[Federal Register Volume 77, Number 141 (Monday, July 23, 2012)]
[Rules and Regulations]
[Pages 42958-42962]
[FR Doc No: 2012-17559]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0704; Directorate Identifier 2012-SW-040-AD;
Amendment 39-17113; AD 2012-13-11]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GmbH Helicopters

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

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter Deutschland GmbH (ECD) Model MBB-BK 117 (all versions) and
BO-105LS A-3 helicopters. This AD requires inspecting the tail rotor
pitch link spherical bearing for proper swaging. This AD is prompted by
a report of a tail rotor pitch link with a spherical bearing that had
migrated out of the bearing bore. The actions specified by this AD are
intended to prevent failure of the tail rotor pitch link and subsequent
loss of control of the helicopter.

DATES: This AD becomes effective August 7, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain documents August 7, 2012.
    We must receive comments on this AD by September 21, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the economic evaluation, any
comments received, and other information. The street address for the
Docket Operations Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.
    For service information identified in this AD, contact Able
Engineering and Support Services, 2920 East Chambers Street, Phoenix,
AZ 85040; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>You may review a copy of the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

FOR FURTHER INFORMATION CONTACT: Sharon Miles, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, TX 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or

federalism impacts that resulted from adopting this AD. The most
helpful comments reference a specific portion of the AD, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit them only one time. We will
file in the docket all comments that we receive, as well as a report
summarizing each substantive public contact with FAA personnel
concerning this rulemaking during the comment period. We will consider
all the comments we receive and may conduct additional rulemaking based
on those comments.

Discussion

    Able Engineering & Component Services (Able) received a report of a
tail rotor pitch link with a spherical bearing that had migrated out of
the bearing bore. Investigation by Able revealed that the migration
resulted from the spherical bearing being improperly swaged during a
repair process and that the affected parts were limited to those
repaired after January 1, 2011. Able determined that an inspection of
other tail rotor pitch links repaired after that date is necessary to
determine their airworthiness and issued Alert Service Bulletin (ASB)
No.: 2012-001, Revision IR, dfated March 7, 2012 (Able ASB).
    On March 19, 2012, Eurocopter issued one ASB with multiple numbers:
Eurocopter Emergency Alert Service Bulletin (EASB) No. BO105 LS-30A-013
for model BO-105LS A-3 helicopters; EASB No. BO105 LS A-3-STC-0654/
3058-30A-001 for model BO-105LS A-3 Superlifter helicopters; EASB No.
MBB-BK117-30A-115 for model MBB-BK 117 A-1, A-3, A-4, B-1, B-2, and C-1
helicopters; and EASB No. MBB-BK117 C-2-67A-016 for model MBB-BK117 C-2
helicopters, all Revision 0. The EASB specifies complying with the
inspection described in the Able ASB.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other helicopters of these same type
designs.

Related Service Information

    We reviewed the Able ASB, which identifies certain tail rotor pitch
links (pitch links) that are affected by the improper swaging of the
spherical bearings. The Able ASB describes procedures to remove the
pitch links and visually inspect the spherical bearings with an 8X
magnifying glass for a bearing that has not been swaged and will
migrate out of the bearing bore. If a pitch link is discovered with a
bearing not properly swaged, the Able ASB specifies removing the pitch
link from service and returning it to Able Engineering.

AD Requirements

    This AD requires:
     Removing the pitch link from the helicopter and cleaning
the spherical bearings.
     Applying hand pressure to the bearing faces and inspecting
with an 8X or higher power magnifying glass for complete swaging of the
bearing bore.
     If the pitch link has not been completely swaged, removing
the pitch link and replacing it with an airworthy pitch link.

Differences Between This AD and the Service Information

    The service information requires returning unairworthy pitch links
to Able Engineering; this AD does not. The Eurocopter ASB applies to
the Model BO105 LS A-3 ``Superlifter,'' and this AD does not as that
model is not type certificated in the U.S.

Costs of Compliance

    We estimate that this AD will affect 130 helicopters of U.S.
Registry, and that operators may incur the following costs in order to
comply with this AD. Inspecting each pitch link will require about 1.5
work hours at an average labor rate of $85 per hour, for a total cost
per helicopter of about $127 and a cost to the U.S. operator fleet of
$16,510. If required, replacing a pitch link with an airworthy pitch
link will require about 1.5 work hours at an average labor rate of $85
per hour, and required parts will cost $1,442, for a total cost per
helicopter of about $1,569.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because some of the corrective
actions must be accomplished before further flight.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and that good
cause exists for making this amendment effective in less than 30 days.

