  SEQ CHAPTER \h \r 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

DATE:		April 5, 2010

SUBJECT:	Charge questions for the FIFRA Scientific Advisory Panel
meeting on “Re-Evaluation of Human Health Effects of Atrazine:  Review
of Experimental Animal and In Vitro Studies and Drinking Water
Monitoring Frequency” to be held April 26-29, 2010

FROM:	Tina Levine, Ph.D.

		Director

		Health Effects Division (7509P)

TO:		Joseph Bailey

		Designated Federal Official

		FIFRA Scientific Advisory Panel

		Office of Science Coordination and Policy (7201M)

On March 30, 2010, EPA transmitted its draft issue paper entitled
“Re-Evaluation of Human Health Effects of Atrazine:  Review of
Experimental Animal and In vitro Studies and Drinking Water Monitoring
Frequency” to the FIFRA Scientific Advisory Panel (SAP) in preparation
for the April 26-29, 2010 meeting.  This memo contains the charge
questions for the April SAP meeting.

SAP CHARGE

As part of the re-evaluation of the health effects of atrazine, three
meetings of the FIFRA Scientific Advisory Panel (SAP) are scheduled in
2010.  The first of these was held February 2-4, 2010.  In preparation
for the April meeting, the Agency developed a draft issue paper focused
on 1) a review of the recent scientific literature on the mode of action
and toxicological profile of atrazine and 2) approaches to determine
appropriate drinking water monitoring frequencies.   The purpose of the
April meeting is to solicit feedback from the SAP on the status and
overall scientific direction of the Agency’s re-evaluation in these
two areas including preliminary conclusions about some aspects of the
experimental toxicology data.  The Agency will use the Panel’s
feedback to inform the weight of the evidence (WOE) analysis that will
be developed in the coming months and reviewed at the September 2010
SAP.  The experimental toxicology portion of the draft April issue paper
(Sections 3 & 4, Appendices A & B) represents the state of the science
up to January 30, 2010.  Since that time, new data have become available
and more will become available in the spring and summer of 2010 that
will provide further characterization of some key areas, such as
describing the causal linkage between key events in the mode of action,
the dose-response concordance of these key events, and the relationship
between the precursor events with functional outcomes.  These new
studies will be incorporated into the September SAP.

Question 1.0:  In Vivo & In Vitro Experimental Toxicology in Mammals

In 2003, the human health risk assessment was based on a mode of action
in which exposure to atrazine leads to a reduced release of gonadotropin
releasing hormone (GnRH) from the hypothalamus thereby lessening the
afternoon pituitary luteinizing hormone (LH) surge in female Sprague
Dawley rats.  As a result, the estrus cycle lengthens.  This, in turn,
leads to increased estrogen levels and an increased incidence of mammary
tumors in female Sprague Dawley rats.  EPA determined that atrazine’s
cancer mode of action (i.e., premature reproductive aging) in the
Sprague-Dawley rat is not likely to be operative in humans (a conclusion
consistent with the SAP recommendation in 2000).  The Agency will be
evaluating the cancer classification further as the experimental
toxicology data are integrated with the epidemiology literature; new
experimental toxicology studies (Section 3.6 of the draft issue paper)
do not suggest a change to the Agency’s previous conclusion that
atrazine is “not likely to be carcinogenic to humans.”

Although the cancer mode of action may not be operative in humans, it is
not unreasonable to assume that atrazine might cause adverse effects on
hypothalamic-pituitary function in humans.  Thus, the same endocrine
perturbations that induce tumors in rats may play a role in at least
some reproductive/developmental effects (not associated with
reproductive aging) that may be relevant to humans.  Accordingly, the
Agency identified disruption of estrous cyclicity and delays in puberty
onset (males and females) occurring as a consequence of disruptions to
the hypothalamic-pituitary-gonadal (HPG) axis as the critical endpoints
of concern (Sections 2.0 & 3.2 of the draft issue paper).

The Agency continues to believe that this disruption of the HPG axis is
critical to affecting estrous cyclicity and delayed puberty onset.
However, as discussed in Questions 1.2-1.6 (See Figure 3 of the draft
issue paper), new information has been published that indicates a more
expanded understanding of how atrazine may perturb the pathway leading
to reproductive effects.   These new data indicate that atrazine
disrupts the hypothalamic-pituitary-adrenal (HPA) axis altering the
central nervous system’s control of the pituitary and adrenal which,
in turn, disrupts the HPG axis. Furthermore, a hypothesis for a direct
effect of atrazine on the adrenal cortex and the gonads which may impact
steroidogenesis directly is also supported by the available data.

Question 1.1

With the caveat that the review of the epidemiological literature is
still on-going, please comment on the Agency’s preliminary conclusion
that new experimental data from in vitro and in vivo laboratory animal
studies do not support a change in the conclusions from the 2003 risk
assessment that atrazine is unlikely to be a human carcinogen.

Question 1.2

Based on an evaluation of the studies examining the mode of action of
atrazine on neuroendocrine function (Section 3.2 of the draft issue
paper), the Agency has preliminarily concluded that atrazine affects
both the HPG axis and the HPA axis.  With respect to the temporal
concordance, recent studies show that atrazine induces a rapid (within
minutes) increase in ACTH and adrenal cortical hormones (corticosterone
and progesterone) in both male and female rats (Fraites et al., 2009;
Laws et al., 2009; Pruett et al., 2009), while changes in the HPG axis,
such as the suppression of the LH surge, may take up to 2-3 days (Cooper
et al., 2009).  This sequence of HPA alterations followed by HPG changes
indicates that the suppression of the surge may be, in part, mediated by
activation of the HPA axis (i.e., a corticosterone suppression of the
GnRH and LH release).  In addition, with respect to dose-response
concordance, atrazine-induced increases in ACTH, corticosterone and
adrenal progesterone are seen following a single dose of atrazine (50
mg/kg).   In contrast, the HPG is not altered following a single dose up
to 200 mg/kg. However, when treated for multiple days, the dose
necessary to alter the HPA axis is lower than or equal to the one needed
to affect the HPG axis.

Please comment on the Agency’s preliminary hypothesis for the mode of
action involving atrazine’s alteration of both the HPA and HPG axes.
Does the document adequately and clearly describe the hypothesis in the
context of a “toxicity pathway” (i.e. cellular response pathways
that, when sufficiently perturbed, are expected to result in adverse
health effects)?  Does the document clearly describe the data used to
test the proposed hypothesis? To what extent do the available data
establish key events in the proposed mode of action hypothesis?  What
are the strengths and limitations of the data available on this
hypothesis?

Please include in your comments a discussion of the Agency’s
interpretations of the data linking the initial perturbations in HPA
axis to changes in the HPG axis.

Please comment on the evidence that the initial perturbations in the HPA
axis may lead to impairment in reproductive function and/or
developmental consequences.  Which event(s) is/are viewed as critical in
leading to health consequences? Are there data on other substances that
would inform this question?

