SS Part A 18OCT2017

Goal of the study: The purpose of this annual assessment under the cooperative agreement is to identify: 1) jurisdictional legal frameworks governing CDC-funded childhood lead poisoning prevention programs in the United States; and 2) strategies for implementing childhood lead poisoning prevention activities in the United States.

Intended use of the resulting data: The information collection instrument will be used to: 1) identify common characteristics of funded childhood lead poisoning prevention programs and 2) inform guidance, resource development, and technical assistance activities conducted by the CDC Healthy Homes and Lead Poisoning Prevention Program (HHLPPP) in support of the ultimate goal, which is blood lead elimination in children. Assessment findings will be shared on the HHLPPP website and in response to inquiries by the public, press, and Congress. The dissemination of results will support the ability for both funded and non-funded jurisdictions to: 1) identify policies and other factors that support or hinder childhood lead poisoning prevention efforts, 2) understand what strategies are being used by funded state and local governments (or their bona fide fiscal agents) to implement childhood lead poisoning prevention activities, and 3) use this knowledge to develop and apply similar strategies to support the national agenda to eliminate childhood lead poisoning.

Methods to be used to collect: Data will be collected annually from the project managers of funded lead poisoning prevention programs of state and local governments (or their bona fide fiscal agents) using a web-based information collection instrument or a MS Word document via email.

Populations to be studied: The population to be studied includes 48 state and local governments (or their bona fide agents) that receive funding from the CDC HHLPPP as part of their annual program performance requirements.

How data will be analyzed: Data will be analyzed by CDC staff using Epi Info^TM 7 to calculate and organize descriptive statistics and qualitative response themes respectively.

Part A. Justification

A.1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC) is requesting approval for a 3-year Paperwork Reduction Act (PRA) clearance for this new information collection request (ICR) titled “Awardee Lead Profile Assessment (ALPA).” The information collected will allow the CDC Healthy Homes and Lead Poisoning Prevention Program (HHLPPP) to: (1) identify common characteristics of funded childhood lead poisoning prevention programs, and (2) inform guidance, resource development, and technical assistance for the activities that the HHLPPP conducts in support of its ultimate goal to eliminate blood lead in children.

Lead, a naturally occurring metal, is used in a wide variety of products around the globe. Lead paint is still found in many homes built before the 1978 ban on lead in residential paint was enacted in the U.S. (Jacobs et al, 2002). Lead paint in homes is the primary source of lead exposure in young children (Levin et al, 2008). Lead, extracted and used in consumer products and occupational settings, also contributes to morbidity and mortality in children and adults. To date, a safe blood lead level has not been identified. High blood lead levels can result in decreased academic achievement, decreased IQ, and behavioral problems in children. In extreme cases, lead poisoning can result in death. Children under six years of age are at an increased risk for adverse effects of lead exposure due to their accelerated development and behaviors, like hand to mouth tendencies, which contribute to exposure (National Institute of Environmental Health Sciences, 2015).Despite tremendous strides toward the elimination of lead poisoning in the United States, an estimated 535,000 children aged 1–5 years have blood lead levels at or above the reference value for blood lead, contributing to intellectual and behavioral shortcomings in children across the nation (Wheeler and Brown, 2013).

Since 1988, when the Lead Contamination and Control Act became public law (Attachment 1), the CDC has been charged with: 1) developing programs and policies to prevent childhood lead poisoning; 2) educating families, caregivers, and clinical providers about childhood lead poisoning; 3) providing funding to state and local health departments to collect surveillance data concerning childhood lead poisoning; and 4) supporting research to determine the effectiveness of prevention efforts at federal, state, and local levels (Centers for Disease Control and Prevention, 2015).

