[Federal Register Volume 64, Number 13 (Thursday, January 21, 1999)]
[Notices]
[Pages 3302-3303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1363]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1169]


Draft Guidance for Industry on Content and Format for Geriatric 
Labeling; 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availability of a draft guidance for industry entitled ``Content and 
Format for Geriatric Labeling.'' FDA established the ``Geriatric use'' 
subsection in the labeling for human prescription drug products in a 
final rule. The Geriatric use subsection includes biological drug 
products in order to provide for the inclusion of information pertinent 
to the appropriate use of drugs in the elderly (persons aged 65 and 
over). This draft guidance is intended to provide industry with 
information on submitting geriatric labeling for human prescription 
drug and biological products, including who should submit revised 
labeling, the implementation schedule, a description of the regulation 
and optional standard language in proposed labeling, the content and 
format for geriatric labeling, and the applicability of user fees to 
geriatric labeling supplements.

DATES: Written comments may be submitted on the draft guidance by March 
22, 1999. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single 
copies of ``Content and Format for Geriatric Labeling'' to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
or to the Office of Communication, Training and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist that office in 
processing your request. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Diana M. Hernandez, Center for Drug Evaluation and Research (HFD-
006), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-6779; or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), 1401 Rockville Pike, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Content and Format for Geriatric 
Labeling.'' This draft guidance has been developed in response to a 
final rule that published in the Federal Register of August 27, 1997 
(62 FR 45313), establishing, in the ``Precautions'' section of 
prescription drug labeling, a subsection on the use of drugs in elderly 
or geriatric patients (aged 65 years or over) (Sec. 201.57(f)(10) (21 
CFR 201.57(f)(10))). The geriatric labeling regulation recognizes the 
special concerns associated with the geriatric use of prescription 
drugs and acknowledges the need to communicate important information so 
that drugs can be used safely and effectively in older patients. The 
medical community has become increasingly aware that prescription drugs 
can produce effects in the elderly that are significantly different 
from those produced in younger patients. Geriatric labeling information 
is of increasing importance because of the growing proportion of the 
population that is over 65 years of age

[[Page 3303]]

and the significant use of medications by this age group.
     This draft guidance discusses which application holders are 
responsible for submitting revised labeling and summarizes the 
implementation schedule for submitting geriatric labeling. The 
geriatric labeling regulation includes six paragraphs 
(Sec. 201.57(f)(10)(i) through (f)(10)(vi)) that outline various 
options for statements in the ``Geriatric use'' subsection, based on 
the type of information available and the interpretation of that 
information. The draft guidance summarizes the requirements of 
Sec. 201.57(f)(10)(i) through (f)(10)(vi), and it provides detailed 
guidance on the submission of this information. In addition, the 
content and format for geriatric labeling, as well as the applicability 
of user fees to geriatric labeling supplements, are discussed in detail 
in the draft guidance document.
     This draft guidance is a level 1 draft guidance document 
consistent with FDA's good guidance practices (62 FR 8961, February 27, 
1997). It represents the agency's current thinking on the content and 
format of geriatric labeling. It does not 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, regulations, or both.
     Interested persons may submit written comments on the draft 
guidance 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. The draft guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 13, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1363 Filed 1-20-99; 8:45 am]
BILLING CODE 4160-01-F