SSA_PREP PYP_Final Aug 2017

Justification for the Collection of Information for Local Evaluations as part of the Personal Responsibility Education Program (PREP): Promising Youth Programs (PYP)

OMB Information Collection Request

New Collection

Supporting Statement

Part A

August 2017

Submitted By:

Office of Planning, Research and Evaluation

Administration for Children and Families

U.S. Department of Health and Human Services

4th Floor Mary Switzer Building

330 C St, SW

Washington, D.C. 20201

Federal Project Officer:

Seth Chamberlain (COR)

Project Monitor:

Kathleen McCoy

A1. Necessity for the Data Collection

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) oversees the Personal Responsibility Education Program (PREP), which comprises several teen pregnancy prevention programs. All grantees receiving PREP funding must educate youth on both abstinence and contraception. ACF’s Family and Youth Services Bureau (FYSB) administers PREP programs, and ACF’s Office of Planning, Research, and Evaluation (OPRE) collaborates with FYSB to conduct PREP research and evaluation efforts.

ACF is proposing to collect data related to PREP in two different areas:

1. Local evaluation information. ACF seeks approval to request information from PREP-funded grantees about their grantee-led evaluations, called “local evaluations.” This request will support reviews of analysis plans, monitoring, and ongoing technical assistance.

2. Interviews/focus groups with youth to inform curriculum development. ACF seeks approval to conduct interviews and focus groups with youth to inform the development of curricula to address PREP related needs for underserved populations. This work will involve talking with youth about how they make decisions related to sexual health and their experiences with formal sexual health education programs.

This work will be conducted under a new contract, called the Personal Responsibility Education Program: Promising Youth Programs (PYP) project; Mathematica Policy Research is the contractor.

Background

To reduce the risks related to sexual activity, Congress authorized PREP as part of the 2010 Affordable Care Act. It was reauthorized in 2015 for an additional two years of funding through the Medicare Access and CHIP Reauthorization ACT of 2015. PREP programs are administered by ACF’s Family and Youth Services Bureau (FYSB). FYSB awards PREP grants under four separate but related programs: (1) State PREP (SPREP), (2) Competitive PREP (CPREP), (3) Personal Responsibility Education Innovative Strategies Program (PREIS), and (4) Tribal PREP (TPREP). PREP programs must educate youth on both abstinence and contraception for the prevention of pregnancy and sexually transmitted infections, and must provide instruction to prepare youth for adulthood. FYSB supports programs that exhibit evidence of effectiveness, innovative adaptations of evidence-based programs, and promising programs. They encourage, and in some cases require, grantees to conduct evaluations to inform the field’s current efforts and future programming for youth risk behavior prevention.

For the first component of this information collection request (ICR), the local evaluation, the study team will primarily gather data from PREIS and TPREP grantees:

• PREIS supports the development of innovative strategies to prevent teen pregnancy. This program targets services to high-risk, vulnerable, and culturally underrepresented youth populations. This includes youth who are homeless, live in foster care, reside in areas with high teen birth rates, are members of racial or ethnic minority groups, or have HIV/AIDS. Programs may also target pregnant and parenting youth up to age 21. Projects must be based on some evidence of effectiveness, represent a significant adaptation of an effective program, or offer an innovative approach. Projects are also required to generate lessons learned by documenting the intervention, conducting process and outcome evaluations, and disseminating findings. The second cohort of PREIS grantees received funding in September 2016 for five year grant periods (pending continued funding of PREP).

• The overall goal of the TPREP grantees is to reduce teen pregnancy and birth rates and the spread of STIs among American Indian/Alaska Native (AI/AN) youth. TPREP programs are expected to replicate evidence-based programs (using culturally and linguistically appropriate adaptations as necessary), substantially incorporate elements of programs that have been proven to be effective at changing behaviors based on scientific research, or substantially incorporate elements or practices from programs that have demonstrated effectiveness within AI/AN tribal communities. All TPREP grantees are required to conduct a local evaluation. The current cohort of TPREP grantees received funding in September 2016 for five year grant periods (pending continued funding of PREP).

Pending funding, we may also collect local evaluation information from state PREP grantees. If funded, program templates will be revised to make them applicable to these grantees. The revised templates will be submitted to OMB for review. If the revisions are minimal and/or not substantive they will be submitted as a nonsubstantive change.

