Application for Participation in the Medical Device Fellowship Program; Form FDA 3608

Forms and Documents

Document Name	Status
Form FDA 3608 Application for Participation in the Medical Device Fellowship Program; Form FDA 3608 Form and Instruction	Modified
0551_Supporting Statement.doc Supporting Statement A	2016-12-01

IC Document Collections

IC ID	Document Title	Status
6273	Application for Participation in the Medical Device Fellowship Program; Form FDA 3608 Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0551	ICR Reference No: 201612-0910-001
Status: Historical Active	Previous ICR Reference No: 201401-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/23/2017
	Date Received in OIRA: 12/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	03/31/2017
Responses	250	0	250
Time Burden (Hours)	250	0	250
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from individuals who wish to participate in the Medical Device Fellowship Program (MDFP). The program develops a pool of qualified external scientific experts and increases the range and depth of collaborations between FDA's Center for Devices and Radiological Health (CDRH) and the outside scientific community. Applications for the MDFP enable CDRH to determine the applicant's level of education, experience, expertise, citizenship, and the existence of conflicts of interest. Collecting applications for the MDFP allows CDRH to promote and protect the public health by encouraging outside persons to share their expertise.

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Authorizing Statute(s): US Code: 5 USC 1104 Name of Law: null
   US Code: 5 USC 3301 Name of Law: null
   US Code: 5 USC 1302 Name of Law: null
   US Code: 5 USC 3304 Name of Law: null
   US Code: 5 USC 3320 Name of Law: null
   US Code: 5 USC 3361 Name of Law: null
   US Code: 5 USC 3393 Name of Law: null
   US Code: 5 USC 3394 Name of Law: null
  

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:
	81 FR 61221	09/06/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 85579	11/28/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Application for Participation in the Medical Device Fellowship Program; Form FDA 3608	FDA 3608	Medical Device Fellowship Program

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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	250	250	0	0	0	0
Annual Time Burden (Hours)	250	250	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: $14,350

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? 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: 12/08/2016

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