[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85968-85972]
[FR Doc No: 2016-28733]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0735]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Superimposed Text in
Direct-to-Consumer Promotion of Prescription Drugs

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.

DATES: Fax written comments on the collection of information by
December 29, 2016.

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-NEW nd
title Superimposed Text in Direct-to-Consumer Promotion of Prescription
Drugs. 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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.

Superimposed Text in Direct-to-Consumer Promotion of Prescription
Drugs--OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The proposed study seeks to extend previous research on the effects
of superimposed text (supers) in advertising to today's modern direct-
to-consumer (DTC) pharmaceutical promotion. Although earlier research
on the effects of supers in other consumer settings suggests that
altering text size can influence consumer comprehension of information,
it is unclear if these findings extend to DTC promotion of prescription
drugs and are applicable over 20 years later when viewing promotional
materials using today's modern technologies (e.g., tablets). Moreover,
other factors such as text/background contrast may also influence both
the understanding of the superimposed information (Ref. 1) and the
effects of text size. The proposed research seeks to update these
earlier findings and also to answer new questions concerning
presentation of supers.
    Part of FDA's public health mission is to ensure the safe use of
prescription drugs; therefore it is important that the information
provided in DTC promotion is clear and understandable for consumer
audiences, avoids use of deceptive or misleading claims, and achieves
``fair balance'' in presentation of benefits and risks. For example,
varying presentation formats including type size, bulleting, amount of
white space, and use of ``chunking'' or headlines can all influence
consumer perceptions of information (Ref. 2). A systematic review of
presentation formats in prescription drug labeling found that these
``clear communication'' characteristics positively influenced
consumer's comprehension of information and prescription drug behaviors
(i.e., adherence) (Ref. 3). In one randomized controlled study, young
and older adults were presented with 12 otherwise identical over-the-
counter drugs bottled with varied container labels along various
dimensions, one of which was text size (7 vs 10 point). While younger
participants performed equally well with both font sizes, elderly
populations had significantly reduced recall and comprehension when
exposed to the smaller text size (Ref. 4). Another study found that
both young and older populations preferred the larger text size, and
that patients read labels with larger font more rapidly and accurately
than labels with smaller font (Ref. 5). Although these studies were
specific to prescription drug container labels, it is plausible that
the effects of font sizes would be applicable to drug promotion.
    Some early research in the late 1980s and 1990s examined the size
of text information in advertising topics outside of prescription drugs
(Refs. 6, 7, and 8). These studies all generally found that text size
was associated with comprehension, such that larger text sizes
increased understanding of the material (and, conversely, smaller text
sizes interfered with comprehension). For example, Foxman and
colleagues (Ref. 6) found that whereas ``small'' text size (<\1/2\ inch
size) was associated with accurate comprehension for 59% of
respondents, ``large'' text size (>\1/2\ inch size) was associated with
comprehension for 79% of respondents. Studies by other researchers
(Refs. 7 and 8) found similar patterns such that increasing the text
size of supers generally corresponded with increased comprehension.
    We know of no studies that have examined other commonly variable
factors, such as text/background contrast, that may interact with text
size to influence comprehension. Early research on text readability
determined that the contrast between text and background has a
consistent but small effect. Specifically, while the contrast of color
has a small effect (Ref. 9), the contrast in brightness, or luminance,
makes the largest difference (Ref. 10). These studies showed that black
text on a white background results in the highest readability (Ref.
11), but that other effects of color contrasts are unclear (Ref .1).
Some studies have demonstrated that contrast interacts with text size,
such that contrast becomes a more important discriminator as the text
size decreases (Ref. 12).
    The earlier research on supers is limited in their applicability to
today's DTC promotion in several ways. None of these studies
specifically focused on prescription drug promotion, but rather
explored the effects of superimposed text in a variety of social and
consumer advertising contexts. Another limitation is that these earlier
studies were conducted with populations (i.e., undergraduate students)
that are not representative of today's prescription drug users. It is
not clear if the effects of supers would translate to older adult
populations, who represent the greatest proportion of prescription drug
users (Ref. 13). Perhaps most importantly, it is unknown if the effects
of supers would be found today, considering the prevalent use of modern
technologies, including large (40+ inches) TV screens and personal
tablets. Our proposed study seeks to address these unanswered questions
regarding the use of supers in prescription drug promotion.

General Research Questions

    1. Does the size of the superimposed text, the contrast behind the
superimposed text, and/or the device type influence the noticeability,
recall, and perceived importance of the super information?
    2. Does the size of the superimposed text, the contrast behind the
superimposed text, and/or the device type influence the recall of and
attitudes toward the promoted drug?
    3. Are there any interaction effects among any combination of
independent variables?

Design

    To test these research questions, we will conduct one randomized
controlled study. We will examine reactions to supers in a fictitious
DTC prescription drug promotional video on two types of viewing devices
with a general population sample. The study design will be a 3 x 2 x 2
factorial design, where participants are randomly assigned to one of 12
experimental study arms differentiated by:
     Super text size (small, medium, large);
     Device type (television, tablet);
     Super text contrast (high, low).

                                                      Table 1--Design and Cell Sizes for Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
               Device type                                      TV                                            Tablet
-----------------------------------------------------------------------------------------------------------------------------------------      Total
               Super size                      Small          Medium           Large           Small          Medium           Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contrast:
    High................................             106             106             106             106             106             106             636
    Low.................................             106             106             106             106             106             106             636
                                         ---------------------------------------------------------------------------------------------------------------
        Total...........................             212             212             212             212             212             212           1,272
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The sample will be split evenly across three cities (Los Angeles, CA; Cincinnati, OH; and Tampa, FL), with 424 participants per city.