State PREP provides funding to state agencies and local organizations, respectively, to educate youth on both abstinence and contraception to prevent teen pregnancy and STIs. Grantees are encouraged to replicate evidence-based programs identified by the HHS Teen Pregnancy Prevention Evidence Review and are required to educate youth on at least three adulthood preparation subjects, for example healthy relationships, financial literacy, or healthy life skills. State PREP targets programming to high-risk populations, for example youth in foster care, minority youth, or pregnant and parenting teens.

PREP grantees are expected to focus programming on those at risk of pregnancy and other negative sexual health outcomes. There are some populations of youth for which no evidence-based curricula exist, or who are otherwise underserved by existing abstinence and contraception programming. For the second component of this ICR, the study team will interview and hold focus groups with youth from populations of youth that either have no evidence-based curricula or are underserved by current curricula, to inform curriculum development.

Legal or Administrative Requirements that Necessitate the Collection

Section 215 of the Medicare Access and CHIP Reauthorization Act of 2015 extends funding through FY2017 for PREP formula grants to states. The legislation mandates the Secretary to evaluate the programs and activities carried out with funds made available through PREP. To meet this requirement, FYSB and OPRE within ACF contracted with Mathematica Policy Research to conduct the PREP: Promising Youth Programs (PYP) project. The project:

• provides support to a subset of grantees who are conducting local evaluations to ensure the studies are designed and implemented with rigor; and

• supports development of curricula to make them more effective for and accessible to underserved youth populations.

A2. Purpose of Survey and Data Collection Procedures

Overview of Purpose and Approach

One of the broad objectives of the PYP project is to provide evaluation support to grantees and their local evaluators. One purpose of the information collection instruments submitted through this request is to help the federal government and contractor staff provide evaluation technical assistance by providing the grantees feedback on their evaluation’s progress. This will help to ensure that grantees plan for and conduct high-quality evaluations designed to meet ACF’s evaluation standards and the HHS Teen Pregnancy Prevention Evidence Review standards.¹

The project also aims to develop curricula for underserved youth to address sexual health and other PREP-related priorities. To inform the development of curricula appropriate for the selected target populations, the project team will collect information from members of the target populations to better understand their specific circumstances, needs, and preferences regarding sexual health education.

Universe of Data Collection Efforts

Local evaluation information. The information collected by the contractor for the local evaluation component of this ICR will help monitor the evaluations and provide evaluation technical assistance. The study team will provide support to up to 16 local evaluations with an impact design, and 13 local evaluations with a descriptive design. To achieve this, the study team proposes to collect information from grantees, which will differ by the proposed design. Table A2.1 shows which grantees will complete each instrument, based on the evaluation design proposed.

Table A2.1 Data Collection Instruments, by Grantees’ Proposed Evaluation Design

Instrument	Grantees conducting local evaluations with an impact design	Grantees conducting local evaluations with a descriptive design
Instrument 1: Evaluation abstract template	X	X
Instrument 2: CONSORT diagram template	X	X
Instrument 3: Baseline equivalence template	X

Evaluation abstract (Instrument 1). All grantees receiving technical assistance through the PYP project will complete the abstract template. The abstract is a structured summary of the intervention, outcomes of interest, sample, setting, and planned evaluation design including data collection. Grantees will complete this template once the evaluation design is approved by ACF, and will update the abstract in the second year of the grant to reflect any modifications to the evaluation. The abstract will be used for registering the evaluation at a registry such as clinicaltrials.gov and potentially posted on the FYSB Adolescent Pregnancy Prevention Evaluation website, hosted by ACF.

CONSORT diagram (Instrument 2). All grantees receiving technical assistance through the PYP project will complete the CONSORT² diagram template. The CONSORT diagram template collects data on the number of youth and clusters, if applicable, enrolled in the evaluation and retained through data collection. For study participants not retained, grantees will also be asked to report reasons for survey non-completion. To monitor the progress of each evaluation, this template will be completed by grantees every six months while the study is enrolling sample and collecting data.

Baseline equivalence template (Instrument 3). Only grantees conducting local evaluations with an impact design (i.e. those with a comparison group) will complete the baseline equivalence template. To assess whether treatment and comparison groups differ at baseline, data will be collected on key demographics and behavioral measures. The template will automatically calculate the differences between groups in a consistent way, minimizing the burden on grantees. To monitor the progress of each evaluation, this template will be completed by grantees every six months while the study is enrolling sample and collecting data.

