[Federal Register: February 12, 2003 (Volume 68, Number 29)]
[Notices]
[Page 7124-7125]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe03-45]
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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