Recordkeeping for Electronic Products, Specific Product Requirements -- 21 CFR 1020, 1030, 1040, and 1050

ICR 199810-0910-001

OMB: 0910-0213

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0213 199810-0910-001
Historical Active 199410-0910-001
HHS/FDA
Recordkeeping for Electronic Products, Specific Product Requirements -- 21 CFR 1020, 1030, 1040, and 1050
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 12/03/1998
Retrieve Notice of Action (NOA) 10/07/1998
  Inventory as of this Action Requested Previously Approved
12/31/2001 12/31/2001
22,981 0 0
39,230 0 0
0 0 0

The Radiation Control for Health and Safety Act (Pub. L. 90-602) became effective on October 18, 1968. When the Safe Medical Devices Act (Pub. L. 101-629) was signed into law on November 28, 1990, these electronic product radiation control provisions were transferred from the Public Health Service Act to the Federal Food, Drug, and Cosmetic Act. The purpose of this subchapter of the Act is to protect the public from unnecessary exposure to radiation from electronic products. Section 532 directs the Secretary of the Department of Health and Human Services to establish and carry out an electronic....

None
None


No

1
IC Title Form No. Form Name
Recordkeeping for Electronic Products, Specific Product Requirements -- 21 CFR 1020, 1030, 1040, and 1050

  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 22,981 0 0 22,981 0 0
Annual Time Burden (Hours) 39,230 0 0 39,230 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/07/1998


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