[Federal Register: August 5, 2010 (Volume 75, Number 150)]
[Rules and Regulations]
[Page 47201-47203]
[DOCID:fr05au10-11]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0713; Directorate Identifier 2009-SW-63-AD;
Amendment 39-16369; AD 2010-15-03]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Model EC 130 B4
Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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SUMMARY: This amendment adopts a new airworthiness directive (AD) for
the specified Eurocopter France helicopters. This action requires
inspecting certain electrical harnesses for damage and if damage is
found, repairing the electrical harness; protecting the electrical
harness from damage; installing harness clamp blocks; and inspecting
each fairing attachment screw to determine the length and replacing
attachment screws, if they exceed a certain length. This amendment is
prompted by a report of an in-flight incident that led to the inflation
of the emergency floatation gear (emergency floats) and the activation
of various warnings. The actions specified in this AD are intended to
prevent interference between an electrical harness and the lower
structure fairing attachment screws. Damage to an electrical harness by
a lower structure fairing attachment screw could lead to short-
circuiting of various warnings, inflation of the emergency floats
during flight, and subsequent loss of control of the helicopter.

DATES: Effective August 20, 2010.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of August 20, 2010.
    Comments for inclusion in the Rules Docket must be received on or
before October 4, 2010.

ADDRESSES: Use one of the following addresses to submit comments on
this AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, TX
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://
www.eurocopter.com.
    Examining the Docket: You may examine the docket that contains the
AD, any comments, and other information 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 Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: DOT/FAA Southwest Region, George
Schwab, Aviation Safety Engineer, ASW-112, Rotorcraft Directorate,
Safety Management Group, 2601 Meacham Blvd., Fort Worth, Texas 76137,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    This amendment adopts a new AD for Eurocopter France Model EC 130
B4 helicopters that have been modified in accordance with MOD 073774,
and have not had MOD 073591 nor the modification specified in
Eurocopter Drawing No. 350A085340 incorporated. This action requires,
within 10 hours time-in-service (TIS), removing the lower forward
right-hand, left-hand, and center lower structure fairings (fairings);
inspecting each electrical harness for chaffing, tears, holes, or other
damage at the location of each attachment screw and repairing any
damage; protecting electrical harnesses by wrapping them with
electrical tape; installing harness clamp blocks; and inspecting each
attachment screw to determine the length and replacing any attachment
screw that is longer than 14mm. This amendment is prompted by a report
of an in-flight incident in which an attachment screw that secures the
right-hand lower center fairing damaged the electrical harness and
caused several short circuits, resulting in the described incident.
This condition, if not detected, could lead to inflation of the
emergency floats during flight, and subsequent loss of control of the
helicopter.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2006-0344 R1, dated May 10, 2007, to correct an unsafe condition
for Eurocopter France Model EC 130 B4 helicopters. EASA advises that
their AD was initially issued as an Emergency AD, following a report of
an in-flight incident which led to activation of various warning lights
and inflation of the emergency floats. The pilot was able to land the
helicopter without damage. EASA AD No. 2006-0344 R1 revises EASA
Emergency AD 2006-0344-E, dated November 13, 2006.

Related Service Information

    Eurocopter France has issued Emergency Alert Service Bulletin
(EASB) No. 88A001 R1, dated April 17, 2007, which specifies procedures
for detecting and correcting interference between an electrical harness
and a fairing attachment screw. The EASA classified this EASB as
mandatory and issued AD No. 2006-0344 R1, dated May 10, 2007, to ensure
the continued airworthiness of these helicopters.

FAA's Evaluation and Unsafe Condition Determination

    This helicopter has been approved by the aviation authority of
France and is approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, their technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by the EASA and determined the unsafe condition
exists and is likely to exist or develop on other helicopters of this
same type design.

Differences Between This AD and the EASA AD

    This AD requires inspections by a qualified mechanic rather than
checks, which may be conducted by a pilot. Also, this AD requires
contacting the FAA, Safety Management Group, ASW-112, instead of
contacting Eurocopter France to define a certain customized repair
solution before returning the helicopter to flight configuration if 4
or more electrical wires or cables need repair. Additionally, this AD
uses the term ``hours time-in-service'' instead of ``flight hours''.

FAA's Determination and Requirements of This AD

    This unsafe condition is likely to exist or develop on other
helicopters of the same type design. Therefore, this AD is being issued
to prevent, on helicopters post MOD 073774, any interference between an
electrical harness and an attachment screw. Embodiment of a
modification in accordance with Eurocopter drawing 350A085342 is
considered to be a temporary solution to be applied rapidly in order to
ensure that there is no interference. Embodiment of a modification in
accordance with Eurocopter Drawing 350A085340 is the permanent
solution. The EASA AD has been revised to provide additional
information that MOD 073591 also is a permanent solution and has been
incorporated on new helicopters. This AD requires removing the
fairings; inspecting each electrical harness for any chaffing, tear,
hole, or other damage at the location of each attachment screw and
repairing any damage; protecting electrical harnesses by wrapping them
with electrical tape; installing harness clamp blocks; and inspecting
each attachment screw to determine the length and replacing any that
are longer than 14mm.
    Accomplish the actions by following specified portions of the EASB
described previously. The short compliance time involved is required
because the previously described critical unsafe condition can
adversely affect the controllability of the helicopter. Therefore,
inspecting each electrical harness for damage at the location of each
attachment screw and repairing any damage, if found; protecting the
electrical harness by wrapping with electrical tape; installing harness
clamp blocks; and inspecting each attachment screw to determine the
length and replacing any that are longer than 14mm, are required within
10 hours time-in-service (TIS), a short compliance time, and this AD
must be issued immediately.
    Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable, and that good cause exists for
making this amendment effective in less than 30 days.

