[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)]
[Notices]
[Pages 25591-25593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0166]


Agency Emergency Processing Under the Office of Management and 
Budget Review; MedWatch--The Food and Drug Administration Safety 
Information and Adverse Event Reporting Program; Proposal to Survey 
MedWatch Partners Organizations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). This notice solicits 
comments on a proposal for the MedWatch program to deploy and conduct a 
web-based customer satisfaction survey of certain health care 
professional trade and specialty organizations that voluntarily have 
chosen to participate in the FDA MedWatch's Partners program. The 
survey will solicit information about the utility of the FDA MedWatch 
safety alerts and monthly safety labeling changes that are posted on 
the MedWatch Web site and disseminated to partner organizations for 
sharing with members of the organizations.

DATES: Fax written comments on the collection of information by May 31, 
2006. FDA is requesting approval of this emergency processing by May 
31, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, Fax: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this

[[Page 25592]]

proposed collection of information under section 3507(j) of the PRA (44 
U.S.C. 3507(j)) and 5 CFR 1320.13. This information is needed 
immediately so that the agency can effectively assess and re-evaluate 
its FDA MedWatch risk communication efforts in drug safety as part of a 
broader center level (the Center for Drug Evaluation and Research 
(CDER)) reorganization action to enhance its risk communication 
activities for CDER-regulated products, and address public expectations 
for timely dissemination of clinically useful safety information to 
both providers and their patients at the point of care.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

MedWatch--The FDA Safety Information and Adverse Event Reporting 
Program; Proposal to Survey MedWatch Partners Organizations

    The MedWatch Partners program is an FDA outreach effort directed at 
health care provider professional organizations. The effort facilitates 
the timely dissemination of clinically important new safety information 
on the drugs, devices, and other human medical care products regulated 
by FDA and prescribed, dispensed, or used by the membership of these 
professional societies. In voluntarily agreeing to work with FDA 
MedWatch, these partner organizations disseminate this important safety 
information to their members and their members' patients so that 
medical products necessary to efforts to improve a patient's health may 
be used more safely and reduce the risk of harm.
    Risk communication is one of the essential elements in the risk 
management paradigm accepted as a framework within CDER since described 
in the ``Report to the FDA Commissioner from the Task Force on Risk 
Management'' in May 1999. As an agency that regulates a broad range of 
clinical medical products--drugs, therapeutic biologics, blood 
products, medical devices, and dietary supplements--FDA's public health 
mission includes the timely dissemination of new safety information 
identified during post-marketing surveillance activities. This 
information includes class 1 recalls, public health advisories, notice 
of counterfeit drug product, and labeling changes such as new black box 
warnings or contraindications to drug product use. In recent years, 
there has been a public commitment to actively disseminating this new 
safety information, both to health care providers and their patients, 
and to leveraging this risk communication activity by developing 
partnerships and alliances with non-governmental organizations. This 
commitment was explicitly identified as an objective in the strategic 
plan for ``Improving Patient Safety'' of former Commissioner of Food 
and Drugs, Mark McClellan. That objective states that FDA will ``take 
appropriate actions to communicate risks and correct problems 
associated with medical products'' and ``will identify new ways to 
inform physicians, pharmacists, nurses, and patients about the safety 
of FDA-regulated products.''
    The MedWatch program is currently located in the Office of Drug 
Safety, CDER. MedWatch disseminates safety information on FDA-regulated 
medical products to both health care professional and consumer/patient 
audiences. MedWatch maintains a comprehensive Web site at http://www.fda.gov/medwatch for this purpose. The FDA MedWatch program has 
about 120 Partner organizations that represent clinical care providers 
(doctors, nurses, pharmacists, etc.). As a ``Partner,'' the 
organization has agreed to support the goals of the MedWatch program: 
Participating in the dissemination of FDA-approved safety information 
and promoting the voluntary reporting to FDA of adverse events. In 
order to communicate quickly with MedWatch Partner organizations, a 
listserve, supported by the National Institutes of Health, is 
maintained, with contacts for each MedWatch Partner group. Partner 
organizations have voluntarily agreed to receive these FDA MedWatch 
safety alerts and monthly safety labeling changes. Each organization 
receives e-mail notification of two types of FDA MedWatch safety 
information at the time it is added to the MedWatch Web site--safety 
alerts for individual products and, once a month, a listing of the 30 
to 60 drugs that have had safety labeling changes for that month.
    The FDA MedWatch program, in order to implement this safety 
information dissemination process effectively, needs to evaluate 
satisfaction of these customer groups so that FDA MedWatch can improve 
the dissemination process and content of this safety information and 
increase its use and application to direct patient care and to the 
public's health.
    The purpose of the survey is to fulfill phase one of Executive 
Order 12862, ``Setting Customer Service Standards,'' which directs 
agencies to continually reform their management practices and 
operations to provide service to the public that matches or exceeds the 
best service available in the private sector. There is no duplication 
of effort. The MedWatch program is the only one planning to perform 
this survey. By actively gathering this survey information from 
MedWatch partner customers, the agency will achieve a better 
understanding customer satisfaction with this program, and be able to 
direct limited resources to produce an improved program that is most 
useful to both health care provider customers and, secondarily, their 
patients.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden \1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                                                           Respondents         per Response          Responses           Response         Total Hours
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Partner Organizations                                                 120                     1                120                 .5                 60
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    This burden estimate of total hours was developed by using: (1) The 
number of known MedWatch partner health care organizations, (2) the 
number of times the survey will be deployed, and (3) the expected time 
to complete the response

[[Page 25593]]

based on internal pilot testing of the survey instrument at the agency.

    Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6461 Filed 4-28-06; 8:45 am]
BILLING CODE 4160-01-S