    For both the pretest and main study, we will work with two market
research firms to recruit adult participants and conduct in-person data
collection in three U.S. cities: Los Angeles, CA, Cincinnati, OH, and
Tampa, FL. In addition to our aim for regional variation, we selected
these three cities with the aim of recruiting a sample that is diverse
on gender, race/ethnicity, education, and age characteristics.
    Participants from the general population will be invited to a
market research facility to watch one video for a fictional
prescription drug that treats asthma. In-person administration of study
procedures will enable us to control the television and tablet watching
experience in terms of size, distance, and other variables.
Participants will watch the video twice and then answer questions
addressing recall of risks and benefits, perceptions of risks and
benefits, and questions regarding the salience of information in text.
The questionnaire is available upon request. Participation is estimated
to take approximately 20 minutes.
    To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance
(ANOVA).
    Pretesting will take place before the main study to select super
sizes for the main study and to evaluate the procedures and measures
that will be used. We will exclude individuals who work in healthcare
or marketing settings because their knowledge and experiences may not
reflect those of the average consumer. We conducted a priori power
analyses to determine sample sizes for the pretest and the main study.
    In the Federal Register of March 9, 2016 (81 FR 12503), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received 10 comments total. Six comments
were outside the scope of the proposed research (``Ban DTC''), leaving
four substantive comments.
1. Abbvie
    a. Comment: Mobile users can change font size and viewing size--we
should incorporate this into our study.
    Response: Although the font size for certain text (such as
newspaper articles) or closed captioning text size can be changed on a
tablet, supers within a developed video cannot be manipulated.
Participants will be allowed to hold the tablet as they normally would,
but it is important to establish experimental control over many user
settings to avoid threats to internal validity. Thus, font and viewing
size will be standardized for this study.
    b. Comment: Recommend looking at use of TV and mobile devices
concurrently, as some people use them this way.
    Response: This is a good suggestion for future research, but is out
of scope for the current study.
2. Lilly
    a. Comment: Generally supportive; research objectives and study
approach are reasonable.
    Response: Thank you.
    b. Comment: Recommend showing supers in black box at bottom of the
screen and not superimposing them over moving, contrasting color field
to mimic common practices in television commercial advertising.
    Response: Our high contrast condition indeed presents the supers in
white font on a black background at the bottom of the screen. Our low
contrast condition shows lettering over the moving scenes because not
all advertisements show their supers in a black banner.
    c. Comment: Lilly requests clarity about how the size of text and
level of contrast were developed when the agency reports the results of
the study.
    Response: We used cognitive interviews and will use the pretest to
make these determinations. We will be sure to include this information
when we report the results of the study.
    d. Comment: Recommend qualitative pre-test instead of quantitative
pretest.
    Response: We fulfilled this suggested purpose with a set of nine
cognitive interviews that were conducted in April.
    e. Comment: Request clarity about quota sampling and other
techniques we may plan to use to ensure a diverse sample. Also suggest
groups of at least 50 in each cell for analysis purposes.
    Response: As this study is not intended to be nationally
representative, we will not employ strict quota sampling procedures.
However, we will work closely with our recruitment firms to monitor
recruitment and ensure that our sample is diverse with regard to
factors including race, education, age and gender. Further, selection
of our three U.S. cities for data collection (Los Angeles, Cincinnati
and Tampa) was purposive to help achieve diversity on these factors.
    To answer the second part of the comment, we are aware of no
statistical or research standard that specifies that groups must
contain 50 individuals. However, we conducted power analyses and
determined that in order to have enough power for the proposed
statistical tests, we will exceed this number per experimental cell.
    f. Comment: Recommends replacing the pre-test question about the
importance of the text information (Question 5) with a question such as
``how noticeable or legible was the text information?''
    Response: We agree that the noticeability and legibility of the
text information is important, and we have other questions that address
this. We are specifically interested in the perceived importance of the
text information as a moderator variable.
    g. Comment: Recommends removing semantic differential questions
(Question 9) and essentially any questions that ask about perceptions
because it is a pretest.
    Response: Our pretest study is not designed to test the main study
questionnaire. Rather, the main purposes of the pretest are to (1) test
consumer perceptions of superimposed-text size with the aim of choosing
perceptibly different levels of size (small, medium, large) for use in
the main study; and (2) test our planned

procedures for implementation of the intervention (TV and tablet) and
in-person data collection. However, to make the most use of our
resources, we also plan to test the properties of certain main study
survey items (e.g., means, ranges, etc.) to ensure the utility of the
items for use in the main study.
    h. Comment: Calls out an inconsistency in terms of how many times
participants will view the ad.
    Response: Thank you for noting that discrepancy. Participants will
view the ad once. We have corrected all materials to reflect this
change. Lilly recommends showing it twice. We agree that if the goal is
to learn about user experience (preferences and such, or trying to
improve the presentation) then two or more viewings makes sense.
However, our goal is to test differences in cognitive processing based
on the varied size/contrast presentations of the supers. Thus, we do
not want to artificially enhance the scrutiny participants pay to the
ad above and beyond the experimental situation. For example, small
supers may interfere with cognitive processing as hypothesized, but
this interference may be overcome upon a second viewing. In a real
world viewing situation, consumers rarely see an ad two times in a row.
    i. Comment: Question 12: Attributes are very similar and will be
duplicative.
    Response: The three survey items for question 12 (attitudes towards
the ad) are conceptually similar and will be used as a multi-item
scale. Conventionally, three items is the minimum recommended to assess
inter-item reliability.
    j. Comment: Question 12 and 14: Suggest bolding or underlining
``drug'' or ``ad'' in these questions to differentiate them for
participants.
    Response: We agree and have added language to the survey items to
better make this distinction. For items specific to attitudes towards
the drug we now begin the item with ``Overall, DRUG X is . . .''
whereas items about the ad begin with ``Overall, the ad was . . .''
    k. Comment: Would be interesting to include an open-ended question
about whether any additional information could have or should have been
provided in the ad, such as accessibility to the drug, information
about the disease, etc.
    Response: These are great ideas and would provide additional
information about various communication issues relevant to DTC
television promotion. However, we regret that we must make difficult
choices about what to include and not include in this study and these
issues fall outside the scope of the current research questions.
3. Merck
    a. Comment: FDA's execution may not yield useful data. For example,
we are examining TV and tablet use, but people may be viewing promotion
on mobile devices.
    Response: We agree that the ways in which people view their media
are multiplying and that we have not captured all of them. However,
rather than simply study superimposed text on a television screen, we
opted to add an examination of viewing on a tablet, which is an
increasingly popular option for viewing shows. We regret that we do not
have the opportunity to explore viewing on all possible new
technologies, but we believe that the current study will offer insights
above and beyond the television screen.
    b. Comment: Prior to the implementation of results from individual
studies on the content, format, and presentation of information in DTC
advertisements on television, FDA should conduct research on the
combination of all of the individual factors.
    Response: This comment is outside the scope of the present project.
It is not directed at the improvement of the study and does not appear
to require the abandonment of the current study.
4. GlaxoSmithKline (GSK)
    a. Comment: Allowing participants to view the TV at the distance
they usually view it and to interact with the tablet the way they
ordinarily do would better reflect a real-world experience.
    Response: We agree that these details are important to consider
when conducting valid research. We must make a decision between the
trade-off of experimental control and real-world generalizability. We
have attempted to do this by setting up the television and chair in the
room at the average distance that people tend to sit from their
televisions in their living room and instructing participants to wear
glasses or contact lenses if needed. Television viewing is a more fixed
experience than more modern technologies. We also agree that allowing
individuals to hold the tablet or place it on a table as they normally
would is appropriate for both experimental control and ecological
generalizability.
    b. Comment: Including a medium contrast instead of just a high and
low contrast may be informative.
    Response: We appreciate this comment because we considered it when
designing the study. We decided to use only high and low contrast in
the study because our main variable of interest in this particular
study is the size of the text. Thus, we are expending resources to
attempt to determine multiple sizes of text to test in order to get a
fuller appreciation of the role of text size in DTC promotion. We have
found in past studies that identifying a medium level is difficult
(e.g., OMB Control No. 0910-0695) and chose in this study to focus on
size rather than contrast. That said, we do feel that contrast is
valuable enough to add as a variable of interest, so we are planning to
devote two conditions to it.
    c. Comment: It would be useful if the questionnaire is posted along
with the notice on regulations.gov.
    Response: We are happy to provide the questionnaire to anyone who
requests it.
    d. Comment: Suggests an FDA-Industry working group might be helpful
in the furtherance of this research.
    Response: This is an intriguing idea and may have merit after we
obtain empirical data that is specifically applicable to DTC promotion.
Without this data, it is unclear what this working group would
contribute. We will consider this idea in further detail upon
interpretation of results.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual    Average burden  per response  (in hours)     Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Pretesting
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to complete the screener (assumes 50%             338               1             338  0.08 (5 minutes)..........................              27
 eligible).

