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Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices

public health implications, on the basis
of ATSDR’s authority to prepare
toxicological profiles for substances not
found at sites on the National Priorities
List. The agency will do so in order to
‘‘...establish and maintain inventory of
literature, research, and studies on the
health effects of toxic substances’’ under
CERCLA Section 104(i)(1)(B), to respond
to requests for consultation under
section 104(i)(4), and to support the sitespecific response actions conducted by
ATSDR, as otherwise necessary.
DATES: Nominations from the Substance
Priority List and/or additional
substances must be submitted on or
before August 19, 2013.
ADDRESSES: You may submit
nominations, identified by Docket No.
ATSDR–2013–0002, by any of the
following methods:
*Internet: Access the Federal
eRulemaking portal at http://
www.regulations.gov. Follow the
instructions for submitting comments.
*Mail: Division of Toxicology and
Human Health Sciences, 1600 Clifton
Rd. NE., MS F–57, Atlanta, Ga., 30333
Instructions: All submissions must
include the agency name and docket
number for this notice. All relevant
comments will be posted without
change. This means that no confidential
business information or other
confidential information should be
submitted in response to this notice.
Refer to the section Submission of
Nominations (below) for the specific
information required.
FOR FURTHER INFORMATION CONTACT: For
further information, please contact
Commander Jessilynn B. Taylor,
Division of Toxicology and Human
Health Sciences, 1600 Clifton Rd. NE.,
MS F–57, Atlanta, Ga., 30333, Email:
[email protected]; phone:
1–800–232–4636.
SUPPLEMENTARY INFORMATION: The
Superfund Amendments and
Reauthorization Act of 1986 (SARA) [42
U.S.C. 9601 et seq.] amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) [42
U.S.C. 9601 et seq.] by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(EPA) with regard to hazardous
substances most commonly found at
facilities on the CERCLA National
Priorities List (NPL). Among these
statutory requirements is a mandate for
the ATSDR Administrator to prepare
toxicological profiles for each substance
included on the Priority List of
Hazardous Substances. This list
identifies 275 hazardous substances that
ATSDR and EPA have determined pose

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the most significant current potential
threat to human health. The availability
of the revised list of the 275 priority
substances was announced in the
Federal Register on November 3, 2011
(76 FR 68193). For prior versions of the
list of substances, see Federal Register
notices dated April 17, 1987 (52 FR
12866); October 20, 1988 (53 FR 41280);
October 26, 1989 (54 FR 43619); October
17,1990 (55 FR 42067); October 17, 1991
(56 FR 52166); October 28, 1992 (57 FR
48801); February 28, 1994 (59 FR 9486);
April 29, 1996 (61 FR 18744); November
17, 1997 (62 FR 61332); October 21,
1999 (64 FR 56792); October 25, 2001
(66 FR 54014), November 7, 2003 (68 FR
63098); December 7, 2005 (70 FR
70284); and March 6, 2008 (73 FR
12178).
Substances To Be Evaluated for Set 27
Toxicological Profiles
Each year, ATSDR develops a list of
substances to be considered for
toxicological profile development. The
Set 27 nomination process includes
consideration of all substances on
ATSDR’s Priority List of Hazardous
Substances, also known as the
Substance Priority List (SPL), as well as
other substances nominated by the
public. The 275 substances on the SPL
will be considered for Set 27
Toxicological Profile development. This
list may be found at the following Web
site: www.atsdr.cdc.gov/SPL and in the
docket at www.regulations.gov
Submission of Nominations for the
Evaluation of Set 27 Proposed
Substances: Today’s notice invites
voluntary public nominations for
substances included on the SPL and for
substances not listed on the SPL. All
nominations should include the full
name of the nominator, affiliation, email
address. When nominating a non-SPL
substance, please include the rationale
for the nomination. Please note email
addresses will not be posted on
www.regulations.gov.
ATSDR will evaluate all data and
information associated with nominated
substances and will determine the final
list of substances to be chosen for
toxicological profile development.
Substances will be chosen according to
ATSDR’s specific guidelines for
selection. These guidelines can be found
in the Selection Criteria announced in
the Federal Register on May 7, 1993
(58FR27286–27287). A hard copy of the
Selection Criteria is available upon
request or may be accessed at: http://
www.atsdr.cdc.gov/toxprofiles/
guidance/
criteria_for_selectingtpsupport.pdf.
Please ensure that your comments are
submitted within the specified

