Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive, 32029-32030 [E8-12648]
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Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Notices
person. The hours burden imposed by
the pretest will be approximately 8.5
hours (100 respondents 5 minutes for
each).
The FTC staff estimates that the
survey of 1,000 respondents also will
require no more than 5 minutes per
person or 83.5 hours (1,000 respondents
5 minutes for each).
Thus, the estimated total hours
burden attributable to the telephone
survey research is 242 hours (150 + 8.5
+ 83.5).
The combined total hours burden
attributable to both research projects is
378.5 hours (242 + 136.5).
3. Estimated Cost Burden
The cost per respondent should be
negligible. Participation is voluntary
and will not require any labor
expenditures by respondents nor
capital, start-up, operation,
maintenance, or other similar costs.
William Blumenthal
General Counsel
[FR Doc. E8–12590 Filed 6–4–08: 8:45 am]
[Billing code: 6750–01–S]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Biodefense
Science Board
Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
yshivers on PROD1PC62 with NOTICES
AGENCY:
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services is hereby giving notice that the
National Biodefense Science Board
(NBSB) will be holding a meeting. The
meeting is open to the public.
DATES: The meeting will be held on June
18, 2008, from 8:30 a.m. to 5 p.m.
ADDRESSES: The Sheraton National
Hotel, 900 S. Orme Street, Arlington,
VA 22204. Phone: 703–521–1900.
FOR FURTHER INFORMATION, CONTACT:
CAPT Leigh A. Sawyer, D.V.M., M.P.H.,
Executive Director, National Biodefense
Science Board, Office of the Assistant
Secretary for Preparedness and
Response, U.S. Department of Health
and Human Services, 200 Independence
Ave SW., Room 638G, Washington, DC
20201; 202–205–3815; fax: 202–205–
0613; e-mail address:
leigh.sawyer@hhs.gov.
Pursuant
to section 319M of the Public Health
Service Act (42 U.S.C. 247d–7f) and
section 222 of the Public Health Service
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
14:51 Jun 04, 2008
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Act (42 U.S.C. 217a), the Department of
Health and Human Services established
the National Biodefense Science Board.
The Board shall provide expert advice
and guidance to the Secretary on
scientific, technical, and other matters
of special interest to the Department of
Health and Human Services regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate. The Board may also
provide advice and guidance to the
Secretary on other matters related to
public health emergency preparedness
and response.
Topics to be discussed include
updates from the Pandemic Influenza
Working Group, the Disaster Medicine
Working Group, the Markets and
Sustainability Working Group, and the
U.S. Medical Countermeasure Research
and Development Processes for
Chemical, Biological, Radiological and
Nuclear Agents Working Group.
Additionally, the NBSB will discuss
preparedness and planning issues
related to at-risk populations and
pandemic influenza , consider issues
related to medical response and
preparedness for radiological and
nuclear events, and receive an update
on the activities of the Homeland
Security Presidential Directive #21,
Federal Biosurveillance Working Group.
The NBSB will also receive a briefing on
issues related to the Department of
Health and Human Services
development of MedKits. This agenda is
subject to change as priorities dictate. A
tentative schedule will be made
available on June 6, 2008 at the NBSB
Web site, https://www.hhs.gov/aspr/
omsph/nbsb.
Any member of the public interested
in presenting oral comments at the
meeting may notify the Contact person
listed on this notice by June 11, 2008.
Interested individuals and
representatives of an organization may
submit a letter of intent and a brief
description of the organization
represented. In addition, any interested
person may file written comments with
the committee. All written comments
must be received prior to June 11, 2008
and should be sent by e-mail with
‘‘NBSB Public Comment’’ as the subject
line or by regular mail to the Contact
person listed above. Individuals who
plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person.
PO 00000
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32029
Dated: May 30, 2008.
RADM William C. Vanderwagen,
Assistant Secretary for Preparedness and
Response, U.S. Department of Health and
Human Services.
[FR Doc. 08–1321 Filed 6–2–08; 2:27pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0474] (formerly
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 each proposed
extension 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 drugs and
animal feeds containing Veterinary Feed
Directive drugs.
DATES: Submit written or electronic
comments on the collection of
information by August 4, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05JNN1.SGM
05JNN1
32030
Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Notices
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 collection of information,
including 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 the proposed collection of
information 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
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—21 CFR Part
558 (OMB Control Number 0910–
0363)—Extension
With passage of the Animal Drug
Availability Act, Congress enacted
legislation establishing a new class of
restricted feed use drugs called
Veterinary Feed Directive (VFD drugs).
The VFD class of drugs may be
distributed without involving State
pharmacy laws. Although controls on
the distribution and use of VFD drugs
are similar to controls for prescription
drugs regulated under section 503(f) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 503(f), the implementing
VFD regulation under section 558.6 (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 the
distribution records of all medicated
feeds containing VFD must be
maintained. The VFD regulation ensures
the protection of the public health while
enabling animal producers to obtain and
use needed drugs as efficiently and costeffectively as possible.
FDA estimates the burden of 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
.25
93,750
300
1
300
.25
75
20
1
20
.25
5
558.6(d)(2)
1,000
5
5,000
.25
1,250
514.1(b)(9)
1
1
1
3.00
3
558.6(d)(1)(i)
through (d)(1)(iii)
558.6(d)(1)(iv)
Total
1 There
16,321
95,083
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
Recordkeeping
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
yshivers on PROD1PC62 with NOTICES
1 There
Total Annual
Records
Hours per
Record
Total Hours
117,500
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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
VerDate Aug<31>2005
14:51 Jun 04, 2008
Jkt 214001
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–12648 Filed 6–4–08; 8:45 am]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY:
ACTION:
Frm 00081
Fmt 4703
Food and Drug Administration,
HHS.
BILLING CODE 4160–01–S
PO 00000
Food and Drug Administration
Sfmt 4703
E:\FR\FM\05JNN1.SGM
Notice.
05JNN1
]]>Agencies
[Federal Register Volume 73, Number 109 (Thursday, June 5, 2008)]
[Notices]
[Pages 32029-32030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12648]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-N-0474] (formerly 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 each proposed extension 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
drugs and animal feeds containing Veterinary Feed Directive drugs.
DATES: Submit written or electronic comments on the collection of
information by August 4, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the
[[Page 32030]]
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 collection of information, including 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 the proposed collection of information 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 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--21 CFR Part 558 (OMB Control Number 0910-
0363)--Extension
With passage of the Animal Drug Availability Act, Congress enacted
legislation establishing a new class of restricted feed use drugs
called Veterinary Feed Directive (VFD drugs). The VFD class of drugs
may be distributed without involving State pharmacy laws. Although
controls on the distribution and use of VFD drugs are similar to
controls for prescription drugs regulated under section 503(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 503(f), the
implementing VFD regulation under section 558.6 (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 the distribution
records of all medicated feeds containing VFD must be maintained. The
VFD regulation ensures the protection of the public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost-effectively as possible.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual
21 CFR Section No. of Respondents Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5) 15,000 25 375,000 .25 93,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i) through (d)(1)(iii) 300 1 300 .25 75
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(d)(1)(iv) 20 1 20 .25 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(d)(2) 1,000 5 5,000 .25 1,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.1(b)(9) 1 1 1 3.00 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 16,321 .................... .................... .................... 95,083
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Recordkeeping 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 117,500 .................... .............. .............. 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: May 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12648 Filed 6-4-08; 8:45 am]
BILLING CODE 4160-01-S
