[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Notices]
[Pages 67033-67034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0448]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information and to allow 60 days 
for public comment in response to the notice. This notice solicits 
comments on a proposed survey of FDA Safety Alert and Public Health 
Advisory recipients.

DATES: Submit written comments on the collection of information by 
February 18, 1997.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600

[[Page 67034]]

Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 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.

Survey of FDA Safety Alert/Public Health Advisory

    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 recent alerts include 
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) (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 the problem discussed in the alert or advisory is identified, 
how easily the problem is understood, 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:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours 
                                                     Response        Responses       Response                   
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308                                                     3             924                .17          157       
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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 was estimated at 10 
minutes per survey. This was derived by CDRH staff completing the 
survey, in addition to discussions with contacts in trade associations.

    Dated: December 11,1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32189 Filed 12-18-96; 8:45 am]
BILLING CODE 4160-01-F