Costs of Compliance

    We estimate that this AD will affect about 13 helicopters of U.S.
registry. We also estimate that it will take about 12 work-hours per
helicopter to remove the lower structure fairings; inspect an
electrical harness for interference and damage; repair an electrical
harness, if necessary; shorten the attachment screws; install harness
clamp blocks; and reinstall the lower fairings. The average labor rate
is $85 per work-hour. Required parts will cost about $120 per
helicopter. Based on these figures, we estimate the cost of this AD on
U.S. operators is $1,140 per helicopter, $14,820 for the entire fleet.

Comments Invited

    This AD is a final rule that involves requirements that affect
flight safety and was not preceded by notice and an opportunity for
public comment; however, we invite you to submit any written data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2010-0713; Directorate
Identifier 2009-SW-63-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the AD. We will consider all
comments received by the closing date and may amend the AD in light of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
docket Web site, you can find and read the comments to any of our
dockets, including the name of the individual who sent the comment. You
may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have 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 the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me by the
Administrator,

the Federal Aviation Administration amends part 39 of the Federal
Aviation Regulations (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. Section 39.13 is amended by adding a new airworthiness directive to
read as follows:

2010-15-03 Eurocopter France: Amendment 39-16369. Docket No. FAA-
2010-0713; Directorate Identifier 2009-SW-63-AD.
    Applicability: Model EC 130 B4 helicopters that have been
modified in accordance with MOD 073774, and have not had MOD 073591
nor the modification specified in Eurocopter Drawing No. 350A085340
incorporated, certificated in any category.
    Compliance: Required within 10 hours time-in-service (TIS),
unless accomplished previously.
    To detect interference and prevent damage to an electrical
harness by a lower structure fairing attachment screw (attachment
screw), which could lead to short-circuiting of various warnings,
inflation of the emergency floatation gear (emergency floats) during
flight, and subsequent loss of control of the helicopter, accomplish
the following:
    (a) Remove the lower forward right-hand, left-hand, and center
fairings.
    (b) Inspect each electrical harness for chaffing, a tear, a
hole, or other damage at the location of each attachment screw as
depicted in Details B, C, and D in Figure 1 in Eurocopter Emergency
Alert Service Bulletin No. 88A001 R1, dated April 17, 2007 (EASB),
and as shown at point (a) in Figure 2 and Figure 3 in the EASB.
    (1) If there is no chaffing, tear, hole, or other damage to the
electrical harness at any attachment screw:
    (i) Determine the length of each attachment screw that secures
the fairings. Replace any attachment screw that is longer than 14mm
with an airworthy attachment screw, part number (P/N)
A0164TK050S014X;
    (ii) Install the spacer on the electrical harness in accordance
with paragraph 2.B.3.a. of the Accomplishment Instructions of the
EASB;
    (iii) Relocate the electrical harness on the cable holders in
accordance with paragraph 2.B.3.b. of the Accomplishment
Instructions of the EASB; and
    (iv) Install the harness clamp blocks in accordance with
paragraph 2.B.4. of the Accomplishment Instructions of the EASB.
    (2) If there is chaffing, a tear, a hole, or other damage to an
electrical harness at the location of an attachment screw, remove
any protective tape from the electrical harness as shown at point
(b) in Figure 2 of the EASB and inspect the insulation on each
electrical wire and cable strand for chaffing, a tear, a hole, or
other damage at the attachment screw location.
    (i) If there is no chaffing, tear, hole, or other damage to the
insulation on any wire or cable strand, wrap the electrical harness
with protective tape and comply with paragraphs (b)(1)(i) through
(b)(1)(iv) of this AD.
    (ii) If there is chaffing, a tear, a hole, or other damage to
the insulation on any electrical wire or cable strand, but the
electrical wire or cable strand is not damaged, wrap the electrical
wire or cable strand that has damaged insulation with protective
tape and wrap the electrical harness with protective tape, then
comply with paragraphs (b)(1)(i) through (b)(1)(iv) of this AD.
    (c) If 3 or less electrical wires or cable strands in the same
immediate area are damaged:
    (1) Repair each damaged electrical wire or cable strand with an
extension lead, P/N E0541-10, in accordance with the Appendix to the
EASB; test the electrical continuity of the repaired electrical wire
or cable strand using an ohmmeter, continuity test light, or
equivalent device; and functionally test the system affected by the
repair;
    (2) Wrap the electrical harness with protective tape; and
    (3) Comply with paragraphs (b)(1)(i) through (b)(1)(iv) of this
AD.
    (d) If 4 or more electrical wires or cable strands in the same
immediate area are damaged:
    (1) Contact the Safety Management Group, Rotorcraft Directorate,
FAA, ATTN: George Schwab, Aviation Safety Engineer, 2601 Meacham
Blvd., Fort Worth, Texas, 76137, telephone<PHONE_NUMBER>, fax (817)
222-5961, for an approved electrical conductor repair procedure; and
    (2) Comply with (b)(1)(i) through (b)(1)(iv) of this AD.
    (e) Reinstall the fairings.
    (f) Contact the Manager, Safety Management Group, Rotorcraft
Directorate, FAA, ATTN: George Schwab, Aviation Safety Engineer,
2601 Meacham Blvd., Fort Worth, Texas, 76137, telephone (817) 222-
5114, fax<PHONE_NUMBER>, for information about previously approved
alternative methods of compliance.
    (g) The Joint Aircraft System/Component (JASC) Code is 3297:
Landing Gear System Wiring.
    (h) The inspections, modifications and repairs, if needed, shall
be done in accordance with the specified portions of Eurocopter
Emergency Alert Service Bulletin No. 88A001 R1, dated April 17,
2007. The Director of the Federal Register approved this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies may be obtained from American Eurocopter
Corporation, 2701 Forum Drive, Grand Prairie, TX 75053-4005,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://
www.eurocopter.com. Copies may be inspected at the FAA, Office of
the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth, Texas or 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.
    (i) This amendment becomes effective on August 20, 2010.

