Attachment G -- 30 day FRN

Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
Correction
In the Federal Register of June 22,
2015, in FR Vol. 80, No. 119, on page
35649, in the third column, on lines 13–
14, correct the ADDRESSES caption to
read:
ADDRESSES: CECANF will convene its
meeting at the Madison Marriott West,
1313 John Q. Hammons Drive,
Middleton, Wisconsin. This site is
accessible to individuals with
disabilities. The meeting also will be
made available via teleconference and/
or webinar.
Dated: June 30, 2015.
Amy Templeman,
Acting Executive Director.
[FR Doc. 2015–16698 Filed 7–7–15; 8:45 am]
BILLING CODE 6820–34–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Assessing the Impact of the National
Implementation of TeamSTEPPS Master
Training Program.’’ In accordance with
the Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on April 10th, 2015 and
allowed 60 days for public comment. No
substantive comments were received.
The purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by August 7, 2015.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer). Copies of the proposed
collection plans, data collection
instruments, and specific details on the
estimated burden can be obtained from
the AHRQ Reports Clearance Officer.

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SUMMARY:

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FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at [email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Assessing the Impact of the National
Implementation of TeamSTEPPS Master
Training Program
AHRQ, in collaboration with the
Department of Defense’s (DoD) Tricare
Management Activity (TMA), developed
TeamSTEPPS® (‘‘Team Strategies and
Tools to Enhance Performance and
Patient Safety’’) to provide an evidencebased suite of tools and strategies for
teaching teamwork-based patient safety
to health care professionals. In 2007,
AHRQ and DoD coordinated the
national implementation of the
TeamSTEPPS Program. The main
objective of this program is to improve
patient safety by training a select group
of stakeholders such as Quality
Improvement Organization (QIO)
personnel, High Reliability Organization
(HRO) staff, and health care system staff
in various teamwork, communication,
and patient safety concepts, tools, and
techniques. Ultimately, TeamSTEPPS
will help to build a national and statelevel infrastructure for supporting
teamwork-based patient safety efforts in
health care organizations.
The National Implementation of
TeamSTEPPS Master Training Program
includes the training of ‘‘Master
Trainers’’ in various health care systems
capable of stimulating the utilization
and adoption of TeamSTEPPS in their
health care delivery systems, providing
technical assistance and consultation on
implementing TeamSTEPPS, and
developing various channels of learning
(e.g., user networks, various educational
venues) for continuing support and
improvement of teamwork in health
care. AHRQ has already trained a corps
of over 5,000 participants to serve as the
Master Trainer infrastructure supporting
national adoption of TeamSTEPPS. An
anticipated 2,400 participants, who are
undergoing training now, will be
studied in this assessment. After
training, these participants will become
Master Trainers in TeamSTEPPS and
will have the opportunity to observe the
program’s tools and strategies in action.
In addition to developing a corps of
Master Trainers, AHRQ has also
developed a series of support
mechanisms for this effort including a
data collection Web tool, a
TeamSTEPPS call support center, and a
monthly consortium to address any
challenges encountered implementing
TeamSTEPPS.

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Participants applied to the program as
teams representing their organizations
and were accepted as training
participants after having completed an
organizational readiness assessment.
Due to the differences among the types
of organizations participating in the
program, participants will apply the
tools and concepts differently within
and/or beyond their home
organizations. For example:
• Health care system staff (or
implementers) from hospitals, home
health agencies, nursing homes, large
physician practices, and other direct
care organizations are more likely than
other participants to implement the
TeamSTEPPS materials on a daily basis
and will be more likely to affect specific
work processes being conducted within
an organization. As a result, health care
system participants are likely to have a
focused and specific impact that is
limited to their organization.
• QIO\HRO\Hospital
Association\State Health Department
participants (or facilitators) will be more
likely to have both an in-depth and
broad impact if they use the
TeamSTEPPS materials to assist a
particular organization in its patient
safety activities, as well as to provide
general patient safety guidance to a large
number of organizations.
To clarify the differences among the
participants, a logic model has been
developed that highlights the roles of
the different types of participants, the
types of activities in which they are
likely to engage after training, and the
potential outcomes that may stem from
these activities. The logic model served
as a guide for developing questions for
a web-based questionnaire and
qualitative interviews to ensure that
participant and leadership feedback is
captured as thoroughly and accurately
as possible.
AHRQ is conducting an ongoing
evaluation of the National
Implementation of TeamSTEPPS Master
Training Program. The goals of this
evaluation are to examine the extent to
which training participants have been
able to:
(1) Implement the TeamSTEPPS
products, concepts, tools, and
techniques in their home organizations
and,
(2) spread that training, knowledge,
and skills to their organizations, local
areas, regions, and states.
The National Implementation of
TeamSTEPPS program is led by AHRQ
through its contractor, the Health
Research and Educational Trust (HRET).
This study is being conducted by
HRET’s subcontractor, IMPAQ
International. The work is being

