[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30614-30616]
[FR Doc No: 2014-12281]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1422]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Eye Tracking Study of
Direct-to-Consumer Prescription Drug Advertisement Viewing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
27, 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--New and
title, ``Eye Tracking Study of Direct-to-Consumer Prescription Drug
Advertisement Viewing.'' 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.

Eye Tracking Study of Direct-to-Consumer Prescription Drug
Advertisement Viewing--(OMB Control Number 0910-NEW)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes 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(b)(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.
    Current regulations require that a product's major risks be
included in at least the audio of direct-to-consumer (DTC) prescription
drug television ads; this disclosure of major risks is sometimes
referred to as the major statement. FDA has proposed including such
risk information in superimposed text as well as in the audio (75 FR
15376, ``Direct-to-Consumer Prescription Drug Advertisements;
Presentation of the Major Statement in Television and Radio
Advertisements in a Clear, Conspicuous, and Neutral Manner''). In
addition, Title IX of the Food and Drug Administration Amendments Act
(Pub. L. 110-85) required a study to determine if the statement ``You
are encouraged to report negative side effects of prescription drugs to
FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088'' (the MedWatch
statement) is appropriate for inclusion in DTC television ads. These
communications have been tested separately by FDA. The first study
found that participants were better able to recall the drug risks when
they were presented in superimposed text as well as in audio (OMB
Control Number 0910-0634; ``Experimental Evaluation of the Impact of
Distraction''). The second study found that the inclusion of the
MedWatch statement does not interfere with participants' understanding
of the risk information (OMB Control Number 0910-0652; ``Experimental
Study: Toll-Free Number for Consumer Reporting of Drug Product Side
Effects in Direct-to-Consumer Television Advertisements for
Prescription Drugs''). However, these two new communications have not
been examined together.
    In addition, questions continue to arise about the use of
potentially distracting images and sounds during the major statement of
risks in DTC television ads. The first study referenced previously
found no differences among ads that differed in the affective tone of
static, non-moving visuals presented during the major statement of
risks. Previous research has shown that factors such as multiple scene
changes and music in advertising can be distracting. The effects of
distraction during the major statement of risks on consumers'
perceptions and risk recall has not been tested in the presence of
risk-reinforcing superimposed text.
    This project is designed to use eye tracking technology to
determine how superimposed risk information and the MedWatch statement
are perceived in DTC ads and also the impact of distraction. Eye
tracking technology is an effective method to determine the extent to
which consumers attend to risk information presented in DTC television
ads. This technology allows researchers to unobtrusively detect and
measure where a participant looks while viewing a television ad and for
how long, and the pattern of their eye movements may indicate attention
to and processing of information in the ad.
    We plan to collect descriptive eye tracking data on participants'
attention to (1) the superimposed text during the major statement of
risk information and (2) the MedWatch statement. Further, we plan to
examine experimentally the effect of distraction. We hypothesize that
distracting audio and visuals during the major statement will decrease
risk recall, risk perceptions, and attention to

superimposed text risk information. To test these hypotheses, we will
conduct inferential statistical tests such as analysis of variance.
With the sample size described further in this notice, we will have
sufficient power to detect small-to-medium sized effects in the main
study.
    We plan to conduct one 60-minute pilot study with 30 participants
and then one 30-minute main study with 300 participants. All
participants will be 18 years of age or older who self-identify as
needing to lose more than 30 pounds. We will exclude individuals who
work in healthcare or marketing or who wear bifocals or hard contact
lenses to watch television. The studies will be conducted in person in
at least five different cities across the United States.
    The pilot study and main study will have the same design and will
follow the same procedure. Participants will be randomly assigned to
one of two test conditions (low and high distraction in a DTC
television ad). The ad will be for a fictitious weight loss
prescription drug. The ads have been created and pretested to ensure
that consumers perceive different levels of distraction across the ads
(OMB Control Number 0910-0695; ``Stimuli Development and Pretests for
an Attentional Effects Study''). For instance, as the distraction level
increases, the number of scene changes and on-screen activity during
the major statement increases. Pretesting led us to using two rather
than three ads, as we proposed in the 60-day Federal Register notice.
    When participants start the study, we will explain the study
procedure and calibrate the eye tracking device. To collect eye
tracking data, we will use an unobtrusive computer-interfaced eye
tracker with a minimum speed of 60 Hertz. The test images will be shown
on a computer monitor with a minimum size of 23 inches and a minimum
display resolution of 1,920 x 1,080. To simulate normal television ad
viewing, participants will watch an approximately 5 minute video clip
followed by a series of three ads. One of the ads will be the study ad.
The video clip and non-study ads will be unrelated to health. The order
of the non-study ads will be counterbalanced, and only eye tracking
data from the study ad will be analyzed. Next, participants will
complete a questionnaire that assesses risk perceptions, risk recall,
recall of the MedWatch statement, and covariates such as demographics
and health literacy. In the pilot study, participants will also answer
questions as part of a debriefing interview to assess the study design
and questionnaire. The questionnaire is available upon request.
    In the Federal Register of November 29, 2013 (78 FR 71621), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received.

