Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 69494-69496 [2014-27517]
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69494
Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices
Substances Prohibited From Use in
Animal Food or Feed—21 CFR Part 589
(OMB Control Number 0910–0627—
Revision)
This regulation prohibits the use of
certain cattle origin materials in the
food or feed of all animals to help
prevent the spread of bovine spongiform
encephalopathy (BSE) in United States’
cattle. BSE is a progressive and fatal
neurological disorder of cattle that
results from an unconventional
transmissible agent. BSE belongs to the
family of diseases known as
transmissible spongiform
encephalopathies (TSEs). All TSEs
affect the central nervous system of
infected animals. These measures will
further strengthen existing safeguards
against BSE.
Description of Recordkeeping for
Respondents: Rendering facilities,
medicated feed manufacturers, livestock
feeders.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section 589.2001; substances
prohibited from use in animal food or
feed
Number of
recordkeepers
Number of
records per
recordkeeper
Average
burden per
recordkeeper
Total annual
records
Total hours
Operating and
maintenance
costs
589.2001(c)(2)(vi) and (c)(3)(i) ................
589.2001(c)(2)(ii) ......................................
589.2001(c)(3)(i)(A) ..................................
175
50
175
1
1
1
175
50
175
20
20
26
3,500
1,000
4,550
$59,500
17,000
80,580
Total ..................................................
........................
........................
........................
........................
9,050
157,080
1 There
are no capital costs associated with this collection of information.
The number of recordkeepers times
the number of records per recordkeeper
equals total annual records. Total
annual records times average burden per
recordkeeper equals total hours.
Description of Respondents for
Reporting: The final regulation on BSE
(73 FR 22720) included a provision that
exempts cattle materials prohibited in
animal feed (CMPAF) from designated
countries from the prohibition on its use
in animal feed. A foreign country
seeking this designation will submit a
written request to FDA that includes a
variety of information about the
country’s BSE status (§ 589.2001(f)).
During the past 6 years, FDA received
2 requests from countries to be
exempted from CMPAF restrictions.
FDA estimates the reporting burden
for this information collection as
follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
One-time (initial) burden ......................................................
Burden from future review ...................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR Section 589.2001(f)
1
1
1
1
1
1
Total hours
80
26
80
26
are no capital costs or operating costs associated with the collection of information.
One-Time (initial) Reporting Burden
There will be a one-time burden to
countries that apply to FDA seeking to
be designated as not subject to
restrictions applicable to CMPAF. We
estimate that each country that applies
for an exclusion will spend 80 hours
putting information together to submit
to FDA. Table 2 row 1 presents the onetime burden for the exclusion. (See final
BSE regulation at 73 FR 22754).
undergoing a review in the future about
one third the time and effort it did when
the information was submitted. Table 2
row 2 presents the expected recurring
burden.
Dated: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–27518 Filed 11–20–14; 8:45 am]
BILLING CODE 4164–01–P
Recurring Burden
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Average
burden per
respondent
Total annual
responses
18:00 Nov 20, 2014
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Food and Drug Administration
[Docket No. FDA–2011–N–0535]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notification of a
Health Claim or Nutrient Content Claim
Based on an Authoritative Statement
of a Scientific Body
AGENCY:
Countries that successfully petition
FDA to be designated as exempt from
certain BSE-related restrictions
applicable to animal feed will be subject
to future review by FDA to ensure that
their designation remains appropriate.
As part of this process, FDA may ask
designated countries from time to time
to confirm that their BSE situation and
the information submitted by them in
support of their original application
remains unchanged. We assume it will
take FDA and the designated country
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 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,
SUMMARY:
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69495
Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment.
This notice invites comments on the
collection of information associated
with the submission of notifications of
health claims or nutrient content claims
based on authoritative statements of
scientific bodies of the U.S.
Government.
Submit either electronic or
written comments on the collection of
information by January 20, 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.
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
SUPPLEMENTARY INFORMATION:
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, 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.
Notification of a Health Claim or
Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body—(OMB Control Number 0910–
0374)—Extension
Section 403(r)(2)(G) and (r)(3)(C) of
the Federal Food, Drug and Cosmetic
Act (the FD&C Act) (21 U.S.C.
343(r)(2)(G) and (r)(3)(C)), as amended
by the FDA Modernization Act of 1997,
provides that any person may market a
food product whose label bears a
nutrient content claim or a health claim
that is based on an authoritative
statement of a scientific body of the U.S.
Government or the National Academy of
Sciences (NAS). Under this section of
the FD&C Act, a person that intends to
use such a claim must submit a
notification of its intention to use the
claim 120 days before it begins
marketing the product bearing the
claim. In the Federal Register of June
11, 1998 (63 FR 32102), we announced
the availability of a guidance entitled
‘‘Guidance for Industry: Notification of
a Health Claim or Nutrient Content
Claim Based on an Authoritative
Statement of a Scientific Body.’’ The
guidance provides the Agency’s
interpretation of terms central to the
submission of a notification and the
Agency’s views on the information that
should be included in the notification.
