Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards, 21631 [E8-8680]
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Federal Register / Vol. 73, No. 78 / Tuesday, April 22, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2008–N–0050]
[Docket No. FDA–2006–D–0302] (formerly
Docket No. 2006D–0419)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Voluntary National Retail Food
Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Voluntary National Retail Food
Regulatory Program Standards’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of January 15, 2008 (73
FR 2500), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0621. The
approval expires on March 31, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–8680 Filed 4–21–08; 8:45 am]
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
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 May 22,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0442. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Devices; Device Tracking—
(OMB Control Number 0910–0442)—
Extension
Section 211 of the Food and Drug
Administration Modernization Act
(FDAMA) (Public Law 105–115) became
effective on February 19, 1998. FDAMA
amended the previous medical device
tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360i(e)(1) and (e)(2)) and were
added by the Safe Medical Devices Act
of 1990 (SMDA) (Public Law 101–629).
Unlike the tracking provisions under
PO 00000
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21631
SMDA which required tracking of any
medical device meeting certain criteria,
FDAMA allows FDA discretion in
applying tracking provisions to medical
devices meeting certain criteria, and
provides that tracking requirements for
medical devices can be imposed only
after FDA issues an order. In the Federal
Register of February 8, 2002 (67 FR
5943), FDA issued a final rule which
conformed existing tracking regulations
to changes in tracking provisions
effected by FDAMA under part 821 (21
CFR part 821)).
Section 519(e)(1) of the act, as
amended by FDAMA provides that FDA
may require by order, that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary), use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances, (2) system and content
requirements for tracking, (3)
obligations of persons other than device
manufacturers, e.g., distributors; records
and inspection requirements, (4)
confidentiality, and (5) record retention
requirements.
Respondents for this collection of
information are medical device
manufacturers, importers, and
distributors of tracked implants or
tracked l/s-l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
In the Federal Register of February 5,
2008 (73 FR 6729), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
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[Federal Register Volume 73, Number 78 (Tuesday, April 22, 2008)]
[Notices]
[Page 21631]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8680]
[[Page 21631]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-D-0302] (formerly Docket No. 2006D-0419)
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Voluntary National Retail Food
Regulatory Program Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Voluntary National Retail Food
Regulatory Program Standards'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 15, 2008
(73 FR 2500), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0621.
The approval expires on March 31, 2011. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8680 Filed 4-21-08; 8:45 am]
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