[Federal Register Volume 63, Number 55 (Monday, March 23, 1998)]
[Notices]
[Pages 13865-13866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
April 22, 1998.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC, 20503, Attn: Desk 
Officer for FDA.

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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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

    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 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.
    In the Federal Register of December 11, 1997 (62 FR 65273), the 
agency invited comments on the collections of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                             Table 1.--Estimated Annual Reporting Burden: Screener1                             
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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.                                                                                                  


[[Page 13866]]


                                   Table 2.--Annual Reporting Burden: Survey1                                   
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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                .32          320       
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: March 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7475 Filed 3-20-98; 8:45 am]
BILLING CODE 4160-01-F