41966 Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Notices

side effects claims, unless the claim is

true and substantiated by scientific

evidence.

Part II prohibits respondents from

making any representation for any food,

drug, or dietary supplement that

contains ephedrine alkaloids that

consumers can appropriately take such

product in an amount that exceeds the

level established by any regulation of

the Food and Drug Administration

(‘‘FDA’’) for ephedrine alkaloids or any

other ingredient in the product.

Part III requires the following clear

and prominent disclosure in all future

advertising and labeling of, and all

consumer communications concerning,

any ephedrine-alkaloid-containing

product sold by respondents:

Warning: This product contains

ephedrine which can have dangerous

effects on the central nervous system

and heart and could result in serious

injury. Risk of injury increases with

dose.

Under Part III, if the product is subject

to an FDA rule or regulation that

requires a labeling warning, that

warning is required in labeling in lieu

of the warning set forth above.

Part IV prohibits respondents from

assisting others, including by selling

product to them, when respondents

have reason to believe that they are

deceptively promoting respondents’

ephedrine-containing products.

Part V prohibits misrepresentations

about endorsements and testimonials.

Part VI prohibits respondents from

directing to individuals under the age of

twenty-one advertising and promotional

activities for Ecstasy or any other

ephedrine product marketed as an

alternative to an illegal drug or for its

euphoric, psychotropic, or sexual

effects. Part VI includes examples of

prohibited activity, including

advertisements and promotions to

audiences half or more under twentyone.

Part VII requires the respondents to

conduct and submit annual analyses of

the levels of ephedrine alkaloids in any

ephedrine-containing product that they

sell for the next five (5) years.

Part VIII provides that nothing in the

order permits the respondents to market

any product (1) in a state where its sale

has been banned; (2) in a manner that

is inconsistent with state restrictions on

its sale; or (3) in a way that is

inconsistent with any applicable FDA

rule or regulation.

Parts IX and X provide safe harbors

for claims approved pursuant to FDA’s

regulation of the labeling for drugs and

foods, respectively.

Part XI requires respondents to send

a letter (Attachment A to the order) to

anyone who provides the public with

information about any of respondents’

ephedrine-containing products. The

letter advises the recipient that the

disclosure required by Part III of the

order must be made in all

communications with consumers

concerning any of respondents’

ephedrine-containing products and that

the only permissible statement about the

dose of any such product is the

information on the label. Part XII sets

forth the record keeping and

surveillance requirements with respect

to Part XI.

Part XIII requires respondents to send

a letter (Attachment B to the order) to

distributors and resellers, including any

person who purchases more than 100

units of any of respondents’ ephedrinecontaining products in any there (3)

month period. The letter describes the

Commission’s action in this case and

advises recipients to discontinue use of

any promotional materials that do not

comply with the order. Part XIV set

forth the record keeping and

surveillance requirements with respect

to Part XIII.

The remaining parts of the order

contain standard provisions pertaining

to record keeping, compliance,

sunsetting of the order, and similar

matters.

The purpose of this analysis is to

facilitate public comment on the

proposed order, and it is not intended

to constitute an official interpretation of

the agreement and proposed order or to

modify in any way their terms.

Donald S. Clark,

Secretary.

[FR Doc. 97–20450 Filed 8–1–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA) will

publish periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans, call the HRSA Reports Clearance

Officer on (301) 443–1129.

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

or other forms of information

technology.

Proposed Project: Reporting

Requirements for the National Health

Service Corps (NHSC) Non-Grant

Sites—New—The National Health

Service Corps (NHSC) is a component of

the Bureau of Primary Health Care,

Health Resources and Services

Administration, Department of Health

and Human Services. The mission of the

NHSC is to assist in the development,

recruitment, and retention of

community-responsive, culturally

competent, primary care providers to

serve people in health professional

shortage areas. The mission is

implemented through assignment of

personnel to 365 BPHC grant-supported

health care sites and 312 sites receiving

no grant support.

The NHSC is required to collect

specific data from the sites to which

NHSC providers are assigned. For grantsupported sites, this is accomplished

through the Uniform Data System

(UDS)(OMB No. 0915–0193). The UDS

data are utilized to comply with

congressionally mandated actions such

as billing sites for the reimbursement of

the cost of NHSC assignees and

preparing reports for Congress. The UDS

data are also utilized for evaluating the

overall effectiveness of the NHSC to

include appropriateness of NHSC

assignee placements and expenditure of

funds.