Question 1.3

The Agency has preliminarily concluded that atrazine directly targets
cells within the HPA axis (Sections 3.2 & <IP_ADDRESS> of the draft issue
paper) and that the increased activity of the adrenal axis does not
reflect nonspecific stress.  Evidence for this conclusion is based on
the following observations.

Several studies report increased adrenocorticotropic hormone (ACTH) and
corticosterone levels immediately following a single exposure to
atrazine and its two metabolites (deisopropyl-atrazine, DIA;
deethyl-atrazine, DEA) but not diamino-s-chlorotriazine (DACT; Laws et
al., 2009; Fraites et al., 2009; Pruett et al., 2009).

A single intravenous administration of DEA in vivo (Fraites et al.,
2009) also causes an immediate increase in ACTH and adrenal hormone
release, indicating that a chlorotriazine-induced gastrointestinal
distress is not driving the hormonal response.

The adrenal corticosterone response to continued oral exposure to
atrazine did not habituate in rats (Fraites et al., 2009; Laws et al.,
2009) or mice (Pruett et al., 2009).

Although, atrazine induced a rapid increase in ACTH, prolactin secretion
was not affected in the same animals (Laws et al., 2009).  This is
unusual in that an increase in both ACTH and prolactin are typically
observed in response to a number of physiological and psychological
stressors.

Please comment on the extent to which the available evidence supports
the preliminary conclusion that atrazine and its intermediate
metabolites (DIA and DEA) induce changes in the HPA axis as a result of
a direct action on the HPA tissue and such changes are not due to a
generalized or non-specific stress response.  Are there data on other
substances that would support this conclusion?

Question 1.4

Based on a review of in vitro studies evaluating the effects of atrazine
on estrogen production, the Agency has preliminarily concluded that
atrazine does not have a direct effect on the catalytic activity of
aromatase.  However, with continued exposure (> 24 hrs) atrazine can
cause increased estrone and estradiol production in the H295R and JEG-3
cell lines (Sanderson et al., 2000; Laville 2006; Higley et al., 2010).
 These changes in estrogen production have been associated with
increased cAMP and CYP19 mRNA (Sanderson et al., 2000, 2001) that are
part of a complex mode of action through which atrazine up-regulates the
gene expression of aromatase and possibly other enzymes within the
steroidogenic pathway (Section <IP_ADDRESS> & Figure 3, Arrow 7of the draft
issue paper).  The hypothesis that atrazine alters multiple steroids is
supported by  increased testosterone concentrations in H295R cells
following exposure to atrazine (Higley et al., 2010), and in vitro
studies demonstrating that atrazine affects a number of signal
transduction pathways and/or transcription factors in a variety of cell
lines (Suzawa and Ingraham, 2008; Albanito et al., 2008).  Up-
regulation of the expression of a group of major steroidogenic genes has
been observed in JEG-3 cells (Suzawa and Ingraham, 2008).  In vivo,
there is little evidence that atrazine alters aromatase per se (Modic,
2004) and the evidence associating atrazine exposures to increases in
serum estrogens appears to be related to a general increase in gonadal
and adrenal progesterone and androstanedione (Modic 2004; Laws et al.,
2009).

Please comment on the extent that the available data do or do not
support the Agency’s preliminary conclusion that atrazine has a
general stimulatory effect on steroidogenesis, as opposed to a direct
effect on aromatase.

Question 1.5

A series of studies evaluating the effect of either peripubertal or
gestational exposure of atrazine in the male rat indicate that atrazine
decreases testosterone concentrations and may lower androgen dependent
tissue weights but that it has little effect on basal LH secretion in
the male.  This response generally occurs at doses of 50 mg/kg and
above.  In contrast, atrazine in vitro has been found to consistently
increase steroid hormone production.  Thus, there is an apparent
discrepancy between the in vivo and in vitro data.  However, our
understanding of the interplay between the adrenal and the gonadal axes
may provide an explanation.   At the doses used in the in vivo studies,
atrazine induces an activation of the adrenal axis (increased ACTH and
corticosterone) and the increase in corticosterone does not habituate
(i.e., it does not lessen with repeated dosing). There are a number of
studies in the literature demonstrating that prolonged corticosterone
stimulation will impair testosterone production by a direct action on
steroidogenesis in the Leydig cells. Therefore, the in vivo effects on
testosterone synthesis are likely the result of an adrenal
hormone-mediated down regulation of HPG axis (through corticotropin
releasing hormone [CRH] modulation of GnRH pulsatility) or directly on
the testis (through a glucocorticoid receptor mediated change in
steroidogenesis).

Please comment on the degree to which the proposed mode of action
(Figure 3 of the draft issue paper) provides a biologically plausible
explanation for the decrease in serum and testicular testosterone
identified in the in vivo studies.  Please comment on the extent that
the available data do or do not support this hypothesis.

Question 1.6

Based on a review of the neurotoxicity studies (Section 3.4 of the draft
issue paper), the Agency has preliminarily concluded that several recent
studies provided further support for the concern that dopaminergic
neurotransmission may be affected by atrazine, a concern that was raised
by studies prior to 2003.  However, the Agency has also concluded that
several aspects of these studies of the dopaminergic neuronal pathways,
in particular the changes noted in stereological evaluations and the
observed changes in behavior, should be considered as preliminary
findings.  This conclusion is based on the notable limitations
identified in the data including:  (1) lack of clear dose-response
relationships, (2) lack of inclusion of suitable positive controls to
confirm the competency and reliability of the procedures utilized in
examining dopaminergic systems in the brain, (3) limited data to
corroborate stereological findings, (4) limited or no supporting
histological and behavioral assessments, and (5) no consideration of the
potential role of the HPA axis (e.g. alterations in corticosterone).
EPA has further determined that two non-dopaminergic neurotoxicity
studies--one on brain somatostatinergic systems and the other on
neurobehavior in mice -- also have significant limitations (e.g., lack
of details on source and purity of atrazine, and age and body weights of
the mice; poor quality of amino cupric silver staining photomicrographs;
limited presentation of reverse-transcriptase polymerase chain results;
lack of data to corroborate conclusion of neuronal degeneration;
reference citations did not support statements made in the text; no
explanation of biological plausibility of alterations in
somatostatinergic receptor subtypes; inappropriate statistical
evaluation of data (litter vs. pup); discrepancies in number of pups
examined for behavioral endpoints, and lack of objective and validated
behavioral tests).  Please comment on these preliminary conclusions
regarding the neurotoxicity findings.

The Agency has preliminarily concluded that the available studies
indicate that the neurotoxicity endpoints examined are not more
sensitive than those evaluated for neuroendocrine function following
atrazine exposure (e.g., attenuation of LH surge and estrous cycle
disruptions in female Sprague-Dawley rats which form the basis for the
current chronic RfD).  In addition, the Agency has concluded that there
is no association between atrazine exposure and development of
Parkinson’s Disease on the basis of non-specificity of effects on
brain dopaminergic systems, lack of histological and behavioral features
characteristic of Parkinson’s Disease, and results of epidemiological
studies. Please comment on this preliminary conclusion.

