Change Request Justification

Non-material/non-substantive change request

Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments

Approved OMB No. 0920-1353 Exp. Date 11/30/2024

NARRATIVE Description of Changes:

Changes requested to the Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments Information Collection Request package (OMB No. 0920-1353) are intended to improve clarity, readability, flow, and efficiency for recipients. For example, several questions on two data collection forms (Comp1_APR_Form, Comp 2_APR_Form) have been reworded for clarity, but the requested information has not changed. None of the changes requested will increase their reporting burden so there is no change to the burden table. The data collection for Year 2 will move from PDF forms to Research Electronic Data Capture (REDCap) secure web application. REDCap is a powerful and secure web application for building and managing online surveys and databases and is used widely across CDC. Health department respondents will access the data collection form through a URL provided by CDC staff. Use of REDCap for electronic data submission will reduce burden to the respondents by incorporating branching logic, which will reduce potential for data entry errors. For example, in REDCap, if an answer in a section is marked “Not started” then subsequent questions in that section will not be displayed and the tool will automatically skip to the next relevant question. In addition, some fields will be auto-populated, which will minimize confusion about what should be entered into different fields.

Form	Current Question/Item/Page	Requested Change	Rationale
Comp 1_APR_Form_Year1_12-08-2021	Reporting period (page 1)	Add date range (MM/DD/YY-MM/DD/YY) for each year	Clearly convey timeframe associated with each year of NOFO
Comp 1_APR_Form_Year1_12-08-2021	“Use this space if needed to provide additional information related to Section 1.X” After fields for all Section 1.1 measures (page 4) After fields for all Section 1.2 measures (page 12) After fields for all Section 1.3 measures (page 16)	Revise question as shown below. “Please use this space to provide information about challenges and successes experienced when implementing Strategy X activities. Include additional contextual information that would help us interpret your annual performance data.”	Clarifies the type of information that we need in this field (and is consistent with previously approved form instructions).
Comp 1_APR_Form_Year1_12-08-2021	Table containing information related to Measures 1.2.2.a - 1.2.2.c, 1.2.3.a Page 7	Minor update to language used for response options. Examples – change from “Total” to “Total laboratories”. Change from “Number” to “Number ≤90 days”, Change ‘Total” to “Total cases”.	To improve ability to distinguish numerator value from denominator value
Comp 1_APR_Form_Year1_12-08-2021	Table containing information related to Measures 1.2.2.d- 1.2.3.b and Table containing information related to Measures 1.2.2.e Page 8, 9, 10	Minor update to language used for response options. Examples – Change from “Number” to “Number complete”, Change ‘Total” to “Total cases”.	To improve ability to distinguish numerator value from denominator value
Comp 1_APR_Form_Year1_12-08-2021	Table containing information related to Measures 1.2.2.d- 1.2.3.b Page 8	Addition of an “Unknown” response check box, as currently used elsewhere on the form.	To more accurately capture and identify a missing response (failed to respond) from a true unknown response (respondent unable to calculate a response).
Comp 1_APR_Form_Year1_12-08-2021	Table containing information related to Measures 1.2.3.c Page 11	Minor update to language used for response options. Change from “Number” to “Number in registry”, Change ‘Total” to “Total cases”.	To improve ability to distinguish numerator value from denominator value
Comp 1_APR_Form_Year1_12-08-2021	Tables under “This section is to be completed in Year 1 ONLY” Page 13	Remove section	This section is not part of APR and measures for the NOFO. This was only added for Year 1 only to support NEEMA activities
Comp 1_APR_Form_Year1_12-08-2021	Table containing information related to Measures 1.3.1.a-1.3.1b, 1,3,1.d, 1,3,2.a Page 14	Minor update to language used for response options. Examples – Change from “Number” to “Number ≤90 days”, Change ‘Total” to “Total cases”.	To improve ability to distinguish numerator value from denominator value
Comp 1_APR_Form_Year1_12-08-2021	Table containing information related to Measures 1.3.1.c-1.3.2b, Page 15	Minor update to language used for response options. Examples – Change from “Number” to “Number complete”, Change ‘Total” to “Total cases”.	To improve ability to distinguish numerator value from denominator value
Comp 2_APR_Form_Year1_12-08-2021	Reporting period (page 1)	Add date range (MM/DD/YY-MM/DD/YY) for each year	Clearly convey timeframe associated with each year of NOFO
