[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]
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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.
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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