2012-15796. Supplemental Submission for OMB Review; Comment Request

Title: Mother and Infant Home Visiting Program Evaluation: Baseline collection of saliva for measuring cotinine.

OMB No.: 0970-0402.

Description: In 2011, the Administration for Children and Families (ACF) and Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) launched a national evaluation called the Mother and Infant Home Visiting Program Evaluation (MIHOPE). This evaluation, mandated by the Affordable Care Act, will inform the federal government about the effectiveness of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program in its first few years of operation, and provide information to help states develop and strengthen home visiting programs in the future. OMB is currently reviewing a data collection package for Phase 1 of the study that includes a survey of parents at baseline (study entry) and various surveys of home visiting program staff and other service providers in the community.

The purpose of the current document is to request approval of collection of saliva at baseline from women participating in the study. Saliva will be used to measure cotinine, a metabolite of nicotine that indicates the extent to which the individual smokes or is subject to second-hand smoke. Smoking is a strong predictor of adverse outcomes for both parents and children and baseline data on smoking will play a key role in the MIHOPE analysis. Prior studies of home visiting have found larger program effects for smokers. Saliva offers a more accurate means to measure smoking compared with self reports.

Saliva for measuring cotinine is being proposed for baseline data collection in response to public comment on the Phase 1 data collection package. To provide the opportunity for public comment, the addition of cotinine is being reviewed separately from the main Phase 1 data collection package.

Respondents: Saliva will be collected from enrolled parents, which will include pregnant women and mothers of children under six months old.

Annual Burden Estimates

The following burden table provides information on the burden of data collection efforts during Phase 1. It is divided into three sections: (1) Data collection related to site recruitment that was previously approved by OMB, (2) data collection currently being reviewed by OMB, and (3) saliva collection. Data collection will take place over a three-year period.

Annual Burden Estimates

	Number of respondents	Number of responses per respondent	Average burden hours per response	Total annual burden hours
Approved (Site Recruitment)
Telephone contact with state administrators	49	1	1.00	49
First round visits with state administrators	18	1	1.50	27
Second round visits with state administrators	15	1	1.50	23
Visits and calls with local program directors	120	1	3.00	360
Site Recruitment Total				459
Under Review (Data Collection)
Family baseline survey	1,700	1	1.00	1,700
State administrator interview:
Baseline	8	1	2.00	16
12 Month	8	1	2.00	16
Program manager survey:
Part 1, Baseline	29	1	0.50	15
Part 2, Baseline	29	1	1.00	29
Part 3, Baseline	29	1	1.00	29
12 month	29	1	2.00	58
Supervisor survey:
Baseline	33	1	1.25	41
12 month	33	1	1.25	41
Home visitor survey:
Baseline	170	1	1.25	213
12 month	170	1	1.25	213
Community service providers survey	510	1	0.10	51
Other home visiting programs survey	142	1	0.10	14
Supervisor logs	33	60	0.20	396
Home visitor logs	170	60	0.20	2,040
Group interview:
Program manager	29	1	1.50	44
Supervisor	33	1	1.50	50
Home visitor	85	1	1.50	128
Home visitor individual interview	85	1	1.50	128
Interview participant questionnaire	232	1	0.05	12
Data Collection Total				5,234
New (Saliva Collection)
Baseline saliva collection	1,700	1	0.10	170
Saliva Collection Total	1,700	1	0.10	170
Estimated Total Annual Burden Hours				5,863

In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. This information collection is a supplement to the Maternal, Infant and Early Childhood Home Visiting Evaluation collection described in a 60 day Federal Register Notice, published on December 12, 2011 (Volume 76, No. 238, Page 77236). Per OMB guidance, ACF requests comments on this supplemental information collection within 30 days of this publication. Comments on and requests for copies of the proposed information collection may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, Email address: [e-mail]. All requests should be identified by the title of the information collection.

The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 30 days of this publication.

Steven M. Hanmer,

Reports Clearance Officer.