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15420 Federal Register / Vol. 71, No.

59 / Tuesday, March 28, 2006 / Notices

caused or contributed to death or complete the requirements for this Dated: March 20, 2006.
serious injury or has malfunctioned in section. The number of respondents was Jeffrey Shuren,
such a way that should the malfunction estimated by consolidating the total of Assistant Commissioner for Policy.
recur, it would be likely to cause or all new reporting entities together. The [FR Doc. E6–4427 Filed 3–27–06; 8:45 am]
contribute to a death or serious injury. 3.3 hours was estimated by FDA, as this BILLING CODE 4160–01–S
Device importers report deaths and section deals with a respondent creating
serious injuries to the manufacturers new MDR procedures and is a one-time
and FDA. Importers report malfunctions function. The ‘‘total hours’’ for this DEPARTMENT OF HEALTH AND
only to the manufacturers, unless they section equals approximately 726 hours. HUMAN SERVICES
are unknown, then the reports are sent Under § 803.18, 30,000 respondents
to FDA. represent distributors, importers, and Food and Drug Administration
The number of respondents for each other respondents to this information [Docket No. 2005N–0508]
CFR section in table 1 of this document collection. FDA estimates that it should
is based upon the number of take them approximately 1 1/2 hours to Agency Information Collection
respondents entered into FDA’s internal complete the recordkeeping requirement Activities; Submission for Office of
databases. FDA estimates, based on its for this section. Total hours for this Management and Budget Review;
experience and interaction with the section equal 45,000 hours. Comment Request; Survey of Health
medical device community, that all Care Practitioners Regarding Their
reporting CFR sections are expected to Dated: March 20, 2006.
Jeffrey Shuren, Preferences for Public Health
take 1 hour to complete, with the Notifications
exception of § 803.19. Section 803.19 is Assistant Commissioner for Policy.
expected to take approximately 3 hours [FR Doc. E6–4426 Filed 3–27–06; 8:45 am] AGENCY: Food and Drug Administration,
to complete, but is only required for BILLING CODE 4160–01–S HHS.
reporting the summarized data quarterly ACTION: Notice.
to FDA. By summarizing events, the
total time used to report for this section DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
is reduced because the respondents do HUMAN SERVICES Administration (FDA) is announcing
not submit a full report for each event that a proposed collection of
they report in a quarterly summary Food and Drug Administration information has been submitted to the
report. Office of Management and Budget
The agency believes that the majority [Docket No. 2006N–0118] (OMB) for review and clearance under
of manufacturers, user facilities, and the Paperwork Reduction Act of 1995.
importers have already established Agency Information Collection DATES: Fax written comments on the
written procedures to document Activities; Announcement of Office of collection of information by April 27,
complaints and information to meet the Management and Budget Approval; 2006.
medical device reporting (MDR) Guidance for Reagents for Detection of
requirements as part of their internal ADDRESSES: OMB is still experiencing
Specific Novel Influenza A Viruses
quality control system. There are an significant delays in the regular mail,
estimated 30,000 medical device AGENCY: Food and Drug Administration, including first class and express mail,
distributors. Although they do not HHS. and messenger deliveries are not being
submit MDR reports, they must accepted. To ensure that comments on
ACTION: Notice. the information collection are received,
maintain records of complaints, under
§ 803.18(d). OMB recommends that written
SUMMARY: The Food and Drug
The agency has estimated that on comments be faxed to the Office of
Administration (FDA) is announcing
average, 220 user facilities, importers, Information and Regulatory Affairs,
that a collection of information entitled
and manufacturers would annually be OMB, Attn: Fumie Yokota, Desk Officer
‘‘Guidance for Reagents for Detection of
required to establish new procedures, or for FDA, FAX: 202–395–6974.
Specific Novel Influenza A Viruses’’ has
revise existing procedures, in order to been approved by the Office of FOR FURTHER INFORMATION CONTACT:
comply with this provision. Management and Budget (OMB) under Denver Presley, Office of Management
Therefore, FDA estimates the one- the Paperwork Reduction Act of 1995. Programs (HFA–250), Food and Drug
time burden to respondents for Administration, 5600 Fishers Lane,
FOR FURTHER INFORMATION CONTACT: Rockville, MD 20857, 301–827–1472.
establishing or revising procedures to be
2,200 hours (220 respondents x 10 Karen Nelson, Office of Management
hours). For those entities, a one-time Programs (HFA–250), Food and Drug
compliance with 44 U.S.C. 3507, FDA
burden of 10 hours is estimated for Administration, 5600 Fishers Lane,
has submitted the following proposed
establishing written MDR procedures. Rockville, MD 20857, 301–827–1482.
collection of information to OMB for
The remaining manufacturers, user SUPPLEMENTARY INFORMATION: An agency review and clearance.
facilities, and importers, not required to may not conduct or sponsor, and a
revise their written procedures to person is not required to respond to, a Survey of Health Care Practitioners
comply with this provision, are collection of information unless it Regarding Their Preferences for Public
excluded from the burden because the displays a currently valid OMB control Health Notifications (PHNs)
recordkeeping activities needed to number. OMB has now approved the The PHN is one of the tools that the
comply with this provision are information collection and has assigned Center for Devices and Radiological
cprice-sewell on PROD1PC66 with NOTICES

considered ‘‘usual and customary’’ OMB control number 0910–0584. The Health (CDRH) uses to get an important
under 5 CFR 1320.3(b)(2). approval expires on September 30, message to the user community about
The annual burden for recordkeeping 2006. A copy of the supporting risks associated with the use of medical
to respondents follows. Under § 803.17, statement for this information collection devices. This particular tool is meant to
FDA estimates 220 respondents will is available on the Internet at http:// serve a specific purpose not served by
spend approximately 3.3 hours to the other communication tools at our

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