Agency Emergency Processing Request Under OMB Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0320]

Agency Emergency Processing Request Under OMB Review

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 emergency processing under the

Paperwork Reduction Act of 1995 (the PRA). The proposed collection of

information concerns 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).

DATES: Submit written comments on the collection of information by June

22, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:

Desk Officer for FDA. 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:

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

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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

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 market a food

product whose label bears a nutrient 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.

Elsewhere in this issue of the Federal Register, FDA is announcing

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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No. of

No. of Responses per Total Annual Hours per Total Annual

Respondents Respondent Responses Response Hours

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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 sections

403(r)(2)(G) and 403(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.

FDA has requested emergency processing of this proposed collection

of information under section 3507(j) of the PRA and 5 CFR 1320.13. The

information is needed immediately to implement FDAMA, and it is

essential to the agency's mission of protecting and promoting the

public health. The use of normal clearance procedures would be likely

to result in the prevention or disruption of this collection of

information.

Dated: June 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-15484 Filed 6-10-98; 8:45 am]

BILLING CODE 4160-01-F