This information collection request is approved as amended and revised by FDA. FDA will revise the survey instrument in accordance with its email memo of 12/17/2007 prior to fielding.
Inventory as of this Action
Requested
Previously Approved
12/31/2010
36 Months From Approved
1,927
0
0
258
0
0
0
0
0
The authority for FDA to collect the information derives from the FDA Commissioners authority, as specified in section 902(d)(2) of the Federal Food, Drug, and Cosmetic Act (the Act, 21 U.S.C. 393(d)(2)).
Also under the above section of the Act, FDA is engaged in a variety of communication activities to inform health care providers about new risks of regulated medical products, including prescription drugs, biologics, and medical devices (for example, pacemakers, implantable cardiac defibrillators, coronary stents, orthopedic implants, infusion pumps). More recently, FDAs communication activities have also included the general public. Communications activities include, but are not limited to, communications through the press (press releases, public health advisories) and in medical journals, letters to health care providers sent out in cooperation with product manufacturers, and notifications and information sheets about recalls, withdrawals, and new product safety information on FDAs Internet site.
Extensive publicity regarding serious side effects from certain commonly used prescription drugs, as well as certain implantable medical devices, has spurred public pressure to make risk information available sooner. In opposition to such public pressures, however, at least some prescribers and medical societies have suggested that early disclosure of potential side effects (emerging risks) may have unintended negative effects on patient care. For FDA to plan informed programmatic communication activities we need better empirical data on the impact on providers and patient care of disseminating emerging risk information.
Research is limited not only concerning the impact of communication from FDA to the public, but also concerning specific barriers to the likelihood of physicians reporting patient adverse events to FDA or to product manufacturers. Such reporting provides the basis for identification of emerging risks associated with regulated products. Therefore, optimizing such reporting is critical to the public health. Yet we have no data evaluating FDAs efforts to improve reporting.
Given differing perspectives on the value and timing of providing risk information to medical experts and the public at large, FDA believes it is critical to assess how well it is communicating with physicians - the health care provider group with primary responsibility for deciding whether to use medical products to address patient problems. This information is critical both to plan programmatic communication activities and to improve the effectiveness of our reporting systems. Therefore, FDA plans to conduct a survey of a nationally representative group of physicians about these issues.
Key information to be collected includes the following: the impact on physicians, their patients, and their practices of the disclosure of still uncertain, emerging risks associated with medical 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.
Physician's Survey Responses.doc
FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication about Medical Products