(Comment 1)

    The first suggestion in this comment was to avoid biasing
participants by ensuring that at the beginning of the study
participants are not aware that (1) the study is being conducted by or
for FDA and (2) the advertisements are the subject of interest in the
study. We are aware of these issues and have designed the wording of
the study materials accordingly.
    The second suggestion was to increase the minimum display
resolution from 1,280 x 1,024 to 1,920 x 1,080 and the minimum computer
monitor size from 20 inches to 24 inches. We agree that a bigger screen
is better and have changed the minimum conditions to the following
specifications: A display resolution of 1,920 x 1,080 pixels on a
monitor of at least 23 inches measured diagonally.
    The third suggestion was to exclude individuals who wear
progressive or other multifocal lenses and individuals with any form of
strabismus or nystagmus from participating in the study. We will
exclude individuals who wear bifocals or hard contact lenses while
watching television. In response to the next comment, we explain why
these individuals need to be excluded. We do not believe we need to
exclude participants who wear progressive or other multifocal lenses to
collect usable data with the eye trackers in this study. Because we
will use binocular tracking (where we track both eyes) we do not need
to exclude individuals with strabismus or nystagmus; if we encounter
these conditions in one eye, we will track the other eye. In addition,
we cannot test for or diagnose these conditions and individuals may not
know they have these conditions, making excluding these individuals
difficult.

(Comment 2)

    The first request in this comment was to specify the study
timeline, comment on whether the results of this study will be
incorporated into the draft guidance, ``Presenting Risk Information in
Prescription Drug and Medical Device Promotion,'' and state whether the
draft guidance will be re-issued for public comment. Regarding the
study timeline, data collection on the study cannot begin until OMB
approval is received. We estimate that data collection will be
completed within a year after OMB approval. If the results of the study
suggest that changes are needed to the draft guidance we will consider
that at the time. The draft guidance will be reissued for public
comment if changes are necessary as a result of the study.
    The second request in this comment was to explain why individuals
who wear bifocals or hard contact lenses would be excluded and to
consider including such individuals in the study to avoid biasing the
sample. First, only individuals who can only wear bifocals or hard
contacts to watch television will be excluded from the study. If
individuals can wear regular glasses or soft contacts during the study,
they may participate. There are two reasons to exclude participants who
wear only bifocals or contact lenses to watch television. The first is
that the glasses themselves may have ``lines'' on them which impact the
data being recorded by the eye tracker's camera. To record properly,
the eye trackers must make accurate estimates of the pupil, and the
``lines'' on the glasses distort these estimates. A similar problem
exists with hard contact lenses, which are smaller than soft lenses and
project sharp lines around their circumference. The second reason to
exclude individuals who wear bifocals to watch television is that many
people who wear bifocals move their heads up and down to get their best
vision of a particular target. This head bobbing also impacts eye
tracking because the cameras must constantly adjust to head movement.
If we do not screen for these conditions and have several individuals
who cannot be tracked well, we will have to discard their data, which
will impact both the study design (which is based on the assumption of
having equal sample sizes across conditions) and the power of our
statistical tests. In an effort to measure any sampling bias, we will
move this question to the end of the pilot study screener so we can
compare the demographic information of those who are excluded with
those who are not.
    This comment suggested that we create a more ``real world''
environment in the study by using a 30-minute video clip instead of a 2
to 5 minute video clip as proposed. We understand the concern, but
there are tradeoffs inherent in any study. Although a 30-minute video
clip may be a stronger proxy for ``typical'' TV viewing, it would
require more resources and a greater burden on participants. We have
taken steps to try to increase the ecological validity of the
experiment. First, we have created ads that are very realistic. Second,
we will

use a real TV show clip that is closer to 5 minutes long, which is the
length of a typical news story segment. Third, we will include two
additional, ``real'' advertisements, rather than just showing the
experimental ad.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
   Eye tracking study of DTC                       Number of
       prescription drug           Number of     responses per   Total annual    Average burden     Total hours
     advertisement viewing        respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Pilot Study Screener..........             200               1             200  0.03 (2 minutes)               6
Main Study Screener...........           2,000               1           2,000  0.03 (2 minutes)              60
Pilot Study...................              30               1              30  1...............              30
Main Study....................             300               1             300  0.50 (30                     150
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             246
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12281 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67042-67043]
[FR Doc No: 2022-24216]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-4324]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ANGELMED GUARDIAN SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ANGELMED GUARDIAN SYSTEM
and is publishing this notice of that determination as required by law.
FDA has made the determination because of the submission of an
application to the Director of the U.S. Patent and Trademark Office
(USPTO), Department of Commerce, for the extension of a patent which
claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 6, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 8, 2023. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 6, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-E-4324 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ANGELMED GUARDIAN SYSTEM.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device ANGELMED GUARDIAN
SYSTEM. ANGELMED GUARDIAN SYSTEM is indicated for use in patients who
have had prior acute coronary syndrome (ACS) events and who remain at
high risk for recurrent ACS events. The ANGELMED GUARDIAN SYSTEM is
indicated as an adjunct to patient recognized symptoms. The ANGELMED
GUARDIAN SYSTEM detects potential ongoing ACS events, characterized by
sustained ST segment changes, and alerts the patient to seek medical
attention for those potential ACS events. An ANGELMED GUARDIAN SYSTEM
alert is a more accurate predictor of ACS events when compared to
patient recognized symptoms alone and demonstrates a reduced rate over
time of patient presentations without ACS events (false positives) when
compared to patient recognized symptoms alone. In the absence of
symptoms, the ANGELMED GUARDIAN SYSTEM may identify asymptomatic ACS
events and prompt the patient to seek medical attention. Subsequent to
this approval, the USPTO received a patent term restoration application
for ANGELMED GUARDIAN SYSTEM (U.S. Patent No. 6,609,023) from Angel
Medical Systems, Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 13, 2019, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of ANGELMED GUARDIAN SYSTEM represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ANGELMED GUARDIAN SYSTEM is 4,037 days. Of this time, 2,916 days
occurred during the testing phase of the regulatory review period,
while 1,121 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption for this device, under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)), became effective: March 23, 2007. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) for human tests to begin, as required under section 520(g) of the
FD&C Act, became effective March 23, 2007.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): March
16, 2015. FDA has verified the applicant's claim that the premarket
approval application (PMA) for ANGELMED GUARDIAN SYSTEM (PMA P150009)
was initially submitted March 16, 2015.
    3. The date the application was approved: April 9, 2018. FDA has
verified the applicant's claim that PMA P150009 was approved on April
9, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,827 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24216 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P