Question 1.7

Based on a review of two studies of the potential effects of atrazine on
the prostate (Section <IP_ADDRESS> of the draft issue paper), the Agency has
concluded that the results of the Rayner et al. (2007) study of pregnant
rats treated during gestation support previous observations (Stoker et
al., 1999) that atrazine treatment to the rat dam either perinatally or
early postnatally can increase prostate weights (due to an increase in
inflammatory infiltrate) in the male offspring.  This effect on the
offspring was shown to be due to a suppression of prolactin in the
atrazine-exposed dams during lactation, and is consistent with the mode
of action of atrazine on neuroendocrine function.   The Agency also
preliminarily concluded that further research is needed to provide more
convincing evidence that atrazine-mediated suppression of prostate
cancer in the probasin/SV40T antigen transgenic rat (androgen-dependent
prostate cancer rodent model)  may possibly be due to caloric
restriction rather than endocrine-related as postulated by Kandori et
al. (2005).  Please comment on these preliminary conclusions regarding
the recent prostate findings.

Please comment on the extent to which the available data support the
proposed mode of action for prostatitis and the appropriateness of the
rodent model in the context of human health.

Question 1.8

Based on data obtained in studies to assess the effects of atrazine on
the immune system following developmental and adult exposure, as well as
in vitro mechanistic studies, EPA concluded that atrazine has the
potential to affect the immune system (Section 3.5 of the draft issue
paper).  However, the Agency has also concluded that underlying
mechanisms of atrazine-mediated immunotoxicity and its relevance to
potential adverse health effects in humans are still not thoroughly
understood.  It is well established that products of the endocrine
system modulate immune function.  However, adult rodent studies have not
determined whether immune system effects are caused by direct effects of
atrazine and/or its metabolites or whether they are the result of
modulated endocrine hormone production, which in turn affects immune
cells.  Two published studies indicate that exposure to atrazine during
immune system development may result in altered immune function in
offspring, although no conclusions were drawn on the potential adversity
of the effects, because immunosuppression was observed in one study and
immunoenhancement was observed in the other.   Please comment on
potential explanations for the disparate findings reported by Rooney et
al. and Rowe et al.  Many immunotoxicologists consider immunomodulation,
i.e., suppression or enhancement of immune function, as a potentially
adverse alteration of homeostasis, because both have been associated
with disease states.   Thus, while the results Rooney et al. and Rowe et
al. may appear to be contradictory, together the data indicate
unintended immunomodulation at approximately the same dose in two
species.  Please comment on characterizing the effects of gestational
atrazine exposure as immunomodulation, when describing the
immunotoxicological outcome of developmental immunotoxicity studies.

Appendix B of the draft issue paper describes experiments conducted by
EPA scientists on the potential developmental immunotoxicity of
atrazine.  The results of the experiments provide conflicting results.
Additional studies did not provide a suitable explanation of the
differences.  The Agency believes both sets of data are of high quality.
 However, in the context of hazard assessment, such differences are
difficult to interpret.  Please comment on the information contained in
Appendix B and provide suggestions for interpreting such data as part of
the atrazine re-evaluation.

The available data do not indicate that atrazine-induced immunotoxicity
is a more sensitive endpoint than the atrazine-induced effects on
neuroendocrine function, (e.g., attenuation of LH surge and estrous
cycle disruptions which form the basis for the current chronic RfD) in
female Sprague-Dawley rats.  Please comment on the degree to which these
preliminary conclusions are supported by the available data

Question 1.9

After the April 2010 SAP, the Agency will evaluate the weight of
evidence (WOE) for atrazine by integrating the experimental toxicology
data with the epidemiological studies.  As part of this work, the Agency
will consider the available data on hormonal changes and functional
outcomes that may be used as endpoints for deriving PoDs across
different durations of exposure and for different populations (including
potentially sensitive ones).  Important studies evaluating the
dose-response relationships for hormones involved in the HPA axis are
still on-going.  These studies are expected to provide high quality data
that can be used to characterize the entire dose response curve.  With
the caveat that these data are not available now, given the current
understanding of atrazine’s mode of action, please comment on what
would be appropriate endpoints to consider for use in deriving points of
departure in a possible future risk assessment.

Given that the duration of the toxicological concern is a key factor in
evaluating the frequency of drinking water monitoring, please include in
your response a consideration of the magnitude and duration of changes
in key events in the toxicity pathway that are sufficient perturb normal
function and comprise human health.   In defining the exposure window of
interest, please comment on the toxicokinetic/dynamic considerations
with respect to atrazine's effects on the HPA/HPG axis.

Question 2.0:  Approaches to Evaluating Water Sampling Strategies &
Frequency of Monitoring

In conjunction with the toxicological review presented in the issue
paper, the Agency has also discussed methods for re-evaluating the
sampling frequency that is necessary for determining, with confidence,
concentrations of the pesticide in water that sources drinking water.
These have included different methods for estimating pesticide
concentrations between known sampling events and examining the
performance of different sampling strategies for averaging periods of
different durations.  The Agency seeks feedback from the Panel with
regard to how the uncertainty and variability in both the monitoring
data and in the toxicity data (i.e., point of departure) can be
integrated to characterize and to interpret the potential significance
of atrazine concentrations in drinking water.

Question 2.1

Given the nature of the temporal patterns of pesticide occurrence in
surface waters described in Section 5.2, including serial correlations
from day to day, periodicity in elevated concentrations within seasons
and from year to year, below quantitation data, and uncertainty in the
shape of the pesticide distributions in surface waters--what statistical
approaches should the Agency consider in determining confidence bounds
on exposure estimates from monitoring data? Please comment on how the
approach may vary depending on the duration of concern.

Question 2.2

The first two simulation methods presented in Section 5.5 are applicable
to the specific data sets they describe, although some generalities
regarding shape patterns appear to exist.  Given this information,
please comment on the strengths and weaknesses of the approaches and on
the practical merits of pursuing them or some other numerical approach
with a larger set of higher concentration systems.  Please comment on
how the methods for determining confidence bounds might apply given
these considerations.

Question 2.3

As described in Section 5.4.2, the Agency is considering the use of a
confidence interval or prediction interval approach to characterize the
uncertainty of exposure estimates derived from monitoring data of
varying sampling frequencies.  Please comment on the strengths and
weaknesses of either placing confidence bounds on the rolling average
estimates and comparing the upper limit from monitoring against the
level of concern (LOC) or, conversely, placing confidence bounds on the
LOC.

Question 2.4

Please comment on the relative merits of the various modeling approaches
the Agency described in Section 5.4.1 and 5.6 for interpolating
pesticide concentrations between sampling points and, in particular, on
the strengths and weaknesses of these methods as the frequency of
samples decreases. Considering the health endpoint(s) being considered
for atrazine, particularly data for the HPA axis, and the exposure time
frame needed to induce the health effect(s) which is shorter than that
used in the 2003 risk assessment, please comment on the advantages and
disadvantages of each model for evaluating the likely occurrence and
exposure via drinking water of short, moderate, and long duration
concentrations.  Please comment on the Agency’s proposed approach for
evaluating these methods, as described in Section 5.7.1.  To what extent
should the Agency consider other factors, such as the shape of the
chemograph (Section 5.5.3), weather patterns, stream flow, and/or
pesticide use patterns in evaluating the modeling approaches?

