80 FR 39119 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 80, Issue 130 (July 8, 2015)
Agency for Healthcare Research and Quality
Federal Register Volume 80, Issue 130 (July 8, 2015)
| Page Range | 39119-39121 | |
| FR Document | 2015-16646 |
[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)] [Notices] [Pages 39119-39121] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16646] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 [email protected] (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. 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[supreg] (``Team Strategies and Tools to Enhance Performance and Patient Safety'') to provide an evidence-based 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 state-level 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. 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 [[Page 39120]] 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 post-training 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 post- training. 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, Mid-Atlantic, 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 Form name Number of responses per Hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- Semi-structured interview....................... 9 9 60/60 81 Training participant questionnaire.............. 240 10 20/60 800 --------------------------------------------------------------- Total....................................... 249 NA NA 881 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Total burden Average hourly Total cost Form name respondents hours wage rate * burden ---------------------------------------------------------------------------------------------------------------- Semi-structured interview....................... 9 81 $45.31 $3,670 Training participant questionnaire.............. 240 800 45.31 36,248 --------------------------------------------------------------- Total....................................... 249 881 NA 39,918 ---------------------------------------------------------------------------------------------------------------- * 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 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 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 [[Page 39121]] 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
![Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices 39119
Correction FOR FURTHER INFORMATION CONTACT: Participants applied to the program as
In the Federal Register of June 22, Doris Lefkowitz, AHRQ Reports teams representing their organizations
2015, in FR Vol. 80, No. 119, on page Clearance Officer, (301) 427–1477, or by and were accepted as training
35649, in the third column, on lines 13– email at doris.lefkowitz@AHRQ.hhs.gov. participants after having completed an
14, correct the ADDRESSES caption to SUPPLEMENTARY INFORMATION: organizational readiness assessment.
read: Due to the differences among the types
Proposed Project of organizations participating in the
ADDRESSES: CECANF will convene its
Assessing the Impact of the National program, participants will apply the
meeting at the Madison Marriott West,
Implementation of TeamSTEPPS Master tools and concepts differently within
1313 John Q. Hammons Drive,
Training Program and/or beyond their home
Middleton, Wisconsin. This site is
organizations. For example:
accessible to individuals with AHRQ, in collaboration with the
• Health care system staff (or
disabilities. The meeting also will be Department of Defense’s (DoD) Tricare
implementers) from hospitals, home
made available via teleconference and/ Management Activity (TMA), developed
health agencies, nursing homes, large
or webinar. TeamSTEPPS® (‘‘Team Strategies and
physician practices, and other direct
Tools to Enhance Performance and
Dated: June 30, 2015. care organizations are more likely than
Patient Safety’’) to provide an evidence-
Amy Templeman, other participants to implement the
based suite of tools and strategies for
Acting Executive Director. TeamSTEPPS materials on a daily basis
teaching teamwork-based patient safety
[FR Doc. 2015–16698 Filed 7–7–15; 8:45 am] and will be more likely to affect specific
to health care professionals. In 2007,
work processes being conducted within
BILLING CODE 6820–34–P AHRQ and DoD coordinated the an organization. As a result, health care
national implementation of the system participants are likely to have a
TeamSTEPPS Program. The main focused and specific impact that is
DEPARTMENT OF HEALTH AND objective of this program is to improve limited to their organization.
HUMAN SERVICES patient safety by training a select group • QIO\HRO\Hospital
of stakeholders such as Quality Association\State Health Department
Agency for Healthcare Research and Improvement Organization (QIO)
Quality participants (or facilitators) will be more
personnel, High Reliability Organization likely to have both an in-depth and
(HRO) staff, and health care system staff broad impact if they use the
Agency Information Collection
in various teamwork, communication, TeamSTEPPS materials to assist a
Activities: Proposed Collection;
and patient safety concepts, tools, and particular organization in its patient
Comment Request
techniques. Ultimately, TeamSTEPPS safety activities, as well as to provide
AGENCY: Agency for Healthcare Research will help to build a national and state- general patient safety guidance to a large
and Quality, HHS. level infrastructure for supporting number of organizations.