The CDC HHLPPP, formerly the CDC Childhood Lead Poisoning Prevention Branch, provides allowable and available funding to U.S. state and local governments, or their bona fide fiscal agents, in the form of cooperative agreements. State and local programs are funded to develop, implement, and assess lead poisoning prevention activities. The CDC HHLPPP also: 1) trains public health professionals on lead poisoning prevention and healthy homes principles; and 2) develops and implements internet technology solutions to conduct surveillance of childhood lead poisoning, providing a no-cost surveillance system for use by state and local lead poisoning prevention programs. All funded agencies are required to submit continuation applications and annual progress reports consistent with federal reporting requirements in response to the Governmental Performance and Results Act of 1993 (GPRA).

The current cooperative agreement, under the funding opportunity announcement (FOA) entitled PPHF 2017: Lead Poisoning Prevention- Childhood Lead Poisoning Prevention---financed partially by Prevention and Public Health Funds (CDC-RFA-EH17-1701PPHF17) (Attachment 3), will build upon national gains made by awardees under past cooperative agreements. Awardees will include 48 state and local governments or their bona fide fiscal agents.

This information collection falls under the following program areas from the 10 essential public health services: 1) development of policies and plans that support individual and community health efforts; and 2) evaluating effectiveness, accessibility, and quality of personal and population-based health services.¹

The HHLPPP also supports the following Healthy People 2020 goals:

Environmental Health Goal: Promote health for all through a healthy environment.
- Objective EH-8 - Reduce blood lead levels in children.
  - Objective EH-8.1 - Reduce blood lead level in children aged 1–5 years.
  - Objective EH-8.2 - Reduce the mean blood lead levels in children.
- Objective EH-20 - Reduce exposure to selected environmental chemicals in the population, as measured by blood and urine concentrations of the substances or their metabolites.
  - Objective EH-20.3 - Reduce exposure to lead in the population, as measured by blood and urine concentrations of the substance or its metabolites.
  - Objective EH-22.1 - Increase the number of States, Territories, Tribes, and the District of Columbia that monitor diseases or conditions that can be caused by exposure to lead poisoning.

The HHLPPP is authorized under Sections 301(a), 317A, and 317B of the 1944 Public Health Service Act, as amended by the 1988 Lead Contamination Control Act.In addition, this program is authorized under Section 4002 of the Patient Protection and Affordable Care Act of 2010 (ACA), P. L. 111-148, (42 U.S.C. Section 300u-11); and under Section 2204 of the Water Infrastructure Improvements for the Nation (WIIN) Act of 2016 [Public Law No: 114-322] (Attachment 1). The 60-day Federal Register Notice was published on April 27, 2017 (Attachment 2) and is further discussed in Section A.8.

A.2. Purpose and Use of the Information Collection

In 2015, CDC HHLPPP piloted among eight professionals, and then conducted the “Baseline Profile of State and Local Healthy Homes and Lead Poisoning Prevention Programs (PROF-LEAD)” collection among 35 awardees from the previous HHLPPP cooperative agreement program.² The information provided was found to provide a useful snapshot of the status of funded childhood lead poisoning prevention programs. After revisions were made to the PROF-LEAD questionnaire to ease answering via the availability of standard responses, an annual ALPA questionnaire for program performance measures is now proposed (Attachments 5 and 6).

The ALPA information collection will serve to: 1) identify common characteristics of awarded childhood lead poisoning prevention programs; and 2) inform guidance and resource development in support of the ultimate elimination goal. The dissemination of results obtained from this information collection will enable jurisdictions to: 1) identify policies and other factors that support or hinder childhood lead poisoning prevention efforts; 2) understand what strategies are being used by funded state and local governments (or their bona fide fiscal agents) to implement childhood lead poisoning prevention activities; and 3) use this knowledge to develop and apply similar strategies to support the national agenda to eliminate childhood lead poisoning. Both funded and non-funded jurisdictions will be able to apply these principles to their childhood lead poisoning prevention programs. Findings will be shared on CDC’s HHLPPP website and in response to inquiries by the public, press, and Congress.

