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, 18031-18032 [05-7024]
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18031
Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices
and specifies where the notification
should be sent. These notifications are
sent only for an initial export;
subsequent exports of the same product
to the same destination, or in the case
of certain countries identified in section
802(b) of the act (21 U.S.C. 382), would
not result in a notification to FDA.
The recordkeepers for this
information collection are exporters
who export human drugs, biologics,
devices, animal drugs, foods, and
cosmetics that may not be sold in the
United States to maintain records
demonstrating their compliance with
the requirements in section 801(e)(1) of
the act.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
1.101(d) and (e)
1 There
Annual Frequency
per Response
419
Total Annual
Responses
2.8
Hours per
Respondent
1,164
Total Hours
17
19,788
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
1.101(b) and (c)
1 There
324
2.8
Hours per
Recordkeeper
901
scientific bodies of the U.S.
Government.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0124]
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
Food and Drug Administration,
HHS.
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 a 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
based on authoritative statements of
SUMMARY:
VerDate jul<14>2003
19:00 Apr 07, 2005
Jkt 205001
Submit written or electronic
comments on the collection of
information by June 7, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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 requirement 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
DATES:
BILLING CODE 4160–01–S
ACTION:
Total Annual
Records
26
Total Hours
23,426
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7023 Filed 4–7–05; 8:45 am]
AGENCY:
Annual Frequency
per Record
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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.
Guidance for Industry: 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 act) (21 U.S.C. 343(r)(2)(G) and
(r)(3)(C)), as amended by the FDA
Modernization Act of 1997 (FDAMA),
provides that a food producer 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. Under this section of the act,
a food producer that intends to use such
E:\FR\FM\08APN1.SGM
08APN1
18032
Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices
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),
FDA 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. The agency believes that
the guidance will enable food producers
to meet the criteria for notifications that
are established in section 403(r)(2)(G)
and (r)(3)(C) of the act. In addition to the
information specifically required by the
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. FDA intends
to review the notifications the agency
receives to ensure that they comply with
the criteria established by the act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the Act/Basis of Burden
No. of
Respondents
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
403(r)(2)(G) (nutrient content claims)
1
1
1
250
250
403(r)(3)(C) (health claims)
2
1
2
450
900
Guidance for notifications
3
1
3
1
3
Total
1,153
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
our jurisdiction. Because the claims are
based on an authoritative statement of
certain scientific bodies of the Federal
Government or the National Academy of
Sciences or one of its subdivisions, FDA
believes that the information submitted
with a notification will either be
provided as part of the authoritative
statement, or readily available as part of
the scientific literature to firms wishing
to make claims. Presentation of a
supporting bibliography and a brief
balanced account or analysis of this
literature should be fairly
straightforward.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7024 Filed 4–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0120]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Carbohydrate Content Claims
on Food Labels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate jul<14>2003
19:00 Apr 07, 2005
Jkt 205001
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a consumer experimental study of
carbohydrate content claims on food
labels.
Submit written or electronic
comments on the collection of
information by June 7, 2005.
ADDRESSES: Submit electronic
comments to https://www.fda.gov/
dockets/ecomments. 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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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
DATES:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
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
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.
Experimental Study of Carbohydrate
Content Claims on Food Labels
The authority for FDA to collect the
information for this experimental study
derives from the Commissioner of Food
and Drugs’ authority, as specified in
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18031-18032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7024]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0124]
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: 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 a 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 based on authoritative statements of scientific
bodies of the U.S. Government.
DATES: Submit written or electronic comments on the collection of
information by June 7, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 requirement 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.
Guidance for Industry: 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 act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as
amended by the FDA Modernization Act of 1997 (FDAMA), provides that a
food producer 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. Under this section of the act, a food producer
that intends to use such
[[Page 18032]]
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), FDA 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. The agency believes that the guidance
will enable food producers to meet the criteria for notifications that
are established in section 403(r)(2)(G) and (r)(3)(C) of the act. In
addition to the information specifically required by the 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. FDA
intends to review the notifications the agency receives to ensure that
they comply with the criteria established by the act.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section of the
Act/Basis of No. of No. of Responses Total Annual Hours per Total Hours
Burden Respondents per Respondent Responses Response
----------------------------------------------------------------------------------------------------------------
403(r)(2)(G) 1 1 1 250 250
(nutrient
content claims)
----------------------------------------------------------------------------------------------------------------
403(r)(3)(C) 2 1 2 450 900
(health claims)
----------------------------------------------------------------------------------------------------------------
Guidance for 3 1 3 1 3
notifications
----------------------------------------------------------------------------------------------------------------
Total 1,153
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on FDA's experience with health claims,
nutrient content claims, and other similar notification procedures that
fall under our jurisdiction. Because the claims are based on an
authoritative statement of certain scientific bodies of the Federal
Government or the National Academy of Sciences or one of its
subdivisions, FDA believes that the information submitted with a
notification will either be provided as part of the authoritative
statement, or readily available as part of the scientific literature to
firms wishing to make claims. Presentation of a supporting bibliography
and a brief balanced account or analysis of this literature should be
fairly straightforward.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7024 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S