MEMORANDUM

Date

October 17, 2008

To

Marla Smith, Work Assignment Manager

From

Bob Lordo, Battelle Work Assignment Leader

Chris Sroka, Battelle Statistician

Subject

EPA Contract No. EP-C-05-030, Work Assignment No. 3-13:

316b: Laboratory Test Data Related to Entrainment

This memorandum presents entrainment data from studies that assessed the
performance of fine mesh screens in reducing impingement mortality and
entrainment under controlled laboratory conditions.  These entrainment
data originated from documents which we have been reviewing on this work
assignment and its predecessor in support of the Section 316(b)
rulemaking effort.

This memorandum also summarizes the results of statistical analyses to
evaluate whether slot width and slot velocity have a significant impact
on the percentage of organisms that are entrained through the screens.

Measure of Performance Considered in the Laboratory Studies

Ideally, we would use the laboratory study data to derive the same
performance measure as that used in the field studies:  percentage
reduction in entrainment.  Recall that this measure requires
measurements from paired density samples taken in front of and behind a
screened intake.  However, none of the encountered laboratory studies
performed this type of sampling.  Instead, the laboratory studies
measured the extent of entrainment (and impingement mortality)
associated with the installed screens within the test flume.  Therefore,
the percentage of organisms that were entrained through the screen
(i.e., percent entrainment) is the performance measure used in the
summaries and analyses of laboratory data in this memorandum.  Note that
because field and laboratory studies are utilizing different entrainment
performance measures, it is not possible to make direct comparisons in
the values of the performance measures between field and laboratory
studies.

Sources of Entrainment Data from Laboratory Studies

The summarized entrainment data used in this evaluation are documented
in Tables 1 through 3.  Table 1 summarizes entrainment for all organisms
(i.e., all life stages), while Table 2 considers entrainment data for
eggs only, and Table 3 documents entrainment for larvae (non-eggs) only.
 These data represent summaries calculated across species of the data
presented within the source specified in the first column.  The
summaries are presented by slot size and, when specified, slot velocity
and screen orientation (parallel or perpendicular to water flow).  The
Study ID is assigned to the given data within Battelle’s performance
evaluation database.  (The data from EPRI [2003] currently exist in
separate Excel worksheets, as they were captured in electronic form from
a PDF version of the study report.)Table 1.	Percent Entrainment of All
Organism Types by Screen Orientation, Slot Size, and Slot Velocity, as
Reported from Controlled Laboratory Studies

Data Source	Study ID	# Species	Screen Orientation*	Slot Size (mm)	Slot
Velocity (m/s)	# Entrained**	# Released	Avg. % Entrained**	Avg. %
Retained

Appendix C of EPRI, 2003	2001 WW lab study	1	0	0.50	0.15	39.70	2,000
1.99

	2001 WW lab study	1	0	0.50	0.30	249.50	1,900	13.13

	2001 WW lab study	1	0	1.00	0.15	255.20	1,800	14.18

	2001 WW lab study	1	0	1.00	0.30	357.60	1,800	19.87

	2001 WW lab study	1	0	2.00	0.15	504.60	1,800	28.03

	2001 WW lab study	1	90	0.50	0.15	2.20	1,800	0.12

	2001 WW lab study	1	90	0.50	0.30	2.20	1,800	0.12

	2001 WW lab study	1	90	1.00	0.30	304.10	1,050	28.96

	2001 WW lab study	1	90	2.00	0.15	893.70	1,800	49.65

Appendix D of EPRI, 2003	2002 WW lab study	4	 NS	0.50	0.15	649.60	5,688
11.42

	2002 WW lab study	5	 NS	0.50	0.30	471.70	4,285	11.01

	2002 WW lab study	3	 NS	1.00	0.15	1477.40	2,525	58.51

	2002 WW lab study	3	 NS	1.00	0.30	1859.70	2,773	67.06

	2002 WW lab study	1	 NS	2.00	0.15	900.40	1,125	80.04

	2002 WW lab study	2	 NS	2.00	0.30	427.60	1,874	22.82

Table 2-4 of EPRI, 2008	116	1	90	0.50	 NS	9.00	120	7.50	92.50

	116	4	90	0.50	 NS	57.89	1,250	4.63	95.37

	116	5	90	0.50	 NS	36.54	1,695	2.16	97.84

Table 1 of Tomljanovich et al., 1978	248	5	90	0.50	 NS	 	 	0.36	99.64

	249	6	90	1.00	 NS	 	 	19.97	80.03

	250	9	90	1.30	 NS	 	 	35.67	64.33

	251	4	90	1.80	 NS	 	 	20.20	79.80

	252	4	90	2.50	 NS	 	 	32.60	67.40

Page 401 of Hanson et al., 1977	253	1	 NS	1.01	 NS	16.00	100	16.00

* 0=parallel to flow; 90=perpendicular to flow.

