If approved by the DOA, the approval for the venting and repair
methods must include the DOA-authorized signature.
    (2) If the disbonding is greater than 50 mm in width, or greater
than 150 mm in length: Before further flight, repair using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA. If
approved by the DOA, the approval must include the DOA-authorized
signature.
    (3) If any damage other than disbonding (e.g., liquid ingress)
is confirmed during any inspection required by paragraph (h) of this
AD, before further flight, repair, using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or EASA; or Airbus's EASA DOA. If approved by the
DOA, the approval must include the DOA-authorized signature.

(j) Parts Installation Limitation

    As of the effective date of this AD, you may install, on any
airplane, a rudder assembly having part number A55471500XXX (where
XXX stands for any numerical value), provided the inspection
required by paragraph (h) of this AD and all applicable repair
actions required by paragraph (i) of this AD are done before further
flight.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (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
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
Airbus's EASA 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 Airworthiness Directive 2013-0270R1, dated November 27,
2013, 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-2014-0525.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (m)(3) and (m)(4) of this AD.

(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) Airbus Alert Operators Transmission A55L001-12, dated
December 20, 2012, including Inspection Flow Chart AOpT ref.:
A55L001-12, not dated. The document number and date of this document
are identified on only the first page of this AOT.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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 Renton, Washington, on January 15, 2015.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-01184 Filed 1-29-15; 8:45 am]
BILLING CODE 4910-13-P


Supporting Statement

for

Course Approval and Records for Merchant Mariner Training Schools

OMB No.:  1625-0028

COLLECTION INSTRUMENTS:  Instruction

A.  Justification

1)  Circumstances that make the collection of information necessary.

Title 46 United States Code (U.S.C.) 2103 authorizes the Secretary
(under which the Coast Guard is operating) to prescribe regulations to
carry out the provisions of Subtitle II regarding Vessels and Seamen,
including the interests of marine safety and seamen’s welfare.  Title
46 U.S.C. 2104 provides that the Secretary may delegate such duties to
any officer, employee, or member of the Coast Guard, which would include
National Maritime Center (NMC) personnel.  Additionally, 46 U.S.C. 7315
authorizes a license or document applicant to substitute the completion
of an approved course for a portion of the required sea service.  Title
46 Code of Federal Regulations (CFR) 10.402 specifies the information
that must be submitted for the Coast Guard to evaluate and approve each
course.  Title 46 CFR 10.403 specifies recordkeeping requirements that a
school teaching approved courses must meet for each student taking each
course.  The Coast Guard is obligation under the STCW Convention to
validate the training received by merchant mariners and to ensure that
the approved training is part of a Quality Standards System (QSS).

This information collection supports the following strategic goals:

Department of Homeland Security

Prevention

Protection

Coast Guard

Maritime Safety

Protection of Natural Resources

Prevention Policy & Response Policy Directorates (CG-5P & CG-5R)

Safety: Eliminate deaths, injuries and property damage associated with
commercial maritime operations.

Human and Natural Environment: Eliminate environmental damage associated
with maritime transportation and operations on and around the nation’s
waterways.

2)  Purpose of the information collection.

On a daily basis, NMC personnel review submitted information to ensure
training courses and programs meet minimum standards for Coast Guard
approval.  Members of the public, including U.S. merchant mariners,
attend approved courses to meet regulatory requirements or to enhance
their ability to perform their jobs.  The agency uses the information to
enforce regulations, and to compare existing courses with new
international standards for specific training.

The recordkeeping requirements helps the Coast Guard monitor the
performance of schools with approved courses.

3)  Consideration of the use of improved technology.

Information is submitted in writing or electronically via e-mail to
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>or online at  HYPERLINK
"http://www.uscg.mil/nmc/training/audit/mtad.asp"
http://www.uscg.mil/nmc/training/audit/mtad.asp .  For guidance on
submissions, see Coast Guard Navigation and Vessel Inspection Circular
(NVIC)   HYPERLINK
"https://www.uscg.mil/hq/cg5/nvic/pdf/2014/nvic-03-14_Course_Approval_Fi
nal_with_encls_20140122.pdf"  03-14 .  We estimate that 100% of the
reporting and recordkeeping requirements can be done electronically.  At
this time, we estimate that 50% of the responses are collected
electronically.

