Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices 65273

approval of the revised State plan

preprint pages for Section 2.1,

Establishing Paternity and Securing

Support, Section 2.4, Collection and

Distribution of Support Payments,

Section 2.5, Services to Individuals Not

Receiving Title IV–A and IV–E Foster

Care Assistance, Section 2.8, Medical

Support Enforcement Activities, Section

2.12–16 State Law Authorizing

Suspension of Licenses, Section 2.12–

20, Adoption of Uniform State Laws,

and Section 3.16, Cooperation by

Applicants for and Recipients of Part A

Assistance. The information collected

on the State plan pages is necessary to

enable OCSE to monitor compliance

with the requirements in Title IV–D of

the Social Security Act and

implementing regulations.

Respondents: State governments.

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

State Plan ......................................................................................................................... 54 2.32 .717 90

Estimated Total Annual Burden

Hours: 90.

Additional Information: Copies of the

proposed collection may be obtained 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, Robert

Driscoll.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–32372 Filed 12–10–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0488]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

continuation of national surveys of

prescription drug information provided

to patients.

DATES: Submit written comments on the

collection of information by February 9,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(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(c) 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,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, 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.

Years 1998 and 2000 Continuation of

National Surveys of Prescription Drug

Information Provided to Patients—

(OMB Control Number 0910–0279—

Extension)

FDA implements the provisions of the

Federal Food, Drug, and Cosmetic Act

(the act), designed to assure the

adequate labeling of prescription (Rx)

drugs. Under section 502(a) of the act

(21 U.S.C. 352(a)), a drug product is

misbranded if its labeling is false or

misleading in any particular, and under

section 201(n) of the act (21 U.S.C.

321(n)), a drug’s labeling is misleading

if its labeling or advertising fails to

reveal material facts. FDA also has the

authority to collect this information

under Title VI of Pub. L. 104–180

(Related Agencies and Food and Drug

Administration) section 601 (Effective

Medication Guides), which directs the

development of ‘‘a mechanism to assess

periodically * * * the frequency with

which the [oral and written

prescription] information is provided to

consumers.’’

To assure that Rx drugs are not

misbranded, FDA has historically

asserted that adequate labeling requires

certain information be provided to
65274 Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices

patients. In 1982, when FDA revoked a

planned initiative to require mandatory

patient package inserts for all Rx drugs

in favor of private sector initiatives in

this area, the agency indicated that it

will periodically conduct surveys to

evaluate the availability of adequate

patient information on a nationwide

basis. Surveys of consumers about their

receipt of Rx drug information were

carried out in 1982, 1984, 1992, 1994,

and 1996. This notice is in regard to

continuing the survey in years 1998 and

2000.

The survey is conducted by telephone

on a national random sample of adults

age 18 and over who received a new

prescription for themselves or a

household member within the past 4

weeks. The interview assesses the extent

to which oral and written information

was received from the doctor, the

pharmacist, and other sources. Survey

respondents are also asked attitudinal

questions, and demographic and other

background characteristics are also

obtained. The survey enables FDA to

determine the frequency with which

such information is provided to

consumers. Without this information,

the agency would be unable to assure

that adequate Rx labeling and

information is provided.

Respondents to this collection of

information are adults (18 years or

older) in the continental United States

who have obtained one or more new

(nonrefill) prescriptions at a pharmacy

for themselves or a member of their

household in the last 4 weeks.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Year No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

1998 11,044 1 11,044 .03 331

1999 0 0 0 0 0

2000 11,044 1 11,044 .03 331

Annual average 7,363 7,363 221

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

Year No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

1998 1,000 1 1,000 .323 20

1999 0 0 0 0 0

2000 1,000 1 1,000 .32 320

Annual average 667 667 213

1There are no capital costs or operating and maintenance costs associated with this collection of information.

This estimate of 434 total annual

burden hours is based on the 1996

survey administration, in which 11,044

potential respondents were contacted to

obtain 1,000 interviews.

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32460 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0486]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

requirements governing the registration

of producers of drugs and listing of

drugs in commercial distribution.

DATES: Submit written comments on the

collection of information by February 9,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(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

1320.39(c) 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,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed