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_Supporting Statement_2018.doc Supporting Statement A	2018-05-21

IC Document Collections

IC ID	Document Title	Status
215616	CBER 513(g) Requests Instruction	Modified
197892	CDRH 513(g) Requests Instruction	Modified

ICR Details

OMB Control No: 0910-0705	ICR Reference No: 201804-0910-001
Status: Active	Previous ICR Reference No: 201501-0910-006
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: 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: 06/25/2018
	Date Received in OIRA: 05/22/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved	06/30/2018
Responses	118	0	118
Time Burden (Hours)	1,416	0	1,416
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects information from manufacturers who wish to obtain information from FDA regarding the classification and regulatory requirements that may be applicable to their individual device. Under section 513 of the Federal Food, Drug, and Cosmetic Act, devices are classified by the regulatory controls needed to provide a reasonable assurance of their safety and effectiveness. FDA classifies these devices into class I (general controls), class II (special controls), or class III (premarket approval). Under section 513(g), within 60 days of receipt of a written request for information respecting the class in which a device has been classified or the requirements applicable to a device under the act, FDA will provide a written statement of classification (if any) of such device and the requirements of this act applicable to the device.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 55381	11/21/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 16865	04/17/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
CBER 513(g) Requests
CDRH 513(g) Requests

---

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	118	0	0	0	0
Annual Time Burden (Hours)	1,416	1,416	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:

---

Annual Cost to Federal Government: $212,400

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.     No

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.     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

---

Common Form ICR:  No

---

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: 05/22/2018

---