[Federal Register Volume 68, Number 29 (Wednesday, February 12, 2003)]
[Notices]
[Pages 7124-7125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0017]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Impact of Risk Management Programs on the Practice of 
Pharmacy

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on FDA's burden estimates to conduct a 
descriptive survey of pharmacists to evaluate pharmacists' knowledge of 
risk management programs, identify barriers to compliance, and assess 
the impact of these programs on the practice of pharmacy.

DATES: Submit written or electronic comments on the collection of 
information by April 14, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (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;

[[Page 7125]]

(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.
    Risk management programs are reviewed by divisions in the Center 
for Drug Evaluation and Research as part of the new drug application 
(NDA) review process as well as during the postmarketing period. In an 
effort to address safety risks associated with drug therapy, several 
risk management programs have been implemented (e.g., for clozapine, 
thalidomide, and bosentan). Many risk management programs require 
pharmacists to actively intervene and implement actions that deviate 
from their normal work procedures. Currently, the impact of risk 
management programs on the practice of pharmacy in terms of 
pharmacists' compliance, knowledge, burden, and barriers is not known.
    The goal of this descriptive survey is to obtain information that 
will help FDA understand how risk management programs affect the 
practice of pharmacy and gain insight on practical interventions for 
future risk management programs. Findings from the survey will offer 
new insight and knowledge in risk management programs, and will enable 
FDA to make better decisions when reviewing new or existing risk 
management programs. Expected outcomes from the survey include a 
collection of data to evaluate pharmacists' knowledge of risk 
management programs, identify barriers of compliance, and assess the 
impact of these programs on the practice of pharmacy.
    The descriptive survey will be sent to a representative sampling of 
pharmacists in the United States. Approximately 5,000 pharmacists will 
be chosen at random from listings of licensed pharmacists obtained from 
participating U.S. State Boards of Pharmacy. Because the number of 
licensed pharmacists in each State varies and the number of respondents 
from each State cannot be predicted, either a simple random or a 
stratified sample design will be used, depending on whether there is 
sufficient number of participating pharmacists to evaluate regional 
differences. The geographic regions would be classified by location in 
one of the four geographic regions of the United States corresponding 
to those used by the U.S. Bureau of Census (northeast, midwest, south, 
west).
    The survey will be conducted via first-class mail. The survey will 
be mailed with a cover letter to randomly chosen pharmacists along with 
a preaddressed, stamped return envelope. To ensure anonymity and 
confidentiality, no premarkings or numbering systems will be recorded 
on the survey or return envelope.
    From the sample size of approximately 5,000 pharmacists, the 
desirable response rate is approximately 75 to 85 percent. If needed, 
actions will be taken to increase the response rate, such as resending 
the survey approximately 2 weeks after the initial mailing.
    FDA estimates that it will take each pharmacist approximately 20 
minutes to respond to the survey and return it to FDA. The burden of 
this collection of information is estimated as follows:

                                Table 1.--Estimated One-Time Reporting Burden\1\
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                                             Annual Frequency    Total Annual     Hours per
           Number of Respondents               Per Response        Responses      Response        Total Hours
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 5,000                                              1             5,000                 .33       1,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 5, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-3433 Filed 2-11-03; 8:45 am]
BILLING CODE 4160-01-S