We believe that the guidance will enable
persons to meet the criteria for
notifications that are established in
section 403(r)(2)(G) and (r)(3)(C) of the
FD&C Act. In addition to the
information specifically required by the
FD&C Act to be in such notifications,
the guidance states that the notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. We intend to
review the notifications we receive to
ensure that they comply with the
criteria established by the FD&C Act.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Section of the FD&C Act
Average
burden per
response
Total annual
responses
Total hours
403(r)(2)(G) (nutrient content claims) ..................................
403(r)(2)(C) (health claims) .................................................
Guidance for Notifications ....................................................
1
1
2
1
1
1
1
1
2
250
450
1
250
450
2
Total ..............................................................................
........................
........................
........................
........................
702
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on our
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
our jurisdiction. To avoid estimating the
number of respondents as zero, we
estimate that there will be one or fewer
respondents annually for nutrient
content claim and health claim
notifications. We estimate that we will
receive one nutrient content claim
notification and one health claim
VerDate Sep<11>2014
18:00 Nov 20, 2014
Jkt 235001
notification per year over the next 3
years.
Section 403(r)(2)(G) and (r)(3)(C) of
the FD&C Act requires that the
notification include the exact words of
the claim, a copy of the authoritative
statement, a concise description of the
basis upon which such person relied for
determining that this is an authoritative
statement as outlined in the FD&C Act,
and a balanced representation of the
scientific literature relating to the
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
relationship between a nutrient and a
disease or health-related condition to
which a health claim refers or to the
nutrient level to which the nutrient
content claim refers. This balanced
representation of the scientific literature
is expected to include a bibliography of
the scientific literature on the topic of
the claim and a brief, balanced account
or analysis of how this literature either
supports or fails to support the
authoritative statement.
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69496
Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices
Since the claims are based on
authoritative statements of a scientific
body of the U.S. Government or NAS,
we believe that the information that is
required by the FD&C Act to be
submitted with a notification will be
readily available to a respondent.
However, the respondent will have to
collect and assemble that information.
Based on communications with firms
that have submitted notifications, we
estimate that one respondent will take
250 hours to collect and assemble the
information required by the statute for
a nutrient content claim notification.
Further, we estimate that one
respondent will take 450 hours to
collect and assemble the information
required by the statute for a health claim
notification.
Under the guidance, notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. The
guidance applies to both nutrient
content claim and health claim
notifications. We have determined that
this information should be readily
available to a respondent and, thus, we
estimate that it will take a respondent 1
hour to incorporate the information into
each notification. We expect there will
be two respondents for a total of 2
hours.
Dated: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–27517 Filed 11–20–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 1999–D–3528 (Formerly
Docket No. 1999D–5046)]
Changes to an Approved Application:
Biological Products: Human Blood and
Blood Components Intended for
Transfusion or for Further
Manufacture; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Changes to an Approved Application:
Biological Products: Human Blood and
Blood Components Intended for
Transfusion or for Further Manufacture;
Guidance for Industry’’ dated December
2014. The guidance document provides
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:00 Nov 20, 2014
Jkt 235001
manufacturers of licensed whole blood
and blood components intended for
transfusion or for further manufacture,
including source plasma, with
recommendations concerning
submission of changes to an approved
biologics license application (BLA). The
guidance document also provides
manufacturers of licensed whole blood
and blood components
recommendations in connection with
the applicability and content of
comparability protocols and labeling
changes. The guidance applies to the
manufacture and distribution of
licensed products. The guidance
announced in this notice finalizes the
draft guidance of the same title dated
June 2013 and supersedes the document
of the same title dated July 2001 (July
2001 guidance).
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
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.
FOR FURTHER INFORMATION CONTACT:
Jonathan McKnight, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Changes to an
Approved Application: Biological
Products: Human Blood and Blood
Components Intended for Transfusion
or for Further Manufacture; Guidance
for Industry’’ dated December 2014. The
guidance document provides
manufacturers of licensed whole blood
and blood components intended for
transfusion or for further manufacture,
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
including source plasma, with
recommendations concerning
submission of changes to an approved
BLA in accordance with the
requirements under Title 21 of the Code
of Federal Regulations 601.12 (21 CFR
601.12). The guidance document also
provides manufacturers of licensed
whole blood and blood components
with recommendations in connection
with the applicability and content of
comparability protocols under
§ 601.12(e) and labeling changes under
§ 601.12(f). Frequently, a manufacturer
of a licensed product determines that it
is appropriate to make a change in its
product, production process, quality
controls, equipment, facilities,
responsible personnel, or labeling as
documented in its approved BLA(s).
