Notice of the Revised Priority List of Hazardous Substances That Will Be Candidates for Toxicological Profiles, 30613-30614 [2014-12262]
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
Persons with comments containing
proprietary information must
distinguish such information from other
comments to the greatest extent possible
and label it as ‘‘Confidential Business
Information’’ (‘‘CBI’’). If a person
making comments wants EPA to base its
decision on a submission labeled as CBI,
then a non-confidential version of the
document that summarizes the key data
or information should be submitted to
the public docket. To ensure that
proprietary information is not
inadvertently placed in the public
docket, submissions containing such
information should be sent directly to
the contact person listed above and not
to the public docket. Information
covered by a claim of confidentiality
will be disclosed by EPA only to the
extent allowed, and according to the
procedures set forth in 40 CFR Part 2.
If no claim of confidentiality
accompanies the submission when EPA
receives it, EPA will make it available
to the public without further notice to
the person making comments.
Dated: May 15, 2014.
Christopher Grundler,
Director, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2014–12017 Filed 5–27–14; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
Notice of the Revised Priority List of
Hazardous Substances That Will Be
Candidates for Toxicological Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Comprehensive
Environmental Response,
Compensation, and Liability Act of 1980
(CERCLA or Superfund), as amended by
the Superfund Amendments and
Reauthorization Act of 1986 (SARA),
requires that ATSDR and the
Environmental Protection Agency (EPA)
prepare a Priority List of Hazardous
Substances commonly found at facilities
on the CERCLA National Priorities List
(NPL). The Priority List of Hazardous
Substances includes substances that
have been determined to be of greatest
public health concern to persons at or
near NPL sites. CERCLA, as amended,
also requires that the Priority List of
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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16:58 May 27, 2014
Jkt 232001
Hazardous Substances be revised
periodically.
This announcement provides notice
that a revised Priority List of 275
Hazardous Substances has been
developed and is now available.
CERCLA, as amended, also requires
ATSDR to prepare and to periodically
revise toxicological profiles on
hazardous substances included in the
priority list. Thus, each priority list
substance is a potential toxicological
profile subject, as well as a candidate for
identification of priority data needs.
In addition to the Priority List of
Hazardous Substances, ATSDR has
developed a Completed Exposure
Pathway Site Count Report. This report
lists the number of sites or events at
which ATSDR is involved and wherein
a substance has been found in a
completed exposure pathway (CEP).
Address for Printed Copy: Requests
for a printed copy of the 2013 Priority
List of Hazardous Substances and
Support Document, including the CEP
report, should be submitted to Ms.
Nickolette Roney, Division of
Toxicology and Human Health Sciences,
ATSDR, Mail Stop F–57, 1600 Clifton
Road, NE., Atlanta, GA 30333.
Electronic Availability: The 2013
Priority List of Hazardous Substances
and Support Document are posted on
ATSDR’s Web site located at
www.atsdr.cdc.gov/SPL. The CEP Report
is posted at www.atsdr.cdc.gov/CEP.
FOR FURTHER INFORMATION CONTACT: Ms.
Nickolette Roney, Division of
Toxicology and Human Health Sciences,
ATSDR, 1600 Clifton Road NE., Mail
Stop F–57, Atlanta, GA 30333,
telephone 800–232–4636.
This is an informational notice only;
comments are not being solicited at this
time.
SUPPLEMENTARY INFORMATION: CERCLA
establishes certain requirements for
ATSDR and EPA with regard to
hazardous substances most commonly
found at facilities on the CERCLA NPL.
Section 104(i)(2)(A) of CERCLA, as
amended,1 requires that ATSDR and
EPA prepare a list, in order of priority,
of at least 100 hazardous substances
most commonly found at facilities on
the NPL and which, in the agencies’ sole
discretion, pose the most significant
potential threats to human health (see
also 52 FR 12866, April 17, 1987).
CERCLA section 104(i)(2)(B) 2 also
requires the agencies to revise the
priority list to include 100 or more
additional hazardous substances (see
also 53 FR 41280, October 20, 1988),
1 42
2 42
PO 00000
U.S.C. 9604(i)(2)(A).
U.S.C. 9604(i)(2)(B).
Frm 00075
Fmt 4703
Sfmt 4703
30613
and to include at least 25 additional
hazardous substances in each of the
three successive years following the
1988 revision (see 54 FR 43615, October
26, 1989; 55 FR 42067, October 17,
1990; and 56 FR 52166, October 17,
1991). CERCLA section 104(i)(2)(B)
further requires ATSDR and EPA at least
annually to revise the list to include any
additional hazardous substances that
have been determined to pose the most
significant potential threat to human
health.
In 1995, the agencies, recognizing the
stability of this listing activity, altered
the priority list publication schedule (60
FR 16478, March 30, 1995). As a result,
the substance priority list is now on a
2-year publication schedule, with
annual informal review and revision.