If the ALPA information collection does not occur, CDC will be unable to: 1) map specific and currently evolving characteristics of lead poisoning prevention programs throughout the U.S. (e.g., identifying blood lead levels (BLLs) that prompt public health action); 2) assess and share characteristics of lead poisoning prevention programs that lend to demonstrated success in preventing childhood lead poisoning; 3) assess gaps in, or achievements of, best practice approaches to lead poisoning prevention; and 4) develop resources for program improvement to ensure childhood lead poisoning elimination.

A.3. Use of Improved Information Technology and Burden Reduction

Data will be collected using a web-based questionnaire devised using Epi Info 7^TM (Attachment 5) or using a questionnaire in Word format (Attachment 6). The data collection methods will allow all respondents to complete and submit their responses electronically. Respondents will be able to complete the questionnaire via an Epi Info web survey (EIWS) link, or respondents can request to receive a Word version of the questionnaire via email. These two methods were chosen to reduce the overall burden on respondents and does not require any special technical expertise or proprietary software. The information collection instrument was designed to collect the minimum information necessary for the purpose of this information collection.

A.4. Efforts to Identify Duplication and Use of Similar Information

There are no current information and data systems that meet the needs of the proposed information collection. The collection of this information will be part of a federal reporting requirement for funds received by awardees. Publicly-available resource libraries and clearinghouses contain no information related to the information collection described under this effort. A literature search returned no results related to the same.

In 2015, the CDC National Center for Environmental Health (NCEH) partnered with professional organizations, such as the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), and the National Association of Local Boards of Health (NALBOH), along with the National Center for Health Statistics (NCHS) to ensure that the proposed ICR is not in conflict with collections they have or will have in the field within the same timeframe.

Thus, NCEH has determined that CDC has not systematically collected this information, barring the 2015 PROF-LEAD pilot information collection among eight respondents and the associated one-time generic information collection among 35 respondents.³ In addition, NCEH does not have a record of the information in any publicly-accessible resource database.

A.5. Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses.

A.6. Consequences of Collecting the Information Less Frequently

The information collection will occur annually in fulfillment of requirements outlined in the CDC program announcement PPHF 2017: Lead Poisoning Prevention- Childhood Lead Poisoning Prevention---financed partially by Prevention and Public Health Funds (CDC-RFA-EH17-1701PPHF17) (Attachment 3), as well as in future program announcements. The legislative landscape with regard to lead poisoning prevention continues to evolve over time, as do the strategies employed by public health agencies as new best practices are identified. Awardees are required to report performance measures annually as stipulated in the program announcement. The annual ALPA questionnaire will complement the performance measures reporting and is also stipulated in the program announcement.⁴

Less frequent reporting would negatively impact: 1) the tracking of strategies in use by funded lead programs and, 2) the ability of CDC to assess and share the characteristics of lead poisoning prevention programs that lend to demonstrated success in preventing childhood lead poisoning. The annual reporting allows the HHLPPP to respond in a timely manner with up-to-date information to inquiries from stakeholders.

A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances related to this information collection. This request fully complies with the regulation 5 CFR 1320.5.

A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A 60-day Federal Register Notice was published in the Federal Register on April 27, 2017 Vol. 82, No. 80 pp. 19375-19376 (Attachment 2). CDC received one comment and replied with a standard CDC response. The public comment is provided (Attachment 2a) and addressed below.

This information collection is part of required reporting under the funding opportunity announcement (FOA) entitled PPHF 2017: Lead Poisoning Prevention- Childhood Lead Poisoning Prevention---financed partially by Prevention and Public Health Funds (CDC-RFA-EH17-1701PPHF17) (Attachment 3). Cooperative agreement awardees implement tailored strategies to prevent lead exposure from a variety of sources – including, but not limited to, paint, cultural items, and water – to protect children’s health. The proposed information collection allows CDC to better understand how funded states and cities address lead poisoning prevention. The CDC intends to share findings from this information collection with state and local partners and the lay public in a clear and concise manner. The findings from the information collection will shape CDC’s engagement with state and local governments through grants and other mechanisms to maximize the success of all engaged national partners in eliminating childhood lead poisoning. The findings from the information collection will also influence how state and local governments successfully implement tailored activities to eliminate childhood lead poisoning in their jurisdictions.

