Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Notices 61825

Dated: October 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–30333 Filed 11–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Document Identifier: HCFA–R–94

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Medicaid

Sterilization Regulations 45 CFR 96.73,

42 CFR 441 subpart F and Consent

Form; Form No.: HCFA–R–94 OMB

0938–0481; Use: All Medicaid-eligible

individuals seeking sterilization are

required to sign the federally mandated

consent form, acknowledging that they

understand the benefits and risks of

sterilization, and have received oral

information concerning the sterilization

operation from the provider. Frequency:

Other (each time sterilization is sought);

Affected Public: Individuals or

Households; Number of Respondents:

112,526; Total Annual Responses:

112,526; Total Annual Hours: 140,658.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: October 6, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services,Information

Technology Investment Management

Group,Division of HCFA Enterprise

Standards.

[FR Doc. 97–30368 Filed 11–18–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–200]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Request: Revision

of a currently approved collection; Title

of Information Collection: HEDIS 3.0

(Health Plan Data and Information Set),

including the Health of Seniors and

Consumer Assessment of Health Plans

Study (CAHPS) surveys and supporting

regulations 42 CFR 417.470, and 42 CFR

417.126; Form Number: HCFA–R–200

(OMB #0938–0701); Use: HEDIS and

CAHPS will be used for 3 purposes: (1)

To provide summary comparative data

to the Medicare beneficiary to assist

them in choosing among health plans;

(2) to provide information to health

plans for internal quality improvement

activity; and (3) to provide HCFA, as

purchaser, information useful for

monitoring quality of and access to care

provided by the plans; Frequency:

Annually; Affected Public: Individuals

or Households, non-profit and for profit

HMOs which contract with HCFA to

provide managed health care to

Medicare beneficiaries; Number of

Respondents: 293,834; Total Annual

Responses: 293,834; Total Annual

Hours Requested: 181,520.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: October 21, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–30369 Filed 11–18–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Drug Accountability Record;

Submission of OMB Review; Comment

Request

SUMMARY: Under the provisions of

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

Reduction Act of 1995, the National

Cancer Institute, the National Institutes

of Health (NIH) has submitted to the

Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on July 10, 1997, page 37069

and allowed 60-days for public

comment. No public comments were

received. The purpose of this notice is

to allow an additional 30-days for

public comment. The National Institutes
61826 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Notices

of Health may not conduct or sponsor,

and the respondent is not required to

respond to, an information collection

that has been extended, revised, or

implemented on or after October 1,

1995, unless it displays a currently valid

OMB control number.

PROPOSED COLLECTION: Title: Drug

Accountability Record (NIH form 2564)

and Transfer Investigational Drug

Record (NIH form 2564–1). Type of

Information Collection Request:

Revision of a currently approved

collection, OMB No. 0925–0240,

Expiration Date 1/31/98. Need and Use

of Information Collection: Food and

Drug Administration (FDA) regulations

require investigators to establish a

record of the receipt, use and

disposition of all investigational agents.

The National Cancer Institute, NCI, as a

sponsor of investigational drug trails,

has the responsibility to assure the FDA

that investigators in its clinical trials

program are maintaining systems for

drug accountability. In order to fulfill

these requirements, a standard

Investigational Drug Accountability

Report Form (NIH 2564) was designed

to account for drug inventories and

usage by protocols. The Transfer

Investigational Drug Form (NIH 2564–1)

permits intra-institutional transfer of

drugs to other approved investigators for

other approved protocols. The data

obtained from the drug accountability

record will be used to keep track of the

dispensing of investigational anticancer

agents to patients. It is used by NCI

management to ensure that

investigational drug supplies are not

diverted for inappropriate protocol or

patient use. The information is also

compared to patient flow sheets

(protocol reporting forms) during site

visits conducted for each investigator

once every three years. All comparison

are done with the intention of ensuring

protocol, patient and drug compliance

for patient safety and protections.

Frequency of Response: Daily. Affected

Public: state or local governments,

businesses, or other for-profit, Federal

agencies or employees, non-profit

institutions, and small business or

organizations. Type of Respondents:

Investigators, pharmacist; nurses,

pharmacy technicians, data managers.

The annual reporting burden is as

follows: The annualized burden

estimate for record keeping is estimated

to require 3,650 hours for drug

accountability and 120 hours for drug

transfer. The annualized cost to the

respondents is estimated at $94,500.

The reporting burden is the average time

(4 minutes or 0.0666 hour) required to

complete the transfer investigational

drug form multiplied by the number of

forms completed annually. The record

keeping burden represents an average

time required for multiple entries (4

minutes or 0.0666 hour per entry) on the

drug accountability form, the average

number of forms maintained by each

record keeper and the number of record

keepers. These estimates are based on

the 36,500 items shipped by PMB and

the 1,200 items transfer approvals in

calendar year 1996. Cost estimates are

based upon burden hours at an average

cost of $25.00 per hour.

Drug Accountability Form:

No. Of Respondents—4560

No. Of responses per respondent—8

Average Burden per response—0.0666

Annual Burden hours—2430

Drug Transfer Form:

No. Of respondents—1200

No. Of responses per respondent—1

Average burden per response—0.0666

Annual Burden hours—80

Total Annualized Burden For Record

Keeping and Reporting: 2,510.

There are no Capital Costs, Operating

Costs, and/or Maintenance Cost to

report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’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 those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

Direct Comments To OMB

Written comments and/or suggestions

regarding the item(s) contained in this

notice, especially regarding the

estimated public burden and associated

response time, should be directed to the:

Office of Management and Budget,

Office of Regulatory Affairs, New

Executive Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. To request

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact Joseph

High, Head, Drug Management and

Authorization Section, Pharmaceutical

Management Branch, Cancer Therapy

Evaluation Program, Division Cancer

Therapy, Diagnosis, and Centers,

National Cancer Institute, Executive

Plaza North, Room 707, 9000 Rockville

Pike, Bethesda, MD 20892 or call nontoll-free number (301) 496–5725 or Email your request, including your

address to: JoeHigh@nih.gov.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before December 19,

1997.

Dated: November 12, 1997.

Nancie L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97–30322 Filed 11–18–97; 8:45 am]

BILLING CODE 4140–07–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of

Meeting of the Board of Scientific

Counselors

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Board of Scientific Counselors,

National Institute of Child Health and

Human Development, December 5,

1997, in Building 31, Room 2A52.

This meeting will be open to the

public from 8:00 a.m. to 12 noon on

December 5 for the review of the

Intramural Research Program and

scientific presentations. Attendance by

the public will be limited to space

available.

In accordance with the provisions set

forth in section 552b(c)(6), Title 5,

U.S.C. and section 10(d) of Public Law

92–463, the meeting will be closed to

the public on December 5 from 1:00

p.m. to adjournment of the review,

discussion, and evaluation of individual

programs and projects conducted by the

National Institutes of Health, including

consideration of personnel

qualifications and performance, the

competence of individual investigators,

and similar items, the disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy. Ms. Catherine O’Connor, Senior

Biomedical Research Program Assistant,

NICHD, Building 31, Room 2A50,

National Institutes of Health, Bethesda,

Maryland, 20892–2425, 301–496–2133,

will provide a summary of the meeting,

a roster of Board members, and

substantive program information upon

request. Individuals who plan to attend