4)  Efforts to identify duplication.

Similar data in this field is not available.  The Coast Guard is the
only agency collecting this information for use as described in the
answer to item 2 above.

5)  Methods to minimize the burden to small entities if involved.

In general, both the reporting and recordkeeping burden is proportional
to the number of courses that a school submits for approval.  Thus,
small businesses that offer only a few courses would have a reduced
burden.  Additionally, there is no application fee for respondents and
direct communication between applicants and the Coast Guard is
encouraged.  Finally, all training schools seeking approval of courses
must follow the same procedures.

6)  Consequences to the Federal program if collection were conducted
less frequently.

The Coast Guard’s ability to evaluate training received by mariners as
an equivalent to service experience will be reduced. This may lead to
less-qualified mariners and a corresponding increase in maritime
accidents.

7)  Special collection circumstances.

This information collection is conducted in a manner consistent with the
guidelines in 5 CFR 1320.5(d)(2).

8)  Consultation.

A 60-Day Notice will be published in the Federal Register to obtain
public comment on this collection.

9)  Provide any payment or gift to respondents.

There is no offer of monetary or material value for this information
collection.

10)  Describe any assurance of confidentiality provided to respondents.

There are no assurances of confidentiality provided to the respondents
for this information collection.  This information collection request is
covered by the Marine Information for Safety and Law Enforcement (MISLE)
and Merchant Mariner Licensing and Documentation System Privacy Impact
Assessments (PIAs) and the MISLE and Merchant Seamen’s Records System
of Records Notices (SORNs).  Links to the aforementioned PIAs and SORNs
are provided below:

  HYPERLINK
"https://www.dhs.gov/sites/default/files/publications/privacy_pia_uscg_m
isle.pdf"
https://www.dhs.gov/sites/default/files/publications/privacy_pia_uscg_mi
sle.pdf

   HYPERLINK
"https://www.dhs.gov/publication/dhsuscgpia-015-merchant-mariner-licensi
ng-and-documentation-system"
https://www.dhs.gov/publication/dhsuscgpia-015-merchant-mariner-licensin
g-and-documentation-system

  HYPERLINK
"https://www.gpo.gov/fdsys/pkg/FR-2009-06-25/html/E9-14906.htm"
https://www.gpo.gov/fdsys/pkg/FR-2009-06-25/html/E9-14906.htm

  HYPERLINK
"https://www.gpo.gov/fdsys/pkg/FR-2009-06-25/html/E9-14911.htm"
https://www.gpo.gov/fdsys/pkg/FR-2009-06-25/html/E9-14911.htm

11)  Additional justification for any questions of a sensitive nature.

There are no questions of sensitive language.

12)  Estimate of annual hour and cost burdens to respondents.

The estimated annual number of respondents is 324.

The estimated annual number of responses is 3,633.

The estimated annual hour burden is 139,807 hours.

The estimated annual cost burden is $7,256,951.

The burden to respondents is provided in Appendix A.  Respondents are
training providers (some, but not all, offer STCW-related course).  All
wage rates used are in accordance with the current edition of COMDTINST
7310.1(series) for “Out-Government” personnel.

We estimate that it takes 31 hours per course approval submission and
that a submission is done by a technical specialist.  The position of a
technical specialist is equivalent to a GS-13.

We estimate that it takes 40 hours per approved course for student
recordkeeping and that a submission is done by an administrative
specialist.  The position of an administrative specialist is equivalent
to

a GS-9.

We estimate that it takes 206 hours to develop a new STCW QSS Manual and
complete the associated recordkeeping and that the work is done by a
technical specialist.  The position of a technical specialist is
equivalent to a GS-13.  Additionally, we estimate that annually will
receive new QSS Manuals from about 5% of the total number of STCW
training schools.

We estimate that it takes 9 hours to annual review an STCW QSS Manual
and complete the associated recordkeeping and that the work is done by a
technical specialist.  The position of a technical specialist is
equivalent to a GS-13.

