Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 35097-35098 [05-11860]
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35097
Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices
due 90 days after the close of the project
period.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VII. Agency Contacts
Food and Drug Administration
Program Office Contact: Pam Johnson,
330 C St., SW., Washington, DC 20447,
Phone: 202–205–8086, E-mail:
pjohnson@acf.hhs.gov.
Grants Management Office Contact:
Peter Thompson, Grants Officer,
Administration for Children and
Families, Children’s Bureau, 330 C
Street, SW., Room 2070, Washington,
DC 20447, Phone: 202–401–4608, Email: pathompson@acf.hhs.gov.
[Docket No. 2005N–0124]
VIII. Other Information
ACTION:
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: www.Grants.gov.
Applicants will also be able to find the
complete text of all ACF grant
announcements on the ACF Web site
located at: https://www.acf.hhs.gov/
grants/.
Additional information about this
program and its purpose can be located
on the following Web sites: https://
www.acf.hhs.gov/programs/cb/.
For general questions regarding this
announcement please contact: ACYF
Operations Center, The Dixon Group
ATTN: Children’s Bureau, 118 Q Street,
NE., Washington DC 20002–2132,
Telephone: 866–796–1591.
Applicants will not be sent
acknowledgements of received
applications.
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 July 18,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Dated: June 8, 2005.
Susan Orr,
Acting Commissioner, Administration on
Children, Youth and Families.
[FR Doc. 05–11920 Filed 6–15–05; 8:45 am]
BILLING CODE 4184–01–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
Notice.
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
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.
In the Federal Register of April 8,
2005 (70 FR 18031), FDA published a
60-day notice requesting public
comment on the information collection
provisions. One comment was received
that was not relevant to the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
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
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35098
Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of
respondents
Section of the act/basis of burden
Guidance for notifications
No. of responses
per respondent
3
Total annual
responses
1
Hours per
response
3
1
Total
3
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
the agency’s 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: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11860 Filed 6–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0216]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Total hours
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
information collection requirements for
Humanitarian Use Devices.
VerDate jul<14>2003
15:42 Jun 15, 2005
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Submit written or electronic
comments on the collection of
information by August 15, 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 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
DATES:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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.
Medical Devices: Humanitarian Use
Devices—21 CFR Part 814 (OMB
Control Number 0910–0332)—Extension
This collection implements the
humanitarian use device (HUD)
Provision under section 520(m) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360j(m)) and 21 CFR
part 814, subpart H. Under section
520(m) of the act, FDA is authorized to
exempt an HUD from the effectiveness
requirements of sections 514 and 515 of
the act (21 U.S.C. 360d and 360e)
provided that the device do the
following: (1) Is used to treat or
diagnosis a disease or condition that
affects fewer than 4,000 individuals in
the United States; (2) would not be
available to a person with such a disease
or condition unless the exemption is
granted, and there is no comparable
device, other than another HUD
approved under this exemption,
available to treat or diagnose the disease
or condition; and (3) the device will not
expose patients to an unreasonable or
significant risk of illness or injury, and
the probable benefit to health from
using the device outweighs the risk of
injury or illness from its use, taking into
account the probable risks and benefits
of currently available devices or
alternative forms of treatment.
The information collection will allow
FDA to determine whether to do the
following: (1) Grant HUD designation of
a medical device, (2) exempt a HUD
from the effectiveness requirements in
sections 514 and 515 of the act provided
that the device meets requirements set
forth in section 520(m) of the act, and
(3) grants marketing approval(s) for the
HUD. Failure to collect this information
would prevent FDA from making those
determinations. Also, this information
enables FDA to determine whether the
holder of a HUD is in compliance with
the HUD requirements.
E:\FR\FM\16JNN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 115 (Thursday, June 16, 2005)]
[Notices]
[Pages 35097-35098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0124]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 July
18, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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.
In the Federal Register of April 8, 2005 (70 FR 18031), FDA
published a 60-day notice requesting public comment on the information
collection provisions. One comment was received that was not relevant
to the information collection.
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)
----------------------------------------------------------------------------------------------------------------
[[Page 35098]]
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 the agency's 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: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11860 Filed 6-15-05; 8:45 am]
BILLING CODE 4160-01-S
