Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive, 46818-46819 [2011-19603]
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46818
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices
not reviewed by the Office of
Management and Budget.
Submit either electronic or
written comments on the collection of
information by October 3, 2011.
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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
DATES:
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: June 15, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–19650 Filed 7–29–11; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0554]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Veterinary Feed
Directive
AGENCY:
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.
SUMMARY:
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
SUPPLEMENTARY INFORMATION:
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 the passage of the Animal Drug
Availability Act of 1996 (Pub. L. 104–
250), 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 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
srobinson on DSK4SPTVN1PROD with NOTICES
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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
5,000
1
.25
.25
.25
.25
3.00
93,750
75
5
1,250
3
Total ..............................................................................
........................
........................
........................
........................
95,083
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
18:48 Aug 02, 2011
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03AUN1
46819
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
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
.0167
.0167
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 the times required for
record preparation and maintenance is
based on Agency communication with
industry and Agency records and
experience.
Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–19603 Filed 8–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 0910–0016. The
approval expires on June 13, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Food and Drug Administration
Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[Docket No. FDA–2010–N–0258]
[FR Doc. 2011–19602 Filed 8–2–11; 8:45 am]
BILLING CODE 4160–01–P
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), and Generally Recognized
as Safe Affirmation; Electronic
Submission Using Food and Drug
Administration Form 3503
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), and Generally Recognized as
Safe Affirmation; Electronic Submission
Using Food and Drug Administration
Form 3503’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 30, 2010 (75
FR 52954), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:48 Aug 02, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2011–N–0535]
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
the collection of information associated
with the submission of notifications of
health claims or nutrient content claims
SUMMARY:
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on the collection of
information by October 3, 2011.
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 Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
DATES:
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
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Notification of a Health Claim
or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body
AGENCY:
based on authoritative statements of
scientific bodies of the U.S.
Government.
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46818-46819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19603]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0554]
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 either electronic or written comments on the collection
of information by October 3, 2011.
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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
Juanmanuel.vilela@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 Part 558 (OMB Control Number 0910-
0363)--Extension
With the passage of the Animal Drug Availability Act of 1996 (Pub.
L. 104-250), 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)...... 15,000 25 375,000 .25 93,750
558.6(d)(1)(i) through 300 1 300 .25 75
(d)(1)(iii)....................
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....................... .............. .............. .............. .............. 95,083
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 46819]]
Table 2--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records 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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 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: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19603 Filed 8-2-11; 8:45 am]
BILLING CODE 4160-01-P