Page   PAGE  10  of   NUMPAGES  10


[Federal Register Volume 88, Number 87 (Friday, May 5, 2023)]
[Rules and Regulations]
[Page 28993]
[FR Doc No: 2023-09620]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0235]

Safety Zones; Recurring Safety Zones in Captain of the Port Sault
Sainte Marie Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce various safety zones for maritime
events in the Captain of the Port Sault Sainte Marie Zone. Enforcement
of these safety zones is necessary to protect the safety of life and
property on the navigable waters immediately prior to, during, and
immediately after this event. During the aforementioned period, the
Coast Guard will enforce restrictions upon, and control movement of,
vessels in a specified area immediately prior to, during, and
immediately after events. During each enforcement period, vessels must
stay out of the established safety zone and may only enter with
permission from the designated representative of the Captain of the
Port Sault Sainte Marie.

DATES: The regulations listed in 33 CFR 165.918 will be enforced for
the safety zones identified in the SUPPLEMENTARY INFORMATION section
below for the dates and times specified.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
publication, call or email Waterways Management division, LT Deaven
Palenzuela, Coast Guard Sector Sault Sainte Marie, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones in 33 CFR 165.918, Table 165.918, at the following dates and
times for the following events:
    (1) Mackinaw Area Visitors Bureau Friday Night Fireworks (Mackinaw
City, MI): From 8:30 p.m. through 11 p.m. on May 26, 2023; June 2, 4,
9, 11, 16, 18, 23, 25, 30, 2023; July 2, 4, 7, 9, 14, 16, 21, 23, 28,
30, 2023; August 4, 6, 11, 13, 18, 20, 25, 27, 2023; and September 1,
3, 8, 15, 22, 29, 2023.
    (2) Festivals of Fireworks Celebration Fireworks (St. Ignace, MI).
From 9 p.m. through 11 p.m. on June 24, 2023; July 4, 8, 15, 22, 29,
2023; August 5, 12, 19, 26; and September 2, 2023.
    This enforcement includes alternative rain dates one the day after
any affected event.
    Under the provisions of 33 CFR 165.918, entry into, transiting, or
anchoring within the safety zones during an enforcement period is
prohibited unless authorized by the Captain of the Port Sault Sainte
Marie or his designated representative. Those seeking permission to
enter the safety zone may request permission from the Captain of Port
Sault Sainte Marie via channel 16, VHF-FM. Vessels and persons granted
permission to enter the safety zone shall obey the directions of the
Captain of Port Sault Sainte Marie or his designated representatives.
While within the safety zone, all vessels shall operate at the minimum
speed necessary to maintain a safe course.
    This notice of enforcement is issued under authority of 33 CFR
165.918 and 5 U.S.C. 552(a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advance notification of this enforcement period via
Broadcast Notice to Mariners or Local Notice to Mariners. If the
Captain of the Port Sault Sainte Marie determines that the safety zone
need not be enforced for the full duration stated in this notice he or
she may suspend such enforcement and notify the public of the
suspension via Broadcast Notice to Mariners and grant general
permission to enter the respective safety zone.

    Dated May 2, 2023.
A.R. Jones,
Captain, U.S. Coast Guard, Captain of the Port Sault Sainte Marie.
[FR Doc. 2023-09620 Filed 5-4-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45773-45776]
[FR Doc No: 2019-18766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3926]

Request for Nominations for Voting Members on Public Advisory
Panels or Committees; Device Good Manufacturing Practice Advisory
Committee and the Medical Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee (DGMPAC) and the Medical
Devices Advisory Committee (MDAC) device panels in the Center for
Devices and Radiological Health. This annual notice is also in
accordance with the 21st Century Cures Act, which requires the
Secretary of Health and Human Services (the Secretary) to provide an
annual opportunity for patients, representatives of patients, and
sponsors of medical devices that may be specifically the subject of a
review by a classification panel to provide recommendations for
individuals with appropriate expertise to fill voting member positions
on classification panels.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Nominations received on or before October 29, 2019 will be given
first consideration for membership on the DGMPAC and Panels of the
MDAC. Nominations received after October 29, 2019 will be considered
for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, contact the following persons listed in table 1:

             Table 1--Primary Contact and Committee or Panel
------------------------------------------------------------------------
         Primary contact person                 Committee or panel
------------------------------------------------------------------------
Joannie Adams-White, Office of the       Medical Devices Dispute
 Center Director, Center for Devices      Resolution Panel.
 and Radiological Health, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5519, Silver
 Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>LCDR Sara Anderson, Office of            Dental Products Panel,
 Management, Center for Devices and       Hematology and Pathology
 Radiological Health, Food and Drug       Devices Panel, Orthopaedic and
 Administration, 10903 New Hampshire      Rehabilitation Devices Panel,
 Ave., Bldg. 66, Rm. G616, Silver         Radiological Devices Panel.
 Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Aden S. Asefa, Office of Management,     Immunology Devices Panel,
 Center for Devices and Radiological      Microbiology Devices Panel,
 Health, Food and Drug Administration,    Neurological Devices Panel,
 10903 New Hampshire Ave., Bldg. 66,      Ophthalmic Devices Panel,
 Rm. G642, Silver Spring, MD 20993, 301-  DGMPAC.
 796-0400, email:
<EMAIL_ADDRESS>LCDR Patricio G. Garcia, Office of       Clinical Chemistry and Clinical
 Management, Center for Devices and       Toxicology Devices Panel,
 Radiological Health, Food and Drug       Gastroenterology and Urology
 Administration, 10903 New Hampshire      Devices Panel, General and
 Ave., Bldg. 66, Rm. G610, Silver         Plastic Surgery Devices Panel,
 Spring, MD 20993,<PHONE_NUMBER>, email:   Obstetrics and Gynecology
<EMAIL_ADDRESS>            Devices Panel.

