[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Page 15345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7009]



[[Page 15345]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4933]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; FDA Safety Alert/Public Health Advisory 
Readership Survey

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.

DATES: Submit written comments on the collection of information by 
April 21, 2000.

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

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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

FDA Safety Alert/Public Health Advisory Readership Survey (OMB 
Control No. 0910-0341--Extension)

    Section 705(b) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 375(b)) authorizes FDA to disseminate information 
concerning imminent danger to public health by any regulated product. 
The Center for Devices and Radiological Health (CDRH) communicates 
these risks to user communities through two publications: (1) The FDA 
Safety Alert and (2) the Public Health Advisory. Safety alerts and 
advisories are sent to organizations such as hospitals, nursing homes, 
hospices, home health care agencies, manufacturers, retail pharmacies, 
and other health care providers. Subjects of previous alerts included 
spontaneous combustion risks in large quantities of patient examination 
gloves, hazards associated with the use of electric heating pads, and 
retinal photic injuries from operating microscopes during cataract 
surgery.
    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. FDA seeks to evaluate the clarity, timeliness, and impact 
of safety alerts and public health advisories by surveying a sample of 
recipients. Subjects will receive a questionnaire to be completed and 
returned to FDA. The information to be collected will address how 
clearly actions for reducing risk are explained, the timeliness of the 
information, and whether the reader has taken any action to eliminate 
or reduce risk as a result of information in the alert. Subjects will 
also be asked whether they wish to receive future alerts 
electronically, as well as how the safety alert program might be 
improved.
    The information collected will be used to shape FDA's editorial 
policy for the safety alerts and public health advisories. 
Understanding how target audiences view these publications will aid in 
deciding what changes should be considered in their content, format, 
and method of dissemination.
    In the Federal Register of November 26, 1999 (64 FR 66479), the 
agency requested comments on the proposed 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\1\
------------------------------------------------------------------------
                      Annual
     No. of        Frequency per   Total Annual    Hours per     Total
   Respondents       Response       Responses      Response      Hours
------------------------------------------------------------------------
308               3               924            .17\2\        157
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.
\2\ Due to a clerical error, the reporting burden hours for ''Hours per
  Response'' that appeared in the Federal Register of November 26, 1999
  (64 FR 66480) were incorrect. Table 1 of this document contains the
  correct information.

    Based on the history of the safety alert and the public health 
advisory program, it is estimated that an average of three collections 
will be conducted a year. The total burden of response time is 
estimated at 10 minutes per survey. This was derived by CDRH staff 
completing the survey and through discussions with the contacts in 
trade organizations.

    Dated: March 15, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-7009 Filed 3-21-00; 8:45 am]
BILLING CODE 4160-01-F