Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64961

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance document. 

Submit two copies of written comments, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. The 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 

An electronic version of the revised 

CPG is available on the Internet at http:/

/www.fda.gov/ora under ‘‘Compliance 

References.’’

Dated: October 28, 2004. 

John M. Taylor, 

Associate Commissioner for Regulatory 

Affairs.

[FR Doc. 04–24872 Filed 11–4–04; 8:57 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0562]

Revised Compliance Policy Guide Sec. 

110.300—Registration of Food 

Facilities Under the Public Health 

Security and Bioterrorism 

Preparedness and Response Act of 

2002; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised compliance 

policy guide (CPG) Sec. 110.300 entitled 

‘‘Registration of Food Facilities Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002’’ (registration 

CPG). The revised CPG provides written 

guidance to FDA’s staff on enforcement 

of section 305 of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (the 

Bioterrorism Act) and the agency’s 

implementing regulation, which 

requires, beginning on December 12, 

2003, registration with FDA for all 

domestic and foreign facilities that 

manufacture/process, pack, or hold food 

for human or animal consumption in 

the United States.

DATES: This revised CPG is final upon 

the date of publication. However, you 

may submit written or electronic 

comments at any time.

ADDRESSES: Submit written requests for 

single copies of the revised CPG to the 

Division of Compliance Policy (HFC–

230), Office of Enforcement, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

revised CPG may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revised CPG.

Submit written comments on the 

revised CPG 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.

FOR FURTHER INFORMATION CONTACT:

Food for human consumption: Judith 

Gushee, Center for Food Safety and 

Applied Nutrition (HFS–605), Food 

and Drug Administration, 301–436–

2417.

Food for animal consumption: Isabel 

Pocurull, Center for Veterinary 

Medicine (HFV–226), Food and 

Drug Administration, 301–827–

0175.

SUPPLEMENTARY INFORMATION: FDA is 

announcing the availability of revised 

CPG Sec. 110.300 entitled ‘‘Registration 

of Food Facilities Under the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 

2002’’ (registration CPG). This revised 

CPG outlines for FDA staff the agency’s 

policy on enforcement of section 305 of 

the Bioterrorism Act and its 

implementing regulation ((68 FR 58894, 

October 10, 2003); (codified at 21 CFR 

part 1, subpart H, 1.225 through 1.243)). 

The Bioterrorism Act and subpart H 

require that, beginning on December 12, 

2003, all domestic and foreign facilities 

that manufacture, process, pack, or hold 

food for human or animal consumption 

in the United States must be registered 

with FDA.

I. Background

On December 19, 2003, FDA issued 

CPG Sec. 110.300 (the December CPG). 

The December CPG states that for 

domestic firms, FDA would initially 

plan to focus the agency’s efforts on 

educating and otherwise informing the 

industry on how to comply with the 

registration of food facilities interim 

final rule, and that thereafter FDA 

would enforce the registration provision 

as appropriate in each situation. We set 

out in the Regulatory Action Guidance 

section our enforcement approach.

For foreign facilities, the December 

CPG referred to the policies set out in 

CPG Sec. 110.310 entitled ‘‘Prior Notice 

of Imported Food Under the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 

2002’’ (the prior notice CPG).

II. Revised CPG Sec. 110.300

FDA is making only one substantive 

change in the registration CPG. 

Specifically, the revised CPG provides 

that, on November 8, 2004, FDA is fully 

implementing the agency’s enforcement 

policy for domestic food facilities, 

which was set out in the Regulatory 

Action Guidance section of the 

December CPG. For foreign facilities, the 

registration CPG continues to state that 

generally, the registration requirement 

for the facilities of foreign 

manufacturers and shippers will be 

enforced in accordance with the policies 

set out in the prior notice CPG. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability for the revision to the prior 

notice CPG, which is being issued under 

§ 10.115(g)(2) (21 CFR 10.115(g)(2)) as 

level 1 guidance that is effective 

November 8, 2004.

FDA is also issuing the revised 

registration CPG as level 1 guidance 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). Revised 

CPG Sec. 110.300 is being implemented 

immediately without prior public 

comment, under § 10.115(g)(2), because 

FDA has determined that prior public 

participation is not feasible or 

appropriate. Revision of FDA’s prior 

notice enforcement policy directly 

affects the agency’s enforcement of the 

registration requirement for foreign 

manufacturers and shippers. Given this 

relationship, it is appropriate that FDA 

coordinate announcement and 

implementation of the agency’s revised 

enforcement policy for food facilities 

registration with the agency’s 

comparable actions for the prior notice 

of imported food requirement.

III. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the revised CPG. 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 guidance and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

64962 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 

1Under section 403(r)(6)(A) of the act (21 U.S.C. 

343(r)(6)(A)), such a statement is one that ‘‘claims 

a benefit related to a classical nutrient deficiency 

disease and discloses the prevalence of such disease 

in the United States, describes the role of a nutrient 

or dietary ingredient intended to affect the structure 

or function in humans, characterizes the 

documented mechanism by which a nutrient or 

dietary ingredient acts to maintain such structure or 

function, or describes general well-being from 

consumption for a nutrient or dietary ingredient.’’

