Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Federal Register: December 15, 2010 (Volume 75, Number 240)
Notices
Page 78256-78257
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr15de10-71
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2009-N-0360
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug
Administration Public Health Notification Readership Survey (Formerly
Known as the Safety Alert/Public Health Advisory Readership Survey)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information 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 collection of information by January 14, 2011.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0341.
Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850. 301-796-3793.
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.
Food and Drug Administration Public Health Notification Readership
Survey (Formerly Known as the Safety Alert/Public Health Advisory
Readership Survey)--(OMB Control Number 0910-0341)--Reinstatement
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: (1) The Public Health
Notification (PHN) and (2) the Preliminary Public Health Notification
(PPHN). The PHN is published when CDRH has information or a message to convey to health care practitioners in order for them to make informed clinical decisions about the use of a device or device type when that information may not be readily available to the affected target audience in the health care community. CDRH can make recommendations that will help the health care practitioner mitigate or avoid the risk.
The PPHN is also published when CDRH has information to convey to health care practitioners in order for them to make informed clinical decisions about the use of a device or device type. However, two additional conditions exist that make use of this type of notification preferable: (1) CDRH's understanding of the problem, its cause(s), and the scope of the risk; the Center believes that health care practitioners need the information they can provide, however incomplete, as soon as possible, and (2) the problem is actively being investigated by the Center, private industry, another Agency, or some other reliable entity, so that the Center expects to be able to update the PPHN when definitive new information becomes available.
Notifications are sent to organizations affected by risks discussed in the notification, such as hospitals, nursing homes, hospices, home health care agencies, retail pharmacies, and other health care providers. Through a process for identifying and addressing postmarket safety issues related to regulated products, CDRH determines when to publish notifications.
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 notifications for reducing risks are explained, the timeliness of the information, and whether the reader has taken any action to eliminate or reduce risks as a result of the information in the alert. Subjects will also be asked whether they wish to receive future notifications electronically, as well as how the PHN program might be improved.
The information collected will be used to shape FDA's editorial policy for the PHN and PPHN. Understanding how target audiences view these publications will aid in deciding what changes should be considered in their content and the format and method of dissemination.
In the Federal Register of August 24, 2009 (74 FR 42674), FDA published a 60-day notice requesting comments. No comments were received. However, FDA is republishing this 30-day notice for public comment, due to the amount of time that has passed for submission of this information collection request to OMB.
FDA estimates the burden of this collection of information as follows:
Page 78257
Table 1--Estimated Annual Reporting Burden \1\
Annual
Public Health Service Act section
Number of
frequency per
Total annual
Hours per
Total hours respondents
response
responses
response
1701(a)(4).........................................................
308
3
924
0.17
157
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the PHN 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: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
FR Doc. 2010-31387 Filed 12-14-10; 8:45 am
BILLING CODE 4160-01-P