ACTION: Notice. teamwork-based patient safety efforts in To clarify the differences among the
health care organizations. participants, a logic model has been
SUMMARY: This notice announces the The National Implementation of developed that highlights the roles of
intention of the Agency for Healthcare TeamSTEPPS Master Training Program the different types of participants, the
Research and Quality (AHRQ) to request includes the training of ‘‘Master types of activities in which they are
that the Office of Management and Trainers’’ in various health care systems likely to engage after training, and the
Budget (OMB) approve the proposed capable of stimulating the utilization potential outcomes that may stem from
information collection project: and adoption of TeamSTEPPS in their these activities. The logic model served
‘‘Assessing the Impact of the National health care delivery systems, providing as a guide for developing questions for
Implementation of TeamSTEPPS Master technical assistance and consultation on a web-based questionnaire and
Training Program.’’ In accordance with implementing TeamSTEPPS, and qualitative interviews to ensure that
the Paperwork Reduction Act, 44 U.S.C. developing various channels of learning participant and leadership feedback is
3501–3520, AHRQ invites the public to (e.g., user networks, various educational captured as thoroughly and accurately
comment on this proposed information venues) for continuing support and as possible.
collection. improvement of teamwork in health AHRQ is conducting an ongoing
This proposed information collection care. AHRQ has already trained a corps evaluation of the National
was previously published in the Federal of over 5,000 participants to serve as the Implementation of TeamSTEPPS Master
Register on April 10th, 2015 and Master Trainer infrastructure supporting Training Program. The goals of this
allowed 60 days for public comment. No national adoption of TeamSTEPPS. An evaluation are to examine the extent to
substantive comments were received. anticipated 2,400 participants, who are which training participants have been
The purpose of this notice is to allow an undergoing training now, will be able to:
additional 30 days for public comment. studied in this assessment. After (1) Implement the TeamSTEPPS
DATES: Comments on this notice must be training, these participants will become products, concepts, tools, and
received by August 7, 2015. Master Trainers in TeamSTEPPS and techniques in their home organizations
ADDRESSES: Written comments should will have the opportunity to observe the and,
be submitted to: AHRQ’s OMB Desk program’s tools and strategies in action. (2) spread that training, knowledge,
Officer by fax at (202) 395–6974 In addition to developing a corps of and skills to their organizations, local
(attention: AHRQ’s desk officer) or by Master Trainers, AHRQ has also areas, regions, and states.
srobinson on DSK5SPTVN1PROD with NOTICES
email at OIRA_submission@ developed a series of support The National Implementation of
omb.eop.gov (attention: AHRQ’s desk mechanisms for this effort including a TeamSTEPPS program is led by AHRQ
officer). Copies of the proposed data collection Web tool, a through its contractor, the Health
collection plans, data collection TeamSTEPPS call support center, and a Research and Educational Trust (HRET).
instruments, and specific details on the monthly consortium to address any This study is being conducted by
estimated burden can be obtained from challenges encountered implementing HRET’s subcontractor, IMPAQ
the AHRQ Reports Clearance Officer. TeamSTEPPS. International. The work is being
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![Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices 39121
collection of information upon the I. Background time of manufacturing to delivery to the
respondents, including the use of Section 306(a)(2)(B) of the FD&C Act patient, and some drug packaging and
automated collection techniques or (21 U.S.C. 335a(a)(2)(B)) requires inserts were written solely in languages
other forms of information technology. debarment of an individual if FDA finds other than English.
Comments submitted in response to Immediately after establishing Gallant
that the individual has been convicted
this notice will be summarized and Pharma’s presence in the Eastern
of a felony under Federal law for
included in the Agency’s subsequent District of Virginia, on or about
conduct relating to the regulation of any
request for OMB approval of the September 25, 2009, Mr. Khan received
drug product under the FD&C Act.
proposed information collection. All a cease and desist letter from a law firm
On March 11, 2014, the U.S. District
comments will become a matter of on behalf of Medicis, the exclusive
Court for the Eastern District of Virginia
public record. authorized marketer of Restylane and
entered judgment against Mr. Khan for
Perlane in the United States and
Sharon B. Arnold, one count of conspiracy in violation of
Canada. The letter informed Mr. Khan’s
18 U.S.C. 371, and one count of
Deputy Director. company that its marketing of these
introducing misbranded drugs into
[FR Doc. 2015–16646 Filed 7–7–15; 8:45 am] drugs violated the FD&C Act and could
interstate commerce, in violation of 21
BILLING CODE 4160–90–P subject Gallant Pharma to substantial
U.S.C. 331(a) and 333(a)(2) and 18
criminal and civil penalties. The letter
U.S.C. 2.
included Gallant Pharma’s marketing
FDA’s finding that debarment is
DEPARTMENT OF HEALTH AND materials, which falsely claimed that
appropriate is based on the felony
HUMAN SERVICES Gallant Pharma had been ‘‘strictly
convictions referenced herein. The
working with the current FDA rules and
Food and Drug Administration factual basis for this conviction is as
regulations for almost 10 years.’’
