Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive, 33907-33908 [05-11581]
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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
17:22 Jun 09, 2005
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33907
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
E:\FR\FM\10JNN1.SGM
10JNN1
33908
Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Notices
the information will have practical
utility; (2) the accuracy of FDA s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Veterinary Feed Directive (OMB
Control Number 0910–0363)—Extension
With the passage of Animal Drug
Availability Act (ADAA), the Congress
enacted legislation establishing a new
class of restricted feed use drugs, VFD
drugs, which may be distributed
without involving State pharmacy laws.
Although controls on the distribution
and use of VFD drugs are similar to
those for prescription drugs regulated
under section 503(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
353(f)), the implementing VFD
regulation (21 CFR 558.6), is tailored to
the unique circumstances relating to the
distribution of medicated feeds. The
content of the VFD is spelled out in the
regulation. All distributors of medicated
feed containing VFD drugs must notify
FDA of their intent to distribute, and
records must be maintained of the
distribution of all medicated feed
containing VFD drugs. The VFD
regulation ensures the protection of
public health while enabling animal
producers to obtain and use needed
drugs as efficiently and cost-effectively
as possible.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Annual Frequency per
Response
No. of Respondents
558.6(a)(3) through (a)(5)
Total Annual Responses
Hours per Response
Total Hours
15,000
25
375,000
0.25
93,750
500
1
500
0.25
125
20
1
20
0.25
5
558.6(d)(2)
1,000
5
5,000
0.25
1,250
514.1(b)(9)
1
1
1
3.00
3
Total Hours
16,521
558.6(d)(1)(i) through (d)(1)(iii)
558.6(d)(1)(iv)
1 There
95,133
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency per
Recordkeeper
558.6(c)(1) through (c)(4)
112,500
10
1,125,000
.0167
18,788
558.6(e)(1) through (e)(4)
5,000
75
375,000
.0167
6,263
21 CFR Section
Total Annual
Records
Total Hours
1 There
Hours per
Record
Total Hours
25,051
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for
record preparation and maintenance is
based on agency communication with
industry and agency records and
experience.
Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11581 Filed 6–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
AGENCY:
VerDate jul<14>2003
17:22 Jun 09, 2005
Jkt 205001
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: (301)
496–7057; fax: (301) 402–0220. A signed
PO 00000
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Fmt 4703
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Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Identification of H2–Db and HLA–A2
Specific CD8 Epitopes From Human
KDR/VEGFR–2 That Inhibit
Angiogenesis by Vaccination
Drs. Samir Khleif and Yujun Dong
(NCI).
U.S. Provisional Application No. 60/
671,867 filed 15 Apr 2005 (DHHS
Reference No. E–158–2005/0–US–01).
Licensing Contact: John Stansberry;
(301) 435–5236; stansbej@mail.nih.gov.
Vascular Endothelial Growth Factor
Receptor 2 (VEGFR–2/KDR) is a
promising target for cancer therapy due
to its critical role in tumor associated
angiogenesis and vascularization. This
invention describes the amino acid
sequences of seven short peptides based
upon epitopes of human Vascular
Endothelial Growth Factor Receptor-2
E:\FR\FM\10JNN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 111 (Friday, June 10, 2005)]
[Notices]
[Pages 33907-33908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11581]
-----------------------------------------------------------------------
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: Notice.
-----------------------------------------------------------------------
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
[[Page 33908]]
the information will have practical utility; (2) the accuracy of FDA s
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
Veterinary Feed Directive (OMB Control Number 0910-0363)--Extension
With the passage of Animal Drug Availability Act (ADAA), the
Congress enacted legislation establishing a new class of restricted
feed use drugs, VFD drugs, which may be distributed without involving
State pharmacy laws. Although controls on the distribution and use of
VFD drugs are similar to those for prescription drugs regulated under
section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353(f)), the implementing VFD regulation (21 CFR 558.6), is tailored to
the unique circumstances relating to the distribution of medicated
feeds. The content of the VFD is spelled out in the regulation. All
distributors of medicated feed containing VFD drugs must notify FDA of
their intent to distribute, and records must be maintained of the
distribution of all medicated feed containing VFD drugs. The VFD
regulation ensures the protection of public health while enabling
animal producers to obtain and use needed drugs as efficiently and
cost-effectively as possible.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) 15,000 25 375,000 0.25 93,750
through
(a)(5)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i) 500 1 500 0.25 125
through
(d)(1)(iii)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(iv 20 1 20 0.25 5
)
----------------------------------------------------------------------------------------------------------------
558.6(d)(2) 1,000 5 5,000 0.25 1,250
----------------------------------------------------------------------------------------------------------------
514.1(b)(9) 1 1 1 3.00 3
----------------------------------------------------------------------------------------------------------------
Total Hours 16,521 .................... .................... .............. 95,133
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual Hours per
21 CFR Section No. of Recordkeepers Recordkeeper Records Record Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(c)(1) through 112,500 10 1,125,000 .0167 18,788
(c)(4)
----------------------------------------------------------------------------------------------------------------
558.6(e)(1) through 5,000 75 375,000 .0167 6,263
(e)(4)
----------------------------------------------------------------------------------------------------------------
Total Hours .................... .................... .............. .............. 25,051
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimate of the times required for record preparation and
maintenance is based on agency communication with industry and agency
records and experience.
Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11581 Filed 6-9-05; 8:45 am]
BILLING CODE 4160-01-S