IV. Electronic Access

An electronic version of this guidance 

is available on the Internet at http://

www.fda.gov/ora under ‘‘Compliance 

References.’’

Dated: November 2, 2004.

Steve M. Niedelman,

Acting Associate Commissioner for 

Regulatory Affairs.

[FR Doc. 04–24873 Filed 11–4–04; 8:57 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0466]

Draft Guidance for Industry: 

Substantiation for Dietary Supplement 

Claims Made Under Section 403(r)(6) of 

the Federal Food, Drug, and Cosmetic 

Act; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Guidance for Industry: Substantiation 

for Dietary Supplement Claims Made 

Under Section 403(r)(6) of the Federal 

Food, Drug, and Cosmetic Act.’’ This 

draft guidance describes the amount, 

type, and quality of evidence that FDA 

recommends a manufacturer have to 

substantiate a claim under section 

403(r)(6) of the Federal Food, Drug, and 

Cosmetic Act (act). FDA is also 

announcing its decision not to publish 

additional guidance on applying the 

structure/function rule at this time.

DATES: Submit written or electronic 

comments on the draft guidance and the 

collection of information provisions by 

January 10, 2005, to ensure adequate 

consideration in preparation of any final 

guidance document. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written comments 

on the draft guidance document and the 

collection of information provisions to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the draft 

guidance and the collection of 

information to http://www.fda.gov/

dockets/ecomments. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document.

FOR FURTHER INFORMATION CONTACT:

Vickey Lutwak, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–2375, fax: 301–436–2636, e-mail: 

Vickey.Lutwak@cfsan.fda.gov

SUPPLEMENTARY INFORMATION:

I. Background—Substantiation Draft 

Guidance

Section 403(r)(6) of the act (21 U.S.C. 

343(r)(6)) requires that a manufacturer 

of a dietary supplement making a 

nutritional deficiency, structure/

function, or general well-being claim 

have substantiation that the claim is 

truthful and not misleading.1

This draft guidance document is 

intended to describe the amount, type, 

and quality of evidence FDA 

recommends a manufacturer have to 

substantiate a claim under section 

403(r)(6) of the act. This draft guidance 

document is limited to issues pertaining 

to substantiation under section 403(r)(6) 

of the act; it does not extend to 

substantiation issues that may exist in 

other sections of the act.

FDA intends to apply a standard for 

substantiating claims for dietary 

supplements that is consistent with the 

Federal Trade Commission’s (FTC’s) 

standard for dietary supplements and 

other health related products of 

‘‘competent and reliable scientific 

evidence.’’ FDA seeks comments on this 

draft guidance only as they relate to 

FDA’s use and application of the 

standard and approach that are 

described in the guidance. We (FDA) are 

not seeking comment on FTC’s 

application, use, or interpretation of 

their standard.

The agency has adopted good 

guidance practices (GGPs) that set forth 

the agency’s policies and procedures for 

the development, issuance, and use of 

guidance documents (21 CFR 10.115). 

The draft guidance document is being 

issued as a Level 1 guidance consistent 

with FDA’s GGPs. The draft guidance 

document represents the agency’s 

current thinking on the amount, type, 

and quality of evidence FDA 

recommends a manufacturer have to 

substantiate a claim under section 

403(r)(6) of the act. 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 method may be 

used as long as it satisfies the 

requirements of the applicable statutes 

and regulations.

II. Paperwork Reduction Act of 1995—

Substantiation Draft Guidance

This draft guidance document 

contains information collection 

provisions that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (the PRA) (44 U.S.C. 3501–

3520). Under the PRA, Federal agencies 

must obtain approval from the OMB for 

each collection of information they 

conduct or sponsor. ‘‘Collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3 and includes 

agency requests or requirements that 

members of the public submit reports, 

keep records, or provide information to 

a third party. Section 3506(c)(2)(A) of 

the PRA (44 U.S.C. 3506(c)(2)(A)) 

requires Federal agencies to provide a 

60-day notice in the Federal Register

concerning each proposed collection of 

information before submitting the 

collection to OMB for approval. To 

comply with this requirement, FDA is 

hereby publishing notice of the 

proposed collection of information set 

forth in this document.

FDA invites comments on: (1) 

Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Draft Guidance for Industry: 

Substantiation for Dietary Supplement 

Claims Made Under Section 403(r)(6) of 

the Federal Food, Drug, and Cosmetic 

Act; Availability

Section 403(r)(6) of the act requires 

that a manufacturer of a dietary 

supplement making a nutritional 

deficiency, structure/function, or 

general well-being claim have 

substantiation that the statement is 

truthful and not misleading. This draft 

guidance document is intended to 

describe the amount, type, and quality 

of evidence FDA recommends a dietary 

supplement manufacturer have to