[Docket No. FDA-2008-N-0094], 44749 [E8-17576]
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Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices
Dated: July 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17566 Filed 7–30–08; 8:45 am]
Dated: July 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17576 Filed 7–30–08; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
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–0094]
[Docket No. FDA–2008–N–0047] (formerly
Docket No. 2008N–0005)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Channels of Trade Policy for
Commodities With Residues of
Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Channels of Trade Policy for
Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have
Been Revoked, Suspended, or Modified
by the Environmental Protection Agency
Pursuant to Dietary Risk
Considerations’’ 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 Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
In the
Federal Register of May 16, 2008 (73 FR
28484), 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 0910–0562. The
approval expires on July 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.
jlentini on PROD1PC65 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
15:53 Jul 30, 2008
Jkt 214001
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 September
2, 2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0563. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Formal Dispute Resolution: Scientific
and Technical Issues Related to
Pharmaceutical Current Good
Manufacturing Practice—(OMB Control
Number 0910–0563)—Extension
The guidance is intended to provide
information to manufacturers of
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44749
veterinary and human drugs, including
human biological drug products, on
how to resolve disputes of scientific and
technical issues relating to Current
Good Manufacturing Practice (CGMP).
Disputes related to scientific and
technical issues may arise during FDA
inspections of pharmaceutical
manufacturers to determine compliance
with CGMP requirements, or during
FDA’s assessment of corrective actions
undertaken as a result of such
inspections. The guidance provides
procedures that encourage open and
prompt discussion of disputes and lead
to their resolution. The guidance
describes procedures for raising such
disputes to the Office of Regulatory
Affairs (ORA) and center levels and for
requesting review by the dispute
resolution (DR) Panel (the DR Panel).
When a scientific or technical issue
arises during an FDA inspection, the
manufacturer should initially attempt to
reach agreement on the issue informally
with the investigator. Certain scientific
or technical issues may be too complex
or time-consuming to resolve during the
inspection. If resolution of a scientific or
technical issue is not accomplished
through informal mechanisms prior to
the issuance of Form FDA 483, the
manufacturer can formally request DR
and can use the formal two-tiered DR
process described in the guidance.
Tier-one of the formal DR process
involves scientific or technical issues
raised by a manufacturer to the ORA
and center levels. If a manufacturer
disagrees with the tier-one decision, tier
two of the formal DR process would
then be available for appealing that
decision to the DR Panel.
The written request for formal DR to
the appropriate ORA unit should be
made within 30 days of the completion
of an inspection, and should include all
supporting documentation and
arguments for review, as described
below. The written request for formal
DR to the DR Panel should be made
within 60 days of receipt of the tier-one
decision, and should include all
supporting documentation and
arguments, as described in the following
paragraphs.
All requests for formal DR should be
in writing and include adequate
information to explain the nature of the
dispute and to allow FDA to act quickly
and efficiently. Each request should be
sent to the appropriate address listed in
the guidance and include the following:
• Cover sheet that clearly identifies
the submission as either a request for
tier-one DR or a request for tier-two DR;
• Name and address of manufacturer
inspected (from Form FDA 483);
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 73, Number 148 (Thursday, July 31, 2008)]
[Notices]
[Page 44749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17576]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0094]
Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Channels of Trade Policy for
Commodities With Residues of Pesticide Chemicals, for Which
Tolerances Have Been Revoked, Suspended, or Modified by the
Environmental Protection Agency Pursuant to Dietary Risk
Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Channels of Trade Policy for
Commodities With Residues of Pesticide Chemicals, for Which Tolerances
Have Been Revoked, Suspended, or Modified by the Environmental
Protection Agency Pursuant to Dietary Risk Considerations'' 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 Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 16, 2008 (73
FR 28484), 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 0910-0562.
The approval expires on July 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: July 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17576 Filed 7-30-08; 8:45 am]
BILLING CODE 4160-01-S