Interviews/focus groups with youth to inform curriculum development. To develop the theories of change that will inform curricula development for the PYP project, the study team will collect data through qualitative interviews with youth to understand their perspectives and experiences. The study team will conduct in-depth qualitative interviews with no more than 64 youth from four target populations, recruiting via channels linked to the target populations, such as providers that serve targeted youth (including PREP/PREIS grantees).

Youth interview/focus group topic guide (Instrument 4). The discussion guide covers several topics: (1) youths’ experiences receiving sexual health education programs; (2) preferences regarding the content and delivery of sexual health education programs; (3) how youths make decisions regarding relationships, sexual activity, and use of condoms and other birth control methods; and (4) youths’ access to and sources of sexual health information. To ensure that youth from diverse target populations participate in interviews, the project team will conduct the interviews in formats that best fit participants’ circumstances and preferences. This may include individual interviews held in-person, or by telephone videoconference, or focus groups held either virtually or using secure online discussion boards.

A3. Improved Information Technology to Reduce Burden

ACF and its contractors will employ information technology as appropriate to reduce the burden of respondents who agree to participate.

• For the instruments related to the local evaluation tasks, this data collection effort will make use of electronic templates for completion and electronic submission.

• For the instrument related to the interviews/focus groups with underserved youth, this effort may use virtual focus groups or secure online discussion boards, when feasible and appropriate for the targeted youth. Virtual focus groups are conducted via screen-sharing technology, enabling users to attend from their location of choice without losing the visual experience of the focus group. Secure online discussion boards allow users to access focus group questions through a secure online platform and respond to questions at their convenience during a set time period. Moderators of the discussion boards are able to guide the discussion through prompts and follow-up questions to individual participants.

A4. Efforts to Identify Duplication

No other sources of information will allow the study team to assess ACF-funded PREP grantee local evaluations, nor supply the data the study team will obtain through discussions with youth. No unnecessary information is being requested of program staff, grantees, or youth. None of the instruments will ask for information that can be reliably obtained through other sources.

A5. Involvement of Small Organizations

The potential exists for data collection activities to affect small entities associated with the grantee. PREP grantees may conduct evaluations led by local evaluators affiliated with small organizations. Grantees may task the local evaluator with the collection of some or all of the data requested. Proposed data collection efforts are designed to minimize the burden on all organizations involved, including small businesses and entities, by collecting only critical information using standardized templates.

A6. Consequences of Less Frequent Data Collection

The purpose of each information collection instrument included in this submission is described in Item A2, above.

Not collecting information using the local evaluation instruments, or collecting data less frequently, would limit the government’s ability to document the performance of its grantees’ evaluations and to assess the extent to which these federal grants are successful in achieving their purpose. To ensure the federal government has an accurate summary of each study, grantees will need to update their original abstracts to reflect any modifications they make during the early stages of their evaluations. In previous evaluation TA efforts, the contractor has found that monitoring data in CONSORT diagrams and baseline equivalence instruments semi-annually allows the TA provider to help the evaluator and grantee identify problems, discuss potential solutions, and monitor progress in implementing those solutions. If these data were collected less frequently (for example, annually), grantees and their evaluators may not identify and remedy problems related to recruitment, sample assignment, and data collection as early as possible.

Not collecting information using the interview/focus group instrument would limit the government’s ability to understand the target populations’ circumstances, needs, and preferences regarding sexual health education programs. This information is critical for tailoring curricula to the characteristics of these populations. Youth will participate in one focus group or interview.

A7. Special Circumstances

There are no special circumstances associated with this information collection.

A8. Federal Register Notice and Consultation

Federal Register Notice and Comments

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR Part 1320 (60 FR 44978, August 29, 1995), ACF published a notice in the Federal Register announcing the agency’s intention to request an OMB review of this information collection activity. This notice was published on October 19, 2016, Volume 81, Number 202, page 72056, and provided a sixty-day period for public comment. No substantial changes in burden are proposed over those proposed in the 60-Day FRN. During the notice and comment period, no comments were received.

Consultation with Experts Outside of the Study

ACF consulted staff from Mathematica Policy Research and their subcontractor the Center for American Indian and Native American Health at the University of Colorado, Denver when preparing the templates.