Number of completes.........................             240               1             240  0.42 (25 minutes).........................             101
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to complete the screener (assumes 50%           1,785               1           1,785  0.08 (5 minutes)..........................             143
 eligibility).
Number of completes.........................           1,272               1           1,272  0.42 (25 minutes).........................             534
                                             -----------------------------------------------------------------------------------------------------------
    Total hours.............................  ..............  ..............  ..............  ..........................................             805
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

1. Hall R.H. and P. Hanna ``The Impact of Web page Text-background
Colour Combinations on Readability, Retention, Aesthetics, and
Behavioural Intention.'' Behavior & Information Technology. vol. 23
pp. 183-95, 2004.
2. Baur C and C. Prue ``The CDC Clear Communication Index is a Tool
to Prepare and Review Health Information.'' Health Promotion
Practice. vol.15 pp. 629-37, 2014.
3. Shrank W, J. Avorn, C. Rolon, and P.Shekelle ``Effect of Content
and Format of Prescription Drug Labels on Readability,
Understanding, and Medication Use: A Systematic Review.'' Annals of
Pharmacotherapy. vol. 41 pp. 783-801, 2007.
4. Wogalter, M.S. and W.J. Vigilante. ``Effects of Label Format on
Knowledge Acquisition and Perceived Readability by Younger and Older
Adults.'' Ergonomics. vol. 46 pp. 327-344, 2003.
5. Smither, J.A.A. and C.C. Braun ``Readability of Prescription Drug
Labels by Older and Younger Adults.'' Journal of Clinical Psychology
in Medical Settings. vol. 1 pp. 149-59, 1994.
6. Foxman, E.R., D.D. Muehling and P.A. Moore. ``Disclaimer
Footnotes in Ads: Discrepancies Between Purpose and Performance.''
Journal of Public Policy and Marketing. vol. 7 pp. 127-37, 1988.
7. Murray N.M., L.A. Manrai and A.K. Manrai. ``Public Policy
Relating to Consumer Comprehension of Television Commercials: A
Review and Some Empirical Results.'' Journal of Consumer Policy.
vol. 16 pp. 145-170, 1993.
8. Manrai, L.A., A.K. Manrai and N. Murray. ``Comprehension of Info-
aid Supers in Television Advertising for Social Ideas: Implications
for Public Policy''. Journal of Business Research. vol. 30 pp. 75-
84, 1994.
9. Hill A. and L. Scharff. ``Readability of Computer Displays as a
Function of Colour, Saturation, and Background Texture.'' In D.
Harns (Ed.) Engineering Psychology and Cognitive Ergonomics (vol. 4)
Ashgate, Aldershot, United Kingdom.
10. Shieh K-K. and C-C. Lin. ``Effects of Screen Type, Ambient
Illumination, and Color Combination on VDT Visual Performance and
Subjective Preference.'' International Journal of Industrial
Ergonomics. vol. 26 pp. 527-36, 2000.
11. Tinker M.A. and D.G. Paterson. ``Studies of Typographical
Factors Influencing Speed of Reading. VII. Variations in Color of
Print and Background.'' Journal of Applied Psychology. vol. 15 pp.
471-9, 1931.
12. Legge G.E., G.S. Rubin and A. Luebner ``Psychophysics of
reading. V. The Role of Contrast in Normal Vision.'' Vision Research
vol. 27 pp. 1165-77, 1987.
13. Kaufman D.W., J.P. Kelly, L. Rosenberg, T.E. Anderson and A.A.
Mitchell. ``Recent Patterns of Medication Use in the Ambulatory
Adult Population of the United States: The Slone Survey.'' Journal
of the American Medical Association vol. 287 pp. 337-344, 2002.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28733 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Proposed Rules]
[Pages 63348-63349]
[FR Doc No: 2014-25217]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1584]

Same Surgical Procedure Exception Questions and Answers Regarding
the Scope of the Exception; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comment on draft guidance.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Same Surgical Procedure
Exception Questions and Answers Regarding the Scope of the Exception''
dated October 2014. The draft guidance document is intended for tissue
establishments and healthcare

professionals and discusses one of the exceptions for establishments
from certain regulatory requirements.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 22, 2014

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit 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: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions
and Answers Regarding the Scope of the Exception'' dated October 2014.
The draft guidance document is intended for use by tissue
establishments and healthcare professionals. When finalized, the
guidance document will provide our current thinking with respect to the
exception set forth in Title 21 of the Code of Federal Regulations
1271.15(b) (21 CFR 1271.15(b)). The draft guidance is presented in
question and answer format and includes examples based on inquiries
received by the Agency since the final rule, ``Human Cells, Tissues,
and Cellular and Tissue Based Products; Establishment Registration and
Listing'' published in the Federal Register of January 19, 2001 (66 FR
5447).
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 1271 have been approved under
OMB control number 0910-0543.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25217 Filed 10-22-14; 8:45 am]
BILLING CODE 4164-01-P


5B-57.007 Noxious Weed List.

(1) Parasitic Weeds.

(a) Aeginetia spp. (Aeginetia).

(b) Alectra spp. (Alectra).

(c) Cuscuta spp. Only the native Florida species are excluded from this
list. These include:

1. C. americana.

2. C. compacta.

3. C. exaltata.

4. C. gronovii.

5. C. indecora.

6. C. obtusiflora.

7. C. pentagona.

8. C. umbellata.

(d)1. Orobanche spp. (broomrapes), with the exception of:

2. O. uniflora. (oneflowered broomrape)

(2) Terrestrial Weeds.

(a) Ageratina adenophora (crofton weed).

(b) Alternanthera sessilis (sessile joyweed).

(c) Abrus precatorius (rosary pea).

(d) Ardisia elliptica (shoebutton ardisia).

(e) Asphodelus fistulosus (onionweed).

(f) Avena sterilis (including Avena budoviciana) (animated oat, wild
oat).

(g) Borreria alata (broadleaf buttonweed).

(h) Carthamus oxyacantha (wild safflower).

(i) Casuarina equisetifolia (Australian pine).

