Methods of Biospecimen Collection for Women, Infants and Children

Biospecimen and Physical Measurements Formative Research Methodology Studies for the National Children?s Study (NICHD)

Documents and Forms

Document Name Document Type
A.5 LOI3-BIO-0 Brief Questionnaire.docx Instruction
A.6 LOI3-BIO-0 Protocol Description.docx Instruction
A.7 LOI3-BIO-0 Biospecimen Processing Protocol Description.doc Instruction
B.3 LOI2-BIO-20 IRB Protocol.doc Instruction
C.3 LOI2-BIO-24 Exemplar Protocol.pdf Instruction
A.2 LOI3-BIO-0 Consent for ParentGuardian of Participant.doc A.2 LOI3-BIO-0 Consent for Parent Guardian of Participant IC Document
A.3 LOI3-BIO-0 Consent for Adult Participant.doc A.3 LOI3-BIO-0 Consent for Adult Participant IC Document
A.4 LOI3-BIO-0 Child Assent.doc A.4 LOI3-BIO-0 Child Assent IC Document
A.8 LOI3-BIO-0 IRB Approval Letter.pdf A.8 LOI3-BIO-0 IRB Approval Letter IC Document
B.2 LOI2-BIO-20 Exemplar Consent Form.docx B.2 LOI2-BIO-20 Exemplar Consent Form IC Document
B.4 LOI2-BIO-20 IRB Approval Letters.pdf B.4 LOI2-BIO-20 IRB Approval Letters IC Document
C.2 LOI2-BIO-24 Exemplar Consent Form.pdf C.2 LOI2-BIO-24 Exemplar Consent Form IC Document
C.4 LOI2-BIO-24 IRB Approval Letters.pdf C.4 LOI2-BIO-24 IRB Approval Letters IC Document
C 1 LOI2-BIO-24 OIRA Template v2.docx LO12 BIO -24 OIRA template IC Document
A 1 LOI3-BIO-0 OIRA Template v2.docx LO12 BIO 0 OIRA template IC Document
B 1 LOI2-BIO-20 OIRA Template (2) v2.docx LO12 BIO 20 OIRA template IC Document

Information Collection (IC) Details

IC Title:	Methods of Biospecimen Collection for Women, Infants and Children	Agency IC Tracking Number:

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction	A.7 LOI3-BIO-0 Biospecimen Processing Protocol Description.doc	Yes	Yes	Paper Only
Instruction	A.5 LOI3-BIO-0 Brief Questionnaire.docx	Yes	Yes	Paper Only
Instruction	A.6 LOI3-BIO-0 Protocol Description.docx	Yes	Yes	Paper Only
Instruction	B.3 LOI2-BIO-20 IRB Protocol.doc	Yes	Yes	Paper Only
Instruction	C.3 LOI2-BIO-24 Exemplar Protocol.pdf	Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 750	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses for this IC	1,125	0	0	0	0	0
Annual IC Time Burden (Hours)	234	0	0	0	0	0
Annual IC Cost Burden (Dollars)	0	0	0	0	0	0

Documents for IC

Title	Document	Date Uploaded
A.2 LOI3-BIO-0 Consent for Parent Guardian of Participant	A.2 LOI3-BIO-0 Consent for ParentGuardian of Participant.doc	02/15/2012
A.3 LOI3-BIO-0 Consent for Adult Participant	A.3 LOI3-BIO-0 Consent for Adult Participant.doc	02/15/2012
A.4 LOI3-BIO-0 Child Assent	A.4 LOI3-BIO-0 Child Assent.doc	02/15/2012
A.8 LOI3-BIO-0 IRB Approval Letter	A.8 LOI3-BIO-0 IRB Approval Letter.pdf	02/15/2012
B.2 LOI2-BIO-20 Exemplar Consent Form	B.2 LOI2-BIO-20 Exemplar Consent Form.docx	02/15/2012
B.4 LOI2-BIO-20 IRB Approval Letters	B.4 LOI2-BIO-20 IRB Approval Letters.pdf	02/15/2012
C.2 LOI2-BIO-24 Exemplar Consent Form	C.2 LOI2-BIO-24 Exemplar Consent Form.pdf	02/15/2012
C.4 LOI2-BIO-24 IRB Approval Letters	C.4 LOI2-BIO-24 IRB Approval Letters.pdf	02/15/2012
LO12 BIO -24 OIRA template	C 1 LOI2-BIO-24 OIRA Template v2.docx	04/26/2012
LO12 BIO 0 OIRA template	A 1 LOI3-BIO-0 OIRA Template v2.docx	04/26/2012
LO12 BIO 20 OIRA template	B 1 LOI2-BIO-20 OIRA Template (2) v2.docx	04/26/2012

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