** Adjusted for collection efficiency (CE) for WW lab studies.

NS = Not specified

Table 2.	Percent Entrainment of Eggs by Screen Orientation, Slot Size,
and Slot Velocity, as Reported from Controlled Laboratory Studies

Data Source	Study ID	# Species	Screen Orientation	Slot Size (mm)	Slot
Velocity (m/s)	# Entrained*	# Released	Avg. % Entrained*

Appendix C of EPRI, 2003	2001 WW lab study	1	0	0.50	0.15	0.00	900	0.00

	2001 WW lab study	1	0	0.50	0.30	0.00	900	0.00

	2001 WW lab study	1	0	1.00	0.15	0.00	900	0.00

	2001 WW lab study	1	0	1.00	0.30	0.00	900	0.00

	2001 WW lab study	1	0	2.00	0.15	0.00	900	0.00

	2001 WW lab study	1	90	0.50	0.15	0.00	900	0.00

	2001 WW lab study	1	90	0.50	0.30	0.00	900	0.00

	2001 WW lab study	1	90	1.00	0.30	0.00	600	0.00

	2001 WW lab study	1	90	2.00	0.15	21.00	900	2.33

Appendix D of EPRI, 2003	2002 WW lab study	1	 NS	0.50	0.15	0.00	1,122
0.00

	2002 WW lab study	2	 NS	0.50	0.30	100.20	1,737	5.77

	2002 WW lab study	1	 NS	2.00	0.30	407.60	1,125	36.23

* Adjusted for collection efficiency (CE)

NS = Not specified

Table 3.	Percent Entrainment of Larvae (non-eggs) by Screen
Orientation, Slot Size, and Slot Velocity, as Reported from Controlled
Laboratory Studies

Data Source	Study ID	# Species	Screen Orientation*	Slot Size (mm)	Slot
Velocity (m/s)	# Entrained**	# Released	Avg, % Entrained**	Avg. %
Retained

Appendix C of EPRI, 2003	2001 WW lab study	1	0	0.50	0.15	39.70	1,100
3.61

	2001 WW lab study	1	0	0.50	0.30	249.50	1,000	24.95

	2001 WW lab study	1	0	1.00	0.15	255.20	900	28.36

	2001 WW lab study	1	0	1.00	0.30	357.60	900	39.73

	2001 WW lab study	1	0	2.00	0.15	504.60	900	56.07

	2001 WW lab study	1	90	0.50	0.15	2.20	900	0.24

	2001 WW lab study	1	90	0.50	0.30	2.20	900	0.24

	2001 WW lab study	1	90	1.00	0.30	304.10	450	67.58

	2001 WW lab study	1	90	2.00	0.15	872.70	900	96.97

Appendix D of EPRI, 2003	2002 WW lab study	4	 NS	0.50	0.15	649.60	4,566
14.23

	2002 WW lab study	3	 NS	0.50	0.30	371.50	2,548	14.58

	2002 WW lab study	3	 NS	1.00	0.15	1477.40	2,525	58.51

	2002 WW lab study	3	 NS	1.00	0.30	1859.70	2,773	67.06

	2002 WW lab study	1	 NS	2.00	0.15	900.40	1,125	80.04

	2002 WW lab study	1	 NS	2.00	0.30	20.00	749	2.67

Table 2-4 of EPRI, 2008	116	1	90	0.50	 NS	9.00	120	7.50	92.50

	116	4	90	0.50	 NS	57.89	1,250	4.63	95.37

	116	5	90	0.50	 NS	36.54	1,695	2.16	97.84

Table 1 of Tomljanovich et al., 1978	248	5	90	0.50	 NS	 	 	0.36	99.64

	249	6	90	1.00	 NS	 	 	19.97	80.03

	250	9	90	1.30	 NS	 	 	35.67	64.33

	251	4	90	1.80	 NS	 	 	20.20	79.80

	252	4	90	2.50	 NS	 	 	32.60	67.40

Page 401 of Hanson et al., 1977	253	1	 NS	1.01	 NS	16.00	100	16.00

* 0=parallel to flow; 90=perpendicular to flow.

** Adjusted for collection efficiency (CE) for WW lab studies.

NS = Not specifiedThe data in Tables 1 through 3 originate from the
following four documents:

EPRI (2003) is a biological evaluation of cylindrical wedgewire screens
performed at Alden Research Laboratory’s Fish Testing Facility.  Two
distinct sets of tests were performed that involved releasing a
specified number of larvae/eggs into a test flume.  One test was
conducted in 2001, with striped bass larvae (length range:  3.5 to 10.6
mm; width range:  0.1 to 2.0 mm) and a surrogate egg type (diameter
range: 3.6 to 6.3 mm), whose objective was to determine if the test
facility and procedures could be used to evaluate effectiveness of the
various screen types.  After necessary modifications were made to the
procedures based on 2001 testing, more comprehensive testing was done in
2002 that considered additional species that exist within a wide range
of water body types and that represent a greater range of swimming
capabilities.  Eggs used in the 2002 study represented alewife (diameter
range:  0.5 to 0.9 mm) and white sucker (diameter range:  2.8 to 3.5
mm), while larvae represented bluegill, carp, rainbow smelt, winter
flounder, white sucker, and yellow perch.  Mean lengths of these larvae
ranged from 6.1 mm (winter flounder) to 18.5 mm (bluegill), while mean
widths ranged from 0.8 mm (yellow perch) to 5.4 mm (bluegill).  Both of
the 2001 and 2002 studies controlled for the following:

Slot size (0.5, 1.0, 2.0 mm)

Slot velocity (0.15, 0.30 m/s)

Channel (or approach) velocity (0.08, 0.15, 0.30 m/s).

