[Federal Register: June 16, 2005 (Volume 70, Number 115)]
[Notices]
[Page 35097-35098]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn05-49]
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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.
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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\
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Section of the
act/basis of No. of No. of responses Total annual Hours per Total hours
burden respondents per respondent responses response
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403(r)(2)(G) 1 1 1 250 250
(nutrient
content claims)
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403(r)(3)(C) 2 1 2 450 900
(health claims)
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[[Page 35098]]
Guidance for 3 1 3 1 3
notifications
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Total 1,153
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\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