Application for Participation in Food and Drug Administration Fellowship Programs

Forms and Documents

Document Name	Status
0780_Supporting Statement_2017.doc Supporting Statement A	2017-12-22

IC Document Collections

IC ID	Document Title	Status
229549	Regulatory Science Internship Program - Application Other-Regulatory Science Application	New
229539	Medical Device Fellowship Program - Application Other-CDRH Application	New
213537	Commissioner's Fellowship Program - Application Other-Webpage screen shots	Modified

ICR Details

OMB Control No: 0910-0780	ICR Reference No: 201711-0910-008
Status: Active	Previous ICR Reference No: 201410-0910-005
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/05/2018
	Date Received in OIRA: 12/22/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved	03/31/2018
Responses	1,100	0	600
Time Burden (Hours)	1,298	0	798
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from individuals who wish to participate in fellowship programs at the FDA. The programs develop a pool of qualified external experts and increase the range and depth of collaborations between FDA's Center for Devices and Radiological Health (CDRH), Office of the Commissioner (OC) and the outside community. Applications determine the applicant's level of education, experience, expertise, citizenship, and the existence of conflicts of interest. Collecting applications for fellowship programs allows FDA to promote and protect the public health by encouraging outside persons to share their expertise.

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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:
	82 FR 28075	06/20/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 58211	12/11/2017
Did the Agency receive public comments on this ICR? No

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

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

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ICR Summary 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	1,100	600	0	0	500	0
Annual Time Burden (Hours)	1,298	798	0	0	500	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: The program change resulting in burden increase is due to the consolidation of 0910-0551 and development of a form for Regulatory Science Internship. The estimated annual hourly burden, formerly estimated as 798 hours, has increased by 500 hours to a total estimated annual hourly burden of 1,298 hours.

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Annual Cost to Federal Government: $24,206

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? Uncollected

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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: 12/22/2017

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