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nomination period. Nominations
received after the closing date will be
marked as late and may be considered
only if time and resources permit.
Dated: July 11, 2013.
Sascha Chaney,
Acting Director, Office of Policy, Planning
and Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2013–17355 Filed 7–18–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-13–13ZZ]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 and
send comments to LeRoy Richardson,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an email to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information;
(c) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Evaluation of the SAMHSA PDMP
Electronic Health Record (EHR)
Integration and Interoperability
Expansion Program—New—National
Center for Injury Prevention and Control
(NCIPC), Center for Disease Control and
Prevention (CDC).

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Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
Background and Brief Description
In 2009, drug overdose deaths became
the leading cause of injury death in the
United States (U.S.), exceeding motor
vehicle traffic crash deaths for the first
time, a trend that continued in 2010.
Prescription drugs, particularly opioid
pain relievers, have been identified as
the main driver of this increase. The
number of overdose deaths per year
involving opioid pain relievers
increased more than four-fold from 1999
to 2010 (from 4,030 to 16,651),
outnumbering overdose deaths
involving all illicit drugs combined.
Morbidity associated with opioid pain
reliever abuse increased in parallel. The
rate of emergency department visits
associated with the misuse or abuse use
of opioid pain relievers increased 153%
from 2004 to 2011, while rates for illicit
drugs remained largely stable.
Concurrent to this rise in overdose
death rates, the sales of opioid pain
relievers have increased four-fold since
1999. According to the National Survey
of Drug Use and Health, the primary
source of prescription drugs for nonmedical use is from prescribed and
dispensed prescriptions; more than 70%
of those who reported non-medical use
of pain relievers said they obtained the
pain reliever they most recently used
from a friend or relative. Moreover,
multiple studies have found an
association between increased opioid
prescribing—in the amount prescribed
per prescription, the total days’ supply,
and the number of prescriptions per
patient—and increased morbidity and
mortality in the U.S. over the last 10 to
15 years.
Prescription Drug Monitoring
Programs (PDMPs) are now recognized
as a key tool in federal, state, and local
efforts to address prescription drug
abuse and misuse. PDMPs are state
databases to which pharmacies and
other dispensers report dispensed
outpatient controlled substance
prescription information. Forty-nine
states have passed legislation
authorizing a PDMP, and 45 states
currently have an operational program.
In the vast majority of these programs,
prescribers and pharmacists (herein
referred to collectively as providers) can
register to become an authorized user of
the PDMP. Following authorization,
users can then conduct online queries to
obtain prescription histories for their
patients, a process that may take up to
several minutes. For many providers,
accessing patient prescription histories
offers critical input that can inform their
clinical decision-making. This process
has shown promise in preventing
prescribing to patients who appear to be