Evella F. Washington, Office of          Anesthesiology and Respiratory
 Management, Center for Devices and       Therapy Devices Panel,
 Radiological Health, Food and Drug       Circulatory System Devices
 Administration, 10903 New Hampshire      Panel, General Hospital and
 Ave., Bldg. 66, Rm. G640, Silver         Personal Use Devices Panel,
 Spring, MD 20993<PHONE_NUMBER>, email:    Molecular and Clinical
<EMAIL_ADDRESS>          Genetics Panel.
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:

    Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
------------------------------------------------------------------------
                                                     Approximate date
          Expertise needed            Vacancies           needed
------------------------------------------------------------------------
DGMPAC--Experts in medical device              4  Immediately.
 quality management system                     1  General Public
 requirements/current Good                     2   Representative.
 Manufacturing Practices, with                 1  Health Professional
 experience in both 21 CFR part 820                Representatives.
 and International Organization for               Government
 Standardization (ISO) 13485, are                  Representative.
 needed to provide cross-cutting
 scientific or clinical expertise
 concerning the particular issue in
 dispute. Vacancies include a
 representative of the interests of
 the general public, government,
 and representatives of the
 interests of physicians and other
 health professionals.
Anesthesiology and Respiratory                 1  12/1/2019.
 Therapy Devices Panel of the MDAC--
 Anesthesiologists, pulmonary
 medicine specialists, or other
 experts who have specialized
 interests in ventilator support,
 sleep medicine, pharmacology,
 physiology, or the effects and
 complications of anesthesia. FDA
 is also seeking applicants with
 pediatric expertise in these areas.
Circulatory System Devices Panel of            1  Immediately.
 the MDAC--Interventional
 cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists, vascular
 and cardiothoracic surgeons, and
 cardiologists with special
 interest in congestive heart
 failure.
Clinical Chemistry and Clinical                1  Immediately.
 Toxicology Panel of the MDAC--                1  3/1/2020.
 Doctors of Medicine or Philosophy
 with experience in clinical
 chemistry (e.g., cardiac markers),
 clinical toxicology, clinical
 pathology, clinical laboratory
 medicine, and endocrinology.
Dental Products Panel of the MDAC--            1  Immediately.
 Dentists, engineers, and                      1  11/1/2019.
 scientists who have expertise in
 the areas of dental implants,
 dental materials, oral and
 maxillofacial surgery,
 endodontics, periodontology,
 tissue engineering, snoring/sleep
 therapy, and dental anatomy.
Gastroenterology and Urology                   2  1/1/2020.
 Devices Panel of the MDAC--
 Gastroenterologists, urologists,
 and nephrologists.
General and Plastic Surgery Devices            4  Immediately.
 Panel of the MDAC--Surgeons
 (general, plastic, reconstructive,
 pediatric, thoracic, abdominal,
 pelvic, and endoscopic);
 dermatologists; experts in
 biomaterials, lasers, wound
 healing, and quality of life; and
 biostatisticians.
General Hospital and Personal Use              1  1/1/2020.
 Devices Panel of the MDAC--
 Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical
 engineers, human factors experts,
 or microbiologists/infection
 control practitioners or experts.
Hematology and Pathology Devices               2  3/1/2020.
 Panel of the MDAC--Hematologists
 (benign and/or malignant
 hematology), hematopathologists
 (general and special hematology,
 coagulation and hemostasis, and
 hematological oncology),
 gynecologists with special
 interests in gynecological
 oncology, cytopathologists, and
 molecular pathologists with
 special interests in development
 of predictive and prognostic
 biomarkers, molecular oncology,
 cancer screening, cancer risk,
 digital pathology, whole slide
 imaging; devices utilizing
 artificial intelligence/machine
 learning.
Immunology Devices Panel of the                3  Immediately.
 MDAC--Persons with experience in              2  3/1/2020.
 medical, surgical, or clinical
 oncology, internal medicine,
 clinical immunology, allergy,
 molecular diagnostics, or clinical
 laboratory medicine.
Medical Devices Dispute Resolution             1  10/1/2020.
 Panel of the MDAC--experts with
 cross-cutting scientific,
 clinical, analytical or mediation
 skills.
Microbiology Devices Panel of the              2  3/1/2020.
 MDAC--Infectious disease (ID)
 clinicians (e.g., pulmonary
 disease specialists, sexually
 transmitted disease specialists,
 pediatric ID specialists, tropical
 diseases specialists) and clinical
 microbiologists experienced in
 emerging IDs; clinical
 microbiology laboratory directors;
 molecular biologists with
 experience in in vitro diagnostic
 device testing; virologists;
 hepatologists; or clinical
 oncologists experienced with tumor
 resistance and susceptibility.

Molecular and Clinical Genetics                2  Immediately.
 Panel of the MDAC--Experts in                 1  6/1/2020.
 human genetics, molecular
 diagnostics, and in the clinical
 management of patients with
 genetic disorders, e.g.,
 pediatricians, obstetricians,
 neonatologists. Individuals with
 training in inborn errors of
 metabolism, biochemical and/or
 molecular genetics, population
 genetics, epidemiology and related
 statistical training,
 bioinformatics, computational
 genetics/genomics, variant
 classification, cancer genetics/
 genomics, molecular oncology,
 radiation biology, and clinical
 molecular genetics testing, (e.g.,
 sequencing, whole exome
 sequencing, whole genome
 sequencing, non-invasive prenatal
 testing, cancer screening,
 circulating cell free/circulating
 tumor nucleic acid testing,
 digital polymerase chain reaction,
 genotyping, array comparative
 genomic hybridization, etc.).
 Individuals with experience in
 genetics counseling and medical
 ethics are also desired, and
 individuals with experience in
 ancillary fields of study will be
 considered.
Neurological Devices Panel of the              1  Immediately.
 MDAC--Neurosurgeons                           2  12/1/2019.
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric,
 pain management, and movement
 disorders), interventional
 neuroradiologists, psychiatrists,
 and biostatisticians.
Obstetrics and Gynecology Devices              2  Immediately.
 Panel of the MDAC--Experts in                 1  2/1/2020.
 perinatology, embryology,
 reproductive endocrinology,
 pediatric gynecology,
 gynecological oncology, operative
 hysteroscopy, pelviscopy,
 electrosurgery, laser surgery,
 assisted reproductive
 technologies, contraception,
 postoperative adhesions, and
 cervical cancer and colposcopy;
 biostatisticians and engineers
 with experience in obstetrics/
 gynecology devices;
 urogynecologists; experts in
 breast care; experts in gynecology
 in the older patient; experts in
 diagnostic (optical) spectroscopy;
 experts in midwifery; labor and
 delivery nursing.
Ophthalmic Devices Panel of the                3  Immediately.
 MDAC--Ophthalmologists
 specializing in cataract and
 refractive surgery and vitreo-
 retinal surgery, in addition to
 vision scientists, optometrists,
 and biostatisticians practiced in
 ophthalmic clinical trials.
Orthopaedic and Rehabilitation                 2  Immediately.
 Devices Panel of the MDAC--                   2  9/1/2020.
 Orthopaedic surgeons (joint,
 spine, trauma, reconstruction,
 sports medicine, hand, foot and
 ankle, and pediatric orthopaedic
 surgeons); rheumatologists;
 engineers (biomedical,
 biomaterials, and biomechanical);
 experts in rehabilitation
 medicine, and musculoskeletal
 engineering; radiologists
 specializing musculoskeletal
 imaging and analyses, and
 biostatisticians.
Radiological Devices Panel of the              1  2/1/2020.
 MDAC--Physicians with experience
 in general radiology, mammography,
 ultrasound, magnetic resonance,
 computed tomography, other
 radiological subspecialties and
 radiation oncology; scientists
 with experience in diagnostic
 devices, radiation physics,
 statistical analysis, digital
 imaging, and image analysis.
------------------------------------------------------------------------

I. General Description of the Committees' Duties

A. DGMPAC

    The DGMPAC reviews regulations proposed for promulgation regarding
good manufacturing practices governing the methods used in, and the
facilities and controls used for, the manufacture, packing, storage and
installation of devices, and makes recommendations to the Commissioner
of Food and Drugs (the Commissioner) regarding the feasibility and
reasonableness of those proposed regulations. The DGMPAC also advises
the Commissioner on any petition submitted by a manufacturer for an
exemption or variance from good manufacturing practice regulations that
is referred to the committee.

