Application for Participation in Food and Drug Administration Fellowship Programs

Forms and Documents

Document Name	Status
Form Form FDA 5012 FDA Traineeship Program - Application Form and Instruction	New
0780_Supporting Statement_2021.docx Supporting Statement A	2021-01-21

IC Document Collections

IC ID	Document Title	Status
244760	FDA Traineeship Program - Application Form and Instruction	New
229549	Regulatory Science Internship Program - Application Other-Regulatory Science Application	Removed
229539	Medical Device Fellowship Program - Application Other-CDRH Application	Unchanged
213537	Commissioner's Fellowship Program - Application Other-Webpage screen shots	Removed

ICR Details

OMB Control No: 0910-0780	ICR Reference No: 202012-0910-002
Status: Received in OIRA	Previous ICR Reference No: 201711-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Application for Participation in Food and Drug Administration Fellowship Programs
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/21/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2021
Responses	1,250	1,100
Time Burden (Hours)	1,250	1,298
Cost Burden (Dollars)	0	0

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Abstract: The collection of applications for FDA traineeship and fellowship programs will allow FDA to easily and efficiently solicit and review information from students and health care professionals who are interested in becoming involved in FDA-wide activities.

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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:
	83 FR 53065	10/19/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 82488	12/18/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Commissioner's Fellowship Program - Application
Medical Device Fellowship Program - Application
Regulatory Science Internship Program - Application
FDA Traineeship Program - Application	Form FDA 5012	Traineeship Application

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ICR Summary of Burden

	Total Request	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	1,250	1,100	0	-850	1,000	0
Annual Time Burden (Hours)	1,250	1,298	0	-1,048	1,000	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Because FDA is developing a new training program, Trainee Program, our estimated burden for the information collection reflects an adjustment increase of 1,000. FDA has removed the Commissioner Fellowship and Regulatory Science Internship Program from this information collection as the programs have been discontinued.

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Annual Cost to Federal Government: $159,900

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.     Yes

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: 01/21/2021

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