[Federal Register: January 21, 1999 (Volume 64, Number 13)]
[Notices]
[Page 3302-3303]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja99-70]

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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Draft Guidance for Industry on Content and Format for Geriatric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availability of a draft guidance for industry entitled ``Content and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 This draft guidance is intended to provide industry with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DATES: Written comments may be submitted on the draft guidance by March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ADDRESSES: Copies of this draft guidance are available on the Internet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 Submit written comments on the draft guidance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