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