(j) Casuarina glauca (suckering Australian pine).

(k) Chrysopogon aciculatus (pilipiliula).

(l) Colubrina asiatica (latherleaf)

(m) Commelina benghalensis (Benghal dayflower).

(n) Crupina vulgaris (common crupina).

(o) Cupaniopsis anacardioides (carrotwood) Propagation prohibited
effective 7/1/99; sale or distribution prohibited 1/1/2001.

(p) Digitaria scalarum (African couchgrass, fingergrass).

(q) Digitaria velutina (velvet fingergrass, annual couchgrass).

(r) Dioscorea alata (white yam).

(s) Dioscorea bulbifera (air potato).

(t) Drymaria arenarioides (lightning weed).

(u) Emex australis (three-corner jack).

(v) Emex spinosa (devil’s thorn).

(w) Euphorbia prunifolia (painted euphorbia).

(x) Galega officinalis (goat’s rue).

(y) Heracleum mantegazzianum (giant hogweed).

(z) Imperata brasiliensis (Brazilian satintail).

(aa) Imperata cylindrica (cogongrass).

(bb) Ipomoea triloba (little bell, aiea morning glory).

(cc) Ischaemum rugosum (murainograss).

(dd) Leptochloa chinensis (Asian sprangletop).

(ee) Leucaena leucocephala (lead tree).

(ff) Lycium ferocissimum (African boxthorn).

(gg) Lygodium japonicum (Japanese climbing fern).

(hh) Lygodium microphyllum (small-leaved climbing fern).

(ii) Melaleuca quinquenervia (melaleuca).1

(jj) Melastoma malabathricum (Indian rhododendron).

(kk) Mikania cordata (mile-a-minute).

(ll) Mikania micrantha (climbing hempweed).

(mm) Mimosa invisa (giant sensitive plant).

(nn) Mimosa pigra (catclaw mimosa).1

(oo) Nassella trichotoma (serrated tussock).

(pp) Neyraudia reynaudiana (Burma reed).

(qq) Opuntia aurantiaca (jointed prickly pear).

(rr) Oryza longistaminata (red rice).

(ss) Oryza punctata (red rice).

(tt) Oryza rufipogon (wild red rice).

(uu) Paederia cruddasiana (sewer-vine).

(vv) Paederia foetida (skunk-vine).

(ww) Paspalum scrobiculatum (Kodomillet).

(xx) Pennisetum clandestinum (Kikuyu grass).

(yy) Pennisetum macrourum (African feathergrass).

(zz) Pennisetum pedicellatum (Kyasuma grass).

(aaa) Pennisetum polystachyon (missiongrass, thin napiergrass).

(bbb) Prosopis spp.

(ccc) Pueraria montana (kudzu).

(ddd) Rhodomyrtus tomentosa (downy myrtle).

(eee) Rottboellia cochinchinensis (itchgrass).

(fff) Rubus fruticosus (bramble blackberry).

(ggg) Rubus molluccanus (wild raspberry).

(hhh) Saccharum spontaneum (wild sugarcane).

(iii) Salsola vermiculata (wormleaf salsola).

(jjj) Sapium sebiferum (Chinese tallow tree).

(kkk) Scaevola taccada (beach naupaka). Propagation prohibited
immediately and distribution prohibited by July 1, 2007.

(lll) Schinus terebinthifolius (Brazilian pepper-tree).1

(mmm) Setaria pallidefusca (cattail grass).

(nnn) Solanum tampicense (wetland nightshade).

(ooo) Solanum torvum (turkeyberry).

(ppp) Solanum viarum (tropical soda apple).

(qqq) Tridax procumbens (coat buttons).

(rrr) Urochloa panicoides (liverseed grass).

1Department of Environmental Protection permit required for these
species.

Specific Authority 570.07(13), (23) FS. Law Implemented 581.031(4), (5),
(6), 581.083, 581.091 FS. History–New 7-27-93, Amended 2-28-94,
6-30-96, 7-7-99, 10-1-06.


[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6010-6011]
[FR Doc No: 2018-02785]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 7569-006]

University of Notre Dame; Notice of Application Accepted for
Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
Please note that this application was previously noticed by the
Commission on October 3, 2017. However, due to a clerical error, the
Commission is reissuing this notice for public comment. There have been
no significant changes to the exemptee's application since the October
3, 2017.
    a. Type of Application: Application to amend 5 MW exemption from
licensing.
    b. Project No.: 7569-006.
    c. Date Filed: April 24, 2017, and supplemented on September 21,
2017.
    d. Applicant: University of Notre Dame.
    e. Name of Project: South Bend Hydroelectric Project.
    f. Location: The project is located on the St. Joseph River in St.
Joseph County, Indiana.
    g. Filed Pursuant to: 18 CFR 4.104 (2016).
    h. Applicant Contact: Mr. Paul A. Kempf, University of Notre Dame,
100 Facilities Building, Notre Dame, IN 46556,<PHONE_NUMBER>.

    i. FERC Contact: Jennifer Polardino,<PHONE_NUMBER>, or
[email protected].
    j. Deadline for filing comments, motions to intervene, protests,
and recommendations is 30 days from the issuance date of this notice by
the Commission.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, or recommendations using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Please include the project number (P-7569-006) on
any comments, motions to intervene, protests, or recommendations filed.
    k. Project as Authorized: The South Bend project consists of: (1)
An existing reservoir with a surface area of 150 acres and a storage
capacity of 800 acre-feet at a pool elevation of 680 feet mean sea
level; (2) an existing concrete and timber-crib dam approximately 18-
feet-high and 435 feet long; (3) powerhouse containing one 50-kilowatt
(kW) and two 890 kW generating units, for a total authorized capacity
of 1,830 kW; and (4) appurtenant facilities.
    l. Description of Request: The exemptee requests approval to amend
the exemption for the South Bend Hydroelectric Project with the
following modifications to the project's facilities: Ten 250 kilowatt
(kW) units for a total generating capacity of 2,500 kW; a 390-foot-long
conveyance channel, a coarse trash rack at the inlet to the conveyance
channel; a secondary trash rack with a traveling brush; and a 1.5 mile
long, 1.47 kilovolt transmission line buried from the hydro site to the
tie-in point at the Notre Dame campus. The proposed modifications would
require changes to the project's boundary.
    m. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    n. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    o. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    p. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title COMMENTS, PROTEST, or MOTION TO
INTERVENE as applicable; (2) set forth in the heading, the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). All comments,
motions to intervene, or protests should relate to project works which
are the subject of the license amendment. Agencies may obtain copies of
the application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. If an intervener
files comments or documents with the Commission relating to the merits
of an issue that may affect the responsibilities of a particular
resource agency, they must also serve a copy of the document on that
resource agency. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: February 6, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-02785 Filed 2-9-18; 8:45 am]
BILLING CODE 6717-01-P