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, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; 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.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

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):

2012-13-11 Eurocopter Deutschland GmbH Helicopters: Amendment 39-
17113; Docket No. FAA-2012-0704; Directorate Identifier 2012-SW-040-
AD.

(a) Applicability

    This AD applies to Eurocopter Deutschland GmbH (ECD) Model MBB-
BK 117 A-1, MBB-BK 117 A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK
117 B-2, MBB-BK 117 C-1, MBB-BK 117 C-2, and BO-105LS A-3
helicopters, with a tail rotor pitch link (pitch link) part number
(P/N) 117-31821, 117-31822, or B642M1018101 with a serial number
listed in Appendix 1 of Able Engineering & Component Services (Able)
Alert Service Bulletin (ASB) No. 2012-001, Revision IR, dated March
7, 2012, installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as an improperly swaged
spherical bearing on the pitch link, which could result in loss of
tail rotor control and subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes August 7, 2012.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    For pitch links installed within the last 10 hours time-in-
service (TIS), before further flight; for all other affected pitch
links, within the next 10 hours TIS:
    (1) Remove the pitch link.
    (2) Clean the area around the spherical bearings and pitch link
bearing bore chamfer.
    (3) Apply axial hand pressure to the faces of both spherical
bearings as shown in Figure 1 to Paragraph (e) of this AD.
[GRAPHIC] [TIFF OMITTED] TR23JY12.000

    (4) Using an 8X or higher power magnifying glass, inspect the
boundaries between the bearing and the bearing bore chamfer surface.
Determine that the bearings have been completely swaged and there is
no gap between the edge of the bearing and the chamfer as shown in
Figure 2 to Paragraph (e) of this AD.
[GRAPHIC] [TIFF OMITTED] TR23JY12.001

    (5) If a bearing is not completely swaged or there is a gap
between the edge of the bearing and the chamfer, as shown in Figure
3 to Paragraph (e) of this AD, replace the pitch link with an
airworthy pitch link.

[GRAPHIC] [TIFF OMITTED] TR23JY12.002

(f) Special Flight Permits

    Special flight permits will not be issued.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Sharon Miles, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, TX 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 6420: Tail Rotor
Head.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Able Engineering & Component Services Alert Service Bulletin
No. 2012-001, Revision IR, dated March 7, 2012.
    (ii) Reserved.
    (3) For Able Engineering & Component Services service
information identified in this AD, contact Able Engineering &
Component Services, 2920 East Chambers Street, Phoenix, AZ 85040;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth, Texas 76137.
    (5) You may also view this service information 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/code_of_federal_regulations/ibr_locations.html.

    Issued in Fort Worth, Texas, on July 2, 2012.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-17559 Filed 7-20-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30687-30688]
[FR Doc No: 2014-12306]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms, and Record Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstract regarding the Petitions for Exemption
from the Theft Prevention Standard below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published on March 21, 2014 (79 FR 15799). The agency received no
comments.

DATES: Comments must be submitted on or before June 27, 2014.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Departments' estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. Comments to OMB are most effective if OMB
receives them within 30 days of publication.

FOR FURTHER INFORMATION CONTACT: Carlita Ballard at the National
Highway Traffic Safety Administration, Office of International Policy,
Fuel Economy and Consumer Programs (NVS-131), 1200 New Jersey Ave. SE.,
West Building, Room W43-439, NVS-131, Washington, DC 20590. Ms.
Ballard's telephone number is<PHONE_NUMBER>. Please identify the
relevant collection of information by referring to its OMB Control
Number.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Petitions for Exemption from the Vehicle Theft Prevention
Standard (49 CFR Part 543)
    OMB Control Number: 2127-0542
    Type of Request: Request for public comment on a previously
approved collection of information.
    Abstract: Manufacturers of passenger vehicle lines may petition the
agency for an exemption from Part 541 requirements, if the line is
equipped with an anti-theft device as standard equipment and meets
agency criteria. Device must be as effective as parts-marking. 49
U.S.C. Chapter 331 requires the Secretary of Transportation to
promulgate a theft prevention standard to provide for the
identification of certain motor vehicles and their major replacement
parts to impede motor vehicle theft. 49 U.S.C. 33106 provides for an
exemption to this identification process by petitions from
manufacturers who equip covered vehicles with standard original
equipment antitheft devices, which the Secretary determines are likely
to be as effective in reducing or deterring theft as parts-marking.
NHTSA may exempt a vehicle line from the parts marking requirement, if
the manufacturer installs an antitheft device as standard equipment on
the entire vehicle line for which it seeks an exemption and NHTSA
determines that

