Information Collection

Data Submission forms

IC 215891 under ICR 201503-0925-010 · OMB unassigned.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form Attachment 7 Data Submission forms	Form and Instruction
Attachment 7 Clinical Data Forms Attachment 7_Clinical Data Forms.docx	Form and Instruction
Attachment 3_Informed Consent Influenza Test Hopkins.pdf Informed Consent Form- US	IC Document
Attachment 4_Informed Consent Influenza Test_CGMH.docx Informed Consent - Taiwan	IC Document
Attachment 5_Informed Consent Positive JHU.pdf Informed Consent Form- US influenza Positive	IC Document
Attachment 6_Informed Consent Positive_CGMH.docx Informed Consent Form - Taiwan Influenza Positive	IC Document
Attachment 2_Clinical Protocol 14-0076.docx Clinical Protocol	IC Document
Attachment 8_Appointment Reminder Card JHU.docx Appointment Reminder Form - US	IC Document
Attachment 9_Appointment Reminder Card_CGMH.docx Appointment Reminder Form - Taiwan	IC Document
Attachment 10_Manual Operating Procedures JHU.docx Operating Procedures Manual - US	IC Document
Attachment 11_Manual Operating Procedure_CGMH.docx Operating Procedures Manual - Taiwan	IC Document
Attachment 12_IRB approved IFC_Test.pdf IRB Approval for Informed Consent for Influenza Test	IC Document
Attachment 13_IRB approved IFC_Positive.pdf IRB Approval for Informed Consent for Positive Influenza Respondents	IC Document
Attachment 14_HIPPA Waiver.pdf Stamped HIPAA Waiver	IC Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Attachment 7	Clinical Data Forms	Attachment 7_Clinical Data Forms.docx		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title: 09â25â0200, Clinical, Epidemiologic and Biometric Studies of the National Institutes of Health (NIH), HHS/NIH/OD

FR Citation: 62 FR 16596

Number of Respondents: 600

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,200	1,200
Annual IC Time Burden (Hours)	600	600
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Informed Consent Form- US	Attachment 3_Informed Consent Influenza Test Hopkins.pdf	03/30/2015
Informed Consent - Taiwan	Attachment 4_Informed Consent Influenza Test_CGMH.docx	03/30/2015
Informed Consent Form- US influenza Positive	Attachment 5_Informed Consent Positive JHU.pdf	03/30/2015
Informed Consent Form - Taiwan Influenza Positive	Attachment 6_Informed Consent Positive_CGMH.docx	03/30/2015
Clinical Protocol	Attachment 2_Clinical Protocol 14-0076.docx	03/30/2015
Appointment Reminder Form - US	Attachment 8_Appointment Reminder Card JHU.docx	03/30/2015
Appointment Reminder Form - Taiwan	Attachment 9_Appointment Reminder Card_CGMH.docx	03/30/2015
Operating Procedures Manual - US	Attachment 10_Manual Operating Procedures JHU.docx	03/30/2015
Operating Procedures Manual - Taiwan	Attachment 11_Manual Operating Procedure_CGMH.docx	03/30/2015
IRB Approval for Informed Consent for Influenza Test	Attachment 12_IRB approved IFC_Test.pdf	03/30/2015
IRB Approval for Informed Consent for Positive Influenza Respondents	Attachment 13_IRB approved IFC_Positive.pdf	03/30/2015
Stamped HIPAA Waiver	Attachment 14_HIPPA Waiver.pdf	03/30/2015

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.