Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 11443-11444 [2015-04380]
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Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices
expenditures in greater detail to
anticipate any funding issues and to
meet the requirements of ORR
regulations at CFR 400.211 to collect
these data for use in estimating future
costs of the refugee resettlement
program. ORR must implement the
methodology at CFR 400.211 each year
after receipt of its annual appropriation
to ensure that appropriated funds will
be adequate for reimbursement to States
of the costs for assistance provided to
entering refugees. The estimating
methodology prescribed in the
regulations requires the use of actual
past costs by program component. In the
event that the methodology indicates
that appropriated funds are inadequate,
ORR must take steps to reduce federal
expenses, such as by limiting the
number of months of eligibility for
Refugee Cash Assistance and Refugee
Medical Assistance. This proposed
single-page financial report allows ORR
to collect the necessary data to ensure
that funds are adequate for the projected
need and thereby meet the requirements
of both the Refugee Act and ORR
regulations.
Respondents: State governments,
Wilson/Fish Alternative Projects.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ORR Financial Status Report ..........................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
58
4
0.50
116
Estimated Total Annual Burden
Hours: 116.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–04365 Filed 3–2–15; 8:45 am]
BILLING CODE 4184–01–P
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19:24 Mar 02, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0535]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 2,
2015.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0374. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002 PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
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03MRN1
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Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices
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.
In the Federal Register of November
21, 2014 (79 FR 69494), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received in response to the notice.
FDA estimates 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
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.
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
VerDate Sep<11>2014
19:24 Mar 02, 2015
Jkt 235001
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: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–04380 Filed 3–2–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0161]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practices and Related
Regulations for Blood and Blood
Components; and Requirements for
Donor Testing, Donor Notification, and
‘‘Lookback’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 2,
2015.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0116. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Current Good Manufacturing Practices
and Related Regulations for Blood and
Blood Components; and Requirements
for Donor Testing, Donor Notification,
and ‘‘Lookback’’—(OMB Control
Number 0910–0116)—Extension
All blood and blood components
introduced or delivered for introduction
into interstate commerce are subject to
section 351(a) of the Public Health
Service Act (PHS Act) (42 U.S.C.
262(a)). Section 351(a) requires that
manufacturers of biological products,
which include blood and blood
components intended for further
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]]>Agencies
[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11443-11444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04380]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0535]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
2, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0374.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
[[Page 11444]]
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.
In the Federal Register of November 21, 2014 (79 FR 69494), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received in response to the
notice.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Section of the FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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.
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: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04380 Filed 3-2-15; 8:45 am]
BILLING CODE 4164-01-P
