HEARING AID DEVICES: PROFESSIONAL AND PATIENT LABELING AND CONDITIONS FOR SALE

ICR 198908-0910-004

OMB: 0910-0171

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0171 198908-0910-004
Historical Active 198507-0910-005
HHS/FDA
HEARING AID DEVICES: PROFESSIONAL AND PATIENT LABELING AND CONDITIONS FOR SALE
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 11/21/1989
Retrieve Notice of Action (NOA) 08/30/1989
  Inventory as of this Action Requested Previously Approved
11/30/1992 11/30/1992
83 0 0
38,075 0 0
0 0 0

THE REGULATIONS REQUIRE THAT DATA USEFUL IN SELECTING, FITTING AND CHECKING THE PERFORMANCE OF A HEARING AID BE PROVIDED IN A USER BROCHURE. DATA IS USED BY THE PHYSICIANS, AUDIOLOGISTS, AND DISPENSER TO EVALUATE THE APPROPRIATENESS OF A HEARING AID FOR THE USER.

None
None


No

1
IC Title Form No. Form Name
HEARING AID DEVICES: PROFESSIONAL AND PATIENT LABELING AND CONDITIONS FOR SALE

  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 83 0 0 83 0 0
Annual Time Burden (Hours) 38,075 0 0 38,075 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.
08/30/1989


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