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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices

conducted pursuant to AHRQ’s
statutory authority to conduct and
support research, evaluations, and
training on health care and on systems
for the delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to quality
measurement and improvement.
42 U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this
assessment the following two data
collections will be implemented:
(1) Training participant
questionnaires to examine post-training
activities and teamwork outcomes as a
result of training from multiple
perspectives. The questionnaire is
directed to all Master Training
participants, and will cover posttraining activities, implementation
experiences, facilitators and barriers to
implementation encountered, and
perceived outcomes as a result of these
activities. Advance notice, invitations to
participate, reminder emails, and thank
you letters to respondents are included
in the participant questionnaire.
(2) Semi-structured interviews will be
conducted with members from
organizations who participated in the
TeamSTEPPS Master Training Program.
Information gathered from these
interviews will be analyzed and used to

draft a ‘‘lessons learned’’ document that
will capture additional detail on the
issues related to participants’ and
organizations’ abilities to implement
and disseminate TeamSTEPPS posttraining. The organizations will vary in
terms of type of organization (e.g., QIO
or hospital associations versus health
care systems) and region (i.e., Northeast,
Midwest, Southwest, Southeast, MidAtlantic, West Coast). In addition, we
will strive to ensure that the distribution
of organizations mirrors the distribution
of organizations in the Master Training
population. For example, if the
distribution of organizations is such that
only one out of every five organizations
is a QIO, we will ensure that a
maximum of two organizations in the
site visit sample are QIOs. The
interviews will more accurately reveal
the degree of training spread for the
organizations included. Interviewees
will be drawn from qualified
individuals serving in one of two roles
(i.e., implementers or facilitators). The
interview protocol will be adapted for
each role based on the respondent group
and to some degree, for each individual,
based on their training and patient
safety experience. There is also an
informed consent form that each
participant will be required to sign prior
to beginning the interview.
The final product for this evaluation
will be a report that documents the
background, methodology, results

(including any patterns or themes
emerging from the data), limitations of
the study, and recommendations for
future training programs and tool
development. The results of this
evaluation will help AHRQ understand
the extent to which participants and
participating organizations have been
able to employ various TeamSTEPPS
tools and concepts and the barriers and
facilitators they encountered. This
information will help guide AHRQ in
developing and refining other patient
safety tools and future training programs
for patient safety.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondent’s time to participate in the
study. Semi-structured interviews will
be conducted with a maximum of nine
individuals from each of nine
participating organizations and will last
about one hour each. The training
participant questionnaire will be
completed by approximately 10
individuals from each of about 240
organizations and is estimated to require
20 minutes to complete. The total
annualized burden is estimated to be
881 hours.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to participate in the
study. The total cost burden is estimated
to be $39,240.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total
burden hours

Semi-structured interview ................................................................................
Training participant questionnaire ...................................................................

9
240

9
10

60/60
20/60

81
800

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

249

NA

NA

881

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total
burden hours

Average
hourly wage
rate *

Total cost
burden

Semi-structured interview ................................................................................
Training participant questionnaire ...................................................................

9
240

81
800

$45.31
45.31

$3,670
36,248

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

249

881

NA

39,918

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* Based upon the mean of the average wages for all health professionals (29–0000) for the training participant questionnaire and for executives, administrators, and managers for the organizational leader questionnaire presented in the National Compensation Survey: Occupational
Wages in the United States, May 2014, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm.

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
whether the proposed collection of

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information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of

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AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) 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

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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2015–16646 Filed 7–7–15; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2103]

Talib Khan: Debarment Order
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The U.S. Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Talib
Khan from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Mr. Khan was convicted of
two felonies under Federal law for
conduct relating to the regulation of a
drug product. Mr. Khan was given
notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Mr. Khan
failed to respond. Mr. Khan’s failure to
respond constitutes a waiver of his right
to a hearing concerning this action.

