11172 Federal Register / Vol. 66, No. 36 / Thursday, February 22, 2001 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0058]

Guidance on Applying the Structure/

Function Rule; Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

comments on the types of information

that should be included in a guidance

on applying the regulations on

statements made for dietary

supplements concerning the effect of the

product on the structure or function of

the body. This action is being taken to

assist the agency in preparing a

guidance that will be optimally useful

for industry and other interested

persons.

DATES: Submit written comments on the

topics for the proposed guidance by

May 23, 2001.

ADDRESSES: Submit written comments

on the topics for the proposed guidance

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Copies of

this document are available on the

Internet at http://vm.cfsan.fda.gov/

∼dms/ds-ind.html.

FOR FURTHER INFORMATION CONTACT: Rose

E. Cunningham, Center for Drug

Evaluation and Research (HFD–6), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5468.

SUPPLEMENTARY INFORMATION:

I. Background

The Dietary Supplement Health and

Education Act (DSHEA) authorizes

manufacturers of dietary supplements to

claim effects on the ‘‘structure or

function’’ of the body, but not to make

claims to mitigate, treat, prevent, cure,

or diagnose disease (21 U.S.C. 343(r)(6)).

To explain how this part of DSHEA was

to be implemented, FDA published the

‘‘structure/function rule’’ on January 6,

2000 (65 FR 1000) (§ 101.93(f) and (g)

(21 CFR 101.93(f) and (g))). This rule

distinguishes between disease claims,

which create a requirement that

evidence of safety and efficacy be

presented to the agency before

marketing, and structure/function

claims, which do not create such a

requirement. In the preamble to that

final rule, FDA stated that it would

publish guidance on applying the rule.

FDA is seeking public comment on the

topics that should be included in the

guidance.

II. Description of the Guidance

In the preamble to the structure/

function rule, FDA stated that it would

provide, through guidance, examples of

labeling claims that would and would

not be considered disease claims under

the rule, including examples of product

names. FDA also stated that it would

issue guidance, if necessary, on the

citation of a publication or a reference

implying the treatment or prevention of

a disease (§ 101.93(g)(2)(iv)(C)). The

agency invites comments on whether

guidance on this topic is necessary.

Because issues pertaining to the

substantiation of structure/function

claims are outside the scope of the rule

(see 65 FR 1000 at 1032), the agency

does not plan to address such issues in

the guidance that is the subject of this

notice. However, the agency does plan

to issue a separate guidance on the

substantiation of claims.

III. Request for Comments

FDA invites all interested parties to

comment on the topics to be included

in the guidance, to suggest additional

topics for inclusion in the guidance, and

to address any other issue appropriate

for this guidance. Interested persons

may submit to the Dockets Management

Branch (address above) written

comments by May 23, 2001. Two copies

of any comments are to be submitted,

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. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: February 15, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4374 Filed 2–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1315]

Guidance for Industry on How to Use

E–Mail to Submit Information to the

Center for Veterinary Medicine;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance for industry

(#108) entitled ‘‘How to Use E–Mail to

Submit Information to the Center for

Veterinary Medicine’’ (CVM). This

guidance provides guidelines on how to

submit information to CVM as an e-mail

attachment by Internet. These electronic

submissions are part of CVM’s ongoing

initiative to provide a method for

paperless submissions. This guidance

implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the guidance to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the guidance

document.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578, e-mail: jmessenh@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 29,

2000 (65 FR 40109), FDA published the

notice of availability of the draft

guidance entitled ‘‘How to Use E–Mail

to Submit information to the Center for

Veterinary Medicine’’ giving interested

persons until August 28, 2000, to submit

comments. We received no comments.

In the Federal Register of March 20,

1997 (62 FR 13430), FDA published the

electronic records; electronic signatures

regulation. This rule in part 11 (21 CFR

part 11) provides for the voluntary

submission of parts, or all, of regulatory

records in electronic format without an

accompanying paper copy. This rule

also established public docket number

97S–0251 to provide a permanent

location for a list of the documents or

parts of documents that are acceptable

for submission in electronic form

without paper records and the agency

units to which such submissions may be

made. CVM will identify in this public

docket the types of documents which

may be submitted in electronic form. In

Federal Register / Vol. 66, No. 36 / Thursday, February 22, 2001 / Notices 11173

addition, CVM will identify those

documents in guidances or regulations.

