[Federal Register: March 30, 2001 (Volume 66, Number 62)]
[Proposed Rules]
[Page 17375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr01-22]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 17375]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 201
[Docket No. 00N-1269]
RIN 0910-AA94
Requirements on Content and Format of Labeling for Human
Prescription Drugs and Biologics; Requirements for Prescription Drug
Product Labels; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening to June
22, 2001, the comment period for the proposed rule that appeared in the
Federal Register of December 22, 2000 (65 FR 81082). The proposed rule
would, among other things, require that the labeling of new and
recently approved prescription drug and biological products include a
section containing highlights of prescribing information and a section
containing an index to prescribing information. The agency is extending
the comment period in response to a request by a group representing
pharmaceutical manufacturers. The agency is taking this action to
provide interested persons additional time to submit comments on the
proposed rule.
DATES: Submit written or electronic comments by June 22, 2001.
ADDRESSES: Submit written comments to the Docket Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments on the Internet at
http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Nancy M. Ostrove, Center for Drug
Evaluation and Research (HFD-42), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2828, Ostrove@CDER.FDA.GOV
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 22, 2000 (65 FR 81082), FDA
published proposed regulations that would revise the format of
prescription drug and biologic labeling to make it more accessible,
readable, and user-friendly for health care professionals. Comments on
the proposed rule were to be submitted by March 22, 2001. The proposed
format provisions would require that drug product labeling (also known
as the ``package insert,'' ``direction circular,'' or ``package
circular '') be presented in three sections: (1) A section containing
highlights of prescribing information, (2) an index section, and (3) a
section containing comprehensive prescribing information. The
highlights of the prescribing information section would appear first in
labeling and would include information that practitioners most commonly
refer to and view as most important. Specific headings within this
section would also reference the location of more detailed information
on a topic. The index section would contain a list of the major and
minor subheadings in the comprehensive prescribing information section
to assist practitioners in finding specific information of interest to
them. The comprehensive prescribing information section would include
the detailed information that constitutes current labeling. The
proposed rule would reorder and reorganize this information to increase
the prominence of important information and make it easier to find. The
proposed format changes are based on research FDA conducted with
physicians and on comments received from the public in response to a
Federal Register document issued, and public meeting held, before the
proposed rule.
In addition to revising the format of labeling, the proposed rule
would make minor changes to its content and establish minimum graphical
requirements, including a minimum type size. The proposal would also
amend prescription drug labeling requirements for older drugs to
require that certain types of statements currently appearing in
labeling be removed if they are not sufficiently supported. Finally,
the proposal would eliminate certain unnecessary statements that are
currently required to appear on prescription drug product labels (i.e.,
on the immediate container of a drug product) and move other
information that is currently required to appear on labels to the
labeling (i.e., the package insert).
FDA received a request from the Pharmaceutical Research and
Manufacturers of America to extend the comment period an additional 90
days. The request stated that the proposed rule raises significant
legal, compliance, and implementation issues for the pharmaceutical
industry, and that additional time is necessary to formulate a
response. In response to this request, and to provide all interested
persons additional time to comment on the proposed format changes and
other aspects of the proposed rule, FDA is extending the comment period
to June 22, 2001.
II. Comments
Interested persons may by June 22, 2001, submit written or
electronic comments regarding the proposed rule. Written comments
should be submitted to the Dockets Management Branch (address above).
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 through Friday.
Electronic comments may also be submitted electronically on the
Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet
site, select ``OON-1269 Labeling for Human Prescription Drug/Biologic
Products'' and follow the directions.
Dated: March 23, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7837 Filed 3-29-01; 8:45 am]
BILLING CODE 4160-01-S