Comp 2_APR_Form_Year1_12-08-2021	“Have you worked with your surveillance and/or epidemiology teams to identify the total number of CLIA-certified laboratories in your jurisdiction that report hepatitis C antibody testing results?” Measure 2.1.2.a-2.1.2.b (1st question) (page 3) “Of those, have you selected the subset that reports at least 80% of the hepatitis C antibody testing results in your jurisdiction?” Measure 2.1.2.a-2.1.2.b (2nd question) (page 3) “Of the subset, have you performed a needs assessment to identify key barriers and challenges to increasing HCV RNA reflex testing?” Measure 2.1.2.a-2.1.2.b (3rd question) (page 3) “Have you provided recommendations to increase HCV RNA reflex testing?” (5th question) (page 3)	Added “In progress” response choice	Allows recipients to specify that the work is in progress
Comp 2_APR_Form_Year1_12-08-2021	“Identify the stakeholder groups represented on this committee (or coalition).” Measure 2.1.1.a-2.1.1.b (2nd question) (page 1)	Revise to read “Identify the stakeholder groups that are (or will be) represented on this committee (or coalition)”.	Clarifies that current or future groups should be selected
Comp 2_APR_Form_Year1_12-08-2021	“Does the committee (or coalition) plan to support elimination planning for hepatitis C and/or hepatitis B?” Measure 2.1.1.a-2.1.1.b (3rd question) (page 2)	Remove question.	Not needed because reflects intentions/plans and not what they actually did (already covered by measure 2.1.1.c- 1st question)
Comp 2_APR_Form_Year1_12-08-2021	During this reporting period, when did the committee (or coalition) meet? (MM/DD/YYYY) Measure 2.1.1.a-2.1.1.b (4th question) (page 2)	Add option “No meetings held during reporting period”.	Provides recipients the option for a committee to be established but has not met yet
Comp 2_APR_Form_Year1_12-08-2021	“Have you developed a viral hepatitis elimination plan as part of this cooperative agreement?” Measure 2.1.1.c (1st question) (page 2)	Revise to read “Have you developed a viral hepatitis elimination plan?”	Intent to have recipients specify if they have a plan, regardless of when/how it was developed
Comp 2_APR_Form_Year1_12-08-2021	“Of those, have you selected the subset that reports at least 80% of the hepatitis C antibody testing results in your jurisdiction?” Measure 2.1.2.a-2.1.2.b (2nd question) (page 3)	Revise to read “Of the CLIA-certified laboratories you have identified that report hepatitis C antibody testing results, have you selected the subset that reports at least 80% of the hepatitis C antibody testing results in your jurisdiction?”	Clarifies that the question pertains to the CLIA-certified laboratories they identified
Comp 2_APR_Form_Year1_12-08-2021	“Of the subset, have you performed a needs assessment to identify key barriers and challenges to increasing HCV RNA reflex testing?” Measure 2.1.2.a-2.1.2.b (3rd question) (page 3)	Revise first part of the question to read “Of the this subset…” “Of this subset, have you performed a needs assessment to identify key barriers and challenges to increasing HCV RNA reflex testing?”	Clarifies the question relates to this particular subset
Comp 2_APR_Form_Year1_12-08-2021	“What proportion of the subset is conducting HCV RNA reflex testing?” Measure 2.1.2.a-2.1.2.b (4th question) (page 3) “If so, what percent of health systems are promoting routine HCV testing?” and “If so, what percent of health systems are promoting routine HBV testing?” Measure 2.1.3.a-2.1.3.b (3rd and 5th questions) (page 3 and 4)	Change “Unknown” response choice to “In progress”.	Allows recipients to specify that the work is in progress
Comp 2_APR_Form_Year1_12-08-2021	“What are the top 5 highest volume health systems in your jurisdiction?” Measure 2.1.3.a-2.1.3.b (1st question) (page 3)	Change “Unknown” response choice to “In progress”. Add “Not started” response choice.	Allows recipients to specify that the work is in progress or has not yet started
Comp 2_APR_Form_Year1_12-08-2021	“Have you assessed how many of these health systems are promoting routine HCV testing?” Measure 2.1.3.a-2.1.3.b (2nd question) (page 3) “Have you assessed how many of these health systems are promoting routine HBV testing?” Measure 2.1.3.a-2.1.3.b (4th question) (page 4)	Added “N/A (health systems not assessed)” response choice	Other questions in this section have this response choice so adding in for consistency and to give recipients option to specify
Comp 2_APR_Form_Year1_12-08-2021	“Have you provided feedback to the top 5 highest volume health systems with recommendations on promoting routine HCV and/ or HBV testing?” Measure 2.1.3.a-2.1.3.b (6th question) (page 4)	Revise response choices as shown below in red. □ Yes, to all 5 □ No, have not provided feedback to any of them □ N/A (health systems not assessed) Yes, to some but not all □ N/A (health systems not assessed)	Allows recipients to get credit for providing feedback to less than 5 health systems
