[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Notices]
[Page 54999-55000]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se06-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0303]
Draft Guidance for Industry on Public Availability of Labeling
Changes in ``Changes Being Effected'' Supplements; 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availability of a draft guidance for industry entitled ``Public
Availability of Labeling Changes in `Changes Being Effected'
Supplements.'' The guidance announces to holders of a new drug
application (NDA), an abbreviated new drug application (ANDA), or a
biologics license application (BLA), who intend to submit a ``Changes
Being Effected'' supplement (CBE supplement) to make a postapproval
labeling change, that FDA will make labeling revisions identified in a
CBE supplement publicly available upon receipt of the supplement by
FDA. The guidance does not have any bearing on supplements that relate
to chemistry, manufacturing, and controls changes, nor does it expand
the circumstances in which an ANDA holder may effect labeling changes
via a CBE supplement.
DATES: Submit written or electronic comments on the draft guidance by
November 20, 2006. 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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. Send one self-addressed adhesive label to
assist that 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on the draft guidance to the Division of Dockets Management (HFA-305),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access to the draft guidance document.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: Meredith S. Francis, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Public Availability of Labeling Changes in `Changes Being
Effected' Supplements.'' FDA has begun an initiative to facilitate
computerized access to drug information by consumers, pharmacists, and
health care providers so that they will have faster and more
comprehensive access to drug information. As part of this initiative,
the agency has been involved in the development of a computerized
repository of a broad array of drug information, known as ``DailyMed.''
Among other things, DailyMed contains the information referred to as
``content of labeling,'' which includes all the information found in
prescription drug labeling and over-the-counter (OTC) drug facts
labeling, including all text, tables, and figures (see 21 CFR
314.50(l)(1)(i)). To maximize its ability to serve as a useful resource
to consumers, pharmacists, and health care providers, DailyMed must
contain the
[[Page 55000]]
most up-to-date and comprehensive drug information available.
Sections 314.70 and 601.12 (21 CFR 314.70 and 601.12) of FDA
regulations identify the types of supplemental applications that must
be submitted to FDA to effect a labeling change to approved NDAs,
ANDAs, and BLAs. Certain types of changes to labeling should receive
FDA approval before the changes are implemented. These include all
labeling changes that do not fall under Sec. 314.70(c)(6)(iii),
(d)(2)(ix), or (d)(2)(x), or under Sec. 601.12(f)(2) or (f)(3). Other
changes may be implemented by a sponsor upon the agency's receipt of a
CBE supplement. These changes are identified in Sec. Sec.
314.70(c)(6)(iii) and 601.12(f)(2)(i).
In the past, FDA has not made labeling publicly available until it
has been approved, either under a pre-approval supplement or under a
CBE supplement. To make the most current labeling submitted to FDA
available to health care practitioners and the public, and to
facilitate the DailyMed initiative, FDA will make the revised labeling
proposed in a CBE supplement publicly available on its Web site and
through DailyMed shortly after the CBE supplement is received and
before FDA has necessarily reviewed or approved it. If, after reviewing
the CBE supplement, FDA decides it should not be approved, FDA will
either: (1) Remove the labeling submitted with the CBE supplement from
FDA's Web site and from DailyMed and replace that labeling with the
previous labeling; or (2) recommend the sponsor amend its labeling and,
after the sponsor submits the amended labeling, post the amended
labeling on FDA's Web site and provide it to DailyMed promptly.
A sponsor should not submit a CBE supplement to FDA until the
sponsor is ready to distribute the labeling that it proposes in that
CBE supplement. FDA will consider the submission of a CBE supplement to
be consent by the sponsor to post the proposed labeling on FDA's Web
site and on DailyMed.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on public
availability of labeling changes in CBE supplements. 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 on 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. The draft guidance and received
comments may be seen in the Division of Dockets Management 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: September 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7983 Filed 9-19-06; 8:45 am]
BILLING CODE 4160-01-S