    Note:  The subject of this AD is addressed in European Aviation
Safety Agency (France) AD No. 2006-0344 R1, dated May 10, 2007,
which revises European Aviation Safety Agency Emergency AD No. 2006-
0344-E, dated November 13, 2006.

    Issued in Fort Worth, Texas, on July 8, 2010.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-17282 Filed 8-4-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 6, 2009 (Volume 74, Number 43)]
[Notices]
[Page 9822-9823]
[DOCID:fr06mr09-44]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0083]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Gluten-Free Labeling of Food Products Experimental
Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a voluntary consumer study entitled
``Gluten-Free Labeling of Food Products Experimental Study.''

DATES: Submit written or electronic comments on the collection of
information by May 5, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Gluten-Free Labeling of Food Products Experimental Study

    Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating
to foods and to conduct educational and public information programs
relating to the safety of the nation's food supply. FDA is planning to
conduct an experimental study about gluten-free labeling of food
products. The Gluten-Free Labeling of Food Products Experimental Study
will collect information from both consumers who have celiac disease or
gluten intolerance and those who do not have either condition. The
purpose of the study is to gauge perceptions of characteristics related
to claims of ``gluten-free'' and allowed variants (e.g., ``free of
gluten,'' ``without gluten,'' ``no gluten''), in addition to other
types of statements (e.g., ``made in a gluten-free facility'' or ``not
made in a facility that processes gluten-containing foods'') on the
food label. The study will also

assess consumer understanding of ``gluten-free'' claims on foods that
are naturally free of gluten, and gauge consumer reaction to a product
carrying a gluten claim concurrently with a statement about the amount
of gluten the product contains.
    The data will be collected over the Internet from samples derived
from two sources: (1) A membership list from a celiac disease special
interest organization and (2) an online consumer panel. Participation
in the study is voluntary.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
 Questionnaire     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Screener                    6,000                     1              6,000             0.0055                 33
----------------------------------------------------------------------------------------------------------------
Pretest                       140                     1                140               .167              23.38
----------------------------------------------------------------------------------------------------------------
Experiment                  5,000                     1              5,000               .167                835
----------------------------------------------------------------------------------------------------------------
Total           .................  ....................  .................  .................             891.38
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Approximately 6,000 respondents will be screened. We estimate that
it will take a respondent 20 seconds (0.0055 hours) to complete the
screening questions, for a total of 33 hours. A pretest will be
conducted with 140 participants; we estimate that it will take a
respondent 10 minutes (0.167 hours) to complete the pretest, for a
total of 23.38 hours. Five thousand adults will complete the
experiment. We estimate that it will take a respondent 10 minutes
(0.167 hours) to complete the entire experiment, for a total of 835
hours. Thus, the total estimated burden is 891.38 hours. FDA's burden
estimate is based on prior experience with consumer experiments that
are similar to this proposed experiment.

    Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4766 Filed 3-5-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 58 (Monday, March 29, 2021)]
[Rules and Regulations]
[Page 16302]
[FR Doc No: 2021-06146]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2021-0119]

Special Local Regulation; Dutch Shoe Marathon, San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Dutch Shoe Marathon special
local regulation on the waters of San Diego Bay, California on July 23,
2021. These special local regulations are necessary to provide for the
safety of the participants, crew, spectators, sponsor vessels, and
general users of the waterway. During the enforcement period, persons
and vessels are prohibited from anchoring, blocking, loitering, or
impeding within this regulated area unless authorized by the Captain of
the Port, or his designated representative.