Comp 2_APR_Form_Year1_12-08-2021	“Use this space if needed to provide additional information related to Section 2.X” Measure 2.1.3.a-2.1.3.b (last question) (page 4) Measure 2.2.2.g-2.2.2.h, 2.2.3.b (last question) (page 9) Measure 2.3.1.a-2.3.1.d, 2.3.2.a (last question) (page 16)	Revise question as shown below. “Please use this space to provide information about challenges and successes experienced when implementing Strategy X activities. Include additional contextual information that would help us interpret your annual performance data.”	Clarifies the type of information that we need in this field (and is consistent with previously approved form instructions).
Comp 2_APR_Form_Year1_12-08-2021	Measure 2.2.2.a-2.2.2.b (page 5)	Add yes/no questions shown on revised form at this location so grantees can specify each setting type that they will be submitting data for in later sections. If these new questions are added here, subsequent questions will only be asked for specified setting types (i.e., those with “yes” response).	If each setting is specified upfront, subsequent questions can use drop down menus (auto-populated with each setting type) to more easily submit data for each setting
Comp 2_APR_Form_Year1_12-08-2021	“Relationship established to expand HCV testing” “Relationship established to expand HBV testing” “Number of clients seen during this reporting period” Measure 2.2.2.a-2.2.2.b (page 5)	Revise questions that will be asked for each setting type as shown below. “Was relationship established to expand HCV testing?” “Was relationship established to expand HBV testing?” “Number of clients seen at this setting during this reporting period”	Clarifies information needed for each question
Comp 2_APR_Form_Year1_12-08-2021	“Relationship established to expand HCV testing” “Relationship established to expand HBV testing” Measure 2.2.2.a-2.2.2.b (two questions about establishing relationships to expand testing) (page 5)	Add new response choice “In progress” to these two questions (for all setting types specified).	Allows recipients to specify that the work is in progress
Comp 2_APR_Form_Year1_12-08-2021	“Number of clients seen during this reporting period” Measure 2.2.2.a-2.2.2.b (page 5)	Remove “N/A” response choice from this question (for all setting types specified).	This should be answered for all setting types (it is applicable to all recipients funded for this activity)
Comp 2_APR_Form_Year1_12-08-2021	Tables for… Measure 2.2.2.c-2.2.2.f, 2.2.3.a (page 6, 7) Measure 2.2.2.g-2.2.2.h, 2.2.3.b (page 8, 9) Measure 2.3.3.a-2.3.3.d (page 10, 11 ) Measure 2.3.1.a-2.3.1.d, 2.3.2.a (page 11-15)	Remove “N/A” response choice from all these items (for all setting types specified).	These items should be answered for all setting types (they are applicable to all grantees funded for this activity)
Comp 2_APR_Form_Year1_12-08-2021	“Client visits” Measure 2.3.1.a-2.3.1.d, 2.3.2.a (page 11)	Revise “Client visits” to “Total client visits”	Clarifies information needed for this question
Comp 2_APR_Form_Year1_12-08-2021	“Mean (median) syringe coverage rates during this reporting period” Measure 2.3.1.a-2.3.1.d, 2.3.2.a (page 11)	Revise “Mean (median) syringe coverage rates during this reporting period” to “Mean syringe coverage rates during this reporting period”	Clarifies information needed for this question for consistency across responses from recipients
Comp 2_APR_Form_Year1_12-08-2021	“Total number of settings” “Total number of SSPs” All “Total number” fields (pages 6, 7, 9, 11, 15)	Remove these fields throughout form.	This information is no longer needed because it will be automatically calculated through REDCap (based on data entered by the grantee).
Comp 3_APR_Form_Year1_12-08-2021	Reporting period (page 1)	Add date range (MM/DD/YY-MM/DD/YY) for each year	Clearly convey timeframe associated with each year of NOFO
Comp 3_APR_Form_Year1_12-08-2021	Setting types (page 1)	Add yes/no questions shown on revised form at this location so grantees can specify each setting type that they will be submitting data for in later sections. If these new questions are added here, subsequent questions will only be asked for specified setting types (i.e., those with a “yes” response).	If each setting is specified upfront, subsequent questions can use drop down menus (auto-populated with each setting type) to more easily submit data for each setting
Comp 3_APR_Form_Year1_12-08-2021	“Total number of settings” All “Total number” fields (pgs. 2, 5, 6, 8, 9, 10)	Remove these fields throughout form.	This information is no longer needed because it will be automatically calculated through REDCap (based on data entered by the grantee).
Comp 3_APR_Form_Year1_12-08-2021	“Use this space if needed to provide additional information related to Component 3” Measure 3.1.6.a-c, 3.1.7.a (last question) (page 11)	Revise question as shown below. “Please use this space to provide information about challenges and successes experienced when implementing Strategy 3.1 activities. Include additional contextual information that would help us interpret your annual performance data. For example, the number of locations associated with each setting type, or other explanatory notation, could be listed here if needed.”	Clarifies the type of information that we need in this field (and is consistent with previously approved form instructions).