Federal Register / Vol. 65, No. 205 / Monday, October 23, 2000 / Notices 63255

SUPPLEMENTARY INFORMATION:

I. Purpose

Section 921 of the Public Health

Service Act (42 U.S.C. 299c) established

the National Advisory Council for

Healthcare Research and Quality. In

accordance with its statutory mandate,

the Council is to advise the Secretary

and the Director, Agency for Healthcare

Research and Quality (AHRQ), on

matters related to actions of the Agency

to enhance the quality, improve

outcomes, reduce costs of health care

services, improve access to such

services through scientific research, the

promotion of improvements in clinical

practice and in the organization,

financing, and delivery of health care

services.

The Council is composed of members

of the public appointed by the Secretary

and Federal ex-officio members. Donald

M. Berwick. M.D., the Council

chairman, will preside.

II. Agenda

On Friday, November 3, 2000, the

meeting will begin at 8:30 a.m., with the

call to order by the Council Chairman.

The Director, AHRQ, will present the

status of the Agency’s current research,

programs and initiative. Tentative

agenda items include evidence-based

practice centers, patient safety,

translating research into practice

(T.R.I.P.), and Office of Priority

Populations Research. The official

agenda will be available on AHRQ’s

website at www.ahrq.gov no later than

October 20, 2000. The meeting will

adjourn at 4:00 p.m.

Dated: October 13, 2000.

John M. Eisenberg,

Director.

[FR Doc. 00–27104 Filed 10–20–00; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control And

Prevention

[60Day–01–03]

Proposed Data Collections Submitted

for Public Comment and

Recommendations

In compliance with the requirement

of section 3506 (c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Center for Disease Control and

Prevention is providing opportunity for

public comment on proposed data

collection projects. To request more

information on the proposed projects or

to obtain a copy of the data collection

plans and instruments, call the CDC

Reports Clearance Officer on (404) 639–

7090.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

for other forms of information

technology. Send comments to Anne

O’Connor, CDC Assistant Reports

Clearance Officer, 1600 Clifton Road,

MS–D24, Atlanta, GA 30333. Written

comments should be received within 60

days of this notice.

Proposed Projects

Telephone Survey Measuring HIV/

STD Risk Behavior Using Standard

Methodology—New—National Center

for HIV, STD, Tuberculosis Prevention

(NCHSTP), CDC. The goal of the overall

project is to conduct testing of a set of

survey questions intended to obtain

measures of risk behaviors for Human

Immunodeficiency Virus (HIV) and

Sexually Transmitted Diseases (STDs).

This proposed data collection is for the

second phase of this 2-year project.

During the first phase questions were

developed and tested, and a pretest of

203 interviews was conducted. During

this second phase a pilot survey with a

larger number of respondents will be

conducted, and a small number of

additional questions will be included

measuring HIV-related stigma.

Knowledge about the level of HIV risk

behaviors in populations is essential for

effective HIV prevention programs.

Currently, survey-based assessment of

these behaviors depends on a range of

survey questions that differ across

surveys, and that are difficult to

compare and to reconcile. Therefore, the

Behavioral Surveillance Working Group,

coordinated by the National Center for

HIV, STD and Tuberculosis Prevention,

Centers for Disease Control and

Prevention, has developed a draft set of

items to be proposed as standard survey

questions on the topics of sexual

behavior, HIV testing, drug use, and

other behaviors related to risk of

contracting HIV and/or STDs. As part of

this effort, CDC will sponsor a

telephone-based pilot of 400 persons

aged 18–59, selected randomly from

within an urban area, in order to test

these questions.

Further, because some of the survey

questions are private and potentially

sensitive, the project will entail the

testing of a survey administration mode:

Telephone-based audio computerassisted self-interview (T–ACASI), in

which a computer will be used to

administer the most sensitive questions,

and in which the surveyed individual

enters responses directly onto the

telephone keypad. This procedure

eliminates the need for communication

of sensitive questions from the

interviewer to the respondent, as well as

the need for respondents to answer the

questions verbally. In order to test the

effectiveness of this procedure, half of

the interviews will be conducted using

the T–ACASI procedure for the most

sensitive questions, and half using

standard, interviewer-based

administration of all questions. Data

analysis will rely on an assessment of

the response rate under each mode, and

on the nature of the data obtained to the

sensitive questions. The larger sample

size of the year 2 pilot survey will

enable us to test statistical significance

of the effectiveness of the T–ACASI

procedure.

Information and data obtained from

this evaluation will help direct future

surveys, by determining whether it is

feasible to attempt to administer these

standard risk questions using a

telephone survey, and whether a T–

ACASI-based procedure represents a

technological innovation that will

positively contribute to such an effort,

through improvements in data quality.

The total cost to respondents is

$1355.52.