B. MDAC

    The MDAC reviews and evaluates data on the safety and effectiveness
of marketed and investigational devices and makes recommendations for
their regulation. The panels engage in many activities to fulfill the
functions the Federal Food, Drug, and Cosmetic Act (FD&C Act) envisions
for device advisory panels. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
performs the following duties: (1) Advises the Commissioner regarding
recommended classification or reclassification of devices into one of
three regulatory categories, (2) advises on any possible risks to
health associated with the use of devices, (3) advises on formulation
of product development protocols, (4) reviews premarket approval
applications for medical devices, (5) reviews guidelines and guidance
documents, (6) recommends exemption of certain devices from the
application of portions of the FD&C Act, (7) advises on the necessity
to ban a device, and (8) responds to requests from the Agency to review
and make recommendations on specific issues or problems concerning the
safety and effectiveness of devices. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.

    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

II. Criteria for Voting Members

A. DGMPAC

    The DGMPAC consists of a core of nine members including the Chair.
Members and the Chair are selected by the Secretary. Persons nominated
for membership as a health professional or officer or employee of any
Federal, State, or local government should have knowledge of or
expertise in any one or more of the following areas: Quality assurance
concerning the design, manufacture, and use of medical devices in
accordance with 21 CFR part 820 and/or ISO 13485. To be eligible for
selection as a representative of the general public, nominees should
possess appropriate qualifications to understand and contribute to the
DGMPAC's work. Three of the members shall be officers or employees of
any State or local government or of the Federal Government; two shall
be representative of the interests of the device manufacturing
industry; two shall be representatives of the interests of physicians
and other health professionals; and two shall be representatives of the
interests of the general public. Almost all non-Federal members of this
committee serve as Special Government Employees. Members are invited to
serve for overlapping terms of 4 years. The current needs for the
DGMPAC are listed in table 2.

B. Panels of the MDAC

    The MDAC with its 18 panels shall consist of a maximum of 159
standing members. Members are selected by the Commissioner or designee
from among authorities in clinical and administrative medicine,
engineering, biological and physical sciences, and other related
professions. Almost all non-Federal members of this committee serve as
Special Government Employees. A maximum of 122 members shall be
standing voting members and 37 shall be nonvoting members who serve as
representatives of consumer interests and of industry interests. FDA is
publishing separate documents announcing the Request for Nominations
Notification for Non-Voting Representatives on certain panels of the
MDAC. Persons nominated for membership on the panels should have
adequately diversified experience appropriate to the work of the panel
in such fields as clinical and administrative medicine, engineering,
biological and physical sciences, statistics, and other related
professions. The nature of specialized training and experience
necessary to qualify the nominee as an expert suitable for appointment
may include experience in medical practice, teaching, and/or research
relevant to the field of activity of the panel. The current needs for
each panel are listed in table 2. Members will be invited to serve for
terms of up to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified
individuals for membership on one or more of the advisory panels or
advisory committees. Self-nominations are also accepted. Nominations
must include a current, complete r[eacute]sum[eacute] or curriculum
vitae for each nominee, including current business address, telephone
number, and email address if available, and a signed copy of the
Acknowledgement and Consent form available at the FDA Advisory
Nomination Portal (see ADDRESSES). Nominations must also specify the
advisory committee(s) for which the nominee is recommended. Nominations
must also acknowledge that the nominee is aware of the nomination
unless self-nominated. FDA will ask potential candidates to provide
detailed information concerning such matters related to financial
holdings, employment, and research grants and/or contracts to permit
evaluation of possible sources of conflict of interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18766 Filed 8-29-19; 8:45 am]
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[Federal Register: April 10, 2007 (Volume 72, Number 68)]
[Notices]
[Page 17885]
[DOCID:fr10ap07-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER02-1175-003, ER98-4652-004]

Boralex Ft. Fairfield LP, Boralex Stratton Energy LP; Notice of
Filing

April 4, 2007.
    Take notice that on March 21, 2007, Boralex Ft. Fairfield LP and
Boralex Stratton Energy LP each submit corrected FERC Electric Tariffs,
designated as Revised Volume No. 1.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on April 11, 2007.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6679 Filed 4-9-07; 8:45 am]

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[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Notices]
[Page 42165-42166]
[DOCID:fr01au07-128]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56124; File No. SR-NASD-2007-042]

Self-Regulatory Organizations: National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change to Delay the Implementation of NASD Interpretive Material
2210-4, which Requires Certain Member Firms to Provide a Hyperlink to
http://www.nasd.com.

July 24, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 27, 2007, the National Association of Securities Dealers, Inc.
(``NASD'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by NASD.
NASD filed the proposed rule change pursuant to section 19(b)(3)(A)(i)
of the Act,\3\ and Rule 19b-4(f)(1) thereunder,\4\ as one constituting
a stated policy, practice, or interpretation with respect to the
meaning, administration, or enforcement of an existing rule, which
renders the proposed rule change effective upon filing with the
Commission. On July 20, 2007, NASD filed Amendment No. 1 to the
proposed rule change. The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASD is proposing to delay, until October 31, 2007, implementation
of an amendment to Interpretive Material 2210-4 (``IM 2210-4'') \5\
that was scheduled to be implemented on July 7, 2007.\6\ The recent
amendment to IM-2210-4 requires an NASD member referring to its NASD
membership on its Web site to provide a hyperlink to the Internet
domain http://www.nasd.com (``hyperlink requirement''). There are no

proposed changes to the text of NASD rules.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 54740 (November 9,
2006), 71 FR 67184 (November 20, 2006) (SR-NASD-2006-073) (Order
Approving Proposed Rule Change and Amendment No. 1 thereto and
Notice of Filing and Order Granting Accelerated Approval to
Amendment No. 2 to Amend NASD Interpretive Material 2210-4 to
Require Certain Member Firms to Provide a Hyperlink to the NASD's
Internet Home Page) (``Approval Order'').
    \6\ As required by the Approval Order, unless amended, the
implementation date of the hyperlink requirement will be 180 days
following publication of Notice to Members 07-02, which announces
Commission approval of the hyperlink requirement. Notice to Members
07-02 was published on January 8, 2007.
---------------------------------------------------------------------------