SUMMARY:

DATES:

This order is effective July 8,

2015.
Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

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ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Kenny Shade (ELEM–4144), Division of
Enforcement, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:

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I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act.
On March 11, 2014, the U.S. District
Court for the Eastern District of Virginia
entered judgment against Mr. Khan for
one count of conspiracy in violation of
18 U.S.C. 371, and one count of
introducing misbranded drugs into
interstate commerce, in violation of 21
U.S.C. 331(a) and 333(a)(2) and 18
U.S.C. 2.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for this conviction is as
follows: Mr. Khan was a cofounder and
co-owner of Gallant Pharma
International Inc. (Gallant Pharma),
between August 2009 and August 2013.
Gallant was a company dedicated to the
illegal importation and sale of
misbranded and non-FDA approved
chemotherapy drugs and injectable
cosmetic drugs and devices in the
United States.
As cofounder and co-owner of Gallant
Pharma, Mr. Khan was primarily
responsible for the international aspect
of the conspiracy, including: (1)
Determining which drugs and devices to
sell in the United States; (2) establishing
relationships with international
suppliers; (3) directing those suppliers
to send drugs and devices to
transshippers in Canada and the United
Kingdom; (4) arranging for
transshipment from Canada and the
United Kingdom to the United States;
(5) interviewing, hiring, and training
sales representatives in the United
States; (6) and paying suppliers, sales
representatives, and office employees
out of foreign bank accounts. Gallant
Pharma was not licensed as a
prescription drug wholesaler by the
Commonwealth of Virginia. Some of the
drugs and devices that Mr. Khan
acquired were not approved by the FDA
for use on patients in the United States.
Mr. Khan admitted that the drugs sold
by Gallant Pharma were prescription
only and were misbranded in that,
among other things, they did not bear
adequate directions for use and were not
subject to an exemption from that
requirement, and they were
accompanied by non-FDA approved
packaging and inserts. The drugs Mr.
Kahn’s company sold also lacked the
FDA-required pedigree, which protects
patient health by tracking each sale,
purchase, or trade of a drug from the

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time of manufacturing to delivery to the
patient, and some drug packaging and
inserts were written solely in languages
other than English.
Immediately after establishing Gallant
Pharma’s presence in the Eastern
District of Virginia, on or about
September 25, 2009, Mr. Khan received
a cease and desist letter from a law firm
on behalf of Medicis, the exclusive
authorized marketer of Restylane and
Perlane in the United States and
Canada. The letter informed Mr. Khan’s
company that its marketing of these
drugs violated the FD&C Act and could
subject Gallant Pharma to substantial
criminal and civil penalties. The letter
included Gallant Pharma’s marketing
materials, which falsely claimed that
Gallant Pharma had been ‘‘strictly
working with the current FDA rules and
regulations for almost 10 years.’’
Mr. Khan purchased drugs and
devices from suppliers in, among other
places, Turkey, Switzerland, the United
Kingdom, and the United Arab
Emirates. In or around March 2011, after
a coconspirator’s medical license had
expired, Mr. Khan altered the expiration
date on the medical license to make it
appear that the license was still valid.
On at least 18 occasions, Mr. Khan
personally completed false customs
declarations and thereby illegally
imported misbranded drugs and devices
from Canada to the Eastern District of
Virginia. Mr. Khan also personally
accepted and processed orders for
Gallant Pharma customers.
Between August 2009 and August
2013, Gallant Pharma received illegal
proceeds of at least $12,400,000 from
the sale of misbranded and non-FDA
approved drugs and devices in the
United States. Mr. Khan admitted that
he was an organizer or leader of this
criminal activity and he additionally
admitted that his actions were in all
respects knowing, voluntary, and
intentional, and did not occur by
accident, mistake, or for another
innocent reason.
As a result of his conviction, on
March 19, 2015, FDA sent Mr. Khan a
notice by certified mail proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on the finding, under section
306(a)(2)(B) of the FD&C Act, that Mr.
Khan was convicted of felonies under
Federal law for conduct related to the
regulation of a drug product. The
proposal also offered Mr. Khan an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to

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