[Federal Register Volume 63, Number 93 (Thursday, May 14, 1998)]
[Rules and Regulations]
[Pages 26717-26719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12832]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N-0274]


Food Labeling; Petitions for Nutrient Content and Health Claims, 
General Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to define the conditions under which certain petitions for 
nutrient content and health claims shall be deemed to be denied and to 
codify the statutory timeframe within which the agency will complete 
rulemakings on such petitions. FDA is taking this action in response to 
the Food and Drug Administration Modernization Act of 1997 (FDAMA).

DATES:  This regulation is effective May 14, 1998. Submit written 
comments by June 15, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch

[[Page 26718]]

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Hilario R. Duncan, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-8281.

SUPPLEMENTARY INFORMATION: On November 21, 1997, President Clinton 
signed into law FDAMA (Pub. L. 105-115). Section 302 of FDAMA amended 
section 403(r)(4)(A)(i) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 343(r)(4)(A)(i)) so that certain nutrient content 
claim and health claim petitions are deemed denied if FDA does not act 
by certain deadlines. In particular, under amended section 
403(r)(4)(A)(i) of the act, if FDA fails to make a filing decision on 
either type of petition within 100 days of receipt of the petition by 
the agency, the petition shall be deemed to be denied unless an 
extension is mutually agreed upon by FDA and the petitioner. If the 
petition is deemed to be denied in this manner without filing, the 
petition shall not be made available to the public. In addition, if FDA 
fails to issue a proposed rule within 90 days of filing of either type 
of petition, that petition shall be deemed to be denied unless an 
extension is mutually agreed upon by FDA and the petitioner. 
Accordingly, FDA is amending Secs. 101.69(m) and 101.70(j) (21 CFR 
101.69(m) and 101.70(j)) to include the statutory language, i.e., 
``Secretary'' is replaced with ``FDA'' in the appropriate places in the 
regulations. For consistency, FDA also is making a few editorial 
changes in Sec. 101.69, i.e., replacing ``the Commissioner of Food and 
Drugs'' with ``FDA'' in the appropriate places in the regulation.
    Under amended section 403(r)(4)(A)(i) of the act, FDA also must 
publish a final rule within 540 days of receipt of the petition, or FDA 
is required to provide the relevant House and Senate legislative 
committees with the reasons for failing to do so. Accordingly, FDA is 
amending Secs. 101.69(m) and 101.70(j) to state that rulemakings on 
health and certain nutrient content claim petitions shall be completed 
within 540 days of receipt of those petitions. The agency notes that 
Sec. 101.70(j) provides that a final rule in response to a health claim 
petition will be published by FDA within 270 days of the date of 
publication of the proposal but that, for cause, the agency may extend 
the period for agency action no more than twice with each extension 
being for no more than 90 days. In view of amended section 
403(r)(4)(A)(i) of the act, the agency advises that, to ensure final 
action shall be within 540 days of the date of receipt of the petition, 
the agency may be limited to only one such extension for cause, and 
such extension may be limited to fewer than 90 days.
    Additionally, the agency is taking this opportunity to correct and 
clarify some inconsistent references in Sec. 101.69 to FDA and to the 
Commissioner of Food and Drugs so that all references are to the FDA.
    The agency has determined under 21 CFR 25.30(k) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    FDA has examined the economic implications of this final rule under 
Executive Order 12866. Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select the regulatory approach that 
maximizes net benefits (including potential economic, environmental, 
public health and safety effects; distributive impacts; and equity). 
Executive Order 12866 classifies a rule as significant if it meets any 
one of a number of specified conditions, including having an annual 
effect on the economy of $100 million or adversely affecting in a 
material way a sector of the economy, competition, or jobs, or if it 
raises novel legal or policy issues. The agency finds that this final 
rule is not a significant rule as defined by Executive Order 12866. No 
analysis is required for this rule under the Regulatory Flexibility Act 
(5 U.S.C. 601-612) because, as discussed in this document, FDA is 
issuing it without publishing a general notice of proposed rulemaking.
    Finally, in accordance with the Small Business Regulatory 
Enforcement Fairness Act, the administrator of the Office of 
Information and Regulatory Affairs of the Office of Management and 
Budget has determined that this final rule is not a major rule for the 
purpose of congressional review.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Because the amendments set forth in this document incorporate the 
language of section 302 of FDAMA into Secs. 101.69 and 101.70, FDA 
finds, for good cause, that notice and public procedure are unnecessary 
and, therefore, are not required under 5 U.S.C. 553. Nonetheless, under 
21 CFR 10.40(e), FDA is providing an opportunity for comment on whether 
the regulations set forth in this document should be modified or 
revoked. Interested persons may, on or before June 15, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this final rule. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday though Friday.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371.