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

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

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

1. Purpose
    On November 9, 2006, the SEC approved an amendment to IM-2210-4
establishing the hyperlink requirement.\7\ On January 8, 2007, NASD
published Notice to Members 07-02, which announced the Commission's
approval of the hyperlink requirement and established July 7, 2007 as
its implementation date.\8\ Following SEC approval of the hyperlink
requirement, NASD and NYSE Group, Inc. (``NYSE'') announced a plan to
consolidate their member regulation operations into a combined
organization that will be the sole U.S. private-sector provider of
member firm regulation for securities firms that do business with the
public.\9\ To reflect this consolidation, NASD will be changing its
name to the Financial Industry Regulatory Authority, Inc. (``FINRA'')
and changing its internet domain. NASD is delaying implementation of
the hyperlink requirement until its new name and internet domain are
established and is providing sufficient time for firms to make the
necessary changes to their Web sites. NASD will submit a separate rule
change to amend IM-2210-4 to reflect its new corporate name and
internet domain.
---------------------------------------------------------------------------

    \7\ See Approval Order.
    \8\ See NASD Notice to Members 07-02 (January 2007).
    \9\ See SR-NASD-2007-023, which proposes to amend the By-Laws of
NASD to implement governance and related changes to accommodate the
consolidation of the member firm regulatory functions of NASD and
NYSE Regulation, Inc., Securities Exchange Act Release No. 55495
(March 20, 2007), 72 FR 14149 (March 26, 2007).
---------------------------------------------------------------------------

    NASD has filed the proposed rule change for immediate effectiveness
to immediately postpone, until October 31, 2007, the implementation
date of the hyperlink requirement, which otherwise would have been
implemented on July 7, 2007.
2. Statutory Basis
    NASD believes that the proposed rule change is consistent with the
provisions of section 15A(b)(6) of the Act,\10\ which requires, among
other things, that NASD's rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. NASD is delaying implementation of the hyperlink
requirement until its new name and internet domain are established and
is providing sufficient time for firms to make the necessary changes to
their Web sites.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    NASD does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    The foregoing proposal has become effective pursuant to section
19(b)(3)(A)(i) of the Act,\11\ and Rule 19b-4(f)(1) \12\ thereunder, in
that it constitutes a stated policy with respect to the enforcement of
an existing rule. At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(i).
    \12\ 17 CFR 240.19b-4(f)(1).
    \13\ 15. U.S.C. 78s(b)(3)(C). For purposes of calculating the
60-day period within which the Commission may abrogate the proposal,
the Commission considers the period to commence on July 20, 2007,
the date on which NASD filed Amendment No. 1.
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2007-042 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASD-2007-042. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F. Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NASD. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASD-2007-042 and should be
submitted on or before August 22, 2007.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-14834 Filed 7-31-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22671-22674]
[FR Doc No: 2021-08962]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6730]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
requirements for medical device reporting for user facilities,
manufacturers, importers, and distributors of medical devices.

DATES: Submit either electronic or written comments on the collection
of information by June 28, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 28, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 28, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2017-N-6730 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Reporting.''
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, 240-
402-7500.
     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 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device Reporting--21 CFR Part 803

OMB Control Number 0910-0437--Extension

    This information collection supports FDA regulations and FDA's
Medical Device Reporting program. Section 519(a), (b), and (c) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(a),
(b), and (c)) requires user facilities, manufacturers, importers, and
distributors of medical devices to report adverse events involving
medical devices to FDA. These provisions are codified in part 803 (21
CFR part 803), Medical Device Reporting. As amended most recently by
the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), medical
device manufacturers and importers must submit medical device reports
(MDRs) using FDA's electronic submission system. User facilities,
however, may elect to submit reports using paper-based Form FDA 3500A--
MedWatch--Mandatory Reporting (approved under OMB control number 0910-
0291). The regulations also establish recordkeeping requirements and
provide for certain exemptions, variances, or alternative forms of
reporting. Exemptions and/or variances from individual reporting must
be requested in writing and must receive Agency approval. Additionally,
the regulations permit user facilities to submit paper-based annual
reports, for which we have developed Form FDA 3419 entitled ``Medical
Device Reporting Annual User Facility Report.''
    This information collection also includes the use of existing
formats such as Form FDA 3500A \1\--MedWatch--Mandatory Reporting to
allow manufacturers to summarize in a single report multiple events
with shared characteristics for device associated reportable
malfunction events. For example, the Voluntary Malfunction Summary
Reporting Program (VMSRP) \2\ provides recommendations for
manufacturers of certain devices to submit a single report that
summarizes multiple device associated reportable malfunction events on
a quarterly basis. The VMSRP was established under section
519(a)(1)(B)(ii) of the FD&C Act and reflects goals for streamlining
malfunction reporting as outlined in the Medical Device User Fee
Amendments (MDUFA) IV ``Commitment Letter'' for 2018 through 2022
agreed to by FDA and industry and submitted to Congress. The Commitment
Letter was finalized with the passage of FDARA on August 18, 2017, and,
as passed, is entitled ``MDUFA Performance Goals And Procedures, Fiscal
Years 2018 Through 2022.'' \3\
---------------------------------------------------------------------------

    \1\ Form FDA 3500A is approved under OMB control number 0910-
0291.
    \2\ In the Federal Register of August 17, 2018 (83 FR 40973),
FDA issued a notification permitting manufacturers to report certain
device malfunction MDRs in summary form on a quarterly basis.
    \3\ Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.
---------------------------------------------------------------------------

    The information that is obtained from this information collection
will be used to evaluate risks associated with medical devices and
enable FDA to take appropriate measures to protect the public health.
Complete, accurate, and timely adverse event information is necessary
for the identification of emerging device problems so the Agency can
protect the public health under section 519 of the FD&C Act. FDA makes
the releasable information available to the public for downloading on
its website. Respondents are manufacturers and importers of medical
devices and device user facilities.\4\
---------------------------------------------------------------------------

    \4\ Device user facility means a hospital, ambulatory surgical
facility, nursing home, outpatient diagnostic facility, or
outpatient treatment facility as defined in Sec.  803.3, which is
not a physician's office (also defined in Sec.  803.3).

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

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of
        Activity/21 CFR section          FDA  form      Number of     responses per   Total  annual      Average burden  per response       Total hours
                                            No.        respondents     respondent       responses                                               \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions/Variances--803.19..........  ...........              85               4             340  1..................................             340
User Facility Reporting--803.30 and     ...........             520           10.06           5,232  0.35 (21 minutes)..................           1,831
 803.32.
User Facility Annual Reporting--803.33         3419             159               1             159  1..................................             159
Importer Reporting, Death and Serious   ...........             578               1             578  1..................................             578
 Injury--803.40 and 803.42.
Manufacturer Reporting--803.50, 803.52  ...........           1,240          272.50         337,900  0.10 (6 minutes)...................          33,790
 and 803.53.
Voluntary Malfunction Summary           ...........           1,240           54.47          67,546  0.10 (6 minutes)...................           6,755
 Reporting Program.
Supplemental Reports--803.56..........  ...........           1,050          128.71         135,148  0.10 (6 minutes)...................          13,515
                                       -----------------------------------------------------------------------------------------------------------------
    Total.............................  ...........  ..............  ..............  ..............  ...................................          56,968
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.

