[Federal Register Volume 66, Number 62 (Friday, March 30, 2001)]
[Proposed Rules]
[Page 17375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7837]


 ========================================================================
 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.
 
 ========================================================================
 

  Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / 
Proposed Rules  

[[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.

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

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, [email protected]

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