[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Notices]
[Pages 65273-65274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0488]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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, 
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 continuation of national 
surveys of prescription drug information provided to patients.

DATES: Submit written comments on the collection of information by 
February 9, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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, 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.

Years 1998 and 2000 Continuation of National Surveys of 
Prescription Drug Information Provided to Patients--(OMB Control 
Number 0910-0279--Extension)

    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 Pub. L. 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

[[Page 65274]]

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 in this area, the agency indicated that it will 
periodically conduct surveys to evaluate the availability of adequate 
patient information on a nationwide basis. Surveys of consumers about 
their receipt of Rx drug information were carried out in 1982, 1984, 
1992, 1994, and 1996. This notice is in regard to continuing the survey 
in years 1998 and 2000.
    The survey is conducted by telephone on a national random sample of 
adults age 18 and over 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 was received from the 
doctor, the pharmacist, and other sources. Survey respondents are also 
asked attitudinal questions, and demographic and other background 
characteristics are also 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 assure that 
adequate Rx labeling and information is provided.
    Respondents to this collection of information are adults (18 years 
or older) in the continental United States who have obtained one or 
more new (nonrefill) prescriptions 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 Burden1                                  
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                                                      Annual                                                    
              Year                    No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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1998                               11,044               1          11,044                .03          331       
1999                                    0               0               0               0               0       
2000                               11,044               1          11,044                .03          331       
Annual average                      7,363                           7,363                             221       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


                                  Table 2.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
              Year                    No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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1998                                1,000               1           1,000                .323          20       
1999                                    0               0               0               0               0       
2000                                1,000               1           1,000                .32          320       
Annual average                        667                             667                             213       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    This estimate of 434 total annual burden hours is based on the 1996 
survey administration, in which 11,044 potential respondents were 
contacted to obtain 1,000 interviews.

    Dated: December 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32460 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F