This request is to collect a subset of

the UDS data from the non-grant

supported sites in order to facilitate full

compliance with the congressionally

mandated billing and reporting

requirements.

For this purpose a modified reporting

tool with less burden has been

developed for the non-grant supported

sites which will collect information on

services provided, populations served,

staffing and utilization, finances, and

managed care enrollment.

The following burden table was

developed based on experience with
Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Notices 41967

grant supported sites in completing the

UDS:

Type of instrument No. Of

Respondents

Responses

per

Respondent

Hours per

Response

Total Hour

Burden

Modified UDS ................................................................................................... 312 1 5.6 1,747

The annual burden estimates shown

above for the non-grant supported sites

to complete the required six Tables will

be refined through field testing at nine

randomly selected sites.

Send comments to Patricia Royston,

HRSA Reports Clearance Officer, Room

14–36, Parklawn Building, 5600 Fishers

Lane, Rockville, MD, 20857. Written

comments should be received within 60

days of this Notice.

Dated: July 25, 1997.

Jane Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 97–20453 Filed 8–1–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Request for Public Comment: 60-Day

Proposed Collection; IHS Contract

Health Service Report

SUMMARY: In compliance with Section

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

Reduction Act of 1995, to provide a 60-

day advance opportunity for public

comment on proposed data collection

projects, the Indian Health Service (IHS)

is publishing for comment a summary of

a proposed information collection

project to be submitted to the Office of

Management and Budget (OMB) for

review.

Proposed Collection

Title: 09–17–0002, ‘‘IHS Contract

Health Service Report.’’

Type of Information Collection

Request: 3-year reinstatement, with

change, of previously approved

information collection, 09–17–0002,

‘‘IHS Contract Health Service Report’’

which expire 09/30/97.

Form Number: IHS–843–1A,

‘‘Purchase-Delivery Order for Health

Services.’’

Needs and Use of Information

Collection: The Contract Health Service

health care providers complete form

IHS–843–1A to certify that they have

performed the health services

authorized by the IHS. The information

is used to manage, administer, and plan

for the provision of health services to

eligible American Indian patients,

process payments to providers, obtain

program data, provide program

statistics, and, serves as a legal

document for health care services

rendered.

Affected Public: Businesses or other

for-profit, Individuals, not-for-profit

institutions and State, local or Tribal

Government.

Type of Respondents: Health care

providers.

Table 1 below provides: Type(s) of

Data Collection Instruments, Estimated

Number of Respondents, Number of

Responses per Respondent, Average

Burden Hour per Response, and Total

Annual Burden Hour.

TABLE 1

Data collection

instrument

Estimated

number of

respondents

Responses

per

respondent

Annual

number of

responses

Average

Burden hr per

response*

Total annual

burden hours

IHS–843–1A .......................................................................... 9,115 43 393,416 0.05 (3 mins) 19,670

IDS** ..................................................................................... 21,797 1 21,797 0.05 (3 mins) 3,175

* For ease of understanding, burden hours are also provided in actual minutes.

**Inpatient Discharge Summary (IDS).

There are no Capital Costs, Operating

Costs and/or Maintenance Costs to

report.

Request for Comments

Your written comments and/or

suggestions are invited on one or more

of the following points: (a) Whether the

information collection activity is

necessary to carry out an agency

function; (b) whether the agency

processes the information collected in a

useful and timely fashion; (c) the

accuracy of public burden estimate (the

estimated amount of time needed for

individual respondents to provide the

requested information); (d) whether the

methodology and assumptions used to

determine the estimate are logical; (e)

ways to enhance the quality, utility, and

clarity of the information being

collected; and (f) ways to minimize the

public burden through the use of

automated, electronic, mechanical, or

other technological collection

techniques or other forms of information

technology.

Send Comments and Requests for

Further Information

Send your written comments, requests

for more information on the proposed

project, or requests to obtain a copy of

the data collection instrument and

instructions to: Mr. Lance Hodahkwen,

Sr., M.P.H., IHS Reports Clearance

Officer, 12300 Twinbrook Parkway,

Suite 450, Rockville, MD 20852, 1601,

call non-toll free (301) 443–0461, fax

(301) 443–1522, or send your E-mail

requests, comments, and return address

to: lhodahkw@.ihs.gov.

Comment Due Date

Your comments regarding this

information collection are best assured

of having their full effect if received

within 60-days of the date of this

publications.