DATES: The regulations in 33 CFR 100.1101 will be enforced for the
Dutch Shoe Marathon regulated area listed in item 4 in Table 1 to Sec.
100.1101 from 11:30 a.m. to 4 p.m. on July 23, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Lieutenant John Santorum,
Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone
(619) 278-7656, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.1101 Table 1, Item 4 of that section
for the Dutch Shoe Marathon in San Diego Bay, CA from 11:30 a.m. to 4
p.m. on July 23, 2021. This action is being taken to provide for the
safety of life on navigable waterways during this event. Our regulation
for marine events within the Eleventh Coast Guard District, Sec.
100.1101, specifies the location of the regulated area for the Dutch
Shoe Marathon which encompasses the waters of San Diego Bay, CA, from
Shelter Island to Glorietta Bay. Under the provisions of Sec.
100.1101, persons and vessels are prohibited from anchoring, blocking,
loitering, or impeding within this regulated area unless authorized by
the Captain of the Port, or his designated representative. The Coast
Guard may be assisted by other Federal, State, or local law enforcement
agencies in enforcing this regulation.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of this enforcement period via the Local Notice to
Mariners, Safety Marine Information Broadcast, and local advertising by
the event sponsor.
    If the Captain of the Port Sector San Diego or his designated
representative determines that the regulated area need not be enforced
for the full duration stated on this document, he or she may use a
marine information broadcast or other communications coordinated with
the event sponsor to grant general permission to enter the regulated
area.

    Dated: March 19, 2021.
T.J. Barelli,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2021-06146 Filed 3-26-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59076-59079]
[FR Doc No: 2013-23288]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70451; File No. SR-Phlx-2013-95]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Temporary Rule Change to
Change the Expiration Date For Most Option Contracts to the Third
Friday of the Expiration Month Instead of the Saturday Following the
Third Friday

September 19, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 13, 2013, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes a temporary rule to change the expiration
date for most option contracts to the third Friday of the expiration
month instead of the Saturday following the third Friday. The text of
the proposed rule change is available on the Exchange's Web site at
http://nasdaqomxphlx.cchwallstreet.com/nasdaqomxphlx/phlx, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On August 21, 2013, the Exchange filed to change the expiration
date for most option contracts to the third Friday of the expiration
month instead of the Saturday following the third Friday.\3\ The
changes proposed in the Expiration Date Filing became effective on
filing, but will not be operative until September 20, 2013. The Options
Clearing Corporation (``OCC'') and the options exchange industry have
agreed to list certain Long Term Equity Options Series (``LEAPS'')
contracts expiring in January 2016 on September 16, 2013. The LEAPS
expiring in January 2016 will be issued with a Friday expiration

date pursuant to the recently approved rule changes of OCC.\4\ In order
not to disrupt the industry scheduled listing of the new LEAPS, the
Exchange is proposing to adopt a temporary rule that would be
immediately effective and remain operative through September 19, 2013,
the proposed expiration date of the temporary rule. On September 20,
2013, the rule changes in the Expiration Date Filing would become
operative.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 34-70259 (August 26,
2013), 78 FR 53809 (August 30, 2013)(SR-Phlx-2013-89)(``Expiration
Date Filing'').
    \4\ See Securities Exchange Act Release No. 34-69772 (June 17,
2013), 78 FR 37645 (June 21, 2013)(order approving SR-OCC-2013-004).
---------------------------------------------------------------------------

    The Exchange is proposing to change the expiration date for most
option contracts to the third Friday of the expiration month instead of
the Saturday following the third Friday. More specifically, the
Exchange is proposing to amend rule text referencing Saturday
expirations. The Exchange notes, however, that this change will apply
to all standard expiration contracts including those in which the rules
are silent on the expiration date.\5\ The Exchange is making this
filing to harmonize its rules in connection with a recently approved
rule filing made by OCC which made substantially similar changes.\6\
The Exchange believes that the industry must remain consistent in
expiration dates, and, thus, is proposing to update its rules to remain
consistent with those of OCC. In addition, the Exchange understands
that other exchanges have and will be filing similar rules to effect
this industry-wide initiative.\7\
---------------------------------------------------------------------------

    \5\ These standard expiration contracts also include proprietary
products of the Exchange such as Alpha Index option contracts (Rule
1009A(f)), U.S. Dollar-Settled Foreign Currency option contracts
(Rule 1057) and PHLX FOREX option contracts (Rules 1000C-1009C).
Standard expiration contracts also include the MSCI EM Index option
contracts (Rule 1108A) and Full Value MSCI EAFE Index option
contracts (Rule 1109A) which are listed pursuant to a license
agreement with MSCI Inc. Mini Options expirations are the same as
those for standard expirations and would be amended as specified in
this proposal.
    \6\ See note 4 supra.
    \7\ See Securities Exchange Act Release Nos. 70091 (August 1,
2013), 78 FR 48212 (August 7, 2013)(SR-CBOE-2013-073); 69996 (July
17, 2013), 78 FR 44183 (July 23, 2013)(SR-MIAX-2013-32); 70373
(September 11, 2013)(SR-NYSEMKT-2013-73) and 70372 (September 11,
2013)(SR-NYSEARCA-2013-88).
---------------------------------------------------------------------------

