OMB approves this umbrella generic ICR, with the understanding that FDA will submit each individual IC into ROCIS for approval. Justification must be provided for the collection of any personally identifiable information.
Inventory as of this Action
Requested
Previously Approved
01/31/2014
36 Months From Approved
8,848
0
0
2,076
0
0
0
0
0
The Food and Drug Administration (FDA) is requesting approval for collecting information through a variety of research methods for developing and testing communications involving medical devices and radiation-emitting products that are regulated by FDA. This information will be used to assess the need for communications on specific topics and to assist in the development and modification of communication messages. FDA is authorized by Section 1003(d)(2)(D) of the Federal Food Drug and Cosmetic Act (21 U.S.C. Section 393(d)(2)(D))to conduct educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products.
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.
Med Device Generic SS Part B_2010-11-05.doc
Consumer Responses to Medical Device Labeling