NIH Toolbox for Assessment of Neurological and Behavioral Function (NIA)

Forms and Documents

Document Name	Status
Form 1 Children (baseline only + retest) Form and Instruction	New
Form 2 Adult Study Participants (baseline only + 1 retest) Form and Instruction	New
Attach 63 Consent Documents 7.24.2011.pdf Supplementary Document	2011-07-25
Attach 62 - NU IRB Approval Letter 7.24.2011.pdf Supplementary Document	2011-07-25
Attach 61 Certificate of Confidentiality 7.24.2011.pdf Supplementary Document	2011-07-25
Attach 60 Recruitment instructions scripts and letters 7.24.2011.pdf Supplementary Document	2011-07-25
Supporting_Statement_B1_7-24-2011.docx Supporting Statement B	2011-07-25
Attach 65 NIH Privacy Review Act Memo cover.docx Supplementary Document	2011-05-27
Attach 64 Team Member Contact List.pdf Supplementary Document	2011-05-25
Supporting_Statement_A2_comments 7-24-2011.docx Supporting Statement A	2011-07-25

IC Document Collections

IC ID	Document Title	Status
197920	Parent Proxies (baseline only + retest) Instruction	New
197919	Children (baseline only + retest) Form and Instruction	New
197918	Adult Study Participants (baseline only + 1 retest) Form and Instruction	New

ICR Details

OMB Control No: 0925-0638	ICR Reference No: 201105-0925-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: NIH Toolbox for Assessment of Neurological and Behavioral Function (NIA)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/25/2011
	Date Received in OIRA: 05/31/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	36 Months From Approved
Responses	19,350	0	0
Time Burden (Hours)	37,800	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: Although there are many studies that collect information on aspects of neurological function and behavioral health (e.g., cognition, sensation, motor functioning, emotion), there is little uniformity among the measures used to assess these constructs. When individual studies employ unique assessment batteries, comparisons between studies and combining data from multiple studies are quite challenging. Thus, investigators have expressed the need for brief, standard assessment tools to be used across diverse study designs and populations. For example, in 2005, a report (Hendrie et al., Alzheimer's & Dementia, vol. 2, 12-32, 2006) was submitted to the staff of the trans-NIH Cognitive and Emotional Health Project (CEHP) that suggested, among other ideas, the need for "standard questionnaires to measure cognitive and emotional health". In response to these issues, the National Institutes of Health (NIH) Toolbox initiative seeks to assemble brief, comprehensive assessment tools to measure cognitive, emotional, sensory and motor function that will be useful to clinicians and researchers in a variety of settings, with a particular emphasis on measuring outcomes in large longitudinal or epidemiologic studies and prevention or intervention trials across the lifespan. Such comprehensive measures are rarely included in studies of this type, due in part to the lack of brief, well-validated instruments.