    Most option contracts (``standard expiration contracts'') currently
expire at the ``expiration time'' (11:59 p.m. Eastern Time) on the
Saturday following the third Friday of the specified expiration month
(the ``expiration date'').\8\ With the Expiration Date Filing and this
filing, the Exchange has provided advance notice to its members and
member organizations that the expiration date for standard expiration
contracts is changing to the third Friday of the expiration month.\9\
(The expiration time would continue to be 11:59 p.m. Eastern Time on
the expiration date.) The change would apply only to standard
expiration contracts expiring after February 1, 2015, and the Exchange,
similar to OCC, does not propose to change the expiration date for any
outstanding option contracts. The change will apply only to series of
option contracts opened for trading after the effective date of the OCC
rule change and having expiration dates later than February 1, 2015.
Option contracts having non-standard expiration dates (``non-standard
expiration contracts'') will be unaffected by this proposed rule
change, except that FLEX options having expiration dates later than
February 1, 2015 cannot expire on a Saturday unless they are specified
by OCC as grandfathered.\10\
---------------------------------------------------------------------------

    \8\ Examples of options with non-standard expiration contracts
include: FLEX options (Rule 1079), Quarterly Equity and Exchange-
Traded Fund Shares (``ETFs'') Option Series (Rule 1012, Commentary
.08), Quarterly Expiring Index Options Series (Rule 1101A(b)(iv)),
Quarterly Options Index Series Program (Rule 1101A(b)(v)), Short
Term Option Series (Rule 1012, Commentary .11) and Short Term Option
Index Series (Rule 1101A(b)(vi)).
    \9\ The Exchange has provided notice to its members and member
organizations regarding the expiration date change as it relates to
the 2016 LEAP replacement schedule in a memorandum dated August 13,
2013 sent to all option members and member organizations.
    \10\ See note 8 supra.
---------------------------------------------------------------------------

    In order to provide a smooth transition to the Friday expiration
OCC has begun to move the expiration exercise procedures to Friday for
all standard expiration contracts even though the contracts would
continue to expire on Saturday.\11\ After February 1, 2015, virtually
all standard expiration contracts will actually expire on Friday. The
only standard expiration contracts that will expire on a Saturday after
February 1, 2015 are certain options that were listed prior to the
effectiveness of the OCC rule change, and a limited number of options
that may have been listed prior to recent systems changes of the
options exchanges. Phlx will not list any additional options with
Saturday expiration dates falling after February 1, 2015. Phlx
understands that the other exchanges are committed to the same listing
schedule.\12\
---------------------------------------------------------------------------

    \11\ See note 4 supra.
    \12\ See note 7 supra.
---------------------------------------------------------------------------

    The Exchange notes that OCC, industry groups, clearing members and
the other exchanges have been active participants in planning for the
transition to the Friday expiration.\13\ In March 2012, OCC began to
discuss moving standard contract expirations to Friday expiration dates
with industry groups, including two Securities Industry and Financial
Markets Association (``SIFMA'') committees, the Operations and
Technology Steering Committee and the Options Committee, and at two
major industry conferences, the SIFMA Operations Conference and the
Options Industry Conference.\14\ OCC also discussed the project with
the Intermarket Surveillance Group and at an OCC Operations Roundtable.
In each case, there was broad support for the initiative.\15\
---------------------------------------------------------------------------

    \13\ See note 4 supra.
    \14\ Id.
    \15\ Id.
---------------------------------------------------------------------------

    Certain option contracts have already been listed with Saturday
expiration dates as distant as December 2015 (which is the furthest out
expiration as of the date of this filing). For these contracts,
transitioning to a Friday expiration for newly listed option contracts
expiring after February 1, 2015 would create a situation under which
certain options with open interest would expire on a Saturday while
other options with open interest would expire on a Friday in the same
expiration month.
    Clearing members have expressed a clear preference to not have a
mix of options with open interest that expire on different days in a
single month.\16\ Accordingly, OCC represented in its recently approved
filing that it will not issue and clear any new option contracts with a
Friday expiration if existing option contracts of the same options
class expire on the Saturday following the third Friday of the same
month. However, Friday expiration processing will be in effect for
these Saturday expiration contracts. As with standard expiration
options during the transition period, exercise requests received after
Friday expiration processing is complete but before the Saturday
contract expiration time will continue to be processed without fines or
penalties.
---------------------------------------------------------------------------

    \16\ Id.
---------------------------------------------------------------------------

    Exchange Rule 1000(b)(21) defines ``expiration date'' in the case
of options on stocks or Exchange-Traded Fund Shares as ``11:59 p.m.
Eastern Time on the Saturday immediately following the third Friday of
the expiration month.'' This provision effectively limits the
Exchange's ability to list monthly option contracts expiring on any day
other than a Saturday prior to September 20, 2013, the operative date
of the Expiration Date Filing. Thus, the Exchange is proposing to adopt
a temporary rule to change the definition of ``expiration date'' to
permit the scheduled listing of LEAPS expiring

in January 2016 planned for September 16, 2013.
    More specifically, this rule change proposes to amend Rule
1000(b)(21), the definition of ``expiration date'' for each of options
on stocks or Exchange-Traded Fund Shares, on a temporary basis to be
consistent with the revised OCC definition and the changes to be
implemented pursuant to the Expiration Date Filing.\17\ On September
19, 2013, the proposed rule change would expire and the rule changes in
the Expiration Date Filing would become operative on September 20,
2013, thereby permitting the continuous listing of the LEAPS series
referenced above.
---------------------------------------------------------------------------

    \17\ Id.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\18\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \19\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \20\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f (b).
    \19\ 15 U.S.C. 78f(b)(5).
    \20\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes that keeping its rules
consistent with those of the industry will protect all participants in
the market by eliminating confusion. The proposed changes thus allow
for a more orderly market by facilitating the industry-wide listing of
LEAPS expiring in January 2016 by all options exchanges consistent with
each option exchange's rules.
    In addition, the proposed changes will foster cooperation and
coordination with persons engaged in regulating clearing, settling,
processing information with respect to, and facilitating transactions
in securities by aligning a pivotal part of the options processing to
be consistent industry-wide in a similar timeframe. If the industry
were to differ, investors would suffer from confusion and be more
vulnerable to violate different exchange rules. The proposed changes do
not permit unfair discrimination between any members because they are
applied to all members equally. In the alternative, the Exchange
believes that this proposal helps all members by keeping the Exchange
consistent with OCC practices and those of other exchanges.

