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Federal Register / Vol. 73, No.

24 / Tuesday, February 5, 2008 / Notices 6729

information from students and health misrouted within the agency mail a 60-day notice requesting public
care professionals who are interested in system. It will assist the agency in comment on the information collection
becoming involved in CDRH activities. promoting and protecting the public provisions. No comments were received.
The process will reduce the time and health by encouraging outside persons FDA estimate of the burden for this
cost of submitting written to share their expertise with CDRH. collection of information is as follows:
documentation to the agency and lessen In the Federal Register of November
the likelihood of applications being 9, 2007 (72 FR 63614), FDA published

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


5 U.S.C. Section/ No. of Annual Frequency Total Annual Hours per Total Hours
FDA Form No. Respondents per Response Responses Response

1104, 1302, 3301, 3304, 3320, 3361,


3393, 3394/
Form No. 3608 250 1 250 1 250
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA based these estimates on the clearance under 44 U.S.C. 3507. An information collection requirements for
number of inquiries that have been agency may not conduct or sponsor, and the tracking of medical devices.
received concerning the program and a person is not required to respond to, DATES: Submit written or electronic
the number of requests for application a collection of information unless it comments on the collection of
forms over the past 3 years. displays a currently valid OMB control information by April 7, 2008.
Dated: January 30, 2008. number. OMB has now approved the ADDRESSES: Submit electronic
Jeffrey Shuren, information collection and has assigned comments on the collection of
Assistant Commissioner for Policy.
OMB control number 0910–0459. The information to http://
approval expires on January 31, 2011. A www.regulations.gov. Submit written
[FR Doc. E8–2068 Filed 2–4–08; 8:45 am]
copy of the supporting statement for this comments on the collection of
BILLING CODE 4160–01–S
information collection is available on information to the Division of Dockets
the Internet at http://www.reginfo.gov/ Management (HFA–305), Food and Drug
DEPARTMENT OF HEALTH AND public/do/PRAMain. Administration, 5630 Fishers Lane, rm.
HUMAN SERVICES Dated: January 30, 2008. 1061, Rockville, MD 20852. All
Jeffrey Shuren, comments should be identified with the
Food and Drug Administration Assistant Commissioner for Policy. docket number found in brackets in the
[Docket No. FDA–2008–N–0048] (formerly [FR Doc. E8–2076 Filed 2–4–08; 8:45 am] heading of this document.
Docket No. 2007N–0182) BILLING CODE 4160–01–S FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Agency Information Collection Information Officer (HFA–250), Food
Activities; Announcement of Office of DEPARTMENT OF HEALTH AND and Drug Administration,5600 Fishers
Management and Budget Approval; HUMAN SERVICES Lane, Rockville, MD 20857, 301 827–
Information Program on Clinical Trials 1472.
for Serious and Life-Threatening Food and Drug Administration
Diseases: Maintaining a Databank SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
AGENCY: Food and Drug Administration, [Docket No. FDA–2008–N–0050] agencies must obtain approval from the
HHS. Office of Management and Budget
Agency Information Collection
ACTION: Notice. (OMB) for each collection of
Activities; Proposed Collection;
Comment Request; Medical Devices; information they conduct or sponsor.
SUMMARY: The Food and Drug
Device Tracking ‘‘Collection of information’’ is defined
Administration (FDA) is announcing in 44 U.S.C. 3502(3) and 5 CFR
that a collection of information entitled 1320.3(c) and includes agency requests
AGENCY: Food and Drug Administration,
‘‘Information Program on Clinical Trials or requirements that members of the
HHS.
for Serious and Life-Threatening public submit reports, keep records, or
Diseases: Maintaining a Databank’’ has ACTION: Notice.
provide information to a third party.
been approved by the Office of SUMMARY: The Food and Drug Section 3506(c)(2)(A) of the PRA (44
Management and Budget (OMB) under Administration (FDA) is announcing an U.S.C. 3506(c)(2)(A)) requires Federal
the Paperwork Reduction Act of 1995. opportunity for public comment on the agencies to provide a 60-day notice in
FOR FURTHER INFORMATION CONTACT: proposed collection of certain the Federal Register concerning each
Jonna Capezzuto, Office of the Chief information by the agency. Under the proposed collection of information
Information Officer (HFA–250), Food Paperwork Reduction Act of 1995 (the including each proposed extension of an
and Drug Administration, 5600 Fishers PRA), Federal agencies are required to existing collection of information,
Lane, Rockville, MD 20857, 301–827– publish notice in the Federal Register before submitting the collection to OMB
4659. concerning each proposed collection of for approval. To comply with this
rmajette on PROD1PC64 with NOTICES

SUPPLEMENTARY INFORMATION: In the information, including each proposed requirement, FDA is publishing notice
Federal Register of October 19, 2007 (72 extension of an existing collection of of the proposed collection of
FR 59295), the agency announced that information, and to allow 60 days for information set forth in this document.
the proposed information collection had public comment in response to the With respect to the following
been submitted to OMB for review and notice. This notice solicits comments on collection of information, FDA invites

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