[Federal Register: February 18, 2003 (Volume 68, Number 32)]
[Page 7797-7798]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03N-0034]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; FDA Safety Alert/Public Health Advisory Readership 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for the FDA Safety Alert/Public Health Advisory Readership 

DATES: Submit written or electronic comments on the collection of 
information by April 21, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 

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: 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.
    FDA Safety Alert/Public Health Advisory Readership Survey (OMB 
Control No. 0910-0341)--Extension
    Section 705(b) (21 U.S.C. 375(b)) of the Federal Food, Drug, and 
Cosmetic Act (the act) 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) (42 U.S.C. 300u(a)(4) of the Public Health 
Service Act 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 
    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 Reporting Burden\1\
                       Annual Frequency per       Total Annual
 No. of Respondents          Response           [chyph]Responses      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 

[[Page 7798]]

    Dated: February 10, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-3816 Filed 2-14-03; 8:45 am]