As previously mentioned in Section A.4, in 2015, CDC consulted with the following professional organizations: ASTHO, NACCHO, NALBOH, and CDC’s NCHS. Finding no conflicts or duplicated efforts, the CDC HHLPPP formulated the PROF-LEAD questionnaire,⁵ and administered it to 35 state and local lead poisoning prevention program project managers. Because of its success, CDC is now seeking use of a revised version of this instrument for the current ICR, as the ALPA questionnaire (Attachments 5 and 6).

A.9. Explanation of Any Payment or Gift to Respondents

Respondents will not receive payments or gifts for providing information. The questionnaire reporting is required by the program announcement (Attachment 3).

A.10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

This ICR was reviewed on 12/21/2016 by the NCEH/ATSDR Information Systems Security Officer (ISSO) who determined that the Privacy Act does not apply. The ALPA will not involve the collection of personally identifiable or sensitive information. The ALPA involves collection of data regarding childhood lead poisoning prevention programs (“entities”) and not persons. The ISSO also completed a privacy impact assessment (PIA). Controls described are adequate for protecting the aggregated and non-sensitive data being collected through Epi Info 7^TMor Word. Data will be protected with appropriate controls as described in the system documentation for the Epi Info Web Survey, an authorized CDC information collection system (Attachment 4b).

Overview of the Data Collection System

The ALPA questionnaire will collect standardized information from funded programs to identify: 1) laws and regulations governing national CDC-funded childhood lead poisoning prevention programs; and 2) strategies for implementing childhood lead poisoning prevention activities in two modes, in the EIWS or Word format (Attachments 5 and 6). Attachment 5a is a supplemental Word document which provides the response options that are not visible in the EIWS screenshots (Attachment 5).

Each awardee has one project manager for lead poisoning prevention activities. Each project manager will complete the questionnaire in his or her official capacity. The ALPA questionnaire will use the EIWS functionality as the primary method for respondents to complete the information. The EIWS link (Attachment 5) will be sent via an invitation email (Attachment 7) by a staff member (administrative assistant) of the HHLPPP to the attention of all project managers of the funded programs approximately 150 days before the end of the annual budget period. A follow-up email (Attachment 8) will be sent to the attention of all project managers approximately 130 days before the end of the annual budget period. Respondents who do not want to complete the online web questionnaire will be able to complete the Word questionnaire (Attachment 6) that will be emailed to them by a staff member (administrative assistant) of the HHLPPP.

The completed EIWS ALPA questionnaire data will be automatically stored on a secure CDC platform, and a limited number of HHLPPP staff members will be able to view and analyze the data in Epi Info^TM 7. The data will be securely stored in an Epi Info^TM 7 project folder and put on the secure HHLPPP shared drive. The shared drive is only accessible to approved HHLPPP staff members, after secure log on to CDC electronic systems.

If respondents choose to complete the Word questionnaire (Attachment 6), the data will be manually entered into the Epi Info^TM 7 database by a HHLPPP staff member and will be included for analysis using Epi Info^TM 7. The completed questionnaire will be filed for each funded program in its respective file folder on the secure HHLPPP shared drive.

A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions

No personal or sensitive data will be collected. The NCEH/ATSDR Human Subjects Contact has determined that the data collection is not research involving human subjects and IRB approval is not required (Attachment 9).

This information will be collected in fulfillment of the non-research program requirements under PPHF 2017: Lead Poisoning Prevention- Childhood Lead Poisoning Prevention---financed partially by Prevention and Public Health Funds (CDC-RFA-EH17-1701PPHF17), or for future funding opportunities. Participation is required for satisfactory performance.