                               Surtivo[(R)] ULTRA
             Biological insecticide for the integrated control of
Corn earworm, Cotton bollworm, Tomato fruitworm, (Helicoverpa zea  + Tobacco bolworm (Heliothis virescens), Soybean looper (Chrysodeixis includes), Cabbage looper (Trichoplusia ni), Diamondback moth (Plutella xylostella), Velvetbean caterpillar (Anticarsia gemmatalis), Fall Armyworm (Spodoptera frugiperda), Beet Armyworn (S. exigua), Southern Armyworm (S. eridania) on labeled crops

--------------------------------------------------------------------------------
	Active Ingredients*:
--------------------------------------------------------------------------------
	Autographa californica Multiple NPV strain R3:	8.6%
--------------------------------------------------------------------------------
	Chrysodeixis includens Nucleopolyhedrovirus isolate #460:	8.6%
--------------------------------------------------------------------------------
	Helicoverpa zea Nucleopolyhedrovirus strain ABA-NPV-U:	8.6%
--------------------------------------------------------------------------------
	Spodoptera fruigiperda Multiple Nucleopolyhedrovirus strain 3AP2:	8.6%
Other ingredients:		65.8%
--------------------------------------------------------------------------------
	Total:	100.0%
	* Contains a minimum of 7.5 x10[9] occlusion bodies per milliliter of product

                         KEEP OUT OF REACH OF CHILDREN
                                    CAUTION
    See additional precautionary and first aid statements on the back panel

                    Net Contents: 0.25, 1, 2.5 or 5 gallons

EPA Registration Nº: 87978-I
EPA Est. Number:

Manufactured for:
AgBiTech Pty Ltd
8 Rocla Court
Glenvale, Queensland 4350
Australia

Product of USA

Batch code: ___________________

                                   FIRST AID
If on skin or clothing:
* Take off contaminated clothing.
* Rinse skin immediately with plenty of water for 15-20 minutes.
                                HOT LINE NUMBER
Have the product container or label with you when calling a poison control center or doctor, or going for treatment.

For general information concerning this product, call the National Pesticide Information Center (NPIC) at 1-800-858-7378 seven days a week, 8 AM to 12 PM PST or at http://npic.orst.edu.  For medical emergencies, call the poison control center at 1-800-222-1222.

                           PRECAUTIONARY STATEMENTS

                    HAZARDS TO HUMANS AND DOMESTIC ANIMALS
                                    CAUTION

Harmful if absorbed through the skin. Avoid contact with skin or clothing.  Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove and wash contaminated clothing before reuse.

                      PERSONAL PROTECTIVE EQUIPMENT (PPE)

Mixers, Loaders, Applicators and other handlers must wear:
   * Protective eyewear
   * Long-sleeved shirt and long pants
   * Waterproof gloves
   * Shoes plus socks

Mixers/loaders and applicators must wear a NIOSH-approved particulate respirator with any N, R or P filter with NIOSH approval number prefix TC-84A; or a NIOSH-approved powered air purifying respirator with an HE filter with NIOSH approval number prefix TC-21C. Repeated exposure to high concentrations of microbial proteins can cause allergic sensitization.

Follow the manufacturer's instructions for cleaning/maintaining PPE. If no such instructions are available, use detergent and hot water for washables. Keep and wash PPE separately from other laundry.

                           USER SAFETY RECOMMENDATIONS

Users should:
   * Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.
   * Remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.

                            ENVIRONMENTAL HAZARDS

This product may be pathogenic to nontarget Lepidoptera exposed to direct treatment. Do not apply this product while nontarget Lepidoptera are actively visiting the treatment area. Minimize spray drift away from target area to reduce effects to nontarget Lepidoptera.

For terrestrial uses: do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.

Do not contaminate water when disposing of equipment wash waters or rinsate.

                              DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Do not use this product until you have read the entire label.  Do not apply this product in a way that will contact workers or other persons, either directly or through drift.  Only protected handlers may be in the area during application.  For any requirement specific to your State or Tribe, consult the State or Tribal agency responsible for pesticide regulation.

Do not apply by aerial application.

                         AGRICULTURAL USE REQUIREMENTS

Use this product only in accordance with its labeling and with Worker Protection Standard, 40 CFR Part 170.  This Standard contains requirements for the protection of agricultural workers on farm, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification and emergency assistance. It also contains specific instructions and exemptions pertaining to the statements on this label about personal protective equipment (PPE) and restricted-entry interval. The requirements in this box apply only to uses of this product that are covered by the Worker Protection Standard.

Do not enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 4 hours.

PPE required for early entry to treated areas (that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water), is:
   * Coveralls
   * Wear waterproof gloves
   * Shoes plus socks
   * Protective eyewear

                              PRODUCT INFORMATION
This product contains a biological insecticide for the control of the following moth larvae on labeled crops:
                Corn earworm, Cotton bollworm, Tomato fruitworm
                   (Helicoverpa zea  + Helicoverpa armigera)
                    Tobacco bolworm (Heliothis virescens)
                    Soybean looper (Chrysodeixis includes)
                       Cabbage looper (Trichoplusia ni)
                    Diamondback moth (Plutella xylostella)
                Velvetbean caterpillar (Anticarsia gemmatalis)
                     Fall Armyworm (Spodoptera frugiperda)
                           Beet Armyworn (S. exigua)
                        Southern Armyworm (S. eridania)

                                 INSTRUCTIONS

Surtivo Ultra (Autographa californica Multiple NPV strain R3 (AcMNPV) + Chrysodeixis includens Nucleopolyhedrovirus isolate #460 (ChinNPV) + Helicoverpa zea Nucleopolyhedrovirus strain ABA-NPV-U (HearNPV) + Spodoptera fruigiperda Multiple Nucleopolyhedrovirus strain 3AP2 (SfMNPV)) is a pathogen of Lepidopteran insects in the following species:  Helicoverpa zea, Heliothis virescens, Plutella xylostella,  Trichoplusia ni, Chrysodeixis includens, Spodoptera frugiperda, Spodoptera exigua, Spodoptera eridania, and Anticarsia gemmatalis. The effectiveness of Surtivo Ultra is dependent on a number of important factors; larval size, environmental conditions, application and the feeding behavior of the pest.  Because of the requirement for adequate timing of application, coverage, and weather conditions, the performance of Surtivo Ultra may be variable. Once infected, larvae can take up to 8 days to die, although feeding activity is greatly reduced within 1 to 3 days post infection, dependent on larvae size.  Daytime temperatures of 65°F to 95°F are ideal for the infectivity by Surtivo Ultra.  Infected larvae will amplify the virus, and following death will release large amounts of viral occlusion bodies that can result in ongoing control, particularly under environmental conditions suitable for the virus in Surtivo Ultra (warm and humid conditions).

