Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Document Name	Status
0705--513(g) Request for Info--SS--09-26-14.doc Supporting Statement A	2015-03-09

IC Document Collections

IC ID	Document Title	Status
215616	CBER 513(g) Requests Other-513(g) guidance	New
197892	CDRH 513(g) Requests Other-513g Guidance Document	Modified

ICR Details

OMB Control No: 0910-0705	ICR Reference No: 201501-0910-006
Status: Historical Active	Previous ICR Reference No: 201212-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
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: 05/27/2015
	Date Received in OIRA: 03/12/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	118	0	114
Time Burden (Hours)	1,416	0	1,368
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from individuals who wish to obtain a written statement from FDA regarding the classification and regulatory requirements that may be applicable to a particular device. FDA believes that the majority of respondents will be private, for-profit businesses, however individuals, as well as state, local, and tribal governments may also submit "513(g) requests." The agency has issued a guidance entitled "FDA and Industry Procedures for section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" to assist individuals in preparing the supplemental information necessary to process the requests. FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) will use the information submitted in a 513(g) request to provide information regarding classification information and/or regulator requirements for a product.

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Authorizing Statute(s): US Code: 21 USC 360c Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	79 FR 42517	07/22/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 12500	03/09/2015
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
CBER 513(g) Requests
CDRH 513(g) Requests

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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	118	114	0	4	0	0
Annual Time Burden (Hours)	1,416	1,368	0	48	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The total burden hours have increased by 48 hours. This adjustment is due to a slight increase in the number of respondents.

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Annual Cost to Federal Government: $212,400

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: 03/12/2015

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