[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Notices]               
[Page 17561-17562]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap07-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0118]

 
Draft Guidance for Industry on the Content and Format of the 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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[[Page 17562]]

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Dosage and 
Administration Section of Labeling for Human Prescription Drug and 
Biological Products--Content and Format.'' This draft guidance is one 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 complying with the new requirements in the 
final rule on the content and format of labeling for prescription drug 
and biological products (71 FR 3922, January 24, 2006). This draft 
guidance is intended to help applicants select information for 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DATES:  Submit written or electronic comments on the draft guidance by 
July 9, 2007. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857; or the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448. The draft guidance may also be 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 Submit written comments on the draft guidance 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft 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, 301-796-1077; 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 draft guidance for industry 
entitled ``Dosage and Administration Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format.'' The 
draft 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 draft guidance 
is one of a series guidances FDA is developing, or has developed, to 
assist applicants and reviewers 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 and 3999), 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. The 
new 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.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. 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 requirement 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 the draft 
guidance. 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 draft 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 draft guidance 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/guidelines.htm.
.gov/cber/guidelines.htm.

    Dated: March 30, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6508 Filed 4-6-07; 8:45 am]

BILLING CODE 4160-01-S