[Federal Register: March 23, 2010 (Volume 75, Number 55)]
[Notices]
[Page 13766-13767]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr10-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0201] (formerly Docket No. 2007D-0118)
Guidance for Industry on the Content and Format of the Dosage and
Administration Section of Labeling for Human Prescription Drug and
Biological Products; 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 ``Dosage and
Administration Section of Labeling for Human Prescription Drug and
Biological Products--Content and Format.'' This guidance is one of a
series of guidance documents intended to assist applicants in drafting
prescription drug labeling in which prescribing information is clear
and accessible and in complying with the requirements in the final rule
on the content and format of labeling for
[[Page 13767]]
prescription drug and biological products. This guidance is intended to
help applicants select information for inclusion in the ``Dosage and
Administration'' section of labeling and to help them organize that
information.
DATES: Submit written or electronic comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. Submit written comments on the guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: Joseph P. Griffin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993-0002, 301-
796-2270; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Dosage and Administration Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format.'' The
guidance provides recommendations on how to select information for
inclusion in the ``Dosage and Administration'' section of labeling and
how to organize information within the section. This guidance is one of
a series of guidances FDA is developing, or has developed, to assist
applicants with the format and content of certain sections of the
labeling for prescription drugs. In the Federal Register of January 24,
2006 (71 FR 3998), FDA issued final guidances on the format and content
of the ``Adverse Reactions'' and ``Clinical Studies'' sections of
labeling and draft guidances on implementing the new labeling
requirements for prescription drugs and the format and content of the
``Warnings and Precautions,'' ``Contraindications,'' and ``Boxed
Warning'' sections of labeling. In the Federal Register of March 3,
2009 (74 FR 9250), FDA issued a draft guidance on the format and
content of the ``Clinical Pharmacology'' section of labeling. The
labeling requirements (71 FR 3922) and these guidances are intended to
make information in prescription drug labeling easier for health care
practitioners to access, read, and use.
On April 9, 2007, FDA issued a draft of this guidance on the dosage
and administration section of labeling to obtain public comment (72 FR
17561). FDA received 10 comments--9 from the pharmaceutical industry
(individual companies, a trade association, and a consultant) and 1
from an academic medical center. The comments offered generally
favorable impressions of the guidance and its goals. The bulk of the
comments focused on clarifications and further illustrations of issues
discussed in individual sections and subsections of the guidance. FDA
made an effort to address as many of the identified concerns as
possible. A recurring general concern in many industry comments was
that the guidance should more clearly differentiate content that is
required when relevant to a given drug from content that is
recommended. FDA has attempted to make the distinction as clear as
possible by using the word ``must'' and citing the relevant section of
the regulation whenever the guidance is discussing required content and
using the word ``should'' when discussing recommended content.
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 the ``Dosage and
Administration'' section of labeling for human prescription drug and
biological products. 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 submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper 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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 201.57 have been approved under
OMB control number 0910-0572.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.
Dated: March 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6322 Filed 3-22-10; 8:45 am]
BILLING CODE 4160-01-S