Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0909 Supporting Statement 1-10-24.docx	Supporting Statement A	Uploaded 2024-01-10	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
254658	DISCLOSURE: ORA Forms - Funded Grants & Agreements		Modified
254657	RECORDKEEPING: Grants & Agreements Forms		Modified
254624	REPORTING: Standardized Forms	Other-Form	Modified

ICR Details

OMB Control No: 0910-0909	ICR Reference No: 202309-0910-008
Status: Active	Previous ICR Reference No: 202211-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/29/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/22/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2027	36 Months From Approved	11/30/2025
Responses	3,580	0	4,240
Time Burden (Hours)	42,445	0	42,445
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports federally funded public health projects administered by FDA. As part of FDA’s efforts to protect the public health, we work collaboratively with State partners to enhance oversight of FDA-regulated products. Consistent with applicable regulations, we collect information related to an awardee’s progress in completing agreed-upon performance metrics. FDA plans to use tailored forms for program performance metrics including ROI/ROV, identification of best practices, and program effectiveness data collection efforts for its current and newly funded public health projects. We are requesting OMB approval for conclusion of the pilot project and continued use of the forms for programmatic data collection needs.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 40853	07/29/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 73347	10/25/2023
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
DISCLOSURE: ORA Forms - Funded Grants & Agreements
RECORDKEEPING: Grants & Agreements Forms
REPORTING: Standardized Forms

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ICR Summary of Burden

table that charts list 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	3,580	4,240	0	0	-660	0
Annual Time Burden (Hours)	42,445	42,445	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $49,690

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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Common Form ICR:  No

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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: 01/22/2024

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