Respondents No. of

respondents

No. of

responses/

respondent

Avg.

burden per

response

(in hours)

Total

burden

(in hours)

Screening ......................................................................................................................... 1872 1 0.02 37.4

Interview ........................................................................................................................... 400 1 0.33 132.0

63256 Federal Register / Vol. 65, No. 205 / Monday, October 23, 2000 / Notices

Respondents No. of

respondents

No. of

responses/

respondent

Avg.

burden per

response

(in hours)

Total

burden

(in hours)

Total Burden ............................................................................................................. 169.4

Dated: October 17, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–27118 Filed 10–20–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N 0044]

Statements Made for Dietary

Supplements Concerning the Effect of

the Product on the Structure or

Function of the Body; Availability of

Citizen Petitions for Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment of three

petitions submitted by Hyman Phelps &

McNamara (HP&M), the American

Herbal Products Association (AHPA),

and jointly by the Council for

Responsible Nutrition (CRN) and the

Consumer Healthcare Products

Association (CHPA). The petitions

requested, among other things, that

dietary supplements be permitted to

make claims about effects on the

structure or function of the body that are

derived from nutritive value without

being subject to the disclaimer and

notification requirements of the Federal

Food, Drug, and Cosmetic Act (the act).

DATES: Submit written comments on the

petitions by December 22, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA 305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Electronic

comments may be submitted via the

Internet at www.accessdata.fda.gov/

scripts/oc/dockets/comments/

commentdocket.cfm or via e-mail:

fdadockets@oc.fda.gov. All comments

should be identified with the docket

number found in brackets in the

heading of this document. The petitions

are available for review at the Dockets

Management Branch (address above) or

electronically on the agency’s website at

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

dockets.htm. You may also request

copies of the petitions from the Dockets

Management Branch.

FOR FURTHER INFORMATION CONTACT:

Rhonda Rhoda Kane, Office of

Nutritional Products, Labeling, and

Dietary Supplements, Center for Food

Safety and Applied Nutrition (HFS 821),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202–

205–4168.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 6,

2000 (65 FR 1000), in the preamble to

its final rule entitled ‘‘Regulations on

Statements Made for Dietary

Supplements Concerning the Effect of

the Product on the Structure or

Function of the Body,’’ FDA stated that

dietary supplements bearing structure/

function claims must comply with the

notice, disclaimer, and other

requirements of section 403(r)(6) of the

act (21 U.S.C. 343(r)(6)). More

specifically, the agency stated:

Section 403(r)(6) of the act, by its

terms, applies to dietary supplements.

The other possible source of authority to

make structure/function claims on

dietary supplements is section

201(g)(1)(C) of the act, which provides

that ‘‘articles (other than food) intended

to affect the structure or any function of

the body of man or other animals’’ are

drugs. Under this provision, foods may

make claims to affect the structure or

function of the body without being

regulated as drugs. By its terms,

however, section 201(g)(1)(C) of the act

exempts a dietary supplement that bears

a structure/function claim from drug

regulation only if it is also a food. The

last sentence of section 201(ff) of the act

provides, ‘‘Except for purposes of

section 201(g), a dietary supplement

shall be deemed to be a food within the

meaning of this Act.’’ The clear import

of this language is that dietary

supplements are not foods under section

201(g) of the act and therefore cannot

qualify for the ‘‘(other than food)’’

exception to the drug definition in

section 201(g)(1)(C). As a result, dietary

supplements that use structure/function

claims may do so only under section

403(r)(6) of the act and are therefore

subject to the disclaimer, notification,

and other requirements in that section

and in FDA’s implementing regulation.

65 FR 1000 at 1033.

The preamble acknowledged that this

conclusion reverses a position stated in

the Federal Register of September 23,

1997 (62 FR 49859), in the final rule

entitled ‘‘Food Labeling; Requirements

for Nutrient Content Claims, Health

Claims, and Statements of Nutritional

Support for Dietary Supplements.’’ The

preamble to that rule stated that a

dietary supplement could bear a

structure/function claim under the

‘‘(other than food)’’ exception to the

drug definition in section 201(g)(1)(C) of

the act (21 U.S.C. 321(g)(1)(C)), provided

that the claim was truthful,

nonmisleading, and derived from

nutritive value (see 62 FR 49859 at

49860, 49863, and 49864). The reversal

was based on reconsideration of the

plain language of section 201(ff) of the

act.

II. The Citizen Petitions

On February 4, 2000, HP&M filed a

petition requesting, among other things,

that the agency reconsider and revoke

its ‘‘pronouncement’’ in the January 6,

2000, final rule that all structure/

function claims in the labeling of

dietary supplements must use the

section 403(r)(6) of the act disclaimer

and notification procedures. The

petition further requests that FDA

reinstate its previous position that a

structure/function claim in the labeling

of a dietary supplement product need

not comply with the disclaimer and

notification requirements if the claim is

truthful, nonmisleading, and derived

from nutritive value.

Citing United States v. Ten Cartons

***Ener-B Vitamin B 12, 72 F.3d 285,

287 (2d Cir. 1995), HP&M argues that

section 201(g)(1)(C) of the act must be

applied without reference to section

201(ff) of the act. In sum, HP&M states

that the effect of section 201(ff) of the

act ‘‘is merely that a dietary supplement

will not ‘‘automatically qualify as

food.’’’ HP&M further argues that

whether or not a particular dietary

supplement qualifies as food is

determined by Nutrilab, Inc. v.

Schweiker, 713 F.2d 335 (7th Cir. 1983).

That case held that a product is a food

if it is used primarily for ‘‘taste, aroma

or nutritive value.’’ Nutrilab, 713 F.2d at

338. For example, the petition argues