NCEH CBLS - Research Determination

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Human Subjects Tracking Form for Contracts, Purchase (Requisition) & Task Orders,
Modifications to Contracts, and for New, Renewal, and Noncompeting Continuation Grants and
Cooperative Agreements
Instructions:
1.

Complete for each, single award.

2.

For Contracts, Grants & Cooperative Agreements, Purchase (Requisition) & Task Orders, Modifications:
a.

Complete Parts A and B.

b.

Submit to PGO with RFC (Request for Contract), FOA (Funding Opportunity Announcement), purchase
(requisition) request, task order request or modification request.

c.

Note: Some information requested in Part B may not be available until an award is made.

Part A: Complete for each award. (Complete applicable items.)
CIO: __________________________________________________________________
(including Division/Office)
NCEH/DEEHS/Healthy Homes and Lead Poisoning Prevention Program
Purchase Order (Requisition) Number, Contract Number, Grant or Cooperative Agreement number, Task Order Number
(including contract number), Modification Number (including contract number): ___________________________
Lead Poisoning Prevention: Childhood Lead Poisoning Prevention
Title of Project: ____________________________________________________________________________________

_________________________________________________________________________________________________

Name of CIO Project Officer/Program Official:

770-488-3643
Telephone Number: ____________

Kimball F. Credle
EEHS/Healthy Homes and Lead Poisoning Prevention Program

F-58
Mailstop: ______

1.

Are there definite research plans?
If no, state specific reasons below, and skip to signatures:

Yes

No

This is a prevention grant for state/local health department designed primarily to identify high-risk areas, ensure testing
of children less than 6 years of age, and reporting of data associated with testing.
_________________________________________________________________________________________

2.

Will the grantee conduct human subject research in the next funding cycle?
If no, state specific reasons above, and skip to signatures.

Yes

No

Part B: Complete when award involves human subjects.
Identify each of the research activities involving human participants by title and answer each question.
(1) (Title)
_________________________________________________________________________________________
1.

Have IRB approvals been received for each performance site?
Yes
If no, when is/are approval(s) anticipated to be completed for all sites? _________________________
(Estimated Date – MM/YYYY)

No

2.

Are CDC scientists engaged in this research activity?
If yes, has the project been reviewed at CDC for human subjects’ protection?
List the CDC human subject protocol number and date of expiration:

No
No

CDC Protocol Number: _________________

Yes
Yes

Date of Expiration: _______________

CDC 10.24 (E), Revised March 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, March 2013

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Human Subjects Tracking Form for Contracts, Purchase (Requisition) & Task Orders,
Modifications to Contracts, and for New, Renewal, and Noncompeting Continuation Grants and
Cooperative Agreements

3.

Is this activity exempt under one of the 6 exemptions in 45 CFR 46.101(b)?

Yes

No

If yes, provide exemption categories: __________________
4.

Is there more than one site engaged in the research supported under this funding mechanism?
Yes
No
List the funding recipient institution/organization and any additional performance sites. Please include the
Name of the Organization, Federal Wide Assurance (FWA) number and expiration date and the IRB protocol
identifier and expiration date for each site:

__________________________________________________________________________________________
5.

Is a human subjects’ restriction required on the notice of award?
Yes
If yes, identify the reason for the human subjects’ restriction, and the amount of funds to be restricted:

No

__________________________________________________________________________________________

APPROVALS (Signature and Position Title):
Project Officer/Program Official:

DATE

Kimball Credle -S

REMARKS

Digitally signed by Kimball Credle -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Kimball Credle -S,
0.9.2342.19200300.100.1.1=1000689221
Date: 2017.01.31 08:47:28 -05'00'

01/31/2017

Branch Chief or Branch ADS: Sheila R. Stevens S

Digitally signed by Sheila R. Stevens -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=1000277259,
cn=Sheila R. Stevens -S
Date: 2017.01.31 12:01:04 -05'00'

01/31/2017

Division ADS or Human Subjects Contact: Stephanie I. Davis
-S

Digitally signed by Stephanie I. Davis -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=1001232781,
cn=Stephanie I. Davis -S
Date: 2017.01.31 12:47:24 -05'00'

