Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice, 33907 [05-11501]
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Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. 2004N–0401]
[Docket No. 2003D–0386]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on 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
‘‘Guidance for Industry on Formal
Dispute Resolution: Scientific and
Technical Issues Related to
Pharmaceutical Current Good
Manufacturing Practice’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
In the
Federal Register of March 15, 2005 (70
FR 12697), 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 0910–0563. The
approval expires on May 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11501 Filed 6–9–05; 8:45 am]
BILLING CODE 4160–01–S
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Customer/Partner Services Surveys
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Customer/Partner Services Surveys’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn P. Capezzuto, Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of March 4, 2005, (70
FR 10648), 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 0910–0360. The
approval expires on May 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11502 Filed 6–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0210]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Veterinary Feed
Directive
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate jul<14>2003
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SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including renewal of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on reporting and
recordkeeping requirements for
distribution and use of Veterinary Feed
Directive (VFD) drugs and animal feeds
containing VFD drugs.
DATES: Submit written or electronic
comments on the collection of
information by August 9, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane, rm.
4B–41, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed extension of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing notice
of a proposed collection of information
as set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
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10JNN1
Agencies
[Federal Register Volume 70, Number 111 (Friday, June 10, 2005)]
[Notices]
[Page 33907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11501]
[[Page 33907]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0386]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on 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 ``Guidance for Industry on Formal
Dispute Resolution: Scientific and Technical Issues Related to
Pharmaceutical Current Good Manufacturing Practice'' has been approved
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 15, 2005
(70 FR 12697), 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 0910-0563.
The approval expires on May 31, 2008. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.fda.gov/ohrms/dockets.
Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11501 Filed 6-9-05; 8:45 am]
BILLING CODE 4160-01-S