[Federal Register: November 17, 2003 (Volume 68, Number 221)]
[Notices]               
[Page 64902-64903]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no03-103]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0502]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Study to Measure the Compliance of Prescribers With 
the Contraindication of the Use of Triptans in Migraine Headache 
Patients With Vascular Disease

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 distribute an 
Internet-based questionnaire to measure the compliance of prescribers 
with the contraindication of the use of triptans in migraine headache 
patients with vascular disease.

DATES: Submit written or electronic comments on the collection of 
information by January 16, 2004.

[[Page 64903]]


ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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 Management 
Programs (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 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.

Study to Measure the Compliance of Prescribers With the 
Contraindication of the Use of Triptans in Migraine Headache Patients 
With Vascular Disease

    Migraine headaches affect about 20 million Americans. Over the last 
decade, a category of drugs referred to as triptans, has been shown to 
be efficacious in treating migraine and has been prescribed to 
millions. However, triptans are routinely contraindicated in patients 
with vascular diseases due to associated rare occurrence of myocardial 
infarction, stroke, and other ischemic events. In view of the wide use 
of this class of drugs and the potential impact on public health, it 
would be of great use to better understand the prescribing practices as 
a result of this contraindication.
    FDA plans to use the Internet to recruit triptan-user migraine 
headache patients to determine whether prescribers follow the labeling 
recommendation to avoid prescribing this class of drugs to patients 
with pre-existing cardiovascular, cerebrovascular, or peripheral 
vascular syndromes or with cardiac risk factors. The study is intended 
to measure the proportion of patients that were prescribed triptans 
although they have pre-existing cardiovascular, cerebrovascular, or 
peripheral vascular syndromes.
    Soliciting patients over the Internet will identify a cohort of 
triptan users. These patients will then be asked to fill out a 
questionnaire about their medical history with a focus on vascular 
diseases. Following that, a sample of patients' medical records will be 
solicited and reviewed to verify the medical history. Prevalence of 
cardiovascular, cerebrovascular, or peripheral vascular ischemic 
diseases among migraine patients using triptans will be estimated. 
Information about patients' demographics, route of administration 
(oral, injection, intranasal), and duration of exposure to triptans 
will also be collected.
    There are no available estimates about the rates of various 
vascular diseases and cardiac risk factors among migraine headache 
patients using triptans. The current study is considered a pilot study 
aimed at providing estimates of such rates to be used as a basis for 
future studies. Although FDA recognizes that the study population 
obtained through Internet-based recruitment may not reflect the 
population of triptan users at large, a signal of substantial 
prescribing to patients with vascular contraindications in this 
selected population may warrant further action on the sponsor's part to 
improve risk management. Improvement of risk management may include 
further study of the problem, a labeling change, educational programs 
performed by the sponsor, or increased restrictions on prescribing.
    FDA estimates that approximately 500 persons will voluntarily 
complete the questionnaire. The estimated time for completing each 
questionnaire is approximately 2 hours, resulting in a total burden of 
1,000 hours per year. 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 Per
              No. of Respondents                        Response            Total Annual Responses       Hours per Response            Total Hours
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500                                                                   1                         500                         2                     1,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information


    Dated: November 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28581 Filed 11-14-03; 8:45 am]

BILLING CODE 4160-01-S