Each substance on the Priority List of
Hazardous Substances is a potential
subject of a toxicological profile
prepared by ATSDR and, subsequently,
a candidate for the identification of
priority data needs.
The ranking of substances on the
priority list is based on an algorithm
that consists of three criteria, weighted
equally and combined to result in the
total score. The three criteria are: (1)
Frequency of occurrence at NPL sites;
(2) toxicity; and (3) potential for human
exposure. The site-specific information
used to develop the priority list has
been collected from ATSDR public
health assessments and from site-file
data packages used to develop the
public health assessments. Since the
development of the 2011 substance
priority list, additional site specific
information has been collected. The
new information may include more
recent NPL frequency-of-occurrence
data, additional environmental media
concentration data, and more
information on exposure to substances
at NPL sites. Using these additional
data, one substance has been replaced
on the list of 275 substances since the
2011 publication. Changes in the order
of substances appearing on the Priority
List of Hazardous Substances will be
reflected in program activities that rely
on the list for guiding future activities.
Using the current algorithm, a total of
848 candidate substances have been
analyzed and ranked. Of these
candidates, the 275 substances on the
priority list may in the future become
the subject of toxicological profiles.
Additional information on the
existing methodology used in the
development of the Priority List of
Hazardous Substances can be found in
the Support Document and in the abovereferenced Federal Register notices.
In addition to the revised priority list,
ATSDR is also releasing a revised
E:\FR\FM\28MYN1.SGM
28MYN1
30614
Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
Completed Exposure Pathway Site
Count Report. A completed exposure
pathway (CEP) links a contaminant
source to a receptor population. The
CEP ranking is similar to a
subcomponent of the substance priority
list algorithm’s potential-for-humanexposure component. The CEP ranking
is based on a site frequency count and
thus lists the number of sites at which
a substance has been found in a CEP.
This information is derived from
ATSDR public health assessments and
from ATSDR health consultations. The
CEP report therefore focuses on
documented exposure, and lists
hazardous substances according to
exposure frequency.
The substances in the CEP report are
similar to those in the Priority List of
Hazardous Substances. However, some
substances in the CEP report have a very
low toxicity and as a result are not
included in the substance priority list.
Since the substance priority list uses
toxicity, frequency of occurrence, and
potential for human exposure to
determine its priority substances, other
low-toxicity substances will not appear
on the list and, consequently, will not
become subjects of toxicological
profiles. In addition, because CERCLA
mandates the preparation of the Priority
List of Hazardous Substances, that list
only incorporates data from CERCLA
NPL sites. The CEP report, on the other
hand, uses data from all ATSDR-activity
sites at which a CEP has been detected.
Dated: May 21, 2014.
Sascha Chaney,
Acting Director, Office of Policy Planning and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2014–12262 Filed 5–27–14; 8:45 am]
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with NOTICES
[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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
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16:58 May 27, 2014
Jkt 232001
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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
title, ‘‘Eye Tracking Study of Direct-toConsumer 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,
PRAStaff@fda.hhs.gov.
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-toConsumer 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
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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: TollFree Number for Consumer Reporting of
Drug Product Side Effects in Direct-toConsumer 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
E:\FR\FM\28MYN1.SGM
28MYN1
]]>Agencies
[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30613-30614]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12262]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
Notice of the Revised Priority List of Hazardous Substances That
Will Be Candidates for Toxicological Profiles
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (CERCLA or Superfund), as amended by the
Superfund Amendments and Reauthorization Act of 1986 (SARA), requires
that ATSDR and the Environmental Protection Agency (EPA) prepare a
Priority List of Hazardous Substances commonly found at facilities on
the CERCLA National Priorities List (NPL). The Priority List of
Hazardous Substances includes substances that have been determined to
be of greatest public health concern to persons at or near NPL sites.
CERCLA, as amended, also requires that the Priority List of Hazardous
Substances be revised periodically.
This announcement provides notice that a revised Priority List of
275 Hazardous Substances has been developed and is now available.
CERCLA, as amended, also requires ATSDR to prepare and to periodically
revise toxicological profiles on hazardous substances included in the
priority list. Thus, each priority list substance is a potential
toxicological profile subject, as well as a candidate for
identification of priority data needs.
In addition to the Priority List of Hazardous Substances, ATSDR has
developed a Completed Exposure Pathway Site Count Report. This report
lists the number of sites or events at which ATSDR is involved and
wherein a substance has been found in a completed exposure pathway
(CEP).
Address for Printed Copy: Requests for a printed copy of the 2013
Priority List of Hazardous Substances and Support Document, including
the CEP report, should be submitted to Ms. Nickolette Roney, Division
of Toxicology and Human Health Sciences, ATSDR, Mail Stop F-57, 1600
Clifton Road, NE., Atlanta, GA 30333.