A9. Incentives for Respondents

The study team is not proposing to provide incentives to respondents completing instruments for the local evaluation information tasks.

For the interviews/focus groups, the study team proposes to provide a token of appreciation of $20 to youth who complete an interview or participate in a focus group. The study team makes this proposal primarily to increase response rates and reduce nonresponse bias. By encouraging otherwise reluctant young adults, the study reduces the risks associated with nonresponse bias – namely the risk that the research team draws inaccurate or biased conclusions about the program. This is especially important due to the underserved status of the populations under consideration for these interviews, including youth who have experienced trauma, trafficked youth or youth at risk of trafficking, transient youth, cognitively impaired or disabled youth, immigrants and refugees, transgender youth, and parents and caregivers of youth in foster care. The incentive is intended to assist with transportation costs, child care, or other expenses that might prevent some in the target populations under consideration from participating – i.e., those with the greatest financial challenges or other barriers, and whose absence could contribute to nonresponse bias. When participants know that their time will be appreciated, the likelihood increases that those respondents will spend time completing the data activity. Based on the project team’s prior experience with studies of similar youth populations, $20 is high enough to support participation, but not so high that it is overly generous or that participants would feel the incentive is excessive or coercive. The proposed amount for the interviews/focus groups is comparable to the amount used successfully in other recent and ongoing ACF-sponsored and Office of Adolescent Health sponsored evaluations of youth populations, including the PREP Multi-Component Evaluation (OMB no. 0970-0398) the Pregnancy Assistance Fund (PAF) Implementation Study (OMB no. 0990-0428), and the Strengthening Relationship Education and Marriage Services (STREAMS) process study (OMB no. 0970-0481). Research has also shown that such tokens of appreciation are effective at increasing response rates for populations similar to the participants in adolescent pregnancy prevention programs. For example, Berlin et al. (1992) evaluated differences in survey completion rates between no incentive, $20, and $35 and found significantly higher response rates among minority and low education populations when respondents received either the $20 or $35 financial incentive. Similarly, Singer and Kulka (2002) showed that incentives seemed to have more of an impact on increasing response rates for underrepresented populations, including respondents from low-income households, with low education, and minority groups as well as respondents with low levels of community involvement.

A10. Privacy of Respondents

As specified in the contract, Mathematica (the Contractor) shall protect respondent privacy to the extent permitted by law and will comply with all Federal and Departmental regulations for private information. The Contractor shall ensure that all employees, including employees of all subcontractors, who perform work under this contract/subcontract receive training on data privacy issues and comply with the above requirements. Respondents will be informed about the planned uses of data, that their participation is voluntary, and that their information will be kept private to the extent permitted by law.

For the local evaluation information collection, the abstract is the only document expected to be publicly available and the grantees will learn of that in advance of preparing the document.

For the interviews/focus groups, study participants will be informed that participation in data collection is voluntary. Prior to starting a discussion with a youth or a focus group, all respondents will be informed that their full names will not be used during the focus group or in any reporting. Recruitment and interview procedures will incorporate measures for protecting the privacy of participants as well as processes for obtaining informed consent. These procedures will include requiring that focus group participants use only their first names during discussions. In addition, when reporting the results of focus groups, researchers will not identify participants by their real names.

A11. Sensitive Questions

There are no sensitive questions for the instruments associated with the local evaluation information.

The youth discussion guide associated with the interviews/focus groups may generate discussion of topics that may be considered sensitive such as how youth make decisions related to their sexual health and beliefs and attitudes about contraception. The goal of these interviews is to assist with specifying theories of change that will support the development of sexual health education curricula for selected underserved populations. Information on how youth in these underserved populations make decisions related to sexual health and their beliefs and attitudes about contraception is not available from other sources and is needed understand how to develop curricula for the targeted populations. Prior to starting a discussion with a youth or a focus group, all respondents will be informed that their full names will not be used during the focus group or in any reporting. In addition, respondents will be informed that they do not have to answer questions that make them uncomfortable. All respondents will be informed that they can decline to answer any question that they do not wish to answer, with no negative consequences for not responding. Table A11.1 presents the justification for the sensitive topics included in the youth discussion guide.