Good coverage of the feeding sites of the larvae is essential, as the product needs to be ingested to be effective.  If larvae are feeding low down in a heavy crop canopy, and application of Surtivo Ultra does not reach these areas, initial control from the spray will be sub-optimal.  However, larvae that die from the Surtivo Ultra spray will release large amounts of AcMNPV, ChinNPV, HearNPV and SfMNPV which will spread throughout the crop canopy.

                                     USES

Surtivo Ultra should only be used to target small larvae (1[st], 2[nd] and 3[rd] instars). Larvae at the higher end of the recommended size spectrum will take longer to die and cause more significant damage prior to death.

                                 RAIN FASTNESS

The majority of virus uptake occurs within one (1) hour post-application.  For this reason, it is best to avoid applying Surtivo Ultra if heavy rain is expected within one (1) hour following application.  However, do not delay application if only moderate rain is expected, or heavy rain (greater than 0.4 inches per hour) is not imminent.
            CROPS, APPLICATION RATES AND CROP SPECIFIC INFORMATION
Crops
Rate of Lepigen
per acre
Additional Information
Sorghum
0.7 to 1.4 fl. oz.
Use lower application rates when targeting larvae smaller than 0.3 inches in length (1st and 2nd instar) and in mixtures with sprays for midge control (not ULV).  Use higher application rates when targeting larvae larger than 0.3 inches in length (3rd instar) or under high pressure situations.  Applications that are targeted when 50% of heads have reached 100% flowering will provide good control.
Cereal Grains Group (Crop Group 15 excluding Sweet corn) including: Corn (maize), Popcorn, Rice
Alfalfa (hay and seed)
Oilseed Group (Crop Group 20) including: Flax seed, Canola, Safflower, Sunflower
Peanut
Legume Vegetables (Succulent or Dried) Group (Crop Group 6 excluding Peanut and Soybean) including: Adzuki bean, Broad bean, Chickpeas, Cowpea, Faba bean, Field pea, Kidney bean, Lablab bean, Lentil, Lima bean, Sweet lupin, White lupin, Mung bean, Navy bean, Pigeon pea
Vetch
0.5 to 2.0 fl. oz.
Use lower application rates as a preventive measure in vegetative crop stages. Use the high application rate when the pest population has reached economic threshold.
Soybean (including Edamame)
0.5 to 2.0 fl. oz.
Use lower application rates as a preventive measure in vegetative crop stages. Use the high application rate when the pest population has reached economic threshold.
Sweetcorn
1.2 to 2.4 fl. oz.
Application should be made from the vegetative stages until silking. Applications during silking should employ a high application rate and be in conjunction with other control measures. Application of low rates at regular (3 to 5 day) intervals, particularly via overhead irrigation water, is an effective strategy from vegetative stages, through row tassel to silking.

Root and Tuber Vegetables Group (Crop Group 1) including: Carrot, Sweet potato, Sugar beet, Potato
Brassica (Cole) Leafy Vegetables Group (Crop Group 5) including: Broccoli, Brussels sprouts, Cabbages, Cauliflower, Chinese broccoli, Kale, Mustard greens, Mustard spinach, Rape greens
Leafy Vegetables (Except Brassica) Group (Crop Group 4) including: Celery, Endive, Lettuce, Roquette, Silver beet, Spinach
Fruiting Vegetables Group (crop Group 8  -  10) including: Chili, Eggplant, Okra, Peppers, Tomato
Cucurbit Vegetables Group (Crop Group 9) including: Cucumber, Melons Pumpkins Summer and winter Squash, Watermelon, Zucchini
Berries Group (Crop Group 13  -  07) including: Blackberry, Blueberry, Boysenberry, Cranberry, Currants, Gooseberry, Raspberry, Strawberry
Pome Fruit Group (Crop Group 11  -  10) including: Apple, Pear
Ornamental flowers and plants
Avocado
Asparagus
1.0 to 2.4 fl. oz.
Use a higher application rate when flowers, fruit or economic parts of the crop are present, under high pest pressure conditions or to control 3rd instar larvae. Use the lower application rate during vegetative stages of crop production. Application of low rates at regular (3 to 5 day) intervals, particularly via overhead irrigation water, is an effective strategy in horticultural crops.
Cotton
1.2 to 2.4 fl. oz.
High leaf pH in cotton causes rapid NPV deactivation, giving Lepigen very short residual activity and resulting in highly variable performance in this crop. Surtivo Soy should not be solely relied upon when larvae numbers are above economic threshold in cotton.
Tobacco, Hemp
1.0 to 2.4 fl. oz.
Use a higher application rate under high pest pressure conditions or to control 3[rd] instar larvae. Using the lower application rate at regular intervals is an effective strategy in tobacco.

                               MIXING GUIDLINES
Shake the container well before use. Spray water pH should be neutral (pH 7.0)  -  spray water pH above 8 may damage the virus and performance will be reduced. If needed, use a suitable buffer or acidifier.  If mixing with other pesticides or foliar fertilizers in water, add Lepigen to the spray tank after the other products are thoroughly diluted. Surtivo Ultra should be applied within 10 hours after mixing.
Compatibility:
In water: Surtivo Ultra is highly compatible with the majority of herbicides, insecticides fungicides and foliar fertilizers when mixed in water.  Ensure that the mixture has a pH of 8 or less before adding Surtivo Ultra as higher pH levels will damage the virus.

                           APPLICATION INSTRUCTIONS
Use application parameters (nozzles, swath width, pressure, boom height, speed, etc.) to ensure thorough coverage of the target area.

         I.             Legume Vegetables (Succulent and Dried) Group (Crop Group 6 excluding Soybean), Root and Tuber Vegetables Group (Crop Group 1) including: Carrot, Sweet potato, Sugar beet, Potato; Brassica (Cole) Leafy Vegetables Group (Crop Group 5) including: Broccoli, Brussels sprouts, Cabbage, Cauliflower, Chinese broccoli, Kale, Mustard greens, Mustard spinach, Rape greens); Leafy Vegetables (except Brassica Vegetables) Group (Crop Group 4) including: Celery, Endive, Lettuce, Roquette, Spinach; Fruiting Vegetable Group (Crop Group 8 - 10) including: Chili, Eggplant, Okra, Pepper, Tomato; Cucurbit Vegetables Group (Crop Group 9) including: Cucumber, Melon, Pumpkin, Summer and winter squash, Watermelon, Zucchini; Berries Group (Crop Group 13 - 07) including: Blackberry, Blueberry, Boysenberry, Cranberry, Currant, Gooseberry, Raspberry, Strawberry; Pome Fruit Group (Crop Group 11 - 10) including: Apple, Pear; Ornamental Flowers and Plants; Avocado; Asparagus; Tobacco; Hemp.

Ground Rig
Apply Surtivo Ultra by ground rig or hand-held equipment in a minimum of 40 gallons of water per acre.

         II.             Sorghum, Cereal Grains Group, Alfalfa, Oilseed Group, Peanut, Soybean, Sweet Corn, Cotton

Ground Rig
Apply Surtivo Ultra in a minimum of 10 gallons of water per acre.