B. Self-Regulatory Organization's Statement on Burden on Competition

    Phlx does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Specifically, the
Exchange does not believe the proposed rule change will impose a burden
on intramarket competition because it will be applied to all members
equally. In addition, the Exchange does not believe the proposed rule
change will impose any burden to intermarket competition because it
will be applied industry-wide and apply to all market participants. The
proposed rule change is structured to enhance competition because
adopting a rule on a temporary basis that permits the listing of
options contracts with a Friday expiration date will facilitate an
industry-wide listing of a new LEAPS series. This in turn will allow
Phlx to be on equal footing and compete more effectively with other
exchanges making similar rule changes.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received. The Exchange
notes, however, that a favorable comment was submitted to the OCC
filing.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \21\ and Rule 19b-4(f)(6) thereunder.\22\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \22\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \23\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\24\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission notes that
waiver of the operative delay would permit the Exchange to implement
the changes proposed herein immediately.
---------------------------------------------------------------------------

    \23\ 17 CFR 240.19b-4(f)(6).
    \24\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    Under the proposal, the Exchange would amend certain of its rules
pertaining to the trading of options in order to change the expiration
date for most option contracts to the third Friday of the expiration
month instead of the Saturday following the third Friday. The Exchange
represents that a waiver of the 30-day operative delay is necessary and
appropriate to not disrupt the industry scheduled listing of Long Term
Equity Options Series (``LEAPS'') expiring in January 2016.
Specifically, the Exchange notes that the Options Clearing Corporation
and all national securities exchanges that trade options, including the
Exchange, agreed on adding new LEAPS expiring in January 2016 on
September 16, 2013, for those issues that are on the January expiration
cycle. The Exchange further represents that this date was published in
2012 and has been relied upon across the industry.
    Since the Exchange's Rule 1000(b)(21) currently defines
``expiration date'' as the ``Saturday immediately following the third
Friday of the expiration month,'' the Exchange will not be able to list
monthly option contracts expiring on any day other than a Saturday
until this proposal becomes effective. As such, the Exchange represents
that it will be at a significant competitive

disadvantage, and it requests the waiver to facilitate and coordinate
with the listing of the 2016 LEAPS on September 16, 2013. Based on the
Exchange representations above, and since the proposal is based, in
part, on a proposal submitted by the OCC and approved by the
Commission,\25\ the Commission waives the 30-day operative delay
requirement and designates the proposed rule change as operative upon
filing.\26\
---------------------------------------------------------------------------

    \25\ See supra note 4.
    \26\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2013-95 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2013-95. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-Phlx-2013-95 and should be
submitted on or before October 16, 2013.

For the Commission, by the Division of Trading and Markets, pursuant
to delegated authority. \27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-23288 Filed 9-24-13; 8:45 am]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I began seriously vaping when I discovered that nicotine provided sustainable neuropathic pain releif. During an 11 hour brain surgery in 2010, several nerves in my right arm were compressed to the point of permanent damage due to misplacement of my arm while I was unconscious. Without nicotine, the pain returns to it's original intensity. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Notices]
[Pages 4350-4353]
[FR Doc No: 2014-01423]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1432]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guide To Minimize
Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables

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
February 26, 2014.

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 0910-0609.
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.

Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and
Vegetables (OMB Control Number 0910-0609)--Extension

    Fresh-cut fruits and vegetables are fruits and vegetables that have
been processed by peeling, slicing, chopping, shredding, coring,
trimming, or mashing, with or without washing or other treatment, prior
to being packaged for consumption. The methods by which produce is
grown, harvested, and processed may contribute to its contamination
with pathogens and, consequently, the role of the produce in
transmitting foodborne illness. Factors such as the high degree of
handling and mixing of the product, the release of cellular fluids
during cutting or mashing, the high moisture content of the product,
the absence of a step lethal to pathogens, and the potential for
temperature abuse in the processing, storage, transport, and retail
display all increase the potential for pathogens to survive and grow in
fresh-cut produce.
    Sections 301 and 402 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 331 and 342) prohibits the distribution of
adulterated food in interstate commerce. In response to the increased
consumption of fresh-cut fruits and vegetables and the potential for
foodborne illness associated with these products, we recognize the need
for guidance specific to the processing of fresh-cut fruits and
vegetables. The guidance document entitled ``Guide to Minimize
Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,''
which is available at http://www.fda.gov/FoodGuidances, provides our
recommendations to fresh-cut produce processors about how to avoid
contamination of their product with pathogens. The guidance is in
addition to the good manufacturing practice (GMP) regulations found in
part 110 (21 CFR part 110). The guidance is intended to assist fresh-
cut produce processors in minimizing microbial food safety hazards
common to the processing of most fresh-cut fruits and vegetables sold
to consumers and retail establishments in a ready-to-eat form.
Accordingly, we encourage fresh-cut produce processors to adopt the
general recommendations in the guidance and to tailor practices to
their individual operations.
    The guidance provides information and recommended procedures
designed to help fresh-cut produce processors minimize microbial food
safety hazards. The recommended procedures contained in the guidance
are voluntary. Both FDA and fresh-cut produce processors will use and
benefit from the information collected.

