[Federal Register Volume 62, Number 239 (Friday, December 12, 1997)]
[Notices]
[Pages 65432-65433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0443]


Iron-Containing Supplements and Drugs: Label Warning Statements 
and Unit-Dose Packaging Requirements; Small Entity Compliance Guide; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a small entity compliance guide entitled ``Iron-
Containing Supplements and Drugs: Label Warning Statements and Unit-
Dose Packaging Requirements; Small Entity Compliance Guide'' 
(compliance guide). This compliance guide is intended to help small 
entities comply with the final rule requiring label warnings and unit-
dose packaging for iron-containing supplements and drug products. This 
action is being taken under the Small Business Regulatory Enforcement 
Fairness Act of 1996 (the SBREFA).

DATES: Written comments on the compliance guide may be submitted at any 
time.

ADDRESSES: An electronic version of the compliance guide entitled 
``Iron-Containing Supplements and Drugs: Label Warning Statements and 
Unit-Dose Packaging Requirements; Small Entity Compliance Guide'' is 
available on the Internet at ``http://vm.cfsan.fda.gov/dms/
secqiron.html''. Printed copies may be obtained from the Iron Labeling 
and Packaging, Industry Activities Staff (HFS-565), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204. Submit written comments on the compliance 
guide to the contact person below.

FOR FURTHER INFORMATION CONTACT: Linda S. Kahl, Center for Food Safety 
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3101.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 15, 1997 
(62 FR 2218), FDA issued a final rule requiring: (1) Label warning 
statements on products taken in solid oral dosage form to supplement 
the dietary intake of iron or to provide iron for therapeutic purposes 
and (2) unit-dose packaging for iron-containing products that contain 
30 milligrams or more of iron per dosage unit. This final rule became 
effective July 15, 1997.

[[Page 65433]]

     FDA is announcing the availability of a compliance guide entitled 
``Iron-Containing Supplements and Drugs: Label Warning Statements and 
Unit-Dose Packaging Requirements; Small Entity Compliance Guide'' under 
the SBREFA (Pub. L. 104-121). This compliance guide is intended to help 
small businesses comply with the requirements of the new rule, and it 
restates in plain language the legal requirements set forth in the 
current regulation for labeling and packaging of iron-containing 
supplements and drug products. Any statement in this compliance guide 
that goes beyond merely restating the applicable legal requirements 
represents the agency's current thinking on this subject. The 
regulation is binding and has the force and effect of law; however, 
this compliance guide does not, itself, create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

    Dated: November 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32552 Filed 12-11-97; 8:45 am]
BILLING CODE 4160-01-F