[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29337-29338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2610]


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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Draft Guidance for Industry on Complementary and Alternative 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it will consider comments submitted through May 29, 2007, for a draft 
guidance for industry entitled ``Complementary and Alternative Medicine 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Although the comment period for the draft guidance ended on April 30, 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confusion as to the closing date for comments on the draft guidance.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draft guidance, submit written or electronic comments on the draft 
guidance by May 29, 2007.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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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draft guidance to the Division of Dockets Management (HFA-305), Food 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://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access to the draft guidance document.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announced the availability of a draft guidance for industry entitled 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://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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