27298 Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices

testimonials from consumers appearing

in the advertisements for Cholestaway

reflect the typical or ordinary

experience of members of the public

who use the product. The complaint

alleges that the respondents did not

have a reasonable basis for any of these

representations at the time they were

made.

The consent order contains provisions

designed to prevent the respondents

from engaging in similar acts and

practices in the future.

Part I of the order prohibits the

respondents from making the

representations challenged in the

complaint, unless they possess and rely

upon competent and reliable scientific

evidence that substantiates the

representation.

Part II prohibits respondents from

making any representations about the

efficacy, performance, safety or benefits

of any food, dietary supplement of drug

unless they possess and rely upon

competent and reliable scientific

evidence that substantiates the

representation.

Part III prohibits the respondents from

mispresenting the existence, contents,

validity, results, conclusions or

interpretations of any test, study, or

research.

Part IV prohibits the respondents from

representing that the experience

represented by a user testimonial or

endorsement of the product is the

typical or ordinary experience of users

of the product unless the representation

is substantiated or they disclose what

the generally expected results would be

or that consumers should not be expect

the same results.

Part V allows the respondents to make

respondentations for any drug that are

permitted in labeling for that drug under

any tentative final or final Food and

Drug Administration (‘‘FDA’’) standard

or under any new drug application

approved by the FDA.

Part VI allows the respondents to

make representations for any product

that are specifically permitted in

labeling for that product by regulations

issued by the FDA under the Nutrition

Labeling and Education Act of 1990.

Parts VII through X require the

respondents to keep copies of

advertisements making representations

covered by the order; to keep records

concerning those representations,

including materials that they relied

upon making the representations; to

provide copies of the order to certain of

the respondents’ personnel; to notify the

Commission of changes in corporate

structure; and to file complaint reports

with the Commission. Part XI provides

that the order will terminate after

twenty (20) years under certain

circumstances.

The purpose of this analysis is to

facilitate public comment on the

proposed order, and its is not intended

to constitute an official interpretation of

the agreement and proposed order or to

modify in any way their terms.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 98–13142 Filed 5–15–98; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: Financial Status Reporting Form

(SF–269) with Supplemental Form

(ADD–02) for Developmental

Disabilities Council Program.

OMB No.: 0980–0212.

Description: Developmental

Disabilities Council Program funds are

awarded contingent on fiscal

requirements in Part B of the

Developmental Disabilities Assistance

and Bill of Rights Act. The SF–269,

mandated in the revised OMB Circular

A–102, provides no breakouts necessary

for proper stewardship. The proposed

alternative would breakout the

necessary information, but would do so

in a consolidated manner that makes

reporting easier. It will allow proactive

compliance monitoring by the

Government to catch problems early.

Respondents: State, Local or Tribal

Government.

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of respondents per

respondent

Average burden hours per

response

Total burden

hours

ADD–02 ............................................................................................................ 55 2 90 990

Estimated Total Annual Burden Hours: 990

In Compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments 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)

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.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: May 13, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–13111 Filed 5–15–98; 8:45 am]

BILLING CODE 4104–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: Voluntary Surveys of Program

Partners to Implement Executive Order
Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices 27299

12862 in the Administration for

Children and Families.

OMB No. 0980–0266.

Description: Under the provisions of

the Federal Paperwork Reduction Act of

1995 (Pub. L. 104–13), the

Administration for Children and

Families (ACF) is requesting clearance

for instruments to implement Executive

Order 12862 within the ACF. The

purpose of the data collection is to

obtain customer satisfaction information

from those entities who are funded to be

our partners in the delivery of services

to the American public. ACF partners

are those entities that receive funding to

deliver services or assistance from ACF

programs. Examples of partners are

States and local governments,

territories, service providers, Indian

Tribes and Tribal organizations,

grantees, researchers, or other

intermediaries serving target

populations identified by and funded

directly or indirectly by ACF. The

surveys will obtain information about

how well ACF is meeting the needs or

our partners in operating the ACF

programs.

Respondents: State, Local, Tribal

Govt. or Not-for-Profit Institutions

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

State Governments ........................................................................................... 51 10 1 510

Head Start grantees & Delegates .................................................................... 200 1 .5 100

Other Discretionary Grant Programs ................................................................ 200 10 .5 1,000

Indian Tribes & tribal Organizations ................................................................. 25 10 .5 50

Estimated Total Annual Burden Hours: 1,660

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment in

the specific aspects of the information

collection described above. Copies of

the proposed collection of information

can be obtained and comments may be

forwarded by writing to the

Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments 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)

the qualify, utility, and clarify of the

information to be collected; and (d)

ways to minimize the burden of the

collection on information on

respondents, including through the use

of automated collection techniques or

other forms on information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: May 13, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–13112 Filed 5–15–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0513]

Agency Information Collection

Activities; Orphan Drugs: Submission

for OMB Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by June 17,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Orphan Drugs—21 CFR Part 316—

(OMB No. 0910–0167—Reinstatement)

Sections 525 through 528 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360aa through

360dd), give FDA statutory authority to:

(1) Provide recommendations on

investigations required for approval of

marketing applications for orphan

drugs; (2) designate eligible drugs as

orphan drugs; (3) set forth conditions

under which a sponsor of an approved

orphan drug obtains exclusive approval;

and (4) encourage sponsors to make

orphan drugs available for treatment on

an ‘‘open protocol’’ basis before the drug

has been approved for general

marketing. The implementing

regulations for these statutory

requirements have been codified under

part 316 (21 CFR part 316) and specify

procedures that sponsors of orphan

drugs use in availing themselves of the

incentives provided for orphan drugs in

the act and set forth procedures FDA

will use in administering the act with

regard to orphan drugs. Section 316.10

specifies the content and format of a

request for written recommendations

concerning the nonclinical laboratory

studies and clinical investigations

necessary for approval of marketing

applications. Section 316.12 provides

that, before providing such

recommendations, FDA may require

results of studies to be submitted for

review. Section 316.14 contains

provisions permitting FDA to refuse to

provide written recommendations under

certain circumstances. Within 90 days

of any refusal, a sponsor may submit

additional information specified by

FDA. Section 316.20 specifies the

content and format of an orphan drug