[Federal Register: May 13, 2003 (Volume 68, Number 92)]
[Page 25616-25617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03N-0034]

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.


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:  Fax written comments on the information collection by June 12, 

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be 
electronically mailed to sshapiro@omb.eop.gov or faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, 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 
Number 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 
    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

[[Page 25617]]

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.
    FDA estimates the burden of this collection of information as 

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
                          Annual Frequency per
   No. of Respondents           Response        Total Annual Records   Hours per Response        Total Hours
308                                3                   924                      .17                157
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Based on the history of the safety alert and 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: May 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11773 Filed 5-12-03; 8:45 am]