[Federal Register Volume 65, Number 195 (Friday, October 6, 2000)]
[Notices]
[Pages 59849-59851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1534]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Year 2000 Continuation of National Surveys of 
Prescription Drug Information Provided to Patients

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 a national tracking survey, conducted every 
2 years, of prescription drug information received by patients.

DATES: Submit written or electronic comments on the collection of 
information by December 5, 2000.

[[Page 59850]]


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 L. 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; (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.

Year 2000 Continuation of National Surveys of Prescription Drug 
Information Provided to Patients

    FDA implements the provisions of the Federal Food, Drug, and 
Cosmetic Act (the act) designed to ensure the adequate labeling of 
prescription (Rx) drugs. Under section 502(a) of the act (21 U.S.C. 
352(a)), a drug product is misbranded if its labeling is false or 
misleading in any particular, and under section 201(n) of the act (21 
U.S.C. 321(n)), a drug's labeling is misleading if its labeling or 
advertising fails to reveal material facts. FDA also has the authority 
to collect this information under Title VI of Public Law 104-180 
(Related Agencies and Food and Drug Administration) section 601 
(Effective Medication Guides), which directs the development of ``a 
mechanism to assess periodically * * * the frequency with which the 
[oral and written prescription] information is provided to consumers.''
    To ensure that Rx drugs are not misbranded, FDA has historically 
asserted that adequate labeling requires certain information be 
provided to patients. In 1982, when FDA revoked a planned initiative to 
require mandatory patient package inserts for all Rx drugs in favor of 
private sector initiatives, the agency indicated that it will 
periodically conduct surveys to evaluate the availability of adequate 
patient information on a nationwide basis. In addition, FDA has been 
responsible for setting and tracking Healthy People 2000 goals and now 
for Healthy People 2010 goals for the receipt of medication information 
by patients.
    Surveys of consumers about their receipt of Rx drug information 
were carried out in 1982, 1984, 1992, 1994, 1996, and 1998. This notice 
is in regard to conducting the survey in the year 2000.
    The survey is conducted by telephone on a national random sample of 
adults who received a new prescription for themselves or a household 
member within the past 4 weeks. The interview assesses the extent to 
which oral and written information were received from the doctor, the 
pharmacist, and other sources. Survey respondents are also asked 
attitudinal questions, and demographic and other background 
characteristics are obtained. The survey enables FDA to determine the 
frequency with which such information is provided to consumers. Without 
this information, the agency would be unable to assess the degree to 
which adequate patient information and counseling about Rx drugs is 
provided.
    Respondents to this collection of information are adults (18 years 
or older) in the continental United States who have obtained a new 
(nonrefill) prescription at a pharmacy for themselves or a member of 
their household in the last 4 weeks.
    FDA estimates the burden of this collection of information as 
follows:

                             Table 1.--Estimated Annual Reporting Burden:1 Screener
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                                                      Annual
              Year                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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2000                                9,643               1           9,643                .03         289
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                   Table 2.--Annual Reporting Burden:1 Survey
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                                                      Annual
              Year                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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2000                                1,000               1           1,000                .32         320
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 59851]]

    This total estimate of 609 total annual burden hours is based on 
the 1998 survey administration, in which 9,643 potential respondents 
were contacted to obtain 1,000 interviews.

    Dated: October 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-25701 Filed 10-5-00; 8:45 am]
BILLING CODE 4160-01-F