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abusing prescription medications or
obtaining controlled substances
prescribed by multiple providers
without knowledge of the other
prescriptions (referred as doctor
shopping) while enabling appropriate
prescribing and dispensing for
legitimate patients, especially for pain
medication.
However, for many providers, even
the few minutes required to log on to
the PDMP and query a patient’s
prescription history present a barrier to
regular use. Moreover, gaps in patients’
prescription histories due to limited
interstate sharing of PDMP data has
contributed to relatively slow rates of
provider registration with and use of
PDMPs. PDMP reports show that it often
takes four or more years following the
implementation of online PDMP access
for registration in the state to reach 50%
of the prescribers who write controlled
substance prescriptions, thus limiting
the potential impact of these programs.
Various strategies have been proposed
to increase provider use of PDMPs. For
example, several states have recently
passed legislation mandating provider
registration with and use of the PDMP
under certain circumstances. Many
states have also initiated efforts to enroll
providers in educational training
programs on the value of using PDMP
data to counteract the prescription drug
overdose epidemic. The project
described below takes a different
approach to increasing provider use of
PDMPs.
In an effort to increase provider
utilization of PDMPs and to effectively
reduce prescription drug abuse and
overdose, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) funded projects in nine
states beginning in fiscal year (FY) 2012
and lasting for a period of two years
through its PDMP Electronic Health
Records (EHRs) Integration and
Interoperability Expansion (PEHRIIE)
cooperative agreement program. The
goals of this program are to:
(1) Increase provider utilization of
their state’s PDMP by improving realtime access to PDMPs via the integration
of PDMP data and/or access thereof
within health information technologies
(HIT) such as health information
exchanges (HIEs), EHR systems, and/or
pharmacy dispensing software (PDS).
Ultimately, when providers access a
patient’s EHR, s/he will have automatic
access to that patient’s up-to-date
prescription history within the course of
their normal clinical workflow, thereby
obviating the time and effort otherwise
needed to access the PDMP and obtain
this information separately from the
patient’s medical record. Similarly,

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when a pharmacist calls up patient
information via the PDS, the patient’s
prescription history from the PDMP will
be automatically compiled, allowing for
expedited access and review prior to
dispensing.
(2) Increase provider utilization of
PDMP data by increasing the
comprehensiveness and quality of
PDMP data by increasing the
interoperability of PDMPs across state
lines. When providers access a patient’s
prescription history from his or her state
PDMP (either directly or via the systems
described above), data from other state
PDMPs with which the home state
PDMP is interoperable will be
automatically included. By providing a
more complete prescription history,
PDMP data is expected to have greater
utility in clinical decision-making, thus
offering an inducement for providers to
access and utilize PDMP data more
frequently.
Both of these goals are expected to
contribute to improving prescribing and
dispensing practices, resulting in
decreased prescription drug abuse and
misuse and related health consequences
such as fatal and non-fatal overdoses as
well as lead to improvements in care.
Under the cooperative agreements
issued by SAMHSA, the CDC is
responsible for conducting a
comprehensive process and outcomes
evaluation of the PEHRIIE program. The
evaluation team consists of health
scientists on the Prescription Drug
Overdose team within the Division of
Unintentional Injury Prevention,
National Center for Injury Control and
Prevention at CDC, and two subject
matter experts at the PDMP Center of
Excellence at Brandeis University. The
primary goals of the qualitative
evaluation component of this work are:
(1) To understand the processes,
challenges, and successes in
implementing and sustaining
integration of PDMP data with Health
Information Technology (HIT) systems
and interoperability of PDMP systems
across states; and
(2) To understand the experiences of
clinical end users with the systems
being upgraded under the PEHRIIE
program and to capture their
recommendations, if any, for how the
goals of the PEHRIIE could have been
better accomplished.
To achieve these evaluation goals, the
CDC evaluation team will conduct
qualitative interviews with those
individuals involved in the planning
and implementation of the PEHRIIE
projects (i.e., key project staff and
stakeholders) as well as with the clinical
end users (i.e., prescribers and

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pharmacists) of the PDMPs in the states
where these projects are taking place.
This evaluation is consistent with
CDC’s strategic goals of improving
surveillance, informing policy, and
improving clinical practice. CDC
believes that the most effective
interventions in combating the
prescription drug overdose epidemic
include those designed to identify and
address high-risk patients at a stage
when their risky behaviors can be most
effectively addressed. Strong yet
accessible PDMPs that promote
proactive patient interventions are a
critical component of this high-risk
focused strategy. By enabling providers
to identify high-risk patients at the point
of care, via improved access to and use
of PDMPs and improved
comprehensiveness of PDMP data,
providers can intervene with patients
and address their high-risk behaviors,
including providing or redirecting
patients to substance abuse treatment as
necessary. Through this evaluation, CDC
will better understand the impact of
PDMP integration and interoperability
in the funded states.
The total annual estimated burden
hours for the planned qualitative
information collection are 235 hours.
Total burden time includes the time to