A.12. Estimates of Annualized Burden Hours and Costs

Estimated annualized burden hours

Data will be collected from up to 48 respondents - specifically, lead poisoning prevention program project managers of state and local governments or their bona-fide fiscal agents.

The estimate for burden hours for the Awardee Lead Profile Assessment (ALPA) questionnaire is identical to that for the previously administered PROF-LEAD questionnaire.⁶ Details about PROF-LEAD pilot testing are provided in Section B.4. We estimate the time burden to be the same, 7 minutes per response, regardless of mode (EIWS or Word format) (Attachments 5 and 6). We anticipate that the majority, 40 respondents, will choose the EIWS mode due to the ease of use, and that 8 respondents will choose the Word format mode. The total annual time burden requested is 6 hours.

Table 2: Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
State and Local Governments (or their bona fide fiscal agents)	Awardee Lead Profile Assessment (ALPA) Questionnaire – web survey	40	1	7/60	5
	ALPA Questionnaire – Word format	8	1	7/60	1
Total					6

Estimated annualized cost to respondents

Estimates for the average hourly wage for respondents are based on the Bureau of Labor Statistics Occupational Employment and Wages, May 2016, for Medical and Health Services Managers (https://www.bls.gov/oes/current/oes119111.htm). Based on DOL data, an average hourly wage of $52.58 is estimated for all respondents. Table 3 (below) shows estimated annualized burden costs.

Occupation Code & Title	Job Description
11-9111 – Medical and Health Services Managers	Plan, direct, or coordinate medical and health services in hospitals, clinics, managed care organizations, public health agencies, or similar organizations.

Table 3: Estimated Annualized Burden Costs

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
State and Local Governments (or their bona fide fiscal agents)	ALPA Questionnaire – web survey	5	$52.58	$262.90
	ALPA Questionnaire – Word format	1	$52.58	$52.58
Total				$315.48

A.13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

There will be no direct costs to the respondents other than their time to participate in the information collection. The respondents are participating in this information collection as a program requirement.

A.14. Annualized Cost to the Federal Government

The annualized cost to the federal government for ALPA is $1,640,000, and is based on the following:

The annual FY17 cooperative agreement program budget for surveillance activities is estimated to be $875,000.
- This cooperative agreement cost is based on the three-year FY17 program budget of $35,000,000 (Attachment 3).
- One-half of the program budget is estimated to support program management and one half of the program budget is estimated to support surveillance activities, or $17,500,000 per program area for three years, or $5,833,333 per year.
- We estimate that 85 percent of the annual program management activities will be related to performance measures ($4,958,333) to be reported under “CDC Performance Progress and Monitoring Report (PPMR)” (OMB Control No. 0920-1132, expiration date 08/31/2019), while 15 percent of the annual cost of program management will be attributed to activities related to the ALPA survey ($875,000).
The annual federal personnel salary cost for surveillance activities is $765,000.
- This salary estimate is based on a total annual cost of $1,275,000, based on the following positions: Program Chief, Deputy Program Chief, 6 Project Officers, 1 IT Specialist, 2 Epidemiologists, 1 Communications Specialist.^[2] Overall, 60 percent of NCEH personnel time is dedicated to program management ($765,000) and 40 percent of their time is dedicated to surveillance activities ($510,000).
There are no annual travel or contract costs related to the ALPA collection.

A.15. Explanation for Program Changes or Adjustments

This is a new ICR.

A.16. Plans for Tabulation and Publication and Project Time Schedule

The data collection instrument will be fielded to the state and local lead poisoning prevention program project managers in May 2018 and annually through May 2020. The timeline is consistent with other cooperative agreement report timelines. Data collection will take approximately 3 weeks to complete. Data will be cleaned and analyzed by a CDC Health Scientist using Epi Info^TM 7. Data will be tabulated by jurisdiction, and posted to CDC’s HHLPPP website, and distributed in response to inquiries by the public, press, and Congress.

