[Federal Register: May 13, 2003 (Volume 68, Number 92)]
[Notices]
[Page 25616-25617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my03-101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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: Fax written comments on the information collection by June 12,
2003.
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
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
[[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
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency per
No. of Respondents Response Total Annual Records Hours per Response Total Hours
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308 3 924 .17 157
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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]
BILLING CODE 4160-01-S