We estimate that it takes 10 hours to conduct an internal audit of the
STCW QSS and complete the associated recordkeeping and that the work is
done by a technical specialist.  The position of a technical specialist
is equivalent to a GS-13.  Audits are done twice in a 5-year period
(i.e., 40% of the total STCW training schools annually).

13)  Estimate of annualized capital and start-up costs.

There are no capital, start-up or maintenance costs associated with this
information collection.

14)  Estimate of annualized Federal Government costs.

The annualized Federal Government cost estimate is $871,000 (see
Appendix B).  We estimate that is takes a member of a CG Regional
Examination Center about 2 hours to conduct a course review (& if
needed, a site visit write-up).  We estimate that is takes a member of
the CG NMC about 10 hours to conduct a course (& site visit) evaluation
and another 1 hour to complete a course approval determination.  All
Coast Guard activities are done by a GS-13.

15)  Explain the reasons for the change in burden.

The change in burden is an ADJUSTMENT due to a change (i.e., increase)
in the estimated annual number of responses.  There is no proposed
change to the reporting and recordkeeping requirements of this
collection.  The reporting and recordkeeping requirements, and the
methodology for calculating burden, remain unchanged.

16)  Plans for tabulation, statistical analysis and publication.

This information collection will not be published for statistical
purposes.

17)  Approval for not explaining the expiration date for OMB approval.

The Coast Guard will display the expiration date for OMB approval of
this information collection.

18)  Exception to the certification statement.

The Coast Guard does not request an exception to the certification of
this information collection.

B.  Collection of Information Employing Statistical Methods

This information collection does not employ statistical methods.

  International Convention on Standards of Training, Certification and
Watchkeeping for Seafarers.

  Estimated by 12 classes/course, 20 students/class, and 10 min (0.1667
hrs) burden/student record.

1625-0028

  PAGE  3  of   NUMPAGES  4


VOLUME 2 – Program Pink Bollworm Trapping and Boll Sampling Data

DATA OBJECTIVES:

	Data from systematic monitoring (weekly) of pink bollworm population in
eradication zones using pheromone traps and sampling of bolls should be
provided.  Compare wild-type adult pink bollworm capture levels to
sterile adult pink bollworm capture levels.

CONTENTS ADDRESSING OBJECTIVES:

1. TABLE 1	Listing weekly program trapping data for all fields for the
period of June 25 – July 22, 2006.  Data to include total native and
sterile captures per trap per week for each field covering the date
range specified.

(146 pages; attached & labeled)

2. TABLE 2	Lists average number of natives and steriles per field for
the four week combined date range of June 25 – July 22, 2006.

(100 pages; attached & labeled)

3. TABLE 3	Summarizes weekly pink bollworm trapping averages by cotton
types for both natives and steriles.

(1 page; attached & labeled)

4. TABLE 4	Lists preliminary boll sampling data for the week of July 16
– July 22, 2006.  A total of 43 fields were selected at random (23
non-Bt / 20 Bt).  Attempts were made wherever possible to select Bt /
non-Bt pairs that were a mile apart or less.  A total of 100 bolls from
each of four field quadrants comprised the sample.  These were then
examined under magnification for pink bollworm life forms.  Twenty-six
fields were capable of being sampled at this early date.

(2 pages; attached & labeled)

5. DOCUMENT 1	Special Report 2006:  Local Movement of Sterile Pink
Bollworm Moths in the San Joaquin Valley of California.

(4 pages; attached & labeled)

6. MAP 1	Sterile Moth Movement in San Joaquin Valley, California.

(1 page; attached & labeled)

7. DOCUMENT 2	Spatial Analysis of Native and Sterile Pink Bollworm in
the Arizona Pink Bollworm Eradication Program area, June 25-July 22,
2006.

(3 pages; attached & labeled)

8. MAP 2	Kriging Maps of Native and Sterile Pink Bollworm Populations in
Arizona Eradication Program June 25-July 22, 2006.

(9 pages; attached & labeled)