Section 601.12 states the requirements
to report such changes for licensed
biological products to FDA.
The recommendations contained in
the guidance document reflect current
FDA and industry experience with
reporting changes to an approved
application, including reporting the
implementation of new technologies.
The recommendations have been
revised for reporting categories for
certain changes to an approved
application that were in the July 2001
guidance based on the experience
gained over the last decade.
In the Federal Register of May 31,
2013 (78 FR 32668), FDA announced the
availability of the draft guidance of the
same title dated June 2013. FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. In response to comments, the
guidance includes the addition of
numerous appendices with tables to
highlight the appropriate reporting
categories related to certain
manufacturing changes. The guidance
announced in this notice finalizes the
draft guidance dated June 2013.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
E:\FR\FM\21NON1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69494-69496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27517]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0535]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Notification of a Health Claim or Nutrient Content
Claim Based on an Authoritative Statement of a Scientific Body
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our 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,
[[Page 69495]]
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment. This notice
invites comments on the collection of information associated with the
submission of notifications of health claims or nutrient content claims
based on authoritative statements of scientific bodies of the U.S.
Government.
DATES: Submit either electronic or written comments on the collection
of information by January 20, 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, 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.
Notification of a Health Claim or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific Body--(OMB Control Number 0910-
0374)--Extension
Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug and
Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as
amended by the FDA Modernization Act of 1997, provides that any person
may market a food product whose label bears a nutrient content claim or
a health claim that is based on an authoritative statement of a
scientific body of the U.S. Government or the National Academy of
Sciences (NAS). Under this section of the FD&C Act, a person that
intends to use such a claim must submit a notification of its intention
to use the claim 120 days before it begins marketing the product
bearing the claim. In the Federal Register of June 11, 1998 (63 FR
32102), we announced the availability of a guidance entitled ``Guidance
for Industry: Notification of a Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of a Scientific Body.'' The
guidance provides the Agency's interpretation of terms central to the
submission of a notification and the Agency's views on the information
that should be included in the notification. We believe that the
guidance will enable persons to meet the criteria for notifications
that are established in section 403(r)(2)(G) and (r)(3)(C) of the FD&C
Act. In addition to the information specifically required by the FD&C
Act to be in such notifications, the guidance states that the
notifications should also contain information on analytical methodology
for the nutrient that is the subject of a claim based on an
authoritative statement. We intend to review the notifications we
receive to ensure that they comply with the criteria established by the
FD&C Act.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Section of the FD&C Act Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
403(r)(2)(G) (nutrient content 1 1 1 250 250
claims)........................
403(r)(2)(C) (health claims).... 1 1 1 450 450
Guidance for Notifications...... 2 1 2 1 2
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 702
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on our experience with health claims,
nutrient content claims, and other similar notification procedures that
fall under our jurisdiction. To avoid estimating the number of
respondents as zero, we estimate that there will be one or fewer
respondents annually for nutrient content claim and health claim
notifications. We estimate that we will receive one nutrient content
claim notification and one health claim notification per year over the
next 3 years.
Section 403(r)(2)(G) and (r)(3)(C) of the FD&C Act requires that
the notification include the exact words of the claim, a copy of the
authoritative statement, a concise description of the basis upon which
such person relied for determining that this is an authoritative
statement as outlined in the FD&C Act, and a balanced representation of
the scientific literature relating to the relationship between a
nutrient and a disease or health-related condition to which a health
claim refers or to the nutrient level to which the nutrient content
claim refers. This balanced representation of the scientific literature
is expected to include a bibliography of the scientific literature on
the topic of the claim and a brief, balanced account or analysis of how
this literature either supports or fails to support the authoritative
statement.
[[Page 69496]]
Since the claims are based on authoritative statements of a
scientific body of the U.S. Government or NAS, we believe that the
information that is required by the FD&C Act to be submitted with a
notification will be readily available to a respondent. However, the
respondent will have to collect and assemble that information. Based on
communications with firms that have submitted notifications, we
estimate that one respondent will take 250 hours to collect and
assemble the information required by the statute for a nutrient content
claim notification. Further, we estimate that one respondent will take
450 hours to collect and assemble the information required by the
statute for a health claim notification.
Under the guidance, notifications should also contain information
on analytical methodology for the nutrient that is the subject of a
claim based on an authoritative statement. The guidance applies to both
nutrient content claim and health claim notifications. We have
determined that this information should be readily available to a
respondent and, thus, we estimate that it will take a respondent 1 hour
to incorporate the information into each notification. We expect there
will be two respondents for a total of 2 hours.
Dated: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27517 Filed 11-20-14; 8:45 am]
BILLING CODE 4164-01-P
