Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act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
eCopy Guidance.doc Supplementary Document	2012-12-12
eCopy 83c 0910-0705 12-12-12.doc Justification for No Material/Nonsubstantive Change	2012-12-12

IC Document Collections

IC ID	Document Title	Status
197892	FD&C Act 513(g) Other-513g Guidance Document	Modified

ICR Details

OMB Control No: 0910-0705	ICR Reference No: 201212-0910-007
Status: Historical Active	Previous ICR Reference No: 201105-0910-007
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Title: Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/19/2012
	Date Received in OIRA: 12/13/2012
Terms of Clearance: Previous terms of clearance apply: 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	03/31/2015	03/31/2015
Responses	114	0	114
Time Burden (Hours)	1,368	0	1,368
Cost Burden (Dollars)	0	0	0

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Abstract: Section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the act) (21 U.S.C. 360c, et seq.) provides for the classification of devices intended for human use. Under section 513(a), devices are classified by the regulatory controls needed to provide reasonable assurance of their safety and effectiveness into class I (general controls), class II (special controls), or class III (premarket approval). Section 513(g) provides a means of obtaining information from FDA regarding the classification and regulatory requirements that may be applicable to a particular device; specifically, that within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under the act, the Secretary of Health and Human Services shall provide such person a written statement of the classification (if any) of such device and the requirements of this act applicable to the device.

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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

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	114	0	0	0	0
Annual Time Burden (Hours)	1,368	1,368	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: $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: 12/13/2012

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