Substudy application for Generic Clearance to Conduct Formative Research

Mini Supporting Statement A

Name of Study

OMB#

Date

Contact Information

NIH/Program Official

Mini Supporting Statement A

A.1 Circumstances Making the Collection of Information Necessary

Explain the circumstances that make the collection of information necessary for this specific study under the main generic clearance.

A.2 Purpose and Use of the Information Collection

Indicate how, by whom, and for what purpose the information is to be used.

Justify the data collection in terms of positive needs and the negative consequences of not having the information. Emphasize the practical utility to the government of the expected results. State the uses in specific and tangible terms.

A.3 Use of Information Technology to Reduce Burden

Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection.

Describe any consideration of using information technology to reduce the burden. Please identify if a Privacy Impact Assessment (PIA) was done for the database being used to collect the information.

A.4 Efforts to Identify Duplication

Describe efforts to identify duplication. (i.e., duplication of the information requested in a new rule or form), and describe how the agency identified efforts to avoid duplication.

A.5 Impact on Small Businesses or Other Small Entities

N/A

A.6 Consequences of Collecting the Information Less Frequently

Describe the consequences to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

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

This survey will be implemented in a manner that fully complies with 5 C.F.R. 1320.5. *Standard text*

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

N/A

A.9 Explanation of Any Payment of Gift to Respondents

Explain any decision to provide any payment or gift to respondents, except remuneration of contractors or grantees. Reference incentives based on recent studies (not more than 4 years old).

A.10 Assurance of Confidentiality Provided to Respondents

Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. Provide a Certificate of Confidentiality (COA), if not applicable state “private to the extent permitted by law.”

Additionally please include whether Personally Identifiable Information (PII) is collected. Indicate if Privacy Act applies or not. http://oma.od.nih.gov/public/MS/privacy/Pages/privacyact.aspx

A.11 Justification for Sensitive Questions

Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, race, gender, etc., and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

A.12.1 Estimated Annualized Burden Hours

Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

A.12-1 Estimated Annualized Burden Hours

Form Name	Type of Respondent	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours)	Total Annual Burden Hour
A	Children	2,600	1	5/60	217
B	Parents	3,468	1	9/60	520
C	Dentists	80	1	2/60	3

A.12-2 ANNUALIZED COST TO RESPONDENTS

Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included in Item A.14.

A.12-2 Annualized Cost to the Respondents

Type of Respondent	Number of Respondents	Average Burden Per Response (in hours)	Hourly Wage Rate*	Respondent Cost
Children	2,600	5/60	$10	$2,1667.00
Parents	3,468	9/60	$20	$10,404.00
Dentist	80	2/60	$50	$133.33.00

*Site source of hourly wage rate

A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers

Provide an estimate of the total annual cost burden to respondents or record-keepers resulting from the collection of information.

A.14 Annualized Cost to the Federal Government

Provide estimates of annualized cost to the Federal government. This includes FTE and contract cost.

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Contractor Cost
Travel
Other Cost

At a minimum there should be federal oversight costs. Fill others as applicable.

Highlighted shaded areas are exempt from data entry.

A.15 Explanation for Program Changes or Adjustments

N/A

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

For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

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

We are not requesting an exemption to the display of the OMB Expiration date. *standard text*

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

This survey will comply with the requirements in 5 CFR 1320.9. *standard text*

Mini Supporting Statement B

Complete SSB if, the collection of information employs statistical methods and make a separate document.

If the collection of information does not involve any statistical methods, please use the following statement: “This information does not involve statistical methods.”

B.1 Respondent Universe and Sampling Methods

Describe (including a numerical estimate) the potential respondent universe and any sampling or other respondent selection method to be used. Data on the number of entities (e.g., establishments, State and local government units, households, or persons) in the universe covered by the collection and in the corresponding sample are to be provided in tabular form for the universe as a whole and for each of the strata in the proposed sample. Indicate expected response rates for the collection as a whole. If the collection had been conducted previously, include the actual response rate achieved during the last collection.

B.2 Procedures for the Collection of Information

Describe the procedures for the collection of information including:

 Statistical methodology for stratification and sample selection;

 Estimation procedure;

 Degree of accuracy needed for the purpose described in the justification;

 Unusual problems requiring specialized sampling procedures; and

 Any use of periodic (less frequent than annual) data collection cycles to reduce burden.

B.3 Methods to Maximize Response Rates and Deal with Nonresponse

Describe methods to maximize response rates and to deal with issues of non-response. The accuracy and reliability of information collected must be shown to be adequate for intended uses. For collections based on sampling, a special justification must be provided for any collection that will not yield “reliable” data that can be generalized to the universe studied.

B.4 Test of Procedures or Methods to be Undertaken

Describe any tests of procedures or methods to be undertaken. Testing is encouraged as an effective means of refining collections of information to minimize burden and improve utility. Tests must be approved if they call for answers to identical questions from 10 or more respondents. A proposed test or set of tests may be submitted for approval separately or in combination with the main collection of information.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Provide the name and telephone number of individuals consulted on statistical aspects of the design and the name of the agency unit, contractor(s), grantee(s), or other person(s) who will actually collect and/or analyze the information for the agency.