Chemigation (via overhead irrigation water):
Surtivo Ultra can be effectively applied to crops in overhead irrigation water. The product should be introduced to the irrigation water at the appropriate rate using irrigation equipment. If the product is diluted in water prior to injection into the irrigation water, ensure that the dilution water is clean and not silty with a pH of 7 or less and ensure there is constant agitation. Preferably, rainwater should be used for dilution. Ensure any diluted Surtivo Ultra is used within 10 hours of mixing.
For one-pass mobile irrigators (such as: center-pivot, lateral-move, end-tow, side-roll, traveler, big-gun), continuously and evenly introduce the required quantity of Surtivo Ultra into the irrigation water over the course of irrigation. It is recommended to apply Surtivo Ultra s in no more than 0.5 inches of irrigation water. For static irrigators (such as: solid-set or hand-move), introduce the required amount of Surtivo Ultra into the irrigation water just prior to completion of the irrigation period, to maximize the concentration of Surtivo Ultra applied and the amount that remains on the crop. See the CHEMIGATION section (following) for additional information.

CHEMIGATION
General Requirements:
   1) Apply this product only through overhead sprinkler (including center-pivot, lateral-move, end-tow, side-(wheel) roll, traveler, big-gun, solid-set, or hand-move) irrigation systems.  Do not apply this product through soil irrigation systems including drip (trickle).
   2) Crop injury, lack of effectiveness, or illegal pesticide residues in the crop can result from non-uniform distribution of treated water.
   3) If you have questions about calibration, you should contact State Extension Service specialists, equipment manufacturers, or other experts.
   4) Do not connect an irrigation system (including greenhouse systems) used for pesticide application to a public water system unless the pesticide label-prescribed safety devices for public water systems are in place.
   5) A person knowledgeable of the chemigation system and responsible for its operation, or under the supervision of the responsible person, shall shut the system down and make any necessary adjustments should the need arise.

Requirements for Chemigation Systems Connected to Public Water Systems:
   1) Public water supply means a system for the provision to the public of piped water for human consumption if such system has at least 15 service connections or regularly serves an average of 25 individuals daily at least 60 days throughout the year.
   2) Chemigation systems connected to the public water systems must contain a functional, reduced-pressure zone (RPZ), backflow preventer or the functional equivalent in the water supply upstream from the point of pesticide introduction. As an option to the RPZ, the water from the public water system should be discharged into a reservoir tank prior to pesticide introduction. There shall be a complete physical break (air gap) between the flow outlet end of the fill pipe and the top or the overflow rim of the reservoir tank of at least twice the inside diameter of the fill pipe.
   3) The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection pump.
   4) The pesticide injection pipeline must contain a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down.
   5) The system must contain functional interlocking controls to automatically shut off the pesticide injection pump when the water pump motor stops, or in cases where there is no water pump, when the water pressure decreases to the point where pesticide distribution is adversely affected.
   6) Systems must use a metering pump, such as a positive displacement injection pump (e.g., diaphragm pump), effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock.
   7) Do not apply when wind speed favors drift beyond the area intended for treatment.

Requirements for Sprinkler Chemigation:
   1) The system must contain a functional check valve, vacuum relief valve, and low pressure drain appropriately located on the irrigation pipeline to prevent water source contamination from back flow.
   2) The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection pump.
   3) The pesticide injection pipeline must also contain a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down.
   4) The system must contain functional interlocking controls to automatically shut off the pesticide injection pump when the water pump motor stops.
   5) The irrigation line or water pump must include a functional pressure switch, which will stop the water pump motor when the water pressure decreases to the point where pesticide distribution is adversely affected.
   6) Systems must use a metering pump, such as a positive displacement injection pump (e.g., diaphragm pump), effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock.
   7) Do not apply when wind speed favors drift beyond the area intended for treatment.

                                DAYS TO HARVEST
There are no restrictions on applying Surtivo Ultra up to the time of harvest.

--------------------------------------------------------------------------------
STORAGE or DISPOSAL
--------------------------------------------------------------------------------
Do not contaminate water, food, or feed by storage and disposal.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE STORAGE
--------------------------------------------------------------------------------
Care must be taken to avoid exposure of Surtivo Ultra to high temperatures (above 104ºF). Packaged sealed product can be exposed to direct sunlight for brief periods of time (<2 hours), but should be kept out of direct sunlight.
--------------------------------------------------------------------------------

     # --------------------------------------------------------------------------------
   Surtivo Ultra stored in air-conditioned rooms (< 77°F ) will be viable for at least 6 months
     # --------------------------------------------------------------------------------
   Surtivo Ultra stored in cool rooms and refrigerators (0°F to 59°F) will be viable for at least 12 months*
--------------------------------------------------------------------------------
* Surtivo Ultra stored in a freezer (0°F) will remain liquid.
--------------------------------------------------------------------------------
Note.  Exposure of Surtivo Ultra to temperature from 77°F to 104°F for short periods (<36 hours) will not affect efficacy.  Transport time of 36 hours or less in non-refrigerated, covered trucks is acceptable as long as the product does not exceed 104°F.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE DISPOSAL
--------------------------------------------------------------------------------
To avoid wastes, use material in this container by application according to label directions.  If wastes cannot be avoided, offer remaining product to a waste disposal facility or pesticide disposal program (often such programs are run by state or local governments or by industry).
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
CONTAINER HANDLING
--------------------------------------------------------------------------------
[Plastic containers with capacities equal to or less than 5 gallons:] Nonrefillable container. Do not reuse or refill this container. Triple rinse container (or equivalent) promptly after emptying. Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container 1/4 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank, or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times. Then offer for recycling if available or puncture and dispose of in a sanitary landfill, or by incineration. Do not burn, unless allowed by state and local ordinance. If burned, stay out of smoke.
--------------------------------------------------------------------------------

                                   WARRANTY
This product is warranted to contain the amount of active ingredients as described in this label and that the product will be as effective as intended if properly transported, used, and applied per the label instructions. The effectiveness of this product may be degraded by improper storage, transportation or handling and may be subject to environmental factors out of AgBiTech Pty Ltd's control.  The user must monitor the performance of the product as climatic, geographical or biological variables and/or developed resistance may affect the results obtained. To the extent allowed under the applicable law, AgBiTech Pty Ltd and its subsidiaries makes no other warranties, express or implied, of merchantability or of fitness for a particular purpose or otherwise, that extend beyond the statements made on this label or accepts no responsibility in respect of this product. To the extent consistent with applicable law, AgBiTech Pty Ltd and its subsidiaries disclaim any liability whatsoever for special, incidental or consequential damages resulting from the use or handling of this product.