follows: Mr. Khan was a cofounder and Mr. Khan purchased drugs and
co-owner of Gallant Pharma devices from suppliers in, among other
[Docket No. FDA–2014–N–2103]
International Inc. (Gallant Pharma), places, Turkey, Switzerland, the United
Talib Khan: Debarment Order between August 2009 and August 2013. Kingdom, and the United Arab
Gallant was a company dedicated to the Emirates. In or around March 2011, after
AGENCY: Food and Drug Administration, illegal importation and sale of a coconspirator’s medical license had
HHS. misbranded and non-FDA approved expired, Mr. Khan altered the expiration
chemotherapy drugs and injectable date on the medical license to make it
ACTION: Notice.
cosmetic drugs and devices in the appear that the license was still valid.
SUMMARY: The U.S. Food and Drug United States. On at least 18 occasions, Mr. Khan
Administration (FDA or Agency) is As cofounder and co-owner of Gallant personally completed false customs
issuing an order under the Federal Pharma, Mr. Khan was primarily declarations and thereby illegally
Food, Drug, and Cosmetic Act (the responsible for the international aspect imported misbranded drugs and devices
FD&C Act) permanently debarring Talib of the conspiracy, including: (1) from Canada to the Eastern District of
Khan from providing services in any Determining which drugs and devices to Virginia. Mr. Khan also personally
capacity to a person that has an sell in the United States; (2) establishing accepted and processed orders for
approved or pending drug product relationships with international Gallant Pharma customers.
application. FDA bases this order on a suppliers; (3) directing those suppliers Between August 2009 and August
finding that Mr. Khan was convicted of to send drugs and devices to 2013, Gallant Pharma received illegal
two felonies under Federal law for transshippers in Canada and the United proceeds of at least $12,400,000 from
conduct relating to the regulation of a Kingdom; (4) arranging for the sale of misbranded and non-FDA
drug product. Mr. Khan was given transshipment from Canada and the approved drugs and devices in the
notice of the proposed permanent United Kingdom to the United States; United States. Mr. Khan admitted that
debarment and an opportunity to (5) interviewing, hiring, and training he was an organizer or leader of this
request a hearing within the timeframe sales representatives in the United criminal activity and he additionally
prescribed by regulation. Mr. Khan States; (6) and paying suppliers, sales admitted that his actions were in all
failed to respond. Mr. Khan’s failure to representatives, and office employees respects knowing, voluntary, and
respond constitutes a waiver of his right out of foreign bank accounts. Gallant intentional, and did not occur by
to a hearing concerning this action. Pharma was not licensed as a accident, mistake, or for another
prescription drug wholesaler by the innocent reason.
DATES: This order is effective July 8, Commonwealth of Virginia. Some of the As a result of his conviction, on
2015. drugs and devices that Mr. Khan March 19, 2015, FDA sent Mr. Khan a
ADDRESSES: Submit applications for acquired were not approved by the FDA notice by certified mail proposing to
special termination of debarment to the for use on patients in the United States. permanently debar him from providing
Division of Dockets Management (HFA– Mr. Khan admitted that the drugs sold services in any capacity to a person that
305), Food and Drug Administration, by Gallant Pharma were prescription has an approved or pending drug
5630 Fishers Lane, Rm. 1061, Rockville, only and were misbranded in that, product application. The proposal was
MD 20852. among other things, they did not bear based on the finding, under section
adequate directions for use and were not 306(a)(2)(B) of the FD&C Act, that Mr.
FOR FURTHER INFORMATION CONTACT: subject to an exemption from that Khan was convicted of felonies under
srobinson on DSK5SPTVN1PROD with NOTICES
Kenny Shade (ELEM–4144), Division of requirement, and they were Federal law for conduct related to the
Enforcement, Office of Enforcement and accompanied by non-FDA approved regulation of a drug product. The
Import Operations, Office of Regulatory packaging and inserts. The drugs Mr. proposal also offered Mr. Khan an
Affairs, Food and Drug Administration, Kahn’s company sold also lacked the opportunity to request a hearing,
12420 Parklawn Dr., Rockville, MD FDA-required pedigree, which protects providing him 30 days from the date of
20857, 301–796–4640. patient health by tracking each sale, receipt of the letter in which to file the
SUPPLEMENTARY INFORMATION: purchase, or trade of a drug from the request, and advised him that failure to
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Document Created: 2018-02-23 09:12:48
Document Modified: 2018-02-23 09:12:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by August 7, 2015. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 80 FR 39119 |
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