[Federal Register Volume 62, Number 76 (Monday, April 21, 1997)]
[Notices]
[Pages 19323-19324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0129]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by May 
21, 1997.

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,

[[Page 19324]]

Washington, DC 20503, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

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

Survey of FDA Safety Alert/Public Health Advisory

    Section 705(b) of the Federal Food, Drug, and Cosmetic 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: The ``FDA Safety Alert'' and 
the ``FDA 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 1702(a)(4) of the Public Health Services 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 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: April 9, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-10253 Filed 4-18-97; 8:45 am]
BILLING CODE 4160-01-F