Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals, 65408-65409 [2014-26143]
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Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices
Network (FoodNet) Sites According to
Age, Pregnancy, and Ethnicity,’’ Clinical
Infectious Diseases, 54(S5): S401–410,
2012.
4. Goulet, V., C. Hedberg, A. Le Monnier, et
al. ‘‘Increasing Incidence of Listeriosis in
France and other European Countries,’’
Emerging Infectious Diseases, 14(5): 734–
740, 2008.
˜
5. Munoz, P., L. Rojas, E. Bunsow, et al.
‘‘Listeriosis: An Emerging Public Health
Problem Especially Among the Elderly,’’
Journal of Infection, 64: 19–33, 2012.
Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26144 Filed 11–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extralabel Drug
Use in Animals
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
the reporting requirements associated
with extralabel drug use in animals.
DATES: Submit electronic or written
comments on the collection of
information by January 5, 2015.
SUMMARY:
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
ADDRESSES:
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.
Extralabel Drug Use in Animals—21
CFR 530 (OMB Control Number—0910–
0325)—Extension
The Animal Medicinal Drug Use
Clarification Act of 1994 allows a
veterinarian to prescribe the extralabel
use of approved new animal drugs.
Also, it permits FDA, if it finds that
there is a reasonable probability that the
extralabel use of an animal drug may
present a risk to the public health, to
establish a safe level for a residue from
the extralabel use of the drug, and to
require the development of an analytical
method for the detection of residues
above that established safe level.
Although to date we have not
established a safe level for a residue
from the extralabel use of any new
animal drug and, therefore, have not
required the development of analytical
methodology, we believe that there may
be instances when analytical
methodology will be required. We are,
therefore, estimating the reporting
burden based on two methods being
required annually. The requirement to
establish an analytical method may be
fulfilled by any interested person. We
believe that the sponsor of the drug will
be willing to develop the method in
most cases. Alternatively, FDA, the
sponsor, and perhaps a third party may
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs, State, or
Federal Agencies, academia, or
individuals.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
530.22(b) ..............................................................................
rmajette on DSK3VPTVN1PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
2
Average
burden per
response
Total annual
responses
1
2
are no capital costs or operating and maintenance costs associated with this collection of information.
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15:39 Nov 03, 2014
Jkt 235001
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4,160
Total hours
8,320
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices
Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26143 Filed 11–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0403]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Substantiation for
Dietary Supplement Claims Made
Under the Federal Food, Drug, and
Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. 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 invites comments on
the information collection provisions of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) and the guidance
entitled ‘‘Guidance for Industry:
Substantiation for Dietary Supplement
Claims Made Under Section 403(r)(6) of
the Federal Food, Drug, and Cosmetic
Act.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 5, 2015.
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
rmajette on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:39 Nov 03, 2014
Jkt 235001
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
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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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.
Substantiation for Dietary Supplement
Claims Made Under the Federal Food,
Drug, and Cosmetic Act—21 U.S.C.
343(r)(6) (OMB Control Number 0910–
0626)—Extension
Section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 343(r)(6)) requires that a
manufacturer of a dietary supplement
making a nutritional deficiency,
structure/function, or general well-being
claim have substantiation that the claim
is truthful and not misleading. Under
section 403(r)(6)(A) of the FD&C Act,
such a statement is one that ‘‘claims a
benefit related to a classical nutrient
deficiency disease and discloses the
prevalence of such disease in the United
States, describes the role of a nutrient or
dietary ingredient intended to affect the
structure or function in humans,
characterizes the documented
mechanism by which a nutrient or
dietary ingredient acts to maintain such
structure or function, or describes
general well-being from consumption
for a nutrient or dietary ingredient.’’
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
65409
The guidance document, entitled
‘‘Substantiation for Dietary Supplement
Claims Made Under section 403(r)(6) of
the Federal Food, Drug, and Cosmetic
Act,’’ provides our recommendations to
manufacturers about the amount, type,
and quality of evidence they should
have to substantiate a claim under
section 403(r)(6) of the FD&C Act. The
guidance does not discuss the types of
claims that can be made concerning the
effect of a dietary supplement on the
structure or function of the body, nor
does it discuss criteria to determine
when a statement about a dietary
supplement is a disease claim. The
guidance document is intended to assist
manufacturers in their efforts to comply
with section 403(r)(6) of the FD&C Act.
Persons with access to the Internet may
obtain the guidance at https://
www.fda.gov/FoodGuidances.
Dietary supplement manufacturers
collect the necessary substantiating
information for their product as
required by section 403(r)(6) of the
FD&C Act. The guidance provides
information to manufacturers to assist
them in doing so. The recommendations
contained in the guidance are voluntary.
Dietary supplement manufacturers will
only need to collect information to
substantiate their product’s nutritional
deficiency, structure/function, or
general well-being claim if they choose
to place a claim on their product’s label.
The standard discussed in the
guidance for substantiation of a claim
on the labeling of a dietary supplement
is consistent with standards set by the
Federal Trade Commission for dietary
supplements and other health-related
products that the claim be based on
competent and reliable scientific
evidence. This evidence standard is
broad enough that some dietary
supplement manufacturers may only
need to collect peer-reviewed scientific
journal articles to substantiate their
claims; other dietary supplement
manufacturers whose products have
properties that are less well documented
may have to conduct studies to build a
body of evidence to support their
claims. It is unlikely that a dietary
supplement manufacturer will attempt
to make a claim when the cost of
obtaining the evidence to support the
claim outweighs the benefits of having
the claim on the product’s label. It is
likely that manufacturers will seek
substantiation for their claims in the
scientific literature.
The time it takes to assemble the
necessary scientific information to
support their claims depends on the
product and the claimed benefits. If the
product is one of several on the market
making a particular claim for which
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65408-65409]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26143]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0312]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Extralabel Drug Use in Animals
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 the reporting requirements
associated with extralabel drug use in animals.
DATES: Submit electronic or written comments on the collection of
information by January 5, 2015.
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.
Extralabel Drug Use in Animals--21 CFR 530 (OMB Control Number--0910-
0325)--Extension
The Animal Medicinal Drug Use Clarification Act of 1994 allows a
veterinarian to prescribe the extralabel use of approved new animal
drugs. Also, it permits FDA, if it finds that there is a reasonable
probability that the extralabel use of an animal drug may present a
risk to the public health, to establish a safe level for a residue from
the extralabel use of the drug, and to require the development of an
analytical method for the detection of residues above that established
safe level. Although to date we have not established a safe level for a
residue from the extralabel use of any new animal drug and, therefore,
have not required the development of analytical methodology, we believe
that there may be instances when analytical methodology will be
required. We are, therefore, estimating the reporting burden based on
two methods being required annually. The requirement to establish an
analytical method may be fulfilled by any interested person. We believe
that the sponsor of the drug will be willing to develop the method in
most cases. Alternatively, FDA, the sponsor, and perhaps a third party
may cooperatively arrange for method development. The respondents may
be sponsors of new animal drugs, State, or Federal Agencies, academia,
or individuals.
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
----------------------------------------------------------------------------------------------------------------
530.22(b)....................... 2 1 2 4,160 8,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 65409]]
Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26143 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P