Table A11.1. Justification for Sensitive Questions in the Youth Interview/Focus Group Topic Guide (Instrument 4)

Question Topic	Justification
Sexual decision making (questions in section VI.A)	Sexual health education programs for youth aim to influence how youth make decisions about their involvement in sexual activity, including use of contraception when engaging in sexual activity and preventing the incidence of pregnancy and sexual transmitted infections. These questions were adapted from similar instruments used by the Center for Innovative Public Health Research to inform development of their programs: Girl2Girl and Guy2Guy.
Contraception use (questions in section VI.B)	Contraception use is central to both sexual health education programs like the ones planned for development under this project and PREP programs. Collecting this information will allow the research team to understand the preferences of youth in the targeted underserved populations regarding types of contraception and access and use barriers.

A12. Estimation of Information Collection Burden

Table A12.1 provides the estimated annual reporting burden calculations for the five instruments included in this request. This request is for three years of data collection. The total annual burden is estimated to be 241 hours. Assumptions by instrument follow.

Evaluation abstract template (Instrument 1). At most, 29 grantees will complete the evaluation abstract template (i.e. all grantees, regardless of study design). On average, it will take three hours to complete this template. The abstract will be updated each year to make sure that it remains current. The estimated total annual burden for this effort is 87 hours.

CONSORT diagram template (Instrument 2). At most, 29 grantees will complete the CONSORT diagram template (i.e. all grantees, regardless of study design). Respondents will submit a completed CONSORT diagram template every six months while the evaluation enrolls sample and collects follow-up data. Assuming that this could occur over a maximum of three years, the study team expects grantees to submit the CONSORT diagram up to six times and it will take an hour to complete the CONSORT each time. The estimated annual burden for the effort is 58 hours.

Table A12.1 Total Burden Requested Under this Information Collection Request

Instrument	Total Number of Respondents	Annual Number of Respondents	Number of Responses Per Respondent per year	Average Burden Hours Per Response	Annual Burden Hours	Average Hourly Wage	Total Annual Cost
Instrument 1 Evaluation abstract template	29	29	1	3	87	$33.38	$2,904.06
Instrument 2 CONSORT diagram template	29	29	2	1	58	$33.38	$1,936.04
Instrument 3 Baseline equivalence template	16	16	2	2	64	$33.38	$2,136.32
Instrument 4: Youth interview/focus group topic guide	64	21	1	1.5	32	$7.25	$116*
Estimated annual burden					241		$7,092.42

* Assume that half of youth are 18 or over and included in estimate of total annual cost.

Baseline equivalence template (Instrument 3). At most, 16³ grantees will complete the baseline equivalence template (i.e. all grantees conducting an impact evaluation). Respondents will submit the baseline equivalence template every six months while the evaluation enrolls sample and collects follow-up data. Assuming that this could occur over a maximum of three years, the study team expects grantees to submit the baseline equivalence template up to six times and it will take approximately two hours to complete the template each time. The estimated annual burden for this effort is 64 hours.

Youth interview/focus group topic guide (Instrument 4). The study team expects 64 youth to participate in 90-minute interviews or focus groups, with 21 youth participating each year. The estimated annual burden for this effort is 32 hours.

Total Annual Cost

The total annual burden cost is estimated to be $7,092.42. For cost calculations for instruments associated with LES tasks, we estimate the average hourly wage for program directors and managers to be the average hourly wage for “Social and Community Services Manager” ($33.38), taken from the U.S. Bureau of Labor Statistics, Occupational Employment Statistics, 2015. To calculate the burden cost for youth discussions, we used $7.25, which is the federal minimum hourly wage rate; we assume that 50 percent of youth participating in youth discussions will be 18 years or older.

A13. Cost Burden to Respondents or Record Keepers

These information collection activities do not place any additional costs on respondents or record keepers other than those described above.

A14. Estimate of Cost to the Federal Government

The estimated total cost the federal government for data collection associated with this ICR is $156,119. Over three years, the annual cost of data collection is $52,039.

The total cost for the local evaluation data collection activities under this current request, including the development of the templates and monitoring the CONSORT and baseline equivalence reports, will be $47,997. The total cost for data collection associated with the interviews/focus groups is $68,122.

A15. Change in Burden

This is a new data collection. There are no changes or adjustments.

A16. Plan and Time Schedule for Information Collection, Tabulation and Publication

The schedule for data collection is shown below in Table A16.1 and Table A16.2. All dates are dependent on OMB approval of this ICR.

