Agency Information Collection Activities: Proposed Collection; Comment Request; Notification of a Health Claim or a Nutrient Content Claim Based on an Authoritative Statement

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,

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 the submission of notifications of health claims

or nutrient content claims based on authoritative statements of

scientific bodies. This action is in response to provisions of the FDA

Modernization Act of 1997 (FDAMA). In the Federal Register of August

6, 1998 (63 FR 42053), FDA published a notice announcing OMB's approval

of this collection of information (OMB control number 0910--0374).

Since this was an emergency approval that expires on November 30, 1998,

FDA is following the normal PRA clearance procedures by issuing this

notice.

DATES: Submit written comments on the collection of information by

October 13, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

5630 Fishers Lane, 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: Margaret R. Schlosburg, Office of

Information Resources Management (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 below.

With respect to the following collection of information, FDA

invites comments on: (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.

Notification of a Health Claim or a Nutrient Content Claim Based on

an Authoritative Statement (OMB Control Number 0910-0347--

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 FDAMA, provides that a food producer may

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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 Federal Government or the National Academy of

Sciences. Under these sections 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.

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 a notification. 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 estimates the burden of this collection of information as

follows:

Table 1.-- Estimated Annual Reporting Burden1

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Annual

No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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Guidance for Notifications 12 5 60 1 60

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

The agency believes that this 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 during the interim period while

the agency is initiating notice-and-comment rulemaking in this matter.

FDA intends to review the notifications it receives to ensure that they

comply with the criteria established for them by the act.

These estimates are based on FDA's experience with health claims

and nutrient content claims and with other similar notification

procedures that fall under its jurisdiction. Because the claims are

based on authoritative statements 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 be either provided as part of the authoritative

statement or readily available to firms wishing to make claims.

The hour burden estimates contained in Table 1 of this document

are for the information collection requests in the guidance only and do

not include statutory requirements specifically mandated by the act.

Dated: August 6, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-21796 Filed 8-12-98; 8:45 am]

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