    Two general recommendations in the guidance are for operators to
develop and implement both a written Standard Operating Procedures
(SOPs) plan and a Sanitary Standard Operation Procedures (SSOPs) plan.
SOPs and SSOPs are important components to properly implement and
monitor GMP, which are required for processed food operations under
part 110. Other recommended programs that require documentation and
recordkeeping are recall and traceback programs. In the event of a food
safety concern, processors who adopt these recommended programs will be
prepared to recall products from the marketplace or be able to
traceback fresh produce to its source. Fresh-cut produce processors are
also asked to consider the application of Hazards Analysis and Critical
Control Point (HACCP) principles or comparable preventive control
programs to the processing of fruits and vegetables. A HACCP system
allows managers to assess the inherent risks and identify hazards
attributable to a product or a process, and then determine the
necessary steps to control the hazards. FDA, along with other Federal
and State food Agencies and industry and food establishments, have
found such preventive control programs, when properly designed and
maintained by the establishment's personnel, to be valuable in managing
the safety of food products.
    In the Federal Register of November 20, 2013 (78 FR 69684), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received two letters in response to the
notice, with one containing multiple comments. Those comments outside
the scope of the four collection of information topics on which the
notice solicits comments are not discussed in this document.
    One comment suggested that, to ensure the safety of consumers, FDA
should mandate by law the recommendations in the guidance. The comment
stated that the Food Safety Modernization Act (FSMA) gave FDA authority
``to require producers to implement prevention based food safety
standards.'' In response, we note that Agency guidance documents are
issued consistent with our good guidance practices regulations (GGPs)
found at 21 CFR 10.115. Guidance documents represent our current
thinking on a particular subject, but do not create or confer any
rights for or on any person and do not operate to bind FDA or the
public. The guidance document entitled ``Guide to Minimize Microbial
Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' discusses
microbiological hazards presented by most fresh-cut fruits and
vegetables and recommends control measures for such hazards in the
processing of such produce. Firms are free to adopt as many or as few
of the guidance's recommendations as they choose.
    At the same time, we continue our rulemaking efforts under FSMA to
build a food safety system for the future that makes modern, science-,
and risk-based preventive controls the norm across all sectors of the
food system. In the Federal Register of January 16, 2013 (78 FR 3504),
we published a proposed rule proposing to establish science-based
standards for growing, harvesting, packing, and holding produce on
domestic and foreign farms. In the same issue of the Federal Register,
we published another proposed rule proposing to amend our regulation
for current good manufacturing practice in manufacturing, packing, or
holding human food to modernize it and to add requirements for domestic
and foreign facilities that are required to register under the FD&C to
establish and implement hazard analysis and risk-based preventive
controls for human food (78 FR 3646).
    One comment agreed, generally, that the information collection
provisions of the guidance are necessary. Another comment agreed,
generally, that our burden hour estimates are accurate, but suggested
they did not take into account the financial cost of training required
for the HACCP team. With regard to the latter comment, FDA notes that,
although only an estimate of reporting and recordkeeping burden is
included in Federal Register notices announcing agency information
collection activities (5 CFR 1320.5(a)(1)(iv)), we have provided an
estimate of the cost burden to industry in our supporting statement for
this collection, which is available at www.reginfo.gov.
    One comment suggested that we should require all processors in the
fresh-cut industry to electronically upload their SOPs and SSOPs to an
FDA Web site for review and audit. The comment maintained that such a
system ``would reduce the amount of man hours spend [sic] collecting,
reviewing, filing, auditing, and analyzing the written SOPs SSOPS
[sic]. It would also make communication, education, and support readily
available to the fresh-cut industry.'' Finally, one comment suggested
that we should require the fresh-cut industry to use an automated
system and standardized templates to scan and submit data to us for
review. As an example, the comment referenced the system used by
hospitals to submit information to a ``national healthcare regulator.''
The comment also noted the periodic scheduling of audits and
inspections of hospitals by the regulator.
    As previously discussed, the guidance document entitled ``Guide to
Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and
Vegetables'' represents our current thinking on the microbiological
hazards presented by most fresh-cut fruits and vegetables and provides
recommended control measures to protect against these hazards. We may
not impose requirements through Agency guidance.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOP and SSOP: Maintenance..........................................              122            3,315          404,430            0.067           27,097
Traceback development..............................................               10                1               10               20              200
Traceback maintenance..............................................              290                1              290               40           11,600
Preventive control program comparable to a HACCP system: System                   10                1               10              100            1,000
 development.......................................................
Preventive control program comparable to a HACCP system: System                  145              510           73,950            0.067            4,955
 implementation....................................................
Preventive control program comparable to a HACCP system:                         145                4              580                4            2,320
 Implementation review.............................................
                                                                    ------------------------------------------------------------------------------------
    Annual burden hours............................................  ...............  ...............  ...............  ...............           47,172
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

A. Industry Profile

    Estimates of the paperwork burden to the fresh-cut industry are
based on information received from a fresh-cut processor who has
developed and maintained these programs and information from a fresh-
cut produce industry trade association. We estimate that there are 280
fresh-cut plants in operation and that approximately 10 new firms will
enter the fresh cut industry over the next 3 years.