    2. Section 101.69 is amended in paragraph (c) by removing ``FDA's 
Center for Food Safety and Applied Nutrition'' and adding in its place 
``the Food and Drug Administration's (FDA) Center for Food Safety and 
Applied Nutrition''; in paragraph (d) by removing ``the Food and Drug 
Administration'' and adding in its place

[[Page 26719]]

``FDA''; and in paragraphs (l), (m)(4), (n)(3) and (n)(4), and (o)(3) 
and (o)(4) by removing ``the Commissioner of Food and Drugs'', wherever 
it appears, and adding in its place ``FDA''; by revising paragraph 
(m)(3); and by adding paragraphs (m)(4)(iii) and (m)(5) to read as 
follows:


Sec. 101.69   Petitions for nutrient content claims.

* * * * *
    (m) * * *
    (3) Within 100 days of the date of receipt of the petition, FDA 
will notify the petitioner by letter that the petition has either been 
filed or denied. If denied, the notification shall state the reasons 
therefor. If filed, the date of the notification letter becomes the 
date of filing for the purposes of section 403(r)(4)(A)(i) of the act. 
If FDA does not act within such 100 days, the petition shall be deemed 
to be denied unless an extension is mutually agreed upon by the FDA and 
the petitioner. A petition that has been denied, or has been deemed to 
be denied without filing, shall not be made available to the public. A 
filed petition shall be available to the public as provided under 
paragraph (g) of this section.
* * * * *
    (4) * * *
    (iii) If FDA does not act within 90 days of the filing date, the 
petition shall be deemed to be denied unless an extension is mutually 
agreed upon by FDA and the petitioner.
    (5) If FDA issues a proposal, the rulemaking shall be completed 
within 540 days of the date of receipt of the petition.
* * * * *
    3. Section 101.70 is amended by revising paragraph (j)(2), by 
adding paragraph (j)(3)(iii), and by revising paragraph (j)(4)(ii) to 
read as follows:


Sec. 101.70   Petitions for health claims.

* * * * *
    (j) * * *
    (2) Within 100 days of the date of receipt of the petition, FDA 
will notify the petitioner by letter that the petition has either been 
filed for comprehensive review or denied. The agency will deny a 
petition without reviewing the information contained in ``B. Summary of 
Scientific Data'' if the information in ``A. Preliminary Requirements'' 
is inadequate in explaining how the substance conforms to the 
requirements of Sec. 101.14(b). If the petition is denied, the 
notification will state the reasons therefor, including justification 
of the rejection of any report from an authoritative scientific body of 
the U.S. Government. If filed, the date of the notification letter 
becomes the date of filing for the purposes of this regulation. If FDA 
does not act within such 100 days, the petition shall be deemed to be 
denied unless an extension is mutually agreed upon by FDA and the 
petitioner. A petition that has been denied, or has been deemed to be 
denied, without filing will not be made available to the public. A 
filed petition will be available to the public to the extent provided 
under paragraph (e) of this section.
    (3) * * *
    (iii) If FDA does not act within 90 days of the filing date, the 
petition shall be deemed to be denied unless an extension is mutually 
agreed upon by FDA and the petitioner.
    (4) * * *
    (ii) For cause, FDA may extend, no more than twice, the period in 
which it will publish a final rule; each such extension will be for no 
more than 90 days. FDA will publish a notice of each extension in the 
Federal Register. The document will state the basis for the extension, 
the length of the extension, and the date by which the final rule will 
be published, which date shall be within 540 days of the date of 
receipt of the petition.

    Dated: May 6, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-12832 Filed 5-13-98; 8:45 am]
BILLING CODE 4160-01-F