(Not all species of larvae were tested at all slot size/velocity
combinations in the 2002 study.)  In addition, the 2001 study collected
data for two different screen orientations:  parallel (radial slots) and
perpendicular (axial slots) to the water flow.  In 2001, three test
replicates were performed for each set of test conditions, while up to
five replicates were performed in 2002 testing.  The test flume channel
in 2001 testing was 1.5 m wide, and water depth was 1.3 m.  In 2002
testing, flume width and water depth were both 1.8 m.

The 2001 and 2002 data are summarized separately.  In both tests,
entrainment data were reported after being adjusted for net collection
efficiency (as determined from releasing known amounts of fish or eggs
directly into the entrainment collection tank).

EPRI (2008) is a two-year biological evaluation of fine mesh traveling
screens whose main objective was to determine retention and
post-impingement survival of larval fish on the screens.  These tests
were performed in a closed-loop testing facility at Alden Research
Laboratory.  The test flumes were 30.5 cm wide and contained water 30.5
cm deep, and fine-mesh screens were mounted perpendicular to the flow.
Fish larvae were introduced to the system, then the study evaluated the
length of time at which the larvae could be impinged on the screens
before being rinsed off the screens and bypassed to holding tanks.  The
data presented in this memorandum originate from an investigation of the
ability of 0.5 mm mesh screens to prevent the entrainment of larval fish
that occurred within impingement survival testing in Phase I (in 2006).
When using 0.5 mm mesh screens, survival testing involved performing
four replicates for selected combinations of the following:

Larval species (blue catfish, channel catfish, emerald shiner, fathead
minnow, and smallmouth bass)

Approach velocity (0.152, 0.35, and 0.61 m/s)

Duration of impingement on the screens (4, 8, 16 min.).

The lengths of the larvae ranged from 6.9 to 23.4 mm (Table 2-3 of EPRI,
2008).

The study in Tomljanovich et al. (1978) was performed in a fine-mesh
screening test flume (2.4 m wide x 1.2 m deep) at the Tennessee Valley
Authority (TVA) to evaluate the extent to which post-impingement
survival of fish larvae were related to impingement duration, fish
species and size, approach water velocity, and screen mesh size.  The
study measured percent retainment of the larvae within various numbers
of tests for selected combinations of the following:

Species (jewelfish cichlid, threadfin shad, golden shiner/fathead
minnow, white sucker, channel catfish, striped bass, bluegill,
smallmouth bass, largemouth bass, walleye)

Mesh size (0.5, 1.0, 1.3, 1.8, 2.5 mm) of screens oriented perpendicular
to flow.

According to Table 1 of Tomljanovich et al. (1978), approach velocities
ranged from 0.152 to 0.46 m/s among the tests, and test duration ranged
from 0.5 to 16 minutes.  Mean larval lengths ranged from 6.2 (striped
bass) to 39.5 mm (threadfin shad), while mean widths ranged from 0.7
(striped bass) to 4.2 mm (threadfin shad).  Exact numbers of fish in
each test were unknown but ranged from 10 to over 200.

The study in Hanson et al. (1977) was performed in an oval test flume
(0.84 m wide and 1.22 m deep) at the Delmarva Power and Light test
laboratories.  While this reference documents several phases of testing
to evaluate entrainment and impingement of eggs and larvae by a profile
wire screen with 1 mm slot width, only a set of tests involving the
introduction of 100 striped bass larvae into the test flume appeared to
measure entrainment through the screen, and therefore, was relevant for
this memorandum.  These tests were performed at an intake velocity
ranging from 0.152 to 0.46 m/s, and duration of 30 minutes.  Larval
lengths ranged from 8 to 17 mm.

Note that only EPRI (2003) controlled for slot velocity in its tests; no
other document reported slot velocity.  Furthermore, EPRI (2008) and
Tomljanovich et al. (1978) reported “percent retention” data, rather
than percent entrained data.  EPRI (2008) also reported the number of
organisms that were released in the test flume.  As noted below, we
assumed that any fish not “retained” was entrained, and therefore,
we calculated the numbers of organisms entrained as the number released
minus the number retained.  Hanson et al. (1977) did not report the
number of organisms released, and therefore, we calculated percent
entrainment as 100% minus percent retention for this study.

When numbers of entrained (or retained) organisms were reported in these
references, they were summed across species and test replicates.
Likewise, when numbers of organisms released into the test flume were
reported, they were summed in the same manner.  Both sets of sums appear
in Tables 1 through 3.  Percent entrainment was then calculated as the
total number of entrained organisms divided by the total number
released, and the tables include this result.  If a reference only
reported percent entrainment, with no accompanying numbers of organisms
entrained or released, we calculated the average of these percentages
across species and test replicates and presented them in Tables 1
through 3.

