[Federal Register: June 16, 2005 (Volume 70, Number 115)]
[Page 35097-35098]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 

                                 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
 content claims)
403(r)(3)(C)                       2                  1                  2                450                900
 (health claims)

[[Page 35098]]

Guidance for                       3                  1                  3                  1                  3
Total                                                                                                      1,153
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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]