Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive, 57558-57559 [2014-22808]
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57558
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total
burden
hours
Type of respondent
Form name
Public health agency or organization
Fellowship Management System
Host Site.
Fellowship Management System
Application.
Fellowship Management System Directory.
394
1
85/60
558
1,961
1
40/60
1,307
1,382
1
15/60
346
..........................................................
........................
........................
........................
2,211
Fellowship applicants ........................
Fellowship alumni* ............................
Total ...........................................
* Some alumni are deceased or cannot be located. Response burden assumes response from an individual responding alumnus, on average,
every three years (which is a likely overestimate of frequency).
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–22752 Filed 9–24–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Veterinary Feed
Directive
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 (VFD) drugs
and animal feeds containing VFD drugs.
DATES: Submit electronic or written
comments on the collection of
information by November 24, 2014.
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:25 Sep 24, 2014
Jkt 232001
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 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)
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2010–N–0155]
AGENCY:
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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 558;
OMB Control Number 0910–0363—
Extension
With the passage of the Animal Drug
Availability Act, 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) was tailored
to the unique circumstances relating to
the distribution of medicated feeds. 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 feeds 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.
On December 12, 2013, FDA
published a proposed rule in the
Federal Register (78 FR 75515) intended
to improve the efficiency of FDA’s VFD
program. The provisions included in the
proposed rule were based on
stakeholder input received in response
to solicitations for public comment,
including an advance notice of
proposed rulemaking on March 29, 2010
(75 FR 15387), and draft text of
proposed amendments to the current
VFD regulations on April 13, 2012 (77
FR 22247).
While FDA intends to finalize the
VFD rulemaking in 2015, the current
E:\FR\FM\25SEN1.SGM
25SEN1
57559
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
information collection request
supporting the program expires on
December 31, 2014. At this time, the
burden for this information collection
remains unchanged.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
558.6(a)(3) through (a)(5) ......................
558.6(d)(1)(i) through (d)(1)(iii) ..............
558.6(d)(1)(iv) ........................................
558.6(d)(2) .............................................
514.1(b)(9) .............................................
15,000
300
20
1,000
1
25
1
1
5
1
375,000
300
20
5000
1
Total ................................................
..............................
..............................
..............................
1 There
Average burden
per response
0.25
0.25
0.25
0.25
(15
(15
(15
(15
Total hours
minutes)
minutes)
minutes)
minutes)
3.00
93,750
75
5
1,250
3
..............................
95,083
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2 —ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
558.6(c)(1) through (c)(4) ......................
558.6(e)(1) through (e)(4) ......................
112,500
5,000
10
75
1,125,000
375,000
0.0167 (1 minute)
0.0167 (1 minute)
18,788
6,263
Total ................................................
..............................
..............................
..............................
..............................
25,051
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of time required for
record preparation and maintenance is
based on Agency communication with
industry and Agency records and
experience.
Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22808 Filed 9–24–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1344]
Policy Clarification for Fluoroscopic
Equipment Requirements; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Policy Clarification for
Fluoroscopic Equipment
Requirements.’’ This draft guidance
describes FDA’s intent to clarify the
application of certain aspects of the
performance standard requirements for
fluoroscopic equipment when
manufacturers comply with certain
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:25 Sep 24, 2014
Jkt 232001
International Electrotechnical
Commission (IEC) standards. This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 24,
2014.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Policy Clarification
for Fluoroscopic Equipment
Requirements’’ to the Office of the
Center Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Donald Miller, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4646, Silver Spring,
MD 20993–0002, 301–796–3299.
SUPPLEMENTARY INFORMATION:
I. Background
The draft guidance document, ‘‘Policy
Clarification for Fluoroscopic
Equipment Requirements’’ was
developed to describe FDA’s intent to
clarify the application of certain aspects
of the performance standard
requirements in 21 CFR 1020.32 for
fluoroscopic equipment when the
manufacturer has complied with certain
IEC standards. FDA believes that a
declaration of conformity with the
applicable IEC standard and the
applicable measure(s) set forth in this
guidance as part of the 510(k)
submission for their device will
sufficiently address the concerns
intended to be addressed by certain
parts of the requirements of § 1020.32,
such that the public health is adequately
protected.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
E:\FR\FM\25SEN1.SGM
25SEN1
]]>Agencies
[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57558-57559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22808]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0155]
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
(VFD) drugs and animal feeds containing VFD drugs.
DATES: Submit electronic or written comments on the collection of
information by November 24, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 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 558; OMB Control Number 0910-0363--
Extension
With the passage of the Animal Drug Availability Act, 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) was tailored to
the unique circumstances relating to the distribution of medicated
feeds. 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 feeds 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.
On December 12, 2013, FDA published a proposed rule in the Federal
Register (78 FR 75515) intended to improve the efficiency of FDA's VFD
program. The provisions included in the proposed rule were based on
stakeholder input received in response to solicitations for public
comment, including an advance notice of proposed rulemaking on March
29, 2010 (75 FR 15387), and draft text of proposed amendments to the
current VFD regulations on April 13, 2012 (77 FR 22247).
While FDA intends to finalize the VFD rulemaking in 2015, the
current
[[Page 57559]]
information collection request supporting the program expires on
December 31, 2014. At this time, the burden for this information
collection remains unchanged.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)............................... 15,000 25 375,000 0.25 (15 minutes) 93,750
558.6(d)(1)(i) through (d)(1)(iii)....................... 300 1 300 0.25 (15 minutes) 75
558.6(d)(1)(iv).......................................... 20 1 20 0.25 (15 minutes) 5
558.6(d)(2).............................................. 1,000 5 5000 0.25 (15 minutes) 1,250
514.1(b)(9).............................................. 1 1 1 3.00 3
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................................ ................. ................. ................. ................. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
21 CFR Section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(1) through (c)(4)............................... 112,500 10 1,125,000 0.0167 (1 minute) 18,788
558.6(e)(1) through (e)(4)............................... 5,000 75 375,000 0.0167 (1 minute) 6,263
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................................ ................. ................. ................. ................. 25,051
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of time required for record preparation and
maintenance is based on Agency communication with industry and Agency
records and experience.
Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22808 Filed 9-24-14; 8:45 am]
BILLING CODE 4164-01-P