Data Acceptance Criteria

In order to be included in Tables 1 through 3 (and accepted for
statistical analysis), entrainment data needed to achieve the following
criteria:

The data must originate from a study performed at a test laboratory
under controlled conditions (e.g., not in a test barge placed in a
natural water body).

The test screens in this study must be categorized as “fine mesh”
screens, where the mesh size is clearly specified.

From the reported data, it must be possible to determine the percent of
organisms that were entrained through the test screens.

Data sources reporting only numbers of entrained fish were not accepted
if the total number of fish released was not also reported.

Data were not accepted if numbers of entrained organisms could not be
determined with sufficient confidence from them.  For example, if a data
source reported a number or percentage of fish that avoided either
impingement or entrainment and no other data, then these data were not
accepted for use because it would not be possible to determine only
those fish that were entrained from the reported data.

While data were reported specifically on entrainment in EPRI (2008) and
Hanson et al. (1977), the studies in EPRI (2003) and Tomljanovich et al.
(1978) measured “retainment” rather than entrainment.  Organisms are
“retained” when they do not pass through the intake screens, meaning
that they are either impinged on the screens, are able to keep swimming
in front of the screens, etc.  Thus, one may be able to assume that all
organisms that are not retained are entrained through the screens.  In
order to accept data for studies that reported only retention data, it
was necessary to make this assumption.  Therefore, when utilizing data
from EPRI (2003) and Tomljanovich et al. (1978) to characterize
entrainment in this memorandum, this assumption should be noted.

Plots of Percent Entrainment Data

Figures 1 through 6 contain plots of the percent entrainment data, with
Figures 1 and 2 presenting data for larvae, Figures 3 and 4 for eggs,
and Figures 5 and 6 for all organisms.  Odd-numbered figures plot the
data versus screen slot width, with slot velocity noted by the plotting
symbol.  Even-numbered figures include data only for EPRI (2003), with
slot velocity specified along the horizontal axis and screen slot width
given by the plotting symbol.  The values plotted in these figures
represent both parallel and perpendicular screen orientations (relative
to flow).

Figure 1.	Percent of Larvae Entrained by Slot Velocity and Screen Size,
with Screen Size on the Horizontal Axis

Figure 2.	Percent of Larvae Entrained by Slot Velocity and Screen Size,
with Slot Velocity on the Horizontal Axis

Figure 3.	Percent of Eggs Entrained by Slot Velocity and Screen Size,
with Screen Size on the Horizontal Axis

Figure 4.	Percent of Eggs Entrained by Slot Velocity and Screen Size,
with Slot Velocity on the Horizontal Axis

Figure 5.	Percent of Total Organisms Entrained by Slot Velocity and
Screen Size, with Screen Size on the Horizontal Axis

Figure 6.	Percent of Total Organisms Entrained by Slot Velocity and
Screen Size, with Slot Velocity on the Horizontal Axis

Note that because a large portion of the percent entrainment data
values for eggs are zero (from the EPRI 2001 study), Figures 3 and 4
appear to have fewer plotting points compared to the other plots.  As
noted in Table 2, no surrogate eggs were entrained in the EPRI 2001
study except when the 2.0 mm screens were oriented perpendicular to
flow.  In addition, no entrainment of white sucker eggs occurred in the
EPRI 2002 study (although alewife eggs were entrained at high
percentages).  In both studies, the lack of entrainment was due to the
large egg diameters related to the slot widths and the eggs’
“ability to maintain their shape and not be forced through the
screens” (EPRI, 2003).

These plots suggest that percent entrainment tends to increase with
increased screen slot width for both egg and larval life stages.  In
contrast, increased slot velocity was more highly associated with
increased percent entrainment only for eggs.  (This was observed
primarily due to increased entrainment with alewife eggs at the 0.30 m/s
slot velocity in the EPRI 2002 study.)

Conclusions on Slot Width and Slot Velocity as Noted by the Study
Authors

The following types of conclusions were made by the authors of the above
studies upon review and analysis of the entrainment data.  Only EPRI
(2003) based some of its conclusions on entrainment or retainment data
on the outcome of a statistical analysis (ANOVA).

EPRI (2003)

Entrainment increased with increases in slot size and slot velocity.

Entrainment decreased with increases in channel velocity.

The ability to characterize relationships in entrainment among the
various test factors was hampered by interactions among the factors or
data gaps.

Most larvae and eggs were excluded from passing through 0.5 mm screens,
but not larger mesh screens.

In the 2001 study, under the parallel screen orientation, entrainment
rates increased significantly with slot size (at the 0.05 level) and
were higher at the 0.3 m/s slot velocity.

In the 2002 study, statistical analysis was performed by species.  Slot
velocity effects were significant at the 0.05 level on percent
entrainment for larvae of selected species (e.g., winter flounder,
yellow perch, carp).  While it was not statistically significant, the
analysis on winter flounder data indicated that the impact of slot
velocity was greatest at the smallest screen mesh size.

EPRI (2008)

“The 0.5 mm screens used during survival testing were effective in
retaining the majority of fish released.”

“In general, retention increased as (approach) velocity and duration
of impingement increased.”

Tomljanovich et al. (1978)

“Velocity and test duration contributed little to percent
retention.”