This docket is accessible on the Internet

at http://www.fda.gov/ohrms/dockets/

dockets/92s0251/92s0251.htm. The

GPEA of 1998 (Public Law 105–277)

requires Federal agencies, by October

21, 2003, to provide: (1) For the option

of the electronic maintenance,

submission, or disclosure of

information, if practicable, as a

substitute for paper; and (2) for the use

and acceptance of electronic signatures,

when practicable.

CVM accepts certain types of

submissions by e-mail with no

requirement for a paper copy. These

types of documents are listed in public

docket 97S–0251 as required by § 11.2.

CVM’s ability to receive and process

information submitted electronically is

limited by its current information

technology capabilities and the

requirements of the electronic records;

electronic signatures regulation. This

guidance outlines general standards that

should be used for the successful

electronic submission of any

information by e-mail.

II. Significance of Guidance

This Level 1 guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

guidance represents the agency’s current

thinking about using e-mail to submit

information electronically. The

document does not create or confer any

rights for or on any person and will not

operate to bind FDA or the public.

Alternative methods may be used as

long as they satisfy the requirements of

the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

In the notice announcing the

availability of the draft version of this

guidance, FDA published notice of the

proposed collection of information

related to the guidance. The Federal

Register notice also requested

comments on the burden estimates for

the guidance documents. No comments

were received on the estimated annual

reporting burden. The annual reporting

burden estimate of 140 hours therefore

remains unchanged. In the Federal

Register of September 21, 2000 (65 FR

57192), the agency announced that it

was submitting the collection of

information to the Office of

Management and Budget (OMB) for

review and clearance under the

Paperwork Reduction Act of 1995. The

information collection provisions

related to this guidance document have

been approved under OMB control

number 0910–0453. This approval

expires November 30, 2003. An agency

may not conduct or sponsor, and a

person is not required to respond to a

collection of information unless it

displays a currently valid OMB control

number.

IV. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cvm.

V. Comments

As with all of FDA’s guidances, the

public is encouraged to submit written

comments with new data or other new

information pertinent to this guidance.

FDA will periodically review the

comments in the docket and, where

appropriate, will amend the guidance.

The agency will notify the public of any

such amendments through a notice in

the Federal Register.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

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 are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: February 14, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4313 Filed 2–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1314]

Guidance for Industry on How to Use

E–Mail to Submit a Notice of Intent to

Slaughter for Human Food Purposes;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance for industry

(#87) entitled ‘‘How to Use E–Mail to

Submit a Notice of Intent to Slaughter

for Human Food Purposes.’’ The

purpose of this document is to provide

guidance to new animal drug sponsors

(sponsors) on how to submit an

electronic notice of intent to slaughter

for human food purposes (slaughter

notices) to the Center for Veterinary

Medicine (CVM) and the U.S.

Department of Agriculture (USDA). This

electronic submission is part of CVM’s

ongoing initiative to provide a method

for paperless submissions. This

guidance implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of this guidance to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance

document.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578, e-mail: jmessenh@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 29,

2000 (65 FR 40106), FDA published the

notice of availability of the draft

guidance entitled ‘‘How to Use E–Mail

to Submit a Notice of Intent to Slaughter

for Human Food Purposes.’’ Interested

persons were given until August 28,

2000, to submit comments. FDA

received no comments.

In the Federal Register of March 20,

1997 (62 FR 13430), FDA published the

electronic records; electronic signatures

regulation. This regulation (21 CFR part

11) provides for the voluntary

submission of parts or all of regulatory

records in electronic format without an

accompanying paper copy. This rule

also established public docket number

92N–0251 to provide a permanent

location for a list of the documents or

parts of documents that are acceptable

for submission in electronic form

without paper records and the agency

units to which such submissions may be

made. CVM will identify in this public

docket the types of documents which

may be submitted in electronic form, as

an e-mail attachment by Internet, as

those documents are identified in final

guidance or regulations. This docket is

accessible on the Internet at http://