---

Authorizing Statute(s): US Code: 42 USC 410 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 1621	01/11/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 22107	04/20/2011
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Adult Study Participants (baseline only + 1 retest)	24, 26, 27, 28, 29, 31, 32, 33, 35, 36, 37, 38, 39, 41, 42, 43, 44, 45, 46, 52, 57, 58, 59, 55, 56, 34, 2, 1, 6, 3, 4, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 22, 23	Hearing Handicap Inventory (HHI) ,   Automated Audiometry from the NIH Toolbox (AANT) ,   University of Penn Smell Identification ,   Words in Noise ,   Ordor Identification ,   PA Ages 18-85 ,   Sucrose Preference Test ,   Toolbox Taste Test ,   Dynamic Visual Acuity (DVA) ,   Vision Health Related QOL Survey ,   Brief Kinesthesia Test ,   Handedness Assessment ,   Tactile Discrimination Test ,   Dimensional Card Change Sort ,   Bateria III Picture Vocabulary (Spanish only) ,   Imitation Based Assessment of Memory ,   List Sorting ,   Oral Symbol Digit Modalities ,   Pattern Comparison ,   Reading Recognition ,   Vocabulary Comprehension ,   Word Accentuation (Spanish only) ,   Emotional Health Questionaire ,   Supplemental Emotional Health Questionaire ,   Dexterity 9-hole Pegboard ,   Endurance 2-Minute Walk Test ,   Locomotion 4-meter Walk Test ,   Grip Strength Dynamometry ,   Strength Knee Extension ,   Balance Accelerometer Measure ,   Initial Adult Questionaire ,   Additional Somatosensation Questions ,   Additional Audition Olfaction Taste ,   Cognition Information Form ,   Health Care Access and Utilization ,   Instrumental Activities of Daily Living ,   Applied Cognition Adult ,   PROMIS 29 Participant ,   EtOH (Alcohol) Questionaire ,   Education Adult Self-Report ,   Education Proxy Report for Children ,   Text Anxiety Scale ,   Falls Efficscy Scale-International
Children (baseline only + retest)	1, 6, 3, 4, 11, 12, 13, 14, 15, 17, 18, 19, 20, 22, 23, 24, 26, 27, 28, 29, 31, 32, 33, 34, 35, 36, 37, 38, 40, 41, 42, 47, 49, 50, 51, 52, 57, 55, 5, 7, 8, 9	Automated Audiometry from the NIH Toolbox (AANT) ,   University of Penn Smell Identification ,   Words in Noise ,   Ordor Identification ,   Sucrose Preference Test ,   Toolbox Taste Test ,   Dynamic Visual Acuity (DVA) ,   Vision Health Related QOL Survey ,   Brief Kinesthesia Test ,   Tactile Discrimination Test ,   Dimensional Card Change Sort ,   Bateria III Picture Vocabulary (Spanish only) ,   Imitation Based Assessment of Memory ,   List Sorting ,   Oral Symbol Digit Modalities ,   Pattern Comparison ,   Reading Recognition ,   Handedness Assessment ,   Vocabulary Comprehension ,   Word Accentuation (Spanish only) ,   Emotional Health Questionaire ,   Supplemental Emotional Health Questionaire ,   Dexterity 9-hole Pegboard ,   Endurance 2-Minute Walk Test ,   Locomotion 4-meter Walk Test ,   Grip Strength Dynamometry ,   Strength Knee Extension ,   Balance Accelerometer Measure ,   Initial Child/Proxy Questionaire ,   Additional Somatosensation Questions ,   Additional Audition Olfaction Taste ,   Pediatric Perceived Cognitive Child ,   Pediatric PROMIS Physical Function Upper Extremity ,   Pediatric PROMIS Physical Function Mobility ,   Pediatric Funtional Assessment of Chronic Illness Therapy Fatigue ,   PROMIS 29 Participant ,   EtOH (Alcohol) Questionaire ,   Text Anxiety Scale ,   Odor Identification ,   Pain Assessment Ages 3-7 ,   Pain Assessment Ages 8-12 ,   Pain Assessment Ages 13-17
Parent Proxies (baseline only + retest)	7, 8, 9, 31, 32, 41, 42, 27, 43, 44, 48, 51, 53, 54, 59, 40	Emotional Health Questionaire ,   Supplemental Emotional Health Questionaire ,   Additional Somatosensation Questions ,   Additional Audition Olfaction Taste ,   Handedness Assessment ,   Cognition Information Form ,   Health Care Access and Utilization ,   Pediatric Perceived Cognitive Proxy ,   Pediatric Funtional Assessment of Chronic Illness Therapy Fatigue ,   School Performance and Activities ,   Socio-demographic form ,   Education Proxy Report for Children ,   Initial Child/Proxy Questionaire ,   Pain Assessment Ages 3-7 ,   Pain Assessment Ages 8-12 ,   Pain Assessment Ages 8-12

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	19,350	0	0	19,350	0	0
Annual Time Burden (Hours)	37,800	0	0	37,800	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

---

Annual Cost to Federal Government: $5,062,318

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/31/2011

---