8756 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 

Outbreak,’’ P06–131, September 14, 2006, 

available at http://www.fda.gov/po/indexes/ 

2006news.html. 

4. U.S. Centers for Disease Control and 

Prevention, ‘‘Update on Multi-State Outbreak 

of E. coli O157:H7 Infections From Fresh 

Spinach, October 6, 2006, available at http:// 

www.cdc.gov/ecoli/2006/september/updates/ 

100606.htm. 

5. U.S. Department of Health and Human 

Services and U.S. Department of Agriculture, 

‘‘Dietary Guidelines for Americans 2005,’’

January 2005, available at http:// 

www.healthierus.gov/dietaryguidelines/. 

6. U.S. Food and Drug Administration, 

‘‘Guide to Minimize Microbial Food Safety 

Hazards for Fresh Fruits and Vegetables,’’

October 26, 1998, available at http:// 

www.cfsan.fda.gov/~dms/prodguid.html. 

7. U.S. Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, Office of Plant and Dairy Foods, 

‘‘Letter to Firms that Grow, Pack, or Ship 

Fresh Lettuce and Fresh Tomatoes,’’ February 

5, 2004, available at http:// 

www.cfsan.fda.gov/~dms/prodltr.html. 

8. U.S. Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, Office of Plant and Dairy Foods, 

‘‘Letter to California Firms that Grow, Pack, 

Process, or Ship Fresh and Fresh-cut 

Lettuce,’’ November 4, 2005, available at 

http://www.cfsan.fda.gov/~dms/ 

prodltr2.html. 

9. U.S. Food and Drug Administration, 

‘‘Guide to Minimize Microbial Food Safety 

Hazards of Fresh-Cut Fruits and Vegetables,’’

March 2006, available at http:// 

www.cfsan.fda.gov/~dms/prodgui2.html. 

10. U.S. Department of Health and Human 

Services, Public Health Service, Food and 

Drug Administration, FDA Food Code, 2005, 

available at http://www.cfsan.fda.gov/~dms/ 

foodcode.html. 

11. U.S. Food and Drug Administration, 

‘‘Produce Safety from Production to 

Consumption: 2004 Action Plan to Minimize 

Foodborne Illness Associated With Fresh 

Produce Consumption,’’ October 2004, 

available at http://www.cfsan.fda.gov/~dms/ 

prodpla2.html. 

12. Produce Marketing Association and 

United Fresh Fruit and Vegetable 

Association, ‘‘Commodity Specific Food 

Safety Guidelines for the Melon Supply 

Chain,’’ November 7, 2005, available at 

http://www.cfsan.fda.gov/~dms/ 

melonsup.html or http://www.cfsan.fda.gov/ 

~acrobat/melonsup.pdf. 

13. International Fresh-Cut Produce 

Association, Produce Marketing Association, 

United Fresh Fruit and Vegetable 

Association, Western Growers Association; 

Commodity Specific Food Safety Guidelines 

for the Lettuce and Leafy Greens Supply 

Chain; April 25, 2006, available at http:// 

www.cfsan.fda.gov/~dms/lettsup.html or 

http://www.cfsan.fda.gov/~acrobat/ 

lettsup.pdf. 

14. North American Tomato Trade Work 

Group, ‘‘Commodity Specific Food Safety 

Guidelines for the Fresh Tomato Supply 

Chain, May 2006, available at http:// 

www.cfsan.fda.gov/~dms/tomatsup.html or 

http://www.cfsan.fda.gov/~acrobat/ 

tomatsup.pdf. 

Dated: February 21, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 07–891 Filed 2–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Complementary and 

Alternative Medicine Products and 

Their Regulation by the Food and Drug 

Administration.’’ 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. 

DATES: Submit written or electronic 

comments on the draft guidance by 

April 30, 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 

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 

FDA is announcing 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 the United States, the practice of 

CAM has risen dramatically in recent 

years. In 1992, Congress established the 

Office of Unconventional Therapies, 

which later became the Office of 

Alternative Medicine (OAM), to explore 

‘‘unconventional medical practices.’’ In 

1998, OAM became the National Center 

for Complementary and Alternative 

Medicine (NCCAM). NCCAM is a center 

within the National Institutes of Health. 