Electronic Availability: The 2013 Priority List of Hazardous
Substances and Support Document are posted on ATSDR's Web site located
at www.atsdr.cdc.gov/SPL. The CEP Report is posted at
www.atsdr.cdc.gov/CEP.
FOR FURTHER INFORMATION CONTACT: Ms. Nickolette Roney, Division of
Toxicology and Human Health Sciences, ATSDR, 1600 Clifton Road NE.,
Mail Stop F-57, Atlanta, GA 30333, telephone 800-232-4636.
This is an informational notice only; comments are not being
solicited at this time.
SUPPLEMENTARY INFORMATION: CERCLA establishes certain requirements for
ATSDR and EPA with regard to hazardous substances most commonly found
at facilities on the CERCLA NPL. Section 104(i)(2)(A) of CERCLA, as
amended,\1\ requires that ATSDR and EPA prepare a list, in order of
priority, of at least 100 hazardous substances most commonly found at
facilities on the NPL and which, in the agencies' sole discretion, pose
the most significant potential threats to human health (see also 52 FR
12866, April 17, 1987). CERCLA section 104(i)(2)(B) \2\ also requires
the agencies to revise the priority list to include 100 or more
additional hazardous substances (see also 53 FR 41280, October 20,
1988), and to include at least 25 additional hazardous substances in
each of the three successive years following the 1988 revision (see 54
FR 43615, October 26, 1989; 55 FR 42067, October 17, 1990; and 56 FR
52166, October 17, 1991). CERCLA section 104(i)(2)(B) further requires
ATSDR and EPA at least annually to revise the list to include any
additional hazardous substances that have been determined to pose the
most significant potential threat to human health.
---------------------------------------------------------------------------
\1\ 42 U.S.C. 9604(i)(2)(A).
\2\ 42 U.S.C. 9604(i)(2)(B).
---------------------------------------------------------------------------
In 1995, the agencies, recognizing the stability of this listing
activity, altered the priority list publication schedule (60 FR 16478,
March 30, 1995). As a result, the substance priority list is now on a
2-year publication schedule, with annual informal review and revision.
Each substance on the Priority List of Hazardous Substances is a
potential subject of a toxicological profile prepared by ATSDR and,
subsequently, a candidate for the identification of priority data
needs.
The ranking of substances on the priority list is based on an
algorithm that consists of three criteria, weighted equally and
combined to result in the total score. The three criteria are: (1)
Frequency of occurrence at NPL sites; (2) toxicity; and (3) potential
for human exposure. The site-specific information used to develop the
priority list has been collected from ATSDR public health assessments
and from site-file data packages used to develop the public health
assessments. Since the development of the 2011 substance priority list,
additional site specific information has been collected. The new
information may include more recent NPL frequency-of-occurrence data,
additional environmental media concentration data, and more information
on exposure to substances at NPL sites. Using these additional data,
one substance has been replaced on the list of 275 substances since the
2011 publication. Changes in the order of substances appearing on the
Priority List of Hazardous Substances will be reflected in program
activities that rely on the list for guiding future activities. Using
the current algorithm, a total of 848 candidate substances have been
analyzed and ranked. Of these candidates, the 275 substances on the
priority list may in the future become the subject of toxicological
profiles.
Additional information on the existing methodology used in the
development of the Priority List of Hazardous Substances can be found
in the Support Document and in the above-referenced Federal Register
notices.
In addition to the revised priority list, ATSDR is also releasing a
revised
[[Page 30614]]
Completed Exposure Pathway Site Count Report. A completed exposure
pathway (CEP) links a contaminant source to a receptor population. The
CEP ranking is similar to a subcomponent of the substance priority list
algorithm's potential-for-human-exposure component. The CEP ranking is
based on a site frequency count and thus lists the number of sites at
which a substance has been found in a CEP. This information is derived
from ATSDR public health assessments and from ATSDR health
consultations. The CEP report therefore focuses on documented exposure,
and lists hazardous substances according to exposure frequency.
The substances in the CEP report are similar to those in the
Priority List of Hazardous Substances. However, some substances in the
CEP report have a very low toxicity and as a result are not included in
the substance priority list. Since the substance priority list uses
toxicity, frequency of occurrence, and potential for human exposure to
determine its priority substances, other low-toxicity substances will
not appear on the list and, consequently, will not become subjects of
toxicological profiles. In addition, because CERCLA mandates the
preparation of the Priority List of Hazardous Substances, that list
only incorporates data from CERCLA NPL sites. The CEP report, on the
other hand, uses data from all ATSDR-activity sites at which a CEP has
been detected.
Dated: May 21, 2014.
Sascha Chaney,
Acting Director, Office of Policy Planning and Evaluation, National
Center for Environmental Health/Agency for Toxic Substances and Disease
Registry.
[FR Doc. 2014-12262 Filed 5-27-14; 8:45 am]
BILLING CODE 4163-70-P