Stephanie Davis, on behalf of Helen Schurz-Rogers

CIO (Human Subjects Contact): Padmaja Vempaty

01/31/2017
Digitally signed by Padmaja Vempaty
DN: cn=Padmaja Vempaty, o=CDC/ATSDR,
ou=NCEH/ATSDR, email=dmy6@cdc.gov,
c=US
Date: 2017.01.31 13:02:52 -05'00'

01/31/2017

Page 2 of 77

CDC 10.24 (E), Revised March 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, March 2013

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Human Subjects Tracking Form for Contracts, Purchase (Requisition) & Task Orders,
Modifications to Contracts, and for New, Renewal, and Noncompeting Continuation Grants and
Cooperative Agreements

Identify each of the research activities involving human participants by title and answer each question.
(2) (Title)
_________________________________________________________________________________________
1.

Have IRB approvals been received for each performance site?
Yes
If no, when is/are approval(s) anticipated to be completed for all sites? _________________________
(Estimated Date – MM/YYYY)

No

2.

Are CDC scientists engaged in this research activity?
If yes, has the project been reviewed at CDC for human subjects’ protection?
List the CDC human subject protocol number and date of expiration:

No
No

CDC Protocol Number: _________________
3.

Yes
Yes

Date of Expiration: _______________

Is this activity exempt under one of the 6 exemptions in 45 CFR 46.101(b)?

Yes

No

If yes, provide exemption categories: __________________
4.

Is there more than one site engaged in the research supported under this funding mechanism?
Yes
No
List the funding recipient institution/organization and any additional performance sites. Please include the
Name of the Organization, Federal Wide Assurance (FWA) number and expiration date and the IRB protocol
identifier and expiration date for each site:

__________________________________________________________________________________________
5.

Is a human subjects’ restriction required on the notice of award?
Yes
If yes, identify the reason for the human subjects’ restriction, and the amount of funds to be restricted:

No

__________________________________________________________________________________________
Page 3 of 77

CDC 10.24 (E), Revised March 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, March 2013

Email Form

Print

Save Form

Next Page

Previous Page

Human Subjects Tracking Form for Contracts, Purchase (Requisition) & Task Orders,
Modifications to Contracts, and for New, Renewal, and Noncompeting Continuation Grants and
Cooperative Agreements

Identify each of the research activities involving human participants by title and answer each question.
(3) (Title)
_________________________________________________________________________________________
1.

Have IRB approvals been received for each performance site?
Yes
If no, when is/are approval(s) anticipated to be completed for all sites? _________________________
(Estimated Date – MM/YYYY)

No

2.

Are CDC scientists engaged in this research activity?
If yes, has the project been reviewed at CDC for human subjects’ protection?
List the CDC human subject protocol number and date of expiration:

No
No

CDC Protocol Number: _________________
3.

Yes
Yes

Date of Expiration: _______________

Is this activity exempt under one of the 6 exemptions in 45 CFR 46.101(b)?

Yes

No

If yes, provide exemption categories: __________________
4.

Is there more than one site engaged in the research supported under this funding mechanism?
Yes
No
List the funding recipient institution/organization and any additional performance sites. Please include the
Name of the Organization, Federal Wide Assurance (FWA) number and expiration date and the IRB protocol
identifier and expiration date for each site:

__________________________________________________________________________________________
5.

Is a human subjects’ restriction required on the notice of award?
Yes
If yes, identify the reason for the human subjects’ restriction, and the amount of funds to be restricted:

No

__________________________________________________________________________________________
Page 4 of 77

CDC 10.24 (E), Revised March 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, March 2013

Email Form

Print

Save Form

Next Page

Previous Page

Human Subjects Tracking Form for Contracts, Purchase (Requisition) & Task Orders,
Modifications to Contracts, and for New, Renewal, and Noncompeting Continuation Grants and
Cooperative Agreements

Identify each of the research activities involving human participants by title and answer each question.
(4) (Title)
_________________________________________________________________________________________
1.

Have IRB approvals been received for each performance site?
Yes
If no, when is/are approval(s) anticipated to be completed for all sites? _________________________
(Estimated Date – MM/YYYY)

No

2.