the antitheft device is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements. In accordance with 49 U.S.C. 33106, after model year (MY)
2000, the number of new exemptions is contingent on a finding by the
Attorney General as part of its long-range review of effectiveness.
After consulting with DOJ, the agency decided it could continue
granting one exemption per model year pending the results of the long-
term review.
    In a final rule published on April 6, 2004, the Federal Motor
Vehicle Theft Prevention Standard was extended to include all passenger
cars and multipurpose passenger vehicles with a gross vehicle rating of
6,000 pounds or less, and to light duty trucks with major parts that
are interchangeable with a majority of the covered major parts of
multipurpose passenger vehicles. Consistent with the DOJ consultation,
the April 6, 2004 final rule amended the general requirements of
Section 543.5 of Chapter 49 of the Code of Federal Regulations,
allowing a manufacturer to petition NHTSA to grant an exemption for one
additional line of its passenger motor vehicles from the requirements
of the theft prevention standard for each model year after MY 1996. The
final rule became effective September 1, 2006.
    Prior to September 1, 2006, manufacturers were only allowed to
petition NHTSA for high-theft vehicles lines. In its April 6, 2004
final rule, the agency amended part 543 to allow vehicle manufacturers
to file petitions to exempt all vehicle lines that would become subject
to parts-marking requirements beginning with the effective date of the
final rule. As a result of this amendment, vehicle manufacturers are
allowed to file petitions to exempt all vehicle lines that would become
subject to the parts-marking requirements regardless of their theft
status (high or low).
    There are approximately 21 vehicle manufacturers that could request
an exemption (one exemption per manufacturer per model year), although
33 petitions for exemption from the parts-marking requirements were
received by the agency for MYs 2013-2015. This is an average of
approximately 11 responses per year. NHTSA anticipates that this will
remain the average number of yearly responses that will be received by
the agency.
    NHTSA estimates that the average hours per submittal will be 166,
for a total annual burden of 1,826 hours. This is a slight increase
from the previous OMB inventory of 1,808 hours. NHTSA estimates that
the cost associated with the burden hours is $39.49 per hour, for a
total cost of approximately $72,109.
    Affected Public: Motor vehicle manufacturers.
    Estimated Total Annual Burden: NHTSA estimates that vehicle
manufacturers will incur a total annual reporting hour and cost burden
of 1,826 hours and $72,109 respectively. There would be no additional
cost to motor vehicle manufacturers that would require it to comply to
this regulation.

Claude H. Harris,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2014-12306 Filed 5-27-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15323-15324]
[FR Doc No: 2011-6509]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0241]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ATRYN

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ATRYN and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biologic product
ATRYN (antithrombin (recombinant)). ATRYN is indicated for the
prevention of peri-operative and peri-partum thromboembolic events in
hereditary antithrombin deficient patients. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for ATRYN (U.S. Patent No. 6,441,145) from GTC
Biotherapeutics, Inc., and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated February 17, 2010, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of ATRYN
represented the first permitted commercial marketing or use of the
recombinant product. Thereafter, the Patent and Trademark Office
requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
ATRYN is 4,468 days. Of this time, 4,285 days occurred during the
testing phase of the regulatory review period, while 183 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November
15, 1996. The applicant claims November 14, 1996, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was November 15, 1996,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): August 8, 2008. The applicant claims
January 31, 2008, as the date the biologics license application (BLA)
for ATRYN (BLA 125284) was initially submitted. However, FDA records
indicate that BLA 125284 was submitted on August 8, 2008.
    3. The date the application was approved: February 6, 2009. FDA has
verified the applicant's claim that BLA 125284 was approved on February
6, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,243 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by May 20, 2011. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by September 19, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with

the docket number found in brackets in the heading of this document.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-6509 Filed 3-18-11; 8:45 am]
BILLING CODE P


             Bill
             Harnett/RTP/USEP
             A/US                                                    To
<EMAIL_ADDRESS>
             04/08/2007 08:26                                        cc
             PM<EMAIL_ADDRESS>
<EMAIL_ADDRESS>Paul
                                      Balserak/DC/USEPA/US@EPA, Joanna
                                      Swanson/RTP/USEPA/US@EPA, Juan
                                      Santiago/RTP/USEPA/US@EPA, Pam
                                      Long/RTP/USEPA/US@EPA
                                                                Subject
                                      Revised Ethanol Package

Dear Amy,

Here is the revised Corn Milling/Ethanol Package.  There is a claen copy
and a redline strikeout to the previous version you have seen.  Call if
you have questions or comments.

Bill

(See attached file: EthanolFRN4-8-07clean4.doc)(See attached file:
Ethanol FRN compare of 4-08-07 version to 3-16-07 version sent to
OMB4.doc)

 EthanolFRN4-8-07clean45.doc

 Ethanol FRN compare of 4-08-07 version to 3-16-07 version sent to OMB42.doc