“Body length alone was not a good indicator of percent retention.”

In addition, EPRI (2003) cites Hanson et al. (1977) in making the
following statement:  “Impingement and entrainment have been
positively correlated with slot velocity and inversely related to
ambient velocity.”  Hanson et al. (1977) noted that over 90% of the
tested larvae were able to swim for 30 minutes without entrainment when
subject to currents of 1.0 to 1.5 fps.

Statistical Analysis of Percent Entrainment Data in Tables 1 through 3

We utilized analysis of variance (ANOVA) methods to investigate the
possible effect of screen size and slot velocity on the percent of
organisms entrained as reported in Tables 1 through 3 above.  We applied
ANOVA separately to each table (i.e., organisms in the egg life stage,
organisms in the larval (non-egg) life stage, and organisms in both life
stages).  We considered several ANOVA model forms that differed
according to whether percent entrainment was transformed, whether slot
velocity was included as a model predictor, and, if slot velocity was
included, whether an interaction term between screen size and slot
velocity should be included.

Note that for eggs, percent entrainment was reported to be zero for most
test conditions (Table 2), in part due to the limited number of
laboratory studies that considered eggs, and to limited variation in the
different types of eggs that were considered in these studies (EPRI,
2003).  Thus, conclusions from the statistical analyses performed only
on eggs should be made with caution.

βj + (αβ)ij +(ijk					(1)

where Yijk is the “inverse arcsine”-transformed percent entrainment
reported by the kth study under the ith slot width and jth slot velocity
conditions, ( is an overall constant, (i is the amount contributed by
the ith slot width, (j is the amount contributed by the jth slot
velocity, (αβ)ij is the amount contributed by the combination of the
ith slot width and the jth slot velocity, and (ijk is random error left
unexplained by the model.  Because only two values (0.15 m/s and 0.30
m/s) for slot velocity were represented among the available data, we
considered the variable to be categorical like the slot width variable.

The “inverse arcsine” transformation used in model (1), which EPRI
(2003) also considered in its statistical analysis, is defined as
follows:

,

where Xijk is the percent entrained associated with the kth study that
utilized the ith slot width and the jth slot velocity.  We transformed
the percent entrainment measure because plots of residuals from the
ANOVA model fitting suggested that, for all three subsets of data, the
errors were more likely to be independent and normally distributed with
a constant variance upon taking this transformation.  We also considered
a logarithmic transformation, which appeared to perform similarly to the
inverse arcsine transformation.

Upon fitting model (1) to data in Tables 1 through 3, we noted the
following:

The interaction effect between screen size and slot velocity was
significant for percent of larvae entrained (p-value = 0.0134) and
percent of eggs entrained (p-value = 0.0198).  Since there is an
interaction effect, the effect of slot velocity varies by screen size.
For example, percent entrainment of larvae appears to increase at the
lower slot velocity at 2.0 mm mesh size.  The least squares estimates of
the mean percent entrainment for each combination of screen size and
slot velocity are shown in Table 4.

Only screen width was significant for percent of all organisms entrained
(p-value = 0.0263).  The smallest screen width (0.5 mm) had the smallest
percent entrainment, while the largest screen width had among the
largest percent entrainment values.

Table 4.	Least Squares Means and 95% Confidence Limits for Percent
Entrainment Measured in EPRI (2003), by Screen Width and Slot Velocity,
As Estimated from a Two-Way ANOVA Model

Data Set	Screen Width (mm)	Slot Velocity (m/s)	Least Squares Means	95%
Confidence Limits for Least Squares Means

Larvae Only	0.5	0.15	4.3%	(0.6, 22.5)

	0.5	0.30	10.0%	(0.1, 32.4)

	1.0	0.15	43.1%	(12.9, 76.5)

	1.0	0.30	58.3%	(30.4, 83.6)

	2.0	0.15	80.8%	(54.7, 97.1)

	2.0	0.30	2.7%	(10.4, 37.4)

Eggs Only	0.5	0.15	0.0%	(0.0, 1.7)

	0.5	0.30	0.7%	(0.2, 4.4)

	1.0	0.15	0.0%	(0.0, 5.0)

	1.0	0.30	0.0%	(0.5, 2.5)

	2.0	0.15	0.6%	(0.7, 5.5)

	2.0	0.30	36.2%	(16.6, 58.5)

All Organisms	0.5	0.15	3.0%	(2.0, 22.1)

	0.5	0.30	6.0%	(0.5, 28.6)

	1.0	0.15	34.5%	(5.7, 72.2)

	1.0	0.30	37.9%	(11.6, 68.9)

	2.0	0.15	53.1%	(23.0, 82.0)

	2.0	0.30	22.8%	(0.2, 74.8)

One-way ANOVA.  In order to apply more data from the above four
documents into the ANOVA, we also fit a second model that included only
screen mesh width as a predictor variable.  Thus, this model could
assess only the effect of screen mesh width.  The form of this model is:

  Yjk = ( + (i + (jk 					(2)

where the notation is the same as for model (1).  We again investigated
the residuals for this model and concluded that the assumptions of the
ANOVA method were satisfied.  Based on the results of the three runs of
the model, we noted the following:

Screen width had a significant effect on average percent of larvae
entrained (p-value = 0.002) and the average percent of total organisms
entrained (p-value = 0.0109).  This appears to be due to low percent
entrainment outcomes associated with the 0.5 mm mesh size.  Greater
percentages of entrainment were associated with larger mesh sizes.