will be conducted at 39 implementation
sites distributed across all nine PEHRIIE
states (range: 3–8 sites per state).
Interviews will be conducted with three
clinical end users per implementation
site for a total of 117 clinical end user
interviews. Based on pilot testing with
three individuals, each clinical end user
interview will take one hour to
complete. Therefore, 117 clinical end
users at 1 hour each will require 117
hours of interviewee time.
It will take 39 hours of recruiter time
to identify potential clinical end user
interviewees, to collect the contact
information from these clinical end
users, and to disseminate this collected
information to the CDC evaluation time.
The CDC will work with one recruiter
per implementation site to complete
these tasks. Based on the time required
to complete similar tasks during the
planning of the clinical end user pilot
interviews, each recruiter is expected to
spend approximately one hour on these
tasks. Therefore, 39 recruiters spending
one hour each on this information
collection will require 39 hours of
recruiter time.
There are no costs to respondents
other than their time.

conduct interviews with key project
staff/stakeholders and clinical end
users, and the time spent by recruiters
at the PEHRIIE implementation sites to
identify potential clinical end user
interviewees.
It will take 79 hours of interviewee
time to complete all of the key project
staff/stakeholder interviews necessary
for the planned evaluation of the
PEHRIIE program. Interviews will be
conducted with 91 key project staff
members/stakeholders across the nine
PEHRIIE-funded states (range: 6–16
interviews per state) as well as 14 key
project staff/stakeholders representing
five companies working with multiples
states involved in the PEHRIIE program,
for a total of 105 key project staff/
stakeholders interviewees. Based on
pilot testing with three individuals,
each key project staff/stakeholder
interview will take approximately 45
minutes to complete. Therefore, 105 key
project staff/stakeholder interviews at
45 minutes each will require 79 hours
of interviewee time.
It will take 117 hours of interviewee
time to complete all of the clinical end
user interviews necessary for the
planned evaluation of the PEHRIIE
program. Each interviewee will be
interviewed once. End user interviews

ESTIMATED ANNUALIZED BURDEN HOURS
Number of responses per
respondent

105

1

45/60

79

Clinical End Users ............................
Clinical End User Recruiters .............

Key Project Staff/Stakeholders Interview Guide.
Clinical End Users Interview Guide
N/A ...................................................

117
39

1
1

1
1

117
39

Total ...........................................

...........................................................

........................

........................

........................

235

Form name

Key Project Staff/Stakeholders .........

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–17295 Filed 7–18–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Average burden per response
(in hrs)

Number of respondents

Type of respondents

Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Income Withholding Order/
Notice for Support (IWO).

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OMB No.: 0970–0154.
Description: Statutory requirements
under subsections 466(a)(1), (a)(8) and
466(b)(6) of the Social Security Act
require the use of the Income
Withholding for Support (IWO) form in
all child support cases. The form must
be used by child support agencies,
courts, tribes, private attorneys and
other entities when ordering or sending
notices to withhold. 42 U.S.C 666(a)(1)
and (8); 42 U.S.C 666(b)(6).
The Income Withholding for Support
(IWO) form previously approved by the
Office of Management and Budget has
been modified to address items
identified by states and employers/
income withholders. The title of the
form is changed to Income Withholding
Order/Notice for Support (IWO) to
correspond to the first line of the form.

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Total burden
(in hrs)

The blank box for court use is removed
and text shifted to make better use of
available space. Language is inserted to
explain that provisions of the Consumer
Credit Protection Act (CCPA) apply only
to employees and not to independent
contractors. A header with caseidentifying information is added on
Page Two and a Social Security Number
on Page Three to place case-identifying
information on each page and allow
future automated improvements for
employers and states. Clarifications are
added to the Instructions emphasizing
that each IWO should represent the
information for only one case, as
defined in the Code of Federal
Regulations.
Respondents: Not applicable.

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