B. SOPs and SSOPs

    We consider the guidance's recommendation to develop SOPs and SSOPs
to be ``usual and customary'' for manufacturers and processors in the
fresh-cut industry (see 5 CFR 1320.3(b)(2)). Therefore, we do not
calculate this burden.
    We recommend that facilities not only develop but also maintain
SOPs and SSOPs. Of the 280 fresh-cut processors, we estimate that over
half have SOP and SSOP maintenance programs in place. Therefore, for
purposes of estimating the annual recordkeeping burden for SOP and SSOP
maintenance programs, we assume that 40 percent of the existing
processors, or 112 firms, and the 10 new firms do not have SOP and SSOP
maintenance programs in place. We estimate the recordkeeping burden for
SOP and SSOP maintenance programs by assuming that these 122 firms will
choose to implement such a maintenance strategy as a result of the
recommendations in the guidance.
    A typical fresh-cut processing plant operates about 255 days per
year. For an 8-hour shift, assuming the ingredients are received twice
during that time, under the recommendations in the guidance, there
would be about 13 records kept (2 for inspecting incoming ingredients;
2 for inspecting the facility and production areas once every 4 hours;
3 records for equipment (maintenance, sanitation, and visual
inspections for defects); 1 for calibrating equipment; 2 temperature
recording audits (1 time for each of the 2 processing runs); and 3
microbiological audits (ingredients, food contact surfaces, and
equipment)). Therefore, the annual frequency of recordkeeping for SOPs
and SSOPs is calculated to be 3,315 times (255 x 13) per year per firm;
122 firms will be performing these activities to generate a total
404,430 records (3,315 x 122) annually.
    The total time to record observations for SOP and SSOP maintenance
is estimated to take 4 minutes or 0.067 hours per record, and the
number of records maintained is 404,430. Therefore, the total annual
burden in hours for 122 processors to maintain their SOP and SSOP
records is approximately 27,097 hours (404,430 x 0.067). The
maintenance burden for these 122 firms is estimated in row 1 of table
1.

C. Recall and Traceback

    The burden to develop a traceback program is a one-time activity
estimated to take approximately 20 hours. Accordingly, we only need to
estimate the burden of this one-time activity on the 10 new businesses
expected to enter the industry in the next 3 years. We estimate that
the 10 new firms will spend 20 hours each preparing a traceback
program, for a total of 200 hours (10 x 20). The burden estimate of
developing a traceback program is shown in row 2 of table 1.
    Firms may test their traceback programs yearly to see if
adjustments are needed to maintain traceback capabilities. Evaluating
and updating traceback programs is estimated to take 40 hours to
complete. The annual burden of maintaining a traceback program is
estimated for the 280 existing firms in the industry plus the 10 firms
new to the industry. Assuming that each firm completes this exercise
once a year, the total maintenance burden of traceback programs is
11,600 hours yearly (290 x 40). This burden estimate is shown in row 3
of table 1.
    The guidance refers to previously approved collections of
information found in our regulations. The recommendations regarding
establishing and maintaining a recall plan, as provided in 21 CFR 7.59,
have been approved under OMB control number 0910-0249. Therefore, we
are not calculating a paperwork burden for recall plans.

D. Preventative Control Program

    Developing a HACCP plan is a one-time activity during the first
year that is estimated to take 100 hours based on a trained HACCP team
working on the plan full time. Accordingly, we only need to estimate
the burden on the 10 new businesses expected to enter the industry in
the next 3 years. We estimate that the 10 new firms will spend 100
hours each to develop their individual HACCP plans, for a total of
1,000 hours (10 x 100). This burden estimate is shown in row 4 of table
1.
    After the HACCP plan is developed, the frequency for recordkeeping
for implementing or maintaining daily records is estimated to be 510
records per year. The total time to record observations is estimated to
take 4 minutes or 0.067 hours per record. Of the 280 existing firms, we
estimate that approximately 135 firms have not implemented HACCP plans.
We assume that these fresh-cut processors (135 existing firms plus 10
new firms) would voluntarily implement a HACCP plan. Therefore, the
total annual records kept by 145 firms is 73,950 (510 x 145), and the
total hours required are 4,955 (73,950 records x 0.067 hours per record
= 4,954.65, rounded to 4,955). This annual burden is shown in row 5 of
table 1.

    Fresh-cut processors are presumed to review their HACCP plans four
times per year (once per quarter). Estimating that it takes each of the
145 firms 4 hours per review each quarter, the total burden of this
activity is 2,320 (145 x 4 x 4) hours per year. This annual burden is
shown in row 6 of table 1.

    Dated: January 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01423 Filed 1-24-14; 8:45 am]
BILLING CODE 4160-01-P