[Federal Register Volume 64, Number 227 (Friday, November 26, 1999)]
[Notices]
[Pages 66479-66480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30728]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-4933]
Agency Information Collection Activities: Proposed Collection;
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 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 FDA Safety Alert/Public Health Advisory Readership
Survey.
DATES: Submit written comments on the collection of information by
January 25, 2000.
ADDRESSES: 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 document.
FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, 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
[[Page 66480]]
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
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 No.
0910-0341B--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 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 Reporting Burden1
------------------------------------------------------------------------
Annual
No. of Frequency per Total Annual Hours per Total
Respondents Response Responses Response Hours
------------------------------------------------------------------------
308 3 924 1.7 157
------------------------------------------------------------------------
\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: November 19, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-30728 Filed 11-24-99; 8:45 am]
BILLING CODE 4160-01-F