[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78350-78352]
[FR Doc No: 2013-30783]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-13-000]

Houston Pipe Line Company, LP; Notice of Intent to Prepare an
Environmental Assessment for the Proposed 24-Inch Border Crossing
Project and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the 24-Inch Border Crossing
Project (Project) involving construction and operation of border
crossing facilities at the international border between Mexico and the
United States in Hidalgo County, Texas by Houston Pipe Line Company, LP
(HPL). The Commission will use this EA in its decision-making process
to determine whether the Project is in the public convenience and
necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the Project. Your input will help the Commission staff
determine what issues they need to evaluate in the EA. Please note that
the scoping period will close on January 17, 2014.
    You may submit comments in written form or verbally. Further
details on how to submit written comments are in the Public
Participation section of this notice.
    This notice is being sent to the Commission's current environmental
mailing list for the Project. State and local government
representatives should notify their constituents of this planned
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the planned facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the Project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    HPL provided landowners with a fact sheet prepared by the FERC
entitled ``An Interstate Natural Gas Facility On My Land? What Do I
Need To Know?'' This fact sheet addresses a number of typically-asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (www.ferc.gov).

Summary of the Proposed Project

    HPL proposes to construct a new border crossing at the
international boundary between the United States and Mexico in Hidalgo
County, Texas. The Project would consist of approximately 703 feet of
24-inch-diameter natural gas pipeline, directionally drilled underneath
the Rio Grande River in Hidalgo County, Texas. The new pipeline would
have a design capacity of approximately 140 million cubic feet per day
(Mmcf/d) and a maximum allowable operating pressure of 1,300 pounds per
square inch gauge designed to transport natural gas to a new delivery
interconnect with HPL's non-jurisdictional intrastate pipeline and to a
new interconnection with the Pemex Pipeline at the United States-Mexico
border.
    The general location of the Project is shown in Appendix \1\.
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the planned facilities would require ground
disturbance of approximately 4.1 acres of land for temporary workspace.
Following construction, HPL would maintain 0.81 acre for operation of
the Project and the remaining 3.3 acres would be revegetated.
    In its application, HPL indicates that it would also construct
pipeline facilities that are not under the jurisdiction of the FERC.
Although FERC doesn't have the regulatory authority to modify or deny
the construction of these facilities, we will disclose available
information regarding the construction impacts in our EA. These
facilities would include approximately 23 miles of 24-inch-

diameter intrastate pipeline, to interconnect with the existing
Edinburg Lateral Pipeline in Hidalgo County, Texas.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the planned Project under these
general headings:
     geology and soils;
     water resources and fisheries;
     vegetation, wildlife, and endangered and threatened
species;
     land use and cumulative impacts;
     cultural resources;
     air quality and noise; and
     public safety.
    We will also evaluate possible alternatives to the planned project
or portions of the project, and make recommendations on how to lessen
or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section below.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues
related to this Project to formally cooperate with us in the
preparation of the EA.\3\
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    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

    Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the Texas Historical Commission (THC), and to solicit their views
and those of other government agencies, interested Indian tribes, and
the public on the Project's potential effects on historic
properties.\4\ We will define the Project-specific Area of Potential
Effects in consultation with the State Historic Preservation Officer as
the Project develops. On natural gas facility projects, the Area of
Potential Effects at a minimum encompasses all areas subject to ground
disturbance (examples include construction right-of-way, contractor/
pipe storage yards, meter stations, and access roads). Our EA for this
Project will document our findings on the impacts on historic
properties and summarize the status of consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that the Commission receives them in Washington, DC on or before
January 17, 2013.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
Project docket number (CP14-13-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature located on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. This is an easy method for interested
persons to submit brief, text-only comments on a project;
    (2) You can file your comments electronically using the eFiling
feature located on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the Project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
planned Project.
    If we publish and distribute the EA, copies of the completed EA
will be sent to the environmental mailing list for public review and
comment. If you would prefer to receive a paper copy of the document
instead of the CD version or would like to remove your name from the
mailing list, please return the attached Information Request (Appendix
2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor,'' which is an official party to the
Commission's

proceeding. Intervenors play a more formal role in the process and are
able to file briefs, appear at hearings, and be heard by the courts if
they choose to appeal the Commission's final ruling. An intervenor
formally participates in the proceeding by filing a request to
intervene. Instructions for becoming an intervenor are in the User's
Guide under the ``e-filing'' link on the Commission's Web site at
http://www.ferc.gov/help/how-to/intervene.asp.

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP14-
13). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: December 18, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-30783 Filed 12-24-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]
[Page 34448]
[DOCID:fr17jn10-63]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0282; FRL-8832-4]

Pesticides; Draft Guidance for Pesticide Registrants on False or
Misleading Pesticide Product Brand Names; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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

SUMMARY: EPA issued a notice in the Federal Register of May 19, 2010,
announcing the availability of and seeking public comment on a draft
Pesticide Registration Notice (PR Notice) entitled ``False or
Misleading Pesticide Product Brand Names.'' This document extends the
comment period for 60 days, from June 18, 2010, to August 17, 2010.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2010-0282, must be received on or before August 17, 2010.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of May 19, 2010.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register of May 19, 2010 (75 FR
28012) (FRL-8824-8). In that document, the Agency announced the
availability of and sought public comment on a draft Pesticide
Registration Notice (PR Notice) entitled ``False or Misleading
Pesticide Product Brand Names.'' EPA is hereby extending the comment
period, which was set to end on June 18, 2010, to August 17, 2010.
    To submit comments, or access the docket, please follow the
detailed instructions as provided under ADDRESSES in the May 19, 2010
Federal Register document. If you have questions, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.

    Dated: June 11, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.

[FR Doc. 2010-14656 Filed 6-16-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47798-47799]
[FR Doc No: 2020-17177]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0955]

Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed;
Revocation of Approved Method; Correction

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Proposed order; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a
proposed order to revoke the approved method for detecting residues of
carbadox, a carcinogenic new animal drug used in swine feed. The
document was published with an incorrect docket number. This document
corrects that error.

FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of July 20, 2020, in
FR Doc. 2020-15246, on page 43853, the following correction is made:
    On page 43853, in the second column, in the header of the document,
and also in the third column under Instructions, ``Docket No. FDA-2016-
N-0832'' is corrected to read ``Docket No. FDA-2020-N-0955''.

    Dated: August 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17177 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74499]
[DOCID:fr12de06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Holding Company and Transaction
Exemptions and Waivers

December 4, 2006.

IP Gyrfalcon Company.....................  Docket No. PH06-103-000.
Consolidated Midwest.....................  Docket No. PH06-104-000.
Edison International.....................  Docket No. PH06-106-000.
PPL Corporation..........................  Docket No. PH06-107-000.
Sempra Energy............................  Docket No. PH06-108-000.

    Take notice that in October and November 2006 the holding company
and transaction exemptions and waivers requested in the above-captioned
proceedings are deemed to have been granted by operation of law
pursuant to 18 CFR 366.4.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21053 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P