The Institute of Medicine, in its book 

entitled, Complementary and 

Alternative Medicine in the United 

States, stated that more than one-third 

of American adults reported using some 

form of CAM and that visits to CAM 

providers each year exceed those to 

primary care physicians (see Institute of 

Medicine, Complementary and 

Alternative Medicine in the United 

States, pages 34 through 35 (2005)). 

As the practice of CAM has increased 

in the United States, we have seen 

increased confusion as to whether 

certain products used in CAM (which, 

for convenience, we will refer to as 

‘‘CAM products’’) are subject to 

regulation under the act or the 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. (When the draft guidance mentions 

a particular CAM therapy, practice, or 

product, it does so in order to provide 

background information or to serve as 

an example or illustration; any mention 

of a particular CAM therapy, practice, or 

product should not be construed as 

expressing FDA’s support for or 

endorsement of that particular CAM 

therapy, practice, or product or, unless 

specified otherwise, as an agency 

determination that a particular product 


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Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 8757 

is safe and effective for its intended uses 

or is safe for use.) The draft guidance 

makes the following two fundamental 

points: 

• First, depending on the CAM 

therapy or practice, a product used in a 

CAM therapy or practice may be subject 

to regulation as a biological product, 

cosmetic, drug, device, or food 

(including food additives and dietary 

supplements) under the act or the PHS 

Act. 

• Second, neither the act nor the PHS 

Act exempts CAM products from 

regulation. 

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 the regulation of complementary and 

alternative medicine products by FDA. 

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. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: December 6, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3259 Filed 2–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0020] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document; 

Oxygen Pressure Regulators and 

Oxygen Conserving Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and FDA staff entitled ‘‘Class II 

Special Controls Guidance Document: 

Oxygen Pressure Regulators and Oxygen 

Conserving Devices.’’ The draft 

guidance document is intended to assist 

manufacturers in complying with 

minimum performance, testing, and 

labeling recommendations that are being 

proposed for these devices. Elsewhere 

in this issue of the Federal Register, 

FDA is publishing a proposed rule to 

reclassify pressure regulators for use 

with medical oxygen into class II, 

subject to special controls. The proposal 

would also establish separate 

identification classifications for both 

oxygen pressure regulators and oxygen 

conserving devices, and would make 

those oxygen conserving devices that 

incorporate a built-in oxygen pressure 

regulator subject to special controls. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit written or electronic 

comments on the draft guidance by May 

29, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Oxygen 

Pressure Regulators and Oxygen 

Conserving Devices’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request, or fax your request to 1–800–

638–2041. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

101, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Christy Foreman, Center for Devices and 

Radiological Health (HFZ–340), Food 

and Drug Administration, 2094 Gaither 

Rd., Rockville, MD 20850, 240–276–

0120. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance provides FDA’s 

recommendations to manufacturers for 

labeling and for determining ignition 

sensitivity and fault tolerance for 

oxygen pressure regulators. These 

devices are intended to convert medical 

oxygen pressure from a high variable 

pressure to a lower, more constant 

working pressure. The device is affixed 

to a pressurized container of oxygen and 

the regulator controls the gas flow. 

These devices are currently regulated as 

class I devices. However, FDA has 

received reports of fires and explosions 

associated with the use of oxygen 

pressure regulators resulting in serious 

injury to a number of equipment 

operators, including one fatality. The 

draft guidance, if finalized, would serve 

as the special control for these devices. 

FDA believes that conformance with the 

draft special controls guidance, when 

combined with the general controls of 

the Federal Food, Drug, and Cosmetic 

Act (the act), would address the risks 

associated with oxygen pressure 

regulators and provide reasonable 

assurance of their safety and 

effectiveness. 

The draft guidance would also serve 

as a special control for oxygen 

conserving devices with a built-in 

oxygen pressure regulator; a device type 

already classified into class II under the 

generic device type noncontinuous 

ventilator (21 CFR 868.5905). FDA 

believes that conformance with the draft 

special controls guidance, when 

combined with the general controls of 

the act, will provide reasonable 

assurance of the safety and effectiveness 

of oxygen conserving devices with a 

built-in oxygen pressure regulator. 

In the Federal Register of May 27, 

2003 (68 FR 30214), FDA announced its 

intention to reclassify oxygen pressure 

regulators in its semi-annual regulatory 

agenda. FDA received one comment 

supporting the establishment of a 

proposed rule to reclassify these 

devices. 


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