    The number of respondents to the information collection is based on
MDRs received by FDA recently. The annual frequency per response and
total annual responses shown are based on the number of MDRs reported
during the same period. FDA estimates that approximately 10 percent of
malfunction reports are submitted. Approximately 67 percent of the
manufacturer reports received under 21 CFR 803.50, 803.52, and 803.53
are malfunction reports.
    Supplemental Reports--21 CFR 803.56. We estimate that, at most, the
number of supplemental reports is approximately one third of the total
number of individual reports and summary reports submitted annually.
Therefore, our estimate of the number of responses per respondent is
128.71.
    Voluntary Malfunction Summary Reporting Program. The VMSRP includes
the same respondent pool as individual manufacturer reporting. We
expect that a summary report will take approximately the same amount of
time to prepare as an individual report. (Note: device-led combination
products are included in the burden estimate for the VMSRP.) As
discussed in section I of the proposed VMSRP, FDA's Pilot Program for
Medical Device Reporting on Malfunctions showed an 87 percent reduction
in the volume of reporting for malfunction reports with use of
malfunction summary reporting. Assuming 90 percent of malfunction
reports are submitted in summary reports, we estimate that
manufacturers would submit an average of 54.47 summary reports annually
under the program.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           Activity/21 CFR section               Number of      records per    Total annual       Average  burden per  recordkeeping        Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17......................           1,240               1           1,240  3.3.......................................           4,092
MDR Files--803.18...........................           1,240               1           1,240  1.5.......................................           1,860
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           5,952
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents in table 2 is based on the MDRs reported
to FDA's internal databases recently. We believe that the majority of
respondents (manufacturers, user facilities, and importers) have
already established written procedures and MDR files to document
complaints and information to meet the MDR requirements as part of
their internal quality control system. We have therefore adjusted our
estimate downward.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           Activity/21 CFR section               Number of    disclosures per   Total annual         Average burden  per disclosure         Total hours
                                                respondents      respondent      disclosures                                                    \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importer Reporting, Death and Serious                    578               25          14,450  0.35 (21 minutes)........................           5,058
 Injury--803.40 and 803.42.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.

    The number of respondents for each CFR section in table 3 was
identified from the MDRs reported to FDA's internal databases during
the period recently.
    Based on a review of the information collection since our last
request for OMB approval, we have made no changes to our burden
estimate.

    Dated: April 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08962 Filed 4-28-21; 8:45 am]
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[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5819-5820]
[FR Doc No: 2022-02050]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2021-0561; FRL-9486-01-ORD]

Availability of the Draft IRIS Toxicological Review of
Perfluorohexanoic Acid (PFHxA) and Related Salts

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 60-
day public comment period associated with release of the draft
Integrated Risk Information System (IRIS) Toxicological Review of
Perfluorohexanoic Acid (PFHxA) and Related Salts. The draft document
was prepared by the Center for Public Health and Environmental
Assessment (CPHEA) within EPA's Office of Research and Development
(ORD). EPA is releasing this draft IRIS assessment for public comment
in advance of an independent external peer review organized by ERG, a
contractor to EPA. The external peer reviewers will be provided with
all written comments submitted in response to this notice for their
consideration as they conduct their review. To receive future
notification about the peer review, sign up for EPA's IRIS listserv, as
described in this notice. EPA will consider all comments received when
revising the document post-peer review. This draft assessment is not
final as described in EPA's information quality guidelines, and it does
not represent, and should not be construed to represent Agency policy
or views.

DATES: The 60-day public comment period begins February 2, 2022 and
ends April 4, 2022. Comments must be received on or before April 4,
2022.

ADDRESSES: The IRIS Toxicological Review of Perfluorohexanoic Acid
(PFHxA) and Related Salts will be available via the internet on the
IRIS website at https://www.epa.gov/iris/iris-recent-additions and in
the public docket at http://www.regulations.gov, Docket ID No. EPA-HQ-
ORD-2021-0561.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
[email protected].
    For technical information on the IRIS Toxicological Review of
Perfluorohexanoic Acid (PFHxA) or information on the public comment
period, contact Dr. Andrew Kraft, CPHEA; telephone:<PHONE_NUMBER>; or
email: [email protected]. The IRIS Program will provide updates
through the IRIS website (https://www.epa.gov/iris) and via EPA's IRIS
listserv. To register for the IRIS listserv, visit the IRIS website
(https://www.epa.gov/iris) or visit https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.
    For questions about the peer review, please contact: Laurie Waite,
ERG, by email at [email protected] (subject line: EPA PFHxA peer
review); or by phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

Information on IRIS PFAS Assessments

    Per- and polyfluoroalkyl substances (PFAS) are a large class of
man-made chemicals widely used in consumer products and industrial
processes. The basic structure of PFAS consists of a carbon chain
surrounded by fluorine atoms, with different chemicals possessing
different end groups. The five IRIS toxicity assessments are being
developed according to the scope and methods outlined in the publicly
posted systematic review protocol (https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=345065) and they build upon several
other PFAS assessments that have already been developed, and represent
only one component of the broader PFAS action plan underway at the U.S.
EPA (https://www.epa.gov/pfas/epas-pfas-action-plan).
    EPA previously announced peer review activities related to five
IRIS five per- and polyfluoroalkyl substances (PFAS) Integrated Risk
Information System (IRIS) assessments including: Perfluorodecanoic acid
(PFDA; CASRN 335-76-2), perfluorononanoic acid (PFNA; CASRN 375-24-4),
perfluorohexanoic acid (PFHxA, CASRN 307-24-4), perfluorohexanesulfonic
acid (PFHxS, CASRN 355-46-4), and perfluorobutanoic acid (PFBA, CASRN
375 22 4) and their related salts. These documents will undergo
independent external scientific peer review managed by ERG, a
contractor to EPA. EPA will provide updates on the status of the peer
review for PFHxA via the IRIS website (https://www.epa.gov/iris) and
IRIS listserv. EPA encourages all interested stakeholders to register
for the IRIS listserv by visiting the IRIS website at https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect. Specific questions or comments on the peer review
process should be directed to ERG.

II. How To Submit Technical Comments to the Docket at https://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2021-
0561 for the Perfluorohexanoic Acid (PFHxA) IRIS Assessment, by one of
the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: [email protected].
     Fax:<PHONE_NUMBER>. Due to COVID-19, there may be a delay
in processing comments submitted by fax.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>. Due to COVID-
19, there may be a delay in processing comments submitted by mail.
    For information on visiting the EPA Docket Center Public Reading
Room, visit https://www.epa.gov/dockets. Due to public health concerns
related to COVID-19, the EPA Docket Center and Reading Room may be
closed to the public with limited exceptions. The telephone number for
the Public Reading Room is<PHONE_NUMBER>. The public can submit comments
via www.regulations.gov or email.
    Instructions: Direct your comments to docket number EPA-HQ-ORD-
2021-0561 for the Perfluorohexanoic Acid (PFHxA) IRIS Assessment.
    Please ensure that your comments are submitted within the specified
comment period. Comments received after the closing date will be marked
``late,'' and may only be considered if time permits. It is EPA's
policy to include all comments it receives in the public docket without
change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information for which disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.

Timothy Watkins,
Acting Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2022-02050 Filed 2-1-22; 8:45 am]
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