[Federal Register Volume 84, Number 240 (Friday, December 13, 2019)]
[Notices]
[Pages 68170-68171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26864]


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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.

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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 ``Evaluation of Patient-Centered Outcomes Research Trust Fund--
Training Program.''

DATES: Comments on this notice must be received by 60 days after date 
of publication.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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 emails at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Evaluation of Patient-Centered Outcomes Research Trust Fund--Training 
Program

AHRQ Authorization To Provide Researcher Training in Comparative 
Effectiveness Research/Patient-Centered Outcomes Research (CER/PCOR) 
Methods

    Section 6301(b) of the Patient Protection and Affordable Care Act, 
Public Law 111-148 (the ``Affordable Care Act''), enacted section 
937(e) of the Public Health Service Act (``PHS Act''), which authorizes 
AHRQ to build capacity for comparative effectiveness research (CER) by 
establishing grant programs that provide training for researchers in 
methods used to conduct research. It also notes that, ``[at] a minimum, 
such training shall be in methods that meet the methodological 
standards adopted [by the Patient Centered Outcomes Research Institute 
(PCORI)] under section 1181(d)(9) of the Social Security Act.'' In 
addition, section 937(a) of the PHS Act charges AHRQ with disseminating 
patient-centered outcomes research (PCOR) and CER findings into 
practice. AHRQ's PCOR Trust Fund Training Program (PCORTF-TP) invests 
in training grants that build researchers' skills and enhance research 
capacity in these practice areas.
    PCOR is research that assesses the benefits and harms of 
preventive, diagnostic, therapeutic, palliative, or health delivery 
system interventions. This research helps clinicians, patients, and 
caregivers make decisions about health care choices by highlighting 
comparisons and outcomes that matter to people, such as survival, 
function, symptoms, and health-related quality of life. The AHRQ 
PCORTF-TP supports individuals and academic institutions to train 
researchers and clinicians in CER methods applied within the context of 
CER/PCOR via mentored career development award mechanisms for emerging 
independent investigators, as well as targeted skill development and 
applied experiences via research grant mechanisms for independent 
researchers. PCORTF-TP grants support training for recent graduates, 
mid-career professionals, and established professionals in research and 
clinical settings. The program prioritizes expanding capacity in 
underserved and predominantly minority communities.
    AHRQ recognizes the importance of ensuring that its training 
activities are useful, well implemented, and effective in achieving 
their intended goals. Therefore, the PCORTF-TP evaluation reflects 
AHRQ's commitment to ensuring responsible stewardship. The PCORTF-TP 
evaluation comprises analysis of grantee progress reports, a 
bibliometric analysis of grantee publications, key informant interviews 
with AHRQ program staff responsible for managing PCORTF-TP grants, 
focused discussions with the PCORTF-TP evaluation Stakeholder Working 
Group, and surveys of grantees and mentors.
    The purpose of this evaluation is to assess the outputs, outcomes, 
and impact of AHRQ's PCORTF-TP. The evaluation will address the 
following questions:
     What is the nature of PCORTF-TP activities for scholar/
investigator development?
     Which activities for PCORTF-TP scholars/investigators have 
the greatest influence on intended outcomes (e.g., PCOR careers)?
     How have PCORTF-TP and partner institutions developed the 
capacity for

[[Page 68171]]

PCOR training and mentoring, and in what ways is this sustainable?
     What do mentors and mentees perceive to be the most 
important ways that the program has contributed to the field of CER/
PCOR?
    This evaluation is being conducted by AHRQ through its contractor, 
AFYA, Inc., pursuant to AHRQ's authority to carry out the activities 
described in section 937 of the PHS Act. 42 U.S.C. 299b-37.

Method of Collection

    To achieve the goals of this project, the evaluator will survey 
PCORTF-TP awardees, scholars, and mentors. Online surveys: K Awardee 
Survey/K12 Scholar Survey and K Awardee/K12 Scholar Primary Mentor 
Survey will be used to: (1) Collect non-identifying demographic 
information; and (2) ask respondents about their training activities 
and outcomes. Key informant interviews: Key Informant Interview Guide 
will be used to collect qualitative data about program processes, 
outcomes, and lessons learned from K12 scholar program directors.
    AHRQ will use the information collected through this Information 
Collection Request to assess progress toward achieving the PCORTF-TP 
aims. The information collected will facilitate program planning. 
Results will indicate whether grantees are conducting activities 
relevant to CER/PCOR training and whether those activities are 
increasing CER/PCOR capacity. Two surveys, each tailored for four 
respective PCORTF-TP respondent groups as well as key informant 
interviews will yield data on training activities, trainees' career 
plans, trainees' research and clinical activities relevant to CER/PCOR, 
and primary mentor experiences. The surveys are designed to capture 
primarily quantitative data with some qualitative data. The interview 
guide is designed to collect qualitative data.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this evaluation. The survey will be 
completed by approximately 288 awardees, scholars, principal 
investigators (PI), and mentors. The surveys will each require 
approximately 30 minutes to complete. The key informant interview will 
be conducted with approximately 13 PIs. These interviews are expected 
to take one hour each. The total hour burden is expected to be 150.5 
hours for this participant data collection effort.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
K Awardee/K12 Scholar * Survey..................             147               1             0.5            73.5
K Awardee/K12 Primary Mentor Survey.............             128               1             0.5              64
Key Informant Interview Guide for K12 Program                 13               1               1              13
 Directors......................................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................             288  ..............  ..............           150.5
----------------------------------------------------------------------------------------------------------------
* K Awardee/K12 Scholar survey = K01/K08/K99/K18 Awardees and K12 Scholars.

    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to participate in this project. The total cost burden 
is estimated to be $11,134.34.

                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours           rate*          burden
----------------------------------------------------------------------------------------------------------------
K Awardee/K12 Scholar Survey....................             147            73.5        * $74.43       $5,434.59
K Awardee/K12 Primary Mentor Survey.............             128              64        * $74.43        4,732.16
Key Informant Interview Guide for K12 Program                 13              13        * $74.43          967.59
 Directors......................................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
                                                             288           150.5  ..............       11,134.34
----------------------------------------------------------------------------------------------------------------
* Average hourly wage ($73.94) based on the average annual salary for three categories of Health Specialties
  Teachers, Postsecondary (25-1071; Scientific Research and Development Services--$178,090; General Medical and
  Surgical Hospitals--$153,790; and Colleges, Universities, and Professional Schools--$126,890). Data Source:
  National Occupational Employment and Wage Estimates in the United States, May 2018, ``U.S. Department of
  Labor, Bureau of Labor Statistics'' (available at http://www.bls.gov/oes/current/naics4_621400.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's 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 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.

    Dated: December 9, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-26864 Filed 12-12-19; 8:45 am]
BILLING CODE 4160-90-P