Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act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
513g User Fee SS.doc Supporting Statement A	2011-05-19

IC Document Collections

IC ID	Document Title	Status
197892	FD&C Act 513(g) Instruction	New

ICR Details

OMB Control No: 0910-0705	ICR Reference No: 201105-0910-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/13/2012
	Date Received in OIRA: 05/26/2011
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB approves this ICR for a period of three years. If FDA requests an extension of this approval,FDA should make significant progress in making an electronic submission available. If electronic submission is not available, the agency should submit a timeline for implementation and report on progress.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	36 Months From Approved
Responses	114	0	0
Time Burden (Hours)	1,368	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information necessary for FDA to make a determination about the classification of devices intended for human use. Section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the act) (21 U.S.C. 360c, et seq.) provides that devices classified by the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. Within 60 days of the receipt of a written request for information respecting the class into which a device falls or the requirements applicable, the Secretary of Health and Human Services must provide a written statement of the classification. FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) will use the information submitted in this ICR to provide that information.

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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:
	75 FR 22599	04/29/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 30724	05/26/2011
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
FD&C Act 513(g)

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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	114	0	0	114	0	0
Annual Time Burden (Hours)	1,368	0	0	1,368	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: FDA is now issuing 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 for a new medical device classification. 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 single product. Parties seeking information for multiple products must submit separate 513(g) requests for each product.

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Annual Cost to Federal Government: $176,472

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: 05/26/2011

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