REPORTING AND RECORDKEEPING REQUIREMENTS FOR ELECTRONIC PRODUCTS UNDER PUBLIC LAW 90-602, GENERAL REQUIREMENTS

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
109381	REPORTING AND RECORDKEEPING REQUIREMENTS FOR ELECTRONIC PRODUCTS UNDER PUBLIC LAW 90-602, GENERAL REQUIREMENTS Form	Migrated

ICR Details

OMB Control No: 0910-0025	ICR Reference No: 199304-0910-007
Status: Historical Active	Previous ICR Reference No: 198908-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: REPORTING AND RECORDKEEPING REQUIREMENTS FOR ELECTRONIC PRODUCTS UNDER PUBLIC LAW 90-602, GENERAL REQUIREMENTS
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/30/1993
	Date Received in OIRA: 04/27/1993
Terms of Clearance: This information collection request is approved for one year only, as a reinstatement of the reporting requirements under the current rules. FDA issued a proposed rule on October 25, 1990, to reduce the reportin burden. FDA plans to issue a final rule that will be effective within the next year.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/1994	06/30/1994
Responses	23,692	0	0
Time Burden (Hours)	1,389,414	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: IN ORDER TO PROTECT THE PUBLIC FROM UNNECESSARY EXPOSURE TO RADIATION FROM ELECTRONIC PRODUCTS, FDA MUST COLLECT CERTAIN INFORMATION FROM MANUFACTURERS AND DEALERS/DISTRIBUTORS ABOUT ELECTRONIC PRODUCTS THEY SELL AND INSTALL. NOTE: FDA IS IN THE PROCESS OF AMENDING THE 5 YEAR RETENTION PERIOD FROM SOME DEALERS/DISTRIBUTORS.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
REPORTING AND RECORDKEEPING REQUIREMENTS FOR ELECTRONIC PRODUCTS UNDER PUBLIC LAW 90-602, GENERAL REQUIREMENTS	FDA 766, 2877 & 3147

---

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	23,692	0	0	23,692	0	0
Annual Time Burden (Hours)	1,389,414	0	0	1,389,414	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:

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

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 04/27/1993

---