[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Notices]
[Pages 51053-51054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-1169]


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 guidance for industry entitled ``Content and Format 
for Geriatric Labeling.'' FDA established the ``Geriatric use'' 
subsection in the labeling for human prescription drug and biological 
products to provide pertinent information about the appropriate use of 
drugs in the elderly (persons aged 65 and over). This guidance is 
intended to provide industry with information on submitting

[[Page 51054]]

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 the proposed labeling, the content and format for geriatric 
labeling supplements, and the applicability of user fees to geriatric 
labeling supplements.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
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 requests. Submit written comments on the 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Mary E. Ortuzar, Center for Drug 
Evaluation and Research (HFD-006), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6740; or Toni Stifano, 
Center for Biologics Evaluation and Research (HFM-600), 1401 Rockville 
Pike,Rockville, MD 20852, 301-827-6190.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Content and Format for Geriatric Labeling.'' This 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))). A draft guidance by 
the same name was made available for comment by a notice published in 
the Federal Register of January 21, 1999 (64 FR 3302). This guidance 
incorporates minor revisions based on comments the agency received on 
the draft guidance. The final guidance makes clear that the application 
holder is responsible for submitting a supplement to request the 
omission of the ``Geriatric use'' subsection or to request an 
alternative statement and for providing the reasons supporting the 
request.
    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 and the significant use of 
medications by this age group.
    This 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 guidance 
summarizes the requirements of Sec. 201.57(f)(10)(i) through 
(f)(10)(vi) and provides detailed guidance on the submission of this 
information. In addition, the content and format for geriatric labeling 
supplements, as well as the applicability of user fees to geriatric 
labeling supplements, are discussed in detail in the guidance document.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance 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 statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the 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 
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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm.

    Dated: September 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24945 Filed 10-4-01; 8:45 am]
BILLING CODE 4160-01-S