[Federal Register: May 25, 2007 (Volume 72, Number 101)]
[Notices]
[Page 29337-29338]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my07-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0480]
Draft Guidance for Industry on Complementary and Alternative
Medicine Products and Their Regulation by the Food and Drug
Administration; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, we) is announcing that
it will consider comments submitted through May 29, 2007, for a draft
guidance for industry entitled ``Complementary and Alternative Medicine
Products and Their Regulation by the Food and Drug Administration.''
Although the comment period for the draft guidance ended on April 30,
2007, we will consider comments submitted through May 29, 2007, due to
confusion as to the closing date for comments on the draft guidance.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance, submit written or electronic comments on the draft
guidance by May 29, 2007.
[[Page 29338]]
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food
and Drug Administration, 1401 Rockville Pike, suite 200N Rockville, MD
20852-1448. 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draft guidance to the Division of Dockets Management (HFA-305), Food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access to the draft guidance document.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: Philip L. Chao, Office of Policy and
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0587.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 27, 2007, (72 FR 8756), FDA
announced the availability of a draft guidance for industry entitled
``Complementary and Alternative Medicine Products and Their Regulation
by the Food and Drug Administration.'' The term ``complementary and
alternative medicine'' (CAM) encompasses a wide array of health care
practices, products, and therapies that are distinct from practices,
products, and therapies used in ``conventional'' or ``allopathic''
medicine.
In recent years, the practice of complementary and alternative
medicine CAM has increased in the United States, and we have seen
increased confusion as to whether certain products used in CAM are
subject to regulation under the Federal Food, Drug, and Cosmetic Act
(the act) or Public Health Service Act (PHS Act). We have also seen an
increase in the number of CAM products imported into the United States.
Therefore, the draft guidance discusses when a CAM product is subject
to the act or the PHS Act.
The notice announcing the availability of the draft guidance
provided a 60-day comment period, so the comment period for the draft
guidance was scheduled to end on April 30, 2007. Unfortunately, due to
a typographical error in the draft guidance itself (which stated that
the comment period would be 90 days from the date of the notice's
publication in the Federal Register), we became aware that some members
of the public believed that the comment period would or should end on
May 28 or May 29, 2007. This confusion was compounded by another error
that appeared at one section of FDA's Web site; the error, which
appeared at the ``Dockets Open for Comment'' portion of the Web site
where electronic comments are submitted, stated that the comment period
would end on May 29, 2007. (In contrast, other sections of FDA's Web
site retained the April 30, 2007, date.)
Given the amount of confusion as to the comment period, we are
announcing that we will consider all comments on this draft guidance
that are submitted through May 29, 2007. Previously submitted comments
do not need to be resubmitted.
Additionally, we are aware of considerable confusion about the
content of the draft guidance, which has been widely misinterpreted.
Therefore, we want consumers and CAM practitioners to understand that
the draft guidance does not contain or propose any new regulatory
requirements for any complementary and alternative medicine CAM product
marketed in the United States and does not affect any state licensing
requirements for any CAM practitioner or any consumer's ability to buy
or receive a CAM product or be treated by any CAM practitioner.
Public concern based on misinterpretations of the draft guidance
has generated a large volume of comments to the docket. The large
volume of comments has impeded our ability to identify and respond to
extension requests. Consequently, we are addressing those unanswered
extension requests by considering comments submitted through May 29,
2007.
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. 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.
Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-2610 Filed 5-22-07; 3:21 pm]
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