[Federal Register Volume 69, Number 17 (Tuesday, January 27, 2004)]
[Notices]
[Pages 3921-3922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1586]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0575]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 2004 National Tracking Survey of Prescription Drug 
Information Provided to Patients

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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, 
including each proposed extension of an existing 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 March 29, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
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 L. 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, including 
each proposed extension of an existing 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 listed below.
    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.
2004 National Tracking Survey of Prescription Drug Information Provided 
to Patients
    FDA implements the provisions of the Federal Food, Drug, and 
Cosmetic Act (the act) designed to assure 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 assure 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

[[Page 3922]]

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 2010 goals 
for the receipt of medication information by patients.
    Surveys of consumers about their receipt of Rx drug information 
were carried out in 1992, 1994, 1996, 1998, and 2001. This notice is in 
regard to conducting the survey in 2004.
    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 information was 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 oral 
patient information 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\
----------------------------------------------------------------------------------------------------------------
                                                                     Annual
                                                         No. of    Frequency    Total        Hours per     Total
                        Year                          Respondents     per       Annual       Response      Hours
                                                                    Response  Responses
----------------------------------------------------------------------------------------------------------------
Screener
----------------------------------------------------------------------------------------------------------------
    2004                                              15,319           1      15,319           02          306
----------------------------------------------------------------------------------------------------------------
Survey
----------------------------------------------------------------------------------------------------------------
    2004                                               1,000           1      1,000              .32       320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This total estimate of 626 total annual burden hours is based on 
the 2001 survey administration, in which 15,319 potential respondents 
were contacted to obtain 1,000 interviews.

    Dated: January 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1586 Filed 1-26-04; 8:45 am]
BILLING CODE 4160-01-S