Table A16.1 Schedule for PYP Local Evaluation Monitoring Data Collection

Activity	Date
Grant awards	September 30, 2016
Evaluation abstract template	Winter 2018, updated annually
CONSORT diagram template	Spring 2018, updated semi-annually through Summer 2020
Baseline equivalence template	Spring 2018, updated semi-annually through Summer 2020

In order to complete the CONSORT diagram template, grantees will need to tabulate data on the number of youth eligible for the evaluation, the number consented, the number assigned to condition (for impact evaluations), and the number completing each follow-up survey. Mathematica will then use these data to calculate rates of consent, random assignment, and response rates for each follow-up period in each individual evaluation. Mathematica will use that information to generate cross-grantee reports for ACF on the status of the evaluations and identify grantees at risk of not achieving their target sample size or response rates.

Grantees conducting local evaluations with an impact design will complete the baseline equivalence template, which automatically calculates significance tests to assess baseline equivalence in applicant characteristics between program and control/comparison groups. No additional tabulations of these data are expected.

The completed abstracts will be published on ACF’s PREP website. No other publications are expected from this data collection.

Table A16.2 Schedule for PYP Curricula Development Data Collection and Analysis Activity

Activity	Date*
Conduct discussions with youth	November 2017-February 2018
Conduct other data collection activities	September – December 2017
Analyze qualitative interview and other data	November 2017 – March 2018
Develop theories of change	March –April 2018
Stakeholder review of theories of change	May – June 2018
Revise theories of change	July 2018

*Dates are dependent on date of OMB approval.

The data collected through qualitative interviews with youth will support the development of theories of change and curricula for underserved youth. To analyze the qualitative data gathered through the interviews, the study team will use the framework method to identify commonalities and differences within the data for each target population, describe relationships and interconnections across topics, and specify descriptive or explanatory themes (Gale et al 2013). Analysis will involve multiple steps, including two stages of coding, charting data into a framework matrix, and producing internal analytic memos. The coding structure will include deductive codes based on the interview topic guide and inductive codes that “bubble up” or emerge from the transcripts. For example, coders might find that youth repeatedly discuss positive experiences with prior formal sexual health education that emphasized inclusivity for LGBTQ youth.

• Applying thematic codes (first coding stage). Prior to thematic coding, the study team will develop a thematic coding structure that identifies each code and provides a definition. The coding structure will be a dynamic, meaning the team will update it as codes are added and definitions for codes are refined. Using the NVivo qualitative analysis software package, all members of the coding team will code an initial set of three transcripts following the coding structure. The purpose of this step is to support all team members in developing a shared and consistent understanding of the codes. After reviewing the initial transcripts, the coding team will meet to discuss and finalize the thematic coding structure. The study team then will use the coding structure to systematically code all transcripts.

• Identifying and applying analytic subcodes (second coding stage). After thematic coding, the study team will complete analytic subcoding, which will allow for deeper analysis by identifying patterns within each thematic code. Members of the coding team will focus on subsets of thematic codes. For each thematic code, the team member will consider all output for the thematic code to develop additional codes that help to explain the theme. The analysis will focus on identifying commonalities and differences among youth from a target population on topics such as use of and access to methods of contraception or the most important topics for sexual health education or the method of program delivery.

• Developing the framework matrix. Simultaneous with analytic subcoding, the study team will also will chart data into a spreadsheet or matrix where the rows will be individual cases and the columns will be the key categories or themes. In the matrix, for each case, the study team will summarize data for each category or theme, in an effort to reduce the data. The matrix will include interesting and illustrative quotes.

• Producing analytic memos. The final analysis stage will involve producing internal memos around key themes. The memos will discuss the theme, highlight how data supported identification of the theme, and identify support quotations from the transcripts.

Results from these interviews may be summarized in a research brief or journal article.

A17. Reasons Not to Display OMB Expiration Date

All instruments will display the expiration date for OMB approval.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions are necessary for this information collection.

1 http://tppevidencereview.aspe.hhs.gov/pdfs/Review_protocol_v4.pdf

2 CONsolidated Standards of Reporting Trials: see http://www.consort-statement.org/.

3 This is less than the 29 grantees for the other instruments: since not all grantees will conduct local evaluations with an impact design, not all will need to complete this instrument.

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