Screen width alone did not have a significant effect on the average
percent of eggs entrained.

The least squares estimates of the mean effect of screen width are
reported in Table 5.

Table 5.	Least Squares Means and 95% Confidence Limits for Percent
Entrainment Measured in Controlled Laboratory Studies, by Screen Width,
As Estimated from a One-Way ANOVA model with Screen Width as a Factor

Data Set	Screen Width (mm)	Least Squares Means	95% Confidence Limits for
Least Squares Means

Larvae Only	0.5	5.2%	(0.2, 16.3)

	1.0	41.7%	(21.4, 63.6)

	1.3	35.7%	(0.3, 88.6)

	1.8	20.2%	(1.4, 75.4)

	2.0	59.2%	(30.6, 84.8)

	2.5	32.6%	(0.0, 86.4)

Eggs Only	0.5	0.2%	(1.5, 4.0)

	1.0	0.0%	(0.0, 5.2)

	2.0	6.9%	(0.1, 22.6)

All Organisms	0.5	3.8%	(0.4, 10.4)

	1.0	30.7%	(17.5, 46.1)

	1.3	35.7%	(4.9, 75.8)

	1.8	20.2%	(0.2, 59.6)

	2.0	45.1%	(25.4, 65.6)

	2.5	32.6%	(3.6, 73.0)

The outcome of the above statistical analyses were compared to that
observed with percent reduction in entrainment from field studies, as
reported in Battelle’s technical memorandum dated September 29, 2008.
The above analysis on laboratory data noted significant slot velocity
effects (at the 0.05 level) separately for eggs and larvae (but not for
all organisms) which varied according to the slot width size.  However,
as noted in the 9/29 memo, no significant slot velocity effects were
observed in percent reduction in entrainment in field studies for any
life stage, and the interaction of slot velocity and slot width was not
significant.

In both lab and field studies, increased entrainment was observed to
occur with increased mesh sizes.  However, the outcome of the
statistical analyses (involving the one-way ANOVA) differed between the
two types of studies.  While screen mesh size was observed to have a
significant effect on percent reduction in entrainment within the field
studies for eggs only (and not for larvae or total organisms), mesh size
was a significant factor for percent entrainment in the lab studies for
larvae and total organisms (but not for eggs).  For eggs, greater
entrainment levels were observed in the field studies compared to the
lab studies documented in EPRI (2003).  Again, caution should be made
when comparing data outcomes between the field and lab studies due to
differences in how the performance measure was defined and in the ANOVA
models applied to the performance measure data.

References

EPRI (2008).  Laboratory Evaluation of Fine-Mesh Traveling Water Screens
for Protecting Early Life Stages of Fish at Cooling Water Intakes.  Palo
Alto, CA:  Electric Power Research Institute, Inc.  Technical Report No.
1014021.  March 2008.

EPRI (2003).  Laboratory Evaluation of Wedgewire Screens for Protecting
Early Life Stages of Fish at Cooling Water Intakes.  Palo Alto, CA:
Electric Power Research Institute, Inc.  Technical Report No. 1005339.
May 2003.

Hanson, BN, Bason, WH, Beitz, BE, and Charles, KE. (1977).  A practical
intake screen which substantially reduces the entrainment and
impingement of early life stages of fish.  In:  Fourth National Workshop
on Entrainment and Impingement.  LD Jenson, ed.  Melville, NY:  EA
Communications (a division of Ecological Analysts, Inc.)

Tomljanovich, DA, Heuer, JH, and Voighlander, CW.  (1978).
Investigations on the protection of fish larvae at water intakes using
fine-mesh screening.  In:  Larval Exclusion Systems for Power Plant
Cooling Water Intakes:  Proceedings of the Workshop Held at Shelter
Island Inn, San Diego, CA, February 7-8, 1978.  RK Sharma and JB Palmer,
eds.  Argonne, IL:  Argonne National Laboratory.

October 17, 2008

316b:  Laboratory Test Data Related to Entrainment (EP-C-05-030; WA
3-13)

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October 17, 2008

316b:  Laboratory Test Data Related to Entrainment (EP-C-05-030; WA
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[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49323-49324]
[FR Doc No: 2021-18964]

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<EMAIL_ADDRESS>    j. One Hundred River filed its request to use the Traditional
Licensing Process on June 30, 2021, and provided public notice of its
request on June 30, 2021 and July 7, 2021. In a letter dated August 27,
2021, the Director of the Division of Hydropower Licensing approved One
Hundred River's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7
of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Vermont State Historic Preservation Officer, as
required by section 106 of the National Historic Preservation Act, and
the implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating One Hundred River as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. On June 30, 2021, One Hundred River filed a Pre-Application
Document (PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD may be viewed and/or printed on the
Commission's website (http://www.ferc.gov), using the ``eLibrary''
link. Enter the docket number, excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY).
    o. The licensee states its unequivocal intent to submit an
application for a subsequent license for Project No. 9648. Pursuant to
18 CFR 16.20, each application for a subsequent license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by June 30,
2024.
    p. Register online at https://ferconline.ferc.gov/FERCOnline.aspx
to be notified via email of new filings and issuances related to this
or other pending projects. For assistance, contact FERC Online Support.

    Dated: August 27, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-18964 Filed 9-1-21; 8:45 am]
BILLING CODE 6717-01-P