Project Time Schedule per Year after PRA clearance is obtained

Conduct annual information collection (Response period 4 weeks)
- Invitation email sent 30 days before the Awardee Lead Profile Assessment is due
- Follow-up email sent 10 days before the Awardee Lead Profile Assessment is due
Code, quality control, and analyze data (4 weeks)
Prepare reports (5 weeks)
Disseminate results/reports (6 weeks)

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate

The display of the OMB expiration date is appropriate.

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.9.

References

Jacobs, D. E., Clickner, R. P., Zhou, J. Y., Viet, S. M., Marker, D. A., Rogers, J. W., ... & Friedman, W. (2002). The prevalence of lead-based paint hazards in US housing. Environmental health perspectives, 110(10), A599.

Levin, R., Brown, M. J., Kashtock, M. E., Jacobs, D. E., Whelan, E. A., Rodman, J., ... & Sinks, T. (2008). Lead exposures in US children, 2008: implications for prevention. Environmental Health Perspectives, 116(10), 1285.

Centers for Disease Control and Prevention (CDC). “CDC’s Childhood Lead Poisoning Prevention Program.” Available at http://www.cdc.gov/nceh/lead/about/program.htm. Accessed on 8/9/15.

National Institute of Environmental Health Sciences (NIEHS). “Lead.” Available at http://www.niehs.nih.gov/health/topics/agents/lead/. Accessed on 8/9/15.

Wheeler, W. and Brown, M.J. (2013). Blood lead levels in children aged 1-5 years— United States, 1999-2010. MMWR Morb. Mortal. Wkly. Rep 62(13), 245-248.

List of Attachments

Attachment 1. Authorizing Legislation

Attachment 2. 60-day Federal Register Notice

Attachment 2a. Public Comments and Program Responses

Attachment 3. FY17 Funding Opportunity Announcement

Attachment 4a. Privacy Impact Assessment (ALPA)

Attachment 4b. Privacy Impact Assessment (EIWS)

Attachment 5. Awardee Lead Profile Assessment Questionnaire (Epi-Info | Web Version)

Attachment 5a. Awardee Lead Profile Assessment Questionnaire (Epi-Info Response

Descriptions)

Attachment 6. Awardee Lead Profile Assessment Questionnaire (MS Word | Email Version)

Attachment 7. Invitation to Participate

Attachment 8. Follow-up Email

Attachment 9. Research Determination Form

1 For more information on the National Public Health Performance Standards and the 10 essential public health services, see http://www.cdc.gov/nphpsp/essentialservices.html (Accessed 08/18/2016). The Core Public Health Functions Steering Committee developed the framework for the Essential Services in 1994. The committee included representatives from US Public Health Service agencies and other major public health organizations.

2 In 2015, PROF-LEAD was collected under the generic clearance for “Information Collections to Advance State, Tribal, Local, and Territorial (STLT) Governmental Health” (OMB Control No. 0920-0879; expiration date 03/31/2018).

3 “Information Collections to Advance State, Tribal, Local, and Territorial (STLT) Governmental Health” (OMB Control No. 0920-0879; expiration date 03/31/2018).

4 In addition to the ALPA questionnaire, annual performance measures for this FOA will be collected under the existing PRA clearance, “Performance Progress and Monitoring Report” (PPMR - OMB Control No. 0920-1132; expiration DATE 08/31/2019).

5 “Information Collections to Advance State, Tribal, Local, and Territorial (STLT) Governmental Health” (OMB Control No. 0920-0879; expiration date 03/31/2018).

6 “Information Collections to Advance State, Tribal, Local, and Territorial (STLT) Governmental Health” (OMB Control No. 0920-0879; expiration date 03/31/2018).

[2]^[2] Based on OPM Atlanta Locality Pay for Grade and Step 5 Salary Table at https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2017/ATL.pdf.

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
Author	Richardson, Tony (CDC/OD/OADS)
File Modified	0000-00-00
File Created	2021-01-21

SS Part A 18OCT2017