Are CDC scientists engaged in this research activity?
If yes, has the project been reviewed at CDC for human subjects’ protection?
List the CDC human subject protocol number and date of expiration:

No
No

CDC Protocol Number: _________________
3.

Yes
Yes

Date of Expiration: _______________

Is this activity exempt under one of the 6 exemptions in 45 CFR 46.101(b)?

Yes

No

If yes, provide exemption categories: __________________
4.

Is there more than one site engaged in the research supported under this funding mechanism?
Yes
No
List the funding recipient institution/organization and any additional performance sites. Please include the
Name of the Organization, Federal Wide Assurance (FWA) number and expiration date and the IRB protocol
identifier and expiration date for each site:

__________________________________________________________________________________________
5.

Is a human subjects’ restriction required on the notice of award?
Yes
If yes, identify the reason for the human subjects’ restriction, and the amount of funds to be restricted:

No

__________________________________________________________________________________________
Page 5 of 77

CDC 10.24 (E), Revised March 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, March 2013

Email Form

Print

Save Form

Next Page

Previous Page

Human Subjects Tracking Form for Contracts, Purchase (Requisition) & Task Orders,
Modifications to Contracts, and for New, Renewal, and Noncompeting Continuation Grants and
Cooperative Agreements

Identify each of the research activities involving human participants by title and answer each question.
(5) (Title)
_________________________________________________________________________________________
1.

Have IRB approvals been received for each performance site?
Yes
If no, when is/are approval(s) anticipated to be completed for all sites? _________________________
(Estimated Date – MM/YYYY)

No

2.

Are CDC scientists engaged in this research activity?
If yes, has the project been reviewed at CDC for human subjects’ protection?
List the CDC human subject protocol number and date of expiration:

No
No

CDC Protocol Number: _________________
3.

Yes
Yes

Date of Expiration: _______________

Is this activity exempt under one of the 6 exemptions in 45 CFR 46.101(b)?

Yes

No

If yes, provide exemption categories: __________________
4.

Is there more than one site engaged in the research supported under this funding mechanism?
Yes
No
List the funding recipient institution/organization and any additional performance sites. Please include the
Name of the Organization, Federal Wide Assurance (FWA) number and expiration date and the IRB protocol
identifier and expiration date for each site:

__________________________________________________________________________________________
5.

Is a human subjects’ restriction required on the notice of award?
Yes
If yes, identify the reason for the human subjects’ restriction, and the amount of funds to be restricted:

No

__________________________________________________________________________________________
Page 6 of 77

CDC 10.24 (E), Revised March 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, March 2013

Email Form

Print

Save Form

Next Page

Previous Page

Human Subjects Tracking Form for Contracts, Purchase (Requisition) & Task Orders,
Modifications to Contracts, and for New, Renewal, and Noncompeting Continuation Grants and
Cooperative Agreements

Identify each of the research activities involving human participants by title and answer each question.
(6) (Title)
_________________________________________________________________________________________
1.

Have IRB approvals been received for each performance site?
Yes
If no, when is/are approval(s) anticipated to be completed for all sites? _________________________
(Estimated Date – MM/YYYY)

No

2.

Are CDC scientists engaged in this research activity?
If yes, has the project been reviewed at CDC for human subjects’ protection?
List the CDC human subject protocol number and date of expiration:

No
No

CDC Protocol Number: _________________
3.

Yes
Yes

Date of Expiration: _______________

Is this activity exempt under one of the 6 exemptions in 45 CFR 46.101(b)?

Yes

No

If yes, provide exemption categories: __________________
4.

Is there more than one site engaged in the research supported under this funding mechanism?
Yes
No
List the funding recipient institution/organization and any additional performance sites. Please include the
Name of the Organization, Federal Wide Assurance (FWA) number and expiration date and the IRB protocol
identifier and expiration date for each site:

__________________________________________________________________________________________
5.

Is a human subjects’ restriction required on the notice of award?
Yes
If yes, identify the reason for the human subjects’ restriction, and the amount of funds to be restricted:

No

__________________________________________________________________________________________
Page 7 of 77

